Determining indicators, methods and sites for monitoring potential adverse effects of genetically modified plants to the environment: the legal and conceptional framework for implementation (original) (raw)
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Environmental Biosafety Research, 2005
Genetically modified plants (GMPs) may soon be cultivated commercially in several member countries of the European Union (EU). According to EU Directive 2001/18/EC, post-market monitoring (PMM) for commercial GMP cultivation must be implemented, in order to detect and prevent adverse effects on human health and the environment. However, no general PMM strategies for GMP cultivation have been established so far. We present a conceptual framework for the design of environmental PMM for GMP cultivation based on current EU legislation and common risk analysis procedures. We have established a comprehensive structure of the GMP approval process, consisting of pre-market risk assessment (PMRA) as well as PMM. Both programs can be distinguished conceptually due to principles inherent to risk analysis procedures. The design of PMM programs should take into account the knowledge gained during approval for commercialization of a specific GMP and the decisions made in the environmental risk assessments (ERAs). PMM is composed of case-specific monitoring (CSM) and general surveillance. CSM focuses on anticipated effects of a specific GMP. Selection of case-specific indicators for detection of ecological exposure and effects, as well as definition of effect sizes, are important for CSM. General surveillance is designed to detect unanticipated effects on general safeguard subjects, such as natural resources, which must not be adversely affected by human activities like GMP cultivation. We have identified clear conceptual differences between CSM and general surveillance, and propose to adopt separate frameworks when developing either of the two programs. Common to both programs is the need to put a value on possible ecological effects of GMP cultivation. The structure of PMM presented here will be of assistance to industry, researchers, and regulators, when assessing GMPs during commercialization.
Journal für Verbraucherschutz und Lebensmittelsicherheit, 2006
A framework for the design of general surveillance during commercial cultivation of genetically modified (GM) crops according to current EU legislation 2001/18/EC is presented. The framework is based on a previously established concept for environmental post-market monitoring (PMM), which identified clear conceptual differences between case-specific monitoring (CSM) and general surveillance. While CSM focuses on anticipated effects of a specific GM crop, general surveillance is designed to detect unanticipated effects on the environment. Two separate frameworks are proposed for developing either of the two programmes. Considering its focus, general surveillance has to be based both on the subjects of environmental concern (safeguard subjects) that should not be adversely affected by GM crop cultivation and on the environmental quality that should be preserved therein. Unanticipated effects in the defined safeguard subjects may be detectable by using existing monitoring networks and by establishing appropriate reporting systems. Results from general surveillance can, however, not be linked to any specific attribute of GM crop cultivation, and causality to environmental damages will have to be determined via specific risk assessement studies. The proposed structure for general surveillance represents a pragmatic approach to a realistic and feasible PMM programme and will be of assistance to industry, researchers, and regulators when assessing GM crops during commercialisation.
Entomologia, 2014
The environmental impacts of genetically modified crops is still a controversial issue in Europe. The overall risk assessment framework has recently been reinforced by the European Food Safety Authority (EFSA) and its implementation requires harmonized and efficient methodologies. The EU-funded research project AMIGA − Assessing and monitoring Impacts of Genetically modified plants on Agro-ecosystems − aims to address this issue, by providing a framework that establishes protection goals and baselines for European agro-ecosystems, improves knowledge on the potential long term environmental effects of genetically modified (GM) plants, tests the efficacy of the EFSA Guidance Document for the Environmental Risk Assessment, explores new strategies for post market monitoring, and provides a systematic analysis of economic aspects of Genetically Modified crops cultivation in the EU. Research focuses on ecological studies in different EU regions, the sustainability of GM crops is estimated by analysing the functional components of the agro-ecosystems and specific experimental protocols are being developed for this scope.
Environmental Sciences Europe, 2011
Background, aim and scope: According to the Directive 2001/18/EC, genetically modified plants [GMPs] have to be monitored for unintended ecological impacts during their release. Detrimental effects on the biodiversity of agro-ecosystems represent a prime focus of such a monitoring. Although cropping of GMPs has already been permitted in the European Union, the establishment of appropriate monitoring networks lags behind. Here, we provide an overview on Biodiversity-Nature-Safety [BINATS], one of the first national monitoring programs specifically designed and implemented to accompany and survey GMP effects on the biodiversity of agricultural landscapes.
This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six steps for the ERA of GM plants, as indicated in Directive 2001/18/EC, starting with (1) problem formulation including hazard identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The scientific Panel on Genetically Modified Organisms (of the European Food Safety Authority (EFSA GMO Panel) considers seven specific areas of concern to be addressed by applicants and risk assessors during the ERA (1) persistence and invasiveness of the GM plant , or its compatible relatives, including plant-to-plant gene transfer ; (2) plant-to-microorganism gene transfer; (3) interaction of the GM plant with target organisms and (4) interaction of the GM plant with non-target organisms, including criteria for selection of appropriate species and relevant functional groups for risk assessment; (5) impact of the specific cultivation, management and harvesting techniques; including consideration of the production systems and the receiving environment(s); (6) effects on biogeochemical processes; and (7) effects on human and animal health. Each specific area of concern is considered in a structured and systematic way following the above-mentioned steps (1 to 6). In addition, the guidance document is supplemented with several general cross-cutting considerations (e.g. choice of comparator, receiving environment(s), general statistical principles, long-term effects) that need to be considered in the ERA.
A tiered system for assessing the risk of genetically modified plants to non-target organisms
Environmental biosafety research
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 i...
Journal für Verbraucherschutz und Lebensmittelsicherheit, 2007
Within the legal frameworks regulating post-market monitoring (PMM) of genetically modified (GM) crops, both notifier and regulatory authorities have to decide whether an observed environmental effect is relevant, i. e. whether the effect is considered to represent an environmental damage and therefore requires corrective action. Given that presently there is no consensus on applicable criteria to valuate 'environmental damage', notifier and regulatory authorities are facing a number of challenges when being confronted to environmental decisionmaking related to PMM of GM crops. In the present paper, we argue that these challenges mainly have two causes. First, there are methodological limits in data collection and analysis, which in turn challenge decisions whether the observed effects fulfil the proposed criteria for environmental damage. Second, scientific data is valued controversially due to differing value judgement on the environmental entities that should not be affected by the cultivation of GM crops. We analyse both challenges and propose potential perspectives how they could be addressed.
EFSA Journal, 2014
Following a request from the European Commission, a set of assessment criteria was developed to support the selection of existing environmental surveillance networks for post-market environmental monitoring (PMEM) of genetically modified plants (GMPs). In compliance with these criteria, some networks and associated programmes were identified as being of potential use subject to further caseby-case analysis. When considering PMEM of GMPs, the approach would also require comparing sites monitored by the networks and the locations where GMPs are cultivated. The reporting of the sites surveyed by networks and locations of cultivated GMPs should thus follow the same standards in order to ensure interoperability and to potentially establish a causal link between a change observed and the GMPs. In this respect, technical support might be required by networks to transform their data records into workable standards. Moreover, the EFSA GMO Panel was asked by the European Commission to examine the sensitivity of statistical analyses used by the networks to detect change. A decision tree is provided for selecting the optimal method for statistical analysis based on the study design and the datasets from networks. Sufficient statistical power needs to be ensured to detect an effect for a particular indicator. Sample size is one of the main contributing factors in determining the power of any network to detect an effect of a product release into the environment. Increasing the sample size implies variable extra-costs depending on whether data are collected by volunteers or professionals. A more powerful statistical analysis can also be achieved by pooling datasets collected by different networks; this needs further investigation because of important covariates leading to differentiated responses. In general, PMEM would benefit from a move towards 'open data' policies for re-analysis or pooling data collected by different networks.