EFSA Lays Out New Assessment Guidelines for GM Crops

Scientific experts on EFSA’s GMO Panel have updated and further developed its guidance for the environmental assessment of GM applications submitted for authorisation in the EU, in particular with respect to data generation, collection and analysis.

15 Nov 2010 --- The European Food Safety Authority (EFSA) has published updated guidance for the environmental risk assessment (ERA) of Genetically Modified (GM) plants, reflecting the scientific state-of-the-art in this field.

Scientific experts on EFSA’s GMO Panel have updated and further developed its guidance for the environmental assessment of GM applications submitted for authorisation in the EU, in particular with respect to data generation, collection and analysis. The ERA guidance document also addresses the evaluation of possible long-term effects of GM plants and potential effects on non-target organisms (NTOs). This guidance implements the stringent requirements for the environmental risk assessment of GMOs as provided by Directive 2001/18/EC on the deliberate release of GMOs in the environment.

The European Commission requested EFSA in 2008 to further develop and update its guidance on environmental risk assessment,enabling EFSA to build on the work it had initiated in this area in 2007.

In accordance with the conclusions of the Environment Council of December 2008, Member States and stakeholders were closely associated with the review of this guidance. EFSA organised a series of technical discussions on the guidance document with representatives of EU Member States, with non-governmental organisations (NGOs) and with GM applicants to exchange views on the scientific issues. A draft version of the ERA guidance was also launched earlier this year for public consultation which received 494 comments.

In order to assess the safety of a GM plant submitted for authorisation in the European Union, EFSA requires all applicants to follow its guidance documents which specify the type of data and information that should be submitted. In the ERA guidance, EFSA reviewed and updated seven specific areas that need to be addressed when assessing the environmental impact of a GM plant. These include in particular the persistence and invasiveness of the GM plant, taking into account possible plant-to-plant gene transfer; the likelihood and consequences of gene transfer from the plant to micro-organisms; the potential evolution of resistance in target organisms; the potential effects on non-target organisms; the biogeochemical processes, such as changes in soil composition, and the potential impact of the cultivation, management and harvesting techniques of the GM plant.

According to the guidance, the ERA should be carried out in a scientifically sound manner based on available scientific and technical data and on common methodology for the identification, gathering and interpretation of the relevant data. Tests, and measurements, and data generated should be clearly described as well as the assumptions made during the ERA. In addition, the use of scientifically sound modelling approaches could provide further useful information for the ERA. Sufficient scientific data must be available in order to arrive at qualitative/quantitative risk estimates.

The ERA should follow a step-by-step assessment approach. The EFSA GMO Panel 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.

Each risk assessment begins with problem formulation in which the most important questions that merit detailed risk characterisation are identified. Problem formulation helps to make the risk assessment process transparent by explicitly stating the assumptions underlying the risk assessment. At the end, the overall risk evaluation should result in informed qualitative and, if possible, quantitative advice to risk managers, outlining the nature and magnitude of uncertainties associated with the identified risks. The implications of the risk assessment for risk management measures should also be assessed.

The EFSA GMO Panel considers that seven specific areas of concern should 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-micro-organism gene transfer; (3) interaction of the GM plant with target organisms; (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).

The ERA should follow a weight-of-evidence approach considering intended and unintended effects.

The ERA should be carried out on a case-by-case basis, meaning that the required information may vary depending on the type of the GM plants and trait(s) concerned, their intended use(s), and the potential receiving environment(s). Information for ERA can be collected via (1) field-generated data (from field trials, field surveys, semi-field trials, and/or agronomic field trials), (2) molecular characterisation data, (3) compositional data, (4) ecotoxicological testing, (5) modelling, and/or (6) desk and literature studies.

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.

The scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) proposes a step-wise selection process of relevant receiving environments to be addressed for ERA of a GM plant in question. Applicants should follow general statistical principles as outlined in this document. If experimental studies are being used they should allow testing for difference and equivalence. The EFSA GMO Panel also provides statistical guidance for specification of effect size, limits of concern, power analysis, experimental design, analysis and reporting. Recommendations are given how to address uncertainty.

The assessment of long-term effects requires specific information sources and techniques, including experimental or theoretical methodologies, and recommendations for establishing relevant baseline information. Further, GM plants containing stacked events are considered with respect to specific areas of risk.