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).
The ERA of GM plants involves generating, collecting and assessing information on a GM plant in order to determine its impact on human/animal health and the environment relative to non-GMOs, and thus assessing its relative safety.
The present document provides guidance to risk assessors for assessing potential effects of GM plants into the environment and the rationales for data requirements in order to complete a comprehensive ERA, and to draw conclusions for the post-market environmental monitoring (PMEM).
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.