The European Food Safety Authority (EFSA) has published updated guidance on the post-market environmental monitoring (PMEM) of GM plants. The document expands on previous EFSA guidance provided in this area, further strengthening the requirements that applicants must fulfil for the environmental monitoring of GM plants authorised for placement on the EU market. It also makes recommendations for risk managers to improve the way PMEM data are collected and reported in the EU. As with all EFSA guidance documents on genetically modified organisms (GMOs), the Authority engaged in consultation at different stages during its development with Member States and a broad range of stakeholders.
Under EU legislation, applications for the cultivation of GM plants must contain a detailed PMEM plan demonstrating how the GM plant will be monitored for possible adverse effects on human health and the environment. This monitoring is a key feature of the legislative framework on GM plants and, taken together with environmental risk assessment and risk management, forms an important part of the cycle of measures in place to detect and limit possible adverse effects, including those that may occur over a long period of time. EFSA assesses the results of PMEM for GM plants on a yearly basis and makes recommendations to the European Commission to improve the PMEM plan for future years and to conclude about the GM plant’s ongoing safety.
Post-market environmental monitoring of GM plants is comprised of two components. The first is ‘General Surveillance’ and must be carried out in all cases where a GM plant is approved in the EU. It intends to detect unanticipated adverse effects of GM plants and focuses on different aspects of environmental protection such as the conservation of flora and fauna, soil quality and the sustainability of agro-ecosystems. EFSA’s updated guidance document outlines the different tools to be used for General Surveillance, including comprehensive advice on the design and analysis of farmer questionnaires and recommendations on the use of existing biodiversity monitoring networks at Member State level that are relevant for monitoring of GM plants.
Alongside applicants, risk managers also play an important role in the implementation of General Surveillance. The updated guidance document recommends that General Surveillance is considered by Member States as part of general environmental protection monitoring taking place within the EU. In this respect, it proposes that reporting centres are established at a national level to better integrate and harmonise PMEM data collection.
The second component of PMEM is ‘Case-Specific Monitoring’ (CSM) and must be carried out when, in the original Environmental Risk Assessment (ERA) of a GM plant, EFSA identifies a potential risk or level of uncertainty (or both) that can be mitigated during cultivation but nevertheless needs to be monitored on an ongoing basis. For example, in carrying out the ERA, an applicant may identify a potential risk from the exposure of a species of insects to a certain toxin produced by the GM plant that cannot be fully predicted or determined from existing studies or scientific literature. In this instance, specific monitoring is required to confirm assumptions made in the ERA and to assist in the evaluation of the ERA throughout the life-cycle of the GM plant. EFSA’s updated guidance document on PMEM outlines requirements for the statistical design of CSM plans and gives examples of objectives and approaches to monitor identified risks or uncertainties (or both).
EFSA considered it necessary to update its 2006 PMEM guidance in light of the recent update to its guidance on ERA, published in November 2010. On its own initiative, and as part of its commitment to ensuring that unanticipated or long-term environmental effects are taken into consideration when carrying out GM plant risk assessment, EFSA offered its technical support to the European Commission with respect to PMEM activities. In October 2010, EFSA received a mandate from the European Commission to update its 2006 PMEM guidance.
The present updated guidance was informed by the experience of EFSA’s GMO Panel in assessing previous GM plant applications and by comments submitted from stakeholders and interested parties during a period of public consultation. EFSA also held a dedicated session at the second meeting of the EFSA Scientific Network for Risk Assessment of GMOs (Parma, 9 /10 July 2011) with representatives from Member States asked to discuss their contributions to the public consultation.
Environmental Risk Assessment (ERA) is a scientific process that considers the impact on the environment caused by, for example, the introduction of GM plants, the use of certain substances in food, feed and plant protection products or the introduction and spread of plant pests. Companies seeking market approval for GM plants must submit an environmental risk assessment with their original application that is assessed by EFSA alongside the risk assessment for human and animal health of food and feed derived from the GM plant. PMEM is carried out in countries where the GM plant is grown and the collected monitoring data are evaluated by EFSA on a yearly basis. Based on this evaluation, EFSA makes recommendations to the European Commission to improve the PMEM plan for future years and to conclude on the GM plant’s ongoing safety.