A new era in environmental risk assessment

What was the issue?

Environmental Risk Assessment (ERA) is a specialised field of science that considers the impact on the environment caused by, for example, the introduction of GM plants, the use of certain substances in food and feed products or the spread of plant pests.

In the case of GM plants, the current law requires that GM plant developers carry out an ERA and submit it as part of their application for authorisation on the EU market. EFSA is responsible for evaluating this assessment and makes recommendations to risk managers such as the European Commission (EC) and Member States about the environmental safety of the GM plant in question.

The ERA has to be performed in line with EFSA guidance, which gives GM plant developers clear instructions for this type of assessment according to the stringent requirements in EU legislation related to the deliberate release of GMOs into the environment. In 2008, the EC asked EFSA to update its guidance to applicants on the ERA of GM plants.

ERA of GM plants is an area which generates significant scientific and political debate with a wide divergence of opinions among both non-governmental and institutional stakeholders across Europe. Although EFSA has no part to play in the political process concerning the authorisation of GM plants in the EU, in updating its guidance the Authority sought to ensure that all relevant views from stakeholders and interested parties were considered.

What did EFSA do?

In summer 2009, as a first step, EFSA held a three-day consultative workshop in Berlin to share its preliminary work on the guidance and to give stakeholders the opportunity to discuss their views and concerns directly with the EFSA GMO Panel. Further stakeholder input was sought towards the end of 2009 during a two-day European conference on “GMO risk assessment for human and animal health and the environment”. A large part of the event was dedicated to discussing the Authority’s ongoing work on the guidance and presentations were given by Member State experts, environmental NGOs and industry associations. Particular areas of interest were the effects of GM plants on non-target organisms and the long-term environmental impact of GM plants, including how they are monitored if they are approved for cultivation.

The extensive stakeholder feedback gathered through these events was, where scientifically relevant, incorporated by the GMO Panel into its draft ERA guidance document. This was launched for public consultation at the beginning of 2010 and attracted a large number of comments. Key contributors to the consultation were invited by EFSA to take part in technical meetings, giving the GMO Panel the opportunity to hear again directly from interested parties, including those with differing points of view. Following these technical meetings, the GMO Panel finalised the guidance document which was eventually published in November 2010.

What was the impact?

Whilst unanimous agreement amongst all stakeholders on the ERA guidance was unlikely to be achieved, the extensive consultation allowed differing views and opinions to be heard by the GMO Panel and considered in the development of the document. In particular, the series of technical meetings also gave stakeholders and interested parties the opportunity to discuss scientific issues directly with Panel members and to understand more about the possibilities and limitations of the pre-market ERA for GM plants.

The guidelines are the result of two years’ work by scientists from all over Europe and demonstrate EFSA’s commitment to stay at the forefront of recent developments in the area of GM plant environmental risk assessment.

The guidance has recently been complemented by further EFSA guidelines on post-market environmental monitoring (PMEM). Monitoring is a key feature of the legislative framework on GM plants and, taken together with a rigorous pre-market 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.

Following publication of the ERA guidance, the European Commission began discussions with Member State authorities to consider it as a basis for expanding the legally binding provisions in the GMO legislation for environmental risk assessment. EFSA continues to support the Commission with scientific and technical advice during this process.