Public consultations on the draft ERA guidance document and the draft scientific opinion on the assessment of impacts on non-target organisms

On 5 March 2010, EFSA’s GMO Panel has published a draft guidance document for the environmental risk assessment of GM plants and a draft scientific opinion on the assessment of potential impacts of GM plants on non-target organisms.

The draft Guidance Document and the draft scientific opinion are now open for public consultation. The deadline for public comments is 30 April 2010.

Background to the update of the ERA Guidance Document:
In January 2008, EFSA received a mandate from the European Commission (Directorate-General Environment) to update the Guidance Document for the environmental risk assessment of GMOs. The mandate includes four specific tasks

1. Non-target organisms:
1. Development of criteria for the selection of non-target organisms and representative species thereof, focusing on arthropods and other invertebrates, and also considering other relevant organisms in different trophic levels;
2. Selection and recommendation of appropriate methods to study the potential effects of GM plants on these non-target organisms.
2. Development of criteria for field trials to assess the potential ecological effects of the GM plants in receiving environments;
3. Identification of the EU geographic regions where the GM plants may be released and the selection of representative receiving environments.
4. Selection of appropriate techniques to assess potential long-term effects of GM plants.

In addition to these four tasks the update of the ERA Guidance Document will include:

• Update of all sections in light of experience gained with the previous assessment of applications and recent scientific developments;
• The outcome of the EFSA colloquium “ERA of GM plants – challenges and approaches” (Clicke here for more information);
• The guidance for GM stacked events will be included into individual sections of the ERA Guidance Document.

To update the ERA Guidance Document EFSA has established several working groups:

• Sub Working Group Environment ERA Guidance Document: this group coordinates the activities. To see the members and their declaration of interests click here.
• Self-task Working group on Statistics: this group is responsible for field trial design. To see the members and their declaration of interests click here.
• Self-task Working group on non-target organisms: this group deals with the selection of non-target organisms, the methods to study these organisms, the design of field trials to study the potential effects on non-target organisms and receiving environments. To see the members of this working group and their declaration of interests click here.

Furthermore EFSA has consultated Member States and stakeholders to discuss the update of the ERA Guidance Document. A report of the consultation workshop between EFSA and Member States can be found here.