Public consultation on the draft guidance document for the environmental risk assessment of genetically modified plants

EFSA’s GMO Panel has published for public consultation a draft guidance document for the environmental risk assessment of genetically modified plants.

This document provides the most recent update guidance document 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 GMOs. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. In first instance, the EFSA GMO Panel describes the 6 steps for the ERA of GM plants, as described in Directive 2001/18/EC, starting with i) a problem formulation including hazard identification; ii) hazard and iii) exposure characterisation; iv) risk characterisation; v) risk management strategies and vi) an overall risk evaluation. The EFSA GMO Panel considered 7 specific areas of concern to be addressed by applicant and/risk assessors during its evaluation i) the potential persistence or invasiveness of the plant itself, or of its wild relatives, addressed by a “staged approach” including a figure outlining the approach; ii) plant to micro-organisms gene transfer; iii) potential interaction of the GM plant with target organisms and iv) with non-target organisms including criteria for selection of appropriate NTO species selection and relevant functional groups; v) potential impact of the specific cultivation, management and harvesting techniques including the consideration of the production systems and the receiving environment(s); vi) effect of biogeochemical processes and vii) potential effects on human and animal health. Each specific area of concern is developed in a structured and systematic way through the 6 above mentioned steps. In addition, the EFSA GMO Panel supplemented its guidance document with several general cross-cutting considerations (e.g. choice of comparator, receiving environments, general statistical principles, long-term effects) that need to be considered during the ERA of the GM plant. 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 of GM plants.

In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and all stakeholders, EFSA has launched a public consultation on the draft guidance document developed by the EFSA GMO Panel.

Interested parties are invited to submit written comments by 30 April 2010. Please use exclusively the electronic template provided with the documents to submit comments and refer to the line and page numbers. Please note that comments submitted by e-mail or by post cannot be taken into account and that a submission will not be considered if it is:

• submitted after the deadline set out in the call,
• presented in any form other than what is provided for in the instructions and template,
• not related to the contents of the document,
• contains complaints against institutions, personal accusations, irrelevant or offensive statements or material,
• is related to policy or risk management aspects, which is out of the scope of EFSA's activity.

After completion of the public consultation, a summary report of the comments will be prepared and published.

In addition, please note that:

• repeated comments received from the same contributor will appear in the report only once,
• comments submitted by individuals acting in a personal capacity will be published anonymously,
• comments submitted formally on behalf of an organisation will appear with the name of the organisation.

EFSA will assess all relevant comments from interested parties which are submitted in line with the above criteria. The comments will be evaluated by the relevant unit and taken into consideration where they enhance the scientific quality of the documents. Following this procedure, EFSA will publish the relevant comments received, as well as a short report on the outcome of the consultation.