Public consultation on the draft scientific opinion on the assessment of potential impacts of genetically modified (GM) plants on non-target organisms (NTOs)

EFSA’s GMO Panel has published for public consultation a draft scientific opinion on the assessment of potential impacts of genetically modified (GM) plants on non-target organisms (NTOs).

The aim of the scientific opinion is to produce a scientific review of the current guidance of the GMO Panel for Environmental Risk Assessment (ERA), focusing on the potential impacts of GM plants on Non-Target Organisms (NTOs); to propose criteria for NTOs selection, and to provide advice on standardized testing methodology. This initiative was undertaken in response to a need and request from a wide range of stakeholders, including the European Commission, Member States and applicants. The GMO Panel considered the necessity for clear and objective protection goals, for which assessment and measurement endpoints should be developed; the need to initiate the scientific risk assessment by setting testable hypotheses; criteria for appropriate selection of test species and ecological functional groups; appropriate laboratory and field studies to collect relevant NTO data; and the use of statistical techniques that should be an integral part of experimental design. The GMO Panel considered the range of approaches and methodologies of ERA of NTOs as described in the current literature and proposed risk assessment approaches based on selection of functional groups and individual species within a tiered approach. The present scientific opinion provides guidance to risk assessors for assessing potential effects of GM plants on NTOs, together with rationale for data requirements in order to complete a comprehensive ERA for NTOs. In this respect, conclusions and guidance to applicants as outlined in the present opinion have been integrated into the draft updated Guidance Document of the EFSA GMO Panel for the ERA of GM plants (under public consultation in parallel to this document).

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 opinion 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.

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.