The following is an article from SeedQuest on the outcomes of the recent meetings of EFSA around environmental risk assessments and GM plants. Attached are several supporting documents including: public consultation and scientific opinion docs and reports from stakeholder meetings in December of 2009.
June 17, 2010
EFSA scientists held a day of discussions with experts from Member States on the newest scientific developments and approaches to assess possible environmental risks from genetically modified (GM) plants. Experts in the field of environmental risk assessment of GM plants from Member State authorities and members of GMO Panel Working Groups reviewed a guidance document outlining how EFSA carries out its environmental risk assessment (ERA) of GM plants and the data requirements which must be met by applicants.
Participants at the technical meeting held in Berlin discussed comments made by Member States following a public consultation on the draft EFSA guidance document as well as a draft scientific opinion addressing the specific issue of non-target organisms (NTOs). The meeting was webcastlive on EFSA’s website.
EFSA’s GMO Panel continuously seeks to ensure that its risk assessment approach reflects the scientific state-of-the-art in its guidance to applicants It regularly reviews all its guidance documents on GM plants with updates made in 2005, 2006 and 2008. Since 2007, the GMO Panel has been further developing and strengthening its environmental risk assessment (ERA) which is now the subject of the separate guidance document discussed in Berlin. This focuses on potential long-term environmental effects, the potential effects on non-target organisms, and criteria for setting up field trials, taking into account the diverse environments where the GM plant will be cultivated.
”The ERA should follow a step-by-step approach, according to the clearly defined framework laid out in the guidance. Each GMO is unique and must be assessed individually. This requires specific evaluation of the plant, its traits, how it will be used and its possible interactions with the receiving environment,” said Professor Salvatore Arpaia, chair of the GMO Panel’s Working Group on Non-Target Organisms.
When carrying out their assessment, independent experts of EFSA’s GMO Panel use their extensive knowledge and wide experience in evaluating the data provided by applicants as well as all other available scientific literature.
More than 250 comments were received from Member States during the public consultation of the draft ERA guidance. At the meeting, EFSA experts explained specific areas which have to be addressed by applicants and experts carrying out the risk assessment. These include: the possibility of gene transfer between the plant and micro-organisms, the potential invasiveness of the plant itself; the plant’s potential effects on: human and animal health, including both target and non-target organisms; and the implications for cultivation, management and harvesting techniques.
With respect to non-target organisms (NTOs), the draft opinion of the GMO Panel sets out proposals on the criteria for the selection of NTOs and advice on testing methodology. EFSA’s Working Group on NTOs considered the impact of GM plants on invertebrates and also took account of ecosystems that could be altered.
This meeting follows technical discussions during the preparation of the ERA and NTO opinions held last year with Member States and stakeholders such as applicants, environmental groups and non-governmental organisations.
EFSA works closely with Member States in the environmental risk assessment of GMOs; for instance, for cultivation applications for GM plants, an initial environmental risk assessment is carried out by one Member State, which can be assisted by and share expertise with other Member States.
EFSA engages in dialogue with Member States and takes into consideration comments they may have. The discussions at the Berlin meeting will help inform EFSA’s GMO Panel and its Working Groups in view of finalising the documents which are due to be adopted and published by November 2010.
All supporting documents of the Berlin meeting will be published on EFSA’s website as will a written report and video recording of the meeting.
- Agenda (0.1 Mb) http://www.efsa.europa.eu/en/gmomeetings/docs/gmo100617-a.pdf
- Table of Member States and stakeholders comments received during the public consultation on the Guidance Document of the EFSA GMO Panel on ERA of GM plants (1.2 Mb) http://www.efsa.europa.eu/en/gmomeetings/docs/gmo100617-ax01.pdf
- Table of Member States and stakeholders comments received during the public consultation on the Scientific opinion of the EFSA GMO Panel on Non-Target Organisms (0.2 Mb) http://www.efsa.europa.eu/en/gmomeetings/docs/gmo100617-ax02.pdf