April 2, 2008
Source: European Food Safety Authority (EFSA)
Each GM
plant grown in the European Union has to
undergo an extensive environmental risk
assessment to anticipate and, if possible,
to identify any adverse effect it may have
on the environment. The information provided
by an applicant must also include data
covering several seasons of field growing
trials so that any possible adverse effects
on the environment can be detected. So far
only one type of GM plant, the GM Maize MON
810 which is resistant against the European
corn borer, is cultivated in some countries
of the EU.
In addition, each GM application has to be
accompanied by an environmental monitoring
plan demonstrating how the applicant will
monitor the GMO product with annual and
longer term reporting on any possible and
unexpected adverse environmental impact.
This monitoring plan will also provide
important information for the 10-year
renewal assessment for a GMO application.
Once an authorisation is given by the
European Union for a GMO, it must be
reassessed again after a 10-year period in
order to maintain its authorisation on the
market.
In parallel to the evaluation process for GM
applications, EFSA has continued to update
its scientific approach to environmental
risk assessment. EFSA organised for example
a
Scientific colloquium on Environmental Risk
Assessment in June 2007 with leading
experts in the field from Europe and beyond.
The Colloquium considered various approaches
to environmental risk assessment in the
light of current scientific thinking on
issues, such as long-term effects and
adverse impact on non-target organisms such
as insects. EFSA has also developed further
work on Post Market Environmental Monitoring
which, after a public consultation, resulted
in the publication of a specific guidance
document.
Based on this work and feedback received at
a
meeting with Member States on GMO risk
assessment approaches in November 2007,
EFSA’s GMO Panel will continue to develop
its approach to environmental risk
assessment through a self-task activity on
so-called “Non-target Organisms”. This will
consist of further developing guidance for
assessing potential adverse effects that the
GM plants might have on non-target
organisms, such as insects (e.g.
butterflies, beetles), not targeted by the
specific insect-resistant trait expressed by
the GM plant. Many GMOs are developed to be
resistant to certain weeds or pests which
are referred to as “target organisms”.
Non-target organisms would be those plants
or animals which are affected
unintentionally by a GMO resulting in an
undesired effect on plants or animals in the
environment.
At the same time, EFSA has also discussed
and accepted a complementary mandate from DG
Environment of the European Commission.
Under this mandate, EFSA will further update
the current GMO Panel’s Guidance Document
and will also cover some of the issues
discussed during EFSA’s colloquium on
environmental risk assessment. More
specifically, the mandate will cover issues,
such as potential long-term environmental
effects and the development of criteria for
setting up field trials to assess
environmental impact. EFSA “self-tasking”
Working Group on statistics and experimental
design will assist in this. EFSA’s GMO Panel
will complete this work over the next 24
months.
General mandate: update of EFSA guidance on
environmental assessment of GMOs