July 31, 2009
The
European
Food Safety Authority (EFSA) has
published a new opinion aimed at harmonising
how data from field trials carried out for
the risk assessment of GM plants and derived
food and feed are produced and analysed. The
objective of the document is to contribute
to greater transparency in the risk
assessment of GMOs and also to allow for a
more rapid evaluation of applications.
The experts on EFSA’s GMO Panel put forward
some general rules on minimum requirements
for the design of field trials aimed at
ensuring more accurate statistical
evaluation of the safety of GM plants. As
with all guidance, the document may well be
updated in the future in the light of
experience and development of scientific
knowledge.
The opinion listed a set of recommendations
covering elements such as the number of
sites where experiments should be carried
out, growing seasons and the geographical
spread. In addition, it highlighted some
statistical aspects which will benefit from
further research, such as the possibility of
assessing simultaneously many
characteristics of the GM plant. EFSA’s
experts also specified that the principles
proposed in the opinion may be used, in
certain cases, for the evaluation of GMOs
other than plants.
EFSA’s risk assessment of genetically
modified organisms (GMO) is based on the
comparison of the GMO products with their
non-GM counterparts. The equivalence between
the two must be within the range of
variations that would occur between two
non-GMO organisms in nature.
The opinion, entitled “Statistical
considerations for the safety evaluation of
GMOs”, is the product of over two years’
work and capitalises on the experience of
EFSA in the evaluation of GMO applications
under EU regulations. The initial version of
the document was open for public
consultation during a 2 month period, from
July to September 2008; this allowed the
consideration of 98 submissions from various
stakeholders.
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Statistical
considerations
for the
safety
evaluation
of GMOs
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Scientific Documents
Source: http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902768517.htm Statistical considerations for the safety evaluation of GMOs(1) - EFSA Panel on Genetically Modified Organisms (GMO)(2) (3) (4)Question number: EFSA-Q-2006-080
Adopted: 21 April 2009
Opinion (0.6Mb) SummaryThe European Food Safety Authority (EFSA) asked its Panel on Genetically Modified Organisms (GMO) to investigate whether more detailed guidance could be provided regarding the performance of field trials and the analysis of data using appropriate statistical models, with the objective of ensuring a more uniform approach and greater transparency in risk assessment of GMOs. In order to carry out this investigation, the GMO Panel has convened a dedicated statistics Working Group who addressed the issue. A draft document was published on EFSA website from 21 July 2008 until 21 September 2008 for a 2-month period of public consultation. At the deadline EFSA had received 98 submissions, from 9 stakeholders. The table of all received comments together with a summarized response to the most relevant ones is published on the EFSA web site. Following the public consultation, the original document has been revised taking into account all the scientific comments that helped enhancing scientific quality and clarity. The present opinion is the final outcome of this exercise. Report on the outcome of the public consultation (0.3Mb)
Published: 31 July 2009
[1] On request of EFSA,
Question No EFSA-Q-2006-080;
adopted on 21 April 2009.
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