euro-toxicology-2016_scientifictracks-abstracts

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Volume 6, Issue 6(Suppl) J Clin Toxicol 2016
ISSN: 2161-0495, JCT an open access journal
Page 127
Notes:
Euro Toxicology 2016
October 24-26, 2016
conferenceseries.com
Toxicology & Applied Pharmacology
October 24-26, 2016 Rome, Italy
7th Euro-Global Summit on
Proposed criteria for the evaluation of the scientific quality of mandatory rat and mouse feeding
trials with whole food/feed derived from genetically modified plants
Kerstin Schmidt1, Janine Döhring 2, Christian Kohl3, Maria Pla4, Esther J. Kok5, Debora C.M. Glandorf 6, René Custers7, Hilko van der Voet8, Jutta
Sharbati9 , Ralf Einspanier9, Dagmar Zeljenková10, Jana Tulinská10, Armin Spök11, Clare Alison12, Dieter Schrenk13 , Annette Pöting14 , Ralf Wilhelm3,
Joachim Schiemann3, Pablo Steinberg2
1BioMath GmbH, Germany
2University of Veterinary Medicine Hannover, Germany
3Julius Kühn Institute (JKI), Germany
4Universitat de Girona (UDG), Spain
5Wageningen University and Research Centre, The Netherlands
6National Institute for Public Health and the Environment/ Centre for Safety of Substances and Products, The Netherlands
7VIB (Flanders Institute for Biotechnology), Belgium
8Wageningen University and Research Centre, The Netherlands
9Freie Universität Berlin, Germany
10Slovak Medical University, Slovakia
11Alpen-Adria Universität Klagenfurt, Austria
12Roger Alison Ltd., United Kingdom
13University of Kaiserslautern, Germany
14Federal Institute for Risk Assessment, Germany
In recent years, animal feeding trials conducted with whole food/feed have been a focal issue in the controversy on the
safety assessment of genetically modified (GM) plants and derived food/feed. Within the scientific community and among
stakeholders, quite different views have been expressed on how these studies should be conducted, analysed and interpreted,
what they might add in terms of information relevant to safety and whether 90-day rodent feeding trials should be mandatory.
In the context of the ongoing debate on GMO risk assessment in Europe, it is crucial to investigate: Criteria for evaluating the
scientific quality of subchronic, chronic toxicity and carcinogenicity studies with whole food/feed in rats and mice. This will
help risk assessors in evaluating this type of studies when provided in the course of a pre-market risk assessment and will create
a basis for further general debate. This talk specifically addresses the question on how to evaluate whole GM food/feed feeding
trials. It does so by proposing a list of key quality criteria for the evaluation of 90-day and extended feeding trials with whole
food/feed derived from GM plants. The proposed quality criteria should be taken into account when evaluating a feeding trial
in the frame of an application to regulatory bodies and are not intended to be applied in other cases in which a feeding trial is
performed to answer a specific open question in basic research.
Biography
Kerstin Schmidt completed her University degree in Mathematics with specialisation in Statistics and Probability Theory. In 1990, she established her own company
BioMath, an internationally operating consultancy for research institutions and industrial partners in statistics and informatics, especially in the life sciences. She
has been accompanying more than 100 projects in Toxicology, several of them joint/ international projects. She works as a Lecturer for Statistics and Experimental
Design at the University of Rostock. In April 2016, she submitted her Doctoral thesis entitled “Statistical aspects and methods of the risk assessment and post-
market environmental monitoring of genetically modified plants”.
Kerstin Schmidt et al., J Clin Toxicol 2016, 6:6(Suppl)