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t4* Report: A roadmap for hazard monitoring and risk assessment of marine biotoxins on the basis of chemical and biological test systems

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Mardas Daneshian1, Luis M. Botana2, Marie-Yasmine Dechraoui Bottein3,**, Gemma Buckland4, Mònica Campàs5, Ngaire Dennison6, Robert W. Dickey7, Jorge Diogène5, Valérie Fessard8, Thomas Hartung1,9, Andrew Humpage10, Marcel Leist1,11, Jordi Molgó12, Michael A. Quilliam13, Costanza Rovida1, Benjamin A. Suarez-Isla14, Aurelia Tubaro15, Kristina Wagner16, Otmar Zoller17, and Daniel Dietrich1,18
1 Center for Alternatives to Animal Testing – Europe (CAAT-Europe), University of Konstanz, Konstanz, Germany;
2 Department of Pharmacology, Faculty of Veterinary Sciences, USC-Campus de Lugo, Lugo, Spain;
3 National Oceanic and Atmospheric Administration – Center for Human Health Risk, Hollings Marine Laboratory, Charleston, SC, USA;
4 Humane Society International, Washington, DC, USA;
5 IRTA, Marine Monitoring and Food Safety Subprogram, Sant Carles de la Ràpita, Spain;
6 Home Office, Animals in Science Regulation Unit, Dundee, UK;
7 FDA Center for Food Safety & Applied Nutrition, Division of Seafood Science & Technology, Dauphin Island, AL, USA;
8 French Agency for Food, Environmental and Occupational Health & Safety, Laboratory of Fougères, Fougères Cedex, France;
9 Johns Hopkins University, Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA;
10 Australian Water Quality Centre, Adelaide, Australia;
11 Doerenkamp-Zbinden Chair of in-vitro toxicology and biomedicine, University of Konstanz, Germany;
12 CNRS, Institut de Neurobiologie Alfred Fessard, Gif-sur-Yvette Cedex, France;
13 National Research Council of Canada, Measurement Science and Standards, Halifax, Canada;
14 Universidad de Chile, Facultad de Medicina, Santiago de Chile, Chile;
15 University of Trieste, Department of Life Science, Trieste, Italy;
16 German Animal Welfare Federation, Animal Welfare Academy, Neubiberg, Germany;
17 Swiss Federal Office of Public Health, Consumer Protection Directorate, Food Safety Division, Bern, Switzerland;
18 Chair of Human and Environmental Toxicology, University of Konstanz, Germany


Aquatic food accounts for over 40% of global animal food products, and the potential contamination with toxins of algal origin – marine biotoxins – poses a health threat for consumers. The gold standards to assess toxins in aquatic food have traditionally been in vivo methods, i.e., the mouse as well as the rat bioassay. Besides ethical concerns, there is also a need for more reliable test methods because of low inter-species comparability, high intra-species variability, the high number of false positive and negative results as well as questionable extrapolation of quantitative risk to humans. For this reason, a transatlantic group of experts in the field of marine biotoxins was convened from academia and regulatory safety authorities to discuss future approaches to marine biotoxin testing. In this report they provide a background on the toxin classes, on their chemical characterization, the epidemiology, on risk assessment and management, as well as on their assumed mode of action. Most importantly, physiological functional assays such as in vitro bioassays and also analytical techniques, e.g., liquid chromatography coupled mass spectrometry (LC-MS), as substitutes for the rodent bioassay are reviewed. This forms the basis for recommendations on methodologies for hazard monitoring and risk assessment, establishment of causality of intoxications in human cases, a roadmap for research and development of human-relevant functional assays, as well as new approaches for a consumer directed safety concept.


Keywords: marine biotoxins, risk assessment, consumer protection, regulatory toxicology



ALTEX 30(4), 487–545

DOI: 10.14573/altex.2013.4.487

* a report of t4 – the transatlantic think tank for toxicology, a collaboration of the toxicologically oriented chairs in Baltimore, Konstanz and Utrecht sponsored by the Doerenkamp-Zbinden Foundation; participants do not represent their institutions and do not necessarily endorse all recommendations made.

** new address: International Atomic Energy Agency – Environment Laboratories, 4 Quai Antoine Ier, Monaco

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