Task Force on the Use of Mammalian Toxicology Studies in the
Safety Assessment of GM Foods
Background
The safety assessment for human consumption of foods/feeds derived from genetically modified (GM) crops typically considers the potential health effects from any introduced protein(s), the safety of the intended changes (e.g., improved nutrition), and the possible unintended effects attributable to the process of genetic modification within the context of expected consumption. Safety assessment includes an evaluation of whether there is a history of safe consumption of the protein or structurally/functionally related proteins, bioinformatics searches to determine if the protein has homology to known toxins or allergens; characterization of the biochemical mode of action and specificity; and digestibility by enzymes, pH and, sometimes, heat or other processing.1 Assessing the safety of whole foods derived from GM crops is generally conducted by comparing the agronomic properties, composition, and nutritional value of the GM crops and food/feed to that of conventional crops and food/feed.
Acute and/or repeated dose mammalian toxicity studies with the transgenic proteins and subchronic feeding studies with the whole GM food or processed fraction(s) are sometimes conducted to provide additional confirmatory information.1 However, there is no international consensus on when these studies are needed; which studies are most appropriate; their design; and how their results studies should be used. The issues is being addressed by the Task Force and expert panel. The need for additional guidance and a more uniform approach to the design and analysis of these studies has recently been acknowledged by European Food Safety Authority (EFSA)2 and EFSA has taken on the task of developing a protocol for 90-day feeding trials for whole food/feed3
.
Task Force Plan of Action
The Task Force assembled an international panel of scientific experts to develop consensus recommendations on when it is scientifically appropriate to conduct mammalian toxicity studies with genetically modified proteins and/or foods and how to best design and use such studies in the safety evaluation. A draft of the monograph will be discussed with the Organization for Economic Cooperation and Development (OECD) Novel Food Task Force delegates in a workshop. The discussion will inform the final manuscript.
Impact
The Task Force’s work will facilitate international harmonization on the appropriate use of mammalian toxicity studies in the safety assessment of GM foods.
Expert Panelists
Sue Barlow, Independent Consultant, UK
Andrew Bartholomeaus, Food Standards Australia New Zealand
Genevieve Bondy, Health Canada
Bertrand Degallier, OECD observer
Hideaki Karaki, FSA, Japan
John Kough, US Environmental Protection Agency
Li Ning, China Center for Disease Control
Flavio Zambrone, Planitox
Task Force Members
BASF
Bayer CropScience
Dow AgroSciences
Monsanto Company
Pioneer Hi-Bred, A DuPont Company
Syngenta Biotechnology Corporation
Leadership
Daland Juberg, Dow AgroSciences, Chair
1. Delaney et al. (2008). Evaluation of Protein Safety in the Context of Agricultural Biotechnology. Food and Chemical Toxicology. doi:10.1016/j.fct.2008.01.045
2. EFSA. 2008. Safety and Nutritional Assessment of GM Plants and derived food and feed: The role of animal feeding trials. Food and Chemical Toxicology 46 (2008) S2–S70. (redirects to EFSA)
3. Minutes of the 39th Plenary Meeting of the EFSA Scientific Committee, 17 November 2009 (redirects to EFSA)