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I. C. MUNRO and J. J. Hlywka. CANTOX Health Sciences International, 2233 Argentia Rd., Ste. 308, Mississauga, ON L5N 2X7, Canada The premarket safety assessment of foods derived from biotechnology is both rigorous and science-based, incorporating a decision strategy that varies case-by-case with the trait. This premarket safety assessment is designed to identify endpoints of safety, critical to the acceptability of the food and provides sufficient information to estimate the likelihood of any adverse effects to consumers. Postmarket monitoring has not been used to support the safety or regulatory approval of food products, except in a few unique instances. The assessment of biotechnology-derived foods with enhanced nutritional characteristics may require additional consideration of exposure and intended positive effects on human health. However, the feasibility of identifying effects on human health must be derived from testable hypothesis and include appropriate biomarkers for measurement, along with accurate food consumption data. Current exposure assessment principles may be applied to postmarket monitoring of biotechnology-derived foods, but are dependent on the availability of adequate data to assess the fate of the product or commodity within the food supply, as well as requisite information on the consumption of relevant foods. Postmarket monitoring programs may be appropriate when specific hypotheses requiring directed investigation have been identified as a result of the premarket assessment that data generated from premarket studies are unable to address. For example, postmarket monitoring may be useful in certain instances where better estimates of dietary exposure and/or nutritional consequence of a biotechnology-derived food are required, when a potential safety issue cannot be adequately addressed through pre-market studies, to corroborate dietary intakes of a nutritionally improved food with effects on human health, or to monitor changes in dietary exposure resulting from the introduction of a nutritionally modified food.
Session 26, The safety and nutrional assessment of nutrionally improved crops
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