Recommendations for Assessing Human Dietary Exposure to Newly Expressed Proteins in Genetically Modified Crops

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Abstract or Summary

Risk assessment of genetically modified (GM) crops includes an evaluation of hazard and exposure to newly expressed crop constituents, exemplified herein by newly expressed proteins (NEPs). Guidance directing dietary exposure assessments (DEAs) is limited and/or globally inconsistent. Best practices for conducting DEAs are presented and include a preliminary problem formulation step to determine if a formal DEA is necessary to support the risk assessment. If a formal DEA is deemed necessary, the type of exposure (acute or chronic) and the availability of food consumption data relevant to the targeted population should be identified. Exposure should be estimated initially using a simple, straight-forward, and fit-for-purpose DEA (unrefined DEA) approach while ensuring relevance to the risk question. Unrefined assessments, which are very likely to overestimate exposure, provide a high level of protection to consumers of GM crops. If refinement of the DEA is necessary, then the simplest refinements that meet the needs of the risk assessment should be implemented. DEAs are not scientifically necessary for NEPs in GM crops if a hazard has not been identified, since risk is a function of both hazard and exposure. Nonetheless, dietary exposure assessments are sometimes required for regulatory purposes, and this publication outlines some key best practices and considerations for their conduct.

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Recommendations for Assessing Human Dietary Exposure to Newly Expressed Proteins in Genetically Modified Crops (held on an external server, and so may require additional authentication details)

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