Safety Assessment Tools for Assessing Unintended Effects Prior to Commercialization


Current voluntary and mandated safety assessment approaches focus primarily on intended and predictable effects of novel components of GE foods. Introduction of novel components into food through genetic engineering can pose unique problems in the selection of suitable comparators for the analytical procedures that are crucial to the identification of unintended compositional changes. Other jurisdictions, particularly the European Union, evaluate all GE food products prior to commercialization, but exempt from similar evaluation all other GM foods. As is discussed in Chapter 3, the policy to assess products based exclusively on their method of breeding is scientifically unjustified.

The most appropriate time for safety assessment of all new food is in the premarket period prior to commercialization, although verification of safety assessments may continue in the postmarket period, generally in cases when a potential problem has been identified or if there is elevated cause for concern. Examples of specific premarket assessments of newly introduced compositional changes to selected GE food are:

  • protein, fat, carbohydrate, fiber, ash, and water in a proximate analysis;

  • essential macro- and micronutrients in a nutritional analysis;

  • known endogenous toxicants and antinutrients in specific species;

  • endogenous allergens;

  • other naturally occurring, species-specific constituents of potential interest, such as isoflavones and phytoestrogens in soybean or alkaloids in tomato or potato;

  • gross agronomic characteristics;

  • data derived from domestic animal feeding trials to assess the nutritional quality of new crops; and

  • data derived from toxicological studies in animals.

Recommendation 2

The committee recommends that the appropriate federal agencies determine if evaluation of new GM foods for potential adverse health effects from both intended and unintended compositional changes is warranted by elevated concern, such as identification of a novel substance or levels of a naturally occurring substance that exceeds the range of recommended or tolerable intake.

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