positional changes arise with all forms of genetic modification, including genetic engineering. Whether such compositional changes result in unintended health effects is dependent upon the nature of the substances altered and the biological consequences of the compounds. To date, no adverse health effects attributed to genetic engineering have been documented in the human population.

Recommendation 1

The committee recommends that compositional changes that result from all genetic modification in food, including genetic engineering, undergo an appropriate safety assessment. The extent of an appropriate safety assessment should be determined prior to commercialization. It should be based on the presence of novel compounds or substantial changes in the levels of naturally occurring substances, such as nutrients that are above or below the normal range for that species (see Chapter 3), taking into account the organism modified and the nature of the introduced trait.

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 previously 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 inter-

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