Recommendation 3

For those foods warranting further evaluation, the committee recommends that a safety assessment should be conducted prior to commercialization and continued evaluation postmarket where safety concerns are present. Specifically, the committee recommends the following safety assessment actions.

  • Develop a paradigm for identifying appropriate comparators for GE food.

  • Collect and make publicly available key compositional information on essential nutrients, known toxicants, antinutrients, and allergens of commonly consumed varieties of food (see the Research Needs section, later in this chapter). These should include mean values and ranges that typically occur as a function of genetic makeup, differences in physiological state, and environmental variables.

  • Remove compositional information on GE foods from proprietary domains to improve public accessibility.

  • Continue appropriate safety assessments after commercialization to verify premarket evaluations, particularly if the novelty of the introduced substance or the level of a naturally occurring substance leads to increased safety concerns.

Analytical Methodologies


During the past decade, analytical methodologies for separating and quantifying messenger ribonucleic acids, proteins, and metabolites have improved markedly. Applying these methodologies to the targeted analysis of known nutrients and toxicants will improve the knowledge base for these food constituents. The broad application of targeted methods and continuing development of profiling methods will provide extensive information about food composition and further improve the knowledge base of defined chemical food constituents. The knowledge and understanding needed to relate such compositional information to potential unintended health effects is far from complete, however. Furthermore, currently available bioinformatics and predictive tools are inadequate for correlating compositional analyses with biological effects.

Analytical profiling techniques are appropriate for establishing compositional differences among genotypes, but they must also take into account modification of the profile obtained due to genotype-by-environmental interactions (the influence of the environment on expression of a particular genotype). The knowledge base required to interpret results of profiling methods, however, is insufficiently developed to predict or directly assess potential health effects associated with unintended compositional changes of GM food, as is the necessary associative information (e.g., proteomics, metabolomics, and signaling networks). Additionally, predictive tools to identify the expected behavior of complex and compound

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