Safety of Genetically Engineered Foods Approaches to Assessing Unintended Health Effects (2004) / Chapter Skim
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7 Framework, Findings, and Recommendations
7 Framework, Findings, and Recommendations
Pages 175-188
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From page 175... ...
However, the products of this technology are not always distinguishable from other methods of genetic modification. Moreover, application of any technique to produce altered levels of or novel food components can result in unintended compositional changes that may in turn result in an adverse health effect.
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From page 176... ...
176 SAFETY OF GENETICALLY ENGINEERED FOODS Newly Modified Organism Are new or enhanced levels of a potentially hazardous compound present, and/or are levels of beneficial compounds reduced? YES OR UNKNOWN FIGURE 7-1 Flowchart for determining potential unintended effects from genetically modified foods.
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From page 177... ...
However, there are limitations to the application of this framework -- or any other -- because technological advances in analytical chemistry have exceeded our ability to interpret the consequences to human health of changes in food composition. Although compositional changes can be detected readily in food, and the power of profiling techniques is rapidly increasing our ability to identify compositional differences between GE food products and their conventional counterparts, methods for determining the biological relevance of these changes and predicting unintended adverse health effects are understudied.
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From page 178... ...
The following examples illustrate how newly modified organisms would proceed through the process presented in the flow chart, using hypothetical scenarios to illustrate the application of various approaches. In the routine breeding process of crossing -- for example, when one wheat variety is crossed with another to transfer a disease resistance gene -- the resulting variety is genetically modified, but the desired trait that is obtained is not anticipated to be new to the species or to the food supply.
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From page 179... ...
Health outcomes could be associated with the presence or absence of specific substances added or deleted using genetic modification techniques, including genetic engineering, and with unintended compositional changes. The likelihood that an unintended compositional change will occur can be placed on a continuum that is based on the method of genetic modification used (see Figure 3-1)
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From page 180... ...
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.
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From page 181... ...
· 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.
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From page 182... ...
. 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)
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From page 183... ...
with its conventional counterpart indicate they are compositionally very similar, exposure to novel components remains very low. Thus the process of identifying unintended compositional changes in food is best served by combining premarket testing with postmarket surveillance, when compositional changes indicate that it is warranted, in a feedback loop that follows a new GM food or food product long-term, from development through utilization (see Figure 7-1)
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From page 184... ...
· Utilize existing nationwide food intake and health assessment surveys, including NHANES, to: -- Collect comparative information on diet and consumption patterns of the general population and ethnic subgroups in order to account for anthro pological differences among population groups and geographic areas where GM foods may be consumed in skewed quantities, recognizing that this will be possible only under selected circumstances where intakes are not evenly distributed across population subgroups of interest and the relevant outcome data are available, and -- Provide better representation of the long-term nutritional and other health status information on a full range of children and ethnic groups whose intakes may differ significantly from those of the general population to de termine whether changes in health status have occurred as a consequence of consuming novel substances or increased levels of naturally occurring com pounds in GM foods released into the marketplace, recognizing again that this will be possible only under selected circumstances that allow one to assess associations between skewed eating patterns and specified health out comes. Such associations would have to be followed up by other more con trolled assessments.
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From page 185... ...
Recommendation 6 A significant research effort should be made to support analytical methods technology, bioinformatics, and epidemiology and dietary survey tools to detect health changes in the population that could result from genetic modification and, specifically, genetic engineering of food. Specific recommendations to achieve this goal include: · Focusing research efforts on improving analytical methodology in the study of food composition to improve nutrient content databases and increase understanding of the relationships among chemical components in foods and their relevance to the safety of the food.
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From page 186... ...
Nevertheless, substantial gaps remain, including our ability to: · identify compositional changes in food and other complex mixtures, · determine the precise chemical structure of more than a small number of compounds in a tissue, · determine the structure-function relationships between compounds in food and their relevance to human health, and · predict and assess the potential outcome of unintended changes in food on human health. In consideration of the advances and limitations to available analytical techniques, the committee developed an appropriate paradigm for: · identifying appropriate comparators, · increasing understanding of the determinants of compositional variability,
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From page 187... ...
The recommendations presented in this chapter reflect the committee's application of the framework it has developed to questions of identification and assessment of unintended adverse health effects from foods produced by all forms of genetic modification, including genetic engineering and they can serve as a guide for evaluation of future technologies.
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