Genetically Modified Foods:

Experts View Regimen of Safety Tests as Adequate, but FDA's Evaluation Process Could Be Enhanced

GAO-02-566: Published: May 23, 2002. Publicly Released: May 23, 2002.

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Genetically modified foods pose the same risks to human health as do other foods. These risks include allergens, toxins, and compounds known as antinutrients which inhibit the absorption of nutrients. Before marketing a genetically modified food, company scientists seek to determine whether these foods pose any heightened risks. The Food and Drug Administration (FDA) published guidelines in 1992 to ensure that companies worked with the agency to assess the safety of genetically modified foods. GAO found that FDA's evaluation process could be enhanced by randomly verifying the test data provided and by increasing the transparency of the evaluation process, including communicating more clearly the scientific rationale for FDA's final decision on an assessment of genetically modified food. Scientists expect that genetic modifications will increasingly enhance the nutritional value of genetically modified foods. Although current tests have been adequate for evaluating the few genetically modified foods that have, so far, undergone relatively simple compositional changes, new technologies are being developed to evaluate the increasingly complex compositional changes expected. Monitoring the long-term health risks of genetically modified foods is generally neither necessary nor feasible. No scientific evidence exists, nor is there even a hypothesis, suggesting that long-term harm, such as higher cancer rates, results from these foods. Moreover, technical challenges make long-term monitoring infeasible.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: To enhance FDA's safety evaluations of GM foods, the Deputy Commissioner of Food and Drugs should direct the agency's Center for Food Safety and Applied Nutrition to obtain, on a random basis, raw test data from companies, during or after consultations, as a means of verifying the completeness and accuracy of the summary test data submitted by companies.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Open

    Comments: FDA told GAO that it continues to believe that the recommendation to conduct random audits could be useful. However, in view of resource constraints and competing priorities, FDA has not yet been able to conduct such an audit yet.

    Recommendation: To enhance FDA's safety evaluations of GM foods, the Deputy Commissioner of Food and Drugs should direct the agency's Center for Food Safety and Applied Nutrition to expand its memos to file recording its decisions about GM foods to provide greater detail about its evaluations of the foods, including the level of evaluation provided, the similarity of the foods to foods previously evaluated, and the adequacy of the tests performed by the submitting companies.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: FDA has taken actions to make memos to file more detailed as GAO recommended.

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