Safety of food biotechnology products

Abstract

In 2008, 125 million hectares of agricultural crops developed using modern biotechnology were grown in 25 countries. The safety of foods derived from these rDNA plants is evaluated according to a framework adopted by the Codex Alimentarius Commission (Codex). The Codex was established in 1962 under the World Health Organization and Food and Agricultural Organization to establish standards of safety and to ensure fair practices in trade for food. In 1999 the Codex directed a special Task Force to develop standards and guidelines for the safety of foods derived from biotechnology. The resulting documents on risk analysis, the plant guideline for food safety assessment, and accompanying annex on allergenicity assessment of new proteins were adopted by Codex in 2003. The approach to food safety assessment differs from that used for conventional food additives and pesticides. Foods such as rice, corn, soybeans and other whole foods are composed of complex mixtures of chemicals and as such do not lend themselves to traditional toxicological approaches to food safety assessment. Instead, a paradigm developed previously in OECD (referred to as substantial equivalence) and further elaborated by a 2000 FAO/WHO Expert Consultation was adopted that relies upon molecular biological, chemical, and nutritional data that permit a comparison to be made between the new rDNA plant variety and a conventional counterpart. The safety of the intended modification(s), i.e., newly expressed proteins, are assessed for similarities to known toxins and allergens. Nutritional modifications, if any, are assessed for potential effects on the overall diet. The approach also includes steps to reduce the likelihood of unintended effects that would adversely affect health of consumers. A new rDNA variety must be shown to have the expected key nutrients, toxicants, and anti-nutrients within the range of concentrations that has been typical of safely consumed conventional varieties. Thus, any new proteins or other new substances in the new variety must be shown to be safe and the food derived from that variety must not be altered in a manner that would adversely affect health. The goal is to establish that food derived from the new variety is as safe as its conventional counterpart food. This approach, which has been adopted internationally, provides a robust, scientifically-based means to assess the safety for human consumption of foods derived from rDNA plants. Foods that pass this assessment are as safe as their counterpart foods and pose no unique hazards for consumers.