FDA's policy on GMOs


I. Background and Overview of Policy


New methods of genetically modifying plants are being used to develop new varieties that will be sources of foods. These methods, including recombinant DNA techniques and cell fusion techniques, enable developers to make genetic modifications in plants, including some modifications that would not be possible with traditional plant breeding methods. This policy discusses the safety and regulatory status of foods derived from new plant

varieties, including plants developed by the newer methods of genetic modification.

In most cases, the substances expected to become components of food as a result of genetic modification of a plant will be the same as or substantially similar to substances commonly found in food, such as proteins, fats and oils, and carbohydrates. As discussed in more detail in section V.C., FDA has determined that such substances should be subject to regulation under section 409 of the act in those cases when the objective characteristics of the substance raise questions of safety sufficient to warrant formal premarket review and approval by FDA. The objective characteristics that will trigger regulation of substances as food additives are described in the guidance section of this notice (section VII.).

This policy statement reflects FDA's current judgment based on the new plant varieties now under development in agricultural research. FDA invites comments on this document. Because scientific developments in this field are occurring rapidly, FDA will refine its policy, if circumstances warrant, in a future Federal Register notice. Additionally, FDA plans to announce in a future Federal Register notice aworkshop to discuss specific scientific issues. FDA invites comment on topics that might be addressed at such a workshop.

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