products of biotechnology will involve the application of sections 402(a)(1) or 409 of FFDCA (see US Congress 1958, sections 342(a)(1) and 348, respectively).

Section 402(a)(1) does not subject new food products to premarket approval but does establish a safety standard that can come into play depending on the circumstances presented by a given food or food constituent. The section is FDA's primary enforcement tool for regulating the safety of whole foods, including foods derived from genetically modified plants. Any person who introduces food into interstate commerce is responsible for ensuring that the food does not run afoul of the provisions of section 402(a)(1). Under FFDCA, FDA is authorized to seize adulterated food, enjoin its distribution, and prosecute persons responsible for its distribution (US Congress 1958, sections 332-334).

Under the safety standard of section 402(a)(1), food is considered to be adulterated if it contains any substance that occurs unexpectedly in food at a level that may be “injurious to health”. Those substances include naturally occurring toxicants whose levels are unintentionally increased by genetic modification and unexpected toxicants that appear in the food for the first time. The policy provides guidance to the food industry in the form of flowcharts and other instructions regarding scientific approaches to evaluating the safety of foods derived from new plant varieties, including the safety of added substances that are subject to section 402(a)(1). Perhaps most important, FDA encourages voluntary consultations between producers and agency scientists to discuss relevant safety concerns.

Section 409 of FFDCA provides for the regulation of “food additives”, defined broadly as including any substance “the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component of food …and which is not generally recognized as safe” for such use (US Congress 1958, section 321(s)). A food additive must be approved by FDA before being used in food. The statutory mechanism for securing agency approval is the submission of a food additive petition, which must contain data and information that show a reasonable certainty that the additive will be safe for its intended use. The petition is subject to public notice and comment.

The 1992 policy acknowledges that, in some cases, whole foods derived from new plant varieties, including plants developed by new genetic techniques, might fall within the scope of section 409. It is the transferred genetic material and the intended expression product of that material in the plant that could be subject to food additive regulation if such material or expression product is not generally recognized as safe (GRAS). FDA has rarely had occasion to review the GRAS status of foods derived from conventionally bred plants, because these foods have been



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