When Does Similar Mean the Same: A Case for Relaxing Standards of Substantial Equivalence in Genetically Modified Food Crops

Abstract

Plant genetic engineering is rapidly moving from theory to application. Transgenic tomatoes (Lycopersicon esculentum Mill.), potatoes (Solanum tuberosum L.), cotton (Gossypium hirsutum L.), corn (Zea mays L.), soybeans [Glycine max (L.) Merrill], and other crop plants are now being commercially produced and sold. As useful genes are identified and technical knowledge is advanced, an expanding number of crop plants will be genetically modified. This technology has the potential to help solve numerous production and marketing problems common to horticultural crops. Unfortunately, the high cost of developing genetically engineered cultivars may limit the use of this technology in minor-use horticultural crops. These costs come from numerous developmental activities, including basic genetic research, field testing, meeting regulatory requirements, marketing, and public relations work. Improving almost any crop is technically possible; however, unless these costs are minimized, neither private companies nor publicly funded research programs will be able to afford to use these genetic advances for improvement of most horticultural crops. Thus, this technology will not help the majority of horticultural producers solve problems and meet increasingly stringent environmental policies. Meeting federally mandated regulations for food and environmental safety is one of the major costs of developing genetically modified cultivars. The content of these regulations is still in a state of flux. In the future, they may become more stringent, or may be modified, or even removed, as definitive data and experience show safety issues to be of little or no concern to the public. This latter trend is already occurring with respect to field testing and production. Over the past several years, field testing has become much simpler as the U.S. Dept. of Agriculture/ Animal and Plant Health Inspection Service (APHIS) and the Environmental Protection Agency (EPA) have relaxed standards for handling genetically engineered plant materials. However, food safety-related