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A Case for Relaxing Standards of Substantial Equivalence in Genetically Modified Food Crops Stephen L

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A Case for Relaxing Standards of Substantial Equivalence in Genetically Modified Food Crops Stephen L FEATURE When Does Similar Mean the Same: A Case for Relaxing Standards of Substantial Equivalence in Genetically Modified Food Crops Stephen L. Love1 University of Idaho, Aberdeen Research and Extension Center, Aberdeen, ID 83210-0530 Plant genetic engineering is rapidly mov- regulations have remained as strict or stricter present great possibilities for rapidly ing from theory to application. Transgenic than those initially adopted. improving the quantity and quality of food tomatoes (Lycopersicon esculentum Mill.), In the United States, three federal agencies available. The use of these techniques does potatoes (Solanum tuberosum L.), cotton are responsible for regulating genetically not result in food which is inherently less safe (Gossypium hirsutum L.), corn (Zea mays modified organisms, APHIS, EPA, and the than that produced by conventional means.” L.), soybeans [Glycine max (L.) Merrill], and Food and Drug Administration (FDA). The Assuming this is true, there should be little other crop plants are now being commer- role of APHIS, under the Plant Quarantine concern for the safety of foods derived from cially produced and sold. As useful genes are Act, is to ensure that modified organisms do genetically modified plants. However, identified and technical knowledge is ad- not become weedy or pestilent. The EPA caution is wise when utilizing any new tech- vanced, an expanding number of crop plants regulates only organisms that have pesticidal nology. For this reason, confirming food will be genetically modified. This technol- activity and assures environment safety with safety is a critical part of the science of ogy has the potential to help solve numerous respect to the specific pesticidal gene creating improved plant cultivars through production and marketing problems com- product. The FDA becomes involved if a biotechnology, especially in the early stages mon to horticultural crops. Unfortunately, modified organism is to be used as food and of consumer acceptance. However, certain the high cost of developing genetically engi- oversees all food safety issues. It is respon- elements of the current use of the substantial neered cultivars may limit the use of this sible for determining that foods from geneti- equivalence concept add extensive develop- technology in minor-use horticultural crops. cally modified crops are both safe and nutri- mental costs to genetically modified food These costs come from numerous develop- tionally adequate. In Canada, Health and crops. The present interpretation of substan- mental activities, including basic genetic re- Welfare Canada is responsible for regulating tial equivalence dictates that the level of any search, field testing, meeting regulatory re- all aspects of genetically modified organisms measurable constituent in a genetically quirements, marketing, and public relations destined for food use. Agriculture Canada modified cultivar must be similar or equal to work. Improving almost any crop is techni- regulates organisms associated with that in the cultivar from which it was derived. cally possible; however, unless these costs agriculture that are not destined for food use. Under this definition, there is no limit to the are minimized, neither private companies This paper discusses a concept known as number of constituents that must be mea- nor publicly funded research programs will substantial equivalence as it relates to safety sured. For any crop the number that could be be able to afford to use these genetic ad- and nutrition, and consequently, includes the considered nutritionally and toxicologically vances for improvement of most horticul- areas of regulation that fall under the juris- important is immense. If plants from every tural crops. Thus, this technology will not diction of FDA and Health and Welfare transformation event must be analyzed for help the majority of horticultural producers Canada. every imaginable constituent, using samples solve problems and meet increasingly strin- Substantial equivalence is the concept es- from multiple sites and years, developmental gent environmental policies. tablished by a joint committee of the Food costs will skyrocket. For this reason, a bal- Meeting federally mandated regulations and Agricultural Organization (FAO) and ance must be struck between ensuring food for food and environmental safety is one of World Health Organization (WHO) and safety and holding costs to a level that allows the major costs of developing genetically adopted by regulatory agencies in the United this technology to add to food availability. modified cultivars. The content of these regu- States and Canada, as well as in Europe, as a The immediate need is to answer two impor- lations is still in a state of flux. In the future, guide to assess the safety status of food crops tant questions about establishing substantial they may become more stringent, or may be developed via biotechnology (FAO/WHO, equivalence: 1) What is the appropriate modified, or even removed, as definitive data 1991). In current practice, establishing comparative standard within a crop? 2) What and experience show safety issues to be of substantial equivalence involves confirma- are the critical constituents to be analyzed for little or no concern to the public. This latter tion that nutritional composition (meaning any given crop? trend is already occurring with respect to natural toxicants and nutritional components) I believe that the concept of substantial field testing and production. Over the past of genetically modified food crops is similar equivalence is an appropriate one for several years, field testing has become much to or identical with that of the original, unal- evaluating genetically modified crop plants, simpler as the U.S. Dept. of Agriculture/ tered crops from which they were derived. if substantial equivalence is appropriately Animal and Plant Health Inspection Service Because introduction of cultivars of defined. Establishing substantial equivalence (APHIS) and the Environmental Protection genetically modified crops into the food chain for specific prioritized constituents of Agency (EPA) have relaxed standards for is a recent phenomenon, procedures to be genetically modified cultivars is important. handling genetically engineered plant used in establishing substantial equivalence For each crop these critical constituents will materials. However, food safety-related are still being developed. This evolution differ. The thesis of this paper is that ap- includes both identification of acceptable plication of standards for establishing comparatives and generation of lists of key substantial equivalence should be similar to Received for publication 23 July 1999. Accepted compositional constituents. guidelines historically used in traditional for publication 22 Nov. 1999. Manuscript number A 1991 FAO/WHO report states that, breeding and that a limited number of impor- 99717 of the Idaho Agricultural Experiment Station. “Biotechnology has a long history of use in tant constituents can be predetermined for The cost of publishing this paper was defrayed in part by the payment of page charges. Under postal food production and processing. It represents most crops. Having had considerable experi- regulations, this paper therefore must be hereby a continuum embracing both traditional ence with potatoes, I will use this crop as an advertisement solely to indicate this fact. breeding techniques and the latest techniques example, to illustrate the principles I feel 1Research Professor. E-mail address: slove@ based on molecular biology. The newer bio- should dictate the determination of substan- uidaho.edu technological techniques, in particular, tial equivalence. HORTSCIENCE, VOL. 35(5), AUGUST 2000 803 FEATURE EARLY PROCEDURAL as part of the definition of substantial equiva- The range of variability for these same PRECEDENCE lence will provide some flexibility in the constituents among genetically modified po- process of cultivar improvement through bio- tatoes derived from a single cultivar falls Early efforts to establish substantial technology, with little or no change in the within much narrower confines. This is dem- equivalence for genetically modified pota- nutritional value of the overall potato food onstrated by a summary of 1992 trials with toes were closely scrutinized by both re- crop. ‘Russet Burbank’ derived clones transformed search groups and regulatory agencies. Con- A review of 257 release documents for with a Bacillus thuringensis gene (Table 2). sequently, evaluations were thorough and North American potato cultivars revealed There were slight differences among the included over 20 biochemical constituents very little reliance on nutritional constituents clones for several constituents, probably (Lavrik and Love, 1994). Also, only the origi- as selection criteria or as a basis for release because of insertion effects, somaclonal varia- nal cultivar from which the genetically modi- (see references cited in Chase, 1992). There tion, or unknown causes, but the range was fied cultivars were derived was used for are two exceptions. One is for a group of very narrow when compared to that for comparison. Constituents compared included compounds called glycoalkaloids, natural genetically dissimilar cultivars. not only nutritional and toxicological com- toxicants with known mammalian toxicity Historical precedence from past cultivar ponents, but also agronomic characteristics for which a voluntary ceiling has been estab- development work tends to support
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