[PART TWO OF TWO - References and footnotes at end of two] Genetically Engineered Foods: Potential Impact on Health
(concluded..............) What Can Be Done to Ensure Safety? The FDA has done little to ensure safety. Premarket testing is voluntary, except for GE crops registered as pesticides with the EPA. The FDA recommends only that developers conduct a few in vitro tests to assess whether the transgenic protein is similar in biochemical characteristics to a handful of common allergens. In vitro tests are specific for single compounds or antigens. For transgenic proteins of indeterminate allergenicity-for example, those with genes derived from organisms not commonly consumed by humans-the FDA does not require any empirical analysis. (21) What analysis is performed is often flawed. For example, biotech companies test herbicide-tolerant GE seeds before they are treated with the herbicide. Recent tests show biochemical changes, such as alterations in phytoestrogen levels, take place in GE seeds after they are treated with the herbicide glyphosate. (22, 23) The inadequacy of even the voluntary testing recommended by the FDA is clear from the conclusions of a 1994 Conference on Scientific Issues Related to Potential Allergenicity in Transgenic Food Crops hosted by the United States FDA, the EPA, and the Department of Agriculture (USDA). According to the scientists, in vitro tests cannot screen for the vast diversity of unique allergens and toxins of unknown structure and function that may be created through GE manipulations, nor can they assess the potential allergenicity of proteins derived from sources not normally part of the human food supply, or that are generated through the genetic engineering process. (21) The experts also maintained that no adequate animal models exist for assessing human allergenicity. Moreover, use of human subjects in assessing food allergenicity has its own challenges-for example, the large numbers of subjects required because of low incidence of reactions in the human population to any given allergen. In December 1998, scientists representing 29 industrialized countries concluded that effective testing of GE food would require innovative approaches. (21) Test subjects can't consume 100 to 1,000 times the likely intake, as is done when testing drugs, to ensure safety. Instead, food safety testing should use doses that approximate the normal dietary use of food, maintaining a balanced diet for the test subjects. Monitored long-term testing would be necessary to detect long-term effects. Dr. John Fagan considers it essential to establish clear guidelines for premarket assessment of health and environmental effects of each genetically modified organism. Fagan is a molecular biologist who, for 22 years, conducted research in recombinant DNA for the National Institutes of Health. He received research grants totaling $2.5 million. Once he recognized the causes for concern, he returned $600,000 in 1994 and withdrew a grant proposal for $1.25 million. He has since been developing testing to identify GE foods in the market place. Fagan recommends that before human trials, tests with rodents should determine that a genetic food is not actually poisonous. Then, a graduated series of feeding studies with human volunteers should be conducted to screen for toxic and anti-nutrient action of the GE foods that may be slightly less acute, or require longer exposure to become apparent. However, he emphasizes that the best testing methods available cannot guarantee the safety of a new GE product. A further testing challenge is that, as Ralph Waldo Emerson points out, "Science cannot be considered separately from the people doing the science. There is ultimately no science, only scientists." Who, then, are the scientists? The industrialization of academic research imperils the objective search for truth about risks and benefits of GE crops. Who has the resources and incentives to fund research about GE crops? Primarily, it's the affected industries. Who funds the peers who review the research? According to news reports, funders of product research threaten loss of funding to force their researchers to suppress or delay publication of negative evidence. Moreover, studies may be evaluated by biased panels. At the FDA, such panels contain representatives of the affected industries, and the revolving door between personnel departments of the FDA and such regulated companies as Monsanto is well documented. A recent example of potential bias surfaced when the National Academy of Sciences formed a panel to study GE plants producing pesticides, such as bacillicus thuringiensis (Bt) toxins, in their cells. At issue was the fact that the EPA regulates these crops as pesticides; suppliers make pesticide claims, and plants are engineered to kill insects. Before the panel was finalized, study director Dr. Michael Phillips had already told callers that such regulation is inappropriate. (23) Toward the end of the study, Phillips left the National Academy to work for the trade association, Biotechnology Industry Organization. Of 12 panel members, seven had past or present financial ties to biotech or pesticide industries. One attorney and one scientist had represented Monsanto and the biotech industry against federal regulators; four other members received direct or indirect funding from GE seed producers, such as Monsanto and Novartis, and another was a consultant for the pesticide industry. (24) More to the point, the time for unbiased studies assessing risks and benefits is before, not after, release of these organisms into the environment and into the diets of consumers. All factors considered, many non-industry scientists recommend taking a long look before releasing more GE crops. What Are the Consequences of Delay? What has the world to lose by a "go slow" approach to allow for careful study of long-term safety? What if evidence shows that genetic engineering, with the current state of technology, is ill-advised? Biotech companies and some U.S. government leaders would have consumers believe they would be denied tastier, more nutritious food. Yet, so far, most GE crops in today's food confer no benefits on consumers. They merely tolerate a specific herbicide made by the company that engineers the seeds-for example, Roundup Ready soybeans, which now account for 37 percent of the U.S. soybean crop. With few exceptions, the rest produce Bt toxins. Some enhance shelf life or transportability. Consumers would not miss these products. Indeed, scientists and economists raise concern that consumer choice could be limited by extensive corporate integration within the agriculture/food supply chain. In its September, 1999 issue, Consumer Reports identified the companies that dominate research and development in plant genetic engineering as Monsanto, DuPont, Novartis, Austra-Zeneca, and Aventis (formed by the merger of Rhone Poulenc with the shareholders of AgrEvo: Hoechst and Schering). Among them, they also own a substantial and growing portion of the global seed market, and some own food processing companies through acquisition or joint ventures. Such integrated consolidation could reduce the diversity of food products that ultimately reach the supermarket shelves. A compelling argument is that the world will not be able to feed its hungry. Who among us has not responded with sympathy and concern at television pictures of hungry young children from the outer reaches of this planet? The world is hungry and we need to address this situation. The biotech industry tells us that without GE technology, we will never feed the world. Only with the increased production and nutritional enhancement of this technology will all those hungry children find help. Yet the widespread growth in genetic engineering has not reduced hunger. Far from feeding the world, it is intensifying corporate control of food production and distribution. Only the most negligible effort has focused on what less-developed countries need: cheap, labor-intensive, robust, and high-yielding food staples. Genetically modified crop development means that most research and development is undertaken by a relatively small number of large companies who dominate food engineering. Thus, the current focus is on herbicide tolerance and other requirements of labor-saving production by large farms in industrialized countries for developed markets. In areas with burgeoning populations, poverty reduction programs require raising, not lowering, demand for labor. Moreover, GE herbicide-tolerant seeds are more expensive than their unmodified counterparts, and of no benefit to farmers who cannot afford herbicides. (18) New technologies on the horizon promise to work against, rather than for, impoverished farmers. Gene use restriction technology (GURT), commonly known as terminator technology, allows the seed producer to prohibit or restrict the use of farm-saved seeds. The seeds are programmed to produce deadly proteins late in their cycle. GURT ensures that the seeds either cannot germinate, or may require another chemical to reactivate them, which would necessitate purchases of new seeds or chemicals each year from major seed companies. (10, 25) Some gene use restriction technology relies on switch technology, in which a transgene construct has a promoter sequence that determines when and where in the plant the gene will be turned on. These promoters can be engineered to influence through external means in some cases (such as a chemical application). Recent gene use restriction technology targets seeds that won't germinate unless exposed to a specific chemical sold by the GE seed supplier. (10) Patents for the GURT technology are owned jointly by the USDA and a corporation soon to be acquired by Monsanto. A new patent reveals that despite strong opposition to U.S. involvement with GURT technology, USDA funding supports additional terminator research at Purdue University. Among the promises of genetic engineering, according to the biotech industry and their U.S. government supporters, is reduction in the use of pesticides. In fact, Bt crops might render ineffective a natural pesticide that actually does reduce the need for toxic chemicals. The bacteria called bacillicus thuringiensis, which produce Bt toxins naturally, have been used by organic growers in topical sprays since the early 1970s. Unlike the genetically engineered Bt-producing plants, the bacteria can be applied judiciously, as needed, and at appropriate points in the growing process. Naturally occurring Bt bacteria are relatively short lived, and they secrete toxin in a form that becomes activated only in the alkaline digestive systems of certain worms and caterpillars. By contrast, genetically engineered Bt crops secrete an active form of the toxin throughout the plants' life cycle, including the harvest. These toxins in the plant tissue do not wash off, nor are they broken down by sunlight, as are their natural counterparts. Scientists estimate that by creating resistant pests, Bt crops will render microbes ineffective within a few years. (11) According to Consumer Reports, in some cases, herbicide-tolerant cotton needed fewer herbicide applications, but herbicide-tolerant corn required more. While Bt cotton required fewer pesticides for target insects, they required as many or more nontarget insects. (11) Avoiding Genetically Engineered Products At this point, GE products are not allowed in foods with an organic label. Patients can avoid GE foods by exclusive consumption of organic products, provided they can find everything they need from organic sources, and that organic crops are not polluted with transgenes from nearby GE crops. In the United States, a few food producers are attempting to provide some GE-free products. For example, two of the largest U.S. corn processors, A.E. Stanley Mfg. Co., and Arthur Daniel Midland Co., have declined to buy GE corn, which will make it easier for food companies to avoid GE corn in their processed foods. Honda Trading Co., which is a wholly owned division of the Japanese auto maker, said that it will build a processing plant in Ohio to sort and bag GE-free soybeans. All of these developments may affect consumer choice. Many leading scientists recommend extensive study under controlled conditions before introducing GE crops into the food supply and environment. The authors of this article recommend that regulators require labels on products containing transgenes, so that consumers can weigh all evidence for themselves and make informed decisions. We further recommend that for the present, chiropractors advise their patients, as much as possible, to avoid becoming nonconsenting test subjects in a mass experiment. As non-transgenic foods become available and identified, patients are well advised to choose them over foods with unknown genetic makeup. References 1. Ticciate L & Ticciate R, PhD. 1998. Genetically Engineered Foods. Keats Publishing, New Canaan, CT, Introduction. 2. Epstein S, MD. August 1999. "Monsanto's genetically modified milk ruled unsafe by UN." From Herbal Materica Medica, Momboit, G. The Guardian, July 22, 1999, London, UK, press release. 3. Fagan J. November 14, 1997. "Assessing the safety and nutritional quality of genetically engineered foods." Genetic ID, Inc., 1760 Observatory Drive, Fairfield IA 52556. 4. Padgette SR, Taylor N B, Nida, D L, Baily, M R, MacDonald J, Holden, L R & Fuchs R L, 1996. "The composition of glyphosate-tolerant soybean seeds is equivalent to that of conventional soybeans." Journal of Nutrition 126, 702-16. 5. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition CFSAN Handout: 1995 FDA's Policy for Foods Developed by Biotechnology. 6. Hammond BG, Vicine JL, Hartnell, GF, Naylor, MW, Knight, CD, Robinson, EH, Fuchs, RL & Padgette, SR. 1996. "The feeding value of soybeans fed to rants, chickens, catfish, and dairy cattle is not altered by genetic incorporation of glyphosate tolerance." Journal of Nutrition 1126(3) 717-26. 7. Townsend M. Daily Express, March 12, 1999. "Why soya is a hidden destroyer" London, UK. 8. Ewen E & Pusztai A. October 16, 1999. "Effects of diets containing genetically modified potatoes expressing galanthus nivalis lectin on rat small intestine." The Lancet, 354 (9187). 9. Cummins R, March 2, 1999, "Global Resistance against Monsanto & Genetically Engineered Foods." Food Bytes #17 (Bio-democracy), page 3. 10. Crouch ML, Associate Professor of Biology, Indiana University, Bloomington, Indiana. "How the Terminator Terminates." cro...@indiana.edu <mailto:cro...@indiana.edu>. 11. Consumer Reports, "Seeds of Change," September 1999, pages 41-46. 12. Schubbert R, Lettmann, C & Doerfler, W. 1994. "Ingested foreign (phase M13) DNA survives transiently in the gastrointestinal tract and enters the bloodstream of mice." Mol. Gen. Genet. 242: 495-504. 13. Schubbert R, Renz D, Schmitz B & Doerfler W. 1997. "Foreign (M13) DNA ingested by mice reaches peripheral leukocytes, spleen and liver via the intestinal wall mucosa and can be covalently linked to mouse DNA." Proc. Natl. Aca. Sci. USA 94, 961-6. 14. Traavik T. 1995. Too Early May Be Too Late. Ecological risks associated with the use of naked DNA as a biological tool for research, production and therapy (Norwegian), Report for the Directorate for Nature Research, Tungasletta 2, 7005 Trondheim. English translation, 1999. 15. Ho MW, Meyer, H & Cummins J. 1998. "The Biotechnology Bubble." The Ecologist 28(3) 146-15 16. Van der Heihden MG, Klironomos JN, Ursic M, Moutoglis P, Streitwolf-Engle R, Boller T, Wiemken A & Sanders IR. 1998. "Mycorrhizal fungal diversity determines plant variability and productivity." Nature 396, 69-72. 17. Bergelson J, Purrington B & Wichmann G. 1998. "Promiscuity in transgenic plants." Nature 395, 25 18. Nuffield Council on Bioethics. May 27, 1999. "Genetically Engineered Crops: The Ethical and Social Issues." NCBE Report on Genetically Modified Foods, University of Reading, UK. 19. Birch ANE, Geoghegan II, Majerus MEN, Hackett C & Allen J. October, 1997. Interaction between plant-resistant genes, pest aphid-population and beneficial aphid predators. Soft Fruit and Perennial Crops, pp. 68-79. 20. Weiss R. August 15, 1999. "Next food fight brewing is over listing genes on labels." Washington Post, page A17. 21. Fagan J. 1998. Assessing the safety and nutritional quality of genetically engineered foods. In Release and Biosafety of Genetically Modified Foods, Eds. FG Winarno, BSL Jenie, & P Hariyadi. Indonesian Academy of Sciences. In press. 22. Hammond BG, Vicinni JL, Hartnell GL, Naylor MW, Knight CD, Robinson EG, Fuchs RL & Padgette SR. 1996. "The feeding value of soybeans fed to rats, chickens, catfish, and dairy cattle is not altered by genetic incorporation of glyphosate tolerance." Journal of Nutrition 1126(3) 717-26. 23. Lappe MA, PhD, Center for Ethics and Toxins, Gualala, CA, and E. Bailey, Center for Ethics and Toxins, Gualala CA. 24. Patterson M, New York Times, August 16, 1999. "Biotech expert's new job casts a shadow on a report." 25. Keeler B & Urow S. August 1999. Is the FDA biased on genetic issue? Daily Breeze, page B5. -------------- Barbara Keeler has focused on health, nutrition, the environment and regulatory affairs as a journalist and a contributor to health, nutrition, science, and social science textbooks. Shirley Watson is Director of Education for the American Chiropractic Association's Council on Nutrition. [END] -- The silver-list is a moderated forum for discussion of colloidal silver. To join or quit silver-list or silver-digest send an e-mail message to: silver-list-requ...@eskimo.com -or- silver-digest-requ...@eskimo.com with the word subscribe or unsubscribe in the SUBJECT line. 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