|
|
2000 P Street, NW, Suite 308 Washington, DC 20036 Phone: (202)785-1950 · Fax: (202)452-9640 · Email: consumer@ibm.net Web: http://www.consumerscouncil.org |
|
Council Members |
February 9, 1999 The Honorable Frank Loy Re: GMOs/LMOs and Labeling in the Context of the Biosafety Protocol Negotiations Dear Under Secretary Loy: As you prepare to leave for Cartagena, Colombia, this communication is designed to address some of the issues discussed at the meeting you and your State Department colleagues convened on January 26, 1999 to brief non-governmental organizations (NGOs) on the Biosafety Protocol negotiations. We appreciated your taking the time to meet with us. Several issues raised at the meeting urgently require clarification. First, contrary to an opinion State Department staff expressed during the meeting on January 26, that NGOs did not seem to be very interested in the Biosafety negotiations, we continue to be extremely interested in, and very concerned by, a wide variety of important issues being raised through these negotiations. The purpose of this letter is to outline for you our general concerns regarding living modified organisms (LMOs), often referred to as genetically modified organisms (GMOs), and the labeling of products containing, or produced using, LMOs/GMOs. A number of U.S. NGOs also have concerns about advanced informed agreement, the need for case by case assessments, the need to include human health impacts, trade with non-parties, and the pressing need for a fully developed section on liability and redress, among other issues. However, we will not address those issues at this time. Concerns about LMOs/GMOs As we discuss below, there are concerns about the safety of some of these products that are directly attributable to their development through genetic modification, and many unresolved scientific questions about how GMOs may affect environment and health. It has been repeatedly stated by U.S. officials that there are no safety concerns because federal safety agencies give premarket approval to these products. This seems to imply that there is extensive federal testing or federal review of company testing. This assertion is absolutely incorrect. In fact, in the United States, government human health premarket safety reviews are voluntary. The U.S. requirements for company maintenance of premarket test data and reporting to the government are also inadequate. Environmental reviews are incomplete, inadequate, and do not apply to all products. What's more, we can expect that in the future genetically engineered food will be developed and grown in many countries with even fewer premarket safeguards than the minimal ones that exist in the United States. Unless all such products are labeled, it will be difficult to determine the source of, or to control, any toxin, allergen, "gene pollution" or other problem originating in such food. As discussed below, toxin problems can affect humans, livestock and wildlife, which feed on human crops and waste. Some food intended for human or animal consumption could also end up used as seed (i.e. potatoes) and/or could regrow accidentally (as when tomato "volunteers" spring up in compost). Genetic material can migrate from cultivated plants to wild ones. Polls consistently show that 80-90% of US citizens want labeling of genetically engineered food. Polls also find that most consumers say they would buy food with such a label. Clearly the public wants labeling as a precautionary measure, in case any problem should arise, and so that they can exercise their right to choose what they eat. Polls in other countries show similar results. For all these reasons, we support labeling of consumer products and all commodities that contain, are products, or are made using products of genetic engineering. We are concerned that the potential for adverse effects from genetically engineered foods is heightened by a lack of labels indicating when a food (or food supplement) has been genetically engineered or derived from or contains products made by genetically modified organisms. Without labels, consumers will have no way to monitor whether they have eaten a product found to be worrisome. Further, public health and environmental authorities will have no way to trace consumption and use of unlabeled products. For example, one of the very first GMO-derived products introduced into the market was an amino acid called tryptophan which is sold in a number of countries including the United States as a dietary supplement. In the late 1980s, the Showa Denko company of Japan began making tryptophan using genetically engineered bacteria, and selling it in the United States. Within months thousands of people who had taken the supplement began to suffer from eosinophilia myalgia syndrome, which included neurological problems. Eventually at least 1500 were permanently disabled and 37 died (Mayeno and Gleich, 1994). As doctors encountered this syndrome, they gradually noticed that it seemed linked to patients taking tryptophan produced by Showa Denko. However, it took months before this was taken off the market. Had it been labeled as genetically engineered, it might have accelerated the identification of the source of the problem. Showa Denko refused to cooperate in any U.S. government efforts to investigate the cause of the problem. However, subsequent research by scientists suggests that a toxic contaminant, released by the genetically engineered bacteria in quantities well above the quantities released in non-engineered tryptophan, caused the illnesses and death (Mayeno and Gleich, 1994). This is just one example. There are also other ways in which genetic engineering could go awry and result in hazardous toxins in food. Last August, British TV broadcast an interview with Dr. Arpad Pusztai, a world famous researcher at Rowett Research Institute in Aberdeen, Scotland, in which Dr. Pusztai reported results of tests where young rats were fed potatoes into which a snowdrop gene had been transferred to make them resistant to certain insect pests. The rats' growth was stunted and they suffered adverse effects on the immune system as a result of a toxin in the potatoes. Many common plant foods such as tomatoes and potatoes produce highly toxic chemicals in their leaves. New or unexpected toxins can be a problem for humans, livestock, and wildlife of all kinds. While responsible companies check for changes in toxin levels, a serious hazard can be missed as the Showa Denko example shows. Labeling is also needed to prevent food allergy problems. In the United States, about a quarter of all people report that they have an adverse reaction to some food (Sloan and Powers, 1986). Studies have shown that 2 percent of adults and 8 percent of children have true food allergies, mediated by immunoglobin E (IgE) (Bock, 1987; Sampson et al., 1992). People with IgE-mediated allergies have an immediate reaction to certain proteins, ranging from itching to potentially fatal anaphylactic shock. Among the most common are allergies to peanuts, other nuts and shellfish. Genetic engineering can transfer allergies from foods to which people know they are allergic, to foods that they think are safe. In March 1996, researchers at the University of Nebraska in the United States confirmed that an allergen from Brazil nuts had been transferred into soybeans. The Pioneer Hi-Bred International seed company had put a Brazil nut gene into soybeans to improve their protein content for animal feed. In an in-vitro and a skin prick test, the engineered soybeans reacted with the IgE of individuals with a Brazil nut allergy in a way that indicated that the individuals would have had an adverse, potentially fatal reaction to the soybeans (Nordlee et al., 1996). In this case no one was harmed. As Marion Nestle, the head of the Nutrition Department at New York University summarized in an editorial in the New England Journal of Medicine , "In the special case of transgenic soybeans, the donor species was known to be allergenic, serum samples from persons allergic to the donor species were available for testing and the product was withdrawn" (Nestle, 1996: 726). However, in the future proteins will be coming into food crops not just from known sources of common allergens, like peanuts, shellfish and dairy, but from plants of all kinds, bacteria and viruses, whose potential allergenicity is uncommon or unknown. Furthermore, there are no fool-proof ways to determine whether a given protein will be an allergen, except tests involving serum from individuals allergic to the given protein. Nestle continues, "The next case could be less ideal, and the public less fortunate. It is in everyone's best interest to develop regulatory policies for transgenic foods that include premarketing notification and labelling" (emphasis added) (Nestle, 1996: 727). To protect human health from the effects of unrecognized or uncommon allergens, all genetically engineered food must be labeled. Otherwise there will be no way for sensitive individuals to distinguish foods that cause them problems from ones that do not. This need is particularly urgent, since one of the potential consequences is sudden death, and children are part of the population most at risk. Because a transferred trait, such as ability to produce an insecticide in the leaves of the plant, is often not immediately apparent, scientists generally also insert a "marker gene" along with the desired gene into the new plant. The most commonly used marker is a bacterial gene for antibiotic resistance. Most genetically engineered plant food contains such a gene. Widespread use of antibiotic resistance marker genes could exacerbate the growing problem of antibiotic resistance, and consumer labeling would be an important tool in tracking and evaluating any such problem. The genes may move from a crop into bacteria in the environment, and since bacteria readily exchange antibiotic resistance genes, move into disease-causing bacteria and make them resistant too. Antibiotic resistance genes could even be transferred in the digestive tract to bacteria. The genetically engineered Bt maize plant from Novartis includes an ampicillin-resistance gene. Ampicillin is a valuable antibiotic used to treat a variety of infections in people and animals. A number of European countries, including Britain, have refused to permit the Novartis Bt corn to be grown, because of concern that the ampicillin resistance gene could move from the corn into bacteria in the food chain, making ampicillin a less effective weapon against bacterial infections. The fact that the ampicillin resistance gene is connected to a bacterial promoter (a genetic "on" switch) rather than a plant promoter in the Novartis Bt corn could improve the chances that if the gene moved into bacteria it could be expressed. In September 1998, the British Royal Society put out a report on genetic engineering that called for the ending the use of antibiotic resistance marker genes in engineered food products (Anonymous, 1998). Consumer labeling could be a useful tool in tracking migration of antibiotic resistance. The most widely grown genetically engineered crops, accounting for 99 percent of the land under transgenic cultivation world-wide, are engineered for herbicide tolerance, insect resistance, and/or virus resistance (James, 1997). Each of these poses environmental risks, and in each case consumer labeling could be vital to identifying, assessing and remedying a problem. Herbicide-tolerant crops are varieties on which herbicides can be used to kill weeds, without killing the crop itself. These varieties encourage farmers to use more herbicides, which frequently pollute groundwater and can cause various other forms of ecological damage. Insect-resistant crops almost all contain a gene from the bacterium Bacillus thuringiensis (Bt) which causes the plant to produce an endotoxin throughout the plant, including leaves and fruit. Bt corn, cotton, potatoes tomatoes and rice are all being grown in various parts of the world. Crops that continuously produce Bt endotoxin accelerate the spread of resistance to the Bt endotoxin among the pests feeding on the crops. A recent computer model developed by a scientist at the University of Illinois in the U.S. predicted that if all U.S. farmers grew Bt corn, resistance would develop in a single year (Burghart, 1998)! Scientists at the University of North Carolina in the U.S. have already found Bt resistance genes in wild populations of a moth pest that feeds on corn (Gould et. al, 1997). The resistance concerns are serious enough that, just last month, a coalition of the US' major producers of genetically engineered corn seed, under pressure from federal regulators, environmentalists and the weight of scientific studies, said they would require farmers to grow sizable plots of non-engineered corn in an effort to stave off resistance (Weiss, 1999). The Bt crops may also be toxic to beneficial or harmless insects, thereby reducing biodiversity among insects. Researchers from Swiss Federal Research Station for Agroecology and Agriculture, for example, found over 60% mortality among green lacewings larvae (a major predator of corn pests) that ate moth larvae that had fed on Bt corn (Hilbeck et al., 1998). Furthermore, the increased lacewing mortality was seen regardless of whether it ate sick prey (i.e. poisoned by eating Bt) or healthy (i.e. resistant to Bt) prey. Bt-resistant insects could feed on Bt corn, fly off to other plants, and be eaten by lacewing which would then die. The resulting ecological effects could extend well beyond the borders of the area planted to transgenic crops. According to data submitted to the US EPA, Novartis' Bt corn also harmed springtails (Collembola), which are flightless insects that feed on fungi and debris in soil and, as decomposers, are considered to be a beneficial insect. Other studies have shown that the Bt toxin can persist in soils for over forty days (the longest time evaluated) and can retain its toxicity to insects (Koskella and Stotzky, 1997). Thus, continuous production of Bt endotoxin could have toxic effects on non-target organisms. Another serious concern is "gene pollution." Researchers in the southern United States demonstrated that more than 50% of the wild strawberries growing within 50 meters of a strawberry field contained marker genes from the cultivated strawberries. If the gene for herbicide tolerance escapes into wild relatives of crop plants that are weeds, it could result in a new generation of herbicide-tolerant superweeds. In fact, researchers in both Denmark (Jorgensen and Andersen, 1995; Mikkelsen et al., 1996) and the United States (Hileman, 1995) have already demonstrated that the gene for herbicide tolerance can readily move from cultivated canola to close relatives in nearby fields, such as wild mustard. Indeed, in a recent experiment mustard plants engineered to be herbicide tolerant (Bergelson et al., 1998) were roughly 20 times more likely to outcross with other mustard plants than natural mutations. Thus, the act of genetic engineering dramatically increases gene flow, and functionally turned a species that normally only mates with itself into an outcrosser. The authors do not know how to relate these results to other transgenic herbicide tolerant crops, but point out that this transgene has been introduced into dozens of agricultural crops and is promoted as a selectable marker for transgenic plants. The gene for production of the Bt endotoxin might also escape into wild plants. If so, they could become resistant to butterfly, moth and beetle pests, just like the Bt crops. This could upset established ecological balances by either causing the wild plant to flourish excessively and become a plant pest, or by reducing the butterfly or moth population that previously fed on the newly toxic plant. In either case, biodiversity could suffer. Virus-resistant crops almost all contain genes that can mix with genes from other viruses that naturally infect the plant to create new gene combinations, some of which can give rise to new or deadlier viruses. US and Canadian work has shown that wild viruses can hijack genes from engineered crops. The concern was great enough that the U.S. Department of Agriculture held a meeting in October, 1997 to discuss possible restrictions aimed at reducing the risk of creating harmful new plant viruses due to the use of virus-resistant crops (Kleiner, 1997). Gene pollution would be especially problematic in many developing countries, which are the center of origin for many crops, and the repositories of much of the planets genetic diversity. In these areas, traditional crop varieties could become "polluted" with genes from the genetically engineered crops and biological diversity will suffer. In addition to these health and environmental issues, we are concerned that the rules of the World Trade Organization (WTO) may be used to undermine a potentially constructive outcome from the Biosafety Protocol negotiations. First, we are concerned that the United States may seek to establish a hierarchy between trade and biosafety rules through the use of a "WTO savings clause", which would elevate WTO rules above those that may result from the Biosafety negotiations. We urge the United States not to press for such a WTO savings clause. Second, the United States recently submitted a paper to the WTO Committee on Technical Barriers to Trade that challenges the European Union's compulsory labeling scheme for certain GMO products. This paper, by arguing that GMO products do not differ as a class from non-GMO products, that the EU scheme discriminates between these products, and that the EU's measures are more trade restrictive than necessary to provide consumers with information, attacks the heart of labeling based on non-product related criteria and calls into question the United States' commitment to promoting the consumer's right to know. These scientific examples offered above illustrate both the need for caution, for which we urge the United States to firmly endorse the precautionary principle in the text of the Protocol, and the importance of labeling GMOs. GMOs have the potential to behave in unexpected ways, and may even change and mutate in successive generations. GMO monitoring needs to occur all the way through the process, from production to consumption. Consumer labeling is an essential part of understanding and controlling any potential problems that may arise, whether they affect human or animal health, or the environment. Therefore, in response to Mary McLeod's request that we inform the State Department about our positions on labeling, we strongly urge the United States to support labeling of consumer products and all commodities that contain, are products of, or are made using products of genetic engineering. Sincerely, Cameron Griffith Elizabeth Burrows Brennan Van Dyke Michael Hansen, Ph.D. Mark Ritchie Lisa Y. Lefferts
Anonymous, 1998. Call for UK genetic food watchdog. Nature online service. Sept. 3. Bergelson, J., Purrington, C.B. and G. Wichmann. 1998. Promiscuity in transgenic plants. Nature, 395 (6697): 25. Bock, S.A. 1987. Prospective appraisal of complaints of adverse reactions to foods in children during the first 3 years of life. Pediatrics, 79: 683-688. Burghart, T. 1998. Computer model tests "Bt corn." AP (Associated Press) Online. April 9, 1998. Gould, F., Anderson, A., Jones, A., Sumerford, D., Heckel, D.G., Lopez, J., Micinski, S., Leonard, R. and M. Laster. 1997. Initial frequency of alleles for resistance to Bacillus thuringiensis toxins in field populations of Heliothis virescens. Proceedings of the National Academy of Sciences, USA, 94: 3519-3523. Hilbeck, A., Baumgartner, M., Fried, P.M. and F. Bigler. 1998. Effects of transgenic Bacillus thuringiensis corn-fed prey on mortality and development time of immature Chysoperla carnea (Neuroptera: Chrysopidae). Environmental Entomology, 27(2): 480-487. Hileman, B. 1995. Views differ sharply over benefits, risks of agricultural biotechnology. Chemical and Engineering News, August 21, 1995. Koskella, J. and G. Stotzky. 1997. Microbial utilization of free and clay-bound insecticidal toxins from Bacillus thuringiensis and their retention of insectidical activity after incubation with microbes. Applied and Environmental Microbiology, 63(9): 3561-3568. James, C. 1997. Global Status of Transgenic Crops in 1997. ISAAA Briefs No. 5. The International Service for the Acquisition of Agri-biotech Applications (ISAAA): Ithaca, NY. 31 pp. Jorgensen, R. and B. Andersen. 1995. Spontaneous hybridization between oilseed rape (Brassica napus) and weed Brassica campestris: a risk of growing genetically engineered modified oilseed rape. American Journal of Botany, 81: 1620-1626. Kling, J. 1996. Could transgenic supercrops one day breed superweeds? Science, 274: 180-181. Mayeno, A.N. and G.J. Gleich. 1994. Eosinophilia myalgia syndrome and tryptophan production: a cautionary tale. TIBTECH, 12: 346-352. Mikkelsen, T.R., Andersen, B. and R.B. Jorgensen. 1996. The risk of crop transgene spread. Nature, 380: 31. Nestle, M. 1996. Allergies to transgenic foods-Questions of policy. The New England Journal of Medicine, 334(11): 726-727. Nordlee, J.A., Taylor, S.L., Townsend, J.A., Thomas, L.A. and R.K. Bush. 1996. Identification of a brazil-nut allergen in transgenic soybeans. The New England Journal of Medicine, 334(11): 688-692. Sampson, H.A., Mendelson, L. and J.P. Rosen. 1992. Fatal and near-fatal anaphylactic reactions to food in children and adolescents. The New England Journal of Medicine, 327: 380-384. Sloan, A.E. and M.E. Powers. 1986. A perspective on popular perspections of adverse reactions to foods. Journal of Allergy and Clinical Immunology, 78: 127-133. Weiss, R. 1999. Corn seed producers move to avert pesticide resistance. The Washington Post, January 9, page A04. |
