From: Jean-Claude Pommet [jcpommet@videotron.ca] Sent: Saturday, March 24, 2001 9:49 AM To: fdadockets@oc.fda.gov Subject: "Docket 00N-1396 & Docket 00D-1598" FDA, To whom it may concerns, GENETICALLY ENGINEERED PRODUCTS MUST BE LABELED AND TESTED FOR SAFETY! * The FDA must require mandatory pre-market comprehensive environmental review. Unlike conventional pollutants, where a given amount of pollutant causes a limited amount of damage, a small number of mutant genes could have a population explosion and reproduce forever, causing unlimited and irreparable damage. * The FDA must require mandatory pre-market long-term health testing. GE products could be toxic, cause allergic responses, have lower nutritional value, and compromise immune responses in consumers. * The FDA must require mandatory labeling of GE products. Without mandatory labeling, neither consumers nor health professionals will know if an allergic or toxic reaction was the result of a genetically engineered food. Consumers would be deprived of the critical knowledge needed to hold food producers liable should any of these novel products be hazardous. * The FDA must end its cozy relationship with the industries it purports to be regulating. People have been allowed to work for a biotech company, then work for the FDA writing the regulatory rules on that company's product, then go back to working for the company. Ninety-two percent of FDA advisory committee meetings had at least one conflict of interest. ------------------------------------------------------------------------------------ The following was prepared by Consumers for Education about Genetic Engineering. 13 Myths About Genetic Engineering Myth No. 1 - Genetic engineering (GE) is not new. It is just the same as speeded-up selective breeding. FACT: Genetic engineering (GE) and conventional breeding are worlds apart. Breeding does not manipulate genes; it involves crossing of selected parents of the same or closely related species. In contrast, GE involves extracting selected genes from one organism (e.g. animals, plants, insects, bacteria) and/or viruses, or synthesising copies, and artificially inserting them into another completely different organism (eg. food crops). GE usually employs virus genes to smuggle in and promote the inserted genes, and antibiotic resistance genes to act as markers. All these inserted genes are present in every cell of the plant. Myth No. 2 - Genetic engineering is precise. FACT: The function of only a small proportion of the DNA in a higher organism is known. Modern genetics has shown that genes do not operate in isolation. Rather they interact in a complicated way, changing their behaviour in response to influences from other genes. Although a gene can be cut out precisely from the DNA of an organism, its insertion into the DNA of another organism is entirely random. This results in the disruption of the order of the genes on the chromosome and may result in random and unexpected changes in the functioning of the cells. Richard Lewontin, Professor of Genetics at Harvard University, has said of GE: 'We have such a miserably poor understanding of how the organism develops from its DNA that I would be surprised if we don't get one rude shock after another.' Myth No. 3 - GE foods vary from non-GE foods only in the characteristic that has been modified. FACT: The random insertion of foreign genes into the genetic material may cause unexpected changes in the functioning of other genes. Existing molecules may be manufactured in incorrect quantities, at the wrong times, or new molecules may be produced. GE foods and food products may therefore contain unexpected toxins or allergenic molecules that could harm our health or that of our offspring. Myth No.4 - GE food is extensively tested and the GE food at present on our supermarket shelves is perfectly safe to eat. FACT: No GE food testing is done in America. We rely almost entirely on the testing carried out by the GE biotechnology companies that have spent billions of dollars developing the food and intend to make a profit selling it to us. There are serious doubts about the adequacy of the testing and the validity of the conclusions drawn from the results. Independent long-term testing is required before we can be sure that GE food is safe to eat. Another health concern is the possible acceleration of the development of bacterial resistance to antibiotics due to the use of antibiotic resistance genes in the production of GE foods. Myth No. 5 - Genetically engineered food has improved nutritional value. FACT: No GE food produced to date has been shown to be more nutritious than non-GE food. Most GE crops are only designed to be resistant to specific herbicides, to produce their own insecticides or to have an increased shelf life. Myth No.6 - One can always choose not to eat GE food. FACT: At present most foods on American supermarket shelves containing GE ingredients are not labelled, so there is no way of knowing whether we are eating them. GE products are likely to be found in foods containing the following ingredients: Soya flour and oil (in many common foods including breads, sausages, etc.) Lecithin (in chocolate, ice cream etc.) Canola oil Corn (maize) extracts. Myth No. 7 - Farmers will benefit from growing GE crops. FACT: Seeds of genetically engineered crops are more expensive than those of conventional crops. Farmers in the UK and USA report that yields are generally no better, the crops are less reliable and overall have not improved profitability. Non-GE crops now receive a premium and as more countries reject GE foods, the pportunities to sell GE produce overseas are diminishing. Because of risks associated with GE crops insurance companies in the USA and UK are now reluctant to insure them. Farmers growing GE crops have to sign binding contracts with the biotechnology producers. These commit them to using only the herbicides produced by that company and prohibit them from the traditional practice of saving seed for the next season. Most third world farmers certainly will not benefit. Myth No.8 - GE crops will reduce the use of herbicides and pesticides. FACT: Crops engineered to be resistant to specific herbicides may encourage more liberal use of those herbicides. This has been anticipated by one manufacturer, who has applied to ANZFA (Australia New Zealand Food Authority) to have the allowable residue of the herbicide glyphosate (Roundup=AE) in foods sold in New Zealand increased by 200 times. In areas of the USA where crops engineered to produce their own insecticide are grown, pesticide use has not decreased. Myth No. 9 - There is no evidence that GE crops are harmful to the environment. FACT: Insects, birds and the wind carry genetically altered pollen and seeds into neighbouring fields and far beyond. Cross-pollination occurs between GE crops and non-GE crops and their wild relatives. In this way resistance to weed killer, for example, might be transmitted to weeds making them more difficult to control. There is evidence that crops engineered to produce their own insecticide can kill beneficial insects. Myth No. 10 - GE crops will save the world from famine. FACT: A major cause of famine is the unequal global distribution of food. Food mountains exist in much of the western world and food is regularly dumped. Poor people have limited ability to buy either GE or non-GE food. There is no evidence that GE crops produce higher yields than conventional crops or that GE products will be cheaper. Myth No. 11 - You can trust the scientists that GE food is good for you and the world. FACT: The money for scientific research on GE here and overseas comes from either the biotechnology companies or the government. Both are committed to the promises of biotechnology. This means that even when scientists have concerns about the safety or commercial application of the technology, it is often hard for them to risk their careers by being openly critical. One respected scientist in the UK who spoke up about his experimental results showing damaging effects of feeding rats on a type of genetically engineered potato was immediately fired from his job. Myth No. 12 - You can't stop progress. FACT: No of course we can't; and why would we want to? Progress implies change for the better. Change for the worse is regression. We must be sure that GE products have benefits for the consumer and are safe if they are to be introduced into our foods. We must not commit ourselves to a dubious technology that cannot be reversed. Myth No. 13 - There are more important things to worry about than GE foods. FACT: Many scientists don't think so. For example Joseph Rotblat, the British physicist who won a 1995 Nobel Prize says: "My worry is that other advances in science may result in other means of mass destruction, maybe more readily available even than nuclear weapons. Genetic engineering is quite a possible area, because of these dreadful developments that are taking place there." ----------------------------------------------------------------------------------- * Lack of Testing Genetically engineered (GE) foods are being rushed to market without long-term testing. Dr. Ann Clark, Associate Professor of Crop Science at the University of Guelph, looked at the research on all 42 approved biotech foods in Canada. She found that 70% of these crops were approved without laboratory tests for toxicity. None of the crops were tested for allergenicity. Even for the 30% studied for toxicity, the tests were quite limited. For instance potatoes and corn were engineered to contain a toxin to kill insect pests. These foods are already on the market though no one knows the long-term effects on animals or on humans who eat the "toxin enriched" crops. * Combining Genes GE foods combine genes from widely different species. Inserted foreign genes can unpredictably affect the functioning of host genes. Also, since these combinations of genes have never been part of the human diet, unexpected allergies and toxicity are major concerns. But since these foods are not labelled, it is almost impossible to track any damaging effects. * Toxic Effects Already, one genetically engineered soy, developed by Pioneer Hybrid, was allergenic, and could have killed people with life-threatening allergies if it wasn't, by chance, caught and kept off the market. Since GE soy came on the market, soy allergies have risen 50%. In 1989, 37 people died and thousands were permanently damaged after ingesting a genetically engineered food supplement, GE tryptophan. Beneficial insects, such as monarch butterflies and ladybugs, have also died after eating GE crops. Because scientists are creating genetic changes overnight that might in nature take thousands of years, unexpected effects are no wonder. The potential for damage to human health or to the environment is unknown. The British Medical Association, representing 115,000 physicians, calls for a moratorium on all GE crops until more research is done. * Who Needs It? Biotech is not needed to feed the world. There already is enough food to feed the entire globe, if the food were evenly distributed. Studies by the US Department of Agriculture (USDA) show that biotech crops produce on average 7% less yield than conventional crops. In other unexpected effects, biotech cotton in the USA fell off plants prematurely, creating millions of dollars of damage. In another case, GE soy burst open in hot weather, because of increased lignin content. Cross-pollination with biotech crops (genetic pollution) has damaged organic crops and also produced superweeds, which are immune to herbicides. Insects exposed to biotech crops produced superbugs, insect pests immune to synthetic chemicals and natural pesticides, and which damage both organic and conventional crops. * Pesticide Promoters? Contrary to industry hype, genetic engineering has not produced any nutritious wonderfoods. The majority of approved GE foods are herbicide resistant (HR). This allows more use of herbicides to kill weeds without harming crops. The same companies that makes the HR crops make the herbicides, and force farmers to use only their herbicides with their crops, or face fines. Is the main purpose of GE crops to promote herbicide sales? USDA studies show that farmers growing HR crops use up to 2-5 times as much herbicide. Also, as GE crops are patented, biotech companies receive large royalties from farmers growing the crops. Farmers are also disallowed from saving seeds from one season to the next. * Scientists Silenced Government documents show that GE foods were approved in the USA, even though many scientists at the US FDA (Food and Drug Administration) questioned their safety. Two hundred scientists at Health Canada sent a letter to the Minister of Health saying they are concerned that unsafe products are rushed to market. The scientists referred not only to GE foods, but also to antibiotics and hormones administered to food-producing animals. They stated they are pressured to approve products of questionable safety, and that even when they did not recommend approval, products were approved. * Deregulation Built into Canada's Food and Drugs Act is the precautionary principle, which asserts that products should not be approved for sale until proven safe. However, due to industry pressure, products are allowed on the market without adequate testing, and then only removed if there is sufficient evidence of harm (enough "dead bodies"). Deregulation has created several calamities, including Canada's tainted blood mega-disaster, in which 60,000 people received infected blood that was not properly tested. Deregulation in Europe allowed cows to be fed sheep offal, which caused mad cow disease. * Conclusion Have we learned our lesson, or are we going to blindly trust industry and continue to allow genetically engineered on the market without long-term testing? -- Jean-Claude Pommet, Bacc./Sc. University of Ottawa, Canada