--> In FDA-speak: "In most cases, the substances expected to become components of food as a result of genetic modification of a plant will be the same as or substantially similar to substances commonly found in food" (emphasis added). The FDA would only require pre-market review for foods that contained known allergens or toxins or were substantially altered in nutrient content.38
The doctrine of substantial similarity, or substantial equivalence as it later came to be called, meant that the FDA would be taking after-the-fact action to recall products if they caused problems. |  Increasing the amount of a naturally occurring plant allergen is one way that genetic modification might promote allergies. Trypsin inhibiter, a substance found in natural soy, has been identified as a major allergen. According to a published study, the amount of trypsin inhibitor in one variety of GM soybeans is about 27 percent higher than in natural soybeans.3 It is also possible that GM food possesses new allergens, never before found in natural food.
Transferring Allergens
Researchers at Pioneer Hi-Bred, a leading U.S. | | They were venturing into a new technology, the genetic modification of food, and they were actually asking the government to oversee their emerging industry.
But this was late 1986. Ronald Reagan was president and the administration was busily deregulating business. Bush needed convincing. "We bugged him for regulation," said Leonard Guarraia, one of the executives at the meeting. "We told him that we have to be regulated."1
Monsanto was about to make a multibillion-dollar gamble. With this new technology, they could engineer and patent a whole new kind of food. | | According to Sue Mayer, director of the independent research group Genewatch, "These results demonstrate that genetic modification is a clumsy process, not precise as is often claimed. There is no control over how many genes, in what order, or where they are inserted."27
She added, "Additional copies or fragments of genes may affect the operation of the other inserted genes, which could have consequences for the performance and composition of the plant. This may have implications for human and environmental safety. | | The size of genetic modification and problems it may cause us are tremendous.
"If we injure the health prospects of humanity in this and the next and the next generation, then I think those people should be made accountable for the crimes they committed.
"Informing the public is the most important business in this very sorry affair, so one can do something." Due to Pusztai's unexpected "popularity," he was approached by numerous scientists who quietly described their own surprise discoveries, further condemning the safety of GM foods. Some of these stories are described in this book. |  Biotechnologies and food: Assuring the safety of foods produced by genetic modification. Regul. Toxicol Pharmacol. 12:3(part 2) S28-S29.
IFBC (International Food Biotechnology Council). 1990d.
Biotechnologies and food: Assuring the safety of foods produced by genetic modification. Regul. Toxicol Pharmacol. 12:3(part 2) S92-93.
ILSI (International Life Sciences Institute). 1995. Dietary Restriction: Implications for the Design and Interpretation of Toxicity and Carcinogenicity Studies. R.W. Hart, D.A. Neumann, and R.T. Robertson, eds. Washington, D.C.: ILSI Press.
Inoue, S., K. Ito, K. | | Objections that genetic modification is not material also seem weak. The FDA already allowed label statements for production processes: made from concentrate, previously frozen, organically grown, kosher, and irradiated, for example.
In a move that seemed precedent breaking, the FDA conducted focus groups to assess consumer opinions about the labeling issue. To the agency's apparent surprise, practically all of the participants wanted labels to say whether foods were produced through genetic engineering. | | In May 2001, for example, 62% of respondents said agree in response to a question asked this way: Tell me if you agree, disagree, or if you don't know whether information about genetic modification should be required on food labels.2 In contrast, here is an industry-sponsored question: "The U.S. Food and Drug Administration (FDA) requires special labeling when a food is produced under certain conditions: when biotechnology's use introduces an allergen or when it substantially changes the food's nutritional content, like vitamins or fat, or its composition. | | The label not only disclosed the genetic modification but also explained its key elements: a reversed gene for softening and an antibiotic-resistance marker. The FDA approved the tomatoes in 1994, but the company never marketed them. transgenic food, long before it was ready to market. The company's motivation was quite explicit: public relations. If the FDA approved the tomato, consumers would believe it safe to eat. The ensuing ordeal lasted nearly four years. A former Calgene scientist, Dr. Belinda Martineau, recounts these events in her lively 2001 book, First Fruit. |  Although we have no evidence of harmful effects from genetic modification, this of course does not mean that harmful effects can be categorically ruled out," concluded the Royal Society. The absence of evidence is not evidence either of the risk or the safety of a new food. Only the day before, the British Medical Association, representing British doctors, had called for a moratorium on the planting of GM crops because of the uncertainty over their long-term effects on humans.
If the intention of the Royal Society had been to protect the biotech industry in Britain, it was not successful. |  One of the goals of genetic modification is for scientists to change the DNA make-up of plants so they are more resistant to insects and weeds. This way, farmers can use fewer chemical insecticides or herbicides.
To change a food this way, a scientist first inserts an extra gene into a plant. This gene may come from an entirely different species. For example, a bacterium gene is often added to a corn plant so it can create its own insecticide. These modified plants are then bred with ordinary plants to create new varieties. | | For a more complete discussion of traditional and newer methods of genetic modification, see IFBC (1990a).
The past decade has seen the production of transgenic plants of many crop species (Gasser and Fraley 1989, 1992). Much of the early effort was toward improved agronomic traits such as resistance to herbicides or increased yield. |  TOMATOES
Products Prone to Containing Them Canned tomato products, pizza, vegetable soups
COMMENTS AND CAUTIONS Be aware that virtually all commercial yeast is produced using some form of genetic modification. (Beer drinkers now have something else to worry about. See section 91.)
39. Who Can You Trust?
According to Greenpeace's True Food Network's GMO facts (www.true-foodnow.org) at the time of this writing, these are some of the companies that do not me genetically modified ingredients. | | Thus, in addition to genetic modification, processing provides a broad set of options for modifying the concentration of constitutive or added naturally occurring chemicals.
Even the simplest processing of the simplest mixtures results in amazing complexity. A single sugar such as glucose, in water solution at neutral or near-neutral pH and at the temperatures used for cooking or sterilization, produces an array of monomeric and dimeric anhydrides, fragments, and second- and third-order reaction products (Davidek et al. 1990). All of these are derived naturally occurring chemicals. | | Biotechnologies and food: Assuring the safety of foods produced by genetic modification. Regul. Toxicol Pharmacol. 12:3(part 2) S92-93.
ILSI (International Life Sciences Institute). 1995. Dietary Restriction: Implications for the Design and Interpretation of Toxicity and Carcinogenicity Studies. R.W. Hart, D.A. Neumann, and R.T. Robertson, eds. Washington, D.C.: ILSI Press.
Inoue, S., K. Ito, K. Yamamoto, and S. Kawanishi. 1992. Caffeic acid causes metal-dependent damage to cellular and isolated DNA through H202 formation. Carcinogenesis 13:1497-502.
Ip, C, C.A. Carter, and M.M. Ip. 1985. | |
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