Ethiopia goes organic to feed herself - The Institute of Science In ...

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28 Prof. Joe Cummins discovers that dangerous GM pharmaceutical crops have been produced and marketed in the United States for at least two years, unbeknownst to the public, via a gaping loophole in the regulatory process. Pharm Crop Products in US Market There has been a great deal of public opposition recently to the testing of rice genetically modified to produce the human proteins lysozyme and lactoferrin in the United States. So far, plans to commercialize this rice have been stalled (see SiS 22). But, Sigma-Aldrich, a US chemical company, has been marketing the biopharmaceutical products trypsin, avidin and beta-glucuronidase (GUS) processed from transgenic maize, for at least two years. Meanwhile, Prodigene Corporation and Sigma-Aldrich are marketing aprotinin (AproliZean) from maize and from a transgenic tobacco. Trypsin is a digestive enzyme used extensively in research, to treat disease and in food processing. The product TrypZean is marketed as an animal free product, and is produced jointly by Sigma- Aldrich and Prodigene (the company fined for contaminating food crops with biopharmaceuticals in the United States last year). The development of genetically modified (GM) food crops generally follows a certain pattern in the United States: First, controlled field tests are undertaken for a number of seasons. Then, the proponent applies for deregulation of the GM crop following reviews by the Animal Plant Health Service (APHIS) of the Department of Agriculture (USDA), the Food and Drug Administration (FDA) and by the Environmental Protection Agency (EPA) if the GM crop includes a plant incorporated biopesticide. Upon completion of the process, the GM crop is deemed to be deregulated and can be grown without monitoring. However, none of the biopharmaceutical-producing GM crops appears to have gone through the usual regulatory process. Instead they appeared to have progressed from field-testing to marketing without the benefit of final regulatory approval, with apparently full cooperation of the FDA and USDA (the agriculture department has proprietary interest in some of the biopharmaceuticals). The biopharmaceuticals have proceeded to the market via the backdoor, thanks to a loophole in the regulation of field tests. According to the Pew Initiative on Food and Biotechnology, "current APHIS regulations do allow the commercialization of a GE [genetically engineered] crop without a prior affirmative approval by the agency and without public notice. Developers are not required to file a petition for nonregulated status before they produce a plant commercially. It is possible for developers to grow plants at a commercial scale under notification or field trial permits, even if the plants might pose some identifiable environmental or human health risk". Crop production facilities are permitted as "field tests", but locations of such facilities are designated "confidential business information" and are not disclosed to people living nearby, even though the genes and products of such sites can easily contaminate crops, ground water and surface water. There seems to be no direct way to find out where the production facilities are, except via producers and government regulators. The US government seems committed to going ahead with a procedure that bypasses public input and scrutiny, and which if, when disclosed, will threaten the marketability of US food exports. In contrast, the Canadian Food Inspection Service maintains that "plant products of test sites cannot be marketed", even though numerous plant biopharmaceutical products have been tested. The regulation of plant-derived biopharmaceuticals was reviewed by the FDA in 2000; and by the Pew Initiative in 2004. Only the Pew report came to grips with the practice of marketing virtually untested products commercialized without public input. As indicated earlier, test plot permits for crops producing biopharmaceutical proteins are usually designated confidential business information so that the nature of the products is hidden from the public as well as the location of the test sites. APHIS does, however, record the crop and the state in which the modified crop is tested. Between 2003 and 2004, Prodigene had test plots in Nebraska, Texas, Iowa and Missouri. Production of the commercial biopharmaceuticals was, for the most part, achieved using maize, even though it is a food crop of fundamental importance and should not have been used to produce biopharmaceuticals, especially when the products are by no means benign for humans and animals exposed to them. Trypsin is an enzyme produced in the pancreas to digest proteins. It is extensively used in laboratory applications, in wound treatment and to treat diabetes. It is also used in food processing and often put into infant formulations to aid in digestion. The plant-produced product is desirable because it is free of prions and animal viruses. According to the safety data sheets provided by trypsin manufacturers, the product is capable of causing allergy - it is a skin, eye and respiratory irritant and may be a mutagen. Avidin is a protein found in birds' eggs. It functions to bind the vitamin biotin, which is required for many insect pests. The pests are inactivated by the absence of the necessary vitamin. Transgenic maize modified for avidin production is resistant to storage insect pests. A case study done by the Friends of the Earth turned up substantial evidence that the protein avidin caused dangerous biotin deficiency in humans and animals, leading to immune deficiency and growth retardation. Even marginal biotin deficiency is linked to birth defects in mice and in humans. Aprotinin is a protease inhibitor normally prepared from the pan- SCIENCE IN SOCIETY 23, AUTUMN 2004
29 creas and lung of cows. Recombinant aprotinin produced in plants is currently marketed. Bill Freese of Friends of the Earth reviewed the problem of allergy and pancreatic disease associated with this product. Aprotinin is also listed as a reproductive hazard. There is serious danger to those exposed to aprotinin after having had a previous exposure. For example, a two-year old child suffered severe anaphylactic shock (a lifethreatening allergic reaction characterized by swelling of body tissues including the throat, difficulty in breathing, and a sudden fall in blood pressure) after a test dose of aprotinin. Fatal anaphylaxis followed aprotinin exposure in a local application of fibrin glue. A similar application led to an immediate skin reaction following re-exposure to fibrin sealant. Secret field testing of plantbased recombinant aprotinin could result in severe or fatal anaphylaxis, either in a brief exposure in the maize field of someone previously treated during surgery, or exposure of someone exposed to the maize field followed by treatment during surgery. The final commercial recombinant protein in maize is beta-glucuronidiase (GUS). The gene is used in a wide range of experimental situations but does not appear to have therapeutic importance. It has been observed that formula milk for infants had a low content of GUS while mother's milk had elevated GUS. Elevated GUS has been implicated in bilirubinaemia (jaundice) of breast-fed infants and breastfed infants of diabetic mothers. GUS is used extensively as a marker, believed to have little effect on the phenotype of the test organism. However, GUS was found to enhance the feeding activity in the peach aphid, suggesting that the marker may not be entirely without effect on the organism. In conclusion, the secretive production of dangerous pharmaceuticals in food crops is a truly disturbing development. The sale of such products without transparent public approval is adding insult on injury, reinforcing the public perception that the regulatory authorities are putting corporate profit far above public safety. SiS Ban Plant-based Transgenic Pharmaceuticals Prof. Joe Cummins and Dr. Mae-Wan Ho call for a global forum and a ban on testing pharm crops, especially in Third World countries As one after another biotech giant retreated from genetically modified (GM) crops for food and feed in Europe (see "Biotech investment busy going nowhere", this issue), the industry is redoubling its efforts to develop plantbased transgenic pharmaceuticals in North America and elsewhere. In April 2004, California stalled a major attempt to introduce GM rice producing human lactoferrin and lyzozyme into 10 counties, but efforts to use rice and other food crops to produce hazardous pharmaceuticals have continued unabated. On 12 July, the European Union (EU) announced the award of 12 million euros to a network of laboratories in 11 European countries plus South Africa to explore the possibilities of producing pharmaceuticals grown in genetically modified plants. The consortium, "Pharma-Planta", will use plants to produce vaccines and treatments against major diseases including AIDS, rabies, diabetes and TB. Human trials of the drugs are to begin within the next five years. The project is co-ordinated in the UK by Prof. Julian Ma of St. George's Medical School London; and John Innes Centre, UK's top GM crop research institute is also a member of the consortium. A day later, it was revealed that South Africa, the only member of the consortium outside Europe, is to be the test site of the first pharm crops. South Africa's Council for Scientific and Industrial Research is particularly interested in potential vaccines against HIV. Philip Dale, plant technologist at John Innes Centre in Norwich and the project's biosafety co-ordinator, reportedly said that the cost of 24-hour surveillance of GM fields in the UK has made it expensive to conduct similar trials in Britain. The use of Third World countries for testing and producing plant-based pharmaceuticals unacceptable both in Europe and the United States smacks of colonialism. It also raises the spectre of unmonitored and unregulated human exposures to the dangerous products. This problem will be exacerbated as opposition to pharm crops is growing in the United States, and more Third World countries will be targeted for test sites and production facilities. ISIS has played a key role in exposing the marketing of pharm crop products in the United States previously unbeknownst to the public, via a gaping loophole in the US regulatory system (see "Pharm crop products in US market", this issue). A coalition of consumer and environmental organizations in the US issued a call for a moratorium on genetically engineered pharm crops on 21 July. They want the California state agencies to conduct a rigorous investigation of the potential hazards posed by a biotech company's plan to produce pharmaceutical drugs from genetically engineered rice. There is an urgent need for proper international regulation on the testing and production of plant-based pharmaceuticals. The first step may be a wider discussion of the drawbacks and dangers of plant-based pharmaceuticals as well as the "advantages" put forward by proponents in academe and corporations. The overlooked dangers of pharm crops include pharmaceuticals that are toxic, that could produce immune sensitization followed by anaphylaxis, or oral tolerance leading to loss of immunity to pathogens; and general loss of confidence in the food supply. These have been discussed in numerous reviews from the Institute of Science in Society. The United Nations Food and Agriculture Organization (FAO) has run a number of electronic conferences around "Agricultural Biotechnology for Developing Countries - an Electronic Forum". These moderated discussions have been quite productive. It is time to have an electronic forum on "Plantbased Pharmaceuticals in Developing Countries". Do contact the administrator of the FAO project Dr. John Ruane, at biotechadmin@fao.org to call for such a forum as a matter of urgency. The FAO forums are described at the following URL: http://www.fao.org/DOCREP/004/Y2729 E/Y2729E00.HTM It is important that the testing and production of plant-based pharmaceuticals in the Third World are made public before they are quietly and extensively carried out without the informed consent of those directly affected. Meanwhile, it is imperative to impose a ban on field test releases and biopharmaceutical production by multinational corporations and foundations, especially in Third World countries. SiS www.i-sis.org.uk
Page 1 and 2: Science in Society ISSUE 23 Autumn
Page 3 and 4: From the Editor Corporations coveti
Page 5 and 6: 5 dependency ratio and although off
Page 7 and 8: 7 Figure 1. Maize yields in 5 sites
Page 9 and 10: Rice Wars 9 Fantastic Rice Yields F
Page 12 and 13: 12 New Rice for Africa Dr. Mae-Wan
Page 14 and 15: 14 Does SRI Work? The first reality
Page 16 and 17: 16 hybrid rice Liangyoupei 9, which
Page 18 and 19: ier around the field. There is a pa
Page 20 and 21: 20 Chinese researchers have develop
Page 22 and 23: 22 Two Rice Better than One Lim Li
Page 24 and 25: "Silicon Valley of agricultural bio
Page 26 and 27: 26 Approval of Bt11 Maize Endangers
Page 30 and 31: 30 Collusion and Corruption in GM P
Page 32 and 33: 32 Questions over Schmeiser's Rulin
Page 34 and 35: 34 DNA in GM Food & Feed The govern
Page 36 and 37: 36 denum of cattle. The studies wer
Page 38 and 39: Prof. Joe Cummins explains why gene
Page 40 and 41: 40 Technology Watch Bio-remediation
Page 42 and 43: Rethinking health Selenium Conquers
Page 44 and 45: 44 Delivering Good Health Through G
Page 46 and 47: 46 process in which new humans are
Page 48 and 49: 48 molecules in liquid, allowing ra
Page 50 and 51: 50 Water Forms Massive Exclusion Zo

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