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GM Ending?

From the Editor
The Institute of Science in Society (
Science in Society #22
Summer 2004

Jubilation swept through the green and pleasant land like a sunburst after the storm as Bayer CropScience abandoned growing GM maize in Britain, just weeks after the government gave it the go-ahead, aided and abetted by pro-GM scientists shamelessly bending science and scientific evidence. Bayer said the conditions imposed by environment secretary Margaret Beckett made growing GM maize "economically non- viable".

Bayer is not alone. Novartis has also told the government that no GM crops will be grown this year. In fact, all GM trials in the UK have been abandoned except for one, a herbicide-resistant pea tested for drought resistance at John Innes Centre, Norwich. This reflects a precipitous fall in applications for GM field trials from a peak of 159 in 2000-01, 140 in 2001-02 and 42 in 2002-03.

Developments elsewhere have been equally dramatic.

In just over a week at the end of March, 4 States in Australia ruled out large-scale planting of GM crops: Western Australia, the nation's biggest crop producer, took the lead by announcing an outright ban. The next day Tasmania, too, voted for a ban. Victoria followed two days later by extending its moratorium on GM crops for four years. A few days later, New South Wales ruled out a 3 000 hectare trial of GM oilseed rape. And South Australia passed a bill that prevents GM crops from being grown for three years, except under strict conditions. This effectively puts Australia's plans to grow GM crops "on hold indefinitely".

Simultaneously, a grassroots uprising has been gathering momentum in the United States, top grower and exporter of GM crops. In March, Mendocino County of California passed 'Measure H', which bans growing GM crops. A month later, the California Department of Food and Agriculture stalled the planting of a transgenic rice that produces dangerous pharmaceuticals. Then Vermont made history by becoming the first state in the country to require the labelling of GM seeds, and North Dakota drafted a ballot measure that could block Monsanto's GM wheat.

On 21 April, President Chavez of Venezuela announced a ban on cultivation of GM soya in favour of the indigenous yucca. This followed on the heels of Angola's rejection of GM maize aid from the US. Angola has aligned itself with four southern African nations - Zambia, Zimbabwe, Mozambique and Malawi – which have already banned imports of GM maize grain. Zambia made world headlines in rejecting US GM maize aid two years ago in the face of projected famine, opting instead for purchasing food surpluses from within the region (see SiS 16 and 17). Zambia has recovered so well that it is now exporting maize surpluses to Angola.

These are stunning victories for democracy and for science. ISIS and members of the Independent Science Panel (ISP) have been tireless in exposing the corrupt and corrupted science that has fed the GM bubble and brought financial and ecological ruin to family farmers in North America, Argentina and elsewhere.

The GM fight is by no means over. More GM crops are approved for growing in India, despite devastating counter-evidence. The Philippines, Indonesia, Kenya and other African countries are still under threat. The US lodged a complaint against the EU in the World Trade Organisation, and is demanding that the EU lifts its de facto moratorium on GM crop approvals and pay at least US$1.8 bn to the US in compensation for loss of exports over the past six years.

Further evidence of possible GM health hazards has surfaced: debilitating illnesses in villagers living near GM maize fields in the Philippines observed during the last growing season are repeated this year.

The French newspaper Le Monde has seen secret documents revealing health impacts of Monsanto's GM maize Mon 863, which has just received a positive assessment from the European Food Safety Authority. They include kidney malformations and increases in white blood cells in male rats and increase in blood sugar and decrease in reticulocytes (immature red blood cells) in female rats.

It is clear that major struggles remain. The ISP's two-hour briefing to the UK Parliament filled the 100-seater Grand Committee Room to near capacity. Former environment minister Michael Meacher joined the ISP to call for a comprehensive enquiry into GM food safety, for transparency and independence in scientific research, and an end to the victimisation of scientists whose research findings are 'inconvenient' for industry.

The GM-Free sustainable world is within our grasp. Don't let it slip out of reach.


Pharm Crop Products In US Market

ISIS Press Release
May 26, 2004

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.

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, those tests 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 bio-pesticide. 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 non-regulated 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 pancreas 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 life-threatening 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 plant-based 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 breast-fed 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.

A fully referenced version of this article is posted on ISIS members' website


Indonesia Starts Monsanto Inquiry

The Wall Street Journal
May 27, 2004

JAKARTA, Indonesia -- Indonesia's new anticorruption commission has begun its own investigation into allegations that U.S. biotechnology concern Monsanto Co. bribed an Indonesian government official two years ago, providing an early test of the new body's ability to crack down on graft.

The U.S. Department of Justice has been investigating the suspicious Monsanto payment, which could have violated the U.S. Foreign Corrupt Practices Act. Under that law, a company can face a maximum fine of $2 million per violation, while an individual faces up to five years' imprisonment. The U.S. Securities and Exchange Commission also can impose fines.

The investigation was sparked by Monsanto itself, which alerted U.S. regulators in late 2002 to financial irregularities at its Indonesian business. That led to the firing of some Indonesian employees. Monsanto said it is cooperating with authorities.

Indonesia's own investigation will be the first into the activities of a foreign company in Indonesia by the agency which was established in December. There has been skepticism about whether the new agency can make much headway against Indonesia's deeply entrenched corruption problem, an issue often cited as one of Indonesia's biggest obstacles to increased foreign investment.

In an interview, Erry Riyana Hardjapamekas, the vice chairman of Indonesia's Corruption Eradication Commission, said he has summoned officials from Monsanto's Indonesian unit, PT Monagro Kimia, to explain news reports that the company authorized an improper $50,000 payment to an Indonesian government official in early 2002. Mr. Erry said his agency is seeking information from U.S. authorities and would attempt to identify and prosecute the government official who allegedly received the bribe.

Edwin Saragih, Monsanto's head of government and public affairs in Indonesia, said the company intends to meet with the Commission in the next few days to discuss the matter. He declined to say whether Monsanto would reveal the name of the government official allegedly involved.

Monsanto sells Roundup brand herbicide and corn seed in Indonesia, a market that generates less than 1% of the company's global annual revenue. Monsanto closed its genetically modified cotton sales operations in 2003 after two unsuccessful years amid complaints over yields and pricing. During the year ended Dec. 31, 2003, Monsanto's world-wide sales totaled $5.06 billion.

Indonesia set up its anticorruption commission in December after years of delays in response to calls from the International Monetary Fund and other organizations for more effective measures to stop graft in government. Indonesia is regularly ranked among the most corrupt countries in the world by international watchdogs such as Transparency International.

Some critics have complained that the Indonesian Parliament declined to appoint individuals with reputations as aggressive anticorruption fighters to the panel. Others, however, have said the commission should be given time to prove its worth.

Apart from the nascent investigation into Monsanto, the commission also is assisting police in probing corruption allegations against Abdullah Puteh, who is the governor of Aceh, a natural-gas rich province on the northern tip of Sumatra island.

Mr. Abdullah has been accused by citizens' groups of embezzling millions of dollars in government funds in the province, where a war is raging between the military and separatist rebels. He has repeatedly denied the charges.


Ultrastructural Morphometrical and Immunocytochemical Analyses of Hepatocyte Nuclei from Mice Fed on Genetically Modified Soybean

Cell Structure and Function
Vol. 27 (2002) , No. 4 pp.173-18

GM Crops Alter Structure and Function Of Liver, New Research Shows

Manuela Malatesta 1), Chiara Caporaloni 1)2), Stefano Gavaudan 2), Marco B.L. Rocchi 3), Sonja Serafini 4), Cinzia Tiberi1) and Giancarlo Gazzanelli 1)

  1. Istituto di Istologia e Analisi di Laboratorio, via Zeppi s.n., University of Urbino
  2. Istituto Zooprofilattico Sperimentale dell'Umbria e delle Marche
  3. Istituto di Biomatematica, Località Crocicchia, University of Urbino
  4. Istituto di Chimica Biologica "G. Fornaini", via Saffi 2, University of Urbino

ABSTRACT. No direct evidence that genetically modified (GM) food may represent a possible danger for health has been reported so far; however, the scientific literature in this field is still quite poor. Therefore, we carried out an ultrastructural morphometrical and immunocytochemical study on hepatocytes from mice fed on GM soybean, in order to investigate eventual modifications of nuclear components of these cells involved in multiple metabolic pathways related to food processing. Our observations demonstrate significant modifications of some nuclear features in GM-fed mice. In particular, GM fed-mice show irregularly shaped nuclei, which generally represents an index of high metabolic rate, and a higher number of nuclear pores, suggestive of intense molecular trafficking. Moreover, the roundish nucleoli of control animals change in more irregular nucleoli with numerous small fibrillar centres and abundant dense fibrillar component in GM-fed mice, modifications typical of increased metabolic rate. Accordingly, nucleoplasmic (snRNPs and SC-35) and nucleolar (fibrillarin) splicing factors are more abundant in hepatocyte nuclei of GM-fed than in control mice. In conclusion, our data suggest that GM soybean intake can influence hepatocyte nuclear features in young and adult mice; however, the mechanisms responsible for such alterations remain unknown.

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