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Monsanto Fights Back Over Controversial GM Study

By Anthony Fletcher
May 25, 2005

Published details of a Monsanto report are at the center of a new storm over whether genetically modified (GM) food could be harmful to human health, writes Anthony Fletcher.

Details of the report, published by the Independent on Sunday in the UK, are alleged to show that rats fed the genetically modified (GM) corn MON 863 developed internal abnormalities, while these health problems were absent from another batch of rodents fed non-GM food as part of the research project. The controversy comes as the Cartagena Biosafety Protocol summit meets in Montreal this week to discuss issues such as bulk labeling of GM crops and state liability in cases of contamination. Unsurprisingly therefore, food safety campaigners have pounced on the disclosure.

"Monsanto's refusal to hand over animal feeding studies concerning its biotech corn is outrageous,"Bill Freese, research analyst for Friends of the Earth US told

"I think it's fair to ask: Would Monsanto be hiding its safety studies if it didn't have something to hide?"

He points out that controversy surrounding the rat study was first broken by French daily Le Monde over a year ago, and that Monsanto is still refusing to release the study in its entirety.

Nonethlesess, it appears that this most recent disclosure has hit Monsanto hard. Shares were down 34 cents at $57.66 in early trading on the New York Stock Exchange on Monday. But the US biotech giant insists that it supplied all required information to the European Food Safety Authority (EFSA) prior to EFSA's 2004 favorable scientific opinion on the company's MON 863 corn.

What's more, the company is adamant that there is no new information about MON 863, modified to protect itself against corn rootworm, which has not been submitted to EU regulators.

"That is not the case," said Jerry Hjelle, vice president for Monsanto Worldwide Regulatory Affairs. "Monsanto has provided all required data and studies, including the subject rat study, to European regulatory authorities, and EFSA reviewed these studies before issuing its opinion."

Monsanto said that the product, which has been grown commercially in the United States and Canada since 2003, is safe, and that EFSA's Scientific Panel on Genetically Modified Organisms even published a statement on 29 October 2004 verifying this.

The company insists therefore that the research does not provide evidence of any hidden dangers in biotechnology, only inconsequential differences in kidney size and blood composition in the animals used. It has also defended its right not to disclose the full study as it "could be of commercial use to our competitors and exploited by others for commercial advantage, if made available."

It insists that all the information about its MON 863 maize, which was sent to the Independent on Sunday many weeks ago, is available here.

Monsanto, based in St. Louis, Missouri, is the world's leading developer of genetic modifications for corn, soybeans, cotton and canola. It argues that GM corn resistant to corn rootworm larvae could save US business millions of dollars; the US Department of Agriculture estimates that this pest causes $1 billion in lost revenue annually to the US maize crop.

U.S. farmers have largely embraced new bitechnology. But other countries, notably in the European Union, have been slow to approve the products because of questions about how genetic changes in the plants affect humans and animals.

Monsanto is still seeking approval to import the biotech corn for use in processed foods and derived food products, but the EU's 25 governments remain deadlocked over the issue.


Monsanto Agrees To Release Of Feeding Study Evaluations

By GM Free Cymru
Contact: Dr Brian John
Press Notice
May 31, 2005

In a major new development in the MON863 scandal, Monsanto has agreed that it does not object to the widespread dissemination of the "Pusztai Report" on its controversial 90-day rat feeding studies.

After an extended campaign from NGOs to achieve the publication of Dr Pusztai's evaluation, Monsanto's UK head of Corporate Affairs, Tony Combes, has now written to GM Free Cymru (1) to say that the company has not been responsible for the suppression of this Report, and claiming that the refusal to release it into the public domain was entirely down to the German Regulatory Authorities. Some of the findings of the rat feeding study were exposed in a special feature in the "Independent on Sunday" newspaper on 22 May 2005 (2), and the repercussions of the newspaper coverage have gone around the world.

Dr Arpad Pustai, one of the few genuinely independent scientists specializing in plant genetics and animal feeding studies, was asked by the German authorities in the autumn of 2004 to examine Monsanto's 1,139-page report on the feeding of MON863 to laboratory rats over a 90-day period. The study found "statistically significant" differences to kidney weights and certain blood parameters in the rats fed on the GM maize as compared with the control groups, and a number of scientists across Europe who saw the study (and heavily-censored summaries of it) expressed concerns about the health and safety implications if MON863 should ever enter the food chain. There was particular concern in France, where Prof Gilles-Eric Seralini of the University of Caen has been trying (without success) for almost eighteen months to obtain full disclosure of all documents relating to the MON863 study (3).

Dr Pusztai was forced by the German authorities to sign a "declaration of secrecy" before he was allowed to see the rat feeding study, on the grounds that the document is classified as "CBI" or "confidential business interest" (4). However, he assumed that this would not prevent the publication of his findings by the Germans themselves, should his evaluation highlight any health and safety concerns. In the event, his evaluation was highly critical of the methodology of the study, and he also expressed concerns about what the researchers had found. These concerns were identical to those of Prof Seralini and scientists in Germany and elsewhere, but the German Government refused to publish them and insisted that Dr Pusztai should respect his "gagging order." So he has been unable to circulate his written material and unable to speak on the record about what he has found.

The gagging of scientists like Prof Seralini and Dr Pusztai is serious enough, but the MON863 scandal was compounded when the European Food Safety Authority (EFSA) examined the reactions of all the EU regulatory bodies, decided that it did not like what was contained in the "Pusztai Report", and commissioned other experts to evaluate the evaluation (5). Then, having got the recommendation that it wanted -- namely that the statistically significant physiological changes in the rats fed on MON863 were not really significant at all -- EFSA published a Statement (6) advising the EC that MON863 was perfectly safe and wholesome. More seriously, in the EFSA Statement, and in subsequent Monsanto press releases, Dr Pusztai was named and criticized in spite of the fact that it was known by all concerned that he was effectively "gagged" and could not defend himself (7).

The "Pusztai Report" actually consists of three separate short documents (8), and although Dr Pusztai himself cannot release them, they have been circulating widely among NGOs and the GM scientific community in Europe because they have been examined by all of the European GM regulatory authorities and committees. Leaks could not be prevented, and GM Free Cymru obtained copies of the documents from the United States, Brussels and Eastern Europe. Since they were already published through the Email network, it was inevitable that they would eventually find their way onto the internet. They are now accessible via several different web sites (9).

Dr Brian John, speaking for GM Free Cymru, said: "We are delighted that this material is now available for examination by the scientific community, and we are grateful to Monsanto for confirming that it has no objection to the publication of the three documents (1). But we are appalled at the manner in which Dr Pusztai has been prevented from discussing his concerns with fellow scientists, and we will not give up on this issue until the German authorities remove his "gagging order." It will be easier for them to do this now that Monsanto has said that it has no objections to a free and open scientific debate. But we are even more appalled at the behaviour of EFSA, which is supposed to protect the European public from unwanted health hazards. Instead, when the organization has hazards brought to its attention, it refuses to see them. It is now widely perceived as having just one priority as far as GM issues are concerned -- namely the facilitation of GM approvals for the biotechnology corporations (10). The EC should get rid of this complacent and secretive body before it does any more harm."


  1. Email letter from Mr Tony Combes of Monsanto to GM Free Cymru, dated 28 May 2005

  2. "Revealed: health fears over secret study into GM food. Rats fed GM corn due for sale in Britain developed abnormalities in blood and kidneys" By Geoffrey Lean, Environment Editor 22 May 2005 "Rats fed on a diet rich in genetically modified corn developed abnormalities to internal organs and changes to their blood, raising fears that human health could be affected by eating GM food..........."

  3. For the attempts by Crii-gen to obtain key scientific information on MON863 since October 2003, see: Also Le Monde, 23 April 2004 and 14 December 2004

  4. GM Free Cymru has now submitted a request under the EU Freedom of Information legislation for sight of the certificate granting CBI status to the Monsanto rat feeding study, and the "Declaration of Secrecy" that Dr Pusztai was asked to sign.

  5. "Considerations regarding the scientific assessment of the safety of food and feed from GM plants, exemplified with GM insect resistant corn (MON863) as a case," Dr Ib Knudsen for the Swedish Board of Agriculture, 13 November 2004. 7 pp (available as a PDF file)

  6. The EFSA Statement on MON863 is available at

  7. MON 863 Maize 90-Day Rat Feeding Study Design and Conduct Fact Sheet

  8. The three documents in the "Pusztai Report" are as follows: (1) "Interim Report and Preliminary Evaluation..."; (2) "Evaluation and Final Report..."; (3) "Report on the newly provided data..."

  9. EU legislation states that research material on GM crops and foods which has health and safety implications must be placed in the public domain. The German authorities, and the EC, have been breaking their own laws by seeking to restrict consideration of the findings of Prof Seralini, Dr Pusztai and others to specialist committees which do not necessarily act in the public interest. NGOs like GM Free Cymru are determined to see full disclosure of all relevant documents relating to MON863, and will continue to fight against the corruption of GM science.

  10. Press Notice from GM Free Cymru, 24 May 2005 GM MAIZE CONSPIRACY REVEALED In spite of the reservations of their own scientists, delegates from France, Germany and the UK all voted for the approval of MON863 maize at an EU meeting on 19 May 2005: n=60119&m=1FNE520&c=ioycgujovowudvq However, EU members failed to agree, and so the application was rejected. The EC now has the power to approve MON863 on behalf of the member states; but in present circumstances that would be a very irresponsible thing to do.

The reports are available here.


Canada Rapped for 'Censoring' Biotech Critics

By Stephen Leahy
ENVIRONMENT:Inter Press Service News Agency
May 30, 2005

BROOKLIN, Canada (IPS) - A top African scientist and advocate of strong regulation of genetically engineered seeds and crops is demanding punitive action against Canada if authorities continue to try to block delegates like him from taking part in U.N.-sponsored talks.

Tewolde Berhan Gebre Egziabher, Africa's chief negotiator for the Cartagena Protocol on Biosafety and the Ethiopian government's chief scientist, had been denied a visa to attend talks in Montreal on the international movement of genetically engineered organisms until pressure from international non-governmental organisations (NGOs) forced a last-minute reversal by the Canadian government. The talks opened Monday.

His call for punitive steps -- possibly including shutting down U.N. offices in Montreal -- came amid revelations that other delegates from developing countries had been denied access to the U.N. talks in Montreal.

Tewolde, in an open letter to Klaus Toepfer, executive director of the U.N. Environment Programme, asked for a motion to censure Canada for the difficulty Tewolde had in getting a visa and for the continued difficulties he said are being experienced by other delegates to the Montreal conference on liability and labeling of genetically engineered organisms.

While Tewolde missed some meetings and arrived in Montreal May 27, a member of the Iranian delegation, Jafar Barmaki, was denied a visa.

Barmaki is a senior expert at the Ministry of Foreign Affairs responsible for biodiversity-related international agreements. According to the Centre for Sustainable Development and Environment, an NGO in Tehran, Barmaki has played an important role in promoting biosafety in Iran.

An agricultural economist and a farmer from India also were denied visas to appear as speakers at a side event organised by NGOs at the Montreal biosafety meetings. Kavulakunpla Ramanna Chowdry, a professor and adviser to the Andhra Pradesh state government, and Kaka Ramakrishna, a cotton farmer said to have suffered huge losses, were scheduled to speak about their experiences with the genetically engineered cotton.

Several thousands farmers and the government of Andhra Pradesh have demanded compensation from biotechnology major Monsanto Co. and its Indian seed partner, the Maharashtra Hybrid Seeds Company Limited (Mahyco), over the failure of Bt cotton, a genetically modified variety, according to Afsar H. Jafri of New Delhi's Research Foundation for Science, Technology and Ecology (RFSTE), a co-sponsor of the NGO event in Montreal.

"Professor Chowdry was prepared to tell the negotiators in Montreal (about) the extremely irresponsible and reckless behavior of Monsanto with the victim farmers and the government," Jafri said in a statement.

Beth Burrows, director of the U.S.-based NGO Edmonds Institute, also a co-sponsor of the NGO event, added "I never imagined this could happen in Canada. I have brought many people to lecture at side events before and never had a problem like this."

Burrows said she also learned that an NGO from Togo was unable to obtain visas.

"People are impacted by this (genetic engineering) technology and their voices need to be heard," she added.

Headquartered in Montreal, the U.N. Convention on Biological Diversity (CBD) adopted the biosafety protocol in 2000 to address the safe transfer, handling, and use of living genetically modified organisms (GMOs) that could harm the diversity of species living on the planet.

Burrows and others said they suspect Tewolde's and the other visa rejections amounted to an attempt to censor voices opposed to Canada, the United States and other countries that grow GMO crops and that oppose labeling and liability for contamination by genetically engineered pollen and seed.

Canada's department of foreign affairs has yet to officially comment and, despite several requests, declined to be interviewed by IPS.

Tewolde is firmly in support of bulk labeling of genetically engineered products and also liability and redress in the case of any damage to human health or the environment, said Julia Crosfield, a spokesperson for Consumers International, a coalition of 250 organisations in 115 countries.

"This is important to consumers who have rights to information, safety, and to a healthy and sustainable environment," Crosfield said.

Canada has experienced extensive contamination by genetically engineered canola (oilseed rape), where the GMO plants have spread far and wide in the country's western regions. Among the concerns with these crops is that they will mix with indigenous plants, change the genetic composition of valued species, and produce so-called superweeds, or wild plants that have been accidentally pollinated by a genetically modified plant and now contain that plant's abilities to resist herbicides and kill insects.

Presently there is no legal liability in Canada for farmers, nor the producers of the seed, to prevent or clean up any contamination. However, lawsuits have been filed.

And there have been news reports that Canadian genetically engineered canola has been found growing around eight Japanese ports despite rules on handling that are supposed to prevent such contamination.

"The talk in the corridors here by delegates and NGOs is whether or not this was done on purpose," said Lucy Sharatt of ETC Group, a Canadian-based NGO attending the Montreal meeting.

At the opening of the first meetings May 26, a delegate from Egypt expressed his regret at Tewolde's absence and stressed that "host countries are required to facilitate, not hinder, participation," according to the Earth Negotiations Bulletin news service.

Such participation includes not only delegates but also members of civil society who are full participants in the open forums, said Sharatt.

"Some delegates are asking if Canada can be relied on for future meetings," she said.

"If it was an error, why not apologise?" Sharatt asked.


Ireland Intercepts U.S. Biotech Corn

The Associated Press
May 25, 2005

BRUSSELS, Belgium -- Irish port authorities intercepted a shipment from the United States of animal feed that contained genetically modified corn banned in the European Union, the European Commission said Wednesday.

U.S. officials tested the shipment for Bt10 corn before it left, "and notified to Irish authorities before the ship arrived" in Ireland, EU Commission spokesman Philip Tod said.

About 290 tests for Bt10 have been conducted on EU-bound shipments, but this was the first time a test turned up positive, Tod said.

The EU's six-year ban on biotech foods in general ended in May 2004 when the European Commission approved a new corn developed by Swiss agrochemicals company Syngenta.

But a ban against Bt10 remains in place. The EU says it contains a gene that can make that strain of corn resistant to ampicillin, a commonly used antibiotic.

EU rules require the commission to prevent unauthorized genetically modified products from entering Europe.

Europeans have become increasingly wary what they eat, following recent food scares including mad cow disease in beef and poisonous dioxins in chickens.


Global Organic Sector Calls For Strict Liability Under The Cartagena Protocol On Biosafety

By Gerald A, Herrmann, Executive Director IFOAM
May 30, 2005

Organic farming, the systematic conversion of land to certified practices that ensure food safety and security from the farm to the table, a comprehensive and fully traceable system, is developing rapidly throughout the world.

According to the International Federation of Organic Agriculture Movement's study The World of Organic Agriculture: Statistics and Emerging Trends 2005, 36 countries achieved organic mega-country status in 2004, meaning that over 50,000 hectares of certified organic land are currently being cultivated. In total, over 26 million hectares of land are currently certified worldwide, generating over $25 billion in revenue in 2003.

558,449 farms in 108 countries are currently certified, and many millions of people are involved in the production, marketing, processing and distribution of organic products, generating immense income for a great number of people while simultaneously enhancing biodiversity and protecting the environment for future generations.

Organic agriculture is a holistic system that promotes and enhances biodiversity, biological cycles, and soil biological activity. Certified organic products are those which have been produced, stored, processed, handled and marketed in accordance with precise technical specifications (standards) and certified as organic by a certification body. The use of GMOs within organic systems is not permitted during any stage of organic food production, processing or handling.

The International Service for the Acquisition of Agri-Biotech Applications (ISAAA) issues an annual report on the amount of global biotech crop acreage. The 2005 report indicates that there were 14 biotech mega-countries in 2004 countries where more than 50,000 hectares or biotech crops are being grown.

The figures, however, are dubious. For instance, whereas the report claims that 500,000 biotech hectares are being grown in South Africa, a report from Agricultural Biotechnology in Europe, an industry coalition, and a survey team from the University of Reading in the UK show that the ISAAA's figures are exaggerated by factors of 20 and 30 respectively, and a recent report from GRAIN demonstrates that out of 3,000 farmers who originally grew Bt cotton there, only 700 continue to do, and many farmers who chose to grow the cotton are now perilously in debt. Also, 98% of the world's GM crops are still grown in only four nations --- USA, Canada, Argentina and a bit in China, which has remained the same for the last five years.

Biotech crops grown in so-called biotech mega-countries are planted indiscriminately without any substantive regulatory framework, increasing reliance upon dangerous herbicides and pesticides, creating super-weeds and destroying biodiversity in order to increase yields in the short term, but ultimately rendering the cropland useless, while simultaneously contaminating the world's major food crops with undesirable characteristics.

This contamination is not something the biotech industry should flaunt, but rather, the biotech industry should be held strictly liable for all such contamination under the Cartagena Protocol on Biosafety. Biotech crops have been riddled by scandal, from StarLink corn, which was not approved for human consumption but nevertheless entered the food supply, prompting the recall of over 300 contaminated food products from shelves in the USA and continues to linger in the food supply, to the illegal entry of a 1000 tons of Bt10 into the European Union, also not approved for human consumption, and the recent publication of internal Monsanto documents, reviewed by EU scientists, revealing serious health damage to laboratory animals fed Monsanto's new genetically engineered "rootworm-resistant" corn. Rats who consumed the mutant corn developed smaller kidneys and exhibited blood abnormalities.

Biotech crops containing industrial enzymes, pharmaceuticals, viruses, antibiotic resistance markers and other traits have been planted in large-scale field tests for years in the USA, but tests for those experimental crops do not exist, and thus it is likely that contamination of agricultural crops is much more widespread.

Alternatively, organic agriculture ensures food security and safety for future generations, distributing income equitably among those involved in the chain of production, and credibly backing up its claims with thorough documentation.

Organic agriculture also increases or stabilizes yields in developing countries, particularly in marginal and semi-arid areas, increasing productivity without dependency on unaffordable chemicals. The IFOAM Basic Standards include social standards that ensure the protection of workers? rights. IFOAM Accredited certifiers adhere to these social standards, and IFOAM is working together with the International Social and Environmental Accreditation and Labelling (ISEAL) Alliance to improve the effectiveness and compatibility of social and environmental standards and verification systems.

IFOAM calls for strict liability to be imposed for the introduction of GMOs. To insure that the costs of injuries resulting from defective products are borne by the manufacturer that put such products on the market rather than by the injured persons who are powerless to protect themselves, strict liability for GMOs is warranted.

Strict liability ensures that organic farmers and consumer receive protection from problems of proof inherent in pursuing negligence, placing the burden of loss on manufacturers rather than injured parties who are powerless to protect themselves. IFOAM applauds the inclusion of a GMO liability regime in the Cartagena Protocol on Biosafety, an idea that originated from African nations and other Third World nations, and is opposed by the USA and Canada.

IFOAM's Position on Genetic Engineering:

To purchase a copy of The World of Organic Agriculture: Statistics and Emerging Trends 2005, go to the IFOAM website

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