Say No To GMOs! logo

GM Safety Tests 'Flawed' New Scientific Paper Shows

Immediate Release
November 16, 2004

EU approval of Monsanto GM corn questioned

A peer-reviewed scientific paper, published today in Biotechnology and Genetic Engineering Reviews, debunks the myth that genetically modified (GM) crops are thoroughly tested, regulated and proven safe.

The paper, "Safety Testing and Regulation of Genetically Engineered Foods" [a copy can be obtained from Friends of the Earth.], includes a comprehensive case study of two types of insecticide-producing GM maize (chiefly the MON810 variety of biotech giant Monsanto), showing how flawed testing and regulation permitted these varieties onto world markets despite evidence that they could cause food allergies.

The European Commission recently approved 17 maize varieties derived from MON810, a move that was criticized by a number of EU states including Poland, Austria, Italy, Germany, Greece and Denmark.

Friends of the Earth has also raised concerns with UK Environment Secretary, Margaret Beckett about the prospects of Monsanto’s GM maize being grown in the UK. The British Government has assured the public that GM crops would only be grown in Britain following rigorous testing and under tough controls. But unless the Government takes preventative action, Monsanto’s GM maize (MON810) could be grown in the UK by farmers as early as next spring.

The scientific paper reveals fundamental flaws in how biotech companies test GM crops, and the way the U.S. government regulates them. The paper raises serious questions about whether GM foods, which have been on the market since 1994, are in fact safe, as claimed by the biotech industry and U.S. regulators.

Authors Dr. David Schubert and William Freese base their meticulously documented, 25-page paper on nearly 100 sources, including little-known U.S. regulatory documents and unpublished studies by biotech companies.

"One thing that surprised us is that U.S. regulators rely almost exclusively on information provided by the biotech crop developer, and those data are not published in journals or subjected to peer review," said co-author Dr David Schubert.

William Freese said: "In one case, the U.S. Environmental Protection Agency ignored a published study by an Food and Drug Administration (FDA) scientist suggesting that GM corn could cause food allergies, and instead asked Monsanto and Syngenta to essentially re-do FDA’s analysis."

The US is the world’s largest exporter of GM crops and accounts for nearly two-thirds of all biotech crops planted globally. GM soya and GM maize account for 83 percent of all GM crops planted on the planet.

"The picture that emerges from our study of U.S. regulation of GM foods is a rubber-stamp 'approval process' designed to increase public confidence in, but not ensure the safety of, genetically engineered foods," said Schubert. "We outline a testing scheme that would be a first step toward putting regulation of GM foods on a scientific footing," he added.

Friends of the Earth’s GM campaigner, Clare Oxborrow, said: "This paper undermines claims that GM foods are well tested and well regulated in the United States, and raises serious question marks over the safety of GM products that the European Commission is forcing onto the market. The Commission must put the safety of people and the environment ahead of the profits of biotech firms and refuse to licence any new GM food or crops."

See "Key Findings" below for more information on the paper and the authors.


Key Findings: Safety Testing and Regulation of Genetically Engineered Foods

By William Freese & David Schubert

In the U.S. regulatory system, the EPA, not the FDA, has primary responsibility for GM plants that produce insecticides.

Deficiencies in U.S. government regulation

  • The U.S. Food and Drug Administration (FDA) does not require testing of GM foods, but rather has a "voluntary consultation" process. Companies that voluntarily consult with the FDA sometimes fail to respond to FDA requests for additional information. FDA reviews "summary data," not full studies, making a critical review impossible. FDA does not approve GM crops as safe; instead, the GM crop developer is made responsible for the safety of its product.
  • The U.S. Environmental Protection Agency (EPA) regulates insecticide-producing GM plants. EPA often fails to collect data for review of potential human health impacts and accepts substandard testing by biotech companies. EPA has ignored evidence from independent researchers that conflicts with company-provided information. EPA raises the maximum permissible levels of herbicide residues on crops to facilitate introduction of herbicide-tolerant GM crops.
  • The U.S. Dept. of Agriculture (USDA) has not established rigorous rules to prevent GM crops from contaminating conventional crops, even when the contamination could lead to creation of difficult to control "superweeds." USDA permits cultivation of GM pharmaceutical crops, despite two contamination incidents necessitating destruction of large quantities of corn and soybeans. The USDA does not test neighboring fields for GM contamination or require companies to supply test kits.

Flaws in biotech company testing practices

  • The use of surrogate GM proteins for testing rather than the GM plant-produced proteins that people actually consume
  • The failure of companies to test for most possible unintended effects of the unpredictable genetic engineering process; in particular, there is a lack of long-term animal feeding studies
  • The tendency of companies to manipulate test conditions to get the desired results, facilitated by the failure of regulatory agencies to establish test protocols

Case study of GM corn

  • Evidence that insecticide-producing GM corn may cause food allergies has been ignored by the EPA
  • Increased lignin levels in some GM corn varieties was not detected before commercial sale and has still not been explained (lignin is the woody substance in stalks)
  • FDA has fundamentally flawed molecular information on Monsanto’s MON810 corn, reflecting the weakness of its voluntary consultation process

About the authors

David Schubert, Ph.D is on the faculty of the Salk Institute of Biological Studies in San Diego, California, where he is head of the Cellular Neurobiology Laboratory. He has a B.A. in chemistry and a Ph.D. in cell biology. Dr. Schubert's fields of scientific expertise are molecular genetics, cell biology, and protein chemistry. He has published over 200 reviewed manuscripts in these areas and has written and lectured on the potential health hazards associated with genetically modified crops.

William Freese has worked as research analyst with Friends of the Earth since July 2000. He was part of the team that discovered GM StarLink corn, unapproved for human consumption, in the food supply. He has helped inform the public and the food industry about the irresponsible practice of "biopharming" (, and has written and lectured on many aspects of GM crops and their regulation. Freese has a B.A. in chemistry from Grinnell College.


New FDA Guidelines Okay Contamination of Food Supply With Genetically Engineered Crops Still in Field Research

Center for Food Safety
For Immediate Release
November, 19 2004

Washington DC: Late today, the FDA released new guidelines for genetically engineered crops still in testing that would allow them to contaminate the nation s food supply with genetic material. The policy sets guidelines allowing companies to voluntarily seek safety review of genetically engineered traits that could escape field test plots and enter the food supply. Such review could have the effect of exempting such contaminants from being declared food adulterants under existing Federal food safety laws.

"With these guidelines, the government has admitted it cannot protect our food supply from genetic contamination," stated Joseph Mendelson, legal director of the Center for Food Safety (CFS). "The developers of biotech crops still in the testing phase now have no incentive to contain genetic pollution from whatever compounds they are engineering into crop plants."

Expected to be published in Federal Register just before Thanksgiving, the FDA proposal admits to seeking a solution to the increasing problem of genetic pollution the cross pollination of conventional crops with material from genetically engineered crops being grown on test plots. A key provision in the proposal provides for companies to voluntarily perform an abridged safety assessment of genetic material from biotech crops. This confidential, limited review would grant biotech crop manufacturers the legal cover to allow these engineered test crops to enter the American food supply prior to full government pre-market oversight and safety review. The proposed review would involve no safety tests in animals, a standard method to test for toxicity. It also excludes testing for unintended effects caused by genetic engineering, and sets no limits for the amount of contamination of food allowed. The new guidelines, thereby, make an extremely weak safety review even weaker.

The groups also denounced the Federal government s consistent refusal to engage in full environmental review of all genetically engineered field test sites before planting.

"The government is admitting that genetically engineered field test sites are polluting our food supply and environment, yet it consistently exempts these field tests from full environmental review" added Mendelson. We need the agencies to prevent pollution not find new ways to make it okay.

"We need mandatory safety testing for all genetically engineered crops coming to market and not FDA actions allowing companies to contaminate our food supply with unknown genetically engineered test products," Mendelson continued.


Beware Monsanto's "Vistive Soybeans"

ISIS Press Release
November 25, 2004

Prof. Joe Cummins lifts the lid on a new wave of genetically engineered products that claim to offer "healthier foods" and "direct consumer benefits".

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

In September 2004, Monsanto announced a "Vistive soybean" with reduced linolenic (low linolenic or LL) acid content that will be available for planting in the 2005 season. Although promoted as "produced through conventional breeding" because it includes natural genes reducing the oil content of linolenic acid, Vistive also has transgenes conferring the Roundup Ready trait.

Vistive soybean does not appear to have been approved under the usual procedure for transgenic crops because the reduced linolenic acid content was achieved using traditional selection and breeding. Instead, government regulators assumed that the Roundup Ready trait acts independently of the LL trait and for that reason the two kinds of traits could be joined by crossing two strains.

Certainly, there is no precedent for reviewing and approving novel crops produced by conventional breeding, but if the LL trait interacts with the Roundup Ready (glyphosate tolerance) trait, Vistive soybeans should be re-evaluated as an alteration to the original Roundup Ready trait. There is a clear indication that the use of glyphosate on the soybean crop will result in an impact on fatty acid metabolism through the breakdown products of the herbicide (see later).

Vistive soybeans with the Roundup Ready trait are claimed to contain less than 3% linolenic oil, in contrast to the 8% linolenic content for conventional soy oil. Low linolenic oil is more stable, with a better flavour and requires less hydrogenation. Trans fatty acids are produced in the hydrogenation process; and trans fatty acids are linked to heart disease because they lower HDL (good) cholesterol while raising LDL (bad) cholesterol. Ironically, trans-fats labelling is to begin in 2006 in the United States, even though industry and regulators in the United States resist labelling of products containing transgenes.

In plants, fatty acids are produced in the chloroplasts. Two molecules are crucial for fatty acid synthesis: acetyl-CoA and malonly-CoA (acetyl-CoA with an added carbon dioxide molecule). The number of carbon atoms in the long fatty acid chain is always even, and the carbon molecules are added two at a time. The newly synthesized fatty acids may be altered in mitochondria, or the endoplasmic reticulum, or stored in membrane bound lipid vesicles.

Catabolism of the fats is undertaken in organelles called glyoxysomes where the fatty acids are degraded two carbon atoms at a time, by a process called beta-oxidation. Fatty acids are modified in organelles and the endoplasmic reticulum by the lipoxygenase pathway to produce plant defence and signalling compounds such as jasmonates. Glyoxysomes carry out the glyoxylate cycle - a modification of the tricarboxylic acid cycle found in plants and microbes - as well as beta-oxidation. Fatty acid metabolism is crucial to energy transformation in plants, but also contributes to cell structure and to signalling and defence.

The transgenic parent of Vistive soybean is the soybean line GTS40-3-2 (event MON-04032-6), tolerant to glyphosate. The strain was released commercially in the United States in 1994, then Canada (1995), Japan (1996), Argentina (1996), Uruguay (1997), Mexico (1998), Brazil (1998) and South Africa (2001). The transgenic construct includes a synthetic approximation of the EPSPS gene from Agrobacterium for tolerance to glyphosate, adjusted for the codon preference of the crop. The EPSPS gene was driven by the enhanced 35s cauliflower mosaic virus promoter, and the sequence included a chloroplast transit protein from petunia and a nopaline synthesis terminator from Agrobacterium .

Six years after Roundup Ready soy was released to the environment, Monsanto acknowledged that an "inactive" 75 base pair fragment and a 250 base pair fragment of the EPSPS gene were inserted outside the open reading frame of the EPSPS protein (those inserts were over 20% the size of the EPSPS gene). The origin of the gene fragments and their possible activity was curtly dismissed without fuller explanation. The evident instability of these and other crop transgenes has been discussed by Mae-Wan Ho, and raises many biosafety concerns.

Possible interactions between the LL and Roundup Ready genes of Vistive soy cannot be dismissed, as the crop will certainly be sprayed with glyphosate. The herbicide will accumulate to levels toxic to animals and humans if it is not broken down in the plant cell. In plants, glyphosate is normally broken down by glyphosate oxidase (GOX) enzyme (presumably an enzyme present to digest natural products). GOX enzyme accelerates the breakdown of the herbicide glyphosate into two compounds, aminomethylphosphonic acid (AMPA) and glyoxylate. Glyoxylate is commonly found in plant cells and is further broken down by the glyoxylic pathway for lipid metabolism. The increased concentration of glyoxylate due to glyphosate breakdown would certainly disturb the metabolism of fatty acids.

Glyphosate exposure of herbicide tolerant groundnut was observed to increase glyoxylase enzyme. Presently, it is not possible to predict the nature and extent of disturbance of fatty acid metabolism, nor the impact on LL function. The point is that there is a clear link between Roundup Ready and LL traits, which should be explored fully before the Vistive crop reaches general distribution. Every transgenic crop should be reassessed after it has been crossed with a variety derived from conventional selection, especially one that has a clear metabolic association with the transgene, before any release of the crop. There should be a rule to ensure that careful reassessment is done.

The burden of proving that releases such as Vistive are safe rests with the proponent. Experiments must be done to ensure that the Roundup Ready genes and the LL genes are independent of each other, and that any interactions are fully risk assessed. In addition, Roundup Ready soybean itself should be reassessed in light of new scientific evidence raising questions about transgenic instability.


Farmers Urged to Learn about GMOs Before Planting 2005 Crops

November 19, 2004

GMOs are legal minefield for both growers and their neighbors

Pittsboro, N.C. - The commercial production of genetically modified organisms, or GMOs, has created a legal minefield for American farmers and requires that farmers be particularly sure footed, says Farmers' Guide to GMOs, just released by the Farmers' Legal Action Group (FLAG) and Rural Advancement Foundation International-USA (RAFI-USA).

Co-author and attorney David R. Moeller of FLAG says that whether farmers grow GMOs, conventional seeds, or are certified organic, the use of GMOs in commercial agriculture can affect operations and have costly legal ramifications.

"After almost a decade of commercial production, we have reached that point," Moeller said, "where every farmer has a stake and has to be fully aware of the legal ramifications. No farmer should buy seed for next season without having a grasp of the information contained in this Guide."

Co-author Michael Sligh of RAFI, said, "The problems GMOs are creating for farmers are getting increasingly complex. We at RAFI felt it was time to invest in a collaborative effort to inform all farmers of the risks and legal liabilities involved and help them protect their self interests." Copies of the Farmers' Guide to GMOs, the first comprehensive look at the subject, are available free at and

GMO contamination is one of the primary GMO-related problems. "In a world of widespread production of GMO crops, what one farmer plants may seriously affect all of his neighbors' crops. Certain crops, such as corn and canola, cross-pollinate, causing genetic material to migrate," Moeller said. "Farmers may be unable to market contaminated non-GMO crops, and GMO growers may face liability for unintentional contamination of their neighbors' crops."

GMO development and marketing is concentrated in a few biotechnology companies - Monsanto, DuPont, Syngenta and Aventis - who control most of the GMO technology and the resulting seed and chemical markets. GMOs are regulated by three federal agencies. USDA regulates pre-release testing and procedures, including field trials. EPA regulates pesticides contained within GMOs and sets tolerance levels for pesticides that end up as residues in foods. FDA has regulatory authority over food produced from GMOs, claiming that it is "generally recognized as safe."

Moeller said farmers assume significant obligations and legal liabilities when they sign GMO contracts. " Common obligations include how and where to plant, including creating 'refuges' of non pest-resistant varieties; giving up the right to save seed; opening up their fields and all records, including filings usually subject to the Privacy Act, to inspections; and agreeing to specified remedies if the farmer violates the agreement."

In most cases saving seed - an age-old practice among farmers - is prohibited as to GMOs, and there are stiff penalties for doing so. A recent U.S. Supreme Court case limited a statutory seed-saving exemption, and a Canadian case ruled that a farmer could not save seed from a crop contaminated with GMO technology. "Farmers may not save seed containing 'patented' genes resulting from accidental cross pollination from a neighboring GMO group or any other source," Sligh said.

Farmers who sign a technology agreement have little recourse if the company asks to inspect their fields. Where there is no contract, farmers should seek legal counsel and require the company to show cause. In every case when samples are demanded, farmers should make sure an identical independent sample is taken and analyzed, Moeller said.

Selection of uncontaminated seeds, planting at a distance from GMO crops, creating buffer areas, and meticulous cleaning of equipment and storage areas are all important. Moeller counsels farmers to avoid making broad statements of non-GMO warranty and to emphasize efforts made to prevent contamination beginning, of course, with the statement that seed have been certified GMO free. Organic farmers risk losing their certification through GMO contamination.

Recent research on the costs and benefits of GMOs surprisingly shows that pesticide use has increased on herbicide tolerant crops. Sligh says this is due primarily to farmers' reliance on a single herbicide - glyphosate - that must be sprayed in increasing amounts to keep up with the shift in weed populations toward more difficult to control species and the development of resistance to certain weeds.

FLAG is a nonprofit law center dedicated to providing legal services to family farmers and their rural communities to help keep family farmers on the land. RAFI-USA is dedicated to community, equity, and diversity in agriculture. This Farmers' Guide to GMOs is a joint project of FLAG and RAFI-USA with financial support from the Nathan Cummings Foundation and The John Merck Fund, and the Lawson Valentine Foundation.

Additional information, as well as the full text of the Guide, is available at or

top of page