Science in Society Archive

ISP Bid to Stop US "Rubber-Stamping" Transgene Contamination

ISP submitted strong objections to US’s proposed change in policy that would allow companies to contaminate the food supply with unauthorized test crops. Dr. Mae-Wan Ho, Sam Burcher and Rhea Gala

The US Food and Drug Administration (FDA) published a proposal on 24 November 2004 that would allow experimental GM crops grown on "test" sites to legally enter the food chain. The proposal was open for comment until 24 January 2005.

It came in response to a 2002 Bush administration initiative in the wake of widespread contamination in 2000 of US food supplies and exports with unauthorized Starlink GM corn, which continued to be detected in the US grain supply and in food shipments to Bolivia, Japan and South Korea as recently as autumn 2003.

FDA Commissioner Lester Crawford described the proposed policy as "a high priority for the Administration and the industry, to enhance public confidence, avoid product recalls, and provide an international model" for similar policies around the world.

Licence to spread contamination

Bill Freese, research analyst with Friends of the Earth (US) said, "FDA’s new proposal has nothing to do with food safety, it’s designed to provide biotech companies with legal cover for contaminating the food supply with experimental biotech traits. Such contamination has happened in the past and has cost biotech companies more than $1billion." Aside from Starlink, another experimental GM corn containing a pharmaceutical sprouted in a field of soya one year after the trial crop had been harvested. ProdiGene, the company responsible, paid out millions of dollars in damages and a $250 000 fine, although the product never reached the food chain.

The US biotechnology and grain industries are already calling on the US government to "vigorously promote global adoption" of this policy.

It is already virtually impossible to test for the presence of experimental GM food crops in foods imported from or processed in the US, because over two-thirds of US field trials of experimental GM crops involve one or more genes classified as confidential, which therefore cannot be identified and detected. Adrian Bebb of Friends of the Earth Europe added: "This will leave consumers worldwide exposed to new risks from genetically modified foods."

Experiments that are known to the public include crops with radically altered nutritional content for use as animal feed, or anti-fungal compounds that resemble food allergens. Others include crops engineered to be resistant to chemical herbicides, produce their own insecticides or have sterile pollen or seeds. The FDA is also considering a similar proposal to allow residues from experimental pharmaceutical crops to enter the food chain. (See Ban Plant-based Transgenic Pharmaceuticals

Juan Lopez from Friends of the Earth International said: "The Bush Administration, with the active support of the biotechnology industry, is about to force their untested genetically modified experiments into the world’s food supply. This proposal should be ringing alarm bells in every consumer, every food company and every food agency of the planet."

In line with the same policy proposal, Prof. Joe Cummins at the University of Western Ontario points out, "USDA [US Department of Agriculture], which regulates organic certification, has proclaimed that organic food crops polluted with modified genes from wind-borne pollen released from neighbouring farms will still be certified as organic food." (See "GM sugar beet gone sour", this series).

ISP calls for FDA proposal to be withdrawn

The Independent Science Panel (ISP) (, submitted a strongly worded letter to urge Commissioner Crawford to withdraw the proposals, and expressed particular concern over the FDA’s apparent intention that the proposals contained in its guidance to industry will provide "an international model to address the presence of low-level bioengineered plant material in non-bioengineered crop fields".

As the ISP pointed out, the proposed policy sets out loose "food safety evaluation" guidelines under which a company may voluntarily consult with the FDA to have new proteins from experimental GM crops intended for food use deemed "acceptable" as a food contaminant. The early "food safety evaluation" suggested in the guidelines consists largely of paperwork. The proposed scientific evaluation is highly inadequate, as it fails to specify the tests to be conducted, and does not include animal feeding trials or tests for unintended effects caused by genetic modification. "In the absence of a specific and mandatory test protocol," the ISP letter said, "companies will fail to prove safety beyond reasonable doubt; but the FDA’s new policy will nevertheless give biotech companies the legal cover for their experimental GM crops to enter the US food supply."

ISP objections based on scientific evidence

The ISP drew attention to a review on the hazards of GM crops published in its report "The case for a GM-Free Sustainable World" in June 2003; the key findings of which were as follows:

  • Regulations over the releases of GM crops and products have been highly inadequate.
  • Few feeding studies have been carried out, but they raised serious doubts over the safety of the transgenic process itself, which have yet to be followed up by dedicated research.
  • GM varieties are unstable; and this may enhance the horizontal spread of transgenes, with the potential to create new viruses and bacteria that cause diseases; and to disrupt gene function in animal and human cells.
  • Many GM crops contain gene products known to be harmful. For example, the Bt proteins that kill insect pests include potent immunogens and allergens; and food crops are increasingly engineered to produce pharmaceuticals, drugs, and vaccines in the open environment, exposing people to the danger of inappropriate medication and their toxic side effects.
  • Herbicide tolerant GM crops - accounting for 75% of all GM crops worldwide - are tied to the broad-spectrum herbicides glyphosate and glufosinate ammonium, and will probably increase their use. Both herbicides are systemic metabolic poisons linked to spontaneous abortions, birth defects and other toxicities for human beings and laboratory animals. They are also harmful to wildlife and to beneficial organisms in the soil.
  • GM crops have resulted in no benefits to the environment. There has been no reduction in the use of pesticides, while herbicide tolerant weeds and volunteers have emerged, and highly toxic herbicides have had to be brought back in use.

Since its publication, all the major findings of the ISP report have been further corroborated; and the inadequacies of the US regulatory system identified by two US scientists.

The ISP called attention to new evidence that most, if not all GM varieties may be unstable. French government scientists examined five GM varieties already commercialised, and found all the GM inserts had rearranged themselves. Belgian government scientists confirmed these results, and found some of the GM varieties were also non-uniform.

A paper published in 2002 reported that 22 out of 33 transgenic proteins have runs of 6 or 7 amino acids identical to known allergens. These include all the Bt toxins (Cry proteins), the CP4 EPSPS and GOX conferring glyphosate tolerance, the coat protein of the papaya ringspot virus, and even marker proteins such as GUS (b-glucuronidase). A follow-up study confirmed those results, highlighting the inadequacy of current methods to predict the allergenic potential of proteins new to our food chain, and the need to take these positive findings seriously until they can be ruled out by further tests to be "false positives". "This warning is particularly significant", the ISP warned, "as a string of anecdotal evidence – including feeding trials presented by companies to regulatory authorities under "confidential business information" – continue to raise serious doubts over the safety of GM crops and GM food and feed."

There have been more reports from the scientific literature indicating that the natural toxin is not the same as, or "substantially equivalent" to, the GM toxin. Green lacewings suffer significantly reduced survival and delayed development when fed an insect pest that has eaten GM maize containing the Bt toxin Cry1Ab, but not when fed the same pest treated with much higher levels of the natural toxin in bacteria. These findings again suggest that the genetic modification process itself may be unsafe.

Finally, a new report drawing on nine years of US Dept of Agriculture data concludes that overall, GM crops have increased pesticide use by 122 million pounds weight since 1996.

The FDA "irresponsible"

In view of all these known problems and uncertainties over the safety of GMOs, the ISP letter stated, "it would be irresponsible for the FDA to yet further relax regulation, which will almost certainly result in widespread transgene contamination."

In ignoring the threat of serious irreversible damage to human health from unknown and untested GM material, the proposed change in FDA policy is also a clear breach of the Precautionary Principle enshrined in the Cartagena Protocol on Biosafety, the only international law regulating genetic engineering.

As people will be eating these foods for generations once they are released into the environment, the ISP pointed to the need for safety assessments to be "long term, intergenerational and on the whole food, not on just the new substance that the GM organism is designed to produce."

Not only should the FDA withdraw the policy changes proposed in its Draft Guidance for Industry, the ISP said it should be devising strict rules and procedures to prevent contamination of the food supply with experimental transgenic proteins and to replace its current non-rigorous "voluntary consultation" process with a mandatory, science-based review process designed to guarantee that the GM crops are safe for food and feed.

ISP letter in full at

Article first published 27/01/05


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