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Controversy Swirls Around Monsanto Frankencorn

GM corn safety study overlooked, critics
Anna Salleh
ABC Science Online (Australia)
Friday, 17 September 2004

French scientists were concerned about a type of GM corn based on the
findings of a rat study Genetically modified (GM) corn has been approved
as a food ingredient without Australia and New Zealand's safety regulator
considering a study showing adverse effects in rats, critics say.

The Public Health Association of Australia (PHAA) and environmental
organisations are now calling for imports of Monsanto's GM corn, known
as MON863, to be suspended pending independent review.

Last October, Food Standards Australia New Zealand (FSANZ) found the
GM corn safe for human consumption.

But critics are concerned that the assessment did not consider
Monsanto's 90-day rat study. This had been submitted earlier to
European authorities and had led to France's genetic engineering
commission, the CGB, to advise against the corn.

"In its report, CGB concluded it was not able to show the absence of
health risks to animals with regard to MON863 corn," Dr Judy Carman of
the PHAA told ABC Science Online, citing an article in French
newspaper La Monde.

Although the European Food Safety Authority had subsequently given the
corn the all clear in April this year, the Le Monde reported the CGB
remained concerned about the Monsanto study, which found blood and
kidney irregularities in rats fed the corn.

"The feeding study was made available to CGB in June 2003," said
Carman. "Therefore the document existed and was circulating before
FSANZ made its decision on this corn four months later in October

"So FSANZ should have been aware of this study. FSANZ should have made
sure it got a copy of the raw data in the document and it should have
made sure that it took the results of those studies into account in
its assessment," she said.

Carman said the PHAA wanted imports of the GM corn suspended pending
review by an independent body such as the National Health and Medical
Research Council or the PHAA. The Green Party of Aotearoa New Zealand
and Greenpeace have made similar calls.

FSANZ said a Monsanto study found chickens fed the corn grew just as
rapidly as if they had been fed conventional corn (Image: iStockphoto)
Rat study not necessary, says FSANZ

FSANZ said while Monsanto had supplied it with a chicken feeding
study, no studies on rats were provided while the agency was assessing
the corn's safety. And that at the time no further data was thought
necessary or requested.

FSANZ said the New Zealand Greens had informed it earlier this month
of the rat study. The agency said it contacted Monsanto the same day
for further information, which it would evaluate once it had received
the full package of raw data.

But on the data it had received so far, FSANZ believed there were no
concerns for human health.

FSANZ said that it was aware that CGB had raised some concerns about
the rat study but noted that the European Food Safety Authority had
examined the study, along with other data Monsanto had provided, and
concluded that the corn was "unlikely to have an adverse effect on
human and animal health or the environment".

The corn, which may appear unlabelled in processed foods in Australia
and New Zealand, has been engineered to produce an insecticidal
protein normally produced by the bacterium Bacillus thuringiensis

FSANZ said for such foods, studies where the GM plant food as a whole
is fed to the animal added little to safety information.

Toxicity studies

Instead, the agency said it relied more on toxicity studies, in which
high levels of the purified protein, in this case Bt toxin, were
produced by a bacterium and given directly to the animal.

"FSANZ does not require feeding studies in animals, such as this
90-day feeding study in rats, to be submitted as part of an
application to FSANZ for a GM food," it said in the statement.

Carman, from the PHAA, criticised this approach, arguing it assumed
that the GM plant would only produce the new proteins it was designed
to produce, nothing else.

"That's a huge assumption," she said. "Because one of the question
marks is whether the GM crop, because of the way it's made, is going
to throw up novel substances."

She said toxicity studies also assumed the protein bacteria produced
had the same structure and function as the protein as it appeared in
the plant.

"The protein as it appears in the plant is not tested," she said. "And
plants can do things to proteins once they're made, to change their
structure and their function, that bacteria can't. So it's a big
assumption it's going to be exactly the same."

She also criticised the short-term nature of toxicity studies.

Corn cleared by other agencies

Monsanto said that given the European Food Safety Authority concluded
there were no concerns over the corn's safety, claims that the rat
study showed adverse effects were misleading.

A spokesman said the study, which was first forwarded to European
authorities in August 2002, was not given to FSANZ because the agency
did not require it.

"Different countries ask for different studies to be done. So this
study was one that was requested in Europe," he said. "It's not
something the Australian regulators asked for. Hence it wasn't
provided to them."

Monsanto said the corn had been given full approval by authorities in
the U.S., Canada and Japan. It also said that no expert committee in
Europe or in France, apart from the CGB, expressed concerns relating
to the study. While it had received the "final scientific sign-off" in
Europe, politicians had yet to approve it, Monsanto said.

Related Stories
Journals act against publication bias, News in Science 9 Sep 2004
Mexican maize madness, The Slab, ABC Science Online 4 Jul 2002
Controversial corn, News in Science 26 Apr 2002


This GMO news service is underwritten by a generous grant from the Newman's
Own Foundation and is a production of the Ecological Farming Association <>