3-Food: Public Health Association of Australia calls for MON863import ban
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-------------------------------- GENET-news -------------------------------
TITLE: GM corn safety study overlooked, critics
SOURCE: Australian Broadcasting Corporation, by Anna Salleh
DATE: 17 Sep 2004
------------------- archive: http://www.genet-info.org/ -------------------
GM corn safety study overlooked, critics
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
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 2003.
"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.
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
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 (Bt).
FSANZ said for such foods, studies where the GM plant food as a whole is
fed to the animal added little to safety information.
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.
Mexican maize madness, The Slab, ABC Science Online 4 Jul 2002
Journals act against publication bias, News in Science 9 Sep 2004
Controversial corn, News in Science 26 Apr 2002
European NGO Network on Genetic Engineering
Hartmut MEYER (Mr)
Kleine Wiese 6
D - 38116 Braunschweig
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