1.Food watchdog to recheck GM corn
2.GE corn that caused rat abnormalities approved for NZ food use
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1.Food watchdog to recheck GM corn
03 September 2004
http://www.stuff.co.nz/stuff/print/0,1478,3022279a11,00.html

Trans-Tasman food regulator, Food Standard Australia New Zealand, says it is checking the original data from a trial conducted on genetically engineered corn it approved last year for consumption after safety concerns were raised.

"Monsanto are providing us with this data," FSANZ Food Standards general manager Melanie Fisher said from Canberra yesterday.

"We expect it in the next day or two and we will be looking at it immediately."

Safety questions were raised yesterday by the Green Party over the corn, MON863, marketed as Maxguard and genetically engineered to incorporate the CryBb1 variety of Bt insect toxin which makes the corn resist rootworm pests.

The corn was developed for cultivation in North America, but Green Party GE spokeswoman Jeanette Fitzsimons said Monsanto had sought approval for its use in foods around the world, including New Zealand, where it was expected to enter the country mainly in processed foods.

But she said that at the same time FSANZ was approving MON863 for use in NZ foods, the French commission for genetic engineering was expressing grave concerns for its safety and that it was "not able to show the absence of health risks to animals".

The French daily newspaper Le Monde reported in April this year that a 90-day feeding trial by Monsanto showed differences in bin rats fed MON863, compared with those fed conventional corn.

They included:

significant increases in white blood cells in males;

reduced levels of immature red blood cells in females;

significant increases in blood sugar in females; and,

increased abnormalities such as degeneration or inflammation in the kidneys of male rats.
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2.GE corn that caused rat abnormalities approved for NZ food use
Greens press release

The Greens today revealed that a genetically engineered corn variety approved for human food in New Zealand was refused approval by a French scientific committee because of a study showing rats fed with it developed several abnormalities (see attached media background paper for details).

Le Monde reported in April that France’s Commission du Genie Biomoleculaire (CGB) raised serious concerns last year about Monsanto's MON863 corn after it read the company's own three-month rat-feeding study. Its decision to turn down approval was subsequently overturned by the European Food Safety Authority.

In light of the serious implications of the study’s contents and how it has been handled in Europe, the Green Party has now asked Food Standards Australia New Zealand (FSANZ) to reassess its approval for this GE corn and is calling for importation to be suspended until safety can be guaranteed. Today the Greens have also launched a website and postcard campaign to encourage people to tell FSANZ to reconsider its approval of MON863.

“On checking FSANZ’s report, prepared last October when it approved MON863 for New Zealanders to eat, we found no mention at all of the Monsanto rat study,” said Jeanette Fitzsimons, the Green Party’s Genetic Engineering Spokesperson.

“This makes us wonder whether they never saw the study or whether they just chose to ignore it. Either way there is something seriously wrong with the quality of the assessment process.

“The Greens are now asking FSANZ to state whether it had the rat-feeding study when it gave its approval to MON863. We are calling on it to make the study available to the public, to commission an independent review of its significance and review its approval decision in light of the new information,” said Ms Fitzsimons.

Sue Kedgley, the Green Party’s Safe Food Spokesperson, says the MON863 process calls into question the robustness of FSANZ’s safety assessments of all GE food.

“We have long suspected that the FSANZ assessment process is essentially a rubber stamp and its approval of MON 863 seems to confirm this. If abnormal effects such as the ones that were reported here were encountered in pharmaceutical trials they would have triggered an intensive and rigorous assessment. Why did they not trigger a similarly robust response for food destined for the whole population to eat?

“How can consumers have confidence in the safety of data provided by biotech corporations when they refuse to submit it to independent assessment and peer review?” said Ms Kedgley.

BACKGROUND

MON863 & shortcomings in FSANZ’s GE approval process

Food Standards Australia New Zealand (FSANZ) approved Monsanto's genetically engineered corn MON863 for human food use in October 2003. The same month, France’s Commission du Genie Biomoleculaire (CGB) turned down approval of MON863 after it sighted a Monsanto study showing rats developed a range of abnormalities after being fed the corn. It appears that FSANZ may have never considered this document, bringing into question the validity of their approval process.

What effect did MON863 corn reportedly have on the studied rats?

As reported in Le Monde and by the Centre for International Environmental Law, Monsanto’s study found rats fed MON863 corn for three months developed a range of abnormalities, including:

* reduced number of white blood cells in the males (an indicator of a challenge to the immune system);

* reduced immature red blood cells (which carry iron and oxygen) in females;

* a significant increase in blood sugar in the females;

* a higher frequency of physical irregularities, such as inflammation in the kidneys of the males.

On sighting the study, a spokesperson for the CGB panel, Gerard Pascal, Director of Research at the National Institute of Agronomic Research, is reported by Le Monde as saying, “...what struck me in this file is the number of abnormalities. I never saw that in another file.”

What happened next in Europe?

The European Food Safety Authority (EFSA) overrode the CGB’s concerns and approved MON863 for use in the European Union in April this year, saying the reported abnormalities were not significant.

The same month, Le Monde reported the CGB’s view on MON863 and the existence of the Monsanto report. When Greenpeace asked the German regulatory authority for the report (which it only had after being alerted to its existence by the Le Monde story), Monsanto refused to release the government body from the confidentiality agreement it had signed. While European regulators have seen the Monsanto study, it has never, to our knowledge, been publicly released.

What did FSANZ do and what should it do now?

FSANZ’s report on approval of MON863 for New Zealand and Australia makes no mention of the Monsanto rat study. This raises the question as to whether they never saw it or chose to ignore it.

After several months attempting to get more information on MON863 and Monsanto’s report, Green MPs Sue Kedgley and Jeanette Fitzsimons last week applied to FSANZ for a reassessment of its approval of MON863. The Greens are also asking that importation of this corn be suspended until the Monsanto report is properly considered and independent assessment of MON863 is carried out.

What food is MON863 corn used in?

FSANZ’s MON863 assessment report says the corn could be used in the following food:

Unlabelled in:

* modified starch ingredients;

* refined oil;

* high fructose and glucose syrups;

* cereals;

* baking products;

* corn chips;

* dessert mixes;

* canned foods.

It could be in starch, semolina and flour, but it would need to be declared on a label, so is therefore unlikely.

What are the problems with FSANZ’s approval process for GE foods?

FSANZ, like many other food regulatory authorities around the world, accepts information from the applicant without requiring any independent studies or peer review. Animal studies are short term, so do not investigate the effects on the next generation. So when this corn is released on to the market and into the food chain it’s a giant, uncontrolled experiment.

It is often claimed that GE foods are the most tested in the world. However a paper by Pryme and Lembcke and published in Nutrition and Health last year found only nine peer-reviewed studies on the health effects of GE foods on animals have ever been published. Five were conducted in association with the producer and showed no adverse effects on the animals; the others were conducted by independent institutes and all found effects. It also known that industry studies often don't test the food itself, but look instead at a protein derived from a bacterium, rather than one from a plant. Because the former does not include sugar molecules its activity can differ from the latter. This is the case with tests on MON863 that were cited by FSANZ, where the protein tested came from a GE bacterium, not the GE corn.

The Greens are therefore calling for each GE food that FSANZ considers for approval to undergo:

* independent peer-reviewed and long-term testing on animals over more than one generation, which must demonstrate no health effects;

* independently conducted and reviewed allergenicity tests on human blood serum, which must be negative;

* independent peer-reviewed clinical trials on human volunteers before approval for general sale.

* tests that use the actual food for which approval is being sought, not a substitute product.

There should also be a requirement that the applicant hand over ALL studies it conducted to demonstrate the safety of its GE food.

The following papers are available from the Greens:

* Le Monde’s report, in French and English, which revealed the conclusions of the CGB.

* The FSANZ decision to approve MON 863.

* Letter from Sue Kedgley and Jeanette Fitzsimons to FSANZ requesting a reassessment of MON863.

* The Pryme and Lembcke paper reviewing the ten animal-feeding trials of GE food.

* The Centre for International Environmental Law’s report European Communities - Measures Affecting the Approval and Marketing of Biotech Products, which also reports on the Monsanto’s MON863 rat-feeding study.