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3-Food: New Zealand Greens' worries over GE corn spark data checkby regulator



                                  PART I
-------------------------------- GENET-news -------------------------------

TITLE:  Greens' worries over GE corn spark data check by regulator
SOURCE: New Zealand Press Agency / New Zealand Herald
        http://www.nzherald.co.nz/storydisplay.cfm?storyID=3588897&the
        section=news&thesubsection=general
DATE:   3 Sep 2004 

------------------- archive: http://www.genet-info.org/ -------------------


Greens' worries over GE corn spark data check by regulator

Safety concerns have prompted a Transtasman food regulator to check the
original data from a trial conducted on genetically engineered corn it
approved last year for consumption.

"Monsanto are providing us with this data," says Food Standards Australia
New Zealand (FSANZ) general manager Melanie Fisher.

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

The Green Party yesterday raised safety questions 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 that a 90-day
feeding trial by Monsanto showed differences in bin rats fed MON863,
compared with those fed conventional corn. They included:
- Significant rise in males' white blood cells.
- Fewer immature red blood cells in females.
- Significant rise in blood sugar in females.
- More abnormalities such as degeneration or inflammation in the kidneys
of male rats.

A spokesman for the French agency Commission du Genie Biomoleculaire
(CGB), Gerard Pascal, told Le Monde: "What struck me in this file is the
number of abnormalities."

The CGB turned down approval, but its decision was subsequently
overturned by the European Food Safety Authority.

The Le Monde report was based on a leaked copy of a report from the
French commission, which received the Monsanto report in June last year,
Ms Fitzsimons said in Wellington.

"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," Ms Fitzsimons said. "This makes us wonder whether
they never saw the study or whether they just chose to ignore it."

The Green Party had now asked FSANZ to re-assess its approval for the GE
corn. The party wants import of foods containing it to be suspended until
safety could be guaranteed.

Ms Fisher said FSANZ reserved the right to review its decisions if new
scientific evidence came to light.


                                  PART II
-------------------------------- GENET-news -------------------------------

TITLE:  GE corn that caused rat abnormalities approved for NZ food use
SOURCE: The Greens, New Zealand, Press Release
        http://www.greens.org.nz/searchdocs/pr7824.html
DATE:   2 Sep 2004 

------------------- archive: http://www.genet-info.org/ -------------------


GE corn that caused rat abnormalities approved for NZ food use

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 MON863 Media Background 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.


                                  PART III
-------------------------------- GENET-news -------------------------------

TITLE:  MON863 & shortcomings in FSANZ's GE approval process
SOURCE: The Greens, New Zealand, Media Background
        http://www.greens.org.nz/searchdocs/other7823.html
DATE:   2 Sep 2004 

------------------- archive: http://www.genet-info.org/ -------------------


MON863 & shortcomings in FSANZ's GE approval process

In this background:
-	What effect did MON863 corn reportedly have on the studied rats? 
-	What happened next in Europe?
-	What did FSANZ do and what should it do now?
-	What food is MON863 corn used in?
-	What are the problems with FSANZ's approval process for GE foods?

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.




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