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MON863 & shortcomings in FSANZ's GE approval process

Jeanette Fitzsimons, MP

Subjects: Consumer Issues, Food, Genetic Engineering, Research, Science and Technology
Spokesperson: 
Green Party Co-Leader

In this background;

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.