Comments on FSANZ Application A1042 Food derived from herbicide-tolerant corn line DAS-40278-9

19 April 2011

FSANZ Submissions:

Gene Ethics asks FSANZ to reject application A1042 and to also review its approval of all other approved GM varieties, in the light of new and as yet unassessed evidence of potential harm to human and animal health and safety.

The grounds for this rejection are that evidence on the digestibility and degradation of the proteins and DNA in genetically manipulated food crops has not been fully or adequately considered and incorporated into your assessments, especially in the light of recently published new evidence. Modelling is also an inadequate basis for assuming the safety of foods, especially novel foods.

The FSANZ assessment report says:

"The AAD-1 protein was investigated for its potential to be a toxin or allergen. Bioinformatic studies with the AAD-1 protein have confirmed the absence of any biologically significant amino acid sequence similarity to known protein toxins or allergens and digestibility studies have demonstrated that the protein would be rapidly degraded following ingestion, similar to other dietary proteins. Taken together, the evidence indicates that the AAD-1 protein is neither toxic nor likely to be allergenic in humans."

But this assertion appears to be an assumption not a fact, an assumption refuted by a new Canadian study by Aris and Leblanc (attached) which found, according to their abstract:

"Pesticides associated to genetically modified foods (PAGMF), are engineered to tolerate herbicides such as glyphosate (GLYP) and gluphosinate (GLUF) or insecticides such as the bacterial toxin bacillus thuringiensis (Bt). The aim of this study was to evaluate the correlation between maternal and fetal exposure, and to determine exposure levels of GLYP and its metabolite aminomethyl phosphoric acid (AMPA), GLUF and its metabolite 3-methylphosphinicopropionic acid (3-MPPA) and Cry1Ab protein (a Bt toxin) in East- ern Townships of Quebec, Canada. Blood of thirty pregnant women (PW) and thirty-nine nonpregnant women (NPW) were studied. Serum GLYP and GLUF were detected in NPW and not detected in PW. Serum 3-MPPA and CryAb1 toxin were detected in PW, their fetuses and NPW. This is the first study to reveal the presence of circulating PAGMF in women with and without pregnancy, paving the way for a new field in reproductive toxicology including nutrition and utero-placental toxicities."

The exposure of women and their foetuses to undigested and undegraded foreign DNA and protein not previously in the human diet needs more exploration before this GM corn is approved and registered.

FSANZ' assumption concerning protein and DNA degradation is also challenged by Prof Jack Heinemann's Report, entitled "Report on animals exposed to GM ingredients in animal feed" (July 2009) (attached). The report is not cited by the FSANZ assessors so we can assume they have not considered the evidence presented in his review.

Heinemann concludes: "There is compelling evidence that animals provided with feed containing GM ingredients can react in a way that is unique to an exposure to GM plants. This is revealed through metabolic, physiological or immunological responses in exposed animals." The report surveys all published animal feeding studies and subjects them to careful analysis. Though Heinemann refuses to be drawn on health and safety (outside his brief) he finds many deficiencies in the studies which purport to show "no effects" from consumption of GM animal feed. For instance, in some animal feeding experiments GM feed was fed to both the test and control groups, thus masking GM effects. Many animal feeding experiments were also too short to reveal any physiological changes. Other deficiencies  relate to variability in the GM DNA of feed supplies, the sensitivity of the testing methods used, and the use of surrogate proteins rather than whole GM feed in the testing protocols.

Heinemann finds that many studies (including some conducted under the auspices of the GM industry) show statistically significant physiological changes in GM-fed animals, and reveal the presence of "DNA and protein unique to GM plants within animals and animal products."

Gene Ethics calls on FSANZ to reject application 1042, for the approval of herbicide-tolerant corn line DAS-40278-9, on the grounds that:


Aris A, Leblanc S. Maternal and fetal exposure to pesticides associated to genetically modified foods in Eastern Townships of Quebec, Canada. Reprod Toxicol (2011), doi:10.1016/j.reprotox.2011.02.004

Heinemann, J. Report on animals exposed to GM ingredients in animal feed. Prepared for the Commerce Commission of New Zealand (2009)

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