New evidence requires NZFSA to act independently

New evidence requires New Zealand Food Safety Authority to act independently on high lysine corn

Research just published in the prestigious Journal of Clinical Endocrinology and Metabolism reaffirms that advanced glycation endproducts, or AGEs, taken in through food "are pathogenic Š suggesting that dietary AGEs are directly linked to increased [oxidative stress] and the risk of developing CKD [chronic kidney disease] and CVD [cardiovascular disease]."

This new study and evidence that Food Standards Australia New Zealand (FSANZ) have ignored data in their possession that was relevant to assessing the risks of GE high lysine corn LY038 further challenge FSANZ's refusal to reconsider their approval of LY038. That corn has unprecedented concentrations of the substances that combine to form AGEs in food relative to normal corn.

The research is published by the leading US-based group in the biochemistry and testing of AGEs. These compounds form between sugars and proteins or free amino acids such as lysine. High temperatures used for cooking or processing corn in food can accelerate the reactions leading to higher levels of AGEs in the diet.

The European Food Safety Authority (EFSA) have asked the developer of LY038, Monsanto/Renessen, to supply additional scientific information that this corn will be safe for humans to eat. Rather than comply, Monsanto/Renessen has withdrawn its application for EFSA approval of the corn. They say that while "our preference would have been to complete the EU approval of LY038, conducting further studies, as requested in your letter Š can no longer be justified, in view of the additional costs involved and the reduced commercial interest in this product."

Professor Heinemann, director of the Centre for Integrated Research in Biosafey (INBI), considers this unlikely. "We estimate that they have sunk nearly US$1 billion into LY038 development and marketing, and Monsanto estimated a revenue of US$1 billion per year in sales of LY038. The cost of doing the studies would be tiny in comparison. Unless, of course, the studies don't find the corn to be as safe as conventional corn."

FSANZ have refused to reconsider their approval of GE high lysine corn LY038. They dismissed European authorities' concerns saying that "We looked at the data and came to the conclusion that cooking made no difference to safety" despite never having seen or asked for data on the cooked corn.

"It is shockingly arrogant," said Prof. Heinemann, "as far as I'm concerned. This is another example of FSANZ systematically opting for a plausible guess that the corn would be safe and rejecting the plausible scientific evidence that it could be harmful."

INBI has also found that FSANZ have been sitting on evidence that indicated potential adverse effects from GE high lysine foods. "In 2000, they considered and approved another GE high lysine food. Those plants were soybeans and they had two GE traits," said Prof. Heinemann, "one changed the fatty acid profile of the plant and the other was a boost in lysine using the same kind of transgene as in high lysine corn."

In the previous application for soybeans developed by DuPont/Pioneer, the developer heated the soybeans and fed them to animals. FSANZ summarised two separate feeding studies, one involving pigs and the other chickens, where the developer processed the soybeans at cooking temperatures ranging from 80-105ºC. There was an apparent decrease in the growth of the animals per unit food when it was processed at some temperatures. These observations are consistent with an adverse nutritive or toxic effect of heating the food.

"The dramatic difference in animals fed control diets versus GE soybean diets was never explained, but it was explained away," said Heinemann. The pigs required 66% more GE soybean-based food after heating to attain the same weight as pigs fed on a control diet supplemented with lysine from conventional sources. "FSANZ confirmed the potential adverse effect, noting that the 'reason for the decreased performance, compared to the control, of pigs fed the [GE] soybeans processed at 80-85°C is not readily apparent.' Instead of using science to find the reason, they explained away any concerns saying that the 'applicant speculates that the difference may be due to difficulties experienced with the processing of the soybeans in the pilot processing plant.'"

FSANZ have had these data for nine years, but to INBI's knowledge, FSANZ never pursued a scientific explanation for the effect of heated high lysine soybeans on animals. "They were satisfied with dismissing the evidence of a potential adverse effect of the food based on speculation from the manufacturer. Who knows? It could just as well have been an effect of the lysine reacting with sugars in the soy at high temperature reducing actual levels of the lysine or creating AGEs," Heinemann said.

Further embarrassing FSANZ is the release of new peer-reviewed evidence that AGEs in food are harmful. Study lead author Professor Helen Vlassara of the Mount Sinai School of Medicine reported to Food Production Daily that Western diets already could have three times the safe level of AGEs.

FSANZ, in its Final Assessment Report of LY038, accepted that LY038 would produce more and unknown AGEs, saying that "it is reasonable to assume that processed corn products containing LY038 may contain an altered profile of AGE[s] compared to conventional corn." But they never investigated the AGEs in GE corn, claiming instead that "this [altered profile] is unlikely to have a significant impact on the overall diet of consumers."

"Really? You are going to approve something we don't need and that may have harmful compounds on the assumption that people won't eat it?" asked Heinemann. "FSANZ have known at least since 2006 that there are strong links between dietary AGEs and certain human diseases but they haven't even asked for a list of novel compounds that may appear in high lysine corn, much less attempted to evaluate their safety through scientific tests."

"How can FSANZ justify not only increasing the amount of AGEs in the diet, but also the unknown types of AGEs that may form in this corn, when the Western diet is already too high in these toxins?" asked Prof. Heinemann. "This corn has no proven benefits to consumers, while potentially adding to their dietary burden of AGEs. Worse, since restaurants do not have to disclose that the food they use has GE ingredients, consumers may well be exposed without their knowledge."

INBI believes that FSANZ are out of date with the scientific literature and are not putting the "best available science" to work for the people of Australia and New Zealand. They say that it is time New Zealanders demanded that their local regulator New Zealand Food Safety Authority revoke its approval of the product made using the FSANZ assessment until the same safety studies that EFSA and EU member states are asking for are made available and have been properly evaluated.

ENDS

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