High Lysine GM Maize Withdrawn, Safety Concerns

ISIS Press Release 11/11/09

A much touted second generation “nutritionally enhanced” GM crop bites the dust, as company fails to address serious health concerns; but don’t suppose that regulation will triumph Dr. Mae-Wan Ho and Prof. Peter Saunders

Monsanto withdraws maize from regulatory approval citing commercial reasons

In a dramatic move, Monsanto has withdrawn its genetically modified (GM) maize, LY038 from commercial approval in Europe after safety concerns prompted the European Food Safety Authority (EFSA) to request further evidence from the company [1].

At the end of April 2009, two letters were sent to EFSA by Monsanto's European subsidiary company Renessen, withdrawing applications originally submitted in 2005 [2]. The whole episode was shrouded in secrecy before being uncovered by Dr. Brian John of GM-Free Cymru. There has been no mainstream press report, and no record on the EFSA website. Not only LY038, but also the stacked variety LY038 x MON810 - derived from a cross between LY038 and another GM variety MON810 - has been withdrawn. MON810 is currently banned in many countries in Europe [3] Europe Holds the Key to a GM- Free World, 5th Conference of GM-Free Regions, Food & Democracy ( SiS 43), and has its own hazards [4-6] ( GM Maize Disturbs Immune System of Young and Old Mice , GM Maize Reduces Fertility & Deregulates Genes in Mice , SiS
41; MON810 Genome Rearranged Again , SiS 39).

The GM maize LY038, modified to produce high levels of the amino acid lysine, was deregulated in the United States, despite our protest [7] ( Why Not Transgenic High Lysine Maize , SiS 29); and subsequently approved as safe to eat in Canada, Japan, S. Korea, the Philippines and Australia/New Zealand in 2006-7 . It belongs to the much touted “second generation”, “nutritionally enhanced” GM crops that are supposed to benefit consumers, but are insidious health risks instead [8] ( GM Crops and Microbes for Health or Public Health Hazards? SiS 32).

In its letter to the EFSA, Renessen Europe stated that "conducting further studies ... can no longer be justified, in view of the additional costs involved and the reduced commercial interest in this product."

Scientists cite safety

The high lysine maize was also submitted to Food Standards Australia New Zealand (FSANZ) in 2004 and approved as safe for human consumption in December 2007, despite strong scientific objections from the Centre for Integrated Research in Biosafety (INBI) at Canterbury University, Christchurch, in New Zealand [9, 10]. Among the issues raised were risks of cancer, diabetes and Alzheimer's disease.

FSANZ maintains there is no safety issue with LY038, and that it was withdrawn from Europe purely for commercial reasons.

Monsanto spokesman Jonathan Ramsay said [1] “changes in the overall corn market” were among the factors resulting “in a shift of the overall value to customers of this product at this time.”

Geneticist Dr. Jack Heinemann, an associate professor at Canterbury University and director of INBI, believes it was a tactical, rather than purely commercial withdrawal on Monsanto's part, and demands to know why FSANZ still considers it would be safe for “Kiwis” to eat the maize [1].

“Personally, I don't believe the withdrawal of LY038 was for economic reasons,” Heinemann said. “Monsanto estimated the street value of LY038 was going to be US$1 billion a year. Do we really believe that a market of US$1bn a year is too small for Monsanto? I don't. The European Food Safety Authority requested more safety data from Monsanto.”

Heinemann also indicated that from comments released to him, it appears that Finland for example, was not satisfied with either the number or the quality of animal-feeding studies, and Malta voted to reject the maize on the basis of the INBI submission, “the same science that FSANZ attempted to bury down here.”

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