High Lysine GM Maize Withdrawn, Safety Concerns

Institute of Science in Society
ISIS Press Release 11/11/09

High Lysine GM Maize Withdrawn, Safety Concerns

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In a dramatic move, Monsanto has withdrawn its genetically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MON810 - has been withdrawn.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

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that it was withdrawn from Europe purely for commercial

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.”