headline:
High Lysine GM Maize Withdrawn, Safety Concerns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In a dramatic move, Monsanto has withdrawn its genetically modified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been withdrawn.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). ... (cont)
excerpt:
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withdrawn from Europe purely for commercial reasons.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.”
High lysine and sugar create unique risks
Many of the hazards identified by INBI are shared with GM varieties in
general, which ISIS has elaborated in numerous previous reports (see
for example [3-8]). These are summarized in the box. As is usually the
case, these hazards have not been adequately addressed in the risk
assessments submitted by the company and accepted by the regulatory
agencies.
General Hazards of GMOs
1. Uncontrollable and unpredictable effects due to the genetic
modification process
Scrambling the host genome
Widespread mutations
Inactivation of genes
Activation of genes including oncogenes associated with cancer
Creating new transcripts (RNAs) with regulatory roles
Creating new unintended proteins
Creating new metabolites that may be toxic
Activation of endogenous viruses
Creating new viruses by recombination of viral sequences in GM
inserts with those in the host genome
2. Potential effects of the transgenic protein(s) introduced
Becoming allergenic or immunogenic due to alternative processing of
the protein(s)
Creating new proteins that may be immunogenic
3. Effects due to the GM insert and its instability
Genomic rearrangements in subsequent generations with further
unpredictable effects
Horizontal gene transfer and recombination
Spreading antibiotic resistance marker genes
Creating new viral and bacterial pathogens from viral and bacterial
sequences
Creating insertion mutagenesis in the genomes of cells to which the
GM inserts are transferred
However, there are also important hazards unique to each GMO, and in
the case of LY038, it is due to the high concentrations of the amino
acid lysine and derivatives - saccharopine, a -aminoadipic acid (a
neurotoxin), pipecolic acid and cadaverine – present in the grain [9,
10] . The INBI report submitted to FSANZ in 2006 stated that when the
LY038 maize is cooked, it could produce “a spectrum of food hazards
significantly different” from cooked or processed conventional maize
[10]. Lysine and its derivatives could combine with sugars, also
present in high concentrations in maize, to form ‘advanced
glycoxidation endproducts (AGEs) that are strongly implicated in a
variety of diet-related diseases. ... (cont)