Monsanto withdraws maize from regulatory approval citing commercial reasons
By Dr. Mae-Wan Ho and Prof. Peter Saunders
In a dramatic move, Monsanto has withdrawn its genetically modified (GM) maize, LY038, from commercial approval in Europe after safety concerns prompted the European Food Safety Authority (EFSA) to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 .
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 . 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also the stacked variety LY038 x MON810 – derived from a cross between LY038 and another GM variety MON810 – has been withdrawn.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  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  (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  (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FSANZ maintains there is no safety issue with LY038, and that it was withdrawn from Europe purely for commercial reasons.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  “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 .
“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
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 . 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.
In an interview with the Green Party of New Zealand, Heinemann said : “Dietary AGEs have been implicated in causing the symptoms of Alzheimer’s, diabetes (and related autoimmunity), cancer, heart disease and kidney disease. Usually, people with susceptibility to these diseases, or that may suffer from them, are encouraged to eat foods low in compounds that produce AGEs, such as fruits and vegetables. We are concerned that by converting corn into a relatively enriched source of AGEs, everyone loses an important source of nutrition that does not increase our risk for these diseases.”
Although the total lysine content of LY038 is only 50 percent above normal, the concentration of the free amino acid is 50 times greater while the derivatives are also hugely increased. Saccharopine is 110 times higher, a -aminoadipic acid (a neurotoxin) at least 10 times higher and pipecolic acid 100 percent higher .
There are conventional lines of maize that have high lysine, but not free lysine. Lysine is normally incorporated into protein or converted into benign products .
Like other “nutritionally enhanced” GMOs, LY038 is created by grossly unbalancing the metabolic network ; and that is where the metabolic hazards arise. It is well known that overdose of many single nutritional factors is toxic, and it is not surprising that overproduction of any single metabolite creates further toxicities. Another case in point is the notorious ‘Golden Rice’, now mired in controversy as phase 2 clinical trials have been conducted on children with unapproved experimental events. It is well known that high concentrations of pro-Vitamin A can cause birth defects and developmental abnormalities, and the potential for further toxicities in Golden Rice is uncomfortably high  (The Golden Rice Scandal Unfolds, SiS 42).
Heinemann thinks the GM maize would be withdrawn globally because of the high likelihood it would become mixed with other maize and end up in the human food chain in Europe.
“I believe the European member states were dissatisfied with the same level of scientific assurance that FSANZ was completely satisfied with,” he said.
However, it appears that LY038 was probably never grown commercially even in the US, according to the biotechnology industry’s biotrade database .
Dr. Brian John of GM-free Cymru applauds the fact that EFSA has asked Monsanto some hard questions, “having in the past demonstrated over and over again that its GMO panel is simply unfit for purpose,” a view shared by many of us  (GM Food Nightmare Unfolding in the Regulatory Sham, ISIS scientific publication). But John’s applause may be premature.
European Commission, Australia and Monsanto in “scientific consensus”?
There was a session on GMOs at a recent workshop on “societal concerns” held by the Organisation for Economic Cooperation and Development (OECD) at its Paris headquarters. The meeting was held under ‘Chatham House rules’ so we are not allowed to report the discussions, but the three speakers at the session have all posted material on the OECD website , and you can see from that how hard it is going to be to get good regulation, or to get governments to see the futility and dangers of GM crops.
The lead speaker was Marco Valetta from the Directorate General of Health and Consumer Protection of the European Commission. In his presentation , he claims that “Consumers’ decisions and perceptions might be (very) far from a rational science-based approach” and goes on to describe “the EU legislative framework as an attempt to respond to consumers’ resistance.”
In her contribution  Joanna Hewitt, a Consultant writes with satisfaction of the successes of the Australian government in shifting public opinion towards the acceptance of GMOs. She evidently finds it frustrating that there should still be opposition to GM crops “despite clear scientific assessment that no harm to human health or the environment was at issue.”
The lawyer from Monsanto did not need to add anything . He closed with the familiar complaint that Europe has no right to deprive the developing countries of the GM crops he claims they so desperately need .
The mere fact that a GMO has been withdrawn because the company has no answer to the safety concerns raised is not going to change the minds of those governments and bureaucrats in regulatory agencies that are supporting them. They still see their duty as overcoming consumer resistance rather than protecting health and the environment. It is even harder to make progress at the international level, because there, the top priority is trade, not the well being of the planet or its inhabitants.
1. “Europe balks at GE corn in NZ”, Stuff.co, National, 2 November 2009,
2. “Monsanto pulls GM corn amid serious food safety concerns”, Dr. Brian John, Press Notice from GM-free Cymru, 9 November 2009, http://www.gmfreecymru.org/
3. Ho MW. Europe holds the key to a GM-free Europe. Science in Society 43, 21-24, 2009.
4. Ho MW. GM maize disturbs immune system of young and old mice. Science in Society 41, 42, 2009.
5. Ho MW. GM maize reduceds fertility & deregulates genes in mice. Science in Society 41, 40-41, 2009.
6. Ho MW. MON810 genome rearranged again. Science in Society 39, 27, 2008.
7. Cummins J. Why not transgenic high lysine maize. Science in Society 29, 22+24, 2006.
8. Cummins J and Ho MW. GM crops and microbes for health or public health hazards? Science in Society 32, 30-33, 2006.
9. Heinemann J. Rodriguez-Beltran C, Goven J, Moore B, Turner L, Bohn T, Gerrard JA, Cretenet M and Traavik T. Submission on Application A549 food derived from high lysine corn LY039: to permit the use in food of high lysine corn. Submitted to Food Standards Australia/New Zealand (FSANZ), New Zealand Institute of Gene Ecology, 22 January 2005.
10. Cretenet M, Goven J, Heinemann JA, Moore B and Rodriguez-Beltran C. Submission on the DAR for Application A549 food derived from high lysine corn LY039: to permit the use in food of high lysine corn. Submitted to Food Standards Australia/New Zealand (FSANZ), Centre for Integrated Research in Biosafety, 2 June 2006.
11. Interview with Dr. Jack Heinemann regarding Monsanto’s high lysine corn, Green party of Australia New Zealand, 16 August 2006,
12. Ho MW and Cummins J. The Golden Rice scandal unfolds. Science in Society 42, 4-7, 2009.
13. Commercial status of certain agricultural biotechnology products as of October 12, 2009, Bio, Biotechnology Industry Organisation, http://www.biotradestatus.com/default.cfm
14. Ho MW, Cummins J and Saunders PT. GM food nightmare unfolding in the regulatory sham. Microbial Ecology in Health and Disease 2007, Disease 2007, 19, 66-77.
15. Workshop on the Economic and Trade Implications of Policy Responses to Societal Concerns, OECD, Organisation for Economic Cooperation and Development, 2-3 November 2009, Paris, France, www.oecd.org/agriculture/policies/societalconcerns
16. Valetta M. GMOs: scientific disagreements or differing societal perceptions? OECD Workshop on the Economic and Trade Implications of Policy Responses to Societal Concerns, 2-3 November 2009, Paris France, downloaded 9 November 2009, www.oecd.org/agriculture/policies/societalconcerns
17. Hewitt J. Notes for GMO Panel, OECD workshop on societal concerns. OECD Workshop on the Economic and Trade Implications of Policy Responses to Societal Concerns, 2-3 November 2009, Paris France, downloaded 9 November 2009, www.oecd.org/agriculture/policies/societalconcerns
18. Von kameke C. Workshop on the Economic and Trade Implications of Policy Responses to Societal Concerns, 2-3 November 2009, Paris France, downloaded 9 November 2009, www.oecd.org/agriculture/policies/societalconcerns
Posted at Institute of Science in Society.