Objection To The Application By Monsanto For Commodity Clearance Of Its GM Maize Varieties Nk603 X Mon863x Mon810 to The National Department Of Agriculture, South Africa prepared by the African Centre For Biosafety.
SUPPORTED BY: Bishop Geoff, Southern African Faith Communities’ Environmental Institute; South African Freeze Alliance on Genetic Engineering; Earthlife Africa Ethekwini branch; GRAIN; SEED Trust; Ekogaia Foundation; Safe Food Coalition.
The African Centre for Biosafety (ACB) has already submitted its objections to Monsanto’s application for commodity clearance in respect of its genetically modified (GM) maize 863 and 863 x MON 810. It has also objected to a commodity clearance application by Pioneer Hi-Bred in respect of GM maize 59122X NK 603, as well Dow Agrosciences’ application for commodity clearance of triple stacked GM maize 1507 x 59122 X NK 603. The scientific and legal concerns raised in these objections are pertinent to the current GM maize application brought before the Exco by Monsanto. The current application by Monsanto will join the applications to which the ACB has objected to (above), and form part of those commodity clearance applications on hold until the outcome of a study being conducted by the national Department of Trade and Industry (DTI).
Currently, DTI is investigating price distortions of GM maize and its concomitant negative impacts on the South African economy as a whole. The ACB has, when objecting to Monsanto’s application for food safety clearance of its GM maize line MON 863 and MON hybrids MON 863 X MON 810, raised several serious concerns. Amongst these is the need for an enquiry into impacts on the domestic production of non-GM maize in South Africa, the distortions in the market place caused by the sale of GM maize, the predatory pricing policies of international grain exporters such as Cargill and Louise Dreyfus and the huge subsidy regimes available to them by their governments that assist them in obtaining market domination and displacement of local producers and placing at risk, thousands of jobs in the agricultural sector and related industries.1 We repeat these here.
We furthermore, repeat our pertinent and relevant scientific and legal objections raised in previous relevant objections pertaining to the GM maize in question. In this objection, we thus only raise and highlight three key food safety concerns, namely, allergenicity, long term impacts on human health and environmental concerns. We request that the Exco, refuse to grant Monsanto’s application on the basis of the precautionary principle, on the grounds that the GM maize pose unacceptable risks to the health of the South African population.
Monsanto’s “Allergenicity Assessment” is based purely upon the proteins expected to be expressed by the inserted genes in the three separate parent lines (Cry1Ab, Cry3Bb1 and CP4 EPSPS). Yet a recently released study  states “it can not be excluded that unintended effects may result from hybridisation between the two parental GM events”, and “information on the parent lines alone cannot provide full reassurance that the cross will be safe as well.”
A consideration of allergenicity of the whole GM plant is thus essential. Furthermore, Monsanto’s assessments for Cry1Ab, Cry3Bb1 and CP4 EPSPS are themselves, fundamentally flawed. These assessments are based purely on indirect evidence such as analysis of sequence homology and pepsin resistance of bacterial surrogate proteins. Yet, a recent study by Spök et al  casts doubt on the suitability of such studies to address allergenic potential, and Freese & Schubert  found industry procedures often failed to accurately simulate gastric fluid content.
Additionally, for Cry1Ab, Chowdhury et al  found that the protein can pass through the digestive tract and be detected in the faeces of farm animals so claims by Monsanto of “rapid and extensive degradation” observed in pepsin studies cited in application may not occur in reality. Crucially, Prescott et al6 found that a genetically modified pea containing a protein not previously associated with immune reactions provoked immune responses in mice, as well as priming them to react to other foods. This is thought to be due to post-translational modification of the protein, an effect that would not be picked up by the indirect testing used for Cry1Ab, Cry3Bb1 and CP4 EPSPS!!
The FAO/WHO Expert Consultation has itself sought to establish a reliable methodology to assess the allergenicity of GM foods and recommended targeted serum screening and immunogenicity testing in animal models for all GM foods, even from sources not known to be allergenic. Yet South Africa’s risk assessment guidelines only suggest the use of such tests where the source of the introduced gene is considered allergenic, or where there are consistent indications of sequence homology to known allergens, which seems to be quite dated and frankly-remiss, taking into account the findings of Prescott et al. As has already pointed out by us in our numerous objections, there is currently no validated and widely accepted animal model for allergenicity testing, so clearly further research is needed. A fact acknowledged by recent calls for research  from the UK’s Food Standards Agency for bioinformatic and proteomic techniques to identify potential allergens in novel food, and methods to study post-translational modification of transgenic proteins compared with native equivalents. Until research in this area is completed, it seems premature to conclude a low probability of allergenicity.
This is further backed up by the EU’s WTO dispute document,  which states: “Even if given protein per se does not represent an allergen, its expression in another host organism may indirectly upregulate the expression of potential allergens. It is therefore recommended to compare the engineered plant/plant product with that of the parent/wild type plant/plant product regarding IgE reactivity to establish whether the transgenic organism represents a more potent allergen source than the parent/wildtype organism for already sensitized patients. The potentially increased ability of the transgenic organism versus the parent/wildtype organism to induce de novo IgE responses (i.e. allergic sensitization) needs to be compared by immunization experiments.”
Concerns that the allergenicity of the whole crop could have been altered are dismissed almost out of hand by industry and regulators alike, because “maize is not considered a common allergenic food.” Yet this ignores the potential for unintended effects that could occur as a result of hybridisation between the GM parental lines, as discussed above. Additionally, as maize consumption increases, particularly as a staple food in a semi processed form, consumers are widely exposed to the GM maize, so even uncommon allergic reactions could become a major issue due to widespread exposure.
We are concerned about both the short as well as the long-term effects of the GM maize in question-effects on subsequent generations, cumulative toxic effects and the effects on sections of the South African population whose health is already compromised due to poor nutrition, and compromised immune systems.
Compounds in maize have been linked with both carcinogenic and endocrine disrupting effects. For example, maize products have been shown to disrupt the oestrous cycle of rats, either by consumption or through exposure in bedding , extracts of fresh maize and maize cob products have been shown to stimulate breast and prostate cancer cell proliferation in vitro, with sensitivity occurring at molar concentrations  and research identified a mixture of THF-diols in maize that produce endocrine disrupting effects at concentrations 200 times lower than those of classical plant estrogens .
A thorough assessment must be carried out to determine whether the production of these newly identified carcinogenic and endocrine disrupting compounds has been increased as a consequence of genetic modification.
Environmental risk assessment
We are extremely concerned about the potential for dissemination and accidental release of MON863xMON810xNK603 because the imported maize could also be used for domestic production purposes, considering that the importers cannot guarantee that imported GM maize will be immediately milled and only be used for human and animal consumption, or fed as whole grain to animals. Already in Mexico, where despite the fact that only food and feed imports of GM maize were allowed, local landraces of maize were found to be contaminated with GM constructs. It is suggested that GM maize grains sold as food or feed were inadvertently planted, and there are no systems legally required in South Africa, to show that this will not occur here. Resource poor farmers practise maize seed saving in South Africa and maize farmer varieties are still cultivated that represent a valuable source of genetic variation and an important cultural heritage. Contamination of such varieties represents a threat to this heritage.
1 Mariam Mayet and Shenaz Moola, August 2004 Objections to the Application Made by Monsanto South Africa for a Commodity Import Permit of Grain for Feed and Food Purposes that may Contain Maize Grains Derived From Insect-Protected Maize Line Mon863 and Maize Hybrids Mon863 X Mon810 Download 328.56 Kb
2 Paragraphs 546, 536, European Communities-Measures Affecting the Approval and Marketing of Biotech Products: Comments by the European Communities on the Scientific and Technical Advice to the Panel. http://www.foeeruope.org/biteback/EC_case.htm.
3 Spök A et al (2005). Suggestions for the assessment of the allergenic potential of genetically modified organisms. International Archives of Allergy and Immunology 137:167-80.
4 Freese W & Schubert D (2004). Safety testing and regulation of genetically engineered foods. In Harding SE (Ed) Biotechnology & Genetic Engineering Reviews 21.
5 Chowdhury EH et al (2003). Detection of corn intrinsic and recombinant DNA fragments and Cry1Ab protein in the gastrointestinal contents of pigs fed genetically modified corn Bt11. J. Anim. Sci 81(10): 2546-2551.
6 Prescott VE et al (2005). Transgenic expression of bean alpha-amylase inhibitor in peas results in altered structure and immunogenicity. Journal of Agricultural and Food Chemistry 53:9023-30.
8 Paragraphs 717, European Communities-Measures Affecting the Approval and Marketing of Biotech Products: Comments by the European Communities on the Scientific and Technical Advice to the Panel. http://www.foeeruope.org/biteback/EC_case.htm.
9 Markaverich BM et al (2002) Identification of an endocrine disrupting agent from corn with mitogenic activity Biochemical and Biophysical Research Communications 291:692-700.
10 Markaverich BM et al (2002) A novel endocrine-disrupting agent in corn with mitrogenic activity in human breast cancer and prostatic cancer cells. Environmental Health Perspective 110:169-177.