SUBMISSION OF OBJECTIONS BY THE AFRICAN CENTRE FOR BIOSAFETY (ACB)
- 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 Mariam Mayet and Shenaz Moola, August 2004
- CoverLetter_Mon830X810.pdf Cover Letter to the Registrar August 2004
OVERVIEW SCIENTIFIC OBJECTIONS
A scientific assessment was made of the available information. The main findings of this assessment, which are discussed in greater detail later in the document, are:
- A full assessment of the scientific data could not be made because of the designation of large sections of this data as Confidential Business Information
- The molecular characterisation information provided by the notifier indicates several irregularities including open reading frames, a missing stop codon and truncated constructs which could give rise to unintended gene effects
- There is evidence of structural instability arising out of the use of the 35S CaMV promoter and there is a call for the discontinuation of the use of this genetic element in the development of transgenic plants
- The protocols for assessing gene expression in transgenic plants are flawed. Nevertheless, a consideration of the gene expression data provided shows elevated levels of the expressed protein relative to the wild type
- Lack of allergenicity in Cry3B sprays cannot be taken as confirmation that the same applies for the Cry3Bb1 protein due to molecular differences in the transgenic form
- The tests to determine allergenicity have been incorrectly applied (sequence homology assessments), not correlative (digestion studies) and inadequate (several tests not conducted)
- Horizontal gene transfer frequencies are much higher than previously thought and given the presence of an antibiotic resistance marker gene, there is potential for antibiotic resistance transfer to other species
- The decision by the EU to prohibit the use of antibiotic resistance markers in GMOs raises concern about the presence of such a marker in these lines Feeding studies do not supply adequate information for an independent assessment of their validity
- The hybrid should be fully assessed as a genetically engineered organism separate from MON810 and MON863
SUMMARY OF LEGAL ISSUES
- Monsanto has not discharged its onus of proving that its genetically modified (GM) maize is safe for human and animal consumption, as it has failed to submit adequate scientific data for consideration under the GMO Act and thus, it is not possible for the Executive Council to make any reliable safety assessment. Indeed, taking into account our scientific assessment, it is our respectful submission that the Executive Council must refuse the application, on the basis of the precautionary principle as reflected in Article 11(8) of the Cartagena Protocol on Biosafety. The precautionary principle demands a rigorous scientific approach and ensures democratic decision-making in regard to the acceptance of risks. It also requires the seeking and considering of sustainable alternatives precisely because it explicitly considers uncertainty and ignorance.
- The Constitution of the Republic of South Africa obliges the State to ensure that South Africans have the right to safe food-as a critically import socio-economic right. Maize is a critically important agricultural product because it is used as a staple for millions of people not only in South Africa , but also in the Southern African region. It is our submission, taking into account our scientific assessment of the application; that the right to safe food enshrined in the Constitution will be flouted should the Executive Council grant the approval sought by Monsanto. Indeed, the Department of Health has a constitutional and statutory duty to safeguard the consumer from foodstuffs that are harmful or injurious to human health as is also borne out by the rationale for the Foodstuffs, Cosmetics and Disinfectants Act No 54 of 1972.
- The National Department of Agriculture has approved Monsanto’s MON 810 for commercial growing and import as food and feed. It has also approved Monsanto’s GM maize event 863 for import as food and feed. Yet, neither it, nor the Department of Health nor any other government agency has to date, conducted any reliable and proper post commercialisation testing and monitoring for the effects of transgenic maize on animal and human health. Taking into account our scientific assessment, and our submissions below regarding post-commercialisation testing and monitoring, the South African government is entitled to review its earlier decisions taken regarding safety approvals given by it, in respect of Monsanto’s GM maize MON 810 and transformation event 863, in terms of Articles 12 and 11(8) of the Biosafety Protocol.
- The Department of Trade and Industry, the NDA and the Department of Labour should, as a matter of extreme urgency, conduct an assessment on the socio-economic impacts of the importation of GM maize in the hundreds of thousands of metric tons by the animal feed industry in South Africa, from Argentina and the United States. This assessment must include an enquiry into impacts on the domestic production of maize in South Africa, the distortions in the market place caused by the sale of such maize, the long-term food security and food sovereignty impacts for South and Southern Africa, 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.
- We are extremely concerned about the negative environmental impacts that may arise from the spillage of whole GM maize grains during transportation and the milling process itself. We note with alarm that the transportation of GMOs as well as the mills to be used in the processing of GMOs is captured by the extraordinarily wide definition of contained use in section 1 the GMO Act.
We are aware that the Registrar, Dr Julian Jaftha has recently proposed five measures regarding the importation of genetically modified maize that have only commodity clearance in South Africa. Whilst these measures are a welcome step towards greater biosafety, until such time as they are brought within the purview of the GMO Act, the NDA will not have the legal powers to ensure enforcement and compliance.
We also point out, that we are not convinced that any proper monitoring has or will take place, to ensure that GMOs imported for food and feed does not cause harm to the environment as a result of spillage during import, transport and processing phases. In fact, we are not aware of any measures being taken by either the NDA or the Department of Environmental Affairs and Tourism of such monitoring.