SUBMISSION OF OBJECTIONS BY THE AFRICAN CENTRE FOR BIOSAFETY (ACB) and Friends of the Earth U.S.

Objections To The Application Made By Pioneer Hibred Rsa And Dow Agroscience Southern Africa For Commodity Clearance Of Genetically Modified Organisms, Specifically 59122 Maize To The National Department Of Agriculture, South Africa

by African Centre for Biosafety, 8 March 2005. Read here.

Comments On The Application By Pioneer Hi-bred Rsa And Dow Agroscience Southern Africa For Commodity Clearance Of Genetically Modified 59122 Maize To The National Department Of Agriculture, South Africa

by Friends of the Earth U.S., 9 March 2005. Read here.

OVERVIEW SUMMARY OF LEGAL ISSUES

1. EC TO UPHOLD RIGHT TO SAFE FOOD; REFUSE APPLICATION BASED ON PRECAUTIONARY PRINCIPLE

It is our submission, taking into account our scientific assessment; the Executive Council will flout the constitutionally protected rights of South Africans to safe food if it were to grant a safety approval for Pioneer/Dow’s Herculex RW GM maize. Indeed, the Department of Health, who plays an oversight role on the Executive Council in terms of the GMO Act, has on obligation to safeguard the consumer from foodstuffs that are harmful or injurious to human health and ensure a science-based and rigorous review process designed to ensure food safety. As a Party to the Cartagena Protocol on Biosafety, South Africa is entitled to refuse Pioneer and Dow’s application based on the precautionary principle as set out in Article 11(8) of the Protocol.

2. CONTRAVENING INTENTION, SPIRIT AND PROVISIONS OF BIOSAFETY PROTOCOL

The safety approval sought by Pioneer and Dow is in respect of non-existent GM maize, whereas the Biosafety Protocol applies to real situations of cross border trade in GMOs and not to speculative trade in respect of non- existent GMOs. Article 11 of the Biosafety Protocol deals with cross border movement of GMOs for direct use as food, feed or processing and is thus the “kick off” point for the regulation of Pioneer’s application. It is implicit in Article 11 of the Protocol, that prior approval for commercial growing and domestic consumption by the Party of Country of export is required before the transboundary movement can commence alternatively, before the Party of import grants any approval. It was never within the contemplation of those negotiating the Biosafety Protocol that a Party of import would be required to grant a food safety approval of a GMO, in the absence of such approval by the Party or country of export. In fact, Article 11(1) of the Protocol goes further than requiring mere authorisation. It requires that a Party of export inform other Parties to the Protocol of its decision (approval) through the Biosafety Clearing House by way of furnishing to the Biosafety Clearing House, at a minimum, the information specified in Annex II of the Protocol titled “Information Required Concerning Living Modified Organisms Intended for Direct Use as Food or Feed, or For Processing.” These requirements put the other Parties to the Protocol “on notice” that the GMO in question may be exported for food, feed and processing use; and to provide relevant information on that GMO in order for such other Parties to use in making a decision whether or not to allow the import of that GMO for food, feed or for processing . This form of indirect notification serves as a trigger for the provisions of Article 11 to kick in. It stands to reason therefore, that prior approval in the Party/country of export is the first step in the chain of regulatory events that pertain to the transboundary movement of GMO. The second event is the notification by the Party/country of export via the Biosafety Clearing House. The third significant event in this chain is then consideration of the application and decision-making based on the precautionary principle. Since no such prior approval exists, it is our respectful submission that the EC, acting on behalf of the Republic of South Africa as a Party to the Biosafety Protocol, cannot and should not grant the application sought by Pioneer and Dow. If such an application were to be granted, then South Africa could well be in violation of the principles, objectives and provisions of the Biosafety Protocol.

3. PIONEER, DOW’S APPLICATION WILL WORSEN CRISIS IN GRAIN SECTOR IN SOUTH AFRICA

Since the GMO Act came into effect, the EC has authorised several millions of tons of GM maize to be imported into South Africa from Argentina and the USA by especially the animal feed industry because it is cheaper than if they were to purchase maize produced locally and thereby displacing and placing at risk thousand of jobs in the agricultural sector and related industries. Already, South African farmers have sounded the alarm bells during January 2005, when GRAIN SA launched a country wide campaign to raise public awareness about the country’s agricultural crisis because prices of grains, including maize are being kept low because of the dumping of cheaper subsidised maize from other countries. Pioneer and Dow’s application is intended to enable and expedite the imports of cheap subsidised maize from the USA.

4. LACK OF MONITORING, LABELLING EXACERBATES UNCERTAINTIES

South Africans have been eating GM maize for several years yet, neither the National Department of Health nor any other government agency has conducted any post commercialisation testing and monitoring for the effects of transgenic maize on animal and human health. This failure only serves to exacerbate on-going scientific uncertainties about the safety of GMOs, and GM maize in particular.

5. SPILLAGE OF GMOS DURING TRANSPORT, STORAGE

We are extremely concerned that if Pioneer and Dow’s application should be granted there is a possibility that there may be negative environmental impacts arising form the spillage of whole GM maize grains during transportation and the milling process itself because the transport and storage are not adequately regulated under the GMO Act.

SUMMARY OF SCIENTIFIC ASSESSMENT

An assessment was made of the notifier application especially in terms of the claims by the notifier regarding the lack of allergenicity of the Cry34 protein. Some of the issues raised are:

• Problems associated with testing surrogate proteins extracted from organisms unrelated to the genetically modified plant, especially for the purposes of toxicity testing.
• Contrary to notifier claims, there have been reports of allergic responses to Bacillus thuringiensis.
• The Cry34 protein is still an unknown quantity as they have not been food constituents. The currently known allergens and their related gene sequences do not therefore represent the full range of possible protein sequences capable of producing an allergic reaction.
• Loss of function due to heating is not necessarily an indicator of non-allergenicity, but may reflect conformational changes due to heat application. Loss of function may merely indicate denaturation rather than degradation into short peptides, and could therefore still be allergenic.
• Protein abundance in food is not necessarily an indicator of allergenicity and in the Starlink controversy, levels as low as 20 PPB were considered unacceptable because a lower limit for sensitisation could not be determined.
• Whilst the gastric assays is widely accepted as a useful test of allergenicity it does not represent the ultimate predictor of an allergic response and much work remains to be done in method development for allergenicity assessments.
• The application of the kinetic approach to measure gastric digestion is not widely accepted and is currently the subject of discussion and evaluation by the EPA.