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SUBMISSION OF OBJECTIONS BY THE AFRICAN CENTRE FOR BIOSAFETY (ACB)
Objections to the Application made by Syngenta South Africa in Respect of the Following Events to the National Department of Agriculture, South Africa.

Mariam Mayet and Shenaz Moola, July 2004

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SYNOPSIS – AFRICAN CENTRE FOR BIOSAFETY
1. Provision of false and misleading information material to the approvals sought

The notifier claims that there are no wild relatives of cotton in South Africa (5.5 of the application). It has come to our attention that this is not the case and we have a concern that we have been misled by the notifier’s claims in this regard. There are about 39 species of Gossypium. They are found worldwide in the tropics and warm temperate regions with several species cultivated. There are three species in southern Africa, occurring in northern Namibia, Northern Botswana, Northern Province, Mpumulanga, Swaziland and KwaZulu-Natal. These three species of Gossypium are Gossypium anomalum subsp. anomalum which occurs in Namibia, Gossypium herbaceum subsp africanum which occurs in Namibia, Botswana, Limpopo, Mocambique, Swaziland and KwaZulu-Natal and Gossypium triphyllum which occurs in Namibia and Botswana. According to Cotton South Africa and contrary to the notifier claim, cotton does have a wild relative, Gossypium herbaceum subsp. Africanum, found in South Africa . The possibility for gene transfer in locations in Hawaii and Florida, where wild or feral cotton relatives exist has led to the EPA imposing stringent sales and distribution restrictions on Bt crops within these states.

2. Rights of access to information severely restricted; no meaningful public participation

In response to the Centre’s application to the National Department of Agriculture (NDA) in terms of the Promotion of Access to Information Act (“PAIA”) for access to information, we have received an astonishing paucity of information. We have been left with little choice, but to conclude that the NDA and the applicant have obstructed us from conducting any meaningful assessment of the application. Indeed, it is self-evident that the NDA has given the Applicant carte blanche to exercise an arbitrary decision regarding the information that has been withheld from us, on the grounds that such information is considered by the Applicant to be confidential business information (CBI). This biased and grossly inequitable situation has arisen principally, because the NDA has failed to establish a proper formal process for the determination and characterisation of what constitutes CBI. The issue of the public’s right to access information concerning genetically modified organisms (GMOs) has been thoroughly canvassed in the court papers submitted by the Trustees of the Biowatch Trust (“Biowatch”) in its application brought before the High Court of South Africa (Transvaal Provincial Division) Case Number 23005/2002, acting in the public interest. The Centre associates itself with the relief sought by Biowatch, and we expressly reserve our rights in this regard. We also note with extreme dissatisfaction that we have not been furnished with the results of the previous field trials the Applicant says it has conducted in South Africa, despite repeated requests for such information. In the circumstances, we have been severely prejudiced in our abilities to meaningfully participate in this application.

3. Scientific objections

1. The assessment of the application in terms of the protocol and risk assessment was made difficult due to lack of supporting documentation and list of references cited. The data on the previous trials was not supplied to us despite an explicit request in our PAIA application.

2. It is not clear which transgenic lines will be cultivated and at which of the proposed sites. The details of the site are contained within Appendices, copies of which have not been supplied to us

3. The detail of the introduced gene sequences is not clear as several possible permutations are possible as outlined in the Syngenta patent application. None of the molecular characterisation detail has been made available and the designation of the bulk of this information as CBI has compromised our ability to assess the full impacts of the transgene.

4. Contrary to the notifier claim regarding gene stability, unintended effects that are not detected in the lab and that may only become apparent in the long term, cannot be ruled out.

5. The development of insecticide/pesticide resistance is of concern due to losses incurred by food producers, disease spread by resistant insects, the introduction of newer, stronger pesticides and the increased use of pesticides. There is a concern that the development of resistance in the target organism could result in the use of higher toxicity pesticides.

6. No reference has been made to the relatively large body of literature on the impacts of genetically engineered plants, including impacts on non-target organisms, the emergence of superweeds and persistence of the Bt toxin.

7. Several possible categories of non-target organisms, including beneficial species, such as the natural enemies of the target pests, pollinators including insects and avian species, non-target herbivores, soil organisms, endangered species and species that contribute to local biodiversity are at risk of exposure to Bt toxins. The levels of expression of Bt toxins in pollen is much higher than in other parts of the transgenic plants and this has raised concern for the impacts on non-target organisms.

8. Gene stability is a contentious issue and the stability in particular of the CaMV promoter to drive expression of the gene has of late raised concern because of effects such as generation of novel viruses, mutagenicity and carcinogenicity.

9. The literature indicates that a great deal more investigation has to be carried out on the impacts of transgenes before their release into the environment.

4. EC has a constitutional and statutory duty to protect the environment

We strenuously object to the environment of South Africa being exposed to risks just because the world’s largest agrochemical company requires a nursery in the Southern hemisphere, for the breeding of its transgenic seeds, which it intends to export to the United States for cultivation there. It is the Centre’s respectful submission that the Executive Council is obliged to refuse the approvals sought by the Applicant because the release of the GMOs in question, poses unnecessary and unacceptable risks to the environment. Indeed, the EC has a duty to refuse the approvals in terms of section 24 of the Constitution, in order to protect the environment. Taking into account our scientific assessment, it is our respectful submission that the EC has no choice, but to refuse the application, because the statutory framework obliges the EC to adopt a risk adverse approach in assessing environment hazards.

5. Failure to Comply with ECA and ECA Regulations

The “genetic modification of any organism with the purpose of fundamentally changing the inherent characteristics of that organism” is a listed activity in terms of section 6 of Regulations GNR 1182 of 5th September 1997 read together with sections 21 and 22 of the Environment Conservation Act. The ECA Regulations set out, inter alia, the requirements for an application for authorisation to pursue an identified activity. The ECA Regulations make provision for the submission of a Scoping Report together with the required contents of such a report (Regulation 6(1)). In other words, the Applicant is obliged to submit a Scoping Report in terms of the ECA Regulations, and in compliance with its provisions and requirements. These include inter alia, the employment of an independent consultant; identification of environmental issues and full details regarding alternatives, in the said Scoping Report, as required by the ECA Regulations. An examination of the information furnished to the Centre does not reveal any evidence that the Applicant has complied with these provisions. In the circumstances, the Applicant is obliged to withdraw its application. In fact, the EC is not authorised to grant the application sought by the Applicant, until such time as these provisions have been complied with.

6. Environmental Assessment in terms of section 78 of NEMBA

We are aware that the National Environmental Management Biodiversity Bill will come into effect on the 1 August 2004. We place on record, that we will, on the 1 August 2004, be approaching the Minister of Environmental Affairs and Tourism to act in terms of section 78 of what will then be, the National Environmental Management Biodiversity Act (NEMBA) to require an environmental assessment for all of the events the applicant seeks to test in open field trials. We believe that we have provided ample grounds in this submission for the Minister to come to the inescapable conclusion that the GM cotton events “may pose a risk to the environment” and therefore, require that environmental assessments be conducted in terms of Chapter V of NEMA, before the EC takes a decision.

SYNOPSIS – BIOWATCH
Summary

Biowatch, as an interested party, is entitled1 to submit comments and objections to the Registrar, in connection with the proposed permit applications advertised in the notice referred to above, which was published by Syngenta South Africa (Pty) Ltd (“Syngenta”). Biowatch hereby submits its comments and objections to these permit applications and requests that the applications not be granted. Our reasons for this request, in summary include the following:

1. There is a lack of adherence to basic environmental and human rights principles in the administration of the Genetically Modified Organisms Act 15 of 1997 (“GMO Act”). This application does not comply with the risk averse approach of the GMO Act or the basic precautionary principle and other environmental management principles enshrined in the National Environmental Management Act 107 of 1998 (“NEMA”) and the Biosafety Protocol.

2. The central critical issue in the release of GMOs in South Africa is whether environmental impact assessments, required in terms of NEMA, have been done. In our knowledge there have been no environmental impact assessments of any GMO crops (including those to which these permits relate) in South Africa to assess their effect on the biophysical environment, including locally important species, organism assemblages, and organisms found in the different soil types in South Africa, the socio-economic environment or human health.

3. There is insufficient information provided in the public notice (either in relation to the permits applied for or any risk or environmental assessments done) to allow for effective public participation, required in terms of both the GMO Act and NEMA, and the right of the public to comment and participate is severely compromised by this. The ability of the public to remedy the lack of access to information is hampered by the timing for comments (30 days) and timing for the provision of information required to comment properly on these permits in terms of the Promotion of Access to Information Act 2 of 2000 (“PAIA”), which is also 30 days.

4. Scientific evidence of the many negative impacts of GM crops on the environment is mounting over the past decade and as such it continues to represent a badly calculated risk. The known Bt and HT genes have proven to create major environmental mishaps and there is no information about the new gene construct, VIP3A.

5. The socio-economic impact of GM cotton is not being dealt with in this permit application. It is not possible that resource poor farmers will benefit from a crop that:

they can only afford buying on credit (normally double the price);

has patents-holders looking to reap financial benefits;General Comment

will be released in a context of intellectual property rights legislation that favours the commercial seed industry;

they cannot use to produce their own planting material.

6. The Department has admitted in court its own inadequacies in dealing with permit applications and requests from the public. The public is therefore entitled to question whether the Department actually has the competence and capacity to monitor the activities of Syngenta, given Syngenta’s past history of misrepresenting facts to the public.

7. The regulation and monitoring of GMOs in South Africa is inadequate and not up to international biosafety standards and a moratorium on the granting of new permits is therefore required until such time as it can be done in a responsible and accountable manner.

General Comment

1. The Biowatch Trust (“Biowatch”) is a national non-governmental organisation that acts in the public interest. It was established in response to, among other things, concerns arising from the widespread commercialisation of genetically modified organisms (“GMOs”) in South Africa, and the absence of civil society involvement in the determination of policy and law, and in decision-making, regulating their use, control and release.

2. Biowatch is therefore submitting these comments and objections in the public interest and requests that the Executive Council gives due consideration to these comments and objections, as it is required to do in terms of regulation 6(7) of the regulations made under the GMO Act2 (“the Regulations”), and acts in a fair manner as required by the Promotion of Administrative Justice Act 3 of 2000 (“PAJA”).

3. In the absence of access to the risk assessments submitted by Syngenta or any other relevant documentation, these comments and objections cannot be done in a comprehensive and substantive manner. In terms of the GMO Act, the public has 30 days to respond to a public notice, but it also takes a minimum of 30 days to access information from the Department of Agriculture, following the procedure provided for in terms of PAIA. It is therefore not possible at this time to exercise our right to comment or object on the substance of the proposed releases, and we reserve our right to make additional comments and objections once all information has been supplied by the applicant, as is required by the Constitution, the National Environmental Management Act, and the GMO Act and Regulations. We also require to be notified timeously, in writing, of any decisions of the Executive Council in regard to either of the Syngenta public notices, and to be given adequate notice of our right of appeal in terms of the GMO Act against the decisions taken by the Executive Council in relation to these permit applications, which request must be complied with in terms of section 2(b)(iii) and (iv) of PAJA. We reserve our rights of appeal in this matter.