I



NYU Project on International GMO Regulatory Conflicts

Country Study: South Africa

Rosemary Wolson, UCT Innovation

1. Introduction and Context

The advent of democracy in South Africa and the concurrent rise of globalisation have together shaped the significant policy and economic transformation that has taken place in South Africa in the past decade. After years of isolation, the country has re-joined the international community, and on certain issues is beginning to take a prominent role as a mouthpiece for the interests of a broader constituency of African and other developing countries. The insular, inward-focused policies of the past, which were designed to benefit only a minority of privileged citizens, have been discarded and replaced with new measures aimed at redressing the inequities of the past, eradicating poverty and improving quality of life. Simultaneously, policy reforms have been directed at building a competitive local economy capable of integrating into global markets and fuelling national growth.

Despite the extensive restructuring that has taken place, however, the apartheid legacy of a dual economy endures, in which developed and developing world conditions coexist. The gulf between the two remains wide, and interventions that support one sector are sometimes perceived to be in conflict with the interests of the other. South African debates on contentious issues are therefore often a microcosm of similar debates in the international arena, with different stakeholders championing viewpoints typically associated with both the ‘North’ and the ‘South’. The reality, though, is that South Africa is a developing country, despite the ‘pockets’ of developed infrastructure and affluence, and it is imperative that national policies promote sustainable development.

The potential role of genetically modified (GM) crops in supporting or hindering development objectives has given rise to hotly contested debates around the world, and the South African government’s decision to embrace the technology early on has not gone undisputed. The discourse has been wide-ranging, covering the health, environmental and socio-economic implications of genetically modified organisms (GMOs) in food and agriculture, both in favour of and opposing the technology, but participants on both sides of the fence have been confined to small sectors of the population and although awareness appears to be growing, for most South Africans it remains a fairly arcane topic. Nonetheless, the stakes are potentially high, as many believe that the battle for acceptance or rejection of GM crops elsewhere in Africa will be won or lost in South Africa.

While the most crucial ‘GM battle’ is arguably the one currently being waged between the United States (US) and the European Union (EU), the impact of GMOs in Africa is also the subject of extensive discussion – almost disproportionately so, considering the fact that South Africa remains the only African country to produce GM crops commercially, and that no African-developed GM crop events have been brought to market yet. Proponents of the technology believe that it offers enormous potential for food security in the future, while critics argue that multinational seed companies are turning their attention to Africa because other markets are rejecting the technology, and that they are exploiting food security problems as a means of gaining control over Africa’s agriculture. The question of a nation’s freedom of choice over accepting or refusing GM food aid when millions are facing famine is particularly sensitive: some GM supporters allege that rejection of GM food aid is tantamount to murder, while opponents believe that the agencies responsible ought to respect donee countries’ autonomy over their food supply and try harder to source alternative products, rather than dump on the starving GM grain that nobody else wants.

Several stakeholders, including many other African countries, are therefore following developments in South Africa with interest, to see what lessons can be learned from the South African experience with GMOs. This study will evaluate the South African regulatory framework for GMOs against the background of the country’s agricultural biotechnology capabilities (scientific and regulatory), explore the positions of different stakeholder groups, describe some of the key relevant national debates, and examine South Africa’s position in the region vis-à-vis GMOs.

2. Sectoral Background

2.1 The South African Agriculture Sector

Agriculture plays a vital role in the national economy, by contributing to food security and providing a significant source of employment and export earnings. The agro-food sector (consisting of primary agriculture, inputs and agro-processing) makes up about 14% of the gross domestic product (GDP). Farming practices in South Africa are diverse, ranging from the large­scale commercial sector to small­scale operations and subsistence farming. About 50,000 commercial farmers employ one million workers (equivalent to 11% of formal sector employment), and provide housing, schooling and livelihoods for an estimated six million family members of these workers. 240,000 small-scale farmers support over one million family members and provide occasional employment for an additional 500,000 people. It is estimated that there are a further three million subsistence farmers in South Africa.[1]

South Africa is a net exporter of agricultural products. Exported products (in processed and unprocessed form) include wool, maize, sugar, citrus, deciduous fruit, wine and paper, and make up approximately one tenth of the country's total export earnings. South Africa is largely self­sufficient in most primary food crops, other than wheat, rice and oilseeds.[2] South Africa is not a centre of origin or diversity for any major food crops.

Maize is considered the country’s most important field crop, and white maize is the major staple food. The area planted under maize annually is between 3.8 and 4.8 million hectares, representing about a quarter of total arable land. A large variety of cultivars is available, adapted to the different climatic and production conditions found in the country. On average,[3] 4.3 million tonnes of white maize and 3.9 million tonnes of yellow maize are produced commercially annually. About 500,000 tonnes of predominantly white maize is produced each year by subsistence farmers for household consumption. Annual domestic consumption averages 4.4 million tonnes of white maize and 3.1 million tonnes of yellow maize. South Africa imports maize mainly from the US, Argentina and Kenya. The main export markets for South African maize and maize products are SADC, Japan, Iran, Kenya, Venezuela, and Malaysia.[4]

South Africa has a well-established, relatively stable seed industry, supplying good quality seed which meets international requirements. Historically, South African companies dominated the local industry, but recent years have seen increasing penetration by a number of multinational seed companies.[5] Planting seeds are one of the fastest growing agricultural imports from the US, having increased in value from $6.9 million in 1999, to $12.5 million in 2002, and have been identified as one of the best prospects for future US agricultural product sales to South Africa.[6]

Traditional farming is less prevalent than in most other African countries, largely due to apartheid policies which resulted in the forced removal of numerous communities from the land they occupied. Farming in traditional communities is a low­technology enterprise, usually taking place on small areas of private or communal land. Cattle and goat herds often compete with agronomy. Subsistence farmers still plant old cultivars developed from wild plants including millet, yam, okra, cassava, plantain, sorghum, cowpea and sweet lupin, but very limited information is available on the use of traditional varieties and landraces. Commercial crops, attractive to traditional farmers because they are easy to grow and give a greater yield, have been displacing traditional crops over a prolonged period of time, resulting in erosion of the traditional knowledge base and an ongoing loss of genetic diversity. In the past, efforts of the formal plant breeding sector, targeted almost exclusively at commercial farmers, tended to neglect the needs of traditional farmers, who consequently lack access to seed distribution networks. At the same time, local seed systems characteristic of most African countries, through which seed is selected, maintained, replaced and exchanged within communities of small farmers, are also less developed in South Africa than in many other African countries.[7]

Public sector agricultural research is performed by the Agricultural Research Council (ARC), the Council for Scientific and Industrial Research (CSIR) and several universities, as well as seed companies. Both local and foreign seed companies supply the market with new seed cultivars.

Primary agriculture is affected by a number of constraints. Only 14% of the land is estimated to be suitable for crop cultivation (and as little as 3% is considered to be high potential land). Crop yield is dependent upon rainfall, which is highly variable from year to year. All of the major food crops are exotic species which have had to be adapted for local conditions and whose sustainability is dependent upon continued access to imported germplasm.[8] Furthermore, in the past decade, the agriculture sector has also been forced to adjust to new circumstances, due to deregulation,[9] abandonment of protectionism,[10] trade liberalization, land reform[11] and new labour standards, and is currently facing challenges to overcome limited competitiveness, low profitability and skewed participation in the sector due to the deliberate policies of exclusion of designated groups in the past.[12]

These factors help explain why the sector is not functioning at full potential, but despite this, there are signs that restructuring in response to the reforms has made the sector more productive. Many successful operations exist and there is a solid foundation on which to build. Development of the informal farming sector offers opportunities for the alleviation of poverty in rural areas. The 2001 Strategic Plan for South African Agriculture was developed through cooperation of commercial and small-scale farmers, agribusiness and government to map the way forward for the benefit of all participants. The strategic objective of the Plan is ‘equitable access and participation in a globally competitive, profitable and sustainable agricultural sector contributing to a better life for all’. Core and complementary strategies are identified to achieve this. Biotechnology is described as a ‘strategically important’ technology, and government support is called for to ensure better funded and coordinated research and to facilitate partnerships to promote acquisition of appropriate technology, but GM crops are not specifically discussed.

2.2 Biotechnology

2.2.1 General Information on the R&D System in SA

South Africa has a well-established research system, but one which is under strain on a number of fronts. Heavy investment by the former government in technology missions aimed at priority areas such as military dominance and energy self-sufficiency served to establish solid technological capabilities. Expertise in manufacturing, agriculture, mining and minerals was also developed. However, only a small segment of the population was able to participate in the R&D system in the past, and investment in R&D as a proportion of GDP fell for much of the 1990’s, as the new government focused on new national priorities. At present, gross domestic expenditure on R&D is estimated at about $1.5 billion,[13] and amounts to 0.76% of GDP.[14] Government plans to double public spending on R&D over a period of three years to bring total R&D expenditure up to 1% of GDP. The private sector performs just over half of national R&D, the higher education sector a quarter, and government about 20%. The private sector share has increased in recent years, while higher education’s has remained constant and government’s performance has decreased. R&D spending by the public and private sectors respectively is approximately equal.

South Africa has 1.9 full time equivalent (FTE) researchers per 1,000 employed, and 7.3 FTE R&D personnel per 1,000 employed. The heavily skewed demographics of scientists, technologists and engineers (in terms of age, gender and race) is leading to a shrinking population of researchers.[15] A particular cause of concern is the decrease in the share of publications/citations by South African researchers in recent years.[16]

The country’s science and technology policy is set out in a 1996 White Paper on Science and Technology,[17] which adopts the concept of a National System of Innovation. In 2002, a National R&D Strategy[18] was articulated, in which strategic interventions are proposed to address current weaknesses, in an attempt to enhance the impact of the policy and ensure that its vision is sustained. The R&D Strategy rests on three pillars. The innovation pillar articulates four technology missions earmarked for support, having been identified as vital to economic and social development. Biotechnology is considered a key technology platform and, together with information and communication technologies, makes up one of the missions.[19] Human capital and transformation constitutes a second pillar, which focuses on pursuing excellence in global terms and ensuring better representation in science and technology of individuals from previously disadvantaged communities and of women. The third pillar advocates creation of a more effective government science and technology system by giving DST a mandate to co-ordinate cross-cutting issues and integrate the system, while ensuring that appropriate government departments have clear roles and responsibilities in respect of sector-specific R&D institutions. This aims to overcome the current fragmentation in budgeting and reporting amongst the various institutions and agencies which is limiting the effectiveness of the system.

2.2.2 Biotechnology R&D in SA

Table 1: Developments in South African Biotechnology

Mid-1970’s Development of molecular biology research capacity began, with the utilisation of plant tissue culture techniques.

1980’s Genetic modification began to be adopted. Funding was initially directed primarily at the training of scientists.

Mid-1980’s Certain companies began to get involved in genetic modification and several biotechnology research programmes were operating around the country.

1990 The first field trials for genetically modified crops were initiated.

1997 Conditional commercial release permits were granted, and the Genetically Modified Organisms Act (GMO Act)[20] was passed.

1999 The Regulations required for the implementation of the GMO Act came into force.

2001 The National Biotechnology Strategy was published and the first dedicated South African biotechnology venture capital fund was launched.

2002 A Biotechnology Roadmapping Exercise began, to map existing capabilities, market demands and future technology needs for the development of biotechnology in South Africa.

2003 A review of the GM regulatory framework was instituted and implementation of the National Biotechnology Strategy gained momentum.

A 2003 National Biotechnology Survey[21] found over 1,000 biotechnology research groups in South Africa, located at academic institutions, research organisations and within industry, across several sectors.[22] Of these, about one third are estimated to be involved in projects intended to produce a product or process that could be applied in industry, while the remainder are either performing fundamental research, running projects which have the potential to generate biotechnology applications although this is not their main objective, or are operating as biotechnology service providers.

However, research efforts have been fragmented, support mechanisms have been inadequate (both in terms of financial and human resources) for moving innovative technology out of the laboratory into the marketplace, and a risk-averse financial community has not displayed much interest in investing in biotechnology. Despite the research activity, few local biotechnology products and processes (particularly those based on third generation biotechnology) have been commercialised.

The Survey identified 106 companies active in modern biotechnology in South Africa. Forty-seven of these were classified as ‘core biotechnology’ companies (with their businesses substantially focused on biotechnology), while the remainder are considered ‘non-core’ (utilising biotechnology in some aspect of their business activities). There are companies operating in the human health, animal health, plant, food and beverage, industrial and environmental sectors, while some companies offer support services relevant to biotechnology. In the last decade or so, new biotechnology companies have been established at the rate of about two per year, either as new start-ups, or as spin-offs from research groups or existing enterprises. Most companies are private, and have fewer than 50 employees. It is estimated that only 10% of biotechnology companies are conducting innovative, cutting edge research and development (R&D), with the majority involved in new applications of lower-tech modern biotechnology.

Sufficient data is not available to quantify overall funding for biotechnology R&D with any accuracy, but the Survey shows that it exceeded the equivalent of about $47 million.

Plant biotechnology receives the second-largest share of funding,[23] and focuses on development of GM crops, plant propagation, traditional breeding, and biological control. Research areas include:

• Crop improvement (herbicide tolerance, insect resistance, fungal resistance, viral resistance, drought tolerance, metal tolerance, nematode resistance)

• Indigenous plant utilisation

• Fruit improvement

• Forest tree improvement and micropropagation

• Crop and tree fingerprinting

• Plant metabolism (nitrogen metabolism, seed germination)

• Horticultural propagation.

2.2.3 National Biotechnology Strategy

In 2001, a National Biotechnology Strategy[24] (NBS) was released by the Department of Science and Technology, setting out mechanisms for achieving the proposed biotechnology mission of the R&D Strategy. It is recognised that biotechnology has potential to contribute to economic development and address national needs in fields such as health, food security and the environment, but that in order to do so, several associated challenges must be overcome. The NBS is intended to provide an enabling environment appropriate to local conditions, for the development of a South African biotechnology sector which is able to make a positive socio-economic impact.

About $70 million has been made available by government over a period of three years for implementation of the NBS, which is being led by the Biotechnology Regional Innovation Centres (BRICs). The BRICs are tasked with providing technology platforms for defined focus areas, to facilitate the sharing of capital equipment and specialised expertise; selecting and disbursing funding to research programmes at existing R&D organisations, including universities, science councils and industry; and attracting regional anchor investors. Three BRICs have been established in the country’s major commercial centres, each with defined focus areas intended to align national imperatives, market demand and regional expertise. BioPAD (Biotechnology Partnerships and Development) is situated in Gauteng, focusing on biotechnology for animal health, and industrial, mining and environmental biotechnology. Cape Biotech, located in Cape Town, and EcoBio (East Coast Biotechnology Consortium) in Durban, both have focus areas of human health and industrial bioprocessing. A fourth, PlantBio, has a national remit in the area of plant biotechnology and is supported by the other BRICs, as it was felt that no one region contained a critical mass of expertise in plant biotechnology. For the meantime, PlantBio is located alongside EcoBio. Food security crops such as maize, sorghum and cassava will be prioritised initially.

The BRICs have begun setting up infrastructure and disbursing funds, but it remains too soon to assess their impact. While the biotechnology community welcomes the injection of funds dedicated to biotechnology, some questions have been raised about whether the NBS will succeed in meeting its objectives. The available funding, while not insubstantial by local standards, is nonetheless limited. Although DST has given assurance that support will continue beyond the initial three-year allocation (this period being a requirement of the government budget cycle), there is some concern that expectations of outputs from this initial funding might be too high, failing to take into account the long-term nature of biotechnology returns, and that continued support might not be forthcoming if outputs are deemed insufficient. Some believe that the emphasis of the NBS is skewed too much in favour of the commercial end of the R&D pipeline. To some extent, this has been borne out, as up to now, the BRICs have focused on trying to identify projects with the highest potential for commercialisation. However, there have been few project proposals which meet the strict criteria and/or pre-award due diligence examination, and failure to support earlier stage research now is unlikely to increase the number of such projects in the years to come. The NBS also fails to give clear direction in respect of achieving its poverty elimination objectives.

3. Field Trials and Commercial Release of GM Crops

3.1 Field Trials

Crops for which field trial permits have been issued include maize, cotton, soya, wheat, potato, sugarcane and canola.[25] Approval has recently been granted to conduct field trials at six sites around the country for GM potatoes resistant to tuber moth, developed by the Agricultural Research Council in a partnership with Michigan State University. The developers have stated that they hope to commercialise the GM potatoes by 2007.[26]

3.2 Commercial Release

South Africa is still the only African country to grow GM crops on commercial scale. Five types of genetically modified crop traits, listed in Table 2, have been approved for commercial release. These are all based on imported technology. While Bt yellow maize, used primarily for animal feed, was first approved in 1998, with the approval of Bt white maize in 2001, South Africans became pioneers for eating a GM food staple.

Table 2: Genetically modified crops approved for commercial release in South Africa

|CROP |YEAR FIRST APPROVED |

|Insect resistant cotton |1997 |

|Insect resistant maize |1998 |

|Herbicide tolerant cotton |2000 |

|Herbicide tolerant soybeans |2001 |

|Herbicide tolerant maize |2004 |

In 2002, GM soybeans represented over 15% of the total area of soybean planted nationally, GM maize about 18% and GM cotton 85% of the crop planted.[27] The higher percentage experienced for cotton is attributed to the fact that it is not a food crop, but penetration of other GM crops has also been relatively rapid. In 2003, it has been reported that 400,000 hectares of GM crops were planted in South Africa, amounting to 1% of the global area under GM cultivation, and constituting a 33% year-on-year increase from the 2002 crop. The uptake of GM white maize (white maize being the major food staple) has been rapid, increasing from 6,000 hectares when first introduced commercially in 2001, to 84,000 in 2003.[28] South Africa has recently become the second market (after the US) in which Monsanto is selling its Roundup Ready maize.[29] An industry study predicts that the uptake of GM maize will continue to rise rapidly (with that of white maize increasing from 3% of the harvest in 2003, to 8% in 2004 and 16% in 2005), and that in five years’ time more than half of the total maize harvest will be GM.[30]

3.3 Benefits

For maize, preliminary estimates of net cost savings for the 2002/2003 season amount to $14.5 million nationally. A further benefit is peace of mind for farmers, who often apply other pesticides only when signs of insect damage become apparent. Less pesticide in the environment and reduced residue on crops are other positive factors.[31]

For soybeans, the main benefits appear to be that GM soybeans enable minimum or no-till cultivation and soil condition is improved. Since residues do not persist, crop rotation is facilitated.[32]

For cotton, the cost savings realised by reduced use of pesticides are generally balanced out by the higher seed cost and technology fee, but with increased yields, the overall income effect is positive. Reduced use of pesticide generates several benefits: cost savings, time available for other productive pursuits which in the past was spent spraying pesticide by hand, and improvement in health.[33] Other positive effects cited are peace of mind and better crop and risk management.[34]

4. Small-Scale Cotton Farmers

It is of particular interest to note the high adoption rate of insect resistant cotton by small-scale cotton farmers in the Makhatini Flats region of KwaZulu-Natal, estimated to exceed 90%, up from 7% in the 1997/1998 season. This is despite a higher seed cost than for conventional seed and an additional technology fee. The rapid uptake is attributed to the success experienced by the early adopters. Pesticide savings are seen as the greatest benefit, followed by increased yield.[35]

[Additional information to be inserted here, summarising some of the studies of the impact on small-scale cotton farmers – high acceptance rate, real benefits experienced, but questions about sustainability, replicability]

5. Trade

Although the Department of Trade and Industry has overall responsibility for international trade, the International Trade Directorate of the National Department of Agriculture (NDA) is responsible for agricultural trade negotiations. The Directorate states that GMOs have not been a major issue of discussion in its negotiations.

5.1 Import Issues

The major GM commodity imports are maize, soya and canola. Approval is required under the GMO Act. Grain must be milled at the port of entry to minimise environmental impact.

Animal feed is made mainly from imported commodities which are expected to have a fairly high GM content in certain cases. Currently, South Africa does not export meat to Europe. However, should this situation change, since many European meat importers are requiring certification that animals have not been fed on GM-containing feed, it might become necessary to maintain sources of non-GM animal feed and institute identity preservation systems. This will however only be justified if the premium offered for meat derived from animals fed on GM-free feed is sufficient to make up for the additional costs involved, and if local food prices are not unduly adversely affected.[36]

5.2 Export Issues

A recent study[37] attempted to measure the possible impact of GMO commercialisation on trade, according to various scenarios. Due to limited availability of empirical data and restrictive assumptions made as a consequence, though, definitive quantitative results were not generated. As a general conclusion, it is noted that, if it is assumed that GM crops generate sufficient productivity gains to lower the overall costs of producing the crop, and that these savings are passed down along the value chain, adoption of GM crops could promote competitiveness of domestic industry. Conversely, slow uptake of GM crops locally could lead to cheap GM imports being substituted for local products which would adversely affect competitiveness of the local agriculture sector and agriprocessing industries. However, the degree of consumer resistance both at home and overseas remains difficult to predict, and the value of the premiums that consumers will be willing to pay for non-GM food has not been adequately considered.

The EU-SA Trade Development and Cooperation Agreement (TDCA) has been in force since 2000, but GMOs were not discussed in the extensive negotiations leading up to the agreement. The EU is a major export market for South African cotton, but not for any of the other GM commodities produced in South Africa.

Exports to the US were relatively low as a result of the apartheid-era trade sanctions, but have risen sharply in recent years. This is largely attributed to the African Growth and Opportunity Act (Agoa). In 2003 alone, agricultural exports rose by 35%, which is particularly remarkable when the strengthening of the local currency at the same time is taken into account.[38] However, GM products were not a component of these exports. A Free Trade Agreement (FTA) is currently under negotiation between the US and the Southern African Customs Union (SACU, which consists of Botswana, Lesotho, Namibia, South Africa and Swaziland). The US has requested that the FTA incorporate an undertaking that SACU agree to accept GM exports from the US. From the South African perspective, this is unlikely to be problematic, as the biosafety regime provides a framework for approving such imports. For South Africa’s SACU partners, though, this is not necessarily the case.

SADC countries are the destination for more than 80% of both current maize and soybean exports. The growing concerns in certain SADC countries about GMOs must therefore not be taken lightly. For example, Namibia requires non-GM certification of its imported grain for animal feed, in order to preserve European markets for its meat exports.

6. Regulatory and Legislative Treatment of GMO Crop and Food Technologies

6.1 General Attitude of the South African Government to GMOs

The South African government’s stance towards GMOs has been described as ‘guardedly positive’,[39] but many would argue that it is in fact highly supportive of the technology.[40] To some extent, different attitudes are displayed by different government bodies, and positions taken by the Department of Environmental Affairs and Tourism (DEAT) tend to be much more cautious than those of NDA or DST. The Genetic Resources Directorate of the NDA, which is responsible for administering the GMO Act and Regulations,[41] recently issued a public statement reiterating its belief that the use and application of GMOs can play an important role in poverty eradication, but at the same time acknowledged the risks associated with application of the technology.[42]

6.2 History

The South African Committee For Genetic Experimentation (SAGENE), a scientific advisory committee, was set up to monitor and advise on the development of GMOs in the country in 1979. Until the implementation of the GMO Act in 1999, regulation of transgenic crops was carried out by the National Department of Agriculture, utilising the services of SAGENE, which issued regulatory guidelines, informed largely by UK guidelines. Compliance with SAGENE's requirements was voluntary, but there is no evidence of any GMO releases having taken place in contravention of these requirements. The first application for a GM field trial was made in 1989 for Bt cotton. The commercial release of Bt cotton and Bt maize were approved under the SAGENE guidelines before the GMO Act came into effect. SAGENE also participated in drafting the GMO Act. The Advisory Committee established in terms of the GMO Act took over SAGENE’s functions after the Act came into force. Some of SAGENE’s members subsequently became members of the Advisory Committee.

6.3 Current Legislative Framework

6.3.1 NDA

6.3.1.1 Genetically Modified Organisms Act

The GMO Act,[43] in conjunction with its implementing Regulations,[44] came into effect on 1 December 1999. It is intended to promote the responsible development, production, use, and application of GMOs while limiting potential risks, and lays down the requirements for the importation, production, release and distribution of GMOs.

The GMO Act provides for the establishment of several organs:

• An Executive Council (EC) is made up of officials from relevant government departments,[45] to advise, to make decisions on applications and to monitor matters relating to GMOs, including their potential environmental and socio-economic impact.

• The Registrar is responsible for administering the Act (which includes issuing permits for applications approved by the EC).

• An Advisory Committee (AC) consisting of up to eight scientists with GMO-related expertise,[46] and two members of the public sector with knowledge of ecological matters and GMOs, acts as the national advisory body on matters relating to GMOs. It has authority to advise the Minister of Agriculture, the EC, other ministries and other appropriate bodies on request or of its own accord on matters concerning the genetic modification of organisms, and may call for expertise from other bodies or persons and appoint sub-committees to deal with specific matters, as required.

• An inspectorate of officials has authority to examine, inspect and monitor registered facilities and activities authorised under the GMO Act during office hours, without need for a warrant.

Liability for damage caused by the use or release of a GMO is borne by the user of the GMO, who is obliged to take appropriate measures to avoid an adverse impact on the environment which may arise from the use of GMOs.

Further provisions of the Act deal with matters such as conflict of interest, confidentiality, appeals, offences[47] and the scope of regulations under the Act.

The Regulations, supplemented by guidelines,[48] spell out the procedures for implementation of the GMO Act. Permits are required for the importation, exportation, development, production, use, release and distribution of GMOs. However, organisms used under certain conditions of contained use, within a laboratory or growth room in academic or research facilities (but not in a greenhouse), and GMOs previously cleared for commercial release and/or food or animal feed,[49] are exempt from this requirement.

A ‘suitable and sufficient’ assessment of risks to environment and human health must be made before an activity involving genetic modification may be undertaken. It is explicitly stated in the Regulations that ‘(l)ack of scientific knowledge or consensus on the safe use of GMOs shall not be interpreted as indicating a particular level of risk, an acceptable risk or an absence of risk.’ This can be interpreted as a negation of the Precautionary Principle.[50]

Facilities where genetic modification activities take place must be registered and records of risk assessment must be maintained.

Applications for permits are made to the Registrar. The Regulations stipulate the time frames for approval and fees payable for different types of applications. The Registrar reviews an application to ensure compliance with the legislative requirements before submitting it to a review committee of the AC[51] made up of individuals with expertise appropriate to the application. Risk assessment data is evaluated, and the applicant may be asked, via the Registrar, to clarify aspects of the data or submit additional information. Once all concerns have been addressed, a recommendation report is supplied to the Registrar, who then submits the application, the AC review recommendations and all public input to the EC. In making its decision on whether or not to approve an application, the EC will consider all of this documentation. The EC may also consider the potential socio-economic impact of introduction of the GMO in question on a community living in the vicinity of where the GMO is to be introduced. Applicants may be requested by the Registrar to provide clarification of additional concerns raised by the EC. If the EC approves an application, it will authorise the Registrar to grant a permit. If an application is refused, the EC must furnish written reasons for the refusal.

Applications in respect of which a permit has previously been issued may be fast-tracked at the discretion of the Registrar.

An applicant must notify the public of any proposed trial or general release of a GMO, prior to applying for a permit for such release. This must be done by means of a standard notice containing specified information, published in at least three newspapers in circulation in the area in which the proposed release will take place. A copy of the notice and proof of publication must accompany the application for the permit. Any interested party may submit comments or objections to the Registrar, who passes these on for consideration by the EC when making its decision on whether to approve the application concerned.

In the event of an accident involving GMOs, a user is obligated to notify the Registrar verbally and in writing, as well as to take all appropriate short-term, medium-term and long-term measures to avoid or mitigate any adverse impact of the accident on the environment and human health.

6.3.1.2 Additional NDA-Administered Legislation of Relevance to GMOs

The Plant Improvement Act[52] and the Agricultural Pests Act[53] contain certain provisions which might apply to GMOs in certain cases, particularly in respect of importation requirements which must be adhered to.

Plant variety protection is governed by the Plant Breeders' Rights Act (PBRA).[54] South Africa has been a member of the International Union for the Protection of New Varieties of Plants (UPOV) since 1977 and is a party to the 1978 Act of the Convention. 1996 amendments brought South African legislation into compliance with the 1991 revisions of the Convention, which South Africa has signed, but not ratified.[55] The PBRA makes provision for a breeder’s exemption and farmer’s privilege, by providing that certain activities undertaken using legitimately acquired propagating material will not constitute infringement of another party’s plant breeder’s right. These include development of a different variety, bona fide research, private or non-commercial use, and use by farmers of harvested material.[56] A large proportion of registered varieties is held by South African plant breeders, who also register their varieties in appropriate overseas markets.[57]

6.3.2 Relevant DEAT Legislation

6.3.2.1 The National Environmental Management Act

Several principles set out in the National Environmental Management Act (NEMA)[58] could be held to be relevant to GMOs. NEMA stipulates a ‘risk-averse and cautious approach’ to avoid, minimise or remedy the disturbance of eco-systems and loss of biological diversity. Environmental management decisions should take into account the impact of decisions on all people, as well as promote participation of interested and affected parties, take place openly and transparently, and be appropriate in relation to the assessment of social, economic and environmental costs and benefits. Inter-governmental co-ordination and harmonization of policies, legislation and actions relating to the environment is required. The incorporation of the ‘polluter pays’ principle requires that those responsible for harming the environment pay the costs of remedying such damage and its consequent adverse effects as well as the costs of preventing, controlling or minimizing further harm. At the same time, a duty of care is imposed to prevent the occurrence, continuation or recurrence of environmental damage.

NEMA contains provisions which set out the requirements for integrated environmental management. Under NEMA, an activity which will significantly affect the environment will only be authorized after considering, investigating and assessing the impact of such activity on the environment, socio-economic conditions and cultural heritage. This applies even to cases where authorisation is governed by alternative legislation, such as the GMO Act. However, NEMA further lists certain activities which may not be commenced without prior authorization (such authorization requiring an EAI). Activities involving GMOs are not amongst those identified. While some requirements for the envisaged investigation, assessment and communication of potential environmental impacts are laid down, NEMA does not specify that the form of the investigation must comply with the NEMA EAI requirements. EAIs for GMO-related activities therefore cannot be considered mandatory under NEMA.[59]

6.3.2.2 National Environmental Management: Biodiversity Act

The National Environmental Management: Biodiversity Act (the Biodiversity Act)[60] went through multiple drafts over a period of several years before it was finally promulgated in 2004. The first draft submitted for public comment in 2003 did not contain provisions dedicated to GMOs, but in response to comments received, these were reinstated in the final draft. The effect of this is to give DEAT limited, but explicit, oversight over aspects of GMO regulation in certain cases.

One relevant provision of the Act concerns the role of the South African National Biodiversity Institute, an institution established by the Biodiversity Act to assist the government in achieving the objectives of the Biodiversity Act. As one of its functions, the Institute must ‘monitor and report regularly to the Minister on the impacts of any genetically modified organism that has been released into the environment, including the impact on non-target organisms and ecological processes, indigenous biological resources and the biological diversity of species used for agriculture’.

GMOs are also covered in the chapter dealing with species and organisms which pose potential threats to biodiversity. The relevant provisions are intended to ensure that in appropriate cases, EAIs compliant with the requirements stipulated by NEMA are carried out for the purposes of issuing permits under the GMO Act. The provisions will take effect in cases where ‘the Minister has reason to believe’ that a trial release or general release of a GMO into the environment under a permit applied for under the GMO Act ‘may pose a threat to any indigenous species or the environment’. In such cases, the release must be treated as if it were a listed activity under NEMA and the requirements for an EAI in accordance with the NEMA provisions must be followed before a permit may be issued. The onus rests on the Minister to communicate his/her belief about the potential threat of the GMO release concerned to the Registrar of GMOs before the application is approved.

6.3.2.3 Environment Conservation Act

Environmental impact assessments (EAIs) are governed by Regulations under the Environment Conservation Act (ECA).[61] EAIs are mandated for ‘the genetic modification of any organism with the purpose of fundamentally changing the inherent characteristics of that organism’. This seems to refer to contained use rather than release into the environment of already-modified organisms, and is therefore very limited in scope and application.[62] However, under the GMO Act, the EC is authorised to require that an applicant conduct an EIA.

6.3.3 Relevant Department of Health Legislation

6.3.3.1 Foodstuffs, Cosmetics and Disinfectants Act

Regulations governing the labelling of foodstuffs obtained through certain techniques of genetic modification[63] were published under the Foodstuffs, Cosmetics and Disinfectants Act.[64]

• Where the composition or nutritional value of food obtained from GM techniques differs significantly from conventional counterparts, labelling is required to inform the consumer accordingly.

• For foods where mode of storage, preparation or cooking differs from corresponding existing foods, labels must provide clear instructions for use.

• Foods containing listed allergens must be labelled.

• Labels informing the consumer about the origin of a relevant nucleic acid or protein are required for food derived from plant material containing animal-derived nucleic acid or animal or human proteins, and for food derived from animal material containing nucleic acid or protein from a human or different animal taxon.

• Voluntary labelling is permitted for claims about enhanced or improved traits resulting from certain techniques of genetic modification. Such claims must be substantiated by an accredited independent body.

An earlier draft of the Regulations included a section dealing with voluntary labelling to distinguish food as non-GM. It was proposed that this be permitted where GM content was below 1%, provided that the claim was verified by an accredited independent body, supported with an identity preservation audit trail. This section was apparently omitted because South Africa does not currently have an identity preservation system in place. Standards and methods are in the process of being developed by stakeholder groups,[65] and when finalised, the Regulations will be amended accordingly.[66]

The University of the Free State, in an arrangement with a German-based food diagnostic company, has established a facility to test foods for GM content, thus allowing exporters to acquire certification of non-GM products.[67]

[Reactions-to be expanded

Criticisms from opponents that labelling ought to be mandatory

Criticisms from proponents on lack of clarity and danger of fraudulent labelling

Labelling requirements have to tread a delicate balance, on the one hand facilitating the consumer’s right to know, and on the other hand, avoiding the need for bringing in costly procedures on a large scale that will unduly affect prices, particularly of staple foods, since such a large proportion of the population is poor.]

6.4 Cartagena Protocol on Biosafety

South Africa ratified the Cartagena Protocol on Biosafety in August 2003. For the most part, this move was welcomed. Certain changes to the South African regulatory framework have had to be made in response, and some of these will address some of the objections that GM opponents have made in the past. Some supporters of GMOs recognise that the multilateral instrument could help to build confidence in GM technology under the umbrella of an international regulatory framework. However, others believe that the Protocol may lead to trade barriers, due to potentially wide interpretation of certain provisions and additional costs associated with implementation. It has even been suggested that ‘the Cartagena Protocol represents the biggest threat to international agricultural trade, after subsidies’.[68] At this stage, however, there does not appear to be sufficient evidence to support or refute this in the South African context. Shortly before ratification of the Protocol by South Africa, the parliamentary portfolio committee on agriculture expressed concern that accession could lead to job losses in the agriculture sector, by increasing agricultural production costs and reducing profit in the sector. It was noted that no other major grain exporters were at the time willing to accede to the Protocol, and South Africa’s decision to do so could turn the country into a ‘guinea pig’ and have unpredictable consequences. For these reasons, the committee undertook to call for accession to be delayed.[69] Notwithstanding, ratification took place barely a week later.

The office of the Registrar is designated as the Competent National Authority in terms of the requirements of the Cartagena Protocol on Biosafety. Certain changes to procedures regulated by the GMO Act have been necessitated by South Africa’s accession to the Protocol, which came into force for South Africa in November 2003, 90 days after ratification. The revised procedures were first communicated in March 2004, following the first Conference of the Parties in Malaysia the previous month, taking effect immediately. The Registrar reserves the right to amend any procedures in order to comply with the requirements of the Protocol or to accommodate national needs. Exporters may request assistance from the Registrar’s office if difficulties are experienced in complying with the new requirements. New application forms for import, export, contained use, trial release, fast track, general release and commodity clearance have been drawn up, and fairly detailed step-by-step procedures have been set out for exporters and importers applying for permits to take into account the advanced informed consent requirements of the protocol.[70] A guidance document has been made available to assist applicants in completing the relevant application forms.

• For GM grain imports where the GM event in question has already been approved in South Africa, the importer is required to notify the NDA, who will grant an import permit.

• For imports which may contain a GM event not approved in South Africa before, approval will only be granted subject to a full biosafety review, must be sought from the EC.

• For consignments destined for neighbouring countries, but in transit in South Africa, the requirements of the importing country will be taken into account. Where grain must be milled, milling will take place at the port closest to the importing country and the consignment will be shipped as processed product.

Other changes that have been necessitated include the need for certain decisions that in the past were taken by the Registrar now to be taken by the EC, longer stipulated time periods for the granting of some categories of permits, and additional risk assessment documentation requirements.

[Further changes necessary to ensure full compliance?]

7. The Effectiveness of Implementation of the GMO Regulatory Framework

7.1 Public Participation

Critics do not consider the public notice and comment procedure an adequate means of providing for true public participation in the approval process. Since it applies only in respect of permit applications for release into the environment of GMOs, coupled with the fact that there is no civil society representation on the AC, the public has no opportunity to participate in respect of applications which do not require a permit, such as those concerning contained use and prior clearance for commercial release, food or animal feed. It is also considered a shortcoming of the procedure that notification need only be given in the locality of the proposed release, as this could exclude a wider cross-section of the public. Furthermore, it is held that the confidentiality provisions unduly limit the information that can be disclosed, as a result of which meaningful participation can be obstructed, due to the availability of insufficient information.[71]

The appeal procedure is considered to be of limited usefulness as an additional avenue for public participation, as appeals have to be lodged within 30 days of the applicant being notified. However, in the event of an approval, there is no provision made for the public to be notified, so anyone wishing to object bears the onus of enquiring about whether an approval has been granted, and if the information is not obtained in time, will miss the opportunity of invoking the appeal procedure.[72]

7.2 Risk Assessment Process

Risk assessment is based primarily on a technical approach and is analysed by technical specialists. It has been suggested that this phase should be extended to allow for public participation. If the public, as stakeholders, are given the opportunity to communicate their concerns about the relevant risks, even if these are not technical, they can be addressed and stakeholder buy-in can be obtained. The current situation under the GMO Act and Regulations, which does not allow for this, increases the possibility of resistance by stakeholders. However, the integrated environmental management framework set out in NEMA does provide for this type of approach.[73]

[Expand – criticism that risk assessment is based on voluntary guidelines, and that applicants supply the information themselves, rather than be required to get an independent expert to do so.

Impact of Biodiversity Act?]

Proponents of GM believe that these concerns are unfounded. For one thing, much of the information required for the risk assessment is contracted out to independent laboratories rather than performed in-house. Companies are very sensitive to the controversies surrounding the technology and will therefore exercise particular caution. Furthermore, it is believed that the risk assessment information required is sufficiently comprehensive, that it is subject to adequate scrutiny on review and that peer review of self-assessment is in line with acceptable practices worldwide.

7.3 Liability Provisions

The liability provisions of the GMO Act, which render users liable for damage caused by the use or release of a GMO, have been criticised as inappropriate. Users are obligated to ‘ensure that appropriate measures are taken to avoid an adverse impact on the environment which may arise from the use of GMOs’. The definition of ‘user’ includes an end-user or consumer. This has been criticised as contrary to the ‘polluter pays’ principle enshrined in environmental law.[74]

7.4 Conflicts of Interest

[To be inserted – sagene ‘old guard’

Act needs more checks and balances – impression that govt has delegated its responsibility – too far in favour of industry]

7.5 Cost

It has been suggested that the expense involved in conducting a full biosafety risk assessment is the reason why no locally-developed GM events have been approved yet for commercial release.[75] However, it is likely that this is only a partial explanation, and that technical constraints have also played a role.[76]

7.6 Administration

On the whole, companies making use of the system consider it to be workable, although at times somewhat slow. Since EC meetings only take place every six to eight weeks, this is a limiting factor, and where follow-on questions are raised in one meeting, the process is delayed until the response is considered in the following meeting. This means that it is common for the stipulated time frames for the issue of permits to be extended. It is generally felt that the AC is well-qualified and does an adequate job. There is an impression that the EC at times tries to re-evaluate what has already been assessed by the AC, and that representatives of different government departments on the EC sometimes engage in interdepartmental power plays, but for the most part, there are no major problems in the system. The fact that all stakeholder government departments are represented on the EC as a single decision-making body is considered to promote efficiency of the system.[77]

7.7 Monitoring

Permit conditions state when inspectors must visit to monitor compliance, which occurs several times during the course of a season. While some have alleged that inspections are not made often enough, due to limited capacity in NDA, others deny that this is problem.

8. Attitudes and Positions

8.1 Public perception in general

[Rewrite-

While small groups both support and oppose the technology, in general public awareness remains low, although there are signs that it is increasing. Nonetheless, the average consumer is unlikely to be sufficiently informed about relevant issues to formulate an opinion either for or against. However, as more GM food products start to enter the market, awareness will increase and it is not clear at this stage what level of acceptance will develop. It is submitted that while both proponents and opponents of GMOs are attempting to disseminate information in efforts to inform the public, those in opposition have been more effective at getting their message across. The extent to which this is true must be investigated. The recent high profile rejection of GM food aid by countries in the region suffering severe drought and facing famine can be expected to play a role in shaping public opinion in South Africa, which will have a significant impact on the application of agricultural biotechnology.

Brand loyalty for low income consumers sometimes more nb than price[78]

Public Understanding of Biotechnology – DST initiative]

8.2 Main stakeholder groups

8.2.1 Business

• Multinational seed companies – Monsanto, Syngenta (and Pioneer Hi-Bred, Delta & Pine, Stoneville, others)

- To some extent, view SA as a testing ground for GM products in Africa

- If they are not accepted in SA, they are unlikely to be introduced successfully into other African markets

- Monsanto as market leader – aggressive approach

- ‘Support access to information – allows public/govt to make more balanced decisions’ – but confidentiality concerns

• Local seed companies – Pannar

- Cautiously engaging, but GM is not a major focus of their activities

• Food retailers

- Woolworths, a chain with historical links to Marks & Spencers, which caters to an upmarket customer base willing to pay a premium for their preferred product choices, has a policy of avoiding products containing GMOS where possible, and labelling those products containing GMOs when alternatives cannot be sourced

- The other large food retailers (who command far greater market share) declined to follow suit, after consulting with suppliers. One of the reasons cited was the higher costs associated with labelling that would have to be passed on to consumers. The companies concerned also wanted to wait to see what the content of the anticipated labelling guidelines would prescribe.

- These decisions must be put into perspective, as a relatively small percentage of the population shops regularly at the large food retailers, buying instead from the informal sector, supplied by wholesalers, and have not taken a position on GM foods. For these consumers, price is usually the primary consideration, although brand loyalty is also a factor.

8.2.2 NGOs

8.2.2.1 Opposed to GMOs

• SAFeAGE

- South African Freeze Alliance on Genetic Engineering

SAFeAGE describes itself as an alliance of 250,000 consumers and over 130 organisations calling on the SA government to impose a minimum five-year moratorium on field trials and commercial releases of GM crops, ‘until the technology is proven to be safe, environmentally harmless and in the interests of the people of South Africa.’ SAFeAGE is also calling for a freeze on the import and export of GM food and crops and the patenting of genetic resources for food and farm crops.[79]

• Biowatch

Biowatch is a national organisation which plays a role in publicising, monitoring and researching issues of biological diversity, genetic engineering and sustainable livelihoods. Its work involves researching and monitoring the commercialisation of biological resources; promoting sustainable livelihoods, sustainable agriculture and food security; monitoring the impacts of GMOs in South Africa; capacity-building; and raising public awareness on biodiversity issues to encourage informed participation in policymaking.[80] They see themselves as an ‘environmental watchdog’, opposing GMOs on health, environmental and socio-economic grounds.

• African Centre for Biosafety

• Environmental Justice Networking Forum

The Environmental Justice Networking Forum is an umbrella organisation set up to serve the common interests of its non-governmental and community-based organisation members in the areas of environmental justice and sustainable development.[81]

8.2.2.2 Supportive of GMOs

• Africabio

- ‘Pro-GM’ group, who promote biotechnology in Africa, by providing information, holding conferences, commissioning research, etc.

- Civil society organisation or trade organisation?

• African Harvest

8.2.3 Other National Organisations

• Academia/science community

- As a generalisation, scientists working in biotechnology tend to support GMOs, recognising that there are risks involved, but believing that these can be managed.

- Social science research on the non-scientific impacts of technology is fairly limited in SA.

• Farmers groups – small-scale cotton farmers

Very high adoption rates of GM cotton by small-scale farmers in certain areas after a couple of years, as farmers saw the benefits experienced by the early adopters.

- Grain SA

Grain SA, a voluntary organisation representing the interests of South African grain farmers, recently made waves by submitting an objection to an application by Monsanto for import clearance permits under the GMO Act for maize containing Bt traits not previously approved in South Africa.[82] Grain SA objected on the basis that there was a danger of the grain being used for domestic production, as there was no guarantee that it would be milled on entry, and that it had not been evaluated locally for its impact on human and animal health. This was surprising because Grain SA and Monsanto have generally enjoyed a cordial relationship, and a large proportion of Grain SA members have embraced GM technology. While Monsanto has no intention of importing grain itself, it wants to pave the way for others to import Monsanto maize containing the traits concerned. It has been suggested that the real reason underlying the objection might be an attempt by local maize farmers to limit a source of imports. South Africa is currently experiencing a maize surplus and low prices are putting maize farmers under pressure.[83] It is not yet apparent whether this is indeed the case, or whether this signifies the beginning of a backlash by maize farmers against GM technology and the growing pressure and associated transactions costs for operating and verifying separate GM and non-GM streams.

• SANSOR - South African National Seed Organisation

SANSOR was formed in 1989 by the amalgamation of other trade and technical associations. It is a private, non-profit company operating as a Secretariat with permanent staff, and has a membership of about 100. It functions as a representative spokesbody for the South African seed industry, as the seed certification authority for government, and as licensing agent for public varieties of seed crops.[84] SANSOR supports GM crops.

Churches

The Anglican Archbishop of Cape Town spoke out in May 2004 against GM crops, on the basis that they could compromise ‘the rights of future generations to a safe, healthy and diverse environment’, and that they could threaten rural livelihoods, food security and local control over genetic resources as corporations gained ownership of life forms through the patenting of seeds and genes. He described the South African government’s approach to GMO’s as ‘cavalier’ and argued that Africa ought not to adopt GM technology until the consequences were more certain, until it could be proven safe, affordable, containable, suitable for African farmers and farming systems, that it would not reduce jobs, destroy biodiversity or increase dependence on wealthy nations. He stated that if the GM seed companies were genuinely concerned about reducing poverty, ‘they would lobby their governments to stop subsidising their farmers instead of trying to sell Africa newly patented seed’.[85]

A few days later, the South African Council of Churches (SACC) held a consultation on GMOs, out of which a statement was issued, entitled ‘Food is life: the right to food is not negotiable’.[86] The document raised several concerns about GMOs, including the ‘purely technical’ approach taken by proponents, which ‘delink(ed) science from ethics, values, economic and political ideology’, as well as from ‘African communal spirituality about life and food’. Further concerns related to the role of GMOs in perpetuating unequal power relations through a link with globalisation, commodification of life through patenting, supremacy of profits over health, environmental safety and food supply, lack of public awareness and participation (including by the SACC itself) in GMO developments, scientific uncertainties regarding long-term risks in light of the irreversibility of release of GMOs, and erosion of national autonomy through international treaty obligations.

The document calls on the SACC and its members to ‘co-own’ GMOs as part of a ‘longstanding commitment to solidarity with the poor and marginalised’; to intensify efforts to fight poverty; to denounce the ideology of ‘neo-liberal economic globalisation’; to gather material and commission research to empower the church to pursue its position on GMOs through engagement with a range of stakeholders; to petition government ‘while it is still allowing GM technology to operate and have an impact on our environment’ to acknowledge the risk of GM technology, impose a moratorium on new GMO permits and become fully compliant with the Cartagena Protocol; to co-operate at the regional and continental level; to campaign and lobby locally; to institute a strategy process and report on it; and to publicise the document amongst member churches and other stakeholders.

• Trade Unions

Statement at COSATU Congress Sep 2003

Amongst other things, called for a moratorium on making GMOs available for human consumption in retail markets.

8.2.4 International organisations

For the most part, the debates are dominated by local organisations and individuals, although there is engagement and interaction with international organisations on relevant issues. Greenpeace has no South African presence.

USAID’s biosafety initiatives in Africa, where several projects are supported across the continent, has been criticised by the African Centre for Biosafety. It is viewed as ironic that the US, which is not a member of the Convention for Biological Diversity and therefore not in a position to accede to the Cartagena Protocol, is playing such a leading role in biosafety capacity-building. The organisation alleges that the funding of biosafety initiatives by American organisations (with USAID at the forefront), together with ‘ostensibly the provision of food aid, technical assistance, capital investment, agricultural research…’, is in fact a tool to position ‘US agri-business to profit from hunger in Africa’. It is feared that these initiatives will unduly influence policy decisions on biotechnology by African nations, that resistance to GMOs will be lowered, and that weak biosafety regimes will be put in place.[87]

9. Key Disputes, Challenges and Debates

9.1 Review of GMO Act

An Environmental Affairs Parliamentary Portfolio Committee meeting in November 2002 questioned the effectiveness of the GMO Act and Regulations and called for a review. Amongst other things, it was claimed that Parliament was insufficiently informed when it passed the GMO Act, and that it should be revisited on this basis.[88] The same meeting questioned whether GMO regulation would not be located more appropriately under the aegis of Environmental Affairs.

In response, a public conference was subsequently held by the Portfolio Committee on Agriculture and Land in April 2003 to allow all stakeholders to be heard and to provide the basis for a report to Parliament on whether or not such a review is required.

[More on this]

9.2 Biowatch lawsuit

In 2002, Biowatch took legal action against the Registrar of Genetic Resources, the Executive Council for GMOs and the Minister of Agriculture to compel them to make available information on the use and release of GMOs, including details of all pending applications and issued permits, and locations of field trials of GM crops. Biowatch took this course of action after previous failed attempts to acquire this information,[89] as it believed that insufficient access to information was preventing the organisation and the public from assessing whether genetic engineering in South Africa was safe and compliant with national legislation, the Constitution and environmental standards. Monsanto, Stoneville Pedigreed Seed and Delta & Pine Land (the latter two being distributors of Monsanto products) subsequently joined the action in 2003 as further respondents, to protect their rights to confidentiality in their proprietary commercial information. The Open Democracy Advice Centre intervened as amicus curiae to highlight the importance of access to information in an open democratic society.

The case was heard in the Pretoria High Court in May 2004. One of the issues at stake was the extent of information requested by Biowatch. The Office of the Registrar of Genetic Resources claimed that this put too great a burden on the relevant personnel and could therefore not be supplied. The information requested includes a description of the GMO, its purpose, applicant’s name and address, area of use of the GMO, monitoring plans, emergency measures in the event of an accident, and environmental impact studies. It was argued that the government had a clear legislative duty to be open and transparent in respect of environmental matters and that confidentiality considerations should only be invoked to deny access to information where it was clearly justified and supported by factual evidence. In this case, it was submitted that the information should have been in the public domain anyway, so that members of the public and farmers in affected areas could be aware of potential threats. The respondents rejected allegations that they were attempting to repress information…[90]

[Add: Biowatch difficulty in finding a scientist ‘not paid by Monsanto therefore independent’]

Judgment was reserved and had not yet been delivered at the time of writing.

9.3 Monsanto’s Application for Commodity Clearance for GM Wheat

In January 2004, Monsanto announced that it had sought approval for the import of GM wheat into South Africa for food and feed, despite the fact that it had not been commercially approved anywhere in the world (including in the US and Canada, where regulatory delays were being experienced). Monsanto explained that the application was made in anticipation of approval being granted in the US and Canada (two of the major suppliers of wheat imported by South Africa), and that no commercialisation would take place until agreement was obtained all along the value chain, from producers to processors and consumers around the world. However, the move was viewed with concern by some, as a pre-emptive attempt to gain control over the African market for GM wheat.[91]

The SACC and 38 other civil society organisations (including COSATU) objected to the application on the basis that South Africa ought not to be the first country to risk accepting GM wheat when the rest of the world has grave concerns over its social, environmental and economic impact. The groups expressed the fear that South Africa could become a ‘dumping ground for GM crops and a gateway for their distribution to other parts of the continent’. They also noted that there had been too little public debate in South Africa on possible harmful effects of GMOs.[92]

[Monsanto has since announced that it is abandoning its wheat programme as a result of consumer resistance, but it has not withdrawn its application to the NDA[93]]

10. Regional Issues Related to GMOs

10.1 Rejection of GM Food Aid

In 2002, much of Southern Africa experienced a severe drought, and some countries faced famine. Much attention was focused on Zambia, which refused to accept GM food aid as it was feared that maize distributed for food might be replanted, thereby contaminating local crops, which could threaten future agricultural exports, particularly to the EU. While some countries subsequently accepted milled grain, Zambia did not.

Zambia’s decision to reject the food aid out of hand had the effect of banning the distribution of all food aid in the country. Malawi, Mozambique and Zimbabwe eventually accepted GM food aid on condition that the GM grain was milled prior to distribution to prevent planting. Lesotho and Swaziland accepted non-milled maize as food aid, but warned the public that it should be used exclusively as food and not as seed.[94]

This led to an investigation being commissioned by the Southern African Development Community (SADC), which made recommendations to the SADC council of ministers in August 2003.

While Zambia continues not to accept GM food aid, Zambia does import South African commodities which could have GM content.[95]

In 2004, similar controversy erupted, with both Angola and Sudan placing restrictions on the acceptance of GM food aid.[96] Angola insisted on all GM food aid being milled, and Sudan requested GM food aid to be certified ‘GM-free’. These decisions were criticised by the World Food Programme (WFP) and USAID. In response, an open letter was sent by over 60 groups from 15 African countries, representing farmer, consumer, environmental and development organisations to the WFP in protest against the pressure exerted on the Angolan and Sudanese governments by the WFP and USAID to accept GM food aid. The groups believe that there are alternatives to the crude choices laid down by the WFP (namely ‘GM food aid’ versus ‘starvation’), and that the WFP ought to be facilitating freedom of choice and investigating other options, including alternative sources of food aid.[97]

[- Claim that subsidised overproduction in US, much of it GE with limited market, ends up as food aid.

- Role played in publicising GM issues – bringing to public eye]

10.2 Role of South Africa in Influencing Ag-biotech Policies in the Region

South Africa’s position as a regional leader (in this and other areas) means on the one hand recognising that it has a responsibility to share information and experiences and provide support to its neighbours. However, South Africa has also on occasion earned itself a reputation for ‘arrogance’ and engagement with other countries in the region will have to be structured appropriately to ensure that it is effective.

The South African government, as well as other South African organisations and experts, are consulted fairly frequently by other African governments and researchers for advice and assistance on biosafety matters. Some other African countries are said to be considering modelling their biosafety regulatory frameworks on South Africa’s.

[Expand-

For neighbouring countries, there will be particular concern about the potential for illegal spread of seed

Approval by SA carries weight with other African countries[98]

Concern that ‘flawed’ system will be ‘pushed onto’ other countries

Lack of capacity

SADC restructuring to provide member states with a comprehensive development agenda.

Guidelines - Intentions to harmonise seed legislation and biosafety regulation in SADC[99] - seedquest

African Group – SA sometimes in alignment and sometimes taking its own position - Model law

NEPAD - The establishment of a high-level advisory panel is in the pipeline, with the objective of ‘facilitating trade in GM products between African countries by harmonising biosafety regulations’. The terms of reference are not available yet, and it is unclear what the scope and position of the body will be.[100]]

11. Discussion

While some laud South Africa as a leader in biosafety on the continent, it is hard to refute the allegations that the current applications of GM crops in the country do not offer much in the way of tangible advantages to the majority of South Africans, even though some sectors of the population do appear to be benefiting. If GM crops are to have a future in South Africa and in Africa more widely, it is essential that applications are developed by Africans to deal with endemic problems and locally relevant crops. This requires more R&D directed at priority areas and crops.

Is IP likely to be an obstruction? - Impact of organisations like AATF?

Role of private sector

Especially MNCs, and especially in light of growing influence on local seed industry

Advantages and disadvantages

Need for more public participation in process to dispel fears, build trust.

Poor state of SA science reporting

Question of choice for developing countries – do risks outweigh benefits?

Need better information on which to base decisions

Dearth of independent research – especially on socio-economic factors

Need for more impact studies, empirical data

Better information needed on consumer attitudes at home and in export markets

One of the dangers of failing to engage at all is that of being ‘left behind’, while others are making progress and advancing. In Africa, there is already a widening technology gap with the North, which is becoming ever harder to bridge. (for example, if new technologies were developed which addressed some of the current objections). If no efforts are made to build and maintain capacity in GMO R&D and regulation in Africa, it could become almost impossible later on for African countries to participate if the environment were to become more accepting of the technology

Only time will tell whether South Africa is a pioneer, well-placed as an early adopter to reap the major benefits of GM crops, or a naïve guinea pig…

Rosemary Wolson

Intellectual Property Manager, UCT Innovation

Research & Innovation, University of Cape Town, Private Bag, Rondebosch 7701, South Africa

Ph: +27-21-650-2425

Fax: +27-21-650-5778

Cell: +27-83-784-3648

e-mail: Rosemary.Wolson@UCT-Innovation.co.za

August 2004

-----------------------

[1] Department of Agriculture (2001) Strategic Plan for South African Agriculture; Mogford, D. (1996) ‘The use of genetic resources in agricultural crop production and the seed industry.’ In: Proceedings of Land and Agriculture Policy Centre Genetic Conservation Workshop, Johannesburg, 19-20 March.

[2] Department of Agriculture (2000) General Information on Agriculture in South Africa.

[3] Over the past ten years.

[4] National Department of Agriculture, Maize Profile

[5]

[6] GAIN Report #SF303, 19/29/2003, Republic of SA Annual Exporter Guide 2003

[7] Dakora, F.D. (1996) ‘Use of plant genetic resources by traditional farmers.’ In: Proceedings of Land and Agriculture Policy Centre Genetic Conservation Workshop, Johannesburg, 19-20 March; Department of Agriculture (1995) Country Report for South Africa, compiled for the UN FAO International Conference and Programme for Plant Genetic Resources; Department of Environmental Affairs and Tourism (1997) White Paper on the Conservation and Sustainable Use of South Africa's Biological Diversity; Moss, H. (1996) ‘The Application of Intellectual Property Protection to Biodiversity and Agriculture in South Africa: Consequences, Concerns and Opportunities.’ Working Paper 36, Land and Agriculture Policy Centre; Webster, J. and Koch, M. (1995) ‘South African plant biotechnology.’ In: Altman, D.W. and Watanabe, K.N. (eds) Plant Biotechnology Transfer to Developing Countries. RG Landes Company, Austin, Texas, pp. 75-83.

[8] Department of Agriculture – note 5.

[9] Prior to 1997, the agriculture industry enjoyed a high level of protection, with each agricultural commodity being governed by a control board, which regulated price, production and markets. The control boards were abolished by the 1996 Marketing Act. Government agricultural subsidies were eliminated and the agricultural sector moved to a free market environment.

[10] There has been a steady decline in import tariffs, which are currently set at low levels for most products.

[11] This involves government programmes for land restitution and redistribution to previously disadvantaged communities, to redress hardships and inequities suffered under apartheid, such as forced removals.

[12] The Broad-based Black Economic Empowerment Framework for Agriculture (AgriBEE), launched in July 2004, is intended to address this latter problem by facilitating equitable access and participation of previously disadvantaged people throughout the agricultural value chain, including through the setting of targets for land ownership and leasehold rights.

[13] Adjusted for purchasing power parity. It should be noted that the currency is relatively volatile and as a result, dollar amounts stated are only an approximation.

[14] Compared to the OECD average of 2.5%.

[15] Ref’s: R&D Strategy; High-Level Key Results

[16] Chk ref?

[17] Department of Arts, Culture, Science and Technology (1996) White Paper on Science and Technology,



[18] Ref

[19] The others are technology for manufacturing, technology to leverage knowledge from and add value to the natural resource sectors and technology for poverty reduction.

[20] Act 15 of 1997

[21] Mulder, M. (2003) South African National Biotechnology Survey, Idea to Industry cc, The Survey was commissioned by Egolibio Life Sciences Incubator,(in conjunction with DST), in an attempt to generate quantitative baseline data for tracking the South African biotechnology sector over time.

[22] The following sectors are covered by the Survey: human health; animal; plant; food & beverage; industrial; environmental; support services and ‘other’.

[23] After the human health sector.

[24] Ref

[25] Trade doc… Possible impacts of Genetically Modified Food Production on South African Exports - A. Jooste, W.J. van der Walt, M. Koch3, K. le Clus4, H. Otto5 and P. Taljaard

[26] Ref’s

[27] Trade doc…

[28] James

[29] Monsanto has also licensed the technology to Pioneer Hi-Bred. T Kahn, Monsanto maize takes root in SA BD apr 2 2004

[30] Ben Harding Business Report p4 020404

[31] Trade doc…

[32] Trade doc…

[33] Since the adoption of Bt cotton by farmers in the province, reported cases of pesticide poisoning in Kwa-Zulu Natal have dropped by over 60%. (trade doc)

[34] Kirsten, Trade doc…

[35] Kirsten, Africabio status doc

[36] Trade doc

[37] Trade doc

[38] Figures show Agoa has benefited SA Carli Lourens Business Day 31 March 2004

[39] Reuters News Service 22/04/2003

[40] Mayet note … supra points out that the long title to the GMO Act states as its first objective ‘to promote the responsible development, production, use and application of genetically modified organisms’ (emphasis added).

[41] In addition to the National Department of Agriculture, each province has a provincial Department of Agriculture, but biosafety regulation is a national competency.

[42] Mabuza, Z Ntuli, GMOs to eradicate poverty:govt 14 July 2004, BuaNews

[43] Act No 15 of 1997.

[44] Government Notice R1420 of 26 November 1999.

[45] Namely: Agriculture; Environmental Affairs and Tourism; Health; Science and Technology; Trade & Industry; and Labour.

[46] Applicable scientific fields include animal health; human medicine; biochemistry; molecular biology; ecology; entomology; plant pathology; biotechnology; and virology.

[47] A person convicted of an offence under the Act or Regulations may be liable to a fine or imprisonment.

[48] National Department of Agriculture Guideline Document For Use By The Advisory Committee When Considering Proposals/Applications For Activities With Genetically Modified Organisms May 2004. The guidelines were published by the NDA with assistance and recommendations from the EC and the AC, to provide general information on the provisions of the GMO Act, assist public understanding of its administration, and increase transparency of GMO regulation. In particular, the guidelines aim to provide a framework, consistent with the Act and Regulations, for the assessment of ecological risks which might be posed by herbicide-tolerant or Bt crops, based on a strictly scientific and technical approach. The process of risk analysis and assessment is elaborated, the type of information to be considered is outlined, and keys and checklists are provided. These are intended to assist the process and not to be definitive.

[49] GMOs falling into this latter category are listed in a Table annexed to the Regulations.

[50] Mayet M Critical analysis of pertinent legislation regulating genetic modification in food and agriculture in South Africa. May 2001 produced for Biowatch South Africa

[51] The review committee is an AC sub-committee.

[52] Act No 53 of 1976.

[53] Act No. 36 of 1983.

[54] Act No 15 of 1976.

[55] It appears that a political decision was taken not to ratify UPOV 1991, but this does not seem to have any practical effect because of the legislative amendments which have been implemented.

[56] Dold, D.M. (1982) Plant breeders' rights. De Rebus 475, 178; Van der Walt, W.J. (1996) Plant breeders' rights in South Africa. In: Proceedings of Land and Agriculture Policy Centre Genetic Conservation Workshop, Johannesburg, 19-20 March 1996.

[57] Wolson Intellectual Property Rights and Biological Resources: Current Policy and Legislative Developments in South Africa Chapter in Trading in Knowledge: Development Perspectives on TRIPS, Trade and Sustainability, Edited by Christophe Bellmann, Graham Dutfield and Ricardo Melendez-Ortiz, 2003

[58] Act No 107 of 1998.

[59] Mayet crit anal; C Jardine A Review of Risk Analysis for Trial and Commercial Release of Genetically Modified Organisms in South Africa (Second Draft Report – produced for Biowatch) 25 November 2001; Biowatch SA – Input to Biodiversity Bill as published on 24 January 2003

[60] Act No 10 of 2004.

[61] Government Notices R1182, R1183 and R1184 of 5 September 1997 and Act No 73 of 1989 respectively.

[62] Mayet Crit anal

[63] Government Notice R25.

[64] Act No 54 of 1972.

[65] It is intended that testing will be performed by the South African Bureau of Standards and is expected to cost about $3.20/ton. It is unlikely that this testing will be codified into legislation, but it is expected that the standards will nonetheless be deemed sufficient by importing countries.

[66] T Kahn Open wide for genetically modified bite Business Day feb 6, 2004; trade doc

[67] T Kahn BD 14 Aug 2003 Facility to help food keep to standards

[68] Trade doc

[69] W Hartley Concern SA could be biosafety guinea pig Business Day 6 August 2003

[70] National Department of Agriculture, Genetically Modified Organisms – Revised Procedures, Reference number: 17/R – 17 March 2004

[71] Mayet Crit anal

[72] mayet

[73] Jardine

[74] Mayet

[75] Trade doc

[76] No information has come to light on the effect of intellectual property rights local developers’ freedom-to-operate or ability to commercialise.

[77] Trade doc, personal communication

[78] Canad doc, US GAIN doc

[79]

[80] .za

[81] ejnf botany.uwc.ac.za/inforeep/ejnf.htm

[82] The gene concerned, which protects against corn root worm, has been approved in the US, but the corn root worm is not a pest of South African maize, and Monsanto does not intend to incorporate the trait in South African planting seed.

[83] Grain SA against import permit for untested genetically modified maize 7 July 2004 Grain Sa press release; Mabuza, E Business Day Government reassures on gene crops 8 July 2004; Moos, A Nee vir GM-saad straks uit ekonomiese oorweging 15 July 2004 ; ‘Monsanto Reaction to Various Press Reports and Media Statements Regarding the Application of a Commodity Approval for the “Corn Root Worm” Gene’

[84]

[85] Mathys C Archbishop slams use of GM crops Sunday Argus 23 May 2004

[86]

[87] Ref - Mayet

[88] In light of the plethora of legislation that has been promulgated with the new political dispensation since 1994, this is a particularly worrying motivation for review that could undermine much of the new law, but this has not been focused on.

[89] Some information was received on issued permits, but not on risk assessments or environmental impact assessments.

[90] Group seeks order to force govt to reveal GMO information may 25 2004 The Mercury

[91] Monsanto denies plan to bring wheat into Africa T Kahn Business Day 22 January 2004; Mayet M Monsanto pushes GM wheat to secure future access to lucrative African markets SEATINI Bulletin vol 7 no 3 15 Feb 2004

[92] Biowatch press release 28 April 2004 critical month for genetic engineering in South Africa

[93] 17 may biowatch press release ; Fin mail art

[94] Mayet

[95] Trade doc

[96] mayet – afr ag under gm onslaught 22/7/2004

[97] African groups accuse WFP and USAID of denying Africa’s right to choose to reject GM food aid 4 may 2004

[98] Ref?

[99] Seedquest

[100] mayet Africa- the new frontier for the GE industry 12/1/2004

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