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| There is significant variability in regulation and labelling requirements for GM crops across regions. The United States has a GM crop policy diametrically different from that of the European Union and Japan. The United States, as well as Canada and Argentina, have taken an approach to agricultural biotechnology based on the ‘equivalence principle’, regulating products rather than the processes from which they are derived and favouring no labelling or voluntary labelling of products containing GM materials. On the other hand, the European Union and Japan have followed the ‘precautionary principle’ on new agricultural biotechnology. These countries consider the process from which a GM product has been derived, rather than comparing the product with its non-GM counterpart. Additionally, they have imposed strict controls on the import and marketing of GM products. Other countries, including Australia and New Zealand, fall in between these policy stances, implementing individual approval systems and labelling requirements. The variability in regulation and labelling requirements are indicated in table 10. |
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countries |
food safety approval regulations |
labelling regulations |
specificity |
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european union – 25 |
process based mandatory |
stringent, mandatory, includes derived products |
traceability requirements, 0.9% threshold for GM materials |
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Brazil, China, russia, switzerland, norway |
process based mandatory |
stringent, mandatory, includes derived products |
no traceability, low threshold for GM materials |
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Australia, japan, korea, saudi arabia, thailand |
process based mandatory |
‘pragmatic’ mandatory |
many labelling exceptions |
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united states, canada, Argentina, south africa, taiwan |
substantial equivalence mandatory (US: voluntary consultation) |
voluntary for substantially equivalent food |
5% threshold level for labelling |
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indonesia, malaysia, mexico, philippines, vietnam |
mandatory (in place or pending) |
mandatory, introduced but not implemented |
‘pragmatic’ labelling |
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India, kenya |
mandatory (in place or pending) |
intention to require labelling |
slow regulatory process |
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bangladesh, most african countries |
considering mandatory |
no clear position |
wait and see approach |
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a few african countries (zimbabwe, zambia) |
no |
no |
GM free |
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Source: Gruère (2006). |
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| Argentina | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Microeconomic reform and technological innovations in Argentina’s farm sector have led to a substantial increase in agricultural production over the past fifteen years. From the early 1990s, markets were deregulated, import tariffs on inputs and capital goods were reduced and taxes and voluntary restraints on agricultural exports were eliminated. These reforms allowed rapid technological upgrades in the farm sector, including use of improved machinery and equipment, fertilisers and chemicals, and GM crop technologies (Trigo and Cap 2006). As a result, production of grains and oilseeds increased from 40 million tonnes in 1992-93 to around 80 million tonnes in 2005-06 (figure o; SAGPyA (2007). The main crops grown in Argentina are soybeans, maize, wheat, sunflower and sorghum (table 11). Globally, Argentina is a major producer of these crops, ranking third in soybeans and sunflower seed, fifth in maize and sixth in sorghum production. Agriculture makes up around 70 per cent of Argentina’s export income. The majority of Argentina’s crop production is exported to overseas feed markets. Argentina is the largest exporter of soybean meal and oil, and the third largest exporter of soybeans, after the United States and Brazil. Argentina is also an important exporter of sunflower seed oil, sorghum, maize and wheat (table 12). In 2005, soybeans and soybean products comprised 48 per cent of agricultural export income and 22 per cent of total export income. Argentina’s soybeans are mainly exported to China, the European Union and Thailand. The main export destinations for soybean oil are India and China and soybean meal is mostly exported to the European Union, Egypt, Malaysia and Thailand. |
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| Brazil | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Agriculture is a significant sector in Brazil’s national economy, accounting for around 10 per cent of gross domestic product and 40 per cent of total exports. Deregulation of the farm sector over the past three decades has led to dramatic productivity growth and efficiency gains in Brazil’s agricultural sector, leading to significant increases in production of key agricultural commodities such as soybeans, meat and fruit (Jales, Jank, Yao and Carter 2006). Deregulation of the farm sector has been achieved predominantly through the removal of state enterprises, marketing boards, price supports and government purchases of wheat and milk. Export taxes, export restriction and import licences have also been removed. Current assistance focuses on diversification of production and trade expansion and includes preferential credit, some tax exemptions and public research financing. Between 1990 and 2004, the total area planted rose by 14 per cent to 60.4 million hectares in Brazil (Jales et al. 2006). In recent years, soybeans have been the main driver of this increase (figure p, FAO Statistics Division, 2007). The main crops grown in Brazil are soybeans, maize, sugar cane, rice, coffee and wheat (table 13). Globally, Brazil is the second largest producer of soybeans and the third largest of maize. In Brazil, agricultural production has increased faster than consumption, leading to agricultural exports rising from US$8.9 billion in 1990 to $30.9 billion in 2005 (Council and Hanrahan 2006). By 2005, Brazil had the largest agricultural trade surplus in the world, totalling US$27.5 billion, and was the third largest agricultural exporter (following the United States and the European Union). Brazil is the world’s largest exporter of sugar, coffee and tobacco, second in soybeans and soybean products and fourth in maize (table 14). Brazil’s major export markets include the European Union, China, the United States, the Russian Federation and Japan. |
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| India | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Agriculture plays a major role in the Indian economy. It accounts for around 25 per cent of gross domestic product, and 13 per cent of total exports (IBEF 2007). More than 60 per cent of India’s population is employed in the agriculture sector. The sector is dominated by small farming families. Of the approximately 89 million farming households in India, 60 per cent own less than one hectare of land (James 2006). Major crops produced in India include sugar, rice, wheat and maize (table 15). Globally, India is the largest producer of milk, fruit, cashew nuts, ginger, coconuts and tea, the second largest producer of wheat, sugar, vegetables and fish, and the third largest producer of rice and cotton. Major exports from India include tea and coffee, rice, oilseed meals, cashew nuts, spices, fruit and vegetables (table 16). Significant quantities of wheat have also been exported in recent years in an attempt to reduce government stocks. Almost 35 per cent of agricultural exports from India are destined for developed markets. Key export partners include the United States, Bangladesh, the United Kingdom, Indonesia, Germany and Malaysia. India is a leading importer of pulses and oilseeds. Despite being the largest producer of pulses, its production is not sufficient to meet domestic consumption. Edible oils account for almost two-thirds of agricultural commodity imports and pulses account for an additional 20 per cent (IBEF 2006). Other imports include cashew nuts (for processing), tree nuts, fruit, raw cotton, wool and silk. Indian production depends greatly on climatic conditions, and as such, during production shortfalls, wheat, rice and sugar may also be imported. |
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| China | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| China’s economy has undergone rapid development since the early 1990s. Gross domestic product has increased by an average of 9 per cent a year, reflecting high investment levels, new technologies and a transfer of resources to more productive industries (ABARE 2006). While there has been a large movement of the population from rural to urban areas, the agriculture sector has maintained a dominant role in China’s economy. China is the world’s largest producer of rice, wheat, cotton, peanuts and canola. It ranks second in maize and fourth in soybean production. In recent years, there has been a shift in resources away from intensive cereal production as farmers adapt to domestic consumer demand for a greater variety of foods and opt for higher value, labour intensive products, such as meat, vegetables, fruit, eggs and milk. Cereals’ share in agricultural production fell from 63 per cent in 1991 to 33 per cent in 2005. There has also been a shift from wheat and rice into maize production for the livestock industry. Over the past decade, the total area of agricultural plantings has remained stable for oilseeds but fallen for grains (figure q). Following a fall in grain yields and planted area in 2003-04, the government introduced ‘grain production targets’, as well as tax relief payments and guaranteed payments to grain farmers. These measures led to an increase in grain production from 2004-05 (FAS USDA 2005). Rice, maize and wheat are the main crops planted by area in China, accounting for around 70 per cent of total area harvested (table 17). Imports have been used mainly to make up for production shortfalls, primarily in wool and wheat. Prior to 2004, there was only a minimal need for wheat imports, despite a significant reduction in production, as China was able to rely on stocks reserved in the 1990s (ABARE 2006). In 2004-05, however, China became a large importer of wheat. China has also become a major importer of soybeans, soybean oil and palm oil, reflecting increased demand for vegetable oil and feed for the expanding livestock sector. In 2005, China’s agricultural imports were valued at $36.7 billion and sourced primarily from the United States, Brazil, Argentina, the Russian Federation, Australia, Malaysia and Thailand. |
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| Biotechnology policies in Argentina, Brazil, India and China are likely to have implications for the future uptake of GM crops. In particular, improved intellectual property rights protection will be important in attracting further public and private investment in the agricultural biotechnology sector. Also, biosafety and environmental assessment measures will need to be continued, reflecting the demand of consumers and export markets. In this appendix, the regulatory arrangements for agricultural biotechnology in Argentina, Brazil, India and China are outlined. | ||
| Argentina | ||
| Institutions were founded in the early 1990s specifically to regulate biosafety and biotechnology development, establishing a strong base for the introduction of GM crops. For example, Argentina established a Biotech Commission and biosafety guidelines for the release of GM plants and micro-organisms. Other agriculture sector advisory and regulatory bodies responsible for regulating GM crop adoption in Argentina are outlined in box 4. | ||
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| Research and development | ||
| Limited resources are allocated to research and development in the agriculture sector in Argentina. In particular, public sector investment is low — less than 1 per cent of GDP — and between 1991 and 2004, 80 per cent of field trials undertaken for GM crops were from the private sector. | ||
| Intellectual property rights | ||
| IP rights are limited in Argentina and continue to constrain GM crop diffusion. In particular, illegal seed trade makes it difficult to incorporate new biotechnology breakthroughs. In addition, Argentine law stipulates that farmers can store seed for personal use, rather than purchasing seed annually. Illegal seed sales account for approximately 35 per cent of plantings in Argentina with another 30 per cent coming from legally saved seed (Qaim, Subramanian, Naik and Zilberman 2006). Illegal trade, along with the lack of intellectual property rights protection has put downward pressure on seed prices. In 2003, the Department of Agriculture, Livestock, Fisheries and Food (SAGPyA) and the National Institute of Seeds (INASE) both recommended policies to collect royalty payments. While no agreement has yet been reached on seed payments, the adoption of such policies is likely to strengthen IP rights for GM seed suppliers to Argentina. |
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| Brazil | ||
| Under the Biosafety Bill — introduced in 1995 — Brazil addresses all stages of GM crop approval, including research, experimentation, marketing, storage and dissemination (da Silviera and Borges 2007). The National Biosafety Technical Committee (CTNBio) within the Ministry of Science and Technology oversees the implementation of biotechnology regulations. The operation of biotechnology policy has faced obstacles in Brazil. Widespread illegal plantings of GM soybeans in 2003 prompted CTNBio to introduce provisional measures to permit the use of GM soybeans in 2003 and 2004. In 2004 the National Council on Biosecurity — a board representing eleven ministries — was introduced to provide a second opinion on the approval of GM crops. The agriculture sector advisory and regulatory bodies relevant to the use of GM traits in crops in Brazil are further outlined in box 5. |
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| Research and development | ||
| Agricultural biotechnology in Brazil has been largely associated with the adoption of foreign technologies, suited to local tropical conditions (da Silviera and Borges 2007). This adaptation process has been assisted by the National Centre for Research on Genetic Resources and Biotechnology (CENARGEN) which has the role of coordinating technology transfer from other countries. Public institutions contributing to GM crop development are limited and generally lack resources, infrastructure and investment. However, they have made some progress in the development of local crops such as sugar cane, beans and manioc, whereas global companies have focused on the introduction of global cash crops. The Brazilian Corporation for Farming and Livestock Research (EMBRAPA), established in 1973, is the public body responsible for coordinating R&D for GM crops. The National Farming and Livestock Research System (SNPA) encourages cooperation between the private sector and other research institutions and universities. These bodies have focused their efforts on improving coordination between public and private institutions to develop commercial products. |
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| Intellectual property rights | ||
| The introduction of intellectual property rights laws in the late 1990s, including the national Law of Patents (1996) and the Law of Cultivars Protection (1997), has improved coordination between public and private research; and enabled the collection of royalties and fees by technology owners for plant biotechnologies. These laws allow patents for the insertion of a gene into a plant variety, and as a result, seeds can only be reproduced with authorisation from the patent holder. These laws also enable joint technology transfer agreements between local and foreign research entities. For example, these joint agreements have been important for the introduction of Roundup Ready soybeans in Brazil. | ||
| India | ||
| Indian GM policy is focused toward the development of GM crops to suit national growing conditions and socioeconomic requirements. For example, low priority is given to crops that are labour saving, such as those with herbicide tolerant traits, whereas varieties targeting pests and biotic stresses are major objectives (Ramaswami and Pray 2007). GM crops in India must pass several approvals before commercialisation is authorised. Bt cotton was not approved for 5 years after the initial biosafety testing was completed. Further information is included in box 6. |
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| Research and development | ||
| The Indian Government has invested significant funding in public research systems, including the Centre for Plant Molecular Biology, the National Plant Genome Research Centre and the International Centre for Genetic Engineering and Biotechnology. The Indian Council for Agricultural Research supports R&D in crop biotechnology and has developed programs in rice and wheat varieties in particular. Publicly developed GM crop varieties are marketed by the National Seed Corporation and the State Farm Corporation of India. Products developed by the public sector include chickpea, rice, tobacco, cotton, potato, tomato, eggplant and mustard (Ghosh and Ramaniah 2000), but many of these products are yet to be commercialised. A concern with public R&D programs is that resources are spread thinly across many individual projects and not focused toward specific goals (Balasubramanian 2007). Private sector research in India has adapted foreign GM products to suit Indian conditions (Indira, Bhagavan and Virgin 2005). Investment has focused on cotton, rice and vegetables – all with the Bt gene for insect resistance. Significant funding from the private sector has enabled large scale, multilocation field trials to be undertaken. As a result, privately developed GM products — in particular cotton varieties — have entered the market more rapidly than publicly developed products. |
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| Intellectual property rights | ||
| Intellectual property rights in India have increased significantly in recent years. As a result, the private sector has increased its role in agricultural biotechnology research, focusing on commercial crops. India’s intellectual property rights laws come under the Protection of Plant Varieties and Farmers’ Rights Bill 2001. It includes protection for farmers, plant breeders and plant varieties as well as genetic material (Lalitha 2004). These laws have created incentives for international investors and several international biotechnology firms have sought entrance to the Indian market. |
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| China | ||
| China has incorporated agricultural biotechnology as a major national development goal. The National Biotechnology Program was initiated in the early 1980s with the objectives of improving food security, increasing farm income, and improving China’s competitive position in international agricultural markets. Since then, the public sector has made significant investments in biotechnology research capacity. Biotechnology regulations have been regularly updated to meet consumer and export market concerns. In particular, biosafety laws have become stricter and monitoring guidelines for GM crops have been implemented. More extensive testing for GM crops is also required in the form of a pre-production trial, a small scale field trial and a medium scale environmental release trial. Labelling is now required also for all products containing GM food components (box 7). |
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| Research and development | ||
| The Chinese Government has contributed significant funding to R&D programs for GM crops. Biotechnology has been a major focus of the National High-Tech Research and Development Plan initiated in 1986, as well as the National Basic Sciences Initiative (1997) and the Special Foundation of Transgenic Plants Research and Commercialisation (1999). Since the mid 1980s the National Science Foundation of China has also allocated a significant budget to agricultural biotechnology research. Almost all of China’s biotechnology funding has been sourced from the public sector. Funding increased from US$25 million in 1990 to US$120 million in 2003 (Huang et al. 2007). Funding for agricultural biotechnology has enabled China to establish significant research infrastructure and most provinces now have a large scale technological research program. In 2001, there were nearly 150 laboratories working on agricultural biotechnology in more than fifty research institutes and universities (Huang et al. 2007). More than fifty plant GM varieties have been developed, mainly for cotton, rice, maize, wheat, canola and soybeans. |
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| Intellectual property rights | ||
| China has improved its intellectual property rights regime over the past two decades, reflecting domestic and international seed firm requirements. The Plant Variety Protection Act was passed in 1997 and the first applications for patents were accepted in 1999. All major crops, except cotton, are eligible for patent protection and applications more than tripled between 1999 and 2003 (Huang et al. 2007). One key aspect of China’s intellectual property rights system is that commercial varieties can be used as parents in the development of new varieties. These new varieties can then be legally sold without fees or royalties being awarded to the original developer. In response, domestic and international firms have used patents and trademarks in attempt to prevent the use of their varieties. For example, Monsanto in China has patented the process used to create their Bt cotton varieties, as well as certain genes (Huang, Hu, Rozelle and Pray 2005). It is unclear whether these measures have been effective, with evidence indicating that protection is still inadequate under current regulation and enforcements of intellectual property rights. |
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| Federal regulatory arrangements | ||
| Agricultural biotechnology is regulated in Australia by two main government agencies: the Office of the Gene Technology Regulator (OGTR) and Food Standards Australia New Zealand (FSANZ). The OGTR was established in 2001 within the Australian Government Department of Health and Aging under the Gene Technology Act (2000). The role of the OGTR is to regulate the use of genetically modified organisms, while FSANZ is responsible for the regulation of GM food products (box 8). The Gene Technology Regulator grants authorisation for research, manufacture, production, field trials and commercial release of GM organisms. The OGTR also assesses the import of GM organisms for food or feed. Australia has strong standards on potential risks to human health and safety and the environment from biotechnology and these factors are thoroughly assessed by the OGTR before approval will be granted for a GM organisms. The OGTR is also advised by other gene technology committees on potential issues such as ethical concerns and the broader interests of the Australian community. FSANZ assesses the safety of all consumable foods, including imports, before they are permitted for consumption in Australia. This includes all aspects of the food supply chain, including primary production, manufactured food and food retail outlets. Cottonseed oil derived from GM cotton is the only approved GM food product produced in Australia. However, FSANZ has approved for import several GM food products not currently approved for production in Australia. These products include varieties of maize, potato, soybean, sugar beet and canola. FSANZ has also developed standards for the labelling of GM food products, which have been in place since 2001. All food products with GM ingredients are subject to mandatory labelling if introduced DNA or proteins are present in the final product. Non-GM food products with an unintended presence of GM material in a quantity of no more than 10 grams per kilogram per ingredient do not require a GM label (FSANZ 2007). |
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highly refined food, other than with altered characteristics, where the effect of the refining process is to remove novel DNA and/or novel protein