Addressing the Impact of Biosafety Systems

Transcription

1 Addressing the Impact of Biosafety Systems Towards a Regional Approach to Biotechnology and Biosafety for Southern African Countries (RABSAC) a background literature review By Marnus Gouse December 2005

2 1. Introduction Developing countries in general and in particular the Southern African Development Community (SADC) countries, are at crossroads regarding their decision on whether or not to embrace rapidly evolving biological technologies and related products such as genetically modified organisms (GMOs). The pace at which SADC countries are engaging in biotechnology is a cautious and precautionary one. While a number of countries strive to establish the policy and regulatory frameworks on biosafety and biotechnology, few have the capacity to fully enforce them. This emphasises the need for a common regulatory approach and policy position in the SADC region with acceptable standards that could be approved across countries. The Food, Agriculture and National Resources Policy Analysis Network (FANRPAN), in collaboration with national SADC nodes and technical partners and funded by the USAID through PBS, has endeavoured to document a balanced review of the technical information needed to inform SADC s regional biosafety policy choices responsibly. The initiative is designed to generate, for the SADC countries, new information regarding biosafety regulation and legislation, necessary market systems and infrastructure, identification and quantification of possible costs and benefits as well as the economic costs and benefits of attempting to remain a GM-free region. The ultimate aim of this project is to ensure improved food security and incomes in the agricultural systems in the SADC countries through adoption of appropriate productivity enhancing technologies. This project will help to ensure that the SADC countries have a balanced view of the costs and benefits of biotechnology/gmo adoption, for better decision-making. This project has been undertaken in three selected SADC countries, i.e. Malawi, Mauritius and South Africa. The three selected countries have strong national biotechnology institutions and are at different levels of biosafety regulation and legislation development. The aim of this paper is not to stand alone as a document but to serve as source document and literature review to assist in the compilation and compliment the three final project report papers focussing on the real and possible impacts of transgenic crop policies in the three focal countries. The three papers will focus on: Trade in agricultural products Staple food imports, food aid and food aid policies, and

3 Possible effects of commercial adoption of transgenic crops based on crops, production areas and production limiting factors. This paper will focus on a couple of main issues pertaining to genetically modified crops i.e. modern biotechnology and the regimes that govern it, the effect the introduction of GMOs have had on international trade, health effects of GM food and the environmental. A brief overview of global GM crop adoption and a summary of the economic and farm-level impacts of GM crop adoption are supplied. 2. Modern biotechnology and the international regimes that govern it Modern biotechnology According to the FAO publication The State of Food and Agriculture (FAO, 2004), biotechnology can be broadly defined as any technique that uses living organisms or substances from these organisms to make or modify a product for a practical purpose. The Convention on Biological Diversity (CBD) defines biotechnology as: any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products for specific use (Secretariat of the Convention on Biological Diversity, 1992). This definition includes medical and industrial applications as well as many of the tools and techniques that are commonplace in agriculture and food production. The Cartagena Protocol on Biosafety defines modern biotechnology more narrowly as the application of: (a) In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or (b) Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection. ( The FAO Glossary of biotechnology defines biotechnology narrowly as a range of different molecular technologies such as gene manipulation and gene transfer, DNA typing and cloning of

4 plants and animals (FAO, 2001a seen in FAO, 2004). Recombinant DNA techniques, also known as genetic engineering or (more familiarly but less accurately) genetic modification, refer to the modification of an organism s genetic make-up using transgenesis, in which DNA from one organism or cell (the transgene) is transferred to another without sexual reproduction. Genetically modified organisms (GMOs) are modified by the application of transgenesis or recombinant DNA technology, in which a transgene is incorporated into the host genome or a gene in the host is modified to change its level of expression. The terms GMO, transgenic organism and genetically engineered organism (GEO) are often used interchangeably although they are not technically identical (FAO, 2004). These terms are often used as synonyms. Modern agricultural biotechnology includes a range of tools that scientists employ to understand and manipulate the genetic make-up of organisms for use in the production or processing of agricultural products. Some applications of biotechnology, such as fermentation and brewing, have been used for millennia. Other applications are newer but also well established. For example, micro-organisms have been used for decades as living factories for the production of lifesaving antibiotics including penicillin, from the fungus Penicillium, and streptomycin from the bacterium Streptomyces. Modern detergents rely on enzymes produced via biotechnology, hard cheese production largely relies on rennet produced by biotech yeast and human insulin for diabetics is now produced using biotechnology (FAO, 2004). Biotechnology is being used to address problems in all areas of agricultural production and processing. This includes plant breeding to raise and stabilize yields; to improve resistance to pests, diseases and abiotic stresses such as drought and cold; and to enhance the nutritional content of foods. Biotechnology is being used to develop low-cost disease-free planting materials for crops such as cassava, banana and potato and is creating new tools for the diagnosis and treatment of plant and animal diseases and for the measurement and conservation of genetic resources. Biotechnology is being used to speed up breeding programmes for plants, livestock and fish and to extend the range of traits that can be addressed. Animal feeds and feeding practices are being changed by biotechnology to improve animal nutrition and to reduce environmental waste. Biotechnology is used in disease diagnostics and for the production of vaccines against animal diseases. Clearly, biotechnology is more than genetic engineering. Indeed, some of the least controversial aspects of agricultural biotechnology are potentially the most powerful and the most beneficial for the poor. Genomics, for example, is revolutionizing our understanding of the ways genes, cells, organisms and ecosystems function and is opening

5 new horizons for marker-assisted breeding and genetic resource management. At the same time, genetic engineering is a very powerful tool whose role should be carefully evaluated. It is important to understand how biotechnology particularly genetic engineering complements and extends other approaches if sensible decisions are to be made about its use (FAO, 2004) 2.2 Governing modern biotechnology In a January 2003 brief by the International Food and Policy Research Institute (IFPRI, 2003), Peter Phillips found that there are predominately nine international bodies that regulate and govern different aspects of food safety and agricultural biotechnology. Philips divides the institutions into three types. Five are mainly science-based organisations namely: the International Plant Protection Convention (IPPC), International Epizootics Organisation (OIE), Codex Alimentarius (Codex), the Food and Agricultural Organisation (FAO) and the World Health Organisation (WHO). The World Trade Organisation is a trade-based organisation while the remaining three organisations have broader objectives such as environmental protection and other political or social goals: the Organisation of Economic Co-operation and Development (OECD), the Cartagena BioSafety Protocol (BSP) and some Regional Initiatives. These organisations endeavour to establish standards for health, safety, and labelling for GM foods, develop testing procedures to ensure the standards are met, provide rules for allowable policies, and create systems to manage disputes. Philips states that despite substantial effort by these organisations (Table 1), there is no common view on the goal of international regulation. While most bodies agree that safety is the main issue, few can agree on what that means, whose opinion should hold the most weight (scientists or citizens ), or how to handle nonsafety issues like social, economic or ethical concerns. Philips (IFPRI, 2003) summarises the role of each organisation and the linkages and cooperation between them as follows: The FAO and WHO promotes food security and public health and have worked to develop a consensus about the implications of biotechnology for their areas of interest. The IPPC and OIE on the other hand, are multilateral treaties that seek to protect plants and animals from the spread of pathogens through international trade, thereby providing much of the scientific consensus that underlies domestic food safety systems. Both institutions have their own nonbinding dispute avoidance and settlement systems, but their most important role in international trade is through the WTO Sanitary and Phytosanitary Agreement (SPS), which uses the IPPC and OIE standards as the basis for evaluating SPS disputes. National measures based on

6 international standards from either of these institutions will generally not be open to challenge under the WTO dispute resolution process. Furthermore, both the IPPC and OIE nominate experts for WTO SPS dispute panels and provide technical background information to the panels based on their standards. As such, they can have far-reaching economic and political consequences on food trade. Table 1: International regulatory institutions Institution Members Coverage Food and Agricultural Food security programmes Organisation of the United 184 Nations (FAO) World Health Organisation Health science and policy 191 (WHO) International Plant Protection Pests and pathogens (crops) 107 Convention (IPPC) International Epizootics Pests and pathogens (animals) 155 Organisation (OIE) Codex Alimentarius (Codex) 165 Food standards and labels World Trade Organisation Trade rules for all goods; Dispute 139 (WTO) Settlement Mechanism Organisation for Economic Harmonise standards and policies Cooperation and Development 29 (OECD) Regional Initiatives Harmonise science and/or Various progress Cartagena BioSafety Protocol Transboundary movements of Ratified by 130 countries (BSP) living modified organisms Adapted from (IFPRI, 2003) The Codex, under the joint FAO/WHO Food Standards Program, provides a similar service related to processed foods. The Codex develops international food standards, which identify the product and its essential composition and quality factors, identify additives and potential contaminants, set hygiene requirements, provide labeling requirements, and establish the scientific procedures used to sample and analyze the product. Each standard normally takes six or more years to develop. Determination of the safety of the food product is based on scientific risk analysis and toxicological studies. Once a Codex standard is adopted, member countries are encouraged to incorporate it into any relevant domestic rules and legislation, but they may unilaterally impose more stringent food safety regulations for consumer protection, provided the different standards are scientifically justifiable. Codex plays an important role in agri-food trade because its standards, guidelines, and recommendations, like the IPPC and OIE provisions, are acknowledged in the SPS and Technical Barriers to Trade Agreements during consideration of trade disputes. There has been an eight-year process to develop a Codex standard for products of

7 biotechnology, but consensus eludes the negotiators. The OECD, composed of 29 industrial democracies, has actively assisted in harmonizing international regulatory requirements, standards, and policies related to biotechnology since The OECD has through a number of projects attempted to make regulatory processes more transparent and efficient, to facilitate trade in the products derived through biotechnology, and to provide information exchange and dialogue with non-oecd countries (IFPRI, 2003). Various bilateral or multilateral regional initiatives have played an increasingly important role in regulating trade in goods and services. These initiatives help create the consensus necessary to establish international rules, given that many food safety concerns in trade are bilateral and the knowledge base to develop standards resides in a few countries only. Regional agreements, memoranda of understanding, mutual recognition agreements, formal dialogues, and joint research projects are mechanisms that can be used to decrease bilateral regulatory barriers to GM food trade (IFPRI, 2003). The WTO has become the go-to institution for examining and resolving trade disruptions related to GM foods. Although there was a nonbinding agreement on technical barriers to trade in the Tokyo Round of the General Agreement on Tariffs and Trade, the 1995 SPS agreement for the first time extended the newly formalised and binding dispute settlement system to cover trade concerns related to sanitary and phytosanitary rules and technical barriers to trade. The WTO agreement permits national standards or regulations for the classification, grading or marketing of commodities in international trade (Article XI) and the adoption or enforcement of measures necessary to protect human, animal, or plant life or health (Article XX(b)), but also sets some rules on when and how they may be used. Specifically, the SPS Agreement requires that measures (1) do not discriminate between member states; (2) conform where possible to international standards developed by Codex, OIE, or IPPC; (3) be based on scientific principles and the completion of a risk assessment study; and (4) do not constitute a disguised restriction on international trade. Although the WTO is the main locus of dispute resolution for many countries, it has some limitations. Principally, as currently interpreted, the SPS Agreement allows regulations based on science but does not permit regulations that restrict trade based on nonscience concerns such as consumer preference, animal welfare, or nonmeasurable environmental risks (IFPRI, 2003).

8 The Cartagena Protocol on Biosafety was adopted by the Convention on biological diversity in September 2000 and came into force in September The objective of the Protocol is to protect biological diversity from the potential risks posed by safe transfer, handling and use of LMOs resulting from modern biotechnology. Risks to human health are also considered. The Protocol is applicable to all LMOs, except pharmaceuticals for humans that are addressed by other international agreements or organizations. The Protocol sets out an Advance Informed Agreement (AIA) procedure for LMOs intended for intentional introduction into the environment that may have adverse effects on the conservation and sustainable use of biodiversity (FAO, 2004). The Protocol also provides for labeling of GM elements in commodity shipments destined for the food chain. Some supporters of GMOs recognize 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 (Jooste et al., 2004), by potentially introducing additional requirements for cross-border trade in agricultural products, increasing bureaucracy, raising transactions costs and providing a means for countries trying to protect local markets to limit imports. At this stage, however, there does not appear to be sufficient evidence to support or refute this (Wolson, 2005). According to Philips the only conclusion one can derive from his survey of international institutions is that no one institution, and perhaps not even the entire array of institutions, is likely to yield an early resolution to concerns about diverging national policies and regulations concerning GM foods (IFPRI, 2003). According to a June 2005 International Food and Agriculture Trade Policy Council (IPC) Trade Negotiations Brief (IPC, 2004b), the developed world, developing countries will accept and incorporate GM technology in their agricultural policies at different times and in different ways, based on assessment of their own agricultural, environmental and trade policies as well as their social and cultural views of science, technology and innovation. The controversy over GM crops and products, combined with a highly regulated environment in many developed countries has led many developing countries to adopt a very cautious approach to products of GM technology. According to the IPC the most common constraint remains the limited institutional capacity to evaluate, regulate and manage these innovations. Most developing countries want to ensure that

9 these products are tested to the same levels of safety as in the developed world before they are put in the hands of their farmers. This applaudable objective has been and is however hampered by the reality that many countries, particularly least developed countries, do not have the resources human, financial and sometimes institutional to develop a science-based regulatory infrastructure similar to the industrialized economies and the large emerging economies. In the absence of local scientific infrastructure, policy makers in developing countries often feel they cannot proceed with acceptance of innovative GM technology. The fact that some products of GM technology are not approved in major markets provides an additional rationale to postpone decisions (IPC, 2004b). The lack of domestic regulatory policy for testing, release and commercialization of GM products makes it difficult to field test new varieties designed for subsistence farmers or non-commercial crops. Without proper testing and evaluation under the specific climactic and growing conditions in developing countries themselves, it will be impossible for developing countries to collect sufficient information to evaluate GM technologies. While many people cite the tangle of intellectual property rights as the single most important impediment to bringing appropriate GM technology to developing countries, researchers more often cite the lack of internal regulations and regulatory capacity. The absence of an international policy framework on the role of the life sciences in achieving the global objectives of poverty reduction, health care, and environmental conservation is a serious hindrance in the quest of many countries to set up a rational regulatory framework for GM technology. The starting point for a regulatory framework for GM technology in developing countries is the development of a GM technology policy, with a clear vision of the place of innovation in the future of agricultural and environmental policies. Countries like Argentina, Brazil, China and India have embraced GM technology in their long-term agricultural strategies, and built a regulatory framework that considers both agricultural and environmental policy objectives (IPC, 2004b). 3. Implications of agricultural biotechnology for regional and international trade It is said that the current diversity of regulatory regimes constrains the diffusion of agricultural biotechnology to farmers in the developing world as it is difficult for a developing country farmer to satisfy the multiplicity of labelling and regulatory schemes in developed country markets (IPC, 2004b). While developed countries have established their national frameworks to deal with agrobiotechnology and biosafety focusing predominantly on domestic priorities and strategies, most

10 developing countries are doing so under less flexible circumstances. Instead of enjoying the freedom to assess risks and benefits that agricultural biotechnology may bring about and act accordingly, developing countries increasingly seem to be expected to set up their national regulatory schemes based on the requests and expectations of their main trade partners (UN, 2005). According to the IPC report (2004b), some countries regulate based on detectability of genetically-modified protein or genetic material, while others regulate simply on the use of GM technology. Some countries require labelling only on intermediate products; others require it on consumer labels. Some countries require mandatory labels; others allow voluntary labelling. Some countries require positive labels (contains or is derived from genetic material) while others require negative labels (does not contain genetic material). Trade becomes difficult when regulatory regimes vary so widely, particularly for developing countries that often do not have the resources to comply with complex regimes and developing countries are worried about current and potential export markets. The IPC (2004b) suggest that the introduction of GM products coincided with a shift in power in the agri-food system from farmers and first level processors to retailers and consumers. Consumers have gained control of the food sector through purchase power and willingness or lack thereof to fund agricultural support through tax money. As a result, the issue of regulatory, commercial and consumer acceptance of GM products has become crucial for producers in developed and developing countries alike. Even though a number of genetically modified crops and products have been approved by the European Commission International trade does not happen between countries. It is the aggregate of transactions between economic operators in the food chain consumers, producers, food companies, supermarket chains, and others. Though it is unclear how broad consumer concerns about GM technology are, the depth of those concerns in some markets has made food companies wary of embracing the technology. In the late nineties, food companies were confronted with massive campaigns against their products and the European Union announced new regulations on labelling and traceability without clarifying the precise form that this new regulation would take. As a result, many processors, branded food companies, and retailers have sought to minimize their risk by establishing purchasing policies, which in practice have more impact on the decision-making of producers than the formal regulatory requirements. From the perspective of these companies, this creates a safety zone around their supply chain, and it reduces the cost of segregating product streams. It also reduces the pressure to pay premium prices for non-gm supplies of raw materials. The requirements for channelling GM products and the levels of identity preservation imposed by corporate purchasing policies

11 were put in place long before the major importing countries established regulatory standards and in many cases are much stricter than official regulations. For producers in developing countries, it is more difficult to keep their supply contracts with distributors in the developed world intact than to comply with developed country regulatory requirements, per se (IPC, 2004b). According to IFPRI (2003), US exports of maize to the EU have fallen by 70% in the recent couple of years preceding US soya-bean exports have dropped by 48% and Canadian canola exports to the EU have dropped 96%. The EU have in the meanwhile sourced GM-free soya and canola from Brazil and Australia respectively where at the time the GM varieties were not approved just yet. According to IFPRI these changed trade flows have not had significant ramifications with trade simply being reallocated between adopting and non-adopting countries, but over time such policies have the potential to seriously distort trade flows. Accordingly the United States, on May the 13 th 2003 informed the European Commission that it would seek WTO consultations to end an alleged EC moratorium on the approval for commercialisation of agricultural biotechnology products. The US claimed that the alleged moratorium violated provisions of the WTO agricultural, technical barriers to trade (TBT) and sanitary / phytosanitary (SPS) agreements, as well as the General Agreement on Trade and Tariffs (GATT). To its complaint the US added a list of biotech product applications for commercialisation that had been submitted to EC member states from 1996 through 2001, all of which either were pending approval or which had been withdrawn. The majority of the plaintiffs claims of EC violations of WTO rules concern the SPS agreement, however, the panel will almost certainly rule on the violations charged under other agreements as well. The US further justified its complaint by arguing that biotech products were necessary to feed developing countries. The EC characterised the filing of the complaint as legally unwarranted, economically unfounded and politically unhelpful [with regard to EC efforts to develop a regulatory system for GMOs]. Two weeks later, President George Bush brought the GM crop trade dispute to wider public attention by charging that the alleged moratorium on GMO approvals was hindering efforts to reduce hunger in Africa (IATP, 2005). In August 2003, because the EC consultations with the U.S., Canada and Argentina did not result in the ending of the alleged moratorium, the WTO Dispute Settlement Body (DSB) announced the formation of a single panel to rule on the case. In March 2004, the three panellists were named and in April, the first submissions of evidence began. In addition to the three plaintiff

12 WTO members, Australia, Brazil, Chile, Colombia, India, Mexico, New Zealand and Peru requested consultations with the European Communities and reserved their rights as third parties to benefit from the ruling (IATP, 2005). While the EU restarted approvals of GM products in 2004 after a break if close to six years, the end of the Union s de facto biotech ban did not come with the blessing of all its 25 member countries, who repeatedly fail to agree on genetically modified crops. Since 1998, the EU member states have not found enough of a voting majority to agree on any new GMO approvals. Three more GM maize varieties were approved by the European Commission on the 13 th of January 2006, bringing the total number of GM products approved since the end of the alleged moratorium and the new European traceability and labelling regulations entered into force in April 2004 to nine. It is said that whether or not the United States wins the EC-Biotech Products case, it is likely that the U.S. will file another case against the Directive on labeling and traceability of GMOs. As one industry official put it, removal of the moratorium is utterly useless if it is replaced by labeling and traceability rules. (ICTSD, 2006). The WTO dispute panel announced on 3 October 2005 that it will not be able to meet the 10 October deadline that it had announced in July. Ruling was delayed until January or February Commentators speculated that the ruling was delayed out of fear that its findings could have adverse effect on negotiations at the WTO Ministerial Conference in Hong Kong in December The ruling can be expected to be treated as a precedent by future WTO panels ruling on food safety, public health and environmental health measures applied to international traded goods and services. Developing countries, many of which have yet to establish regulatory regimes for GMO crops, will be particularly affected by the ruling (IATP, 2005). However, according to the IPC (2004b), resolution of the current regulatory complexities will not restore calm in the trading environment of agricultural products by itself. Developing countries may decide it is simply easier to avoid the issue altogether by avoiding biotech products. In addition to the regulatory and commercial barriers facing GM products (especially with the new traceability and labelling regulations of the EU), the overall global agricultural trade environment affects the economics of adopting biotechnology in developing countries. Trade-distorting subsidies that depress world commodity prices, coupled with traditional market access barriers such as tariffs and quotas, will make it economically unattractive to adopt new technologies in some crops. Farmers do not have an incentive to make investments in technologies that will

13 improve their productivity if they know that they will continue to have to compete with subsidised imports from developing countries and that they have no hope of being able to export their products to wealthy markets. These considerations are certainly more important for farmers producing cash crops or exporting to world markets, but even subsistence farmers can face competition from subsidised crops imported from rich countries. 4. Possible impacts of agricultural biotechnology on health and the environmental Health Science does not take a broad position that GM crops are safe or unsafe; each GM crop presents potential risks and benefits that must be evaluated on a case-by-case basis. When early farmers began to change the appearance of crops by conventional breeding 10,000 years ago, they also directed changes in crop DNA. In some cases, the changes have been so great that only a welltrained botanist can identify the wild ancestor of a crop. The nature of these changes has become clearer as we have been able to sequence the genetic code of domesticated plants and their wild relatives. We know that practically all plants we eat are extensively genetically modified compared with their wild ancestors. Often these modifications have been achieved through human selection of traits introduced through interspecific hybridization or created by random mutation using radiation or mutagenic chemicals (CAST, 2005). According to a report by the Council for Agricultural Science and Technology (CAST) the potential hazards associated with transgenic crop technology have been studied by the U.S. National Academy of Sciences (NAS). The NAS repeatedly has concluded that biotechnology is no more likely to produce unintended effects than conventional technology indeed the greater precision and more defined nature of the changes introduced may actually be safer. European Union scientists addressed this same issue and concluded that conventional plant breeding produces more unintended changes than are introduced in the construction of a transgenic plant (Cellini et al. 2004). These studies found that there are no new risks associated with the transfer of genes across species barriers. They concluded that transgenic crops on the market today are as safe to eat as their conventional counterparts, and likely more so, given the greater regulatory scrutiny to which they are exposed. After 10 years of safe use, it is fair to conclude that the inherent safety of the technology and the premarket case-by-case safety assessments conducted

14 by regulatory agencies around the world have ensured that foods from transgenic crops are as safe to eat as any food (CAST, 2005). The International Council for Science (ISCU) in 2003 also found, after analysis of findings of approximately 50 science-based reviews 1, published in years , on modern genetics and its applications in food, agriculture and the environment, that foods made from genetically modified crops are safe to eat. Food safety assessments by national regulatory agencies in numerous countries have deemed GM foods as safe to eat as their non-gm or conventional counterparts and suitable for human and animal consumption. The methods used to test the safety of these foods have also been deemed appropriate. This view is shared by a number of intergovernmental agencies including the FAO / WTO Codex Alimentarius Commission of food safety, the European Commission (EC) and the Organisation for Economic Cooperation and Development (ISCU, 2003). To date, world-wide, there have been no verifiable toxic or nutritionally harmful effects resulting from the cultivation and consumption of foods derived from genetically modified crops (GM Science Review Panel, 2004). Millions of people have consumed foods derived from GM plants mainly maize, soybean and oilseed rape without any observed adverse effects (ICSU, 2003). The main food safety concerns associated with transgenic products and foods derived from them relate to the possibility of increased allergens, toxins or other harmful compounds; horizontal gene transfer particularly of antibiotic-resistant genes; and other unintended effects (FAO, 2004). Many of these concerns also apply to crop varieties developed using conventional breeding methods and grown under traditional farming practices (ICSU, 2003). Exhaustive scientific tests by private product developing companies, regulatory bodies and independent laboratories endeavour to ensure that all types of food that reach the consumer market, do not contain abnormal allergens or toxins. 1 This literature study will not go into the details of the different studies and test procedures. Some references to these studies will be supplied in the reference list.

15 4.2 Environmental impacts According to the FAO (2004), agriculture of any type subsistence, organic or intensive affects the environment, so it is natural to expect that the use of new genetic techniques in agriculture will also affect the environment. The ICSU, the GM Science Review Panel and the Nuffield Council on Bioethics (seen in FAO report), among others, agree that the environmental impact of genetically transformed crops may be either positive or negative depending on how and where they are used. Genetic engineering may accelerate the damaging effects of agriculture or contribute to more sustainable agricultural practices and the conservation of natural resources, including biodiversity (FAO, 2004). Releasing transgenic crops for commercial production may have direct effects including: gene transfer to wild relatives or conventional crops, weediness, trait effects on non-target species and other unintended effects. These risks are similar to that of conventionally bred crops (ICSU,2003). Although scientists differ in their views on these risks, they agree that environmental impacts need to be assessed on a case-by-case basis and recommend post-release ecological monitoring to detect any unexpected events (ICSU, Nuffield Council, GM Science Review Panel). Transgenic crops may also have positive or negative indirect environmental effects through changes in agricultural practices such as pesticide and herbicide use and cropping patterns (FAO, 2004). The FAO s State of Food and Agriculture paper of 2004 summarises the main environmental concerns and effects as it is reported in applicable accredited literature: Gene flow: Scientists are in agreement that gene flow from GM crops is possible through pollen from openpollinated varieties crossing with local crops or wild relatives. Gene flow between land races and conventionally bred crops has happened for millennia and it is thus reasonable to expect that it could also happen with transgenic crops. Crops vary in their tendency to outcross, and the ability of a crop to outcross depends on the presence of sexually compatible wild relatives or crops (ICSU, 2003 & GM Science Review Panel, 2003). Scientists do not fully agree whether or not gene flow between transgenic crops and wild relatives matters, in and of itself (ICSU, 2003 & GM Science Review Panel, 2003). If a resulting transgenic/wild hybrid had some competitive advantage over the wild population it could flourish in the environment and potentially disrupt the

16 ecosystem. According to the GM Science Review Panel, hybridization between transgenic crops and wild relatives seems overwhelmingly likely to transfer genes that are advantageous in agricultural environments, but will not prosper in the wild. Furthermore, no hybrid between any crop and any wild relative has ever become invasive in the wild in the UK (GM Science Review Panel, 2003). The ICSU (2003) states that whether the otherwise benign flow of transgenes into land races or conventional varieties would itself constitute an environmental problem is a matter of debate, because conventional crops have long interacted with land races in this way. Weediness refers to the situation in which a cultivated plant or its hybrid becomes established as a weed in other fields or as an invasive species in other habitats. Scientists agree that there is only a very low risk of domesticated crops becoming weeds themselves because the traits that make them desirable as crops often make them less fit to survive and reproduce in the wild. Weeds that hybridize with herbicide-resistant crops have the potential to acquire the herbicide-tolerant trait, although this would only provide an advantage in the presence of the herbicide. The ICSU and the GM Science Review Panel concur that research is needed to improve the assessment of the environmental consequences of gene flow, particularly in the long run, and to understand better the gene flow between the major food crops and land races in centres of diversity (FAO, 2004). Trait effects on non-target insects: Scientists agree that some transgenic traits such as the pesticidal toxins expressed by Bt genes may also affect non-target species (besides the crop pests they are intended to control) but they disagree about how likely this is to happen (ICSU, 2003 & GM Science Review Panel, 2003). The monarch butterfly controversy demonstrated that it is difficult to extrapolate from laboratory studies to field conditions. The GM Science Review Panel (2003) reports that field studies have indicated some differences in soil microbial community structure between Bt and non-bt crops, but these are within the normal range of variation found between cultivars of the same crop and do not provide convincing evidence that Bt crops could be damaging to soil health in the long term. Although no significant adverse effects on non-target wildlife or soil health have so far been observed in the field, scientists disagree regarding how much evidence is needed to demonstrate that growing Bt crops is sustainable in the long term. Scientists agree that the possible impacts on non-target species should be monitored and compared with the effects of other current agricultural practices such as chemical pesticide use. They acknowledge that they need to develop better methods for field ecological studies, including better baseline data with which to compare new crops (FAO, 2004).

17 Indirect environmental effects The ICSU and GM Science Review Panel agree that transgenic crops may have indirect environmental effects as a result of changing agricultural or environmental practices associated with the new varieties. These indirect effects may be beneficial or harmful depending on the nature of the changes involved. The use of conventional agricultural pesticides and herbicides has damaged habitats for farmland birds, wild plants and insects and has seriously reduced their numbers. Transgenic crops are changing chemical, land-use and other farming practices, but scientists do not fully agree whether the net effect of these changes will be positive or negative for the environment and acknowledge that more comparative analysis of new technologies and current farming practices is needed (FAO, 2004). Pesticide use The scientific consensus is that the use of transgenic insect resistant crops have reduced the volume and frequency of chemical insecticide use on maize, soybean and especially cotton in all the adopting countries (FAO, 2004) The environmental benefits include less contamination of water supplies and less damage to non-target insects (ICSU, 2003). Reduced pesticide use suggests that Bt crops would be generally beneficial to in-crop biodiversity in comparison with conventional crops that receive regular, broad-spectrum pesticide applications, although these benefits would be reduced if supplemental insecticide applications were required (GM Science Review Panel, 2003). As a result of less chemical pesticide spraying on cotton, health benefits for farm workers have been documented in China (Pray et al., 2002) and small-scale farmers in South Africa (Bennett et al (2003). Herbicide use The FAO (2004) reports that, Traxler (2004) found that there has been a marked shift away from more toxic herbicides to less toxic forms, but total herbicide use has increased. Scientists agree that HT crops are encouraging the adoption of low-till crops with resulting benefits for soil conservation (ICSU, 2003). There may be potential benefits for biodiversity if changes in herbicide use allow weeds to emerge and remain longer in farmers fields, thereby providing habitats for farmland birds and other species, although these benefits are speculative and have not been conclusively supported by field trials to date (GM Science Review Panel, 2003). There is concern, however, that greater use of herbicides even less toxic herbicides will further erode habitats for farmland birds and other species (ICSU, 2003). The Royal Society has published the results of extensive farm-scale evaluations of the impacts of transgenic HT maize, spring oilseed

18 rape (canola) and sugar beet on biodiversity in the United Kingdom. These studies found that the main effect of these crops compared with conventional cropping practices was on weed vegetation, with consequent effects on the herbivores, pollinators and other populations that feed on it. These groups were negatively affected in the case of transgenic HT sugar beet, positively affected in the case of maize and showed no effect in spring oilseed rape. They conclude that commercialization of these crops would have a range of impacts on farmland biodiversity, depending on the relative efficacy of transgenic and conventional herbicide regimes and the degree of buffering provided by surrounding fields (Royal Society, 2003). Scientists acknowledge that there is insufficient evidence to predict what the long-term impacts of transgenic HT crops will be on weed populations and associated in-crop biodiversity (FAO, 2004). Pest and weed resistance According to the FAO (2004) there is agreement amongst scientist on the fact that extensive longterm use of Bt crops and glyphosate and gluphosinate (the herbicides associated with HT crops) can promote the development of resistant insect pests and weeds. Similar breakdowns have routinely occurred with conventional crops and pesticides and, although the protection conferred by Bt genes appears to be particularly robust, there is no reason to assume that resistant pests will not develop (GM Science Review Panel, 2003). Worldwide, over 120 species of weeds have developed resistance to the dominant herbicides used with HT crops, although the resistance is not only associated with transgenic varieties (ICSU, 2003 & GM Science Review Panel, 2003). Because the development of resistant pests and weeds can be expected if Bt and glyphosate and gluphosinate are overused, scientists advise that a resistance management strategy be used when transgenic crops are planted (ICSU, 2003). Scientists disagree about how effectively resistance management strategies can be employed, particularly in developing countries and the extent and possible severity of impacts of resistant pests or weeds on the environment are subject to debate (FAO, 2004).

19 5. Adoption and economic and on-farm effects of agricultural biotechnology Global status of GM crops According to the recently released International Service for the Acquisition of Agri-Biotech Applications report by Clive James (ISAAA, 2005), 2005 marked the tenth anniversary of the commercialisation of GM crops after first introduction in It is estimated that about 90 million hectares of approved GM crops were planted in 2005; 9 million hectares more than the 81 million of GM crops were grown in 21 countries, 3 up from the 17 in Of the four new countries, three were European Union countries namely Portugal, France and the Czech Republic. France and Portugal resumed Bt maize planting after a gap of 4 and five years respectively and the Czech Republic planted Bt maize for the first time in Five EU countries are now producing Bt maize on a commercial level i.e. Spain, Germany, Portugal, France and the Czech Republic. Transgenic soya-beans continued to be the most planted GM crops covering 54.4 million hectares (60% of the global biotech area), followed by maize covering 21.2 million hectares (24%), cotton covering 9.8 million hectares (11%) and canola with 4.6 million hectares at 5 % of global GM crop area. Genetically modified rice, squash, potato, tomato and papaya still cover only small areas.

20 Economic and on-farm effects of GM crop adoption During the first decade of GM crop adoption, herbicide tolerance has been the dominant trait with insect resistance in the second place. It has been proven by a number of studies across the globe that the use of the herbicide tolerant technology increases weed control efficiency, decreases fossil fuel use, decreases machine hours and increases profitability. Due to these benefits Brazil has, for example, increased their herbicide tolerant soya-bean area by 5 million hectares in 2005 to 9.4 million, from 4.4 in Enough proof that farmers are benefiting. Weeds are a constant obstacle in crops production and it can be generally excepted that a farmer who has weed problems can benefit from herbicide tolerant technology. Pest pressure is however a horse of a different colour. Pest pressure is not constant over seasons and the profitability of insect resistant technology depends on the pest pressure in the specific season. If the particular pests are present but not in sufficient numbers to significantly effect yield, or if the pests affect

21 yield but can be inexpensively controlled by other means, then the producer of the pest resistant crop may not experience a net benefit. If the pests are prevalent to an economically damaging extent in the area, however, then this complete control can result in significant yield increases (Marra, Pardey & Alston, 2002). Insect resistant seed adoption influences the on-farm profitability in mainly three ways: - Increase in yield due to better pest management - Decrease in input cost through savings on insecticide chemicals and application costs - Increase in input cost through a higher seed price and an additional technology fee. Table 2 summarises the findings of a number of more recent studies focussing on different GM crops produced in different countries. Table 2: Summary of GM crop country study findings Crop Country Yield effect Cost of technology ($/ha) Estimated cost savings (including fuel, mechanisation and pesticides) excluding cost of technology ($/ha) and Sources Herbicide tolerant soya-beans Herbicide tolerant maize Herbicide tolerant cotton Herbicide tolerant canola US None $ $17.3 in 2003 $ (Marra et al., 2002), $ (Gianessi & Carpenter, 1999), $ (Carpenter & Gianessi, 2001), $ (Sankula & Blumenthal, 2004) Argentina None $3-4 in 2002 $24-30; (Qaim & Traxler, 2002) Brazil None $15 in 2004 $88 in 2004 Paraguay & None Same as Argentina No country-specific analysis available Uruguay Canada None $26.5 in , $ (George Morris Center, 2004) $40 in 2003, $ South Africa None $26 in 2005 $35 in 2005 (Monsanto S. Africa, 2005) Romania +31% increase and $ & 2000, $ (Brookes, 2003) 2% price premium $ , for cleaner delivered $ , harvest $ inclusive of 4 litres of Roundup US None $14.8 $39.9 (Carpenter & Gianessi, 2001; Sankula & Blumenthal, 2004) Canada None $22 $40.5 (Monsanto, Canada, 2005) South Africa None $13 $18 (Monsanto S.A, 2005) US None $ , $ , $21.32 in 2001 $66.59 in 2001 (Carpenter & Gianessi, 2001; Sankula & Blumenthal, 2004) Australia None $ $ (Doyle et al., 2002; Monsanto Australia, 2005) South Africa None $21 in 2001 $ (Monsanto S. Africa, personal communication, 2005) US +6% $ , $ for glyphosate tolerant & $17.3 all years for glufosinate tolerant $ , $67 in 2002 glyphosate tolerant, and $44.89 glufosinate tolerant (Carpenter & Gianessi, 2001; Sankula & Blumenthal, 2004) Canada $36.5 $32.4 (Canola Council, 2001)

22 Insect resistant maize US +5% $ & 1997, $ & 1999, $22 in 2000 $15.5 all years (James, 2002; Carpenter & Gianessi, 2001; Sankula & Blumenthal, 2004; Marra et al., 2002) Canada +5% As US No specific Canadian studies, impact qualitatively confirmed by Monsanto Canada (2005) Argentina +9% As US Nil all years; no specific Argentine studies identified but values confirmed by Trigo (2005); yield impact based on James (2003) Philippines +25% all years $ & 2004 a $ & 2004 (James, various) Spain +6.3% all years & 1999, , (Brookes, 2002) South Africa Commercial farmers % 1999 & 2000 $8-25 depending on seed use per hectare $ & 2000 (Gouse et al, 2005) Subsistence farmer +32% % 2002 $ Small insecticide saving (Gouse et al, 2006) Insect resistant cotton Others US 9% , 11% 2003 & 2004 $ , $ & 2004 $ , $ & 2004 (Carpenter & Gianessi, 2001; Sankula & Blumenthal, 2004; Marra et al., 2002; Mullins & Hudson, 2004) China +8% , 10% 2000 $42 $ , $ (Pray et al., 2002) Australia None $ & 1997, $ , $ , $ & 2004 $ , $ , $ , $ , $ , $ & 2004 (Doyle, 2005; Fitt, 2003; James, 2002) Argentina +30% $86 $17.47 (Qaim & De Janvry, 2002, 2005) South Africa 24% $63 $21 (Gouse et al, 2003; Ismael et al., 2002; James, 2002) Mexico 3%-37% $ and 1999, $ , $ $ & 1999 onwards, $ & $ (Monsanto Mexico, 2005; Traxler et al., 2001) India 45% 2002, 63% $ , $ , $ , $ & $ (Bennett et al., 2003, 54% 2004 $ ) US: GM IR 3% 2003 & 2004 $42 both years $32 both years (Sankula & Blumenthal, 2004) corn rootworm maize US: GM virus resistant papaya Between 16% and 50% None , $ a Converted to US dollars at prevailing exchange rate. Source: Table adapted from Brookes & Barfoot, 2005 None (Sankula & Blumenthal, 2004) It is clear from the findings summarised in Table 2 that large commercial farmers as well as small-scale or subsistence farmers can benefit from transgenic crops. GM crops should however not be seen as a solve all silver bullet or panacea. GM crops are just another tool in the box of the farmer to decrease production risk and increase production efficiency in order to produce more with less inputs and environmental stress.