SciDev.Net

The African Union (AU) developed the African Model Law on Safety in Biotechnology to help countries across the continent fulfil their obligations under the Cartagena Protocol on Biosafety and manage related issues.

The AU encourages the development of a common position on biosafety regulation (see AU Biosafety Project) across the continent. It does not have the authority to legislate on behalf of its members — but it promotes the Model Law as a framework for individual countries to use in creating their own laws and institutions.

The Model Law is being revised through an ongoing consultation process before submission to AU governments for possible adoption at national level.

This report analyses key issues surrounding decision-making on GM crops in developing countries. The document was written by Ehsan Masood and others as part of Panos’ Communicating Research through the Media Programme, Relay.

Using case studies from Brazil, India, Kenya, Thailand and Zambia, the report explores how policies and regulations are developed, and who is involved in decision-making processes around GM technology. The authors look at the role played by scientists, international bodies, industry and farmers’ groups and the degree of public participation in decision-making, noting that scientific expertise is most influential throughout the process.

The document also examines the degree to which the media succeeds in performing its key role as facilitator of informed debate. In presenting evidence from their survey of media coverage of GM issues in the countries studied, the authors find a general lack of analytical reporting, with many journalists simply relaying government announcements. Farmers’ viewpoints are generally under represented.

This useful and informative report provides real-world examples of decision-making processes on GM in a variety of developing countries. It will be valuable to anyone interested in such processes or in how well the media supports them.

This series of briefing documents is based on a three year research programme into policy and governance issues surrounding agricultural biotechnology, especially GM crops, in developing countries. The research involved collaborators from the UK, China, India, Kenya and Zimbabwe. Co-funded by DFID and the Rockefeller Foundation, the series was coordinated by the Environment Group at the UK’s Institute of Development Studies.

The series consists of thirteen concise summaries focusing on particular topics, such as corporate dominance, biosafety regulation, intellectual property rights and public participation in decision-making. Specific briefings also discuss biotechnology in African farming and experiences with insect-resistant cotton in China, India and South Africa. The series draws together various dimensions of the debates about agricultural biotechnology in the context of development. The authors address the complex socio-economic issues surrounding the adoption of GM technology in the South, and frequently sound notes of caution about the likely benefits for the poor.

Of interest to policy-makers, academics and anyone interested in understanding the global socio-economic and development implications of agricultural biotechnology in developing countries.

More than fifty crops have now been genetically transformed – in the laboratory – in sixteen developing countries. However, regulatory approval and cultivation lags well behind the developed world, having only taken place in a handful of countries, and being restricted to just two crops – cotton and maize. This International Food Policy Research Institute policy briefing discusses some of the reasons for this.

In food safety assessment, developing countries face two problems: weak institutional, infrastructural and technological capabilities; and the lack of common international standards. This creates difficulties for developing countries in relation to their participation in international trade, particularly in terms of: operationalising the concept of 'substantial equivalence' (in which the novel characteristics of a GM product are evaluated against its non-GM counterpart); accessing safety data generated in other countries; building capacity to meet demanding international standards or importers’ requirements; and establishing food safety thresholds.

The authors note that safety assessment is not just about science, but about public perceptions and assuring importers about food safety. Nevertheless, they argue that credible science and reasonable international standards will "allow scientifically defensible decisions in the face of food safety questions coloured by each country’s perceptions and circumstances".

These two highly informative papers - which offer overviews of current status and regulations and of ecological risk assessment - are an excellent overview of the current status of GM crops in commercial production, as well as those that have been approved for release. The regulatory mechanisms surrounding the release of GM crops in different countries are compared, followed by a balanced discussion of the issues surrounding risk assessment and its role in decisions involving GM technology.

The first paper contains a comprehensive list of over 40 transgenic crops approved for commercial release, and discusses legislation in the United States, Argentina, Canada, China, the European Union, Australia, Japan and other countries. The authors caution against "the regulation of risk turning into the risk of regulation", which would lead to a situation in which only a few multinational companies could afford to tackle excessive regulatory processes.

The science of risk assessment is addressed in the second paper, concluding with the socio-economic context of judgements surrounding GM technology. The various concerns regarding the environmental release of transgenic crops are thoroughly discussed, including the likelihood and possible consequences of the invasion of existing ecosystems, outcrossing, horizontal gene transfer, 'superpests' and secondary ecological impacts on biodiversity and other agricultural practices.

The authors emphasise that the plants developed by traditional breeding offer the most appropriate reference point against which the potential impact of a GM crop should be judged, and that these judgements must be made on a case-by-case basis.

This general overview illustrates the importance of effectively managing intellectual property (IP) and tangible property (TP) in the development of biotechnology-based products. It also emphasises the value of partnerships between the public and private sector in projects aimed at helping developing countries, as these nations often lack the capacity and resources to manage such issues.

As well as providing helpful definitions of legal and technical terminologies, the authors use a real and a fictional case study to demonstrate the various issues that inventors should consider. Examples include knowing the origins of every component of the product or system, any associated licences and patents, identifying ownership of resources, and having a suitable recording policy in laboratory notebooks, as well as awareness and training among staff.

As yet there is no international patent system, meaning that extra considerations must be taken when attempting to transfer technology across the globe. This has an impact on products destined for developing countries that must be taken into account early in the development process. However, the authors advise against undue anxiety relating to IP and TP. They stress that these issues should be viewed as simply another aspect of life in modern research laboratories, both in developing and industrialised countries.

Farmers and consumers have benefited from advances in agricultural technology for centuries, but the most recent innovation — transgenic modification of crops — has generated enormous controversy.

It is well known that whereas genetically modified (GM) crops have been grown extensively in Argentina, Canada, and the United States since 1996, environmental and consumer groups have largely blocked the GM crop revolution in Europe and Japan. It is less clear, however, what choices developing countries will make concerning the new technology.

In this discussion paper, Robert L. Paarlberg devises a system for classifying policy choices towards GM crops in the areas of intellectual property rights, food safety, biosafety, trade, and public research investment.

He then presents a snapshot and analysis of policies toward GM crops for four countries: Brazil, China, India, and Kenya. At the time of writing, of these four countries, only China had officially approved the commercial planting of GM crops.

Paarlberg seeks to explain the differences among the four countries in these policy areas, and he determines that international pressures — from, for example, international environmental and non-governmental organisations, international agreements, and donors — have discouraged GM crop adoption in Brazil, India, and Kenya. China has taken a different path in part because it is relatively insulated from such pressures.

This study should be of great interest to any one who follows the international debate over GM foods and crops, including policy-makers, researchers and students, and those in the international private sector.

In a number of countries, concerns over the possible environmental and health implications of modern biotechnology have stimulated regulatory mechanisms for food safety and environmental risk assessment. Over the past two decades, such national biosafety frameworks, guidelines, and regulatory systems have often been implemented in a 'piecemeal' way, in response to the demands or urgent needs of the moment. Ideally, a biosafety system would be developed from a comprehensive plan. However, building such a system and making it operational is complicated by the fact that there is no single best approach nor standard that reflects national environmental, cultural, political, financial, and scientific heterogeneity.

Given these challenges and difficulties inherent in building regulatory systems and associated capacity, the International Service for National Agricultural Research (ISNAR) convened an expert consultation in July 2001. The purpose of this meeting was to develop a conceptual framework to address regulatory implementation and capacity-building needs of developing countries and Parties to the Protocol.

A framework for implementing national biosafety systems emerged, which consists of the following five elements:

• national policies, strategies, and research agendas regarding biosafety;
• national inventory and evaluation;
• the knowledge, skills, and capacity base to develop and implement a biosafety system;
• development of regulations; and
• implementation of regulations.

This conceptual framework clarifies critical decision points in the development of a national biosafety system, systematically examines choices among policy options, and delineates some of the scientific and social dimensions of these options. It complements ongoing regional and global projects that facilitate the development of national biosafety guidelines and frameworks.

Since the 1980s, China’s government has heavily supported research in biotechnology, including the development of high-yielding, insect- and drought-resistant plant varieties that potentially could allow farmers to produce more food from China’s limited land area. However, China now seems to be taking a cautious approach to biotechnology.

Genetically modified (GM) varieties of most of China’s major crops have been developed, but only a few have been approved for commercial use. The long delay in publishing final biotechnology regulations in 2001 and the lack of details in those regulations suggest that China's policy-makers are still debating the issue.

This paper gives a clear and concise summary of the current state of biotechnology research and application in China, the level of consumer acceptance of GM crops, and the regulatory environment that policy-makers are working within.

Central to the debate on genetically modified foods is whether mankind, especially developing countries, can secure the benefits of genetically modified crops while most effectively avoiding any risks they may present.

In this review article, John H Skerritt (Australian Centre for International Agricultural Research) outlines the major issues raised by those opposed to GM crops: effects on human health, potential environmental effects and a less definable sense that genetically modified crops are unnatural. Issues that follow are labelling of GM foods (whether to label, which GM products to label and whether such labelling should be voluntary or compulsory), and whether labelling should be backed up by testing.

This review discusses the scientific and commercial motivations for development of GM crops, current applications of the technology in the context of the debate on safety concerns. The focus of much of the debate has been developed countries such as Europe, but it is possible that the technology could have the greatest utility for developing countries.

This report — produced by a fourteen-member expert panel set up by the Royal Society of Canada — makes a number of recommendations to enhance the regulatory system for foods derived through the use of recombinant DNA technology. The report attracted considerable attention because of its focus upon the risks that may be posed by future biotechnology products, and the regulatory approaches and processes that will be required to assure health and environmental safety.

Given the many scientific uncertainties that remain in the assessment of the safety of GM food products, the panel argues that a prudent, or precautionary approach to the regulation of these technologies will require careful research and rigorous testing in order to reduce these uncertainties, and to maintain public confidence in the management of any potential harms to human, animal or environmental health. The panel also paid close, critical attention to the highly controversial principle of "substantial equivalence" as a regulatory concept. They concluded that the preferred approach would be to carry out a rigorous analysis of the consequences of the presence of the transgene by employing direct testing for harmful outcomes.

The original report covers a range of issues from what is involved in genetic modification and how it is regulated, to possible ecological concerns. It also discusses issues surrounding gene transfer, allergenicity and toxicity, and labelling of foods. It provides recommendations for future policy in this area, including the formation of an over-arching regulatory body to monitor developments and policy.

The update focuses on the effects that GM foods might have on human health and using the principle of substantial equivalence in GM food safety testing. Developments on the environmental aspects of GM crops will be reviewed at a later date.