Cartagena Protocol Research Articles

The Legal Liability Principles facing the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety: Focusing on the Regulation of Genetic Engineering of Germany

The Legal Liability Principles facing the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety: Focusing on the Regulation of Genetic Engineering of Germany

A Study on the Establishing Process and Tasks of Nagoya-Kualalumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety -Focused on the Case of LMO's Release into Environment-

A Study on the Establishing Process and Tasks of Nagoya-Kualalumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety -Focused on the Case of LMO's Release into Environment-

Risk assessment of genetically modified organisms (GMOs)

Risk assessment is a procedure normally carried out prior to decision-making on the release of genetically modified organisms (GMOs) into the environment. Most countries dealing with the release of GMOs have appropriate guidelines. The objectives of this paper are to critically examine the risk assessment provisions of the Malaysian Biosafety Act (2007), and to compare it with several risk assessment provisions in the Cartagena Protocol, as well as regulations in developed countries. There are inadequacies in the risk assessment provisions of the Malaysian Biosafety Act (2007 Act), compared to those of the Cartagena Protocol, as well as those found in European Commission Directives. Although the central objective of the 2007 Act was similar to the Cartagena Protocol, the Act was found to be very basic with only a brief provision on risk assessment and there is no specific coverage on the socio-economic and ethical aspects as well as the precautionary approach. It is hoped that these inadequacies will be improved upon, in order to bring the Malaysian Biosafety Act closer to the level seen in the biosafety laws of more developed countries and to ensure adequate level of protection for the Malaysian people against any adverse effects of GMOs and products. Key words: Risk assessment, biosafety, Malaysian Biosafety Act 2007, genetically modified organisms (GMOs).

Liability and Redress of Trans-Boundary Movement of Genetically Modified Organisms and the Biosafety Law in Malaysia

Biosafety refers to the efforts taken in ensuring the safety of the application of biotechnology, which necessitates for proactive steps to be taken to “reduce and eliminate the potential risks resulting from biotechnology and its products”. Modern biotechnology has enabled scientists to genetically and biochemically modify plants, animals as well as microorganisms. In the effort to increase crop production for the purpose of securing global food supply, the application of biotechnology in the agricultural sector must be carried out in a safe and sustainable manner. The recognition of the potential risks to human health and the environment must not be discounted and countries looking towards the application of biotechnology must ensure its safe application. The need for further regulations on biosafety was discussed in 1992, when the Convention on Biological Diversity (CBD) was adopted. Article 19(3) of the Convention requires its members to consider the need for a protocol on “the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity.” This consequently led to the Cartagena Protocol on Biosafety (CPB), which primarily regulates the trans-boundary movement of living modified organisms (LMOs) or alternatively known as genetically modified organisms (GMOs). In Malaysia, the Biosafety Act 2007 (BSA) was passed to regulate the release, importation, exportation and contained use of GMOs in order to protect inter alia human, plant and animal health as well as the environment and biological diversity. This paper highlights the issues pertaining to liability and redress, which provides for the legal obligation to compensate the damage especially to the environment accruing from the trans-boundary movement of the GMOs, as well as the position of the present Malaysian biosafety law.

Rotulagem de alimentos que contém Organismos Geneticamente Modificados: políticas internacionais e Legislação no Brasil

The increase in surface area planted with genetically modified crops, with the subsequent transfer of such crops into the general environment for commercial trade, has raised questions about the safety of these products. The introduction of the Cartagena Protocol on Biosafety has led to the need to produce information and ensure training in this area for the implementation of policies on biosafety and for decision-making on the part of governments at the national, regional and international level. This article presents two main standpoints regarding the labeling of GM products (one adopted by the United States and the other by the European Union), as well as the position adopted by Brazil and its current legislation on labeling and commercial release of genetically modified (GM) products.

Socio‐economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks

AbstractArticle 26.1 of the Cartagena Protocol on Biosafety left open the possibility for member countries to include in their biosafety regulatory processes the assessment of socio‐economic considerations. Countries may also decide to include such assessments as part of their national legislation or regulations for the approval and deliberate release into the environment of genetically engineered technologies. Countries are debating if and how to implement assessment of socio‐economic considerations. This paper contributes to the ongoing policy dialogue by discussing issues related to socio‐economic assessment including scope, timing, inclusion modalities, methods, decision‐making rules and standards, and the integration of socio‐economic assessments in biosafety and/or biotechnology approval processes. This paper also discusses the implications of such inclusion for technology flows and public and private sector R&D. If inclusion is not done properly, it may negatively impact technology flows especially from the public sector and render an unworkable biosafety system.

A semi-quantitative approach to GMO risk-benefit analysis

In many countries there are increasing calls for the benefits of genetically modified organisms (GMOs) to be considered as well as the risks, and for a risk-benefit analysis to form an integral part of GMO regulatory frameworks. This trend represents a shift away from the strict emphasis on risks, which is encapsulated in the Precautionary Principle that forms the basis for the Cartagena Protocol on Biosafety, and which is reflected in the national legislation of many countries. The introduction of risk-benefit analysis of GMOs would be facilitated if clear methodologies were available to support the analysis. Up to now, methodologies for risk-benefit analysis that would be applicable to the introduction of GMOs have not been well defined. This paper describes a relatively simple semi-quantitative methodology that could be easily applied as a decision support tool, giving particular consideration to the needs of regulators in developing countries where there are limited resources and experience. The application of the methodology is demonstrated using the release of an insect resistant maize variety in South Africa as a case study. The applicability of the method in the South African regulatory system is also discussed, as an example of what might be involved in introducing changes into an existing regulatory process.

Actualités de la convention sur la diversité biologique : science et politique, équité, biosécurité

Relations between science and politics, bioequity, and biosafety, those are the three salient themes in the development of international law of biological diversity. While knowledge about biodiversity is patchy and little shared, an “ intergovernmental science-Policy Platform on biodiversity and ecosystem services” (iPbes) has been formed, with the hope of becoming the equivalent of the intergovernmental Panel on climate change. While sketchy at present, it will serve as a benchmark not just in the context of the convention on biological diversity, but for other international instruments. Within the framework of the convention, two Protocols were developed in 2010. the nagoya Protocol is intended to set out the context for sharing the benefits arising from the use of genetic resources and the associated knowledge. leaving very great freedom to states parties, it is essentially procedural, and confirms the liberal economic vision of biodiversity. the supplementary Protocol to the Cartagena Protocol, known as the Kuala Lumpur Protocol, urges states to adopt rules and procedures on liability in the event of damage in connection with living modified organisms. Here again, states have an almost entirely free hand. these two instruments deal with important issues, but issues that are marginal relative to the core of the convention, the protection of biological diversity, which has barely moved forward. Rio+ 20 opens therefore in an unconvincing context.

Biotecnologia no contexto da Convenção de Diversidade Biológica: análise da implementação do Art. 19 deste Acordo

A biotecnologia moderna constitui-se em uma das ferramentas tecnológicas mais importantes daatualidade, sendo que seu desenvolvimento envolve discussões relacionadas à segurança alimentar eambiental de seus produtos, discussões estas que ocorrem no âmbito de vários fóruns internacionais,dando origem a diferentes acordos sobre o tema. Um dos mais importantes é a Convenção de DiversidadeBiológica – CDB – e o acordo a ela associado, o Protocolo de Cartagena sobre Biossegurança. Esteartigo tem por escopo identificar a forma como a biotecnologia foi tratada no âmbito da CDB, analisandoa implementação de seu artigo 19 e seus reflexos em termos das discussões do marco regulatóriorelacionado à biossegurança. Para tanto, apresenta-se o conceito de biotecnologia e suas implicações,a abordagem do tema no âmbito da Convenção de Diversidade Biológica e do Protocolo de Cartagena,bem como o marco legal brasileiro sobre biossegurança. Após a realização deste estudo, conclui-se que,muito embora o objetivo do artigo 19 da CDB fosse bem mais amplo, qual seja, regular a gestão dabiotecnologia e a distribuição de seus benefícios entre os países membros deste Acordo, tais pretensõesnão foram alcançadas, restringindo-se a discussão ao escopo das questões de biossegurança relacionadasaos transgênicos. O desafio agora é ampliar tal discussão para que os benefícios desta nova tecnologiapossam ser realmente alcançados e distribuídos tanto entre países desenvolvidos como entre países emdesenvolvimento, sempre de forma sustentável.

Genetically modified organisms in agriculture: can regulations work?

Genetically modified (GM) crops have been recognised to be economically beneficial to subsistence farmers and have been projected as essential tools for addressing challenges in hunger, environmental sustainability and international development. Yet the uncertainty of their effects on human health and the undesirable ecological consequences of these organisms have raised concerns on the rapid pace of their production. Regulating the release of these organisms is a critical environmental issue. The Cartagena protocol on bio-safety, the principle legal arrangement for the regulation of these organisms, has ratifications from only 157 countries and has proven to be a weak regulator. Countries like India and Brazil have seen the proliferation of unapproved stealth GM varieties which make regulation even more difficult. In this paper, we explore the debate surrounding the introduction of GM organisms and analyse the effectiveness of existing legal regimes to regulate their use.

Developing a biosafety law: lessons from the Kenyan experience

This document provides a narrative of the passage of the Biosafety Bill, 2009, the Kenyan legislation that covers the use of genetically modified organisms (GMOs) in that country. The authors' declared aim is ‘to document as accurately as possible the process of developing the Biosafety Law through three parliaments and two General Elections’. The document is divided into eight chapters that start with the period in 2000 when the then president of Kenya Daniel arap Moi became the first head of state to sign the Biosafety Protocol, a provision of the UN Convention on Biological Diversity and a procedure designed to encourage investment in agricultural biotechnology. The narrative then proceeds in turn through the tortuous process of the various drafting stages of the bill, the course of the attempts at legislation, and its eventual approval. The decade covered by this process involved numerous workshops, interaction with supportive international agencies and the Kenyan version of ‘realpolitik’. It describes in much detail the personal recollection of those involved in negotiating through the battlefield of public opinion, political expediency, NGO opposition and media involvement. It concludes with lessons that the process may provide to any others in this position. The course of events is very familiar to anyone who has been involved in the various eras of transgenic controversy. The comment that one MP had eaten raw transgenic maize to prove that there was nothing to fear about the technology has echoes of a certain British MP, his daughter and a hamburger (e.g. http://news.bbc.co.uk/1/hi/uk/369625.stm). They authors of this report conclude that ‘The need for sustained political support to the whole process of deploying biotech products from research to commercialisation cannot be overstated’. The overall tone of the document is very supportive of modern biotechnology and it stresses the significant role to be played by such science in aiding the battle against food insecurity in developing countries. This is understandable since this publication was prepared under the aegis of ISAAA, the International Service for the Acquisition of Agri-Biotech Applications, an organisation funded by a consortium of donors, many from the commercial sector, but with some public institutions. Kenya is the only government listed among the direct sponsors and is considered to be a leading nation in the exploitation of biotechnology. The Kenyan Biotechnology Development Policy (2006) states that: ‘The government will adopt productivity-enhancing agricultural biotechnologies that can substantially reverse the fast deteriorating food security and nutrition, farm incomes, spawn the agro-industry and reduce environmental degradation.’ Opponents of transgenic methods in agriculture will not be slow to point out the contrast of this document with that published by the IAASTD (International Assessment of Agricultural Knowledge, Science and Technology Development) in 2009. This report states: ‘Modern biotechnology has developed in too narrow a context to meet its potential to contribute to the small and subsistence farmer in particular. As tools the technologies in and of themselves cannot achieve sustainability and development goals.’ Therein lies the division of views that seem fundamentally irreconcilable. It is unlikely that the enthusiasm and predictions represented in this present report will change any individual's views of biotechnology. In summary, it is more likely that the audience for such a detailed narrative will be limited to those with an academic and specific interest in the political factors determining the uptake of GM technology. Those aiming to exploit the technology already know the issues only too well.

The Cartagena Protocol and genetically modified mosquitoes

The Cartagena Protocol and genetically modified mosquitoes

Transparency as Contested Political Terrain: Who Knows What about the Global GMO Trade and Why does it Matter?

This article explores the prospects for transparency to be a transformative force in global biosafety governance. It analyzes whether information disclosure can further a right to know and choose, and hence facilitate oversight over transnational transfers of genetically modified organisms (GMOs). It examines the question of “Whose right to know what and why?” with regard to GMOs in the agricultural commodity trade in relation to the global Cartagena Protocol on Biosafety. I argue that the limited disclosure obligations in this global context follow rather than shape market developments, and that complex infrastructures of sampling, testing and detection are required to put disclosed information to use. If so, rather than a normative right-to-know of importing countries, a competing norm of caveat emptor (let the buyer beware) prevails. I conclude that the potential of transparency to empower remains unrealized, particularly for the poorest countries most reliant on globally-induced disclosure.

Bt crops and food security in developing countries: realised benefits, sustainable use and lowering barriers to adoption

Transgenic crops producing insecticidal proteins from the bacterium Bacillus thuringiensis (Bt crops) have been cultivated commercially for over 15 years. Worldwide, Bt crops have provided effective control of target pests with fewer applications of insecticide, have increased yield and profitability for farmers, and have reduced risk to the environment and human health compared with non-Bt crops. Sustainable use of Bt crops requires risk management to limit the evolution of pest resistance and adverse effects of the Bt proteins to non-target organisms. Risks are managed by national regulatory authorities; however, the establishment of functional regulatory systems with the necessary scientific capacity is problematic in many developing countries, which hinders the wider deployment of Bt and other transgenic insect-resistant crops. Timely introduction of these crops may also be obstructed by inefficient implementation of international regulatory regimes, such as the Cartagena Protocol on Biosafety (CPB). Regulatory costs limit the number of insect-resistant crops that may be developed, and delay in the introduction of such crops may result in large opportunity costs. Implementing effective risk management while limiting these costs requires clear policy that defines the benefits and harms of cultivating transgenic crops and how those benefits and harms should be weighed in decision-making. Policy should lead to the development of regulatory frameworks that minimise the number of new data requirements and maximise the value of existing studies for risk assessment; costs will thereby be reduced, increasing the prospects for Bt crops, and transgenic insect-resistant crops generally, to improve food security in developing countries.

Assays of the production of harmful substances by genetically modified oilseed rape (Brassica napus L.) plants in accordance with regulations for evaluating the impact on biodiversity in Japan

Environmental risk assessment of transgenic crops is implemented under the Cartagena Protocol domestic law in accordance with guidelines for implementing the assessment established by the Ministry of Agriculture, Forestry and Fisheries (MAFF) and the Ministry of Environment (MOE) in Japan. Environmental risk assessments of transgenic crops are implemented based on the concept of 'substantial equivalence' to conventional crops. A unique requirement in Japan to monitor the production of harmful substances, or allelochemicals, is unparalleled in other countries. The potential for allelochemicals to be secreted from the roots of transgenic crops to affect other plants or soil microflora or for substances in the plant body to affect other plants after dying out must be evaluated. We evaluated the allelopathic potential of seven transgenic oilseed rape (Brassica napus L.) lines that express glufosinate tolerance in terms of substantial equivalence to conventional oilseed rape lines, and established evaluation methods. Our results indicate no potential production of allelochemicals for any of the seven transgenic oilseed rape lines compared with conventional oilseed rape lines.

Liability and Redress in the Context of the Cartagena Protocol on Biosafety

This article outlines and discusses the key elements of the draft Supplementary Protocol on Liability and Redress in the context of the Cartagena Protocol on Biosafety, tabled for adoption at the fifth Session of the Meeting of the Parties to the Biosafety Protocol to be held in October 2010 in Nagoya, Japan. The first section describes the role of liability and redress under the Biosafety Protocol, followed by an overview of the draft Supplementary Protocol's key elements. The subsequent section looks at outstanding issues and the final section gives an outlook on the Supplementary Protocol's adoption and ratification requirements and its potential impact and effectiveness.

Impactos potenciais do Protocolo de Cartagena sobre biossegurança nas exportações brasileiras de soja

O objetivo deste trabalho é verificar os impactos do Protocolo de Cartagena sobre Biossegurança (PCB) para o Brasil no mercado internacional, dado que o País foi o único grande exportador de commodities agrícolas que o ratificou. A análise centrou-se nas discussões do Artigo 18 e no mercado de soja. Calcularam-se os custos adicionais de identificação para Brasil, Argentina e Estados Unidos, com base em propostas feitas durante as negociações. Os números mostraram que esses custos são mais elevados no Brasil e que a diferença em relação aos países concorrentes aumenta quando as exigências de identificação tornam-se mais rígidas. Para verificar o impacto desses custos no mercado internacional, utilizou-se o Equilibrium Displacement Model (EDM) e definiram-se dois cenários. Em um deles, apenas o Brasil cumpriria as normas do PCB e em outro, Argentina e EUA também adotariam medidas equivalentes. Os resultados evidenciaram que ambas as situações implicariam em perdas para o Brasil, que poderiam chegar a US$ 133 milhões no Cenário 1 e a US$ 329 milhões no Cenário 2. Para os outros países, o Cenário 2 apresenta dados mais favoráveis. Dessa forma, espera-se que Argentina e EUA adotem medidas semelhantes às exigidas pelo PCB, no qual o Brasil incorre em perdas maiores.

Transatlantic Environment and Energy Politics: Comparative and International Perspectives - Edited by Miranda A. Schreurs, Henrik Selin, and Stacy D. VanDeveer

Transatlantic Environment and Energy Politics: Comparative and International Perspectives - Edited by Miranda A. Schreurs, Henrik Selin, and Stacy D. VanDeveer

Democratising biotechnology? Deliberation, participation and social regulation in a neo-liberal world

AbstractThere is now significant policy and academic interest in the governance of science and technology for sustainable development. In recent years this has come to include a growing emphasis on issues of public understanding of science and innovative processes of deliberative and inclusive policy-making around controversial technologies such as nuclear power and agricultural biotechnology. Concern with such issues coincides with rising levels of interest in deliberative democracy and its relationship to the structures and processes of global governance. This article connects these two areas through a critical examination of ‘global’ deliberations about agricultural biotechnology and its risks and benefits. It draws on an extensive survey concerned with the diverse ways in which a range of governments are interpreting and implementing their commitments under the Cartagena Protocol on Biosafety regarding public participation and consultation in order to assess the potential to create forms of deliberation through these means. The article explores both the limitations of public deliberation within global governance institutions as well as of projects whose aim is to impose participation from above through international law by advocating model approaches and policy ‘tool kits’ that are insensitive to vast differences between countries in terms of capacity, resources and political culture.

Alone or together? Can cross‐national convergence of biosafety systems contribute to food security in SSA?

AbstractThe quest for effective mechanisms to regulate modern biotechnology has elicited policy responses at various levels the world over, with the main multilateral framework being the Cartagena Protocol on Biosafety. Countries in Sub‐Saharan Africa are at various levels towards developing and implementing domestic frameworks that comply with this Protocol. In addition, several efforts have been made towards regional cooperation in biosafety. After tracing the motivations and imperatives behind these efforts, the challenges and successes met, this paper proposes anchoring the regional cooperation agenda on food security if a consistent and unifying cross‐national biotechnology governance framework is to emerge. Copyright © 2010 John Wiley & Sons, Ltd.