Cartagena Protocol Research Articles

What risks and for whom? Argentina's regulatory policies and global commercial interests in GMOs

Regulatory frameworks on genetically modified crops present several differences, according to the specific procedures they take to deal with what they consider to be risks. Some of these differences have been studied between the United States and Europe, but there are other scenarios and subjects that may also be involved. Argentina not only has one of the major land areas devoted to transgenic agriculture, but it also has one of the first regulatory agencies in the region. Nevertheless, its regulatory policies towards genetically modified organisms (GMOs) have several differences with some international regulatory policies, such as the precautionary approach, the Cartagena Protocol on Biosafety and the labeling of food derived from GM crops. In order to understand this position, we analyze the development and function of GMOs' regulatory framework in Argentina, comparing it with Europe and showing how commercial interests in agriculture may explain each regulatory approach.

Food Labelling and International Trade

National food labelling legislation dealing with matters such as health claims nutritional content and safety warnings are governed by a complex of international agreements the most important of which are the the WTO Agreement on Technical Barriers to Trade (TBT) and on the Application of Sanitary and Phytosanitary Measures (SPS). This article examines the food labelling jurisprudence which has been developed by the recent decisions of the WTO dispute panels and Appeal Body. It seeks to locate this jurisprudence within the complex of other international instruments such as the Cartagena Biosafety Protocol as well as the GATT and the TRIP Agreements.

The Ethics of Global Catastrophic Risk from Dual-Use Bioengineering

Global catastrophic risks (GCRs) are risks of events that could significantly harm or even destroy civilization at the global scale. GCR raises a number of profound ethical issues, with a range of ethical theories suggesting that GCR reduction should be society’s top priority. This paper discusses GCR ethics in the context of dual-use bioengineering: bioengineering that can cause either benefit or harm, including increases and decreases in GCR. Advances in bioengineering offer great promise, but also introduce new perils. Key ethical questions include what phenomena hold intrinsic value and how the phenomena are valued across space and time. Another key question is how decisions about bioengineering risks should be made. The global scope of bioengineering and GCR suggests a role for international law. Bioengineering does not fall neatly within existing international regimes such as the Convention on Biological Diversity, Cartagena Protocol, and Biological Weapons Convention. An international regime with comprehensive coverage of bioengineering would help address dual-use bioengineering as it relates to GCR.

Integrating Bioethical Concerns into Biosafety Law for Genetic Modification Technologies in Malaysia

In considering the use of modern biotechnologies, specifically genetically modified organisms (GMOs), the Malaysian government recognizes the significant potential benefits as well as uncertainties, risks and doubts of this emerging technology. Though great benefits of this technology could help meet future needs, yet, this technology is often accompanied by public debate over its potential risks, which includes bioethical issues. In mitigating these risks in a sustainable manner, biosafety framework is required in order to protect human, plant and animal health, the environment and biodiversity. One of the means to manage the risks is through rule of justice based on law as a decisive technology solution. The government passed the Biosafety Act in 2007 to serve as an “umbrella act” which include the setting up of the National Biosafety Board as well as legal and institutional provisions tailored to comply with the Cartagena Protocol on Biosafety, with the objective to regulate the import, export, deliberate release, contained use and marketing of GMOrelated products in order to protect human, plant and animal health, the environment and biodiversity. The question is how does this law addressing bioethical issues and how effective the law in addressing this issue? The purpose of this paper is to analyse the extent to which this Biosafety Act 2007 and its regulations may be effectively integrating bioethical issues relating to GM crops in realizing its objectives. The article specifically focuses on bioethical issues provisions of GMOs under the Act and its regulations.

The current status of the debate on socio-economic regulatory assessments: positions and policies in Canada, the USA, the EU and developing countries

Article 26.1 of the Cartagena Protocol on Biosafety has the option of considering socio-economic issues in biosafety regulatory approval processes related to genetically engineered organisms. National laws and regulations in some countries have already defined positions and may have enacted policies dealing with socio-economic assessments. Many more countries, especially developing countries, are building their biosafety regulatory systems. This paper considers issues related to socio-economic assessments inclusion in biosafety processes by describing the current status and issues in Canada, USA, EU and selected developing countries. There is broad variation amongst examined countries in terms of inclusion modalities and guidance for assessment implementation. The need exists to define scope and if assessments are strictly socio-economic or expanded to include broader considerations such as ethical, religious, or cultural issues. Countries need to define clearly decision making rules and standards by which to render decisions as unclear procedures can lead to negative outcomes.

Studies on the crossability between the genetically modified sweet potato and wild relatives based on the Cartagena Protocol domestic law

Studies on the crossability between the genetically modified sweet potato and wild relatives based on the Cartagena Protocol domestic law

The Cartagena Protocol on Biosafety and living modified fish

The Cartagena Protocol on Biosafety is an international treaty under the Convention on Biological Diversity that promotes biosafety by establishing practical rules and procedures for the safe transfer, handling and use of living modified organisms (LMOs), with a specific focus on regulating transboundary movements of these organisms from one country to another. The Protocol includes the advance informed agreement procedure which sets rules on how Parties should take decisions regarding the transboundary movement of LMOs for intentional introduction into the environment, including living modified fish for biocontrol of non-native and invasive species. The advance informed agreement procedure places great emphasis on risk assessment and the Protocol includes an annex with general principles, methodological steps and points to consider when conducting a risk assessment. In recent years, the Parties to the Protocol have begun to develop guidance on risk assessment for specific types of LMOs although they have not, to date, specifically addressed living modified fish. Other relevant aspects of the Protocol include its provisions on unintentional and illegal transboundary movements; the handling, transport, packaging and identification of LMOs; and liability and redress.

Distributional Conflict Between Powerful States and International Treaty Ratification1

Why do states ratify international treaties? While previous research has emphasized domestic political factors, we focus on power politics in situations in which powerful states disagree on the merits of a treaty. We argue that states supporting the status quo should discourage third parties from ratifying the treaty, whereas challenger states should entice them to do so. Based on this theory, we expect third parties’ ratification decisions to be influenced by their dependence on the conflicting states. To test the theory, we use data on the conflict between the United States and the European Union over the regulation of trade in genetically modified organisms. The European Union created a new treaty, the Cartagena Protocol, to enhance biosafety regulation and propagate the “precautionary principle” over the “sound science principle” defended by the United States. Our quantitative analysis shows that ratification decisions of third parties were influenced by relations to and dependence on the clashing giants.

GMOMETHODS: The European Union Database of Reference Methods for GMO Analysis

In order to provide reliable and harmonized information on methods for GMO (genetically modified organism) analysis we have published a database called "GMOMETHODS" that supplies information on PCR assays validated according to the principles and requirements of ISO 5725 and/or the International Union of Pure and Applied Chemistry protocol. In addition, the database contains methods that have been verified by the European Union Reference Laboratory for Genetically Modified Food and Feed in the context of compliance with an European Union legislative act. The web application provides search capabilities to retrieve primers and probes sequence information on the available methods. It further supplies core data required by analytical labs to carry out GM tests and comprises information on the applied reference material and plasmid standards. The GMOMETHODS database currently contains 118 different PCR methods allowing identification of 51 single GM events and 18 taxon-specific genes in a sample. It also provides screening assays for detection of eight different genetic elements commonly used for the development of GMOs. The application is referred to by the Biosafety Clearing House, a global mechanism set up by the Cartagena Protocol on Biosafety to facilitate the exchange of information on Living Modified Organisms. The publication of the GMOMETHODS database can be considered an important step toward worldwide standardization and harmonization in GMO analysis.

Business as a regulatory leader for risk governance? The compact initiative for liability and redress under the Cartagena Protocol on Biosafety

In March 2008, the six world leading agro-biotechnology companies, presented a private, international instrument for liability and redress to cover the environmental damage caused by genetically modified organisms. The proposal was rejected by governments, who instead adopted a binding supplementary liability and redress protocol to the Cartagena Protocol on Biosafety, with no content transfer from the business initiative. Elaborating on this case study, it is explained how powerful business proposals can turn into a policy failure. Business conflicts are identified as one major explanatory factor. The fragmentation of business interests and the lack of business support for the six major firms’ initiative have discredited the role of corporations as regulatory leaders. Business unity is found to be a decisive, necessary condition for the endorsement of corporate proposals by policymakers.

The Legal Significance of the Nagoya-Kuala Lumpur Supplementary Protocol: The Result of a Paradigm Evolution

The Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress on Liability and Redress to the Cartagena Protocol on Biosafety is the first global and comprehensive agreement providing for regulatory liability and a definition of damage to biological diversity. By voluntarily assuming a binding obligation to provide for prompt, adequate and effective response measures in the event of damage caused by the transboundary movement of living modified organisms, states expressly accept the responsibility that comes with their consent to the import of living modified organisms. The paper analyzes the evolution of liability mechanisms in international law that culminated in the adoption of the Supplementary Protocol.

The Nagoya–Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety: An analysis and implementation challenges

The Nagoya–Kuala Lumpur Supplementary Protocol on Liability and Redress was finally adopted on 15 October 2010 at Nagoya, Japan. It was negotiated pursuant to a mandate established by the First Conference of the Parties serving as the Meeting of the Parties in 2004 under an enabling provision in the Cartagena Biosafety Protocol. The Supplementary Protocol seeks to deal with damage to biodiversity as well as ‘associated’ traditional material or personal damage. It delineates two pathways to dealing with such damage: the administrative approach that empowers a competent authority to deal with the matter administratively, without initial recourse to courts; and a civil liability approach that requires litigants to seek private law remedies through national legal systems. However, while the Supplementary Protocol has elaborate and comprehensive provisions implementing the administrative approach, it incorporates only a single article on civil liability which does little more than exhort parties to continue to apply their existing domestic law on the subject or establish rules to deal specifically with the matter. This was not the outcome anticipated when the negotiations started. It was the expectation, primarily of developing countries then, that the prospective protocol would deal essentially with civil liability and set out substantive and procedural rules on liability and redress. This article traces how and why all this came to pass. It also analyses the provisions, and the implications, relating to the administrative approach and the single enabling article on civil liability. It deals also with the challenges in implementing the administrative approach, novel to most countries. Finally, it examines the prospect for the emergence in the future of a more elaborate international civil liability regime.

DNA Vector-based RNA Interference to Study Gene Function in Cancer

RNA interference (RNAi) inhibits gene expression by specifically degrading target mRNAs. Since the discovery of double-stranded small interference RNA (siRNA) in gene silencing, RNAi has become a powerful research tool in gene function studies. Compared to genetic deletion, RNAi-mediated gene silencing possesses many advantages, such as the ease with which it is carried out and its suitability to most cell lines. Multiple studies have demonstrated the applications of RNAi technology in cancer research. In particular, the development of the DNA vector-based technology to produce small hairpin RNA (shRNA) driven by the U6 or H1 promoter has made long term and inducible gene silencing possible. Its use in combination with genetically engineered viral vectors, such as lentivirus, facilitates high efficiencies of shRNA delivery and/or integration into genomic DNA for stable shRNA expression. We describe a detailed procedure using the DNA vector-based RNAi technology to determine gene function, including construction of lentiviral vectors expressing shRNA, lentivirus production and cell infection, and functional studies using a mouse xenograft model. Various strategies have been reported in generating shRNA constructs. The protocol described here employing PCR amplification and a 3-fragment ligation can be used to directly and efficiently generate shRNA-containing lentiviral constructs without leaving any extra nucleotide adjacent to a shRNA coding sequence. Since the shRNA-expression cassettes created by this strategy can be cut out by restriction enzymes, they can be easily moved to other vectors with different fluorescent or antibiotic markers. Most commercial transfection reagents can be used in lentivirus production. However, in this report, we provide an economic method using calcium phosphate precipitation that can achieve over 90% transfection efficiency in 293T cells. Compared to constitutive shRNA expression vectors, an inducible shRNA system is particularly suitable to knocking down a gene essential to cell proliferation. We demonstrate the gene silencing of Yin Yang 1 (YY1), a potential oncogene in breast cancer, by a Tet-On inducible shRNA system and its effects on tumor formation. Research using lentivirus requires review and approval of a biosafety protocol by the Biosafety Committee of a researcher's institution. Research using animal models requires review and approval of an animal protocol by the Animal Care and Use Committee (ACUC) of a researcher's institution.

Nouveautés constitutionnelles, juridiques et de politique générale relatives au Droit de l'Environnement et du Développement Durable dans le Royaume du Maroc

While in the past environmental sustainability has been given a lower priority within the overall development policy of the Kingdom of Morocco, the situation has changed significantly in the last decade. Under the reign of King Mohamed VI and already by the end of his father’s regency (King Hassan II) substantial legal, institutional and political developments took place. On the one hand the change is due to drought, the economic crisis, and the recent transitions in the Arab world (“Arab Spring”). On the other hand, international treaties have influenced developments with the effect that laws are being adjusted to a level comparable to those set up by European legislations. This article traces the changes and provides insights into the current situation. With regard to recent constitutional evolutions and their impacts, the rights of citizens to a healthy environment was recognised and institutionalised in an executive authority. Notably, due to a charter environmental matters are now available to a public debate giving public authorities, civil society organisation, the private sector and citizens a right to engage. Currently, the charter awaits its transposition into laws which will be carried out in the coming years. The high significance of international cooperation in environmental – as well as other – matters is acknowledged in the preamble of the Moroccan constitution, with the effect that international treaties, for example the Kyoto Protocol, the Stockholm POP Convention and the Cartagena Protocol, were negotiated and ratified in the national context during recent years. There have also been significant legal developments nationally. While 10 years ago there were hardly any laws addressing the environment in Morocco, today a large number of sectoral regulations acknowledge the value of the different environmental media, defining environmental quality targets as well as addressing authorisation procedures which foresee environmental impact assessment. Further developments involve, for example, the implementation of public participation and access to environmental information, which have already been introduced in some sectoral laws, but will gradually be subject to other sectors, too. These legal developments were followed by institutional changes that generally strengthen the actions of the Moroccan Environmental Department, which itself operates dynamically to fulfil its duties. Nevertheless, the role of local departments needs to be improved since they are still weak in terms of enforcement of the laws. This article concludes with a critical evaluation of the developments by criticising the absence of a strategic evaluation of the environmental situation and the shortcomings in the field of citizens’ rights and enforcement possibilities due to a lack of personnel and financial resources. Moreover, the lack of coordination between the sectors and unintended effects are addressed.

The Turkish Council of State orders a stay on the importation of GMOs

Following an appeal by the Turkish Medical Association, the Council of State ordered a stay of the importation of genetically modified organisms (GMOs) and products made from them, having held that the omission of a provision in the current Regulations, which would have specifically prohibited the import and placing on the market of GMOs containing antibiotic resistance genes, constituted a breach of the country's international obligations vis-a-vis the precautionary principle laid down in the Cartagena Protocol on Biosafety and that a defence, argued by the Ministry, which was based on the mere absence of such a prohibitory provision under the relevant EU legislation was untenable.

Biosafety systems in Eastern and Central Africa

This review examines the biosafety systems of selected countries in the Eastern and Central Africa. The biosafety systems are meant to safeguard human health, animal health and the environment against any possible risks posed by development and application of modern biotechnology. Though the focus is in the Eastern and Central African region, the study gives an overview of worldwide biosafety frameworks as guided by the Cartagena protocol on biosafety. The Eastern and Central African countries covered in this study are Tanzania, Kenya, Uganda, Rwanda, Burundi, Ethiopia and the Democratic Republic of Congo (DRC). An attempt is made to assess the current status on the countries’ compliance to biosafety international conventions, institutional arrangements and regulatory regimes. A critical look is given to the existing biosafety frameworks, pinpointing their weaknesses and giving suggestions on what could be done to address the shortfalls. The study shows that Kenya is leading the group by having all the requirements in place, followed by Uganda. Tanzania has cleared the legal frameworks hurdles, but it is rather slow in processing applications of genetically modified organisms (GMOs) for containment and confined trials. Ethiopia, Rwanda, Burundi and DRC are still in the process of formulating their biosafety laws. The challenges facing the operationalization of the biosafety systems are financial constraints, insufficient trained human resources, poor facilities, low awareness and insufficient political will by some governments. It is argued that while biosafety frameworks stand to safeguard safe application of modern biotechnology, they should not have too stringent regulations, lest they impede the development of modern biotechnology in the Eastern and Central African region. Key words : Biosafety, Cartagena Protocol, genetically modified organisms, regulatory regimes, institutional framework, liability and redress.

The emerging international regulatory framework for biotechnology

Debate about the potential risks of genetically modified organisms (GMOs) to the environment or human health spurred attention to biosafety. Biosafety is associated with the safe use of GMOs and, more generally, with the introduction of non-indigenous species into natural or managed ecosystems. Biosafety regulation—the policies and procedures adopted to ensure the environmentally safe application of modern biotechnology—has been extensively discussed at various national and international forums. Much of the discussion has focused on developing guidelines, appropriate legal frameworks and, at the international level, a legally binding international biosafety protocol—the Cartagena Protocol on Biosafety. The Protocol is one among various international instruments and treaties that regulate specific aspects relevant to agricultural biotechnology. The present article presents the main international instruments relevant to biosafety regulation, and their key provisions. While international agreements and standards provide important guidance, they leave significant room for interpretation, and flexibility for countries implementing them. Implementation of biosafety at the national level has proven to be a major challenge, particularly in developing countries, and consequently the actual functioning of the international regulatory framework for biotechnology is still in a state of flux.

Future challenges in environmental risk assessment of transgenic plants with abiotic stress tolerance

Environmental risk assessment of transgenic plants is a prerequisite to their release into the target environment for commercial use. Risk assessment of the first generation transgenic plants with simple monogenic traits has been carried out with principles and guidelines enlisted in the Cartagena Protocol on Biosafety. For more complex traits such as abiotic stress tolerance, there is a growing need to examine for additional considerations in the risk assessment process based on the different nature of this trait. The salt tolerance-inducingcodA gene is a representative of many abiotic stress tolerance genes that confer salt stress tolerance in transgenic plants. In comparison with simple monogenic Bt trait, the future challenge to environmental release of abiotic stress tolerance genes lies in the question whether these genes such as the salt tolerance-inducing codA will need additional considerations in the risk assessment process?. In the present work, we discussed the nature of abiotic stress tolerance trait, environmental risk assessment issues and comparison of the risk assessment elements on Bt and salt tolerance-inducing codA genes to examine needs for additional considerations in the risk assessment process. We concluded and recommended that the use of abiotic stress tolerance genes such as the salt tolerance-inducing codA gene in transgenic plants does not need additional considerations in risk assessment. Key words: Transgenic plants, abiotic stress tolerance, environmental risk assessment, salt tolerance-inducing codA.

Legislative Measures for the Implementation of Nagoya-Kualalumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety

Legislative Measures for the Implementation of Nagoya-Kualalumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety

Damage and Its Type on Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety

Damage and Its Type on Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety