Abstract

Biotechnology or the engineering of the genetic material of species can give way to avenues of possibilities for the benefit of people, fauna and flora but also has the potential of posing untold and undiscovered threats to human beings and other living organisms. One of the first attempts to legislate on international rules on biotechnology can be traced back to article 19 of the Convention on Biological Diversity (CBD) in 1992. The CBD is indeed the first international legal instrument apart from the then European Community’s relevant directives to suggest that biotechnology is a matter of concern for the international community while providing a basis upon which more detailed procedures would be elaborated in the field of biosafety. While the CBD includes international rules on access to genetic resources, access to and the transfer of technology, the handling of biotechnology and the distribution of its benefits, it does not include a detailed regulation on genetically modified organisms (GMOs) and their possible adverse effects on the environment, human and animal health. It was only with the coming into existence of the Cartagena Protocol on Biosafety (Cartagena Protocol) to the CBD in 2000 that the safe transfer, handling and use of living modified organisms (LMOs) such as genetically engineered plants, animals, and microbes were at last being catered for, albeit leaving aside the broader categories of GMOs. Due to the need for the negotiators of this protocol to make compromises, there were still key issues on the international biosafety framework pertaining mainly to the scope of the GMOs to be covered by this protocol and by the Advanced Informed Agreement procedure; identification and traceability issues; and liability and redress issues. Nine years after the entry into force of the Cartagena Protocol the transboundary movements of GMOs have clearly increased with new categories of GMOs and genetically modified products to regulate. The debate on the safety of GMOs used for food and feed as well as the effects of GMOs on the receiving environment is still very lively throughout the world, amidst a lack of traceability of GMOs or epidemiological studies in the GMO-producing countries. However, there has been some progress on liability and redress with regard to damage resulting from the transboundary movement of LMOs with the adoption of rules and procedures for liability and redress in 2010 with the Nagoya-Kuala Lumpur Supplementary Protocol "(hereafter the Nagoya SP)" to the Cartagena Protocol, which is yet to enter into force. There are also concerns on the harmonisation of national biosafety regulation, risk assessment and risk management standards, the interpretation of socioeconomic considerations, and the monitoring of compliance with the provisions of the Cartagena The scope of the GMOs covered by the Cartagena Protocol is discussed first, which discussion is followed by the discussion of identification and traceability issues, the harmonisation of national biosafety regulation, the harmonisation of risk assessment and risk management standards, the scope of the relevant socio-economic considerations, implementation, and concerns about the settlement of disputes. KEYWORDS: genetically modified organisms; transboundary movements; biosafety regulation; Cartagena Protocol; harmonisation.

Highlights

  • One of the first attempts[1] to legislate on international rules on biotechnology[2] goes back to the controversial[3] article 19 of the United Nations Convention on Biological Diversity4 "(hereafter the CBD)" in 1992

  • The Cartagena Protocol was drafted with the main purpose of addressing the safety of transboundary movements of GM crops, and consensus was not reached on the need for the application of the advance informed agreement (AIA) procedure for all categories of Living Modified Organisms8 (LMOs) covered by the protocol

  • The Intergovernmental Committee for the Cartagena Protocol (ICCP) developed compliance procedures and mechanisms and a Compliance Committee was established during the first meeting of the Conference of Parties (COP) in 2004.100 general compliance with regard to the implementation of the obligations under the Cartagena Protocol[101] needs to be better monitored, while the Biosafety Clearing House (BCH) as a repository pertaining to information on LMOs102 has to be updated regularly by States parties.[103]

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Summary

Introduction

One of the first attempts[1] to legislate on international rules on biotechnology[2] goes back to the controversial[3] article 19 of the United Nations Convention on Biological Diversity4 "(hereafter the CBD)" in 1992. 11 See the Nagoya SP (adopted on 15 October 2010) available at http://bch.cbd.int/protocol/NKL_text.shtml; During the negotiation of the Cartagena Protocol, there was no consensus on the issue of liability and redress for damage resulting from the transboundary movements of LMOs, and only a 27 was included in this biosafety protocol. This paper discusses the scope of the GMOs covered by the Cartagena Protocol, and identification and traceability issues, and highlights concerns about the harmonisation of national biosafety regulation, risk assessment and risk management aspects, the interpretation of socio-economic considerations, the implementation of the protocol’s obligations and GMO-related dispute settlement

The scope of GMOs covered by the Cartagena Protocol
The limited scope of GMOs covered
The AIA procedure
Identification and traceability issues
An international identification system for GM products
Harmonisation of labelling thresholds for GM products
Main concerns about the regulation of biosafety at the international level
Harmonisation of biosafety regulation
The interpretation of socio-economic considerations
Risk assessment and risk management standards
Monitoring of compliance
Conclusion
Literature
Findings
Evaluation for Commercial

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