TWN Info Service on Biosafety
9 December 2024
Third World Network
www.twn.my
Dear Friends and Colleagues
Mainstreaming Biosafety into Legislation, Policies and Institutional Frameworks
The term “biosafety mainstreaming” refers to the integration of biosafety in domestic cross-sectoral and sectoral legislation, policies and institutional frameworks, taking into account national circumstances and priorities. Mainstreaming of biosafety is important for achieving an adequate level of protection against the potential adverse effects of living modified organisms (LMOs) on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
This legislative study provides a comprehensive overview of biosafety obligations and practical ways in which biosafety measures can be mainstreamed into national laws, policies and institutional frameworks. It aims to assist Parties in achieving the integrated implementation of the Cartagena Protocol on Biosafety, the Nagoya Kuala Lumpur Supplementary Protocol on Liability and Redress and the Convention on Biological Diversity.
The study stresses that biosafety mainstreaming may help ensure synergies between and within international and national legal regimes. Mainstreaming may help create opportunities to identify gaps and conflicts in implementation of biosafety and other cross-sectoral and sectoral objectives and obligations and to ensure efficient implementation of biosafety obligations through the sharing of knowledge and expertise, capacity and resources. Moreover, mainstreaming may facilitate strengthened implementation of and compliance with national biosafety frameworks.
Key steps towards mainstreaming biosafety at the domestic level are outlined. These steps include the formulation of a mainstreaming vision; identification of entry points, opportunities and activities for mainstreaming; engagement of authorities and stakeholders; identification of non-legislative tools; and creation of an enabling environment for biosafety mainstreaming.
We reproduce below the Executive Summary and Concluding Remarks of the study.
With best wishes,
Third World Network
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LEGISLATIVE STUDY ON BIOSAFETY MAINSTREAMING
Integrating the Cartagena Protocol on Biosafety into National Sectoral and Cross-Sectoral Policies, Laws and Institutional Frameworks
CBD Biosafety Technical Series 06
https://bch.cbd.int/protocol/issues/mainstreaming
Executive Summary
The present legislative study on the mainstreaming of biosafety was commissioned by the Secretariat of the Convention on Biological Diversity. In the present study, the term “biosafety mainstreaming” refers to the integration of biosafety in domestic cross-sectoral and sectoral legislation, policies and institutional frameworks, taking into account national circumstances and priorities. Through in-depth analysis of international and national laws and policies and domestic examples of biosafety mainstreaming, the study provides a comprehensive overview of biosafety obligations and the practical ways in which biosafety measures can be mainstreamed into the national laws, policies and institutional frameworks of the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, the Nagoya Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety and the Convention on Biological Diversity. This legislative study aims at assisting Parties in achieving the integrated implementation of the Cartagena Protocol. Its target audience may include both those engaged, at the national level, in the development and implementation of biosafety-related legislation, and those engaged in the development and implementation of cross-sectoral and sectoral policies and laws that are indirectly relevant to biosafety.
Living modified organisms (LMOs) are defined in section 3 of the present study, with a specific focus on their relevance for food and in agriculture. Taking into account the potential benefits of LMOs for the food and agriculture sectors, the study considers the importance of biosafety in providing protection against their potential risks, notably for the environment and human health. In section 4 the topic of biosafety is placed in an international legal context through the outlining of provisions of the Convention on Biological Diversity that relate directly to LMOs and biosafety and key legal obligations and procedures under the Cartagena Protocol and the Nagoya-Kuala Lumpur Supplementary Protocol. Also in section 4, brief consideration is given to the relevance of other international instruments for biosafety, notably international trade law.
In sections 5 and 6, the case is made for biosafety mainstreaming. In section 5 the reasons why countries would mainstream biosafety are discussed. First, biosafety mainstreaming may help to ensure synergies between and within national and international frameworks, including the Convention on Biological Diversity and the Kunming-Montreal Global Biodiversity Framework. Second, biosafety mainstreaming may help to facilitate the establishment, development and strengthening of effective national biosafety frameworks. Furthermore, biosafety mainstreaming may help in implementing the Convention and the Cartagena Protocol in a more resource-efficient manner, for example, through sharing of expertise and resources.
In section 6, the key steps towards mainstreaming biosafety at the domestic level are outlined. Those steps include formulation of a mainstreaming vision; identification of entry points, opportunities and activities for mainstreaming; engagement of authorities and stakeholders; identification of non-legislative tools; and creation of an enabling environment for biosafety mainstreaming. In subsections 6.2–6.4, the question of how biosafety can be mainstreamed into cross-sectoral and sectoral policies, legislation and legal institutional frameworks is considered. A multitude of examples of biosafety mainstreaming at the national level are presented, including example provisions, with the aim of illustrating how biosafety may be mainstreamed in domestic contexts and helping readers to identify opportunities for mainstreaming at the national level. Further examples of mainstreaming of biosafety into policies, legislation and institutional frameworks are included in annex III to the present study, entitled “Overview policy and legislative examples of biosafety mainstreaming”.
This legislative study builds on the work previously undertaken on biosafety mainstreaming by the Secretariat of the Convention on Biological Diversity and 19 countries that were part of the pilot project on integrated implementation and mainstreaming of biosafety (2015–2016) and the project on integrated implementation of the Cartagena Protocol on Biosafety, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress and the Convention on Biological Diversity (2017–2018). While the national desk studies that were drafted by those countries provided the foundations for the identification of key examples of biosafety mainstreaming at the national level, the present analysis was complemented by in-depth examination of the texts of laws and policies and review of the literature and enhanced through identification of other and more recent examples associated with the 19 pilot countries through the FAOLEX database. Parts of the present study also built upon information that is included in the modules on biosafety mainstreaming which are available on the Biodiversity e-Learning Platform.
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Concluding Remarks
Target 14 of the Kunming-Montreal Global Biodiversity Framework brings into focus the reason why an integrated approach to law- and policymaking is essential for tackling complex global issues in a holistic manner, with a view to achieving the objectives of the Convention on Biological Diversity. Activities that exert an impact on biodiversity are often outside the remit of biodiversity policy and in order to ensure that biodiversity and the opportunities derived from its conservation and sustainable use are recognized and reflected in decision-making, biodiversity needs to be integrated into relevant cross-sectoral and sectoral policies and legislation. Along similar lines and considering that the Cartagena Protocol on Biosafety and the Convention have partly overlapping objectives and contain related provisions, mainstreaming of biosafety into cross-sectoral and sectoral policies, legislation and (legal) institutional frameworks is important for achieving an adequate level of protection against potential adverse effects of living modified organisms (LMOs) on the conservation and sustainable use of biological diversity, taking also into account risks to human health. Biosafety is integral to the conservation and sustainable use of biodiversity and environmental protection more broadly but can be realized only through involvement of sectors that may wish to use LMOs resulting from modern biotechnology, including the food and agricultural sectors in particular.
The present practical legislative study argues that biosafety mainstreaming may help to ensure synergies between and within international and national legal regimes. Mainstreaming is an inclusive process which requires connections and cooperation between biodiversity, biosafety and other cross-sectoral and sectoral public sector representatives, and private sector actors. Mainstreaming processes and activities may therefore help to create opportunities to identify gaps and conflicts in implementation of biosafety and other cross-sectoral and sectoral objectives and obligations and to ensure efficient implementation of biosafety obligations through the sharing of knowledge and expertise, capacity and resources. Moreover, mainstreaming may facilitate strengthened implementation of and compliance with national biosafety frameworks.
With the aim of assisting Parties in carrying out the integrated implementation of the Cartagena Protocol on Biosafety, the present study has provided important guidance to support mainstreaming of biosafety in domestic contexts. Building upon online resources that were developed by the Secretariat of the Convention on Biological Diversity in collaboration with the Strathclyde Centre for Environmental Law and Governance, the study has outlined key steps for mainstreaming biosafety in cross-sectoral and sectoral legislation, policies and institutional frameworks. It has focused on identifying examples of biosafety mainstreaming at the national level in the 19 countries that participated in the pilot project of the Secretariat on biosafety mainstreaming and the integrated implementation project. Those examples reveal which cross-sectoral and sectoral instruments could be viewed as entry points to biosafety mainstreaming and what kinds of aspects and activities could address biosafety within different entry points. The analysis includes biosafety mainstreaming into national biodiversity strategies and action plans as cross-sectoral policy instruments which may offer opportunities for inter-institutional awareness-raising and capacity-building. Moreover, sectoral instruments such as seed, agricultural and food safety laws may offer opportunities for integrating elements of risk assessment and risk management or integrating labelling requirements. The section of the study on institutional frameworks has focused on institutions that are anchored in legislation, providing examples of governance models that integrate cross-sectoral and sectoral representatives in biosafety institutions and governance models that integrate biosafety representatives in cross-sectoral and sectoral institutions, as well as coordination mechanisms.
The study has described how biosafety mainstreaming into legislation, policy and institutional frameworks can be facilitated by creating an enabling environment, for example, through awareness-raising among relevant institutions of the importance of biosafety (including for delivery of cross-sectoral and sectoral objectives) and strengthening capacity to mainstream biosafety into relevant cross-sectoral and sectoral instruments.
For the present study to be used as a supportive tool for biosafety mainstreaming, it is recommended that it be read in conjunction with the online tools developed by the Secretariat of the Convention on the topic of biosafety mainstreaming which provide further guidance on how to create an enabling environment for biosafety mainstreaming. Elements of those tools are included in the annexes to the study, Notable in this regard is the application entitled “Develop a strategy for biosafety mainstreaming”, the template of which is included as annex II below. Further guidance supporting the implementation of the Cartagena Protocol on Biosafety and the creation of an enabling environment is provided in the Implementation Plan for the Cartagena Protocol on Biosafety and the Capacity-building Action Plan for the Cartagena Protocol on Biosafety.