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Transnational Narratives and Regulation of GMO Risks

By: Giulia Claudia Leonelli
Media of Transnational Narratives and Regulation of GMO Risks
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Published: 18-11-2021
Format: Hardback
Edition: 1st
Extent: 368
ISBN: 9781509937387
Imprint: Hart Publishing
Dimensions: 234 x 156 mm
RRP: £85.00
Online price : £76.50
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Loren Epson

About Transnational Narratives and Regulation of GMO Risks

This book provides an innovative insight into the regulatory conundrum of genetically modified organisms (GMOs), deploying transnational legal analysis as a methodological framework to explore the most controversial area of risk governance.

The book deconstructs hegemonic and counter-hegemonic transnational narratives on the governance of GMO risks, cutting across US law, EU law, the WTO Agreement on Sanitary and Phytosanitary Measures, and hybrid standard-setting regimes. Should uncertain risks be run unless adverse effects have been conclusively established, and should regulators only act where this is cost-benefit effective? Should risk managers make a convincing case that a product or process is safe enough for the relevant uncertain risks to be socially acceptable? How can intractable transnational regulatory conflicts be solved?

The book complements a close analysis of regulatory frameworks and case law with a more encompassing perspective on the political, socio-economic and distributional implications of different approaches to the regulation of health and environmental risks at times of globalisation.

The GMO deadlock thus becomes a lens through which to investigate the underlying value systems, goals, and impacts of transnational discourses on risk governance. Against this backdrop, the normative strand of analysis points to the limited ability of science and procedural deliberation to generate authentic agreement and to identify normatively legitimate solutions, in the absence of pre-existing shared perspectives.

Table Of Contents


1. Introductory Overview: Transnational Narratives, Evidence-Based and Socially Acceptable Risk Approaches, Normative Analysis

I. The Broader Picture: Agricultural Biotechnologies and Transnational Controversies
II. The Methodological Framework: Transnational Legal Analysis and Transnational Narratives
III. The Institutional Strand of Analysis: Transnational Narratives on GE Organisms, Ideal Regulatory Models and Different Forms of Uncertainty
IV. Normative Analysis: Modern Paradigms and Post-Modern Deconstruction of Regulatory Approaches

2. Methodological and Normative Aspects: Transnational Legal Analysis as a Methodological Framework and the Limits of Legal Proceduralisation
I. Law, Globalisation and Transnational Law
II. Transnational Legal Ordering Theory and Transnational Legal Orders
III. Transnational Legal Pluralism: Transnational Law as a Systems Theory Account of Law's Evolution
IV. Transnational Law, Transnational Legal Narratives and Transnational Legal Analysis as a Methodological Framework
V. The Normative Vacuum of Transnational Legal Studies
VI. Recoupling Law and Politics and Mapping Regulatory Conflicts Through Conflicts Law Theory
VII. Applications and Limits of Conflicts Law Theory
VIII. From Procedural Deliberative Paradigms to Substantive Deconstruction and Legal Re-Materialisation?

3. Extra-Territoriality: Foundations and Implications of the Transnational Hegemonic Narrative within US Governance of GE Organisms
I. From the Origins to the 2019 Executive Order: The Product-Based Model and Further Regulatory Streamlining
II. The Role of the APHIS: GE Organisms and Plant Pest Risks
III. The Role of the EPA: Plant-Incorporated Protectants
IV. The Role of the FDA: GE Food
V. Sound Science Approaches and Adherence to Sound Science: Deconstructing Their Implications Through an Analysis of US Governance of GE Organisms
VI. Cost-Benefit Analysis: Deconstructing its Implications Through an Analysis of US Governance of GE Organisms
VII. Conclusions of the Institutional Analysis. Deconstructing the Hegemonic Narrative and Evidence-Based Discourses from Within the Nation State: The Centrality of Individual Rights
VIII. Preliminary Normative Reflections: When (Sound) Science and Procedural Deliberation Fail

4. Across Extra-Territoriality and Legal Pluralisation: EU Regulation of GE Organisms. The Counter-Hegemonic Narrative and the Question of Regulatory Implementation
I. The Pre-2015 Regulatory Framework: The 2001 Deliberate Release Directive and the 2003 Food and Feed Regulation
II. The EU Regulatory Framework and Socially Acceptable Risk Approaches: Prudential Risk Assessment and Uncertainties
III. The EU Regulatory Framework and Socially Acceptable Risk Approaches: The Notion of Intended Level of Protection, The Precautionary Principle and OLFs
IV. Regulatory Implementation: From Socially Acceptable Risk to Evidence-Based Approaches
V. The Substantive Gap Between the EFSA's Approach and More Prudential Perspectives: TestBioTech
VI. The Substantive Gap in Risk Management: The Commission's Alignment with Evidence-Based Risk Governance versus Socially Acceptable Risk Approaches
VII. Interim Conclusions: The Counter-Hegemonic Narrative, Socially Acceptable Risk Approaches and the Failure of Science and Procedural Deliberation
VIII. Final Remarks on Legal Pluralisation (I): The 2015 Reform on the Cultivation of GE Crops
IX. Final Remarks on Legal Pluralisation (II): The 2015 Reform from a Socially Acceptable Risk Perspective. Procedural Compromises and a Twofold Substantive Defeat
X. Conclusions: Findings of the Institutional and Normative Strands of Enquiry

5. Legal Pluralisation: The SPS Agreement, GE Organisms and the Impossible Quest for Scientific Objectivity. From Sound Science to Transnational Regulatory Convergence and Trade Liberalisation
I. The SPS Agreement: Relevant Provisions
II. The Origins: EC – Hormones and Hazard-Related Uncertainties
III. The Appellate Body's Report in EC – Hormones: Ascertainable Risk and Theoretical Uncertainty
IV. Australia – Salmon and Risk-Related Uncertainties
V. Japan – Agricultural Products II and the Scientific Substantiation of SPS Measures Enacted to Comply with the ALOP
VI. Japan – Apples: Article 5.7 as a “Safeguard” Clause, Compliance Proceedings and Stricto Sensu De Novo Review
VII. EC – Biotech: Hazard-Related Uncertainties, Socially Acceptable Risk and the Cartagena Protocol. Sound Science as a Meta-Norm?
VIII. Has Anything Really Changed Since EC – Biotech? Nothing Has Quite Changed
IX. Conclusions: GE Organisms, the SPS Agreement and the Evidence-Based Narrative

6. Legal Hybridisation: The Codex, NGO Regulatory Standards and GE Organisms. Adherence and Challenges to the Hegemonic Narrative
I. The Codex and its Linkage with the SPS Agreement: Towards an Evidence-Based, Baseline Threshold of Safety
II. The Codex Principles and Guidelines on the Assessment of Foods Derived from Biotechnology
III. Normative Reflections: The Gap between Product- and Process-Based Models and the Failure of Deliberation
IV. Regulatory Standards Enacted by Non-Profit NGOs: Back to Socially Acceptable Risk Approaches
V. Precaution, OLFs and the Challenge to Cost-Benefit Analysis: From Agricultural Biotechnologies and Food Security to Food Sovereignty
VI. Diagonal Conflicts and the Impossibility of Embedding Societal Standards

7. Conclusions: Transnational Legal Analysis, Transnational Narratives on Risk and the Failure of Science and Deliberation. Towards Legal Re-Materialisation?
I. Methodology: The Value of Transnational Legal Analysis as a Methodological Framework
II. Institutional Analysis: The Social and Political Construction of Transnational Narratives on GE Organisms and Risk Governance
III. Normative Analysis: The Failure of Science and Procedural Deliberation. Towards Legal Re-Materialisation?


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