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Transnational Narratives and Regulation of GMO Risks

Transnational Narratives and Regulation of GMO Risks

Author: Giulia Claudia Leonelli
Publisher: Hart Publishing
ISBN: 9781509937387

Published In: December 2021
Format: Hardback
Jurisdiction: U.K. ? Disclaimer:
Countri(es) stated herein are used as reference only
Paperback Edition ISBN: 9781509954445

List Price: HKD 1,235.00

HKD 1,197.95 Save HKD 37.05 (3%)

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Description
Contents

Details

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.

Acknowledgements

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?

Bibliography

Index