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Self-Spreading Biotechnology and International Law

Prevention, Responsibility, and Liability in a Transboundary Context
Autor:innen:
Verlag:
 2022

Zusammenfassung

Wer haftet, wenn sich selbst ausbreitende Gentechnik grenzüberschreitende Schäden verursacht? Mit Gene Drives und ähnlichen Verfahren wird es bald möglich sein, das Erbgut wild lebender Arten, Keime und Nutzpflanzen direkt in der Umwelt zu verändern. Dies könnte helfen, drängende Probleme in der öffentlichen Gesundheit, im Naturschutz und in der Ernährungssicherheit zu lösen. Allerdings bergen diese Verfahren auch das Risiko einer unkontrollierten Ausbreitung über Staatsgrenzen hinweg. Anhand einer grundlegenden Untersuchung der einschlägigen Verträge und des Völkergewohnheitsrechts zu Prävention und Haftung für grenzüberschreitende Schäden wird aufgezeigt, dass das derzeit geltende Völkerrecht dieser Herausforderung noch nicht gewachsen ist.

Schlagworte

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Bibliographische Angaben

Copyrightjahr
2022
ISBN-Print
978-3-8487-7377-0
ISBN-Online
978-3-7489-1352-8
Verlag
Nomos, Baden-Baden
Reihe
Beiträge zum ausländischen öffentlichen Recht und Völkerrecht
Band
316
Sprache
Englisch
Seiten
808
Produkttyp
Monographie

Inhaltsverzeichnis

KapitelSeiten
  1. Titelei/Inhaltsverzeichnis 1 - 44 Download Kapitel (PDF)
    1. Download Kapitel (PDF)
        1. I. Basics of Molecular Biology
          1. 1. Genetic Mutation
          2. 2. Sexual Reproduction
          3. 3. Mendel’s Laws of Inheritance
        3. III. Anthropogenic Genetic Change
        1. I. Functioning of Genome Editing
          1. 1. Zinc Finger Nucleases
          2. 2. Transcription Activator-Like Effector Nucleases
          3. 3. CRISPR-Cas
          1. 1. Agriculture
          2. 2. Basic Research and Medicine
          3. 3. Human Germline Editing
          4. 4. Industrial Biotechnology
          1. 1. Off-Target Effects
          2. 2. Genetic Mosaicism
          3. 3. In Vivo Delivery of CRISPR-Cas Components
          1. 1. Alleged Environmental Risks of Genome Editing in Agriculture
          2. 2. Risks and Ethical Concerns Relating to Human Genome Editing
          1. 1. Over-Replication Mechanisms
          2. 2. Interference Mechanisms
        2. II. Development of Engineered Gene Drives
            1. a) Modification Drives
            2. b) Suppression Drives
            3. c) Current State of Development
          2. 2. Control of Invasive Species
          3. 3. Agriculture
          1. 1. Limitations of Current Gene Drive Techniques
            1. a) Unintended Geographic Spread
            2. b) Intended but Unauthorized Spread
            3. c) Undesired Spread to Non-Target Species
            4. d) Dual Use of Gene Drive Techniques
          3. 3. Potential Ecological Effects of Suppressing a Target Species
          4. 4. Potential Transboundary Effects of Gene Drives
      4. D. Horizontal Environmental Genetic Alteration Agents (HEGAAs)
        1. I. Use of Genetically Modified Viruses in Plant Pest Control
        2. II. Self-Disseminating Vaccines
        3. III. Mass Releases of Sterile Genetically Modified Insects
        4. IV. Use of Wolbachia to Suppress Mosquito-Vectored Infectious Diseases
      6. F. Summary
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      1. A. ‘Genetically Modified’ and ‘Living Modified’ Organisms
      2. B. Types of Damage Potentially Caused by LMOs
      3. C. The Distinction Between ‘Responsibility’ and ‘Liability’
      4. D. The ‘Polluter-Pays’ Principle: State or Operator Liability?
      5. E. Standards of Liability: Fault-Based, Objective, Strict, and Absolute Liability
      6. F. Procedural Issues in Enforcing Civil Liability in a Transboundary Context
      7. G. Civil Liability and ‘Administrative Liability’ for Damage to the Environment
      8. H. Summary and Outlook
    1. Download Kapitel (PDF)
            1. a) Living Organism
            2. b) Genetic Material
            3. c) ‘Novel Combination’ of Genetic Material
              1. aa) ‘Application of in vitro nucleic acid techniques…’
              2. bb) ‘… that overcome natural physiological reproductive or recombination barriers…’
              3. cc) ‘… and that are not techniques used in traditional breeding and selection’
              1. aa) Genome Editing
              2. bb) Engineered Gene Drives
              3. cc) Genetically Modified Viruses
              4. dd) Techniques That Harness Natural Mechanisms of Self-Propagation (Wolbachia)
          2. 2. Restriction to Hazardous LMOs?
          3. 3. Activities Covered by the Protocol
          4. 4. Exemption for Transboundary Movement of LMOs Which Are Pharmaceuticals (Article 5)
          5. 5. Conclusions
            1. a) Scope of the AIA Provisions
            2. b) Procedure of Obtaining an Advance Informed Agreement From the Party of Import
            3. c) Risk Assessment
            4. d) Role of the Precautionary Principle in Decision-Making (Article 10(6))
            5. e) Role of Socio-Economic Considerations in Decision-Making (Article 26)
            6. f) Rules for LMOs Intended for Direct Use as Food or Feed, or for Processing (Article 11)
              1. aa) Genuine and Disguised Changes to the Intended Use
              2. bb) Responsibilities of Exporting Parties
              3. cc) Responsibilities of Importing Parties
            8. h) Conclusions
              1. aa) Obligation to Establish Appropriate Risk Management Measures (para. 1)
              2. bb) Imposition of Preventive Measures Based on Risk Assessment (para. 2)
                1. (1) The Notion of ‘Unintentional Transboundary Movement’
                2. (2) Obligation to Take ‘Appropriate Measures’
                3. (3) Requirement of a Risk Assessment
              4. dd) Appropriate Observation Period for Any LMO (para. 4)
              5. ee) Obligation to Cooperate (para. 5)
            2. b) Notification in Case of Unintentional Transboundary Movements (Article 17)
              1. aa) Prevention of Illegal Transboundary Movements (para. 1)
              2. bb) Obligation to Dispose of the LMO in Case of an Illegal Transboundary Movement (para. 2)
            4. d) Handling, Transport, Packaging, and Identification (Article 18(1))
            5. e) Conclusions
          3. 3. Information-Sharing Through the Biosafety Clearing-House (Article 20)
          4. 4. Application in Relation to Non-Parties (Article 24)
          5. 5. Upward Derogation (Articles 2(4) and 14)
          6. 6. Liability and Redress (Article 27)
        3. III. Conclusions
          1. 1. The European Union’s Legal Framework for GMOs
          2. 2. Scope of the GMO Regime in the European Union
          3. 3. Compatibility of the European GMO Regime With the Cartagena Protocol
        1. I. Jurisdictional Scope (Article 4)
        2. II. Prevention of Transboundary Harm (Article 3)
        3. III. Regulation and Control of Risks Associated With the Use and Release of Living Modified Organisms (Article 8(g))
        4. IV. Provision of Information to Parties Receiving LMOs (Article 19(4))
        5. V. Control of Invasive Alien Species (Article 8(h))
          1. 1. Environmental Impact Assessments (lit. a)
          2. 2. Procedural Obligations (lit. c and d)
        7. VII. Examination of the Issue of Liability and Redress (Article 14(2))
        8. VIII. Are Eradication Programmes Prohibited Under the CBD?
        9. IX. Conclusions
        1. I. Key Provisions of International Trade Law
        2. II. Agreement on Sanitary and Phytosanitary Measures: Potential Source of Conflict With the Cartagena Protocol
        3. III. Resolving Potential Conflicts Between International Trade Law and the Cartagena Protocol
      4. D. International Plant Protection Convention
      5. E. World Organisation for Animal Health
      6. F. Codex Alimentarius
      7. G. United Nations Convention on the Law of the Sea
      8. H. International Regulations on the Transport of Hazardous Goods
      9. I. International Health Regulations
        1. I. Biological Weapons Convention
        2. II. ENMOD Convention
        3. III. International Humanitarian Law
        4. IV. Conclusions
      11. K. Summary
    2. Download Kapitel (PDF)
      1. A. The Legal Foundation of the Obligation to Prevent Transboundary Harm
        1. I. Harm
          1. 1. ‘Extraterritorial’ Transboundary Harm
          2. 2. Harm to Areas Beyond National Jurisdiction
          3. 3. Harm to ‘Global Commons’
        3. III. Harm Caused by ‘Physical Consequences’
        4. IV. The Threshold of ‘Significant’ Harm
        5. V. Risk of Harm
          1. 1. Foreseeability as a Precondition of Prevention
          2. 2. The Precautionary Principle (or Approach)
          3. 3. Precaution and the Burden of Proof
          4. 4. Precaution in the Area of Biosafety
          1. 1. Scholarly Opinions
          2. 2. Transboundary Effects of LMOs and the Notion of ‘Significant Harm’
          3. 3. Anticipation of Risk
        8. VIII. Conclusions
      3. C. Prevention of Transboundary Harm as an Obligation of ‘Due Diligence’
        1. I. Adoption and Enforcement of Effective Domestic Regulation
          1. 1. Legal Status
          2. 2. Triggers of the Obligation
          3. 3. Process and Content of EIAs
          4. 4. Standards for Risk Assessments of LMOs/GMOs
          5. 5. Conclusions
        3. III. Use of the Best Available Technologies
            1. a) Timing
            2. b) Addressees
            3. c) Content
            4. d) Procedure
          2. 2. Exchange of Information
          3. 3. Consultations and Negotiations
          1. 1. Legal Status Under General International Law
          2. 2. Public Participation Under the Cartagena Protocol
            1. a) Status Quo
            2. b) The GMO Amendment
            3. c) The Lucca Guidelines
          1. 1. Notification in Emergency Situations
          2. 2. Obligation to Control and Mitigate Damage
        7. VII. Conclusions
        1. I. Occurrence of Harm as an Indication of a Breach
        2. II. Occurrence of Harm as a Prerequisite of a Breach
        3. III. Relationship Between Procedural and Substantive Obligations of Prevention
      6. F. Summary
    3. Download Kapitel (PDF)
      1. A. The Development of COP Decision 14/19
        1. I. Functions of COP Decisions
        2. II. COP Decisions as ‘Soft Law’
        3. III. Soft Law Status of Decision 14/19 for Parties to the CBD
        4. IV. Effect on Non-Parties
          1. 1. References to Precaution in Earlier COP Decisions
          2. 2. Early Deployment of Gene Drives as a Precautionary Measure?
          3. 3. Assessment
            1. a) Status of the Obligation Under International Law
              1. aa) Guidance on Risk Assessment and Monitoring of LMOs
              2. bb) Additional Guidance on Risk Assessment of Engineered Gene Drives
            3. c) Assessment
            1. a) Status of the Obligation Under International Law
              1. aa) Phased Pathway to the Deployment of Gene Drives
              2. bb) Self-Limiting Gene Drives
            3. c) Assessment
              1. aa) CBD Mo’otz Kuxtal Voluntary Guidelines
              2. bb) United Nations Declaration on the Rights of Indigenous Peoples
              3. cc) Assessment
            2. b) Excursus: Consent of Individuals as a Human Rights Requirement?
          4. 4. Conclusions
          1. 1. No Binding International Rules on LMOs in Contained Use
          2. 2. The WHO Laboratory Biosafety Manual
          3. 3. Excursus: Regulation of Gene Drives in Contained Use in the European Union
          4. 4. Containment Standards for Gene Drives Formulated by Researchers
        4. IV. Conclusions
          1. 1. ‘Likely’ Transboundary Movements as ‘Intentional’ Transboundary Movements?
          2. 2. Proposal for a Clarification
        2. II. Transboundary Spreads and the Obligation to Prevent Significant Transboundary Harm
      5. E. Summary and Outlook
    1. Download Kapitel (PDF)
      1. A. Negotiating History
          1. 1. LMOs That Are Pharmaceuticals for Humans
          2. 2. Products Derived From LMOs
          1. 1. Biological Diversity
            1. a) Adverse Effects on Conservation
            2. b) Adverse Effects on Sustainable Use
            3. c) Conclusions
          3. 3. Threshold of Damage: ‘Measurable’ and ‘Significant’
          4. 4. Risks to Human Health
          5. 5. Domestic Criteria to Address Damage
          6. 6. Types of Damage Not Addressed by the Supplementary Protocol
          7. 7. Conclusions
          1. 1. Damage Resulting From Authorized Uses Following Intentional Transboundary Movement (Article 3(2))
          2. 2. Damage Resulting From Unintentional Movements (Article 3(3))
          3. 3. Damage Resulting From Illegal Transboundary Movements (Article 3(3))
          4. 4. Damage Resulting From Transboundary Movements From Non-Parties (Article 3(7))
          5. 5. Damage Resulting From LMOs in Transit
          6. 6. Damaged Caused by Domestic Activities With LMOs
          7. 7. Conclusions
        4. IV. Temporal Scope (Article 3(4))
        5. V. Spatial Scope (Article 3(5))
        6. VI. Conclusions
        1. I. Meaning and Scope of ‘Response Measures’
        2. II. Identification of the Liable Operator
        3. III. Establishment of a Causal Link and Standard of Proof (Article 4)
          1. 1. Requirement of the Operator to Take Response Measures (para. 1)
          2. 2. Responsibilities of the Competent Authority (para. 2)
          3. 3. Measures When There Is a Threat of Damage (para. 3)
          4. 4. Response Measures Taken Instead of the Responsible Operator (para. 4)
          5. 5. Recovery of Expenses by the Competent Authority (para. 5)
          6. 6. Reasoning and Legal Review of Decisions (para. 6)
          1. 1. Provision of ‘Rules and Procedures That Address Damage’ (Article 12(1))
          2. 2. Response Measures Already Addressed by Domestic Civil Liability Law (Article 5(7))
          3. 3. Implementation of Response Measures ‘in Accordance With Domestic Law’ (Article 5(8))
        6. VI. Conclusions
          1. 1. Material or Personal Damage
          2. 2. Damage ‘Associated’ With Biodiversity Damage
        2. II. Provision of Adequate Rules and Procedures on Civil Liability (Article 12(2))
        3. III. List of Elements to be Addressed When Developing Civil Liability Law (Article 12(3))
        4. IV. The Meaning of ‘Adequate’ Rules and Procedures
        5. V. Conclusions
        6. VI. Excursus: Draft Guidelines on Civil Liability and Redress
        1. I. Exemptions From Liability, Time and Financial Limits, and Right of Recourse (Articles 6 to 9)
          1. 1. Right of Parties to Provide for Financial Security (para. 1)
          2. 2. Consistency of Financial Security Provisions With Existing International Law (para. 2)
          3. 3. Study on Financial Security Mechanisms (para. 3)
          4. 4. Conclusions
        3. III. Relationship to State Responsibility (Article 11)
        4. IV. Review of Effectiveness (Article 13)
        5. V. Relationship to Rights and Obligations Under International Law (Article 16)
        6. VI. Governance- and Process-Related Provisions (Articles 14 to 21)
        1. I. Transboundary Harm
        2. II. Designation of a Competent Authority
        3. III. Right of Affected Individuals to Request Action
        4. IV. International Coordination of Response Measures
        5. V. Jurisdiction, Applicable Law, and Mutual Recognition and Enforcement of Judgments
        1. I. Proposed Scope of Domestic Implementing Legislation
        2. II. Identification of the Liable Operator and Exemptions
        3. III. Determination of Damage
        4. IV. Identification of Suitable Response Measures
        5. V. Civil Liability
        6. VI. Conclusions
      8. H. Summary and Outlook
    2. Download Kapitel (PDF)
      1. A. Membership
      2. B. Scope
      3. C. Causation, Identification of the Party Liable and Standard of Liability
      4. D. Defences
      5. E. Response
      6. F. Financial Caps and Time Limits
      7. G. Claims Process, Arbitration and Enforcement
      8. H. Conclusions
    3. Download Kapitel (PDF)
      1. A. Scope of Application and Use of Terms
        1. I. The Standard of ‘Prompt and Adequate’ Compensation
        2. II. Imposition of Strict Operator Liability
        3. III. Compensation Funding
      3. C. Obligation to Provide for Response Measures
      4. D. Obligation to Provide for International and Domestic Remedies
      5. E. Relationship to the Law of State Responsibility
      6. F. Legal Status: Emerging Customary International Law?
    1. Download Kapitel (PDF)
        1. I. Conduct Consisting of an Action or Omission
          1. 1. Conduct by State Organs and Persons Exercising Governmental Authority
              1. aa) Instruction
              2. bb) Direction
              3. cc) Control
              1. aa) Regulatory Oversight
              2. bb) Enterprises Owned and Controlled by a State
              3. cc) Research and Development Activities by Public and Governmental Institutions
              4. dd) State-Funded Research and Development Activities
          3. 3. Attribution of Conduct Acknowledged and Adopted by the State as Its Own
          4. 4. Attribution by Lex Specialis Norms
          5. 5. Attribution of Transboundary Harm Through Human Rights Law?
          6. 6. Conclusions
          1. 1. International Obligation of Any Origin or Character
          2. 2. Conduct in Breach of the Obligation
          3. 3. No Requirement of Fault
          1. 1. Consent
          2. 2. Self-Defence
          3. 3. Countermeasures
          4. 4. Force Majeure
          5. 5. Necessity
          6. 6. Reparation in the Event of a Circumstance Precluding Wrongfulness
        1. I. Obligations of Cessation and Non-Repetition
          1. 1. Recoverable Injury
            1. a) Proof of Causality for Environmental Damage
            2. b) Harm Within the Ambit of the Rule Breached
            3. c) Concurrent Causes of Damage and ‘Shared Responsibility’
              1. aa) Objective of Restitution
              2. bb) Restitution Not Materially Impossible
              3. cc) Disproportionality of Restitution
              1. aa) Loss of Life and Personal Injury
              2. bb) Property Damage
              3. cc) Loss of Profits or Income
              4. dd) Damage to the Environment
              5. ee) Punitive Damages
              6. ff) Interest
            3. c) Satisfaction
          4. 4. Contribution to the Injury and Failure to Mitigate Damage
        3. III. Right to Take Countermeasures
          1. 1. Invocation of Responsibility by Injured States
            1. a) Right of Non-Injured States to Invoke Responsibility
            2. b) Remedies Available to Non-Injured States
          1. 1. The Law of Diplomatic Protection in Cases of Transboundary Harm
          2. 2. The Requirement to Exhaust Local Remedies in Cases of Transboundary Harm
          1. 1. The Claims Process Envisaged in the ARSIWA
          2. 2. Settlement of Disputes
              1. aa) Role, Functions and Procedures
              2. bb) Recent Practice
              3. cc) Legal Status
            2. b) The Relationship Between Non-Compliance Procedures and State Responsibility
          4. 4. Conclusions
      4. D. Summary and Outlook
    2. Download Kapitel (PDF)
      1. A. International Treaties
      2. B. State Practice
      3. C. Human Rights Law
      4. D. International Law Commission
      5. E. Conclusions
    3. Download Kapitel (PDF)
          1. 1. Mitigation Measures
          2. 2. Restoration Measures
          3. 3. Evaluation Measures
          1. 1. Limitation to ‘Reasonable’ Measures
          2. 2. Limitation of Reimbursement to Incremental and Extraordinary Expenses
          3. 3. Limitation of Restoration Costs to the Monetary Value of the Impaired Environment?
        3. III. Compensability of ‘Environmental Solidarity Costs’
          1. 1. The Practice of International Liability Treaties
          2. 2. The Stance of the International Law Commission
          3. 3. Compensability of Environmental Damage in the United Nations Compensation Commission
          4. 4. Compensation of Environmental Damage Before the International Court of Justice (Case of Costa Riva v. Nicaragua)
          5. 5. Conclusions
          1. 1. Compensatory Restoration
            1. a) Valuation Based on Market Prices
            2. b) Non-Market-Based Valuation Techniques
            3. c) Benefit (Or Value) Transfer Method
            4. d) Costs for ‘Hypothetical’ Response Measures
          3. 3. Conclusions
          1. 1. Costa Rica’s ‘Ecosystem Services Approach’
          2. 2. Nicaragua’s ‘Replacement Costs Approach’
          3. 3. Nicaragua’s ‘Corrected Analysis’
          4. 4. The Court’s Judgment: ‘Overall Assessment’ of Environmental Damage
          5. 5. Assessment
      3. C. Summary
    4. Concluding Remarks 665 - 670 Download Kapitel (PDF)
    5. Download Kapitel (PDF)
      1. Chapter 1: The Emergence of Self-Spreading Biotechnology
      2. Chapter 2: Concepts and Terms Relevant to Transboundary Harm Caused by Biotechnology
      3. Chapter 3: The Regulation of Biotechnology in International Law
      4. Chapter 4: Prevention of Transboundary Harm from Biotechnology Under Customary International Law
      5. Chapter 5: The International Governance of Engineered Gene Drives
      6. Chapter 6: The Nagoya – Kuala Lumpur Supplementary Protocol on Redress and Liability
      7. Chapter 7: A Private Liability Scheme: The ‘Biodiversity Compact’
      8. Chapter 8: A Customary Obligation to Ensure Prompt and Adequate Compensation for Transboundary Damage?
      9. Chapter 9: State Responsibility for Transboundary Harm Caused by Biotechnology
      10. Chapter 10: Strict State Liability for Transboundary Harm?
      11. Chapter 11: Compensation for Environmental Damage in International Law
    6. Download Kapitel (PDF)
      1. Kapitel 1: Das Aufkommen von sich selbst ausbreitender Biotechnologie
      2. Kapitel 2: Relevante Konzepte und Begriffe im Kontext grenzüberschreitender Schäden durch Biotechnologie
      3. Kapitel 3: Die völkerrechtliche Regulierung der Biotechnologie
      4. Kapitel 4: Verhütung grenzüberschreitender Schäden durch Biotechnologie im Rahmen des Völkergewohnheitsrechts
      5. Kapitel 5: Die internationale Regulierung synthetischer Gene Drives
      6. Kapitel 6: Das Zusatzprotokoll von Nagoya/Kuala Lumpur über Haftung und Wiedergutmachung
      7. Kapitel 7: Ein privatrechtliches Haftungssystem: Der „Biodiversity Compact“
      8. Kapitel 8: Eine gewohnheitsrechtliche Verpflichtung zur Sicherstellung einer unverzüglichen und angemessenen Entschädigung für grenzüberschreitende Schäden?
      9. Kapitel 9: Staatenverantwortlichkeit für durch Biotechnologie verursachte grenzüberschreitende Schäden
      10. Kapitel 10: Staatliche Gefährdungshaftung für grenzüberschreitende Umweltschäden?
      11. Kapitel 11: Ersatzfähigkeit von Umweltschäden im Völkerrecht
  6. Table of Cases 713 - 720 Download Kapitel (PDF)
  7. Table of Treaties and Instruments 721 - 742 Download Kapitel (PDF)
  8. Bibliography 743 - 808 Download Kapitel (PDF)

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