Chapter
providing a clear and precise structure for NBFS and draft legislation
Implementing a Systematic Approach in Designing NBFs
Complementing the NBF with a Bibliography, Tables, and Diagrams
sustainable development aspects of NBFS
A Partnership for the Safe Use of Modern Biotechnology
Obligations of Developing Countries Relating to the Cartagena Protocol
Developing Countries’ Expectations of the Cartagena Protocol and the Biosafety Clearing-House
How Countries Developed Their NBFs to Meet SD Policy Goals
A Comprehensive National Policy on Biosafety
A System or Framework to Ensure the Safe Use of Modern Biotechnology
Centralising Document Management Relating to the Use of LMOs
Decision-Making Process for Risk Evaluation and Risk Management
Public Participation and Awareness Mechanisms
Monitoring Institutions and Systems
Commercial, Sanitary, and Phytosanitary Aspects of National Biosafety Frameworks
3 Crafting National Biosafety Regulatory Systems
components and characteristics of a functional and protective system
Proportional Risk-Based Reviews
Transparent and Understandable
Efficient, Workable, and Fair
international obligations relevant to biosafety
Cartagena Protocol on Biosafety
World Trade Organization Agreements and Other Relevant Economic Treaties
The Codex Alimentarius Commission
International Plant Protection Convention
part ii Sustainable Development Law and Policy on Biosafety
4 Risk Assessment and Risk Management
the protocols provisions on risk assessment and risk management
comparison of the protocol to other lmo risk assessment frameworks
challenges in implementing risk assessment under the protocol
Determining the Appropriate Level of Detail for Risk Assessment
The Relationship between Risk Assessment and Precaution
5 The Decision-Making Procedures of the Protocol
the advance informed agreement procedure
the procedure for LMOS-FFP
advance informed agreement and prior informed consent
current issues and challenges related to the decision-making procedures
6 Handling, Transport, Packaging, and Information
overview of approaches to HTPI implementation
The Objectives Underlying Article 18 Requirements
FFP Commodities under Article 18.2(a)
Article 18.2(b) Seed Exports
Article 18.2(c) Contained Uses
Article 18.3 Online Review of HTPI Issues
COP-MOP 5 Decision Postponing Review of HTPI Issues
Biosafety Clearing-House and Implementing the COP-MOP 3 Decision
Cartagena Protocol COP-MOP 5 (Nagoya, Japan)
review of implementation laws for HTPI
European Union Traceability and Labelling Directives
Finding Flax in Seeds Shipped for Food
Tracing Seed Impurities in Rice
Tracing Corn Dust in Soybean Meal
Past Food Recalls in Japan: Pringle Potato Chips
Environmental Release: Japans Handling of Unapproved Canadian Canola
Models for Implementation with Minimal Trade Disruption
Role of Industry Stewardship
Codex “Adventitious Presence” Model
International Plant Protection Convention Model
7 The Importance of Public Participation
Public Participation and International Sustainable Development Law
Dimensions of the concept of public participation
Challenging Public Participation in Biosafety Policy
The Cartagena Protocol and Biosafety Policy
Challenges of Public Participation in Biosafety Policy
Mechanisms for Public Participation in Biosafety Policy
Global Public Perceptions on Biotechnology
Public Perceptions and Trust
8 The Biosafety Clearing-House and Sustainable Development Law
Origins and Basis of the Biosafety Clearing-House
The BCH and Sustainable Development Law Principles
9 Use of the Biosafety Clearing-House in Practise
Use of BCH data by Importers, Exporters, and Developers
Initial Controversies and Underlying Objectives
10 Socioeconomics, Biosafety, and Sustainable Development
Socioeconomic Impacts and Biosafety
Biosafety Regimes and Socioeconomic Considerations
Biosafety, Socioeconomics, and Sustainable Development Law
Principle of Integration and Interrelationship
Principle of Sustainable Use of Natural Resources
Principle of Equity and Elimination of Poverty
Principle of Common but Differentiated Responsibilities
The Precautionary Approach to Human Health, Natural Resources, and Ecosystems
Public Participation and Access to Information and Justice
Principle of Good Governance
11 The Compliance Mechanism of the Cartagena Protocol on Biosafety
Legal Basis of the Compliance Mechanism
Development of the Compliance Mechanism
The Intergovernmental Committee for the Cartagena Protocol (ICCP)
First COP-MOP to the Cartagena Protocol (2004)
Decision BS-I/7 on Establishment of Procedures and Mechanisms on Compliance
Similarities and Differences of the Compliance Mechanism Compared to other Compliance Mechanisms
Objective, Nature and Underlying Principles (Section I)
Institutional Mechanisms (Section II)
Functions of the Committee (Section III)
Information and Consultation (Section V)
Measures to Promote Compliance and Address Cases of Non-Compliance (Section VI)
First Report of the Compliance Committee and COP-MOP 2
Draft Rules of Procedure Presented by the Compliance Committee
Rules of Procedure Approved by COP-MOP 2
Second Report of the Compliance Committee and COP-MOP 3
General Issues of Compliance
Considerations and Conclusions of COP-MOP 3
Report of the Compliance Committee to COP-MOP 4 and Outcome
Tasks Assigned to the Compliance Committee by COP-MOP 3
Observations and Recommendations of the Compliance Committee
Measures in Cases of Repeated Non-Compliance
General Issues of Compliance
Other Observations of the CC
Considerations and Conclusions of COP-MOP 4
Measures in Cases of Repeated Non-Compliance
General Issues of Compliance
Other Outcomes of the Considerations of COP MOP-4 of the Report of the CC
12 Biosafety, Liability, and Sustainable Development
International Law on Liability and Redress for Environmental Harm
Development of the Liability and Redress Supplementary Protocol
Nagoya - Kuala Lumpur Supplementary Protocol
Relationship with the CBD, the Cartagena Protocol, and International Law
Scope of the Supplementary Protocol
Exemptions from Liability
Implementation of the Supplementary Protocol and Relationship with Civil Liability
Complementary Liability and Redress Rules
part iii Domestic Implementation of Biosafety Regulatory Aspects
13 Legislative Options for National Implementation
Outcome Orientation: Is Legislation Required?
Implementation Approaches
Effect of Nonlegislative Implementation
In the BCH Legislative Database
Which Cartagena Protocol Tasks Are Mandatory?
Overarching Mandates Underlying the Cartagena Protocol
Positive Mandates: Biosafety
“Antinegative” Mandates: Precaution under the Cartagena Protocol
Regulatory Flexibility Provisions in the Cartagena Protocol
Stricter Legislation and Broader Coverage
Domestic Regulatory Framework
Article 11 Alternative Procedure
14 National Biosafety Regulatory Systems in Central and Eastern Europe
Overview of biosafety policies of CEE countries that are EU Members
Non-EU Countries (Including Candidate and Potential Candidate Countries)
Countries without a Biosafety Policy
National Focal Points and Competent National Authorities
15 Implementing the Cartagena Protocol in West Africa
WAEMU Biosafety Regulatory Systems
Issues Raised During Legal Analysis of Draft Laws and NBFS
Scope of the Biosafety Regulatory System
Which Products Should Be Regulated?
Which Activities Should Be Regulated?
What Issues Should the System Address?
The Decision-Making Process
What Is the Decision Standard?
Public Participation in the Decision Process
Harmonisation of National Biosafety Regulatory Systems
A Potential WAEMU Regional Regulatory System and the Cartagena Protocol Obligations of Individual WAEMU Countries
The Legal Authority for WAEMU to Establish a Regional Biosafety Regulatory System
Legal Authority under WAEMU
Compliance and Enforcement of WAEMU Acts and/or Regulations
Biosafety Topics to Be Included in a WAEMU Regional Biosafety Regulatory System
A Model for Consideration
CILSS/INSAH Regional Biosafety Initiative
Background and Current Status
Summary and Legal Analysis of the Biosafety Convention
The CILSS Common Regulation for the Registration of Pesticides
16 Comparative Analysis of the National Biosafety Regulatory Systems in East Africa
Biosafety Regulatory Systems in Kenya, Tanzania, and Uganda
Comparative Analysis of East African Biosafety Regimes and the African Model Law
Issues Surrounding the Biosafety Systems of Kenya, Tanzania, and Uganda
Comprehensiveness - The Need to Address Potential Food Safety Risks
Adequate Legal Authority - Establishing New Laws
The Standard for Making an Approval Decision: Establishing an Adequate Level of Protection
Addressing Socioeconomic Considerations in the Decision-Making Process
Proportionate Risk-Based Review
Scope of the Biosafety Regulatory System - Inclusion of Products of GMOs
Interim Regulatory Systems
Efficiency: The Value of Institutional Biosafety Committee
Cooperation, Coordination, and Harmonisation of EA Biosafety Regimes
Timing of a Regional Effort
Potential Areas for Collaboration, Cooperation, Coordination, and Harmonisation
Adoption of Codex Standards for Assessing the Food Safety of GE Organisms
Harmonising Applications, Data Submissions, and Government Documents
Establishment of Common Regulatory Pathways for Different Activities Involving GE Organisms
17 The National Biosafety Regulatory Systems in Asian and Near East Countries
Experiences in Asian National Biosafety Framework Development
National Development Priorities
How Did Countries Develop Their NBFs?
NBF: Addressing Public Participation
NBF: Addressing Socioeconomic Issues
Implementing the NBF: Translating the Map into Action
Some Lessons from the Development of NBFS in Asia
Biosafety as a Sustainable Development Issue
Responsiveness to National Needs and Priorities
Conclusion: “Learning by doing”
18 The Regulatory and Institutional Biosafety Systems in the Americas
The Impacts and Challenges Faced in the Field of Agrobiotechnology
Biosafety regulatory and institutional frameworks in the Americas
Regional International Organization for Plant Protection and Animal Health
Central American Commission for Environment and Development
The Inter-American Institute for Cooperation in Agriculture
Outline of the Leading Biosafety Trends in the Americas
part iv Case Studies of Domestic Regimes and Sustainable Development
19 National Experiences with Legislative Implementation of the Protocol
General Policy Approaches
Mandatory Elements: Obligations to Other Parties
Export of LMOS (Notification and Acknowledgement)
Intentional and Unintentional Transboundary Releases and Movement of LMOs
Legislation of Domestic Scope
Risk Analysis and Risk Management
Interpreting the Biosafety Framework: “Stricter Measures”
Deadlines Different from Those in the Cartagena Protocol
Collective and Individual Exceptions to AIA/Article 11 Requirements
Other Provisions Having an Impact on the Cartagena Protocol
Appeal of Permit Decisions
Permit Reopeners and Rescission
Transport and Documentation
Confidentiality and Trade Secrecy
Costs and Conduct of AIA or other Assessment
Harm, Violation and Responsibility
Liability and Legal Redress
Public Participation and Awareness
Emergency Planning and Management
User/Facility Certification and Registry
Linkage to Other Laws and Legal Frameworks
Alien and/or Invasive Species
Bans on Import/Production
Coordination with Other Legal Frameworks
Pharmaceuticals and Medical Research
Access and Benefit Sharing
Other Provisions of Interest
Innovations in Biosafety Administrative Frameworks
Post Facto Application of Biosafety Law to Previously Approved LMO Activities
Delisting Particular LMOs
20 The Costa Rican Legal Framework on Agricultural Genetically Modified Organisms
The Phytosanitary Protection Law and Related Regulations
Authorization to Work with GMOs
Provisions of the Biodiversity Law
Provisions related to Environmental Impact Assessment
Provisions of Seed Law No. 6289
Provisions of the Organic Farming Law
Labelling, traceability, and liability
Claims made before the Administrative Environmental Tribunal
21 Innovations in Biosafety Law in New Zealand
Monitoring and Inspections, Enforcement, and Compliance
22 Liability and Redress in Canadian Case Law
The Decisions of the Courts on the Causes of Action
Court of Queens Bench for Saskatchewan
Duty to Ensure that GM Canola Would Not Infiltrate and Contaminate Farmland
Duty Concerning the Identity Preservation Program
The Rule in Rylands v. Fletcher
The Environmental Management and Protection Act
The Environmental Assessment Act
The Court of Appeal for Saskatchewan
Negligence, Nuisance, and Trespass
The Statutory Causes of Action
Safety in an Economic Veil
Advantages and Burdens, Rights and Responsibilities
23 The Use of GMOs in Chile and the Protection of Indigenous Culture
GMOS in Chilean Food Production
GMOS and Indigenous Culture
Part v Global Policy Trends in Biosafety
24 Sustainable Development, Biosafety, and International Law
Development Paradigms Prior to Stockholm
International Policy Making on Sustainable Development
Sustainable Development Law of Relevance to Biosafety
Key Concepts of International Law
Equity and Respect for Human Rights
Prevention of Serious Transboundary Environmental Harm and State Liability
Integration of Environmental Protection and Social and Economic Development
The World Trade Organization
International Treaty on Plant Genetic Resources for Food and Agriculture
Regional and Domestic Implementation
25 Trade and Investment Implications of Implementing the Cartagena Protocol
Trade Regimes, Investment Rules, and Biosafety Measures: Tools for Sustainable Development?
International Trade Law Obligations
Implications of the EC - Biotech Dispute in the WTO
Regional Trade and Investment Law Obligations Related to Biotechnology
Designing Biosafety Policies with Trade and Investment Considerations
Sustainable Development Objectives of the Global Biosafety Regime
Trade and Investment Implications of Biosafety
Trade Law Implications of Biosafety Measures
Investment Law Implications of Biosafety Measures
Improving Trade and Investment Regimes for Sustainable Development
Strengthening International Legal Coherence for the Green Economy
26 The Cartagena Protocol and the Regulation of Genetically Modified Food Aid
Risks Associated with GM Food Aid Distribution
Economic Concerns - Loss of Export Opportunities
Environmental Concerns - Unintended Contamination
Social Concerns - Human Health and Farming Practices
Application of the Protocol to Consignments of Food Aid
Publication of National LMO-FFP Regulations and Risk Assessments
Identifying Documentation
The Implications of the WTO Agreements for the Regulation of Food Aid
Key Considerations for the Regulation of Food Aid in Domestic Law
Approval Criteria and Risk Management
Labelling and Traceability
Transparency, Public Awareness, and Participation
Biosafety Law: Looking Forward
Biosafety, Integration and Interrelationship
Biosafety, Equity and Poverty Eradication
Biosafety and Common but Differentiated Responsibilities
Biosafety and the Precautionary Approach
Biosafety, Public Participation and Access to Justice
Good Governance for Biosafety
annex i The Components of a National Biosafety Framework (UNEP/GEF Toolkit)
annex ii Cartagena Protocol Implementation Tool Kit
annex iii Risk Management and Risk Assessment
annex iv International Liability and Redress Treaties
annex v Central and Eastern Europe
Legal Aspects of Implementing the Cartagena Protocol on Biosafety
( Treaty Implementation for Sustainable Development )
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