2003年-世界发展银行全球_Biosafety_Regulation___A_Review_of_International_Approaches_58页_271kb

Biosafety Regulation: A Review of International Approaches

Core Content

This report, titled Biosafety Regulation: A Review of International Approaches, provides an overview of the development and implementation of national biosafety systems, with a focus on genetically engineered plants and their implications for environmental and human health. It highlights the importance of biosafety regulation in ensuring the safe use of modern biotechnology, particularly in developing countries, and explores the various international and national approaches to managing these risks.

Main Viewpoints

1. Potential Benefits of Biotechnology

• Modern biotechnology has the potential to significantly increase agricultural productivity and reduce poverty in developing regions.
• It enables the introduction of new traits into plants that cannot be achieved through traditional breeding, such as enhanced disease resistance, drought tolerance, and improved nutritional content.
• Examples include "golden rice" with increased vitamin A and tomatoes with elevated lycopene levels.
• Functional foods like edible vaccines are also being developed.

2. Need for Biosafety Regulation

• The introduction of genetically engineered plants raises concerns about potential adverse environmental and human health consequences.
• This has led to the development of regulatory regimes specifically to assess the safety of these products.
• A biosafety framework is essential to ensure safe access to new biotech products and to build public confidence in their safety.

3. Cartagena Protocol on Biosafety

• The protocol, adopted in 2000, addresses the safe transfer, handling, and use of living modified organisms (LMOs).
• It requires ratification by 50 governments before it can come into force.
• It includes a Biosafety Clearing House for information exchange and Advance Informed Agreement (AIA) procedures for LMOs that are intentionally introduced into the environment.
• The goal is to enable recipient countries to assess the risks of modern biotechnology products.

4. Risk Assessment and Management

• Risk assessment is a science-driven process that evaluates the characteristics of the organism, the introduced trait, the environment, and the intended application.
• It focuses on testable, empirical risks rather than speculative ones.
• The concept of "substantial equivalence" is used to compare genetically engineered plants with their conventional counterparts, based on established safety data.
• While this concept has its limitations, it remains a practical tool for risk assessment in the absence of better alternatives.

5. Capacity Building

• The CBD, Agenda 21, and the Cartagena Protocol all emphasize the need to strengthen human and institutional capacity in biosafety.
• This includes legal, administrative, policy, decision-making, and scientific capabilities.
• Developing countries require assistance, including financial support, to build these capacities.
• Cooperation through global, regional, and national institutions is encouraged to enhance biosafety regulation.

6. Challenges in Regulation Development

• No country has developed a biosafety regulatory system from a comprehensive plan that anticipates all contingencies.
• Most systems evolved piecemeal, starting with voluntary guidelines and standards developed collaboratively by academia, industry, and government.
• These guidelines were later incorporated into statutory instruments under existing or new legislation.
• The development and implementation of biosafety systems are ongoing processes, often involving a mix of voluntary and statutory mechanisms.

Key Information

Regulatory Framework Components

• A national biosafety policy, which may be standalone or part of a broader biotechnology strategy.
• A regulatory system with mechanisms for risk assessment and risk management.
• Monitoring and inspection systems.
• Procedures for transparency, public participation, and accountability.

International Agreements and Initiatives

• Convention on Biological Diversity (CBD): Emphasizes biosafety as a key component of sustainable development.
• Agenda 21: Explicitly addresses biosafety in Chapter 16.
• Cartagena Protocol: The most prominent international agreement on biosafety, focusing on transboundary movements of LMOs.
• UNEP/GEF Global National Project: Aims to develop national biosafety frameworks and promote international cooperation.

Key Capacity Requirements

• Legal and administrative frameworks.
• Policy development and implementation.
• Decision-making processes.
• Scientific analysis and risk assessment.
• Inspection and enforcement mechanisms.
• Integration of biosafety into national policies.
• Transparency and public engagement.
• Regional and international harmonization.

Country-Specific Examples

• Appendix 1 provides detailed examples of biosafety policies and practices from various countries, highlighting differences in regulatory approaches and the integration of socioeconomic considerations.

Conclusion

The report concludes that while there is no single best approach to biosafety regulation, there are common issues and considerations that governments and policymakers must address. These include the design and objectives of regulatory systems, implementation mechanisms, and cross-cutting factors such as transparency, public involvement, and international cooperation. Drawing on country experiences, the report offers policy direction on areas of consensus and emphasizes the importance of capacity building in ensuring the effective and sustainable use of biotechnology.