28 August 2012 Kelebohile Lekoape, for Global Industry Coalition & CropLife International

1. THE COMPACT & THE NAGOYA – KUALA LUMPUR SUPPLEMENTARY PROTOCOL (N-KL SP) NATIONAL RATIFICATION & IMPLEMENTATION 28August 2012Kelebohile Lekoape, for Global Industry Coalition & CropLife International

2. Agenda • Brief Introduction of GIC and its activities • Overview of The Compact • GIC Position on N-KL SP • Implementation Guide • Other GIC Priorities

3. Global Industry Coalition (GIC) • Represents companies engaged in plant science, seed production, agricultural biotechnology, food production, animal agriculture. • Coordinates input from private sector developers and users of biotechnology on all issues under Cartagena Protocol on Biosafety (Protocol). • Is truly “global” – with industry partners in over 25 countries (e.g., EuropaBio, Council for Biotechnology in Japan, AfricaBio, AgroBio Colombia, etc.). • Is a recognized “observer” organization for global industry within the Protocol implementation process. • Organized under the auspices of CropLife International (Sarah Lukie, Executive Director) - represents the plant biotechnology industry, sponsored by six core companies: Bayer, BASF, Dow, DuPont/Pioneer, Monsanto and Syngenta

4. GIC Activities • Focus on all Protocol implementation issues: • Risk assessment • Socio-economic considerations • Shipping documentation requirements • Priority issue: Liability and Redress • Active participant during N-KL SP negotiation process • Developed The Compact to respond to call for product stewardship • Authored N-KL SP Implementation Guide as a capacity building tool for N-KL SP Parties

5. “The Compact - A Contractual Mechanism for Response in the Event of Damage to Biological Diversity Caused by the Release of a Living Modified Organism” • Private Sector Initiative = Voluntary Legally Binding Contract • Designed to be a fair, accessible, and efficient system • Technology Provider Is Responsible for Its Own LMO • Complements N-KL Supplementary Protocol with an existing mechanism that provides Financial Security • An Option for States

6. “The Compact”: Who? … Why? • Current membership – the six largest technology providers (BASF, Bayer CropScience, Dow AgroSciences, DuPont/Pioneer, Monsanto and Syngenta) • Industry Commitment to Protect Biological Diversity • Member Confidence in Safety of Their LMOs • Unique Demonstration of Corporate Responsibility • A Positive Contribution to the International Negotiations

7. Any U.N. Member State Can Choose to File a Claim: Only a State can file a claim. Whether or not a State files a claim, there is no impact on that State’s rights to bring otherwise available legal actions. The State Submitting a Claim Agrees to: Binding arbitration under the terms and conditions of the Compact; Provide plausible evidence for each element of claim; No multiple recovery from Compact Member for the same incident; and Confidentiality. Claims Process

8. THE NAGOYA – KUALA LUMPUR SUPPLEMENTARY PROTOCOL (N-KL SP)RATIFICATION & IMPLEMENTATION

9. GIC Position on N-KL SP Ratification • The GIC fully supports ratification of the N-KL SP because: • It sets forth an administrative approach to response in the event of damage, without prejudice to • The origin of damage i.e. from domestic activities or transboundary movement. • The industry or technology that causes the damage – and not limited to this highly regulated technology; • It can harmonize international law on liability for damage to biological diversity; • It incorporates a clear definition of and the critical role of a science-based determination of “damage”; • It is consistent with the guiding principles advocated by industry.

10. GIC Position on N-KL SP Implementation • Implementation of the N-KL SP will be a complex process for each ratifying Party. • For example, there are 18 separate references in the N-KL SP to the application of domestic law. • To begin the process, implementation requires careful analysis of “domestic law” by each Party to answer several fundamental questions: • Does domesticlaw already meet the specific mandates of the N-KL SP? If yes, the Party may choose to apply existing domestic law. • Does domestic law cover the many issues left to domestic law by the N-KL SP? If no, the Party either must or may, as set forth in the N-KL SP, amend or develop domestic law to addressthose issues. • Is existing domestic law consistent with the N-KL SP? If not, the Party must amend or repeal existing law.

11. GIC Position on Implementation (continued) • In considering the applicability of domestic law, or the development of new domestic law, the GIC urges the Parties to consider: • Guiding principles for efficient and fair resolution of claims of damage; • Characteristics of workable liability & redress systems; and • Examples of reasonable and practical provisions provided by the Compact that address the issues left by the N-KL SP to domestic law or not covered by the N-KL SP at all, include: • Considerations and Elements in determining Damage • Causation • Channeling of Responsibility • Defences • Time & Financial Limitations

12. 1. Guiding Principles for Efficient & Fair Resolution of Claims of Damage • Protection of biological diversity as a “public good” by the State. • Science-based evidence and decisions. • Responsibility channeled to the “operator” who caused the damage. • Legal due process for those against whom claims for damage to biological diversity are made. • Independent unbiased decision-makers. • Respect for precedent in the legal system. • Practical and fair application. • Social responsibility.

13. 2. Characteristics of a “Workable” System • Clear scope and definitions – domestic law must be consistent with N-KL SP: • Damage; • “Significant” adverse effect; and • Response measures. • A definition of “operator” that holds persons in control of the LMO responsible. • The requirements of both factual and legal causation. • Appropriate defenses to protect against unfair imposition of responsibility. • Response measures which are consistent with the N-KL SP definition and focused on remediation. • Reasonable financial and time limitations for claims.

14. GIC Implementation Guide • For the N-KL SP • Addresses both the process of implementation and the substance of a sample implementing regulation • Peer- reviewed by independent experts • Co-chairs of N-KL SP negotiations are highly supportive of it as a capacity building tool • Implementation Guide will be made available at a side event at MOP-6

15. GIC Implementation Guide Example: Definition of “Operator” • N-KL SP definition:

16. GIC Implementation Guide Example: Definition of “Operator” • GIC Implementation Guide Explanatory Text: • This Article of the N-KL SP defers to domestic law and provides a non-exhaustive list of persons who could be held responsible as the “Operator”. If the term “operator” already is defined in an appropriate existing national law, the text in square brackets should be retained and completed with a reference to the law. • In countries where the term is not defined or is not appropriate for this context, it needs to be explicitly defined in the Regulation. To operationalize the “polluter pays principle,” the term “Operator” should focus on the person in operational control of the activity that caused the Damage (i.e., the one who in fact caused it or could have prevented it). Examples of who might be an operator (i.e., importer, etc.) are not necessary or appropriate in the regulation, as the “control” test will establish the identity of the Operator. In cases where appropriate domestic law does not exist, the text in square brackets in paragraph 1 should be deleted.

17. GIC Implementation Guide Example: Definition of “Operator” • GIC Implementation Guide suggested definition: • “Operator” means any person in direct or indirect control of the Living Modified Organism at the time that it caused the Damage [in accordance with which could, as {citation to appropriate and as determined by domestic law}]. , include, inter alia, the permit holder, person who placed the living modified organism on the market, developer, producer, notifier, exporter, importer, carrier or supplier;

18. Other GIC Priorities for MOP-6: Risk Assessment and Risk Management • Parties will consider guidance provided by ad hoc technical expert group for environmental risk assessment, including the “road map”, post-market environmental monitoring, and additional guidance for multiple trait products (stacks), LM trees, LM mosquitoes, and LMOs with abiotic stress tolerant traits • GIC Position: • The work of the AHTEG substantially ignores the massive body of generally recognized resource material on risk assessment • The AHTEG process was fundamentally flawed, arbitrary, and excluded the input of true experts in risk assessment • Therefore, the AHTEG documents must either be substantially edited, or completely replaced with new documents produced by qualified experts

19. Other GIC Priorities for MOP-6: Socio-economic Considerations (SECs) • Parties will consider guidance on how and what SECs should be involved in decision-making • GIC position: • Article 26 requires: 1) may be taken into account in decision to import; 2) must be consistent with international obligations; and 3) must arise from the impact of LMOs on the conservation and sustainable use of biodiversity. Any guidance developed on this issue must be limited by this Protocol language

20. Thank You!