1. Creating a Conducive Environment for Biotechnology: The Cartagena Protocol as an Enabling Framework Drew L. Kershen Earl Sneed Centennial Professor University of Oklahoma College of Law Copyright 2008, Drew L. Kershen – all rights reserved

2. Twin Aspects of Biotechnology Protocol on Biosafety: Official Text (2000) Introduction & Preamble –“great potential for human well-being” Introduction –“The Protocol thus creates an enabling environment for the environmentally sound application of biotechnology, making it possible to derive maximum benefit from the potential that biotechnology has to offer …” Introduction –“… while minimizing the possible risks to the environment and to human health.” Words and phrases –“risk” 67 times –“public concern” 1 time –“great potential” 2 times –“benefit” 1 time Existence versus Interpretation Attitude – Understanding –“an enabling environment”

3. South East Asia: Objectives Comply with International Obligations –World Trade Organization (WTO) Agreements –Cartagena Protocol on Biosafety (CPB) –Seek compatibility between both obligations Focus on Agricultural Biotechnology –Encourage innovation, science and investment –Develop the agricultural sector –Insure food and feed safety –Protect environmental values and resources –Promote health and general welfare Promote Science Based Regulatory Policy –Unless nations use science, cannot fulfill the two prior objectives – i.e. The comply and focus objectives

4. Cartagena Protocol Exemptions: Contained Use, Pharmaceuticals, and Transit Cartagena Protocol –Arts. 5 & 6 – Advance Informed Agreement (AIA) does not apply –Recognizes and defers to other laws and agreements Compatible with WTO –Outside the scope of CPB, no conflict possible –Focus shifts: compatibility of other laws with WTO Concept especially of nondiscrimination between like products South East Asia –Rely upon existing laws and regulations No need for special laws or regulations for transgenic organisms –Rely upon good laboratory practices, good plant breeding protocols, good scientific practices 100 years of scientific plant breeding Field trials

5. Transgenic Crops: Food and Feed and Processed Cartagena Protocol –Art. 11: excludes from Advance Informed Agreement (AIA) –Art. 18: Documents –Art. 13: simplified procedures of notification or exemption Notification from Art. 18 –Art. 14: agreements and arrangements Additional impositions raise significant questions of WTO violations –Not science based –Discriminate against like products –Excessive and disguised barriers South East Asia –Learn that these have approvals and safety in country of export Direct notification Biosafety Clearing House –Nothing else required to comply with CPB and WTO Risk assessment already done in country of export Decisions on science already done in country of export –If any additional questions, use the existing laws on food and feed safety – clearly identify the safety issue, such as a legitimate concern of toxic mixture

6. Transgenic Crops: Introduction into the Environment Cartagena Protocol –(CBD) Convention on Biological Diversity: “conservation and sustainable use of biological diversity” –Arts. 7-10, Arts. 15-16, AIA procedures, risk assessment, and risk management –Core articles and core concern Compatible with WTO if: –Based in science –Nondiscriminatory –Not excessive or disguised barriers to trade South East Asia –equivalent AIA, risk assessment and risk management –Make nondiscriminatory as applying to domestic and non- domestic crops –CPB Arts 13 & 14: simplified procedures Approvals in other nations Rely on already done risk assessments and risk management plans Only reconsider if a specific, legitimate additional concern about biodiversity Approvals should be final – transparent, clear, and certain

7. Cartagena Concepts: Permissive not Mandatory Socio-economic considerations –CPB Art. 26: “… may take into account, consistent with their international obligations …” Permissive, not mandatory WTO obligations are based in science, not socio-economic considerations Nations have no CPB obligation to include socio- economic considerations in its biosafety laws. Liability and redress –CPB Art. 27 “… appropriate elaboration of international rules and procedures …” The appropriate elaboration is no international rules and procedures Nations have no CPB obligation to address liability and redress in its biosafety laws –Use existing laws for comparable harms and damages, if any –Environmental laws about damage should be nondiscriminatory – i.e. should be general laws that do not single out transgenic crops

8. Cartagena Protocol: Concepts Not Mentioned Consumer labeling –Not addressed in CPB –Codex Alimentarius no consensus South East Asia –Use existing laws and regulations about consumer labeling –Label for safety and nutrition – need to know information –Voluntary labels for niche markets at the cost of the retailer and consumer seeking niche product Genetic resources and benefit-sharing –Not addressed in CPB –CBD and International Treaty on Plant Genetic Resources for Food and Agriculture (PGRFA) South East Asia –Transgenic agriculture is only distantly related to these concerns. –Address in laws that are separate and distinct from biosafety laws.

9. Way Forward: Experiences in other Nations European Union (EU) –Spain –UK –France Argentina –New WTO challenge to EU? Brazil –Recent maize approvals Australia –Canola –Wheat field trials China –Top priority India –Rethinking regulatory system South Africa –Success with cotton and food (white) maize –Approvals pending Burkina Faso –Bt cotton planted Kenya & Uganda –Field trials banana –Bt cotton Honduras & Guatemala –Good contrast –Bt maize for Honduras

10. Way Forward: General Ideas Rely upon 20+ years research and 10+ years commercial use of agricultural biotechnology –Do not repeat what has already been done properly and correctly Improve what has already functioned well –Use existing laws and regulations –Use Models that support, rather than undermine, the objectives of South East Asia e.g. Biosafety Regulation Sourcebook, http://www.arentfox.com/modelbiosafetyact.html http://www.arentfox.com/modelbiosafetyact.html –Pay attention to the experiences of other countries ISAAA Annual Reports – best source of information

11. Thank you. I welcome questions and further discussions on these very important issues for the benefit of South East Asia and other developing nations.