1. Guatemala: An evaluation of Biosafety Regulations Drew L. Kershen Earl Sneed Centennial Professor Univ. of Oklahoma, College of Law Copyright 2007, all rights reserved

2. Guatemala: Objectives Comply with International Obligations Comply with International Obligations World Trade Organization (WTO) AgreementsWorld Trade Organization (WTO) Agreements Cartagena Protocol on Biosafety (CPB)Cartagena Protocol on Biosafety (CPB) Seek compatibility between both obligationsSeek compatibility between both obligations Focus on Agricultural Biotechnology Focus on Agricultural Biotechnology Encourage innovation, science and investmentEncourage innovation, science and investment Develop the agricultural sectorDevelop the agricultural sector Insure food and feed safetyInsure food and feed safety Protect environmental values and resourcesProtect environmental values and resources Promote health and general welfarePromote health and general welfare Promote Science Based Regulatory Policy Promote Science Based Regulatory Policy Unless Guatemala uses science, cannot fulfill the two prior objectives – i.e. comply and focusUnless Guatemala uses science, cannot fulfill the two prior objectives – i.e. comply and focus

3. Way Forward: General Ideas Rely upon 20+ years research and 10+ years commercial use of agricultural biotechnology Rely upon 20+ years research and 10+ years commercial use of agricultural biotechnology Do not repeat what has already been done properly and correctlyDo not repeat what has already been done properly and correctly Improve what has already functioned well Improve what has already functioned well Use existing Guatemalan laws and regulationsUse existing Guatemalan laws and regulations e.g. Acuerdo Ministerial No. 386-2006 (AM 386) e.g. Acuerdo Ministerial No. 386-2006 (AM 386) Use Models that support, rather than undermine, the objectives of GuatemalaUse Models that support, rather than undermine, the objectives of Guatemala e.g. Libro de referencia de normativas sobre seguridad de la biotechnología, http://www.arentfox.com/modelbiosafetyact.html e.g. Libro de referencia de normativas sobre seguridad de la biotechnología, http://www.arentfox.com/modelbiosafetyact.html http://www.arentfox.com/modelbiosafetyact.html

4. Transgenic Crops: Food and Feed and Processed Cartagena Protocol Cartagena Protocol Art. 11: excludes from Advance Informed Agreement (AIA)Art. 11: excludes from Advance Informed Agreement (AIA) Art. 18: DocumentsArt. 18: Documents Art. 13: simplified procedures of notification or exemptionArt. 13: simplified procedures of notification or exemption Notification from Art. 18 Notification from Art. 18 Art. 14: agreements and arrangementsArt. 14: agreements and arrangements Additional impositions raise significant questions of WTO violations Additional impositions raise significant questions of WTO violations Not science basedNot science based Discriminate against like productsDiscriminate against like products Excessive and disguised barriersExcessive and disguised barriers Guatemala Guatemala 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 of Guatemala on food and feed safety – clearly identify the safety issue, such as a legitimate concern of toxic mixture

5. Transgenic Crops: Introduction into the Environment Cartagena Protocol Cartagena Protocol (CBD) Convention on Biological Diversity: “conservation and sustainable use of biological diversity”(CBD) Convention on Biological Diversity: “conservation and sustainable use of biological diversity” Arts. 7-10, Arts. 15-16, AIA procedures, risk assessment, and risk managementArts. 7-10, Arts. 15-16, AIA procedures, risk assessment, and risk management Core articles and core concernCore articles and core concern Compatible with WTO if: Compatible with WTO if: Based in scienceBased in science NondiscriminatoryNondiscriminatory Not excessive or disguised barriers to tradeNot excessive or disguised barriers to trade Guatemala – AM 386 Guatemala – AM 386 AM Arts. 4-14 – equivalent AIA, risk assessment and risk management AM Arts. 15-16 – technical scientific advice -- coordinate Make nondiscriminatory, i.e. for all introductions not just for export production AM Arts. 18-20 – 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

6. Transgenic Organisms: Contained Use, Pharmaceuticals, and Transit Cartagena Protocol Cartagena Protocol Arts. 5 & 6 – AIA does not applyArts. 5 & 6 – AIA does not apply Recognizes and defers to other laws and agreementsRecognizes and defers to other laws and agreements Compatible with WTO Compatible with WTO Outside the scope of CPB, no conflict possibleOutside the scope of CPB, no conflict possible Focus shifts: compatibility of other laws with WTOFocus shifts: compatibility of other laws with WTO Concept especially of nondiscrimination between like products Concept especially of nondiscrimination between like products Guatemala Guatemala AM 386 – amend to delete references to contained use Field trials Laboratory experiments 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

7. Cartagena Concepts: Unrelated and Unneeded Socio-economic considerations Socio-economic considerations CPB Art. 26: “… may take into account, consistent with their international obligations …”CPB Art. 26: “… may take into account, consistent with their international obligations …” Permissive, not mandatory Permissive, not mandatory WTO obligations are based in science, not socio-economic considerations WTO obligations are based in science, not socio-economic considerations Guatemala need not and should not include socio- economic considerations in its biosafety laws. Guatemala need not and should not include socio- economic considerations in its biosafety laws. Liability and redress Liability and redress CPB Art. 27 “… appropriate elaboration of international rules and procedures …” The appropriate elaboration is no international rules and procedures Guatemala need not address liability and redress in its biosafety laws Guatemala need not 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. General Concepts: Unrelated and Unneeded Consumer labeling Consumer labeling Not addressed in CPBNot addressed in CPB Guatemala Guatemala Use existing laws and regulations about consumer labelingUse existing laws and regulations about consumer labeling Label for safety and nutrition – need to know informationLabel for safety and nutrition – need to know information Voluntary labels for niche markets at the cost of the retailer and consumer seeking niche productVoluntary labels for niche markets at the cost of the retailer and consumer seeking niche product Genetic resources and benefit-sharing Genetic resources and benefit-sharing Not addressed in CPB CBD and International Treaty on Plant Genetic Resources for Food and Agriculture (PGRFA) Guatemala Guatemala Transgenic agriculture is only distantly related to these concerns. Address in laws that are separate and distinct from biosafety laws.

9. Guatemala: A Law Focused on Agricultural Biotechnology Can be compatible with CPB and WTO obligations. Can be compatible with CPB and WTO obligations. Can be transparent, clear, and certain. Can be transparent, clear, and certain. Can provide a science-based regulatory policy while avoiding unrelated and unneeded concepts. Can provide a science-based regulatory policy while avoiding unrelated and unneeded concepts. Can promote the benefits of modern plant breeding for the good of Guatemalan society without compromising health and environmental safety. Can promote the benefits of modern plant breeding for the good of Guatemalan society without compromising health and environmental safety. Libro de referencia de normativas sobre seguridad de la biotecnología – a Model Libro de referencia de normativas sobre seguridad de la biotecnología – a Model

10. Thank you. I welcome questions and further discussions on these very important issues for the benefit of Guatemala and other developing nations.