Low Level Presence, Trade, Biosafety and Decision Making: Issues for Developing Countries José Falck Zepeda

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1 Low Level Presence, Trade, Biosafety and Decision Making: Issues for Developing Countries José Falck Zepeda Senior Research Fellow International Food Policy Research Institute (IFPRI) Leader Policy Team for the Program for Biosafety Systems (IFPRI - PBS) Contributing Team Guillaume P. Gruère* Patricia Zambrano Antoine Bouet Dedbdatta Sengupta Daniela Horna* *Departed IFPRI

2 IFPRI s Mission and Expertise IFPRI mission as an international non-governmental organization To Provide Research-Based Policy Solutions That Sustainably Reduce Poverty and End Hunger and Malnutrition IFPRI conducts research in policy relevant topics: Trade related impacts Impacts of labelling and low level presence policies Private contracts and standards Compliance ability Ex ante and Ex post socioeconomic impact assessments of adoption Regulatory issues Effects of cost of compliance with biosafety regulations and regulatory delays Coexistence, segregation, identity preservation Regional harmonization approaches IFPRI provides operational and research based policy support to biosafety regulatory agencies and competent authorities in their decision making

3 Sources of LLP Asynchronous: at least one cultivating country has already authorized a GM crop while other countries have not approved for importation Asymmetric: a cultivating country has authorized a GM crop, but its developer does not seek approval in potential or unattractive importing countries Accidental admixture: a country has authorized the cultivation of a GM crop in field trials only. Traces of the commodity end up in the commercial crop supply Source: Stein, A. and E. Rodriguez-Cerezo

4 Mexico Canada Chile Taiwan Australia Peru Japan USA Philippines Russia Korea Indonesia Hong Kong Malaysia Thailand Brunei New Zealand Vietnam Pop. Rep. China Singapore Papua New Guinea Pop. Rep. China Taiwan Korea Canada Mexico Australia Philippines Malaysia Japan Hong Kong Indonesia USA Peru Chile Singapore Russia New Zealand Brunei Thailand Papua New GM food trade and asynchronous approval Growing market shares and trade of GM commodities Increasing pipeline of new GM crops and events Lack of policies and definitions Slow down import regulations 0% tolerance for imports of unapproved GM products Focus on implementation issues Codex Annex: simplified procedure Incentives to move forward 100% 80% 60% 40% 20% 0% 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Percentage of imported soybeans with potential LLP issues Percentage of imported maize with potential LLP issues Source: Gruere 2011

5 Policy options and decision making variables affecting economic welfare Policy Options 1. 0% tolerance level for unapproved GM products 2. A threshold (t %) low level presence policy % tolerance The potential risk of the product The price of the product The cost of enforcing the regulation Optimal Policy Option Source: Gruere, G

6 Some issues identified for consideration on the evaluation of economic welfare of LLPs Price Risk Cost of compliance Tolerance level Probability of rejection Timing of approval Premium differentials Tolerance level Trust in exporter regulations Availability Type of product and use Tolerance level Import volumes Cost structure enforcement Approval delays Enforcement capacity

7 Qualitative implications for key decision parameters identified in assessment studies of economic welfare 1. Tolerance level 2. Approval delays 3. Degree of confidence in domestic and exporter s regulation Increase in Price Risk Cost of implementation Total economic welfare Tolerance level or or Approval delay Confidence Best outcomes with high confidence & low delays, but the optimal tolerance level depends on tradeoff cost versus relative risk perceptions. Source: Gruere, G

8 Limitations to studies on the impact of low level presence policies Complex issue that requires extensive data to estimate impacts Data issues Production, prices, trade volumes, shares of affected imports Testing costs relative to volume Many available studies based on assumptions and relatively simple models Obtain an idea of qualitative direction and a sense of the magnitude of impacts with known limitations

9 Thousands USD Example from Developing Countries- soybean imports in Vietnam Economic welfare effects of a single unapproved GM soybean event in the United States and Canada only N(0.1,0.1) N(0.5,0.5) N(1,1) N(2.5,2.5) In average across simulations and range of assumptions, implementation cost for different tolerance levels are: 0% $18million, 1 % $4.1million, 5 % $580,000 per year Some, but not limited to, relevant question for a regulator could be: τ=0% τ=1% τ=5% Source: Gruere, G Is maintaining a 0% tolerance level - costing an average of $14 million morein order to address perceived safety concerns better than a 1 % presence of an unapproved event that has gone through safety authorization in the country of export? Is the 0% level worth roughly $17+ million more than a 5 % level?

10 Summary selected issues and policies related to economic welfare impacts of LLPs Option Probability trade disruption 0% LLP High High until approval Price Risk Cost Conclusions t % LLP Moderate Moderate Some variability and possible low risk 100% pass 0 0 Larger variability and potential risk Some variability Very high Valid if high perceived risk and no trust in export Moderate to high None Best solution from an economic perspective Valid if prices matter more than anything else Low level presence policies are valid intermediates between 0% tolerance level and 100% pass. Source: Gruere, G

11 Broader regulatory cost of compliance: Issues and Implications identified in existing studies Regulatory delays have a negative impact on returns to investments Projected trigger point is year 6 of regulatory delays for suspending a typical investment of$136 million in new R&D projects Average regulatory approvals of 48 months implies reaching suspension point likely Regulatory delays increase investment risk Uncertainty increases likelihood that an investment will not be made Source: Smyth, McDonald and Falck-Zepeda, 2013

12 Implications increases of cost of compliance for public goods in developing countries Cost are not as important, exceptions National research organizations International research systems developing public goods Small private firms Impact on the number/type of technologies More higher return products and less public good products? Source: Beyer, Norton and Falck-Zepeda 2010

13 Black Sigatoka Resistant Bananas in Uganda Considered irreversible and reversible costs and benefits for estimation With one year delay, forego potential annual (social) benefits of +/- US$200 million Photos credits: Kikulwe 2009 and Edmeades 2008 Source: Kikulwe, Birol, Wesseler and Falck-Zepeda 2011.

14 Summary LLPs are becoming an important trade issue Need to understand better asynchrony sources and the various approaches to manage LLPs Critical need for reliable information and data to make the best possible judgment on the way forward Different thresholds have different impacts More cost/benefit studies are needed Existing studies indicate that lower thresholds tend to have higher costs Cost of compliance with regulations can impact potential stream of technologies available to developing countries especially those of a public good nature

15 Potential issues for discussion How can we reduce asynchronicity? What are regulators and/or decision makers roles and responsibilities? How about developers/industry? Other stakeholders? Building trust in the system including regulations How can information sharing improve our ability to make decisions? Food/feed and environmental safety information sharing mechanisms and approaches Use of Codex Alimentarius guidelines? Use of FAO GM Foods Platform to share information for LLP situations? Other knowledge platforms i.e. Biosafety Clearinghouse? Finance additional data/information collection needed to examine relevant policy issue in more detail? Developing roadmaps to the exploration of realistic solutions to LLPs?

16 José Benjamin Falck-Zepeda, Ph.D. Senior Research Fellow / Leader Policy Team Program for Biosafety Systems IFPRI 2033 K Street NW Washington, DC USA j.falck-zepeda@cgiar.org Brief bio/pubs: Blog: Follow me on

17 References Bayer, J. C., G. W. Norton, and J. B. Falck-Zepeda Cost of compliance with biotechnology regulation in the Philippines: Implications for developing countries. AgBioForum 13(1): Gruere, G Asynchronous Approvals of GM Products and the Codex Annex: What Low Level Presence Policy for Vietnam?. International Food and Agricultural Trade Council Discussion Paper. Kikulwe, E.M., E. Birol, J. Wesseler, J. Falck-Zepeda A latent class approach to investigating demand for genetically modified banana in Uganda. Agricultural Economics. Smyth, S. and J. Falck-Zepeda Socio-economic Considerations and International Trade Agreements. Estey Centre Journal of International Law and Trade Policy by 14(1): Stein, A. and E. Rodriguez-Cerezo Low-Level Presence of New GM Crops: An Issue on the Rise for Countries Where They Lack Approval. AgBioForum. 13(2):