JOIN T D E PA RTM EN TA L D ISC U SSION PA PER 3 69830 AG R I C U LT U R E A N D R U R A L D E V E L O P M E N T & E N V I R O N M E N T D E PA R T M E N T S THE STATUS AND IMPACT OF BIOSAFETY REGULATION IN DEVELOPING ECONOMIES SINCE RATIFICATION OF THE CARTAGENA PROTOCOL Morven McLean, Mary-Ellen Foley, and Eija Pehu JUNE 2012 J O I N T D E PA R T M E N TA L D I S C U S S I O N PA P E R 3 THE STATUS AND IMPACT OF BIOSAFETY REGULATION IN DEVELOPING ECONOMIES SINCE RATIFICATION OF THE CARTAGENA PROTOCOL Morven McLean, Mary-Ellen Foley, and Eija Pehu © 2012 International Bank for Reconstruction and Development / International Development Association or The World Bank 1818 H Street NW Washington DC 20433 Telephone: 202-473-1000 Internet: www.worldbank.org This work is a product of the staff of The World Bank with external contributions. 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C O NT E NTS III TABLE OF CONTENTS Abbreviations and Acronyms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Chapter 1: Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Chapter 2: The Impact of the Cartagena Protocol on Biosafety Regulation . . . . . . . . . . . . . . 5 2.1 GEF-Funded Capacity Building for Implementation of the Protocol . . . . . . . . . . . . . . . . . . . . 5 2.2 Ongoing Assistance to Parties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Chapter 3: The Impact of Biosafety Regulation in Developing Countries . . . . . . . . . . . . . . . . 9 3.1 Biosafety Regulations Affecting Research and Development . . . . . . . . . . . . . . . . . . . . . . . 9 3.2 Biosafety Regulations Affecting Product Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3.3 The Role of Risk Assessment and Non-Safety Considerations in Biosafety Decision Making . . . . . .11 3.4 Asynchronous and Isolated Foreign Approvals of GE Crops. . . . . . . . . . . . . . . . . . . . . . . .13 3.5 The Cost of Biosafety Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 3.6 The Effectiveness of the Regulatory Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 Chapter 4: Opportunities to Advance Biosafety Regulation . . . . . . . . . . . . . . . . . . . . . . . . .17 4.1 Revisit the Context for Biosafety Regulation of GE Crops . . . . . . . . . . . . . . . . . . . . . . . .17 4.2 Rationalize Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 4.3 Consider Risk and Bene�t Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 4.4 Harmonize Biosafety Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 4.5 Integrate Capacity Building into Investment Programs . . . . . . . . . . . . . . . . . . . . . . . . . 22 References and Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 IV C ONTENTS LIST OF FIGURES Figure 3.1: Approvals of GE Events by Developing Countries since 2003 . . . . . . . . . . . . . . . . . . . . . . . . . .10 Figure 3.2: Approvals of GE Events by Developed Countries since 2003 . . . . . . . . . . . . . . . . . . . . . . . . . .11 LIST OF BOXES Box 1.1: Elements of a Functional Biosafety Regulatory System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Box 1.2: Key Drivers Affecting Biosafety Policy and Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Box 2.1: Project on Development of National Biosafety Frameworks . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Box 2.2: Projects Funded by the Global Environment Facility for Implementing National Biosafety Frameworks. . . . . 7 Box 3.1: The Case of Bt Brinjal in India . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Box 3.2: Examples of Non-Safety Considerations for GE Crop Approvals . . . . . . . . . . . . . . . . . . . . . . . . .12 Box 3.3: Costs in 10 Markets of Regulatory Approval of a GE Event Developed by the Private Sector . . . . . . . . . .13 Box 3.4: Examples of Regulatory Costs for GE Plants in the Philippines . . . . . . . . . . . . . . . . . . . . . . . . .14 Box 3.5: Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol . . . . . .14 Box 4.1: Example of Environmental Bene�ts from GE Crops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 Box 4.2: Regulatory Harmonization Efforts in West Africa. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Box 4.3: Harmonization between Canada and the United States Remains a Missed Opportunity . . . . . . . . . . . 21 LIST OF TABLES Table 3.1: Summary of Countries that have Approved at Least One GE Event for Environmental Release . . . . . . . .10 Table 4.1: GE Events Developed by Public Organizations and Approved for Environmental Release in at Least One Country . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 TH E STATUS A ND IMPACT OF BIOSA FETY R EGULATION AC K N OW L E DGE ME NT S V ACKNOWLEDGEMENTS This paper was prepared by the Center for Environmental Risk Assessment (CERA) at the International Life Sciences Research Institute (ILSI) Research Foundation on behalf of the World Bank. The study team was led by Morven McLean, Director, CERA with direct oversight and substantive input provided by Eija Pehu and Mary-Ellen Foley of the World Bank’s Agriculture and Rural Development (ARD) Department and the Environment (ENV) Department respectively. The team would like to extend their gratitude to the internal and external peer reviewers, acting in their personal capacity, for their valuable feedback and insight on the content of the biosafety regulation paper: Valerie Hickey, Biodiversity Specialist, World Bank; Willem Janssen, Lead Agriculturist, World Bank; Ruth Mackenzie, Senior Lecturer, International Law, University of Westminster; Stephen Mink, Lead Economist, World Bank; Robert Paarlberg, Professor of Political Science, Wellesley College; and, Robert Potter, Biotechnology Research Expert, Potter Consulting. The report was edited by Kelly Cassaday and the publication process was managed by Kaisa Antikainen. Their support is gratefully acknowledged. JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 VI A B B R EV IATIONS A ND AC R ONY M S ABBREVIATIONS AND ACRONYMS ABDC Agricultural Biotechnology in Developing Countries Conference Bt Bacillus thuringiensis CBD Convention on Biological Diversity CILSS Comité Permanent Inter Etats de Lutte contre la Sécheresse dans le Sahel (Permanent Committee for Drought Control in the Sahel) EC European Commission ECOWAS Economic Community of West African States EU European Union FAO Food and Agriculture Organization (of the United Nations) GE Genetically engineered GEAC Genetic Engineering Approval Committee GEF Global Environment Facility GM Genetically modified GMO Genetically modified organism INSAH Institut du Sahel (Sahelian Institute) LMO Living modified organism NBF National biosafety framework OECD Organisation for Economic Co-operation and Development R&D Research and development UNEP United Nations Environment Programme USA United States of America TH E STATUS A ND IMPACT OF BIOSA FETY R EGULATION E X E C U T I V E S UMMARY V II EXECUTIVE SUMMARY Common to all of the countries where genetically engineered (GE) crops are cultivated is a system to regulate these products and particularly to ensure their evaluation for human health and environmental safety (commonly referred to as biosafety) prior to any commercial release. This paper explores how the Cartagena Protocol to the Convention on Biological Diversity, as well as other important drivers, have affected the regulation of GE crops in developing countries. It examines the impact of biosafety regulation on research and development of GE crops and on product approvals. Finally, it identifies opportuni- ties to advance biosafety regulation in those developing countries that wish to access the potential benefits of agricultural biotechnology. The early adopters of GE crops, like the United States, Canada, and Argentina, developed regulatory systems to respond to the impending release of GE crops for cultivation. In most developing countries, however, the establishment of national biosafety regulatory systems was a by-product of the ratification of the Cartagena Protocol on Biosafety and its entry into force in 2003. The Cartagena Protocol is the only international environmental agreement that is concerned exclusively with products of modern biotechnology. Its interpretation and implementation have had a significant impact on biosafety regula- tion, especially in developing countries. Over the past decade, more than 140 developing countries or countries with transi- tional economies have received assistance to develop or implement national biosafety frameworks. Only a small number of developing countries have moved beyond these projects to operationalize their biosafety regulatory systems effectively, so that they may be considered functional—that is, they implement regulatory submission, assessment, and decision-making processes in a consistent, transparent, and predictable manner. As is true for capacity development in other regulatory arenas, progress in biosafety regulation in developing countries is often impeded by limited political and financial commitments from national governments and by insufficient technical, human resource, and institutional capacity for implementation. It is also confounded by competing or redundant capacity- building projects and the absence of products to regulate. Only a limited number of developing countries have substantive public sector research programs in agricultural biotechnology or are considered markets of interest for private sector invest- ments in this area. In effect, there is limited demand to drive regulatory development (or reform) forward, and policy makers’ attention is necessarily redirected to other priorities. Private sector developers of GE crops are generally disinterested in entering markets, even those in which farmers demand GE crops, unless the biosafety regulatory system is operational and predictable. More critically, public sector and donor initiatives that focus on improving the productivity of staple crops using biotechnology will be unsuccessful unless there is a clear path for improved crop varieties actually to move from laboratories to field trials to farmers. Even with these challenges, there are opportunities to advance biosafety regulation in ways that could particularly benefit developing countries. These opportunities include:  Revisiting the context for biosafety regulation of GE crops to ensure that both the risk assessment and any non-safety considerations that are used to inform decisions are not defined solely by environmental protection goals but also by other development priorities, such as improving agricultural productivity, food security, and rural development.  Rationalizing environmental risk assessment information and data requirements to focus exclusively on issues that are relevant to assessing plausible adverse environmental impacts of GE crops. Improved and cost-effective approaches to biosafety regulation generally, and risk assessment particularly, can be pursued without compromising environmen- tal protection and management goals.  Incorporating the assessment of environmental benefits of GE crops in agricultural ecosystems in addition to the stan- dard evaluation of potential adverse environmental impacts. JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 VIII EXEC UTIV E S UM M A RY  Aggressively pursuing harmonization of risk assessment requirements and processes between countries—for example, by recognizing scientific opinions arising from risk assessments by other regulatory authorities, establishing regional approaches to risk assessment, or, more ambitiously, adopting decisions taken by other governments where appropriate.  Improving biosafety capacity building so that it moves past the development of national biosafety frameworks and associated short-term technical training to pursue sustained commitments to operationalize, monitor, and improve the regulatory systems that are put into place. Capacity-building programs should promote the rationalization of biosafety regulation and opportunities to strengthen the scientific and knowledge base in ways that will provide benefits that extend beyond the often transient need for biosafety risk assessment and decision making. TH E STATUS A ND IMPACT OF BIOSA FETY R EGULATION C H A P T E R 1 — INT RODUCT ION 1 Chapter 1: INTRODUCTION The World Development Report 2010: Development and Genetically engineered (GE) plants, the most widely adopted Climate Change highlights the link between biotechnology, products of agricultural biotechnology, are strictly regulated development, and environment. Aside from recognizing bio- by governments internationally through the implementa- technology’s potential to improve crop productivity, increase tion of national biosafety regulatory systems (Box 1.1). The crop adaptation to climatic stresses such as drought, and impending release of GE varieties drove the establishment mitigate greenhouse gas emissions, the report emphasizes of national biosafety2 regulatory systems in developed coun- the need to establish science-based regulatory systems “so tries, but not in most developing countries. In those coun- that risks and benefits can be evaluated on a case-by-case tries, the establishment of biosafety regulatory systems was basis, comparing the potential risks with alternative tech- catalyzed when the Cartagena Protocol on Biosafety came nologies� (World Bank 2010). Safe access to new technolo- into force, along with associated capacity-building initiatives gies, including agricultural biotechnology, is also a strategic to assist the Parties in meeting their obligations under that goal articulated in the World Development Report 2008 international agreement. For many national governments, and Agriculture Action Plan (World Bank 2008, 2009). Its however, the operationalization of biosafety regulatory sys- importance was emphasized again in an array of documents tems that meet environmental and agricultural priorities prepared for the Agricultural Biotechnology in Developing remains elusive. Countries Conference (ABDC-10) convened by the Food and In 2003, the year the Cartagena Protocol came into force, Agriculture Organization (FAO), as well as in the final confer- the World Bank published a review of the key issues and ence report.1 policy options pertaining to the development and imple- All of these documents recognize that agricultural biotechnol- mentation of national biosafety systems, illustrated by ogies can contribute to poverty reduction and food security in country-specific examples of biosafety policies and prac- developing countries but that the adoption and deployment tices related to crop biotechnology. Since then circum- of products developed using the tools of modern biotechnol- stances have altered the political and regulatory context ogy need to be evaluated within a regulatory framework that of biosafety regulation (Box 1.2). With the objective of considers the potential environmental consequences of such exploring the impact of these circumstances, specifically in releases, including impacts on biodiversity. As a key conclu- developing countries, this document examines: sion of the ABDC-10 Report states, “Governments need to  The status of biosafety regulation since the 2003 develop their own national vision and policy for the role of World Bank review. biotechnologies, with options and opportunities examined  How implementation of the Cartagena Protocol has within the context of national economic, social, and rural sus- affected biosafety regulation. tainable development and environmental strategies, objec-  The impact of biosafety regulation on research, devel- tives, and programmes. � opment, deployment, and trade of GE crops. 1 Documents prepared for, and arising from, ABDC-10 are available 2 In this document, “biosafety� refers to actions taken to pro- at http://www.fao.org/biotech/abdc/backdocs/en/. Particularly rel- tect biodiversity, including agricultural biodiversity, through the � evant are: “Conference Report, (http://www.fao.org/fileadmin/ assessment and management of potential adverse impacts user_upload/abdc/documents/report.pdf); “Current Status and associated with the release of GE organisms in the environment. Options for Crop Biotechnologies in Developing Countries, � Note that this definition excludes the safety of foods and live- (http://www.fao.org/fileadmin/user_upload/abdc/documents/ stock feeds derived from GE organisms. Interestingly, biosafety crop.pdf); and “Policy Options for Agricultural Biotechnologies is not defined either in the Convention on Biological Diversity or in Developing Countries� (http://www.fao.org/fileadmin/user_ the Cartagena Protocol on Biosafety. upload/abdc/documents/policy.pdf). JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 2 CH A PTER 1 — INTR OD UC TION BOX 1.1: Elements of a Functional Biosafety Regulatory System A functional biosafety regulatory systema is a prerequisite for realizing the benefits that agricultural biotechnology can, and does, provide to poor producers and poor consumers in developing countries.b Environmental protection is the over- arching priority of any biosafety regulatory system, and confidence in the process and decisions that governments make on behalf of the public is a precondition for the acceptance and adoption of agricultural biotechnology products. There is no best model for a biosafety regulatory system. Each system is necessarily influenced by the social, cultural, economic, environmental, and related development objectives and priorities of a country. A number of common issues must be considered when establishing or revising a biosafety regulatory system, however. Elaboration of a national policy consistent with other objectives related to economic, social, and rural develop- ment; natural resource management; and environmental protection and sustainability. This policy forms the basis for the development of specific legislation and/or regulations, leading finally to the design and implementation of the structural elements necessary for risk analysis, inspection, monitoring, and enforcement. An assessment and gap analysis of the national development priorities, agricultural policies, existing regulatory regimes, and national and regional scientific and technical means necessary for a biosafety regulatory system to function. This national appraisal provides a means to identify and characterize available resources and regulatory infrastruc- tures, assess their adequacy for supporting a biosafety system, and identify gaps where capacities need to be strengthened. Building a strong base of scientific knowledge in support of the regulatory system and developing core competen- cies in biotechnology product evaluation. These activities allow an improved scientific basis for assessments of potential risks and/or benefits, and they strengthen the scientific capabilities for risk management, inspection, and monitoring. This scientific knowledge and skill base, however, needs to be supplemented with complementary capacities in the delivery of extension services and in the seed production and distribution system, particularly capacities that are public sector driven. The development of biosafety regulations to effect specific public policy goals (as articulated in a national bio- safety or biotechnology strategy). Decisions on an appropriate regulatory structure should be informed by the assess- ment and gap analysis as well as extensive consultation with stakeholders, including the public. This process is particu- larly vital if a country chooses to incorporate issues external to science (that is, issues other than those used to assess safety, such as economic, social, and/or ethical considerations) into its decision making. Implementation of regulations through the operationalization of the biosafety regulatory system. Generally, the central issues around the implementation of biosafety regulations involve the establishment of appropriate mech- anisms for risk assessment, risk management, and risk communication. Decisions made during the implementation phase impinge directly on the economic costs associated with assessing and mitigating risks and ensuring compliance. Important considerations include opportunities for international cooperation at a technical level (for example, sharing human and scientific resources and expertise) and establishing scheduled phasing-in of regulations (for example, initial voluntary guidelines entrenched in legislation over time). Addressing cross-cutting issues that are common to each stage in the development and implementation of a national biosafety system. These issues include public information and participation, which relate to the transparency of the regulatory system, and the degree to which the public has input either into the formulation of regulatory policy or into specific regulatory decisions. Human, financial, and infrastructure resources largely determine the scientific and administrative capacity of any country and so obviously influence any biosafety-related policy or program. Resources must be available to develop and implement a national biosafety system; to support the infrastructure required; to facilitate communication and public participation; to train scientific and regulatory personnel; and to foster the research required to assure that risk assessments are sound. These cross-cutting issues affect the implementation of the system designed to assess biosafety and, perhaps more importantly, those nontechnical factors that are crucial to public accep- tance and confidence in the decisions that are made by government on behalf of the people. Source: McLean et al. 2002; World Bank 2003. a. In this document, a biosafety regulatory system is considered functional when the regulatory submission, assessment, and decision-making processes are implemented in a consistent, transparent, and predictable manner. b. World Bank 2008. TH E STATUS A ND IMPACT OF BIOSA FETY R EGULATION C H A P T E R 1 — INT RODUCT ION 3 BOX 1.2: Key Drivers Affecting Biosafety Policy and Regulation RATIFICATION OF THE CARTAGENA PROTOCOL ON BIOSAFETY The Global Environment Facility (GEF) Council adopted the GEF Initial Strategy on Biosafety in November 2000. The strat- egy was aimed at assisting countries to prepare for the coming into force of the Cartagena Protocol on Biosafety through the establishment of national biosafety frameworks (NBFs). The entry into force of the Protocol in 2003 was followed by a marked acceleration in the number of countries that accessed resources through GEF-funded capacity-building projects (enabling activities) to develop national biosafety regulatory systems. DEVELOPING COUNTRY INVESTMENTS IN AGRICULTURAL BIOTECHNOLOGY Countries such as China, India, and Brazil have adopted policies that explicitly recognize the importance of agricultural bio- technology as a driver of their respective economies. Under these policies, significant innovation in agricultural research is taking place in the public sector. China and India have rich pipelines of both commodity and pro-poor GE crops in development and approaching commercialization. Brazil recently approved herbicide-tolerant soybean CV127-9, the first example of a GE product developed and commercialized through a public-private partnership (Embrapa and BASF). The fact that new product development of this kind is no longer the (almost) exclusive purview of private enterprises in the United States, Canada, and European Union has significant implications for both agricultural development and interna- tional trade. The imperative of at least some of the product development in countries like China and India is to meet domestic food needs. Considerations related to any trade disruptions that may result if unapproved GE products enter the global value chain may be considered incidental to achieving food security. APPROVAL AND LARGE-SCALE CULTIVATION OF GE CROPS IN MAJOR GRAIN-EXPORTING COUNTRIES From 2003 to 2010, the global area planted with GE crops doubled from 68 to 148 million hectares. In 2010, the United States, Brazil, Argentina, India, Canada, China, Paraguay, Pakistan, South Africa, and Uruguay accounted for 98% of the area planted to GE crops.a Major commodity exporters of maize, soybeans, and/or cotton cultivate GE varieties of these crops, and there is limited segregation of GE and non-GE harvests in these countries. Globally, governments have taken disparate approaches to regulating GE crops; the resulting asynchronicity in product evaluations and approvals can result in significant and costly trade disruptions.b For example, in 2009 trace levels of a GE maize eventc approved in the United States but not the European Union were detected in U.S. soy shipments, and 200,000 tons of soy was refused entry at European Union ports.d Situations like this will become more common as the number of GE crop and trait combinations increases. It has been estimated that over 120 different transgenic events may be commercialized worldwide by 2015, compared with approximately 30 GE events in commercially cultivated crops in 2008, and that half of them will be devel- oped and first approved in India, China, and Brazil.e CATALYSTS FOR NEW PRODUCT DEVELOPMENT Drivers such as agricultural adaptation to climate change, the food security crisis of 2008–09, and increasing demand for renewable energy have accelerated plant biotechnology research on a range of new traits and new plant species. Drought-tolerant maize, salt-tolerant rice, sorghum that uses nitrogen more efficiently, and soybeans with modified oil profiles are all expected to advance to commercialization within the next decade. Genetic engineering is being applied to improve existing plant sources of biomass for ethanol and biodiesel production and to modify less-familiar, non-food plant species for large-scale cultivation to meet growing demand for biofuel feedstocks. Novel traits for pest and disease resistance are being introduced into many plant species, and the use of these GE plants in integrated pest management systems increasingly is viewed as integral to sustainable agricultural production.f Source: Authors. a. James 2011. b. Magnier, Konduru, and Kalaitzandonakes 2009; Gruere 2009; Stein and Rodríguez-Cerezo 2010b. c. The term “event� is used in agricultural biotechnology to refer to each unique genotype produced from the genetic transformation of a plant species using a specific genetic construct. For example, two varieties of a plant species transformed with the same genetic construct constitute two events. Risk assessments and authorizations for commercial cultivation are for the particular event. This means that lines, varieties, or hybrids derived from an approved event through conventional plant breeding are also approved for the same uses. � d. “Blocking Biotech Feed Harms Farmers: EU Farm Chief, 2009. e. Stein and Rodríguez-Cerezo 2010a. f. Romeis, Shelton, and Kennedy 2008; Kos et al. 2009; Chandler et al. 2011; Naranjo 2011. JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 C H A P T E R 2 — T HE IMPACT OF T HE CARTAGEN A PR OTOC OL ON BIOSA FETY REGULATION 5 Chapter 2: THE IMPACT OF THE CARTAGENA PROTOCOL ON BIOSAFETY REGULATION A number of international agreements affect the regulation of The Protocol makes clear that Parties must develop or have GE crops in the same way that they influence the regulation access to the necessary capacities to act on and respond of other non-GE plants and plant products (for example, in the to their rights and obligations. These capacities are related areas of plant health or trade): Agreement on the Applications to legal and administrative matters, policy development and of Sanitary and Phytosanitary Measures; Agreement on implementation, decision making, and scientific analysis. Technical Barriers to Trade; Agreement on Trade Related Successful implementation of the Protocol is contingent Aspects of Intellectual Property Rights; and the International on the development of national biosafety capacity in Party Treaty on Plant Genetic Resources for Food and Agriculture. countries that have yet to establish, or are in the process of The most significant multilateral agreement, however, and establishing, biosafety frameworks. the only one that directly addresses biosafety regulation, The Protocol provides considerable flexibility in how Parties is a supplementary treaty to the Convention on Biological may meet their obligations with respect to decisions related Diversity (CBD), the Cartagena Protocol on Biosafety. to risk management and their implementation. Article 16, The Cartagena Protocol addresses the safe transfer, han- dealing with risk management, states that each Party has an dling, and use of living modified organisms (LMOs).1 It is obligation to establish and maintain appropriate mechanisms, the only international environmental agreement concerned measures, and strategies to regulate, manage, and control exclusively with products of modern biotechnology, and its risks identified in the risk assessment provisions. Parties interpretation and implementation have had a significant have agreed to carry out these risk management functions impact on biosafety regulation in developed and developing under the Protocol, but the Protocol does not specifically countries.2 The Protocol entered into force on September 11, prescribe how a country should fulfill this obligation. The 2003 and has been ratified by 161 countries.3 Protocol explicitly recognizes that developing country Parties and Parties with economies in transition require assistance Pursuant to Article 19, paragraph 3 of the CBD, the Protocol (Article 22), including financial support (Article 28), to imple- seeks to protect biological diversity from the potential risks ment the Protocol. posed by LMOs. It establishes an advance informed agree- ment procedure for ensuring that countries are provided with the information necessary to make informed deci- 2.1 GEF-FUNDED CAPACITY BUILDING FOR IMPLEMENTATION OF THE PROTOCOL sions before agreeing to import LMOs into their territory. The Protocol refers to a “precautionary� approach and reaf- Since 2000, when the Cartagena Protocol was adopted, the firms the precautionary language in Principle 15 of the Rio Global Environment Facility (GEF) has approved or endorsed Declaration on Environment and Development. The Protocol an array of capacity-building projects to assist eligible Parties:5 also establishes a Biosafety Clearing-House,4 an online portal  Six global projects, including the United Nations designed to facilitate the exchange of information on LMOs Environment Program (UNEP)-GEF Project on and assist countries in implementing the Protocol. Development of National Biosafety Frameworks (Box 2.1) and the UNEP-GEF Project for Building 1 A “living modified organism� is any living organism that possesses Capacity for Effective Participation in the Biosafety a novel combination of genetic material obtained through the Clearing-House of the Cartagena Protocol. use of modern biotechnology. “Modern biotechnology� means the application of: (1) in vitro nucleic acid techniques, including  Four regional capacity-building projects to promote recombinant deoxyribonucleic acid (rDNA) and direct injection of compliance with the Protocol. nucleic acid into cells or organelles, or (2) fusion of cells beyond the taxonomic family that overcomes natural physiological repro-  Fifty-four country-specific projects for the implementa- ductive or recombination barriers and that is not achieved through tion of national biosafety frameworks (NBFs) (Box 2.2). techniques used in traditional breeding and selection (Article 3). 2 A detailed explanation of the Cartagena Protocol is available in MacKenzie et al. (2003). 3 As of October 25, 2011. 5 � United Nations Development Programme, “Biosafety, 4 Biosafety Clearing-House, http://bch.cbd.int/. http://hqweb.unep.org/biosafety/, accessed April 22, 2011. JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 6 CHAPTER 2 — TH E IMPACT OF TH E C A RTAGENA PR OTOC OL ON BIOSA FETY R EGULATION BOX 2.1: Project on Development of National Biosafety Frameworks In 2001, the United Nations Environment Programme (UNEP) initiated the National Biosafety Framework (NBF) develop- ment project, which was designed to help signatories to the Protocol prepare to comply with its provisions. The NBF devel- opment project had three major activities: (1) to assist countries to establish their biosafety frameworks; (2) to promote information sharing and collaboration, especially at the regional and subregional level; and (3) to promote collaboration with other organizations to assist in building capacity to implement the Cartagena Protocol on Biosafety.a Implementation of the NBF development project required participating countries to follow a prescribed process. Phase 1 was Preparatory Activities and Gathering Information (months 1–6); Phase 2 was Analysis and Consultation (months 7–12); and Phase 3 was Preparation of Draft National Biosafety Framework (months 13–18),b according to a format proposed by UNEPc Participating . countries received a “toolkit� providing practical guidance for starting an NBF project (Phase 0) and the follow-on phases (1–3). The toolkit contained five modules prepared between 2001 and 2004.d The global nature of the NBF development project effectively guaranteed its impact: 123 countries have completed, or are participating in, the development of NBFs.e The effectiveness of UNEP’s approach—arguably necessitated by the scale of the project—can be questioned, however, if the measure of effectiveness is an active, operational regulatory system. For example, of 38 African countries that completed their NBFs, only 3 have taken decisions about the use of GE plants outside of containment facilities such as laboratories and greenhouses. Tanzania and Nigeria both authorized confined field trials (although Tanzania’s first approvals preceded its NBF development project), and Burkina Faso assessed and approved a GE plant for commercial release (insect-resistant cotton in 2008). This situation is representative of several circumstances: (1) an absence of applications for research and development (R&D), field trials, or commercial release of GE crops to “activate� nascent regulatory systems in many African countries; (2) insufficient resources to sustain biosafety regulatory systems in the absence of support from international donors such as the Global Environment Facility; and (3) the highly precautionary stance of some African countries, such as Zambia and Ethiopia, which developed NBFs or legislation to effectively limit access to living modified organisms.f These circumstances also apply to many developing countries outside of Africa. Source: Authors. � a. “UNEP Biosafety Development Projects, http://www.unep.org/biosafety/Development_Projects.aspx, accessed April 22, 2011. b. UNEP (2006). c. UNEP (undated). � d. “UNEP Toolkit for the Development Project, http://www.unep.org/biosafety/Toolkit.aspx, accessed April 22, 2011. e. Draft NBFs are available at http://www.unep.org/biosafety/National%20Biosafety%20frameworks.aspx, last updated 2 August 2010. . f. The Zambian Biosafety Law was passed in 2007 Ethiopia has a draft biosafety bill under consideration. See also Morris (2008). GEF grants for these projects have totaled US$ 105,394,357, others have also pointed out that tailoring interventions to with an additional US$ 94,271,107 of cofinancing.6 the specific country context is essential for projects to suc- ceed (Johnston et al. 2008; Chapotin, McLean, and Quemada In 2005, the GEF Office of Monitoring and Evaluation evalu- 2009; Araya-Quesada et al. 2010). Projects to build biosafety ated GEF support for biosafety capacity building (GEF 2006). capacity should utilize needs assessments and gap analyses While generally favorable to the projects, the report identi- to identify and prioritize interventions that will further the fied a number of limitations related to project design and operationalization of a functional regulatory system. Although implementation. The prescriptive, phased approach of the the NBF development project did include a requirement for NBF development project was considered “too ambitious in comprehensive stock-taking, countries were still expected to terms of high goals within limited time schedules, and it did use the same step-wise approach to complete the develop- not have a sufficient flexibility to adapt the level of funding ment of their NBFs, irrespective of the outcomes of national and the measures of required technical assistance to the needs assessments. For example, both the NBF development needs of each country� (GEF 2006:6). project brief and the project toolkit7 were commonly inter- This “one size fits all� approach to biosafety capacity build- preted by national subprojects and UNEP’s regional project ing is not unique to the NBF development project, and 7 Particularly Phase 3 Toolkit Module Part (I), “Developing the 6 GEF project and other databases, http://www.gefonline.org/, � Regulatory Regime, http://www.unep.org/biosafety/Documents/ accessed October 10, 2010. Drafting_the_NBF_Formulation_of_the_regulatory_regime.pdf. TH E STATUS A ND IMPACT OF BIOSA FETY R EGULATION C H A P T E R 2 — T HE IMPACT OF T HE CARTAGEN A PR OTOC OL ON BIOSA FETY REGULATION 7 BOX 2.2: Projects Funded by the Global Environment Facility for Implementing National Biosafety Frameworks The first 12 projects for implementing national biosafety frameworks (NBFs) assisted countries that had developed their biosafety regulatory frameworks prior to the Cartagena Protocol; the projects helped those countries to adapt and/or implement those frameworks to meet their obligations as Parties.a This effort included:b  Reviewing NBFs and drafting regulations and guidelines to support their implementation.  Making regulatory and administrative systems for handling applications and related biosafety matters operational.  Setting up decision-making mechanisms to handle applications for releases and transboundary movements of living modified organisms (LMOs).  Developing technical guidelines for risk assessment and risk management, monitoring, and enforcement.  Strengthening capacity for risk assessment/management, including setting up and/or improving and equipping special laboratories for this purpose.  Strengthening information systems on LMOs.  Enhancing public awareness, public education, and participation.  Setting up of biosafety databases for the purpose of the Biosafety Clearing-House. Countries had considerable flexibility in the design and execution of the projects, which had varying degrees of success. Six countries (China, Colombia, India, Kenya, Mexico, and Uganda) now have functional regulatory systems, but all 12 countries continue to be challenged to meet all of their Protocol obligations, such as the timely provision of required information to the Biosafety Clearing-House.c An additional 42 countries have transitioned, or are in the process of tran- sitioning, from NBF development projects to implementation projects.d Source: Authors. a. The 12 countries were: India and Colombia (projects implemented by the World Bank); Malaysia and Mexico (projects implemented by the United Nations Development Programme); and Bulgaria, Cameroon, China, Cuba, Kenya, Namibia, Poland, and Uganda (projects implemented by UNEP). The eight countries undertaking UNEP-coordinated projects had participated in the preceding UNEP-GEF Pilot Project on Development of National Biosafety Frameworks in 18 Countries, which ran from 1997 to 2000. See GEF (2000). b. GEF (2001). c. Article 20 of the Cartagena Protocol established a biosafety clearing-house to “facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, living modified organisms� (http://bch.cbd.int/protocol/text/article.shtml?a=cpb-20), accessed April 2012. d. GEF project database, http://www.gefonline.org/, accessed October 10, 2010. coordinators to require the development of new laws to that seek to support the development of biosafety regulatory regulate LMOs (GEF (2006:63–64). This perception resulted systems should explicitly require meaningful interministerial in the development of complex regulatory frameworks that consultation and a clear delineation of roles and responsibili- were inconsistent with the national capacities identified dur- ties between competent authorities. ing stock-taking reviews. Only a limited number of countries pursued alternative approaches, such as adapting their plant This type of interministerial coordination, while necessary, health and quarantine regulatory regimes as an interim mea- has been challenging to obtain in practice. As indicated dur- sure for meeting Protocol obligations in the short term. ing the 2003 Sub-Regional Workshop for Latin American Countries on the Development of a Regulatory Regime and International support for establishing biosafety regulatory Administrative Systems, the primary conflict identified for the systems has favored the creation of new regulatory entities implementation of NBFs was the coordination of administra- under ministries other than agriculture. The Protocol, and tive tasks and competencies of the institutions involved in more specifically the GEF-funded capacity-building projects them (UNEP 2003b). This challenge was stressed in a similar in support of the Protocol, has been particularly influential workshop for Asian countries, where it was noted that “much in this regard. The relationship of the Protocol to the CBD of the administrative system seemed to be in place in many means that national grants for NBF development and imple- countries, and that coordination was the major challenge mentation projects were provided largely to ministries of where different agencies were working separately� (UNEP environment. Agricultural biotechnology regulation intersects 2003a). For many countries, both developed and developing, the mandates and interests of multiple ministries, especially intragovernmental coordination on biosafety policy and regu- agriculture, but also ministries of science and technology, latory issues remains a challenge (CBD 2009; SCBD 2009; environment, health, and trade. Capacity-building projects Birner et al. 2007; Reddy 2009). JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 8 CHAPTER 2 — TH E IMPACT OF TH E C A RTAGENA PR OTOC OL ON BIOSA FETY R EGULATION 2.2 ONGOING ASSISTANCE TO PARTIES from national governments, and that technical capacity alone A report in 2010 summarized progress under the Action Plan is not sufficient to ensure effective biosafety regulation. for Building Capacities for the Effective Implementation of the The number of national, regional, and global programs imple- Protocol8 and the capacity-building needs of Parties (UNEP mented to build biosafety capacity over the past decade is 2010b). Based on a small pool of countries9 responding to a impressive, yet their collective effectiveness and particularly questionnaire prepared by the CBD Secretariat, an extensive their sustainable contributions to operationalizing biosafety list of capacity-building needs was identified, which generally regulatory systems are less so. This outcome can be attributed, corresponded to the elements of the Action Plan, such as at least in part, to an absence of project and program coordina- risk assessment, risk management, and scientific, technical, tion. While most donor organizations clearly view coordination and institutional capacity building. The questionnaire did not as a necessity, it is a challenge to identify a single country ask countries to identify critical constraints to the establish- where biosafety project coordination has been achieved suc- ment of functional regulatory systems versus less imperative cessfully. For example, the Capacity-Building Coordination “needs� (such as the construction of contained greenhouses), Mechanism under the Cartagena Protocol “allows Parties, so priorities for capacity building were not established. Parties other governments, relevant organizations and donors involved are supposed to provide national reports on capacity-building in implementing and/or funding biosafety capacity building needs and priorities to the CBD Secretariat, but compliance initiatives to share information and experiences on their ongo- with this requirement has been limited.10 As with results from ing initiatives; exchange resource materials and information the questionnaire, national reports have identified an array of about existing capacity-building opportunities; identify key capacity-building needs and have only in some cases priori- biosafety capacity building issues and priority needs and ways tized them as immediate, medium-term, or longer-term priori- to address them; and identify overlaps and potential areas for ties (UNEP 2010a). Prioritization should be a required element collaboration, 13 but it does not actively foster “coordination � of all assessments of biosafety capacity needs; without this and interaction between those involved in biosafety capacity- necessary contextual information, managers of capacity-build- building activities� (UNEP 2007; Johnston et al. 2008). ing projects are left to determine where to focus interventions. Coordination is typically considered a responsibility of the Of the many ongoing national, bilateral, and multilateral proj- various organizations that fund or deliver biosafety capacity- ects to build biosafety capacity, some are linked directly to building programs, which may be exactly why effective project the Protocol (as with the GEF implementation projects), and coordination has remained elusive. Many donors and imple- others seek to improve the capacity of developing countries menting agencies with divergent mandates, objectives, and to access, develop, or evaluate GE crops.11 Most projects political agendas operate within countries or regions, and it is focus on developing biosafety regulatory systems and/or unrealistic to expect that they will all work together. Instead, provide technical support, particularly in risk assessment the responsibility lies with national governments to ensure and risk management. Recent reports have recommended that capacity-building programs are designed and delivered an assortment of improvements to make biosafety capacity to meet pressing national priorities in a cohesive, strategic building more effective.12 The reports all recognize that stra- manner. This level of oversight requires the various ministries tegic, longer-term programs are necessary, that sustainable involved in implementing an NBF to work collaboratively to progress requires both political and resource commitments develop a national plan for capacity building. The implementa- tion process for such a plan should incorporate mechanisms 8 “Action Plan� (for Building Capacities for the Effective Implemen- tation of the Cartagena Protocol on Biosafety), http://bch.cbd.int/ for carefully analyzing project goals and projected impacts protocol/cpb_art22_actionplan.shtml. before projects are accepted, as well as for ex post assess- 9 The countries that had responded by June 2010 were Benin, ments of project effectiveness and sustainability. An approach Côte d’Ivoire, Croatia, Dominican Republic, Egypt, Latvia, Lithu- ania, Mexico, Niger, Nigeria, Poland, Republic of Moldova, Saint like this might ensure that the national plan is revisited and Lucia, Togo, and Venezuela. revised based on a regular evaluation of progress. It may also 10 National reports have been submitted by Barbados, Bulgaria, potentially require ministries to forgo funding or projects that Cameroon, China, Costa Rica, Croatia, the Former Yugoslav Republic of Macedonia, India, Kenya, Panama, Qatar, Syria, do not align with the plan, which may be an unrealistic expec- Uganda, and the United Republic of Tanzania; see UNEP (2010b). tation for governments with severe resource constraints. 11 Biosafety capacity-building projects have been the subject of recent reviews. See Johnston et al. 2008; UNEP (2010a,b); John- ston et al. (2008). 13 “The Capacity-Building Coordination Mechanism� [for the 12 See Chapotin, McLean, and Quemada (2009); Araya-Quesada et Action Plan], http://bch.cbd.int/protocol/cpb_art22_actionplan al. (2010); Johnston et al. (2008); UNEP (2010a). .shtml#coord. TH E STATUS A ND IMPACT OF BIOSA FETY R EGULATION C H A P T E R 3 — T HE IMPACT OF BIOSAF E T Y REG U LATION IN D EVELOPING COUNTR IES 9 Chapter 3: THE IMPACT OF BIOSAFETY REGULATION IN DEVELOPING COUNTRIES 3.1 BIOSAFETY REGULATIONS AFFECTING process as for commercial releases, demonstrating that RESEARCH AND DEVELOPMENT regulators, national biosafety committees, and sometimes The early stages of developing a GE crop (consisting essen- capacity builders and trainers do not appreciate that the tially of laboratory and greenhouse work) are constrained risk mitigation measures used to confine these trials render only nominally by biosafety regulations but quite significantly more extensive environmental risk assessments unneces- by the scarcity of funds to pursue such a program. National sary. A detailed risk assessment is more correctly applied to agricultural research systems commonly suffer from inad- the environmental release of GE events outside of confine- equate investments even in their traditional research and ment. This misperception has been exacerbated by the fact development (R&D) programs. A transgenic research pro- the Cartagena Protocol does not differentiate between these gram requires capital-intensive investments in laboratory and two distinct activities1 and, as a consequence, many NBFs greenhouse infrastructure and sustained funding to support do not either. GE crop development cannot advance past the research operations, including training and retention of sci- laboratory stage unless biosafety regulatory systems permit entific personnel. The need for sustained, significant invest- the confined field evaluation of GE plants of uncertain risk. ment applies not only to the transformation and regeneration work that leads to the development of GE events but to the follow-on programs essential for GE crop R&D, particularly 3.2 BIOSAFETY REGULATIONS AFFECTING plant breeding. Insufficient or transient investments in R&D, PRODUCT APPROVALS along with other systemic limitations in policies related to To date, 16 countries plus the European Union have autho- agricultural research (intellectual property rights, for example, rized GE events for environmental release2 (Table 3.1). or participatory approaches to establishing research pri- Another 8 countries (Czech Republic, El Salvador, Malaysia, orities) collectively make it almost impossible for low-income the Netherlands, Russia, Switzerland, Taiwan, and the United countries to pursue basic research for GE crop development. Kingdom3) have approved at least one GE event for use in food and/or livestock feed. In the later stages of GE crop development (field research), however, biosafety regulations have a significant impact. Since 2003, when the Cartagena Protocol came into force, Without exception, national biosafety regulatory authorities only three developing countries have further assessed require permits to conduct confined field trials of experimen- and approved GE crops for cultivation for the first time tal GE crops. These small-scale trials of experimental plants (Table 3.1) although the number of events approved glob- are essential to the collection of biosafety data for regulatory ally has been increasing (Figures 3.1 and 3.2) (Stein and dossiers. They also provide an opportunity to evaluate agro- nomic performance in general, ascertain the efficacy of the 1 The Protocol differentiates between contained use (exempt particular GE trait (information that is necessary for selecting from the advance informed agreement procedure) and inten- tional introduction into the environment (the advance informed the most promising events), and generate sufficient plant agreement procedure applies). A confined field trial may be con- material for required food safety and livestock feed safety sidered as an intentional introduction into the environment and analyses. The confined nature of these trials is achieved consequently the risk assessment procedures of Article 15 and Annex III apply. through a number of management practices that are usually 2 Other countries, such as Bolivia, Honduras, and Pakistan, have prescribed by the permitting authority. been identified as permitting the commercial cultivation of GE crops; however, regulatory authorizations in these countries have Highly restrictive requirements for confined field trials have yet to be publicly disclosed by the competent authorities. Coun- tries such as Chile and Costa Rica have permitted the cultivation been a common feature of developing country regulatory of GE events for counter-season seed production for export but systems, and they have limited product developers’ ability differentiate this activity from commercial cultivation, as none of to conduct field research (Spielman, Cohen, and Zambrano the harvest is permitted to stay in the country. 3 Approvals in the Netherlands (1997) and the United Kingdom 2006). A common misunderstanding is that confined field tri- (1996 and 1997) occurred prior to the implementation of EU als should be subject to essentially the same risk assessment regulations. JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 10 CH A PTER 3 — TH E IMPACT OF BIOSA FETY REGULATION IN D EVELOPING C OUNTR IES TABLE 3.1: Summary of Countries That Have Approved at Least One GE Event for Environmental Release TOTAL LINES YEAR OF FIRST APPROVED TO APPROVAL COUNTRY FIRST LINE(S)a APPROVED DATEa CROPS APPROVED TO DATE 1992 United States Delayed-ripening tomato 81 Canola (Brassica napus), chicory, cotton, flax (linseed), maize, papaya, plum, potato, rice, soybean, sugar beet, tobacco, tomato 1995 Australia Modified flower color carnation 16 Canola (B. napus), carnation, cotton 1995 Canada Herbicide-tolerant canola 60 Alfalfa, canola (B. napus, B. rapa), flax (linseed), maize, potato, soybean, sugar beet 1995 Mexico Delayed-ripening tomato 3 Cotton, maize, soybean 1996 Argentina Herbicide-tolerant soybean 20 Cotton, maize, soybean 1996 European Union Male sterile chicory 7 Carnation, chicory, maize, potato 1996 Japan Delayed-ripening tomato; herbicide- 55 Alfalfa, canola (B. napus), cotton, maize, tomato, soybean, tolerant soybean; insect-resistant maize sugar beet 1997 South Africa Insect-resistant maize; insect-resistant 11 Cotton, maize, soybean cotton 1997 Uruguay Herbicide-tolerant soybean 8 Maize, soybean 1997 China Insect-resistant cotton ?b Cotton, maize, rice 1998 Brazil Herbicide-tolerant soybean 22 Cotton, maize, soybean 2000 Colombia Modified flower color carnation 4 Carnation, cotton, maize 2002 India Insect-resistant cotton 3 Cotton 2002 Philippines Insect-resistant maize 5 Maize 2004 Paraguay Herbicide-tolerant soybean 1 Soybean 2008 Korea Insect-resistant maize 2 Maize 2008 Burkina Faso Insect-resistant cotton 1 Cotton Source: CERA 2011 (GM Crop Database). a. “Lines� includes primary events developed through genetic engineering and stacked events derived through conventional crossing of primary events. b. The absence of transparency in decisions taken by the Chinese government prevents an accurate accounting of the number of approved lines. FIGURE 3.1: Approvals of GE Events by Developing Countries since 2003 10 Argentina 9 Brazil 8 Number of events approved India 7 South Africa 6 Korea 5 Burkina Faso 4 Colombia 3 Philippines 2 Paraguay Uruguay 1 0 2003 2004 2005 2006 2007 2008 2009 2010 Year Source: CERA 2011 (GM Crop Database). TH E STATUS A ND IMPACT OF BIOSA FETY R EGULATION C H A P T E R 3 — T HE IMPACT OF BIOSAF E T Y REG U LATION IN D EVELOPING COUNTR IES 11 FIGURE 3.2: Approvals of GE Events by Developed Countries since 2003 10 Australia 9 Canada 8 Number of events approved Japan 7 USA 6 EU 5 4 3 2 1 0 2003 2004 2005 2006 2007 2008 2009 2010 Year Source: CERA 2011 (GM Crop Database). Rodriguez-Cerezo 2010a; CERA 2011). While it would Biotechnology4 or under the auspices of the Cartagena appear that the majority of the world’s countries have been Protocol, have established risk assessment benchmarks attempting to establish biosafety regulatory frameworks, that are commonly imbedded in national regulatory sys- only a minority have made, or had an opportunity to make, tems. Arguably, it is not the risk assessment in itself that biosafety regulatory systems operational, and even fewer has led to the adoption or non-adoption of GE crops on a have taken decisions relative to commercial approvals of country-by-country basis, but factors other than safety, as GE crops or foods. discussed below.5 Economic, social, and other non-safety concerns are often 3.3 THE ROLE OF RISK ASSESSMENT AND the most important considerations in the public’s acceptance NON-SAFETY CONSIDERATIONS IN BIOSAFETY of new biotechnology applications. Consequently they can DECISION MAKING play a determining role in whether a government approves a GE event for commercial use (Box 3.1). National biotechnology policies must integrate an array of political, social, ethical, health, economic, and environmental When examining how non-safety considerations are considerations and translate these into a strategy for how addressed in national biotechnology policy, it helps to dif- decisions will be made regarding the safe and appropriate ferentiate policies related to promoting or guiding innovation use of biotechnology methods and products. from those related to the commercialization of biotechnology National biosafety regulatory systems include a science- based risk assessment process as a prerequisite to com- 4 OECD, “Environmental Biosafety, � http://www.oecd.org/ mercialization of a GE event. The national, regional, and document/10/0,3746,en_2649_34385_47257482_1_1_1_1,00 international approaches for assessing the risk of GE crops .html, accessed April 2012. 5 In this document, “non-safety� issues include all regulatory currently in use vary in their application of legislative trig- issues required to be addressed by developers of a GE event gers, guidance, and terminology (World Bank 2003). Some that go beyond issues of evaluation of potential harm to human, approaches are highly prescriptive, whereas others offer animal, and plant health and the receiving environment. Such non-safety issues have primarily focussed on the economic and greater flexibility to regulatory agencies and decision mak- socio-economic impacts from the cultivation of transgenic crops, ers. Internationally developed standards or guidance for bio- such as the loss of export markets, increased costs of commod- safety risk assessment, as developed by the Organisation for ity segregation, or the reduction of product value through com- mingling. Other non-safety issues may be considered in regula- Economic Co-operation and Development (OECD) Working tory decision making, however, such as ethics, culture, or public Group for the Harmonization of Regulatory Oversight in opinion. JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 12 CH A PTER 3 — TH E IMPACT OF BIOSA FETY REGULATION IN D EVELOPING C OUNTR IES BOX 3.1: The Case of Bt Brinjal in India BOX 3.2: Examples of Non-Safety Considerations for GE Crop Approvals Transgenic brinjal (eggplant, Solanum melongena) was developed by the Indian seed company, Mahyco, to con- Although functional regulatory systems are largely fer resistance to the Lepidopteran pest Leucinodes orbo- science based, product commercialization may be nalis (fruit and shoot borer). In October 2009, India’s apex determined by other factors, as seen in the following regulatory authority, the Genetic Engineering Approval examples. Committee (GEAC), approved Mahyco’s Bt brinjal event Argentina: An explicit review of the economic impact EE1 for environmental release and use in food and feed on national agricultural production and marketing is after three years of deliberation, including two expert included prior to GE crop approvals. This review is sepa- panel reviews of the safety-related data submitted to rate from the food and environmental safety risk assess- GEAC by Mahyco. As the first transgenic food crop to be ment and is required only for commercial cultivation. approved in India, Bt brinjal was extremely controversial and was popularly characterized in the media as unsafe Australia: State and Territory governments have author- for human health and the environment. Immediately fol- ity over land use and have used it to institute moratoria lowing GEAC’s approval of Bt brinjal, India’s Minister of on the cultivation of certain approved GE crops, primarily Environment and Forests undertook a series of regional based on economic considerations. consultations and additionally reached out to the inter- European Union: Member countries have invoked a national scientific community to solicit opinions on safeguard clause to prohibit cultivation of certain GE the safety of Bt brinjal. In February 2010, the Minister events, citing potential risks. They have maintained took the unprecedented action of ignoring GEAC’s risk the prohibition even after the European Food Safety assessment and decision to approve Bt brinjal when Authority has provided scientific opinions that the risks he unilaterally placed a moratorium on its commercial are not significant. release. The Minister stated, “It is my duty to adopt a cautious, precautionary principle–based approach and South Africa: The Genetically Modified Organism impose a moratorium on the release of Bt-brinjal, till such Amendment Act, passed in 2006 to give effect to the time independent scientific studies establish, to the sat- Cartagena Protocol, requires the inclusion of both safety isfaction of both the public and professionals, the safety and socio-economic considerations in product-specific of the product from the point of view of its long-term decision making. The criteria for assessing the socio- impact on human health and environment, including the economic impacts of a GE crop release have yet to be rich genetic wealth existing in brinjal in our country.� clearly described in guidance, yet non-safety consider- Source: Authors; MoEF 2010a,b. ations are affecting product approvals. In 2009, South Africa’s Executive Council for Genetically Modified Organisms rejected a permit application for the general products. In the case of innovation policy, ethical, moral, release of SpuntaG2, a potato that is resistant to the social, and economic concerns all influence policy delibera- potato tuber moth. SpuntaG2 was jointly developed tions through dialogue and debate at the national level. In the by the South African Agricultural Research Council and case of commercialization, market and trade considerations Michigan State University specifically for smallholder are the most significant drivers, and they are influenced by farmers. The Executive Council indicated its primary national priorities as well as international trade-related agree- reason for not authorizing the potato “had to do with ments, such as the agreements on Sanitary and Phytosanitary the fact that both commercial and small-scale farmers Measures and Technical Barriers to Trade and the Biosafety will be unlikely to switch to the GM potato. a Potatoes � Protocol, which limit the types of non-safety considerations SA, representing the South African potato industry, that can be legitimately used to affect trade in biotechnology opposed the release of SpuntaG2 on the grounds that it products. Technological innovations in agricultural biotechnol- would affect domestic consumption of potatoes as well ogy have not been subject to the same degree of scrutiny or as international trade, particularly with the European government intervention as, for example, research into stem Union. cells. Instead, it is the products of agricultural biotechnology Source: Authors. research, and not the research itself, that have been most a. Mannak (2009). affected by non-safety considerations (Box 3.2). TH E STATUS A ND IMPACT OF BIOSA FETY R EGULATION C H A P T E R 3 — T HE IMPACT OF BIOSAF E T Y REG U LATION IN D EVELOPING COUNTR IES 13 3.4 ASYNCHRONOUS AND ISOLATED FOREIGN 3.5 THE COST OF BIOSAFETY REGULATION APPROVALS OF GE CROPS It is widely held that biosafety regulation is a significant Differences in governments’ approaches to biosafety regu- constraint to realizing the benefits that GE crops may afford lation and decision making can have significant impacts on developing countries, both in terms of the direct costs of global trade. One example is the effects of asynchronous and meeting regulatory requirements and in terms of the indirect isolated foreign approvals (see also Box 1.2). or opportunity costs. Such costs may include forgone profits to farmers, product developers, and other actors in the agri- Asynchronous approvals occur when a country of export cultural production and value chains; costs associated with approves a GE event for cultivation before its trade partners the use of alternative crop production practices and their have done so, meaning that seed or commodity exports may environmental impacts; and market or trade disruptions. High contain GE events not yet approved by the recipient coun- regulatory costs such as those reported in Box 3.3 impede try.6 In such cases, the exported shipment is deemed by the both innovation and commercialization of GE technologies by importing country to have regulated or “illegal� content, and all but the large multinational companies and, in particular, it may be embargoed or returned to the point of origin. To exert a chilling effect on research in minor crops, such as pro- avoid this problem, private sector product developers seek poor staple food crops, and in countries where market size approvals in key markets and delay large-scale commercial cannot justify the fixed-cost investments (Qaim 2009). cultivation until they are obtained. The least efficient regula- tory system becomes rate limiting, and delays of even one year between approvals in key markets can mean tens of millions of dollars in lost revenue. BOX 3.3: Costs in 10 Markets of Regulatory Approval of a GE Event Developed by the Private Sector Isolated foreign approvals occur when a product developer that has received approval of a GE event for cultivation in one Direct compliance costs to obtain regulatory approval country has no intention to seek approval in other areas of of a private sector–developed GE event in 10 markets the world. For example, the Government of China has made (Argentina, Australia, Canada, China, the European Union, no submissions to other national regulatory authorities for Japan, Korea, the Philippines, Taiwan and the United approvals of GE crops that it has developed for its domestic .1 States) were estimated to range from US$ 7 million market and that are currently in cultivation. Isolated foreign to US$ 14.4 million for insect-resistant maize and US$ approvals may prove a more challenging reality to address 6.2 million to US$ 14.5 million for herbicide-tolerant than asynchronous approvals. Governments in countries of maize.a The differences in costs across product develop- import will have to decide to either forgo testing of commod- ers were attributed to: ity or seed shipments that could potentially contain unap-  Different strategies taken as product developers proved events understood to be in widespread cultivation in attempted to anticipate the effect of evolving the country of export (in other words, don’t look for what you regulatory guidance (for example, the appropriate don’t want to find) or implement extensive and expensive number of confined field trials required for data testing programs and take action (such as a trade embargo) if generation or the kinds of studies that should be unapproved events are discovered. submitted in the regulatory dossier).  Costs associated with specific types of test- 6 The presence of unapproved GE events in seed, food, and feed ing, including production of plant tissue for exports can also arise when: (1) GE seed is smuggled into a coun- analyses, compositional assessment, protein try and cultivated illegally in absence of any regulatory approvals production and characterization, and molecular (one example is the illegal cultivation of GE cotton in India before 2002; see Sadashivappa and Qaim 2009); (2) when an event is characterization). released accidentally into the value chain (for example, the detec-  Overhead costs for facilities and management. tion in commercial rice samples of GE rice event LL601, grown in field trials from 1998 to 2001 in the United States but never These costs did not take into account indirect compli- submitted for regulatory approval, affected the United States rice export market; see Li et al. 2010); or (3) when there are asyn- ance costs associated with early research and develop- chronous approvals within a country (StarLink maize, approved ment or unanticipated delays that can arise during the in the United States for use in livestock feed but not for human consumption, was detected in processed maize food products, regulatory approval process. resulting in food recalls and lost sales of United States maize to Source: Authors. markets like Japan and South Korea; see Taylor and Tick 2001). a. Kalaitzandonakes, Alston, and Bradford (2007). JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 14 CH A PTER 3 — TH E IMPACT OF BIOSA FETY REGULATION IN D EVELOPING C OUNTR IES It is a reality that public sector product developers, like their prior to the commercialization of any new GE event and to private sector counterparts, must contend with the costs of meet applicable regulatory requirements in these key mar- bringing a GE product to commercialization in a global mar- kets (BIO 2007). While this consideration is also valid for ketplace (Box 3.4). These costs are often cited as the primary product developers in the public sector, it will add costs to deterrent for public sector investments in agricultural bio- product development and commercialization. An alternative technology, especially in developing countries (Qaim 2009; to individual product developers seeking country-by-country Graff, Hochman, and Zilberman 2009). approvals is to encourage national governments to adopt regional approaches to biosafety risk assessment and possi- In addition to costs associated with meeting biosafety regu- bly decision making, which could mitigate some of the costs latory requirements in the country where a GE event is to and potential consequences of inter-country movement of be cultivated, product developers must also consider the GE events (see Chapter 4). Regional approaches may be potential consequences of unanticipated actions, such as particularly helpful to developers of pro-poor crops, which trade disruptions that can occur as a result of accidental, or because of their particular traits or farmers’ preferences may sometimes deliberate but illegal, transboundary movement already have limited geographic distribution (in other words, of GE seed from a jurisdiction where it is approved for cul- they are not globally traded commodity crops like soybeans, tivation to one where it is not (Box 3.5). This consideration maize, or rice). is particularly significant in relation to developing countries, where border controls restricting the movement of viable BOX 3.5: Nagoya-Kuala Lumpur Supplementary plant material may be limited and where seed of improved Protocol on Liability and Redress to the varieties is commonly informally exchanged within and Cartagena Protocol across borders. The major multinational product developers have adopted product launch policies to undertake a mar- In October 2010, the Nagoya–Kuala Lumpur Supple- ket and trade assessment to identify key import markets mentary Protocol on Liability and Redress to the Cartagena Protocol was adopted. This Supplementary BOX 3.4: Examples of Regulatory Costs for GE Plants Protocol was the culmination of six years of contentious in the Philippines discussion about how liability and redress for damage to biological diversity resulting from the transboundary Direct regulatory costs for four GE events (Bt egg- movement of living modified organisms (LMOs) should plant, virus-resistant tomato, Bt rice, and virus-resistant be managed. The Supplementary Protocol provides inter- papaya) currently being advanced by public institu- national rules and procedures that countries may incor- tions in the Philippines were reported to range from porate as they develop their own national approaches to US$ 249,500 to US$ 690,680.a These costs are signifi- establishing compensation mechanisms. It remains to cantly lower than the USD $2.6 million estimated for the be seen how the Supplementary Protocol will be imple- technical and commercial development of Monsanto’s mented and how it will interact with other international insect-resistant maize event MON810 in the Philippines. treaties on trade. The private sector has developed a The discrepancy can be attributed to the fact that the contractual mechanism, the Compact, which provides direct costs for the four public sector events are for a very States with recourse in the event of damage to biologi- limited set of activities taking place in the Philippines cal diversity caused by LMOs. It has been signed by the and exclude research and development, technology six major multinational developers of GE plants and is transfer, and compliance testing for these events or their open to other private or public organizations that meet novel proteins that took place outside of the Philippines the requirements for membership, which includes the or had already been completed for like products. The financial capacity to respond to damages. Neither the cost for MON810 commercialization in the Philippines Supplementary Protocol nor alternative mechanisms reflected the studies and activities conducted from the for dealing with liability and redress, like the Compact, gene discovery phase to the first set of laboratory and alleviate the post-commercial costs that a public sec- greenhouse experiments in the United States, as well tor product developer may consider when deciding to as in-country costs.b pursue the development of GE crops (or a government Source: Authors. may consider when allocating resources to agricultural a. Bayer, Norton, and Falk-Zepeda (2010). b. Manalo and Ramon (2007). research and development). Source: Authors. TH E STATUS A ND IMPACT OF BIOSA FETY R EGULATION C H A P T E R 3 — T HE IMPACT OF BIOSAF E T Y REG U LATION IN D EVELOPING COUNTR IES 15 3.6 THE EFFECTIVENESS OF THE REGULATORY of licenses or permits that they have issued, information PROCESS about compliance infractions resulting from inspections, The costs of meeting regulatory requirements leading to and (most commonly) summary decisions about GE event the commercialization of a GE event can be quantified, but risk assessments or authorizations for commercial use it is much more challenging to measure the effectiveness which demonstrate, at least in part, the outcomes of these of a biosafety regulatory system in meeting its objectives. regulatory activities. These sorts of information are poor Over the course of the development continuum for a GE metrics for evaluating the effectiveness of a biosafety regu- product, biosafety regulatory authorities have multiple latory system, however. If regulatory processes provide real points of engagement, including but not limited to: permits value—for example, in providing significant environmental for importation of experimental plant materials; licensing safeguards—then the monetary costs of their implemen- of R&D facilities where recombinant DNA research takes tation may be considered justified. If these interventions place; permits for confined field trials; pre-market environ- are redundant with other regulatory operations, are applied mental, food, and feed safety assessments and approvals/ inconsistently or discriminately, or are used as barriers to disapprovals; post-market environmental monitoring; and technological access, innovation, or trade, then biosafety inspection and enforcement activities during all of these regulation is significantly more costly than described in stages. Regulatory authorities often publish the number Section 3.5. JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 C H A P T E R 4 — OP P ORT UNIT IE S TO ADVANCE BI O SA FETY REGULATION 17 Chapter 4: OPPORTUNITIES TO ADVANCE BIOSAFETY REGULATION Maintaining crop productivity at current levels is already chal- 4.1 REVISIT THE CONTEXT FOR BIOSAFETY lenged by urbanization and its attendant competition for land REGULATION OF GE CROPS and water, increasing demand for non-food products (such Ratification and implementation of the Cartagena Protocol as feedstocks for biofuels), access to water for irrigation, and have significantly raised both the profile and importance of limited scope for agricultural land expansion without signifi- biosafety regulation as a contributing element to biodiversity cant negative impacts on biodiversity. These challenges will conservation. As discussed, the Protocol has also situated the be exacerbated by the impact of climate change, particularly biosafety of LMOs, first and foremost, as an environmental in developing countries, where crop yields are projected issue, which affects how biosafety is considered by national to remain static or decrease by as much as 14 percent in governments as they attempt to meet their Protocol obliga- irrigated rice and 28 percent in irrigated wheat, with sub- tions. Biosafety is typically the responsibility of ministries of Saharan Africa and South Asia being particularly hard hit environment and natural resources, as evidenced by the fact across most important crop species (Nelson et al. 2009). that 71 percent of the national focal points for the Cartagena Agricultural adaptation to constraints on production requires Protocol are situated in ministries of environment and natu- many kinds of interventions, and one of the most important ral resources (11 percent are in ministries of agriculture and is the ability to maintain, let alone increase, crop yields under 17 percent in other ministries) (SCBD 2011). current and future biotic and abiotic stress scenarios. The breeding and selection of adapted plant varieties require inte- GE crops, the only significant class of LMOs in international grated approaches ranging from conventional breeding with trade, are by default the organisms first considered when landraces and crop wild relatives to more advanced methods developing country governments establish and implement such as marker-assisted selection and genetic engineering. biosafety regulatory systems. The challenge, however, has been to ensure that the regulatory context for these crops is Biosafety regulation, properly applied, should provide devel- relevant to their use in agriculture. More specifically, both the oping countries that choose to access the potential benefits risk assessment and any non-safety considerations that are of agricultural biotechnology with an effectual process for used to inform decisions should not be defined exclusively doing so. As described in Chapters 1 and 2, however, only by environmental protection goals but by additional develop- a small number of the many developing countries that have ment priorities, such as improving agricultural productivity, developed NBFs have operationalized them, and even fewer food security, and rural development. have actually taken biosafety-related decisions such as permitting confined field trials or authorizing GE events for Many countries have framed biosafety regulatory systems to cultivation. As noted in the conference report from ABDC-10: consider GE crops only in the narrow context of environmen- tal harm. In some cases, this was a deliberate action in sup- Both the lack of policies and regulatory mechanisms as port of a policy decision to ban GE crops. In others, it was per- well as overly stringent regulations hinders development haps the unintentional consequence of following an approach of, and access to biotechnologies. Effective and enabling advocated for NBF development without due consideration of national biotechnology policies and science-based regu- the potential trade-offs that would arise when highly precau- latory frameworks can facilitate the development and tionary language (effectively impeding access to the technol- appropriate use of biotechnologies in developing coun- ogy) was imbedded in laws or regulations. Countries develop- tries; and ongoing reviews, improvement and harmoni- ing NBFs in the early 2000s, as many did with GEF funding, zation of existing biotechnology policies and regulatory may not have viewed GE crops as a potentially useful tool frameworks can keep them current and rational. for agricultural development. At that time, commercially avail- able GE events were limited almost exclusively to commod- FAO (2010) ity crops developed for industrialized agricultural production There are opportunities to advance biosafety regulation in systems. GE crop and trait combinations suitable for small- ways that could particularly benefit developing countries. holder farmers in developing countries were limited primarily Some of these are introduced below. to a few public sector R&D projects, and governments might JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 18 C H A PTER 4 — OPPORTUNITIES TO A DVA NCE BIOSA FETY R EGULATION reasonably have assumed that this controversial technology opportunities to rationalize biosafety regulations and guidance. would have limited applicability to their own agricultural sys- Instead, the emergence of new analytical tools, particularly tems. A decade later, the scenario has changed (as described in molecular biology, has led to the addition of new informa- in Box 1.2), and governments that have been apathetic or even tion or data requirements for environmental risk assessment, antagonistic to agricultural biotechnology are reevaluating its although no evidence of adverse environmental impacts with potential as a tool to improve crop production and manage- the cultivation of GE crops has emerged. For example, the ment practices and thus contribute to improved food security European Commission has published two compendia of the and agricultural sustainability. In these cases, governments results of 25 years of European Union–funded research on may need to reconsider biosafety (and other) regulatory sys- GE crops (EC 2000, 2010). The most recent compendium tems to ensure that they encourage innovation in agriculture stated that “there is no scientific evidence associating GMOs while still ensuring adequate environmental protection. [genetically modified organisms] with higher risks for the environment or for food and feed safety than conventional � plants and organisms. Despite this accumulation of scientific 4.2 RATIONALIZE RISK ASSESSMENT knowledge and experience, environmental risk assessment Biosafety regulatory systems in all countries are dynamic. guidance published by regulators in the European Union and The flexibility to accommodate change is essential, as a countries such as Canada, Australia, and Japan remains rela- regulatory system must be able to adapt quickly to both pre- tively unchanged, with the possible exception of molecular market and post-market perturbations. Such perturbations characterization data requirements, which have become more include rapid advances in biotechnology research and their elaborate and costly over the past decade. effects on product development, assessment, adoption, and Private sector product developers, particularly multinational stewardship; they also include the trade impacts that occur companies, have the resources to respond to new data require- after product commercialization, such as changes in market ments, irrespective of their applicability to risk assessment and access or the consequences of detecting unapproved GE environmental safety. Arguing against requests for new studies material in grain or seed shipments. Effective management can delay decision making and time to market. The cost of com- of such changes is a challenge for all biosafety regulatory sys- plying with ad hoc or new requests is nominal when compared tems, which is why key regulatory functions like risk assess- with forgone profits from missed seed sales, and so product ment should be continually reevaluated and improved. developers are inclined to acquiesce when such requests arise. The establishment of new biosafety regulatory systems and Over time, precedents for new studies have become estab- the reform of existing systems should reflect the accumu- lished requirements in guidance, the costs of regulatory compli- lated experience with the cultivation of GE crops, so that risk ance have risen, and it has become increasingly difficult for the assessment and risk management (that is, decision making) public sector and smaller enterprises to pursue GE crop com- are commensurate with the actual level of risk associated with mercialization (as evidenced by Table 4.1). If the environmental, GE crop production (Falk-Zepeda, Cavalieri, and Zambrano development, and economic benefits of GE crops, especially 2009). Unfortunately, this goal seems to remain at once obvi- pro-poor GE crops, are to be realized, then the rationalization of ous yet elusive, as governments have largely failed to realize risk assessment information and data requirements must be TABLE 4.1: GE Events Developed by Public Organizations and Approved for Environmental Release in at Least One Country APPROVALS (COUNTRY AND COMMERCIALLY CROP EVENT DEVELOPER DESCRIPTION YEAR) AVAILABLE IN 2011 Flax (linseed) FP967 University of Saskatchewan Sulfonylurea herbicide tolerance Canada, 1996 No (Canada) USA, 1999 Papaya 55-1/63-1 Cornell University (USA) Resistance to papaya ringspot USA, 1996 Yes virus X17-2 University of Florida (USA) Resistance to papaya ringspot USA, 2008 No virus Plum C5 U.S. Department of Agriculture Resistance to plum pox virus USA, 2007 No (USA) Soybean BPS-CV127-9 Embrapaa (Brazil) Imidazolinone herbicide tolerance Brazil, 2009 No a. Developed jointly with BASF. Source: CERA 2011 (GM Crop Database). TH E STATUS A ND IMPACT OF BIOSA FETY R EGULATION C H A P T E R 4 — OP P ORT UNIT IE S TO ADVANCE BI O SA FETY REGULATION 19 pursued aggressively. It can, and should, be led by developing BOX 4.1: Example of Environmental Benefits from country policy makers, with technical inputs from regulatory GE Crops authorities and scientists involved in risk assessment. This task will be particularly challenging to accomplish in the context of Benefits of engineered herbicide tolerance: Crops the highly polarized dialogues/debates around risk assessment that have been genetically engineered to tolerate the that take place under the auspices of the Cartagena Protocol, herbicide glyphosate have had both direct and indirect but opportunities for meaningful bilateral and regional discus- environmental benefits. The direct benefits have come sions exist (see the discussion in Section 4.4). Improved and with a shift in the types and pattern of herbicide use.a cost-effective approaches to biosafety regulation generally, and The indirect benefits are associated with the widespread risk assessment particularly, can be pursued without compro- adoption of conservation tillage practices, which aid in mising environmental protection and management goals. conserving soil moisture and improving soil structure and water quality. The shift from conventional tillage to low-till or no-till systems has been facilitated by the 4.3 CONSIDER RISK AND BENEFIT ASSESSMENT introduction of herbicide-tolerant soybeans, maize, cot- ton, and oilseed rape.b These benefits may eventually be It is often assumed that the potential adverse environmen- compromised, as the widespread adoption of glyphosate- tal impacts of GE crops will be greater for developing than tolerant crops has been associated with shifts in weed developed countries (Qaim, Subramanian, and Sadashiviappa populations and the selection of weeds that are also tol- 2009; Heinemann et al. 2009). Concerns have been raised erant to herbicide.c that shifts in agricultural practices or in the selection and genetic diversity of cultivated crops could affect natural biodi- Benefits of Bt crops: Significant reductions in insec- versity or compromise the genetic resource base provided by ticide use, and the resulting human health and envi- centers of origin for domesticated crop species. An additional ronmental benefits, have been attributed to the adop- concern is that many developing countries still face inade- tion of Bt cotton in almost every country where it has quate technical capacity to undertake the environmental risk been grown.d Bt maize and Bt cotton have become assessments that inform the decision to approve or deny the important components of integrated pest manage- environmental release of a GE crop. Arguably, however, the ment programs, because the reduction in pesticide potential environmental benefits afforded by GE crops may use improves opportunities for both natural and intro- also be greatest for developing countries, although this pos- duced biological control of other maize and cotton sibility is seldom considered in biosafety regulatory systems. pests.e Source: Authors. The paradigm for environmental risk assessment that has a. Dill, CaJacob, and Padgette (2008). been established in countries with mature biosafety regula- b. Givens et al. (2009); Gusta et al. (2011); Frisvold, Boor, and Reeves (2010). tory systems focuses on identifying potential adverse impacts c. Owen (2008). d. Fitt (2009). that might be associated with the environmental release of e. Hellmich et al. (2008); Naranjo et al. (2008). GE plants. Only rarely are potential environmental benefits taken explicitly into account as part of the risk assessment. One example is the Environmental Protection Agency in the countries lacking sufficient human, institutional, and financial United States, which regulates GE plants with pesticidal traits resources to operate a regulatory system that may be used such as Bt crops (named for Bacillus thuringiensis, the bacte- only intermittently. In such cases, a regional or subregional rium from which the pest resistance is transferred) under the approach to risk assessment may be the most practical, cost- Federal Fungicide, Insecticide, and Rodenticide Act, which is a effective option. It could include recognizing scientific opinions risk benefit statute. This missed opportunity is particularly puni- arising from risk assessments by other regulatory authorities, tive in the context of developing country agriculture, where establishing regional approaches to risk assessment, or—more alternative strategies for managing biotic or abiotic productivity ambitiously—adopting decisions taken by other governments. constraints may not exist or may have negative environmental Harmonization of risk assessment requirements and pro- (and health) effects (see Box 4.1). cesses within a subregional or regional bloc of countries could also serve as an enticement for product developers to invest in the resulting common market, if the costs of achieving regula- 4.4 HARMONIZE BIOSAFETY RISK ASSESSMENT tory compliance become competitive. Smaller countries might As discussed, biosafety regulation is often pursued as a then have access to otherwise unavailable technologies and national activity, and it becomes particularly challenging in products, potentially at a better price if competition between JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 20 C H A PTER 4 — OPPORTUNITIES TO A DVA NCE BIOSA FETY R EGULATION product developers improves. Regulatory harmonization may harmonizing risk assessment criteria, information require- also be the most effective means of mitigating the trade con- ments, evaluation standards, and, to some extent, legal and sequences of asynchronous approvals. regulatory systems provides a more sustainable alternative. The Economic Community of West African States (ECOWAS) Many developing country governments recognize that has developed a draft regulation for regional risk assessment developing a comprehensive national capacity in biosafety (Box 4.2), and the Common Market for Eastern and Southern regulation is neither feasible nor desirable if cooperation in Africa has developed draft regional biosafety guidelines for BOX 4.2: Regulatory Harmonization Efforts in West Africa The potential value of a subregional approach to biosafety regulation in West Africa was first explored in a five-country study of human resource capacity, infrastructure, and the general awareness of biosafety in Cameroon, Côte d’Ivoire, Ghana, Nigeria, and Senegal in 2000; a follow-on study in 2002 added Burkina Faso and Mali.a In 2004, the Institut du Sahel (INSAH) completed a stock-taking exercise in each of the five member countries of the Permanent Interstate Committee for Drought Control in the Sahel (CILSS) plus Ghana, to gain a better understanding of the structure of the seed sector in each. This exercise led to the development of the Framework Convention Instituting Common Regulations for Conventional and Transgenic Seeds in the CILSS Area (the CILSS Convention). The preambles to the convention recognize that modern biotechnology has both benefits and potential risks and that a subregional approach to biosafety regulation should be undertaken, as “each country is neither able to individually take advantage of the known and poten- tial benefits of genetically modified organisms (GMOs), nor cope with their known and potential risks. � In 2005, the Economic Community of West African States (ECOWAS) published an action plan with three operational objectives for the development of biotechnology and biosafety in the subregion, one of which was to develop a subre- gional approach to biosafety regulation.b The action plan accepted that such an approach would make it possible to pool resources; facilitate the exchange of experiences, information and data; and maximize the potential of the subregion’s limited human, institutional, financial, and technical resources for biosafety. This approach was considered consistent with the goals of other West African subregional organizations like CILSS, the West African Economic and Monetary Union, and the West and Central African Council for Agricultural Research and Development, and it was also consistent with Party , obligations under the Cartagena Protocol. In March 2007 the ECOWAS Agriculture and Environment Ministers reached an agreement to adopt a subregional biosafety program which would be based on the CILSS Convention. The operational model, selected during the Preparatory Meeting to Launch the Regional Consultative Committee on Biosafety in July 2007 , was a mechanism whereby the science-based risk assessment function would be undertaken by a subregional body, but all decisions (GE product approvals) would remain at the national level. The subregional body would be responsible for undertaking risk assessments for specific types of applications (such as confined field trials, GE food safety assessment, and environmental risk assessment of GE plants) and would provide scientific opinions to the member countries. In August 2008, the Experts Group Meeting on ECOWAS Biosafety Regulation was attended by environment and agri- culture representatives from 14 ECOWAS countries. The meeting concluded with a request to INSAH-CILSS to revise the CILSS Convention; to circulate the revisions for consideration by all countries; to make final revisions; and then to submit the documents for adoption by ECOWAS. During a series of four subregional meetings, and with additional bilat- eral inputs from engaged ECOWAS country representatives, the CILSS Convention was substantively rewritten in an effort to address the activities of the subregional process consistently and without duplication. The contained, confined, and unconfined uses of GE organisms were clearly differentiated, and the regulatory responsibilities for each of these activities were defined. The technical annexes, which describe the technical information required for applications to the regional scientific review panel, were more clearly aligned with the types of applications that will be received in the sub- region and, importantly, with existing international standards and guidance related to the regulation of GE organisms as established by Codex Alimentarius, the Organisation for Economic Co-operation and Development, and the Cartagena Protocol. The resulting ECOWAS document, “Regulation C/Reg.1/12/08 Establishing a Procedure for the Review and � Authorisation of Products of Modern Biotechnology within the ECOWAS, awaits signature and implementation. Source: Authors. a. Alhassan (2002, 2003). b. ECOWAS (2005). TH E STATUS A ND IMPACT OF BIOSA FETY R EGULATION C H A P T E R 4 — OP P ORT UNIT IE S TO ADVANCE BI O SA FETY REGULATION 21 its member states. The Government of Vietnam has pursued BOX 4.3: Harmonization between Canada and the a different model for harmonization, as it permits a written United States Remains a Missed Opportunity certification of eligibility for use of GE organisms in food if the subject of the application has been permitted by at least In 2001, the Canada-United States Bilateral Agreement on five developed countries for use as food and no risk has Agricultural Biotechnology harmonized technical require- been seen in these countries. This approach to regulatory ments for environmental risk assessment of GE crops, approvals is both practical and scientifically defensible; the but this agreement has not resulted in any appreciable Vietnamese Ministry of Health considers the biosafety regu- gains in efficiency or effectiveness within or between latory systems of certain other countries to be consistent the representative regulatory agencies. Cooperation in with that of Vietnam, and it regards the risk assessment and joint reviews of regulatory dossiers remains extremely approvals undertaken by those countries as equivalent to limited (simultaneous reviews remain the standard those undertaken in-country. practice), although the 2001 Agreement stated “The results of this meeting, and other activities, may lead While achieving regional harmonization for risk assessment is to considering mutual acceptance of assessments in possible (the European Food Safety Authority’s GMO Panel,1 � the future. Mutual acceptance of the scientific opin- the CILSS’ Common Regulation for Pesticide Registration2), it is ions arising from regulatory risk assessments has yet not a simple process. For example, ECOWAS was critical of the to occur, and mutual recognition of decisions to approve slow progress in achieving a subregional biosafety framework in or deny approval of a specific GE event may be simply West Africa, which it attributed to “an absence of political sup- unattainable in absence of political support for doing so. port in the field of biotechnology and biosafety; lack of commu- Source: Authors. nication between stakeholders, even within the same country; lack of coordination between the concerned ministries in the member countries; and poor subregional co-operation on the avoid the divisiveness that occurs in international fora where subject� (ECOWS 2005). These constraints apply as much to the ideological differences between the United States and developed countries as to developing countries, as evidenced Europe tend to dominate discussions and inhibit progress. by the United States and Canada, countries that engaged in For example, the Cartagena Protocol provides an obvious harmonization efforts earliest (Box 4.3). point of departure for promoting risk assessment harmoni- zation, particularly the language in Article 15 and Annex III. Subregional and regional harmonization could also serve as Efforts to elaborate Annex III by the Online Expert Forum a means for trading partners to mitigate the lack of prog- and an Ad Hoc Technical Expert Group on Risk Assessment ress in achieving international consensus on guidance or and Risk Management yielded a draft document, “Guidance standards for the environmental risk assessment of GE. on Risk Assessment of Living Modified Organisms, 3 but its � Negotiations within a smaller group of countries, particu- content and utility for risk assessors in developing countries larly if they share economic and development goals, could are debated.4 The OECD Working Group on Harmonization of Regulatory Oversight of Biotechnology continues to expand 1 The GMO Panel carries out risk assessments (based on reviews of scientific information and data to evaluate the safety of a given its extensive body of consensus and guidance documents GMO) to produce scientific opinions and advice for decision mak- in support of environmental risk assessment harmonization.5 ers (http://www.efsa.europa.eu/en/gmo/aboutgmo.htm). Conclu- sions from these risk assessments, which have typically found that the GE plant in question is “unlikely to have adverse effects 3 According to the CBD (http://www.cbd.int/decision/mop/ on human health and the environment, in the context of its ?id=12325), the objective of the guidance is “to provide a refer- intended uses, have had little effect on authorizations for cultiva- � ence that may assist Parties and other Governments in imple- tion in the EU. menting the provisions of the Protocol with regards to risk 2 The Common Regulation for Pesticide Registration in CILSS coun- assessment, in particular its Annex III and, as such, this Guid- tries served both as an impetus and a model for the development ance is not prescriptive and does not impose any obligations of the Framework Convention Instituting Common Regulations � upon the Parties. The guidance document is available from the for Conventional and Transgenic Seeds in the CILSS Area. Accord- Biosafety Clearing-House (http://bch.cbd.int/onlineconferences/ ing to INSAH (http://www.insah.org/protectiondesvegetaux/csp/ ra_guidance/testing.shtml). RCenglish.pdf), “The main objective of this Common Regulation 4 � Biosafety Clearing-House, “Archived Discussions, http://bch.cbd was to combine the expertise on pesticide evaluation and man- .int/onlineconferences/archived_discussions_ra.shtml, accessed agement of all CILSS Member States for pesticides registration. April 2012. The Sahelian Pesticide Committee (CSP), the common pesticide 5 OECD, “Documents on Harmonization of Regulatory Oversight registration body, became operational in 1994. It assesses reg- in Biotechnology and the Safety of Novel Foods and Feeds, istration dossiers submitted by the agro-chemical industry and http://www.oecd.org/document/55/0,3746,en_2649_34385_ grants sales permits valid for all its Member States.� 2500215_1_1_1_1,00.html, accessed April 2012. JO I NT D E PART ME NTAL DISCUSSION PAP ER 3 22 C H A PTER 4 — OPPORTUNITIES TO A DVA NCE BIOSA FETY R EGULATION The Working Group comprises OECD member countries, a government’s capacity for biosafety regulation, including OECD accession countries (Russia), OECD enhanced risk assessment, risk management, and communications engagement countries (Brazil, India, Indonesia, People’s capabilities, might be more sustainably achieved if product- Republic of China, and South Africa), and other countries related applications are ready to “prime the regulatory such as the Philippines that participate through the OECD � pump. These applications may be for laboratory activities Global Forum on Biotechnology. The limited participation of related to R&D; field trials of experimental GE products developing country representatives in Working Group meet- (including transgenic plants, insects, and fish); or pre-market ings means that alternative perspectives on the prevailing applications for environmental, food, and/or livestock feed biosafety regulatory and risk assessment paradigm are not safety assessment. being sufficiently integrated into the harmonization agenda. Consequently, biosafety capacity building initiatives can have This situation needs to be rectified so that the potential more value and impact if they are implemented in the con- impact of guidance or recommendations on the development text of investments that are already planned or underway in of GE crops of relevance to non-industrial countries is explic- wider economic and social development plans. For example, itly considered during document development. the design of the GEF-funded West Africa Regional Biosafety Program under the World Bank was driven by the fact that 4.5 INTEGRATE CAPACITY BUILDING INTO three of the proposed beneficiary countries were already INVESTMENT PROGRAMS implementing important projects and policy reforms on Only a limited number of developing countries have substan- agricultural diversification, research, and extension with the tive public sector research programs in agricultural biotech- World Bank; the Bank was supporting institutional reforms, nology (Argentina, Brazil, China, India, and South Africa are producer organizations, strengthening of nascent food sup- examples) or are considered markets of interest for private ply chains, and export promotion for agricultural products. sector investments in this area. The paucity of strong bio- An additional factor was that all of the countries had actively technology research programs, in addition to human and sought support in developing their cotton sector, including institutional resource constraints, may explain why so few the regulatory aspects. countries have implemented NBFs. In effect, there is an Capacity-building programs should also pursue opportunities absence of demand to drive regulatory development (or to strengthen the scientific and knowledge base in ways that reform) forward, and policy makers’ attention is necessarily will provide benefits that extend beyond biosafety risk assess- redirected to existing priorities. As a result, countries may ment and decision making. Many developing countries have develop “model� biosafety regulatory systems that are dis- only a transient need for biosafety risk assessment, given engaged from agricultural, environmental, or development that regulatory authorities may receive an application for a realities, and any improvements in human resource capac- field trial or pre-market approval only once a year or once ity are transient, because personnel have no opportunity to every few years. However, investments in education and implement what they have learned. research in the scientific disciplines that support biosafety Biosafety capacity building must therefore move past the risk assessment and regulation can have wide reaching pay- development of NBFs and the concurrent short-term tech- offs for risk assessment and risk management programs that nical training. 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