Economic Considerations of Biosafety and Biotechnology Regulations in India

Economic Considerations of Biosafety and Biotechnology Regulations in India PROCEEDINGS OF A CONFERENCE New Delhi, India • 24–25 August 2006 sustainable solutions for ending hunger and poverty Supported by the CGIAR Copyright © 2007 International Food Policy Research Institute. All rights reserved. Sections of this volume may be reproduced without express written permission of, but with acknowledgment to, the International Food Policy Research Institute. Contact the Communications Division for permission to reprint: [email protected]. Suggested citation: International Food Policy Research Institute and Research and Information System for Developing Countries. 2007. Economic considerations of biosafety and biotechnology regulations in India: Proceedings of a conference, August 24–25, 2006, New Delhi, India. Washington, D.C.: IFPRI. These proceedings have been peer reviewed but have not undergone a formal peer review by IFPRI’s Publications Review Committee. TABLE OF CONTENTS Executive Summary vi PART 1. INAUGURAL SESSION 1 Welcome Remarks - Dr. Ashok Gulati, International Food Policy Research Institute (IFPRI) 2 Welcome Remarks - Dr. Nagesh Kumar, Research and Information System for Developing Countries (RIS) 2 Theme Presentation and Program Overview - Dr. Mark Rosegrant, International Food Policy Research Institute (IFPRI) 3 Keynote Speech - Dr. G. K. Chadha, Office of the Prime Minister of India’s Economic Advisory Council 3 PART 2. TECHNICAL SESSIONS 5 Session 1. Economic Effects of Biosafety Regulations: The Production Side 6 Economic Impacts of Transgenic Crops in Developing Countries 6 High Cost of Biosafety Regulation, an Impediment to Introducing Technology in Smaller Crops 8 Illegal Seeds and Regulatory Costs of Bt Cotton in India 9 Regulations and the Private Sector in India 10 iii Open Discussion 11 Session 2. Marketing Regulations of GM Food: The Consumer Side 14 Labeling, Segregation, and Traceability of Genetically Modified Food: An Overview of the Economic Effects in Developed Countries 14 Labeling Policy in China 16 Labeling Policy in the Philippines 17 Labeling Policy in India: A Preliminary Economic Analysis 18 Open Discussion 19 Session 3: International Trade Concerns 21 Regulating GM Foods: A Comparison of Approaches 21 GM Crops and International Trade: the Case of India 22 Harmonizing Trade-Related Regulations of GM Food 23 Effects of International Regulatory Harmonization and International Agreements 25 Open Discussion 25 Session 4: Regulating Environmental Externality: Post-Release Regulations of GM Crops 27 Evolution of Regulation and Policy Surrounding GM Crops in Asia and Africa 27 Insect Resistance Management: Economics of Bt Cotton Refuge in China 28 Biosafety and Biodiversity: Issues for India 29 Biosafety of Transgenic Crops to Non-Target Organisms 30 Open Discussion 30 Session 5: Information Policy and Public Acceptance of Biotechnology 32 Opening Remarks 32 Consumer Response to Information and Second-Generation Genetically Modified Foods in India 33 Consumer/Farmer Information, the Media, and Perceptions of Biotechnology 34 Information Needs for Farmers: Education, Extension, Outreach 35 Pressure Groups and Information Biases: Are Poor Farmers Well Represented in the Decisionmaking Process? 36 Open Discussion 36 iv Session 6: South Asia Initiatives on Biosafety and Biotechnology 38 International Support for Agricultural Biotechnology and Biosafety Lessons from the World Bank 38 Challenges for Countries to Implement the Biosafety Regulations: Economic and Legal Issues 39 Public–Private Partnerships: The Example of CIMBAA for Insect-Resistant Vegetables 41 Indian Council of Medical Research 41 Overview of ABSPII Initiatives on Biotechnology in South Asia 42 South Asia Biosafety Program 42 Open Discussion 43 Session 7: Policy Panel Discussion: Economic Considerations and Biotechnology Regulations in India 44 Opening Remarks 44 Dr. V. Ramanaiah, Department of Biotechnology, Government of India 44 Mr. Sanjay Kumar, Department of Commerce, Government of India 45 Dr. S. Rao, JK Agri-Genetics Limited 46 Dr. S. R. Rao, Ministry of Science and Technology, Government of India 46 Dr. Manoranjan Hota, Ministry of Environment and Forest, Government of India 47 Open Discussion 47 RECOMMENDATIONS/OUTCOMES 49 Regulatory Issues 49 Research Needs 50 Post-Release Issues 50 Labeling 51 Capacity Development 52 International Trade Issues 52 Public–Private Partnership 53 References 54 Appendix 1. Conference Program 55 Dr. Mark W. Rosegrant (left), Director, EPTD, in discussion with Dr. Lawrence Paulson (right), Appendix 2. Conference Participants 59 Agricultural Development Officer, USAID-India. v Dr. Xiangyang Chang (left), Professor and Deputy Head, Department of Management, Nanjing Agricultural University, China, and Mr. Abraham Manalo (right), Executive Secretary, Biotechnology Coalition in the Philippines, Philippines, listen to the open discussion. EXECUTIVE SUMMARY India was one of the first Asia Biosafety Program (SABP) organized a Asian countries to invest in agricultural policy dialogue on August 24 and 25, 2006, biotechnology research and to set up a in New Delhi, India, in collaboration with biosafety system to regulate the approval of the Research and Information System for genetically modified (GM) crops. Despite the Developing Countries (RIS). The dialogue was vi Government of India’s acknowledged interest designed to provide a platform for national and in encouraging growth in the biotechnology international economic experts and important sector and the increasing number of research Indian stakeholders to discuss economic initiatives in the public and private domains, considerations related to biosafety and the approval of new applications of transgenic biotechnology in India. These proceedings are crops has been rather slow. a summary of the discussions held during the The country has only approved one dialogue. GM crop, Bt (Bacillus thuringiensis) cotton, The policy dialogue highlighted the which was planted on 1.3 million hectares following six critical economic issues and by 1 million farmers in 2006. There are associated recommendations on biotechnology several other GM crops and traits in the and biosafety regulations in India: biosafety regulatory pipeline. At the same 1) The cost and stringency of the current time, an increasing number of ministries and regulatory system and its impact on the government departments are getting involved overall growth of the sector calls for in biosafety, marketing, and trade regulations. further examination. As a result, the Indian agribiotech sector is in 2) The relevance and economic feasibility a transition phase both in terms of research of the proposed mandatory labeling applications and the regulatory framework. regulation of GM food and feed in In this context, the International Food India is largely questioned by policy Policy Research Institute under the South specialists and economists. 3) The compliance with and enforcement More generally, the conference revealed of post-release regulations have to be the need for a better convergence of the addressed, particularly with regard Indian government’s overall objectives on to insect-resistance management and agricultural biotechnology in terms of the illegal seeds. agricultural development process, the federal 4) The existing research and application regulatory framework, and the capacity vii competence (including capacity for needed to provide safe access to approved developing crops of Indian priority) biotechnology innovations to Indian farmers. and consumers’ and farmers’ ability As a response to these critical policy to understand and adopt agricultural issues, the Government of India should biotechnology need to be strengthened. consider conducting policy research to 5) There is a lack of clarity on GM food evaluate the benefits and costs of different import approval, and segregation biosafety and biotechnology regulatory options strategies for non-GM crops should for transgenic crops and the products derived be encouraged to maintain all export thereof, in order to maximize the economic opportunities while allowing the potential of agricultural biotechnology for all beneficial use of safe GM technology for Indian farmers and consumers in a safe and Indian farmers. responsible manner. L 6) The limited clarity, transparency, and leadership in the regulatory procedure mean that better coordination is required across all ministries to adapt policies to manage environment, agriculture, consumer, and trade issues together. Economic Considerations of Biosafety and Biotechnology Regulations in India 1 PART 1. INAUGURAL SESSION WELCOME AND OPENING REMARKS Dr. Nagesh Kumar Director General Research and Information System for Developing Countries (RIS) India Dr. Kumar called this a very timely and important Dr. Ashok Gulati initiative and said that RIS was very pleased to Director in Asia join hands with IFPRI and the South Asia Biosafety International Food Policy Research Institute (IFPRI) Program (SABP) to organize this dialogue. He said India that biotechnology is emerging as an important core technology in India in parallel with other important Dr. Gulati welcomed all the participants and noted that technologies like information and communication 2 the monsoon season in India has exhibited different technology. However just like any other new technology, forms: either there is very little rain in some parts of the biotechnology is not free of challenges. In particular, country, causing drought, or

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