INTRODUCTION

The need for a long-term policy on applications of biotechnology in agriculture has been felt for quite sometime. This subject is, at present, being dealt in three different Ministries/Departments viz. Ministry of Agriculture, Ministry of Environment and Forests and Department of Biotechnology, Ministry of Science and Technology. It is therefore of utmost importance to formulate a long-term policy on agro-biotechnology, which could be used to prepare a blueprint for further action in this regard by the Ministries/Departments concerned.

The legislative framework on agro-biotechnology is provided under the Environment (Protection) Act. The Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/Genetically Modified Organisms or Cells formulated under the Environment (Protection) Act which is administered by the Ministry of Environment and Forests provides for the following multi-tiered regulatory framework to assess and ensure biosafety of genetically engineered organisms:

1. The Recombinant DNA Advisory Committee (RDAC) under the Department of Bio-technology to recommend appropriate safety regulations in recombinant research, use and applications.
     

2. The Review Committee on Genetic Manipulation (RCGM) under the Department of Bio-technology to monitor safety related aspects in respect of ongoing research projects and activities involving genetically engineered organisms. The RCGM lays down procedures/regulations regarding research, production, sale, import and use of genetically engineered organisms with a view to ensure environmental safety.
     

3. The Institutional Biosafety Committee (IBSC) to prepare site-specific plans for use of genetically engineered microorganisms.
     

4. The Genetic Engineering Approval Committee (GEAC) under the Ministry Environment and Forests to consider proposals relating to release of genetically engineered organisms into the environment.
     

5. The State Bio-technology Coordination Committee (SBCC) to inspect, investigate and take punitive action in case of violations of safety and control measures in the handling of genetically engineered organisms.
     

6. The District Level Committee to monitor safety regulations in installations engaged in the use of genetically modified organisms and their applications in the environment.

The procedures under the Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/Genetically Modified Organisms or Cells, are lengthy. With accelerated research in the area of agro-biotechnology, a spate of proposals for the commercial release of several transgenic crop varieties is likely to come up for consideration of the GEAC in the future. Hence, It is time that government reviews the existing procedures so that biosafety can be assessed concurrently with agronomic performance. The rigour of the biosafety assessment should not be compromised. The government has also to devise a policy in regard to segregation, traceability and labeling of produce/product, which would arise upon commercial release of transgenic crops. Procedures relating to biotechnology applications are already being reviewed by a Committee under the Chairmanship of Secretary, Environment & Forests in which the representatives of DAC and ICAR are also included. The Ministry of Health is also putting together a paper relating to genetically modified food for consideration of the Committee of Secretaries, which would, probably, also cover the issues of labeling and traceability.

As these committees do not cover applications of biotechnology in agriculture, the Department of Agriculture & Cooperation, set up in May, 2003 a Task Force on Application of Biotechnology in Agriculture under the Chairmanship of Prof M S Swaminathan with the following terms of reference :

1. Formulate a draft long-term policy on applications of biotechnology in agriculture.  
    

2. Suggest modifications in the existing administrative and procedural arrangements in order to streamline/harmonize decision making under various Ministries/Organizations.
     

3. Suggest the future role of Ministry of Agriculture in view of the developments taking place in the field of agriculture biotechnology.  
     

4. Awareness generation on matters relating to agricultural biotechnology.  

2.  The order dated 14^th May 2003, provides details concerning the setting up of the Task Force and its composition (Annexure-1). The Task Force was asked to submit its recommendation within three months. 

3.  The first meeting of the Task Force was held on 11^th July 2003. A decision was taken in this meeting to expand the Task Force so as to include key stakeholders like other Government Departments, Seed Industry and experts in Animal Sciences. As a result, the Government modified its earlier order regarding the Task Force to include the following as members:

i)                   Secretary (Health), Ministry of Health & Family Welfare

ii)                 Secretary, Department of Food

iii)              Secretary, Department of Commerce

iv)                Dr. Amrita Patel, Chairperson, National Dairy Development Board

v)                  Dr. Syed E. Hasnain, Director, Centre for DNA Fingerprinting & Diagnostics, Hyderabad.

vi)                President, Association of Seed Industry

vii)             President, Seed Association of India.

3.1     It was also felt that it would not be possible for the Task Force to submit its Report by mid July 2003 as was envisaged in the initial order in view of the immensity and complexity of the work involved. It was therefore decided to request the Government to allow the Task Force to submit its Report by 31^st December 2003. The term was further extended upto 15^th February 2004.

3.2     At its first meeting on 11 July 2003, the Task Force also decided to set up Working Groups to prepare base papers for each term of reference, which could be used as the starting point for discussions by the entire Task Force.

3.3     It was also decided that besides developing the long-term policy on the application of agricultural biotechnology, the Task Force would also hold discussions with other stakeholders like Industry (CII, ASSOCHAM, FICCI, etc.), State Government representations, NGOs, and Civil society Organisations, Policy Makers, Mass Media representatives and Farmers’ groups so as to incorporate their views into the report of the Task Force.

4.     Professor R.B. Singh, Ex-Assistant Director General, FAO also made a presentation on bio-security as a strategy for livelihood security. The presentation made a case for establishment of a National Authority for Bio-security, which would coordinate the use of the latest developments in science to provide for, enhanced and sustained productivity through the development of enabling capacities.

5.   The Task Force noted the inability of Dr. (Mrs.) Kiran Mazumdar Shaw, Chairperson, Biocon India to be a member of the Task Force due to her business pre-occupation. 

6.     Following the decision in the first meeting, the composition of the Task Force was enlarged vide order dated July 28, 2003 and its term was extended upto 31^st December 2003 (Annexure-2). Five working groups were constituted. The terms of reference for the Working Groups and names of the Chairperson of the Working Groups were decided as under:

1. “Biotechnology Applications in Agriculture : Developing a long term policy” to be prepared by the by a Working Group Chaired by Prof. V.L. Chopra, President, National Academy of Agricultural Sciences  and former DG, ICAR and Secretary, DARE
     

2. “Role of the Ministry of Agriculture” to be prepared by a Working Group Chaired by Shri R.C.A. Jain, Secretary, Department of Agriculture & Cooperation
     

3. “Regulatory Procedures in Agriculture” to be prepared by a Working Group under the Chairpersonship of Dr. Manju Sharma, Secretary, Department of Biotechnology
     

4. “Applications of Biotechnology in Animal Husbandry” to be prepared by a Working Group Chaired by Dr. Amrita Patel, Chairperson, NDDB
     

5.  “Promoting Public Awareness on matters relating to Agricultural Biotechnology in India” to be prepared by Dr. Mangla Rai, Secretary, DARE & DG, ICAR

The base papers prepared by the above Working Groups are included in Part B of this Report. It should be emphasized that these represent only the views of the respective Working Groups.

6.1     The base papers prepared by the five working groups were discussed by the Task Force in its meetings held from time to time. Modifications as suggested on the basis of discussions among members of the Task Force were carried out by various Working Groups. The modified base papers were considered by the Task Force to develop its recommendations. In order to ensure that the recommendations of the Task Force are based on the views held by major stakeholders, Task Force members had detailed discussions with representatives of farmers, NGOs, Associations of Seed Industry, Association of Industry, representatives of the State Governments and representatives of media. Written submissions were also made by some stakeholders, particularly, State Governments. They are included in Part B of this Report.

7.       The Task Force held 11 meetings. The calendar of the meetings and the subjects discussed in those meetings are given in Annexure-3. Part ‘A’ of the report comprises of the Chairman’s Preface, Executive Summary, Terms of Reference and Composition of the Task Force, and the Recommendations of the Task Force. Part ‘B’ comprises of Reports of the working groups addressing specific topics and submission made by various states and stakeholders.