November 12, 2012
To: Hon’ble Justices Swatanter Kumar & S.J Mukhopadhyay
Supreme court of India
In the case of Aruna Rodrigues Vs. Union of India (Writ Petition (Civil) No. 260 of 2005)
Sub: Request to accept the interim report submitted by the court-appointed Technical Expert Committee on the matter of field trials of GM crops and passing Orders on the same
Never in the history of agricultural science had a technology been as controversial as Genetic Engineering/Genetic modification of crops. The unpredictability and irreversible nature of Genetic Modification (GM) as a living technology and the uncontrollability of Genetically Modified (GM) crops in the environment, coupled with scientific studies pointing at the potential risk to human health and environment has resulted in a controversy across the world where questions around the safety as well as the very need for introducing such potentially risky organisms into our food and farming system are being raised. Added to this is also the issue of corporate control of the seeds, the most important input in agriculture, through this technology (rigid Intellectual Property Rights go hand in hand with this technology, given the ease with which tinkering at the level of genes allows exclusive monopolistic rights to accrue to commercial entities; most such IPRs on important components and processes of GM are already in the hands of a handful of MNCs). In the Indian context there are also concerns on massive displacement of farm labour if Herbicide Tolerant GM crops are introduced. Given that the world is heavily tilted against the introduction of the technology at this point of time, with a majority of nations not opting for it, this also raises serious trade security issues. All of these issues have been appropriately taken on board by the TEC appointed by the Court.
The debate around GM crops in India started in late 1990s, around the time when the field trials of Bt cotton, the first and only GM crop to have been commercialised in our country, started. It has grown in sum and substance over time with increasing scientific evidence on the adverse impacts of GM crops, both potential and real, emerging from within the country and outside. This debate was most visible around Bt Brinjal, the first GM food crop that had reached commercial approval stage in 2009 and has only got stronger ever since. It was the scientific concerns on the open releases of GM crops in general and Bt brinjal in particular from both eminent global and Indian Scientists along with specific concerns on the inadequacy of the biosafety assessments for GM crops in our country and the inability of our regulatory system to do assessments and monitoring of GM crops that finally led to the indefinite moratorium on the commercial release of Bt Brinjal by the then Minister for Environment and Forests, Sri Jairam Ramesh. As said in the moratorium order by him, that decision was indeed “responsive to science and responsible to society”.
The debate around Bt Brinjal as well as regular reports from around the country brought out by investigations on field trials by certain state governments and civil society groups also opened up various issues with regard to any open release of GM crops including field trials.
It is necessary to look at the Technical Expert Committee’s recommendations in this context and hence, our letter to the learned judges requesting you to fully appreciate the important and critical recommendations of the Committee.
The fact that members of the TEC, who are eminent scientists in the fields of biodiversity, nutrition science, toxicology, molecular biology etc. were jointly agreed upon by the petitioners and the respondent (Union of India) adds to its credibility. It is worthwhile to remember that safety assessment is the matter in question (not the technologist’s job of creating a GMO) and the TEC members are experts in that field. It is also noteworthy that the committee followed the Terms of Refrence given to it by the Court which again was mutually agreed upon by both the parties in the case. Added to this is the process through which the Committee has come to its set of recommendations in this first report. The Committee has heard experts from all fields and interest groups before arriving at its own conclusions. The Committee’s first report submitted to the Hon’ble Court on the 7th of Oct 2012 has a thorough scientific assessment of the situation with regard to various aspects of GM crops and its impact, both potential and actual, in the Indian scenario. The report also does a comprehensive analysis of the regulatory system for any open releases of GMOs in our country.
A lot of us in the scientific fraternity hence feel that this is a Committee which has credibility in its composition, clarity in mandate and has taken up an elaborate and detailed process to come to its conclusions. The conclusions and recommendations themselves are sound and scientific, as the reasoning in the report showcases.
It is no surprise that the Committee has come up with logical recommendations on the matter of field trials of GM crops. To start with, the Committee’s stress on a precautionary approach towards GMOs in which potential risks from such a novel technology and its living products need to be identified and minimised, is a globally accepted norm. So it is completely logical when the committee says that “a comprehensive assessment including the risk assesment should start with a need assessment of the technology/product and should encompass a socio-economic analysis which looks at impact of it on various sections of the society and economy”.
The need for overhauling the unsound regulatory system
Given the serious questions raised on the design, capacity, intention and implementation of our regulatory system (from the time field trials of Bt cotton started), the committee has looked at the various aspects of the existing regime. This included the way approvals for field trials have been given, when they are given and the way they have been conducted besides the manner in which monitoring during and after the trials has happened in the country.
The glaring gaps in the regulatory system whether it is lack of rationale for deciding on a particular crop or a trait, particular time or location, incorrect sequencing of biosafety assessment, lack of comprehensive risk assessment including long term independent testing besides serious issues of conflicts of interest are all real issues that beg for an immediate correction. It is to be remembered that unlike any regulatory mechanism in other sectors, regulation here deals with living organisms that can contaminate, reproduce, spread and remain in the system for ever. Hence utmost care needs to be put in place in keeping them contained, until and unless, based on a credible set of biosafety assessments, one can say with confidence that these novel organisms do not pose a threat to health of humans or environment, now or in future.
The recommendations of the Committee not to permit event selection trials outside contained conditions in greenhouses/glasshouses and the need to do a set of biosafety tests including food safety and toxicity studies including sub-chronic feeding studies on rodents along with molecular characterisation of the Genetically Engineered plant, potential toxicity of the novel protein and potential allergenicity before open field trials merit attention and action from this Court.
The Committee also stresses the need for independent, long-term, inter-generational feeding studies to be conducted as part of the risk assessment as food is something that we consume throughout our life and this would help in determining safety at various stages of development starting from conception till end of the life cycle.
Delving further into the existing risk assessment procedure by looking at the Bt cotton biosafety data, the Committee observed that there were instances where the number of samples were lower than minimum prescribed, thereby affecting the quality and sensitivity of the tests even though such dossiers passed through the lax regulatory system. There were also cases of significant differences in bioindicators like blood cell parameters, tissue and organ health and integrity, milk yield between Bt and control samples. The fact that hundreds of hybrids of Bt cotton have been approved by our regulator over the last 10 years with all these gaps in biosafety assessment is a testament of the weakness in the review of biosafety data in the existing regulatory regime. This had been pointed out many a times in the past including during the Bt Brinjal consultations. The Committee is therefore correct in asking for a review of all biosafety data both of approved GMOs as well as ones in the pipeline.
This, when viewed along with the observation by the Expert Committee that there is a serious issue of conflict of interest, completes the picture of an inadequate and unscientific regulatory regime with clear vested interests. The issue of conflict of interest had come into focus several times in the past too, and has vitiated the entire regulatory process of GMOs in India, including field trials. There have been instances of GM crop developers with their products in the pipeline sitting in both RCGM and GEAC, the two nodal agencies for risk assessment and approval for open releases.
Besides putting in place a rigorous biosafety and risk assessment protocol, the TEC also felt that there is a need for a wider set of representation to be included in the regulatory system including sociologists, agriculture economists, toxicologists, ecologists, plant breeders, representatives from civil society and farmers’ unions to ensure a rigorous assessment of GMOs beyond just biosafety checks.
10-Year Moratorium on Bt crops’ field trials:
The TEC found serious flaws in the safety conclusions from the Bt cotton biosafety dossier as the examples cited in the report indicate. Further, there are several scientific studies which point out to the serious problems with this technology for pest control, including pest resistance, changes in pest ecology, impacts on soil biology etc. This is true with Bt cotton in India too, with pest resistance as well as secondary pests being reflected including in official records. Even after ten years of Bt cotton, there has been no official review and the lack of post-marketing monitoring was clearly noted by the TEC also. Issues around Bt GMOs’ safety to animal and human health are unresolved. The unsustainability of the science of Bt technology for pest management is well-noted in other processes of inquiry too. The then Minister for Environment & Forests is reported to have quipped that “Bt is a solution looking for a problem,” given that highly successful alternatives to chemical pesticides and Bt crops exist for crop pest management, which are farmer-controlled, nature-friendly, safe and affordable. The Bt brinjal biosafety dossier analysed by eminent scientists also pointed to the inadequacies in the safety conclusions of that Bt product which began with something as basic as incorrect molecular characterization! It is all in all very appropriate that the TEC had called for a moratorium on Bt crops’ field trials.
Protecting Centres of Origin and Diversity:
The TEC’s recommendation not to permit field trials of those crops for which India is a Centre of Origin/Diversity is a matter that needs urgent attention. It is a globally accepted norm that regions which are rich genetic pools in the megabiodiversity countries like India need to be protected and enriched. This is essential both for the survival of communities who are dependent on them for their livelihoods and also for the growth of science. GMOs have been acknowledged as one of the main threats to this biodiversity in global treaties like the Convention on Biological Diversity (CBD) which has stressed on the need for precaution when dealing with GMOs. Given that India hosted the CBD last month and that we are a presiding nation for the next two years, we should take a leadership role in protecting biodiversity from potential threats. It should not be forgotten that we have only seen the ‘tip of the iceberg’ of the wild genepool that has been the basis of our agricultural breeding and development. It will be an injustice to our future generations if we promote its destruction without even getting a chance to unravel and utilise such diversity sustainably.
Moratorium until a comprehensive independent review of Herbicide Tolerant GM crops:
The other major recommendation is the need to revisit our policy of permitting any open releases of herbicide tolerant GM crops due to various scientific concerns emerging on the impact of such GM crops and the related usage of herbicides, on human health and environment. This is more so in a country like ours where farm sizes are small and application of herbicides cannot be restricted to one’s boundaries. There is also a serious concern on the socioeconomic impact of these crops as they are being brought in to replace farm labour. It is important to remind ourselves that we are still an agrarian country with majority of our population dependent on agriculture. More than 80 percentage of our farmers are small, marginal and landless and depend on agricultural work like weeding for sustenance. So any technology that takes away such employment chances especially for rural women will have serious socioeconomic repercussions. In fact this was pointed out by the Taskforce on Agricultural
Biotechnology led by Dr M.S Swaminathan set up by the government way back in 2003. This Task Force also recommended the avoidance of this technology in India.
TEC recommendations reinforce other such in-depth inquiry processes in India:
The TEC interim report comes after the report on GM food crops by the Parliamentary Standing Committee on Agriculture on 9th of August, 2012. The Standing Committee, comprising of 31 Parliamentarians from across party lines including those from the ruling coalition, did widespread consultations over two and half years with diverse experts and stakeholders before coming to the conclusion that the country should not embrace GM crops in a haste and that there should be a precautionary-based approach towards GM crops. Identifying the inherent risks of GM crops to human health, that of livestock and biodiversity and the inadequacy of the regulatory system to conduct field trials, the Parliamentary Committee had recommended for a stopping of all field trials.
Several recommendations of the TEC also find resonance in the report of the Task Force on Agricultural Biotechnology, set up by the Government of India, whose report was accepted in 2004. Similarly, the Bt brinjal public debate and the subsequent moratorium order also reflected the main concerns and recommendations of this TEC.
It is to be remembered that the scientific debate around environmental release of GMOs is happening around the globe and a majority of countries have decided to stop the open releases of them until the answers to various concerns have been arrived at. Any haste in doing this will not only impact the society and the environment but also impede scientific progress. Already there is a growing concern amongst the scientific community that Genetic Engineering and GMOs are getting undue attention where as other non controversial and sustainable technologies like agro ecology are getting ignored in the process. Within the vast area of biotechnology, there are many safer and proven tools which need to be harnessed better.
All open-air field trials are deliberate releases of untested organisms:
The TEC was absolutely right in recognizing that all field trials are essentially deliberate open air releases of untested and unknown organisms and has correctly given its recommendations based on such an analysis (the issue of open air releases gains more significance in the context of repeated violations of biosafety norms and Rules, with impunity) – the fact that need assessment should take place before clearing all applications, that certain traits and crops should be avoided, that biosafety testing should precede open air testing at least to some extent, that regulation should be devoid of conflict of interest, that safety assessment should be comprehensive with more tests including long term and inter-generational, that monitoring and liability regimes have to be put into place, that biosafety review capabilities have to be built etc. are all welcome suggestions based on the legally and scientifically valid Precautionary Principle.
WE would like to specifically point out that many who argue that ‘America has allowed GM crops on a large scale and so should we’ are fundamentally wrong in making a comparison with America – neither our food production nor our food consumption patterns are comparable, not to mention the socio-economic conditions of our producers and consumers. Further, the American regulatory system is very lax and does not even have any segregation or labeling systems. There are no studies that indicate that some of the increasing health problems in the USA are not connected to GMOs. Chemical use in agriculture has been increasing there, while superweeds and superpests are a major issue that farmers are contending with. Some of the biggest losses of the biotech industry are from the US due to contamination from field trials. America is also facing threat to its agri-trade security by adopting transgenics. Any comparison with America is untenable.
As part of the scientific community in India, we hope that the Hon’ble Court will not overlook important analysis and recommendations of the TEC, and would take a prudent, science-based and precautionary approach. We sincerely hope that the learned judges will accept the recommendations of the court appointed TEC in toto. This is important for upholding the scientific temper in India and most importantly not losing vision of humanity while translating science into technologies.
Padma Bhushan Dr Pushpa Bhargava, Hon Distinguished Professor, School of Life Sciences, JNIAS, Founder-Director of Centre for Cellular & Molecular Biology (CCMB) – Supreme Court-appointed Observer in India’s apex regulatory body for GMOs (GEAC)
Dr A Biju Kumar, Associate Professor and Head, Dept. of Aquatic Biology & Fisheries, University of Kerala, Thiruvananthapuram, Kerala
Dr A K Yadav, Rajendra Agri University, Pusa, Bihar
Dr Alok Mukhopadhyay, Managing Trustee, Health for the Millions
Dr Amol Patwardhan, Entomology expert, Prof of Zoology, Thane
Dr Anbazhagan Kolandaswamy, Molecular Biologist, Post doctoral Research engineer on human immune cells, France
Dr Anupam Paul, Agriculture Scientist, State Agricultural Technologists’ Service Association, West Bengal
Dr Anurag Goel, Agriculture Scientist, WAPRED
Dr Aruna Chakraborty, Consultant Biochemist, BN Hospital, Kolkata
Dr Atul Mehta, Plant Breeder, Anand Agriculture University
Dr B Chaudhary, Former Director Research, RAU, PUSA.
Dr B N Viswanath, Agricultural Entomologist, Consultant in Organic Farming, Bangalore
Dr C T S Nair, Former Chief Economist (Forestry Dept), Food and Agriculture Organisation (FAO) and Former, Exec-Vice President, Kerala State Science Technology and Environment Council
Dr Chandrakant Pandav, Professor & Head, Centre for Community Medicine, AIIMS
Dr D G Bhapkar, Retd. Director of Research, Mahatma Phule Krishi Vidyapeeth, Rahuri, Maharashtra
Dr Debal Deb, Centre for Inter-disciplinary Studies, Odisha.
Dr Dhanya Bhaskaran, Asst Professor (Environmental Science), University of Agriculture Sciences, Raichur
Dr Dileep Kumar R, Post Doctoral Fellow, Institute of Venom Science, Centre for Computational Biology and Bio informatics, University of Kerala,Thiruvananthapuram
Dr Dinesh Abrol, Scientist, NISTADS
Dr E Kunhikrishnan, Professor, Dept of Zoology, Kerala University
Dr Elizabeth Joseph, Retd. Scientist (Fisheries), Kerala Agriculture University
Dr G S Kaushal, Retd. Director Agriculture, Govt of MP
Dr Goldin Quadros, Senior Scientist, Wetland Ecology Division, Salim Ali Centre for Ornithology and Natural History, Coimbatore
Dr H R Prakash, Retd. Soil Scientist, Department of Agriculture, Bangalore
Dr Hrideek T.K, Scientist, Genetics and Tree Breeding, Kerala Forest Research Institute
Dr J K Roy, Joint Director (Retd), Central Rice Research Institute, Cuttack.
Dr Jagdish Parikh, Medical Scientist, Ex-Deputy Director, National Institute for Occupational Health (NIOH)
Dr Johannas Manjrekar, Associate Professor, Microbiology Department, MS University
Dr K V Sankaran, Former Director, Kerala Forest Research Institue, Peechi, Kerala
Dr K M Shyamprasad: Chancellor, Martin Luther Christian University, Shillong, India
Dr Lalitha Vijayan, Sr Scientist, Salim Ali Foundation and formerly, Acting Director and Senior Principal Scientist, Salim Ali Centre for Ornithology and Natural Studies (SACON), Coimbatore
Dr Latha Anantha, Director, River Research Centre, Thrissur, Kerala
Dr M Ganapathy, Executive Director, Public Health Resource Network, New Delhi
Dr M S Chari, Former Director, CTRI (Managing Trustee, CSA, Hyderebad)
Dr M Seenath, Professor, Zoology, University of Calicut
Dr Madhuri Pejavar, Zoologist, Principal of B. N. Bandorkar College, Thane
Dr Manas Pandit, Associate Professor, Dept of Vegetable Crops, Bidhan Chandra Krishi Viswavidyalaya, West Bengal
Dr Mangal Borkar, Prof. of Botany, Thane
Dr Meenakshi Gautham, Public Health Specialist
Dr Mira Shiva, Coordinator, Initiative for Health & Equity in Society
Dr Mogalli Ganesh, Hampi University, Karnataka
Dr N Paul Sunder Singh, Karunalaya Social Service Society, Chennai
Dr Nandita Shah, Medical Doctor, Homeopath, SHARAN
Dr Nimisha Shukla, Professor, Gujarat Vidyapeeth
Dr Om Rupela, Soil Microbiology, Formerly with ICRISAT
Dr P K Prasadan, Botanist, University of Calicut
Dr Partha Chakraborty, Scientist, CSIR, IICB
Dr Partha Sarathi Ray Asst Prof, IISER, Kolkata
Dr Ponnammal Natarajan, Retd Dean, Anna University
Dr Priti Joshi, Botany, National Organisation for Community Welfare, Wardha
Dr R K P Singh, ICRA, Patna
Dr Ramanjaneyelu GV, Executive Director, Centre for Sustainable Agriculture, Hyderabad
Dr Ravi Narayan, Community Health Advisor, SOCHARA
Dr Rudraradhya, Retd Senior Plant Breeder, University of Agricultural Sciences, Bangalore
Dr S Jeevananda Reddy, Former Chief Technical Advisor – WMO/UN & Expert – FAO/UN
Dr Sagari Ramdas, Veterinary scientist & Director, Anthra
Dr Sant Kunmar Gautam, Plant Breeder, Delhi.
Dr Santhi, Ecologist, Trivandrum
Dr Santosh M. Tungare, Environmental Chemistry, TechnoGreen Environment Solutions, Pune
Dr Sasikumar Menon, Expert in Medicinal Plants & Species Conservation, Univ of Mumbai
Dr Siddhartha Gupta, Pathologist, CPT Hospital
Dr Sivaraman, Siddhha Expert, AROGYA
Dr Sujatha Byravan, PhD, Scientist based in Chennai, Former President, Council for Responsible Genetics, Cambridge, Massachusetts
Dr Sujatha Lakhani, Agriculture Scientist, WAPRED
Dr Sultan Ismail, Soil Biologist & Ecologist, Tamilnadu.
Dr Sunita Rajadhyaksha, Pharmacology, Mumbai University
Dr Sunita Rao, Ecologist, Vanastree and ATREE (Ashoka Trust for Research in Ecology and the Environment), Sirsi
Dr T A V S Raghunath, Entomologist, Centre for Sustainable Agriculture, Hyderabad
Dr T K Maqbool, Professor in Zoology, Calicut University
Dr T S Channesh, Agriculture Scientist, UAS Bangalore
Dr Tarak Kate, Organic Farmers’ Association of India, Wardha
Dr Thelma Narayan, Director, SOCHARA School of Public Health, Equity and Action
Dr Thomas Varghese, Soil Scientist (Retd.), Kerala Agriculture University, Ex-Chairman, Kerala State Agriculture Prices Board
Dr Tushar Chakraborty, Principal Scientist, CSIR, IICB, Kolkata
Dr TV Sajeev, Scientist (Entomologist), Forest Health, Kerala Forest Research Institute
Dr Usha Balram, Professor and Head (Retd.), Dept of Zoology, All Saints College, Trivandrum, Kerala
Dr V S Vijayan, Chairman, Salim Ali Foundation, Former Chairman, Kerala State Biodiversity Board; Former and Founder Director, Salim Ali Centre for Ornithology and Natural Studies (SACON, a Centre of Excellence of the Govt of India)
Dr Vanaja Ramprasad, Founding member of Foundation for Genetic resources, Energy, Ecology and Nutrition ( Green Foundation), Bangalore, Karnataka
Dr Vijaya Venkat, Founder of The Health Awareness Centre (THAC), Mumbai, Maharashtra
Prof A Prasada Rao, Retd Professor, Acharya N G Ranga Agricultural University (ANGRAU)
Prof B N Reddy, Professor of Botany, Osmania University
Prof Jalapati Rao, Professor in Agronomy and Registrar (Retd), ANGR Agricultural University, Hyderabad
Prof K R Chowdhary, Retd Professor, Acharya N G Ranga Agricultural University, Hyderabad
Prof Lalit M Nath, Retd Professor & Dean, Centre for Community Medicine, AIIMS
Prof M K Prasad, Ex-Pro-VC, Calicut University, Ex-Chairman, Information Kerala Mission
Prof Mahadeb Pramanik, Dept of Agronomy, Bidhan Chandra Krishi Viswavidyalaya, WB
Prof N Venugopala Rao, Retd Professor of Entomology, ANGRAU, Andhra Pradesh
Prof R N Basu, Retd. Vice Chancellor, Kolkata University
Prof S Krishnaswamy, Structural Biologist and Former President, Tamil Nadu Science Forum
Prof Satya Prasad, Professor of Botany, Osmania University, Andhra Pradesh.
Prof Shree Ram Padmadeo, Convener, Department of Biotechnology, Patna University, Patna.
Prof Sudarshan Iyengar, Vice Chancellor, Gujarat Vidyapeeth
Prof T K Bose, Former Director-Research, Bidhan Chandra Krishi Viswavidyalaya, WB
Prof Veena Shatrughna, Deputy Director (Retd), National Institute of Nutrition, Hyderabad