Goverment apathy a bottleneck in biotech reasearch.Able AG News on Apr 25, 2017
Biotechnology applications in agriculture should be a part of the package of solutions to address the economic and social needs of a growing population. As per ISAAA brief 44 report more than 18 million farmers in 27 countries planted 175m ha of biotech crops in 2013, reflecting a five million or three percent increase in global biotech crop hectarage. It is time our nation witnessed concerted action for farmers, science, and economic growth. While science and technology is very precise, perceptions could be subjective; hence it is important to look at scientific facts in such matters. Let us look at a few facts.:-
1. The GM regulatory process in the country is defined by the Rules, 1989 of EPA, 1986 and is one of the best in the world. As per processes defined by Indian laws, two committees, RCGM (Review Committee on Genetic Modification) under the Ministry of Science and Technology and GEAC (Genetic Engineering Appraisal Committee) under the Ministry of Environment carry out extensive assessment of the biosafety and environmental safety of the technology before approving field trials. These committees comprise of renowned scientists and policy makers from multiple Ministries including the Ministry of Health. Is it right for the Indian Government to depend on politicians, NGOs and social activists for scientific assessment considering it fails to TRUST its own law and also the top regulatory body? All scientific assessment including field trials is a part of the regulatory process after which GEAC decides whether a particular GM event in a crop is fit for cultivation in India or not. In that context stopping field trials does not serve any purpose. If we do not generate trial data, how are we going to assess the profile of the technology and improve our decision making process? While imposing a moratorium on Bt brinjal in 2010 Shri Jairam Ramesh asked GEAC to define the additional tests to be conducted for further assessment of the technology. These additional tests have not been defined for four years now! It is a pity that the GEAC meeting was called for only once a year in the last three years.The net result is a virtual stagnation in R&D in GM crops for the last four years. I wonder how the approval of GM crops is not acceptable while GM medicines and vaccines approved by the same GEAC are fine for the population of this country. The industry just wants predictable regulatory regime.
2. The question we need to answer is ‘how do we define safety?‘ The regulatory processes around the world follow another concept called ‘substantial equivalence’. The concept of substantial equivalence goes by the principle that we test GM foods in comparison to the non-GM version of the same and see if there is any difference in the composition. If they are substantially equal, then we classify them as safe. There is a scientific process behind these assessments. Safety of GM foods cannot be assessed by politicians or farmers or any other common man. . .GEAC is our top scientific body which is authorized to do this. It is important to note that increased regulatory requirements have pushed up the cost of regulatory approval beyond 100M$ per event at the global level. This is slowly making this space exclusive for big corporates as they are the only people who can afford to spend such money. We have to note that RCGM and GEAC look at the exhaustive safety data generated and satisfy themselves before permitting open field trials. There is nothing to fear about open field trials as it has been proved in India and many countries.
3. The safety of the GM technology to humans, animals and the environment is well established in all the countries where it is approved, including India. For all those who claim that Europe does not support GM technology, a visit to the website of European Food Safety Commission will show that GM foods carrying about 25 different GM events are approved for import and consumption in Europe. There are plenty of studies, carried out by scientific institutions, which have established the safety of GM foods. The famous study of the French scientist Seralini published in 2012, well quoted by all activists mentioning rats developing tumours after being fed on GM corn, turned to be an inadequate paper and was later retracted in 2013 by the very journal, Elsevier which published it originally. Every technology evolves over a period of time. Research is an essential part of evolution of technology. We need to use new technologies as they keep evolving instead of waiting eternally. A country like India which has a high priority on increasing agricultural productivity and alleviating rural poverty cannot afford to ignore beneficial technologies. In India itself Bt cotton, the only approved trait, has produced outstanding benefits for farmers, through a reduction in pesticide application and resultant higher yields. Since the introduction in 2002, the acreage under cotton has gone up from 9 million hectares to around 12 million hectares while the cotton production has gone up from 13 million bales to 34 million bales, thus an increase of 165 per cent. India’s cotton yield which was 200 kg per ha in 2000, rose to 362 kg per ha in 2005-06 and 510 kg per ha in 2010-11. From being an importer of cotton in 2002, today India is the second largest exporter of cotton. 60 lakh cotton farmers of India would not use a technology if it has not delivered results. The issue of patenting seed is misplaced. Indian Patent Act does not provide patents on plants and plant parts including seeds. Seeds are not patented. We have to differentiate between seeds and biotech traits. Seeds are carriers of traits, much like how computers carry a chip. The companies who develop seeds through their own research protect them under the Plant Variety Protection Act, 2002. Under this Act the farmer has all the freedom to save seed and reuse it. The Government has full rights to intervene if any particular seed is demanded and the company is not making it available. There are enough safeguards in the Act. The biotech traits are patentable under the Patents Act. But it will not cause any food security issues as the seeds are available irrespective of the biotech trait. As mentioned earlier the biotech trait is given only once to the seed company through donor seed and it is an irreversible process. We have to note that the seed is not imported. All the Bt cotton seed is produced in India.
4. The safety and socio, economic and environmental benefits of two popular GM traits in the world — insect resistance and herbicide tolerance—is well documented in India and outside. Between 1996 and 2012, biotech crops have made positive contributions through: decreased production costs and increased productivity (estimated at 377 million tons) valued at US $117 billion; environmental benefits by eliminating the need for 497 million kg (a.i.) of pesticides; reduced CO2 emissions by 27 billion kg in 2012 alone (equivalent to removing 12 million cars from the road for one year); conserving biodiversity by saving 123 million hectares of land from being placed in agricultural production during the period 1996 to 2012; and alleviating poverty for 16.5 million small farmers and farm families, totaling more than 65 million people. (Source: ISAAA)
5.If there should be a social debate before the introduction of every technology that affects the people then what about various other technologies which are being used by urban people? Why only single out technologies which are helping 60 per cent of our population who are dependent on agriculture? Why only single out technologies which are aimed at reducing the back breaking drudgery of our farmers? It will be a good idea for the Government to create a platform of multi stakeholders where data based and scientific assessment debate can take place on important technological interventions in our country.
6. A written biotech policy of the Government of India, drafted by a Committee headed by Dr MS Swaminathan ten years ago clearly supports the use of GM technology in all crops including food crops. The only exception made was Basmati Rice. There was no other ban on the use of this technology in the policy document. Since 2010 there is a wide gap between the policy and the implementation which has caused uncertainty in the technology deployment, investments and further scientific work in jeopardy. The Government of India spends thousands of crores of rupees every year including ongoing work in public institutions on GM technology. If the policy and the Government investments are pointing in one direction and the implementation is pointing in another direction, what message are we giving to the researchers, investors, corporates and even biotech students who are pursuing this technology? There is a complete demoralization in the ranks of all these sections of society. If we are we talking about scrapping genetic modification or applying biotechnology in agriculture, then it would be death knell for education, research and commerce in this field which goes contrary to our Biotech policy. 9. This is in contradiction to what the Prime Minister mentioned in his recent speech to agricultural scientists on the occasion of the 86 ICAR foundation day, where he stressed the need to disseminate technologies to farmers in a simple manner and make “per drop, more crop”. Quoting Mr Modi, “We have to find ways to produce more on less land and in less time without any quality erosion.” There are many technological traits available in the GM space which could be of great use to India in the coming years in its effort to fight drought, salinity, high fertilizer subsidy, improving agricultural productivity and so on. The country is going to face serious shortage of pulses and oilseeds in the next 10-15 years as we try to meet the changing food habits of our increasing population. We are going to see a serious shortage of farm labour which will demand technologies that can work with less labour force. The humongous amount of water we use for cultivating transplanted paddy, just to use water as a weed management mechanism, will shortly become a luxury that we cannot afford. We need to find different ways of cultivating paddy and using other technologies to control weeds, while using the water to grow other crops.There is a need for a serious debate on the entire crop portfolio of the country, the priority crops for GM technology interventions, the priority GM traits which will be essential for the country and the areas where GM technology will not be necessary or will not be allowed.
7. Denigrating the country’s premier institutions will not help anyone achieve their ulterior motives.It is the facts which matter, and not whims and fancies of organisations. Institutions like Genetic Engineering Approval Committee (GEAC), Department of Biotechnology (DBT), Union Agriculture Ministry and the Scientific Advisory Committee to the Prime Minister have endorsed the need for deployment of GM technology in the country. Scientific assessment should be done by scientists and scientific bodies set up by the Government. A farmer leader or any scientist supporting GM technology cannot be labelled as an agent of multinational corporates. With globalization, most of the corporate have direct or indirect operations in other countries. Why is this labelling as an agent of multinationals happening only in agriculture and not in other sectors?
8. The environmental impact of GM technology is well documented by a series of studies by Brooks and Barfoot of UK and has brought out enormous benefits derived by 14.4 million small and resource poor farmers, a 9 per cent reduction in pesticide consumption and various other benefits. In the past year, Brazil and China have approved the world’s latest biotechnologies – either for cultivation or for food/ feed purposes or both. Farmers in the US and Sub-Saharan Africa will access Drought Tolerant Corn seeds in the next 12 months while farmers in India who faced a drought last year have no clarity, on whether they will have these choices.
9. Five different Bt technologies are approved in cotton in India including one from Monsanto, two from Indian companies, one from China and one from CICR. The market share of the gene depends on various factors including its efficacy in the field. It is driven by market forces. Bt is made available in both hybrids and Open Pollinated Varieties (OPV) of cotton in India. Let us clarify that Bt cotton seed or for that matter any seed (except some vegetable seeds) are not imported but produced in India. 100 per cent of Bt cotton seed is produced in India by the Indian seed growers. 95 per cent of the Bt cotton seed is produced by small and medium sized Indian seed companies. The remaining 5 per cent is produced by Multi Nationals in India. This is a technology generating employment, rural livelihoods, agricultural production and large scale economic benefit to Indians in India. It is a misconception that a technology provider charges a royalty as is the case in any industry whether it is IT or Pharmaceuticals or GM technology. The ultimate test is in the market and the customer decides what price he needs to pay for a particular product. Considerable research has taken place in public institutions. Out of the total regulatory pipeline of about 9 crops and more than 50 events, more than 50 per cent are from public institutions. If we want to encourage Indian public sector in this field, as is done in China, we should provide them with the right support to deregulate their products and bring them into the market. . About future traits and crops, we need to formulate suitable policies if we are worried that there could be exploitative and monopolistic practices. The best way to counter it is to encourage competition in the market.
Finally let us look at the issue of our regulatory system. According to the Central government’s affidavit in the Supreme Court in the current case between Aruna Rodrigues and the Govt of India, “the UoI firmly believes that the present system of regulating field trials and safeguards employed for conduct of such trials are science based, robust and comparable to International best practices. Moreover, improvement in regulatory system is a dynamic process based on the advances in science. UoI is committed to continuously follow up and update regulatory oversight based on the scientific advancement but without halting the research and development in the country……” It is very clear that improving the regulatory mechanism is a continuous process because of the continuous research that goes on in the area of technology development. Our current regulatory system is on par with the best in the world. While agreeing that there is a need for a wider debate we submit that scientific assessment of technology should not be subjected to wider debate. It should be done by the scientific bodies appointed by the Government. Efforts should be made to strengthen the scientific bodies like RCGM and GEAC rather than denigrating them at every opportunity. A debate can take place once the scientific assessment is done. Brinjal is one of the most widely consumed vegetables in India, being one of the most pesticide sprayed crops for pests like the fruit and shoot borer (FSB) insect, with a national average of 20-25 sprays per season, and up to 75 sprays in West Bengal. The introduction of the Bt gene in the Brinjal crop is to protect the crop against these insects. Bt brinjal reduces the need to spray pesticides by more than 70% which has enabled farmers to substantially increase their income due to increase in marketable yields and savings on pesticides, while consumers benefit from having access to ‘humble’ brinjal which is relatively much less sprayed with pesticides. While imposing a moratorium on Bt brinjal in 2010 Shri Jairam Ramesh had asked GEAC to define the additional tests to be conducted for further assessment of the technology, after GEAC gave its approval of environmental release of Bt.brinjal. These additional tests have not been defined for four years now! On the contrary GEAC had already scrutinized the exhaustive and detailed biosafety testing on bt brinjal by then. While seeking more data may not be unjustified, not defining the additional trial requirements till now clearly anti-technology. The net result is a virtual stagnation in R&D in GM crops for the last four years. If still tests need to be conducted can the GEAC define them or issue a statement on the relevance of those tests in 2014? Let us look at the four basic points made by Shri Jairam Ramesh for imposing the moratorium: State governments cutting across party lines and ideologies did not support commercialization.
It would be interesting to know what efforts were made by the Central Government to engage the states in a dialogue based on scientific facts rather than allowing them to take unilateral political stand against a particular technology based on the myths created by activists. Second, there appeared to be no overwhelming consensus on it in the domestic and international scientific community. It is not always possible to achieve complete consensus on any of the scientific discoveries or inventions or applications as we have seen for centuries. Overwhelming consensus of the scientific community should not be a hall mark for the decision taken by the regulatory bodies, especially in case of GM technology where it is easy to find divided opinions. Our regulatory bodies consist of scientists having experience in that field. The question is: whom do you believe and rely upon? Now that Bangladesh has approved the cultivation of Bt. brinjal do we know if there is any overwhelming consensus among the international and national scientific community in Bangladesh? 3) Concerns that seed supply would be the monopoly — direct and indirect — of one multinational company. Bt brinjal application was made by Mahyco, an Indian Company. Two Indian Universities (University of Agricultural Sciences, Dharwar and Tamil Nadu Agricultural University, Coimbatore) were collaborators in the project. Both hybrids and OP Varieties were proposed to be released with Bt gene. While the gene belonged to a foreign company, the entire seed system was under the Indian companies and Universities. There is no apparent risk of a Multinational company monopolising the seed supply. The issue of multinationals taking over our agriculture is used more to scare the general public rather than to present a logical view. There is no restriction on multinationals having their business in seeds and biotechnology in India. When a multinational licenses its gene to a local seed company, the global firm gives the gene only once through the donor seed. So there is no risk that the technology provider can control the seed supply system in such cases. Incidentally, Bangladesh through the NCB (the Bangladeshi equivalent of the Genetic Engineering Appraisal Committee) approved commercial planting of four Bt brinjal varieties developed by the Bangladesh Agricultural Research Institute (BARI), incorporating Mahyco’s proprietary gene construct technology in Oct 30, 2013, becoming the first country in the world to do so. 4) There appeared to be a persuasive case for more tests and trials under an agreed protocol and under an independent regulatory agency that would inspire wider confidence. If more trials were required why were they not prescribed for the last four years? Why was it concluded that GEAC was not independent enough and there was a need for another ‘independent’ regulatory body? If GEAC is not independent enough how can we trust the various GM vaccines and medicines which were approved by the same GEAC? Why was GEAC found to be not independent only for agricultural biotech applications?
Finally, Shri Ramesh says, ‘Strengthening public sector R&D and reviving the public sector seed industry are critical imperatives if India is to move ahead in this vital area. The U.S. approach has been one of permissions, while the European approach has been one of prohibitions. The moratorium was the middle path based on precautions’. There is no doubt that public institutions have been investing heavily into GM technology development prior to 2010. The Government has invested more than Rs. 8000 crores in research on GM. More than 50 per cent of the events under regulatory process are from public institutions. It is already happening. If the Government is serious about encouraging public institutions they should set up institutional mechanism to help them with regulatory support and to bring their products to market. The industry welcomes it. Regarding Europe let the myth not continue to be perpetrated. Five European countries have approved GM crops for cultivation. Europeans import and consume different GM foods every year as can be seen from the list of approved GM foods on the website of European Food Safety Commission. There is no evidence to suggest that the questions raised by Dr Swaminathan in his letter, as quoted by Shri Jairam Ramesh, were addressed by the Government. If an eminent scientist like Dr Swaminathan had suggested some steps to be taken before considering Bt Brinjal for approval, such steps should have been taken by the MOEF. Even the speech of Prime Minister Dr Manmohan Singh talked of using GM foods ‘….with appropriate regulatory control based on strictly scientific criteria’. Both Dr Swaminathan and Dr Manmohan Singh advocated an approach in which we should generate data and satisfy ourselves before taking up GM food crops. This should be perfectly fine with any person. Even the industry does not want the GM technology to be used without proper testing and public acceptance. But these steps should be taken in a constructive and predictable way so that there is clear objective, complete transparency and swiftness in the process. In this context the last four years stalemate and the current slow progress on allowing trials are unjustifiable. If we stop trials it will kill the technology. Shri Ramesh may be aware that blending technology with conventional plant breeding is essential to improve crop yields. Our focus should be to develop high priority traits using GM technology where traditional plant breeding may not have solutions or would take too long to provide solutions. . We do not recommend GM as a silver bullet. It is only a part of a package of solutions for our food security.