With the National Food Security Bill generating much debate and even sections within the government questioning the viability of the scheme it envisages, a line of thought has emerged in favour of introducing genetically modified (GM) foods and crops in order to meet the requirements of the scheme on a long-term basis. While the Bill itself is inadequate in its coverage and is exclusionary at various levels, it has given rise to the spectre of GM foods once again.
The final report of the Technical Expert Committee (TEC) set up by the Supreme Court following a public interest petition regarding the environmental release of genetically modified organisms (GMOs) becomes all the more important in this context. The report, released on June 30, has found major gaps in the existing regulatory system and rejected the proposal to release GMs crops on the grounds that there are no “compelling” reasons for allowing the release of Bt (Bacillus thuringiensis, a commonly occurring bacterium found in insect-rich habitats and soils) for food.
It has recommended that GM crops should not be allowed in areas of origin or diversity as the committee’s understanding seems to be that the release of a GM crop into such areas could have great ramifications and has the potential for a negative impact on non-GM crop varieties. It has noted that to justify the introduction of GM crops in areas of origin “there needs to be extraordinarily compelling reasons” and an absence of “other choices”. “GM crops that offer incremental advantages or solutions to specific and limited problems are not sufficient reasons to justify such release. The TEC did not find any such compelling reasons under the present conditions. The fact is that unlike the situation in the 1960s [when there was a shortage of foodgrains], there is no desperate shortage of food [now] and, in fact, India is in a reasonably secure position,” it has noted. In a letter on July 23, the contents of which underscore the urgency of the issue, representatives of the Coalition for a GM-free India urged Prime Minister Manmohan Singh to accept the report without delay.
The six-member TEC reserved its most scathing indictment for the regulatory mechanism. The report comes in the context of the introduction of the contentious Biotechnology Regulatory Authority of India (BRAI) Bill, which, according to experts and representatives of political parties, is not only inadequate but rather shorn of anything even remotely to do with proper regulation of GMOs. Rather, the Bill was perceived as a facilitator.
The TEC has noted that the regulatory system “has major gaps and these will require rethinking, investment and relearning to fix”, and these need to be addressed before conducting more field trials. It has also called for a moratorium on field trials of Bt (as suggested in its interim report in October 2012) in food crops intended for commercialisation until there was more definitive information from a sufficient number of studies about the long-term safety of Bt crops.
Apparently, the largest number of applications for field trials of GM crops received by the Genetic Engineering Appraisal Committee (GEAC) was for Bt transgenics, including in food crops such as rice. The TEC has taken the view that the safety of Bt transgenics with regard to chronic toxicity has not been established. The largest deployment of transgenics worldwide is in soyabean, corn, cotton and canola, all of which are primarily used for oil or feed after processing. The TEC is emphatic that as there are no global examples of Bt transgenics “for any major food crop that was being directly used for human consumption”, there is no “compelling reason for India to be the first to do so”.
The second largest number of applications, the TEC has observed, are for herbicide-tolerant (HT) crops. The committee’s view is that “HT crops would most likely exert a highly adverse impact over time on sustainable agriculture, rural livelihoods and environment” and has found them completely unsuitable in the Indian context. It has also recognised the fact that the first GM food crop to be approved for commercial release was Bt brinjal in 2009 but the then Minister of Environment and Forests, Jairam Ramesh, rejected the recommendation and placed a moratorium on the release following widespread protests by farmers. It has been the status quo since then. The incumbent Minister, Jayanthi Natarajan, is not known to be in favour of GM crops unlike Union Agriculture Minister Sharad Pawar, who rightly or wrongly feels that the introduction of GM crops will help address food security issues. That there is a lack of consensus on the issue in the government is not surprising.
Explaining the need for a foolproof biosafety protocol, the report notes: “Based on the review of the dossiers, the professional expertise and standards across the institutions appears unsatisfactory… it is ultimately the expertise available in the regulatory system that sets the standards for conducting and evaluating the biosafety tests. Unless this expertise and capacity is present, no amount of facility creation will address the issues.” It has said “a deeper understanding of the process of risk assessment is needed within the regulatory system for it to meet the needs of a proper biosafety evaluation. This is not available in the country at present.”
It further states: “In several cases, the reporting of data as well as methods and analysis has been incomplete and cursory; there are also deficiencies in selection of samples, methods of analysis, and statistical tests, making it difficult to draw meaningful conclusions…. the number of such cases that have come to the notice of the TEC also reflects on the manner in which the toxicology data has been examined and the regulatory body for having accepted the reports… that there are serious deficiencies in reporting of the data in the dossiers and more importantly in the way in which these have been examined and conclusions accepted by the regulatory body.” It has pointed out that unless the purpose of the tests is kept in mind, “the risk assessment is likely to fail to meet its objectives”.
The TEC has recommended the setting up of a secretariat of experts to fix gaps in biosafety needs, necessarily supplemented with international expertise and the evaluation of GM safety dossiers in reputed regulatory bodies. It has maintained that it is not possible for a single committee such as the GEAC or the Review Committee on Genetic Manipulation to carry out all the evaluation. It has suggested that the regulatory bodies be located either in the Ministry of Environment and Forests or in the Ministry of Health and Family Welfare and that members of this body be free of conflict of interest.
Positions and perceptions The TEC considered a wide spectrum of positions and perceptions on the regulation of GM crops, which included a belief that the regulation was excessive and that it restricted the scope of biotechnology and denied the benefits of GM crops to society, especially the poor. A second view was that this technology was relatively new and there was limited information on safety, especially food safety, and the effects of long-term and widespread consumption and commercial release of GM crops on the environment. This view advocated that it would be prudent to carry out extensive field trials to evaluate the health and environmental aspects of allowing GM crops.
A third view, which was not mutually exclusive of the other two, was that the concentration of intellectual property and resources for research on GM crops in the private sector was resulting in perverse and exploitative relationships of public institutions with the private sector in developing countries and that these had not been successful in meeting the development and sustainability goals. This view held that the control of GM crop biotechnology by the private sector was affecting the ability to deploy it towards the public good in developing countries.
The TEC has taken a balanced view on the matter. The technology, according to it, comes with the promise of benefits as well as associated risks with regard to environmental safety and health. These risks need to be recognised and addressed for GM products to gain social acceptance. The report has taken stock of the fact that in view of the broad scope of GM technology and the range of possible products, risk assessment will have to be considered on a case-by-case basis even though there may be some issues common to most cases. But it is firm that unless the gaps in the regulatory system are addressed, public confidence in it will suffer. On the sequence of testing GM crops, the TEC says, that the tests “should be done under the minimum conditions of exposure”.
The Coalition for a GM-free India has urged the government to take the recommendations “seriously and act on them in the interests of food safety, security, and sovereignty as well as protection of environment and farm livelihoods”.
The TEC consisted of Imran Siddiqi, plant development biology scientist and a group leader of the Hyderabad-based Centre for Cellular and Molecular Biology; P.S. Ramakrishnan, professor emeritus of environmental sciences and biodiversity, Jawaharlal Nehru University; P.S. Chauhan, a genetics technology and food safety expert; P.C. Kesavan, a former scientist of the Bhabha Atomic Research Centre; B. Sivakumar, former Director of the National Institute of Nutrition, Hyderabad; and R.S. Paroda, former Director-General of the Indian Council for Agricultural Research.
It is learnt that Paroda, the Agriculture Ministry’s nominee who was inducted into the committee as its sixth member in November 2012 after the interim report was filed, did not endorse the final report. His inclusion was perceived as controversial as his organisation was said to be receiving funding from biotech majors, which constituted a clear conflict of interest. The TEC’s recommendations on the conflict of interest assume special significance in this respect.
The TEC has also pointed out, quoting from the Agriculture Ministry’s submission to the committee, that the Ministry had no locus standi or rationale to challenge its interim report as it was a conflicted party and by its own admission, as quoted in the report, had no mandate in biosafety assessment and was only carrying out the role of promotion with regard to transgenic technology. The Ministry did not concur with the interim report and submitted a rejoinder in the court.
The coalition has urged the government to accept the “well-reasoned, reasonable and sound recommendations” and “start overhauling the process of modern biotechnology regulation in India”. “Vested interests should not be allowed to prevail and prevent the acceptance of this report which is based on sound science, justice and the principle of sustainability,” it has said.
The TEC recommendations could have an impact on the BRAI Bill, which is with the Standing Committee on Science and Technology, Environment and Forests. “When read together with the TEC final report and the existing critiques of the Bill, it is evident that the BRAI Bill that your government has introduced in Parliament should be withdrawn as it is designed to be a single-window mechanism for easy approval of GMOs without regard for independent, rigorous scientific assessments and pertinent issues beyond science,” the coalition has stated.
Senior political parties, such as the Left parties, have thrown their weight behind the TEC report. There is no doubt that there is an urgent need to address these issues. Hastily crafted laws are hardly the answer to such complex issues that have far-reaching and long-term consequences for food security and agriculture.
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