Genetic Technology and Its Regulatory Regime in India

Ashwini Siwal, Doctoral Fellow, Faculty of Law, Jamia Millia Islamia, New Delhi

Genetic Modification or Genetic Engineering is concerned with deliberately changing a gene of an organism in order to alter one or more of its characteristics1. The progress in the biological sciences had been relatively slow as compared to physics and chemistry which dominated for a long time, but since the second half of the previous century the development in it are now coming to the fore. The elucidation of the DNA Double Helix by Crick and Watson in 1953, followed some years later by the discovery that threads of DNA could be cut at specific sites and could be attached at to another segment of DNA, meant that a specific gene could be removed from one organism and reinserted in an unrelated one, thus removing the species barrier thereby creating organisms that are very unlikely to have occurred in nature. Today, Genetic Modification might allow crops to be grown in otherwise unfavourable conditions, and with far less application of pesticides and fertilizers. However, like any other technology the biotechnology is also “JANUS FACED”2that is having both negative as well as positive sides. The issue of Genetically Modified products encompasses agriculture, human health and environmental issues. Some are afraid of potential hazards while some view it as just one more step in the corporate dominance of the food and agriculture system. On the other hand, it allows plants with desired traits like pest resistance or high nutritional value. More optimists view it as a solution to the food problem of the planet3. Nevertheless, agricultural biotechnology has the potential to alleviate poverty, facilitate rural development, and strengthen trade and economic competitiveness and sustainability while delivering benefits to the farmers.

There is a perception that the GM disrupts the natural order where man is seen as a gene artist, playing God4and which might open the floodgates of catastrophe5. Thus, the modern society is moving towards a runaway world which defines modern life- an archaic, haphazard world over which one has no control, but is rather carried along by a mixture of economic, technological and cultural imperatives. What we are witnessing today is a “CRISIS OF CONFIDENCE” in society’s relationship with science. A section of society had the heightened dilemma due to irreversibility and scale of the possible consequences and is more fearful due to the fact that they see GM as a product of globalization. They fear that the Monsanto Landscape may become the global landscape; the crops offering “FOOD.HOPE.HEALTH”6.

The effects of the spread and consumption of such products at large is a “known unknown”.7These diverse challenges to the future adhere to the DANGER BELIEF view of GM products8. This, as was the case with the 17th Century Diggers, is typically a land- based resistance, encompassing also a concern for animal welfare. Among the Diggers of 1649, for example, ‘tender hearts grieved to see their cows bruised and swollen after being beaten by the lord of the manor’s bailiffs’.9The current generation of activists belong also to a tradition of protest against the social and psychological effects of industrialization which goes back to the Luddites.

One Such issue that came in controversy recently was the Bt. Brinjal, the first commercial GM crop in India. The controversy on this particular crop is symptomatic of the Crisis of Confidence and the Danger Belief as will be seen in the preceding sections.

Further, after a overview of the existing legal regulatory mechanism in existence in India, the paper will argue that the existing regime offers a “Technocentric Approach” to the GM problem. That is the definition of problems is necessarily science led and solutions depend upon the mobilization of scientific experts. Examining these and the low threshold and standards this paper in end will argue that public opinion must be generated before any decision is taken as to what the farmers and consumers will grow.

GENETIC MODIFIED SAFETY ASSESSMENT GUIDELINES IN INDIA

The development of a GM crop involves a complex process starting from gene identification, selection, product commercialization and safety assessment has to be undertaken at all stages of its development. Taking into account each gene’s source, previous consumer exposure to the source, and whether there is a history of safe use for source material, the gene and its scientific products. After genetic modification, specific GM crop line is selected through a variety of steps in the greenhouse and field during which the biological and agronomic equivalence of the GM crop is compared with its traditional counterpart10. Biosafety regulations have been put in place in India. Biosafety can be defined as those as those concerns regarding damage to human beings, the environment and other living organisms due to intentional or unintentional, authorized or unauthorized experiments using biotechnology. India is a party to the Cartegana Protocol is committed to the safe handling of living modified organisms or genetically modified organisms. Cartegana Protocol provides a broad framework on Biosafety and is a supplement to the Convention on Biological Diversity that seeks to protect biological diversity from the potential risks posed by living modified organisms. The protocol makes it clear that products from new technologies must be based on the Precautionary Principle, in accordance with the Precautionary Approach contained in Principle 15 of the Rio Declaration on Environment and Development11.

The regulation of Genetically Modified Organisms in India is governed by the, “Rules for Manufacture, Use, Import, Export, and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989” framed under Section 6, 8 and 25 of the Environmental Protection Act, 1986. Under that the two agencies primarily responsible for the implementation of the 1989 Rules are:

  • Ministry of Environment and Forests (MoEF), and
  • Department of Biotechnology (DBT) of the Ministry of Science and Technology.

The 1989 Rules provide for competent authorities and their composition for handling of various aspects of the Rules. They are:

  • The Recombinant DNA Advisory Committee (RDAC);
  • The Review Committee on Genetic Manipulation (RCGM);
  • Institutional Bisafety Committee (IBSC);
  • The Genetic Engineering Approval Committee (GEAC);
  • State Biosafety Coordination Committees (SBCs);
  • District Level Committees (DLCs).

The Ministry of Health and Family Welfare is responsible for ensuring the quality and safety of food marketed in the country and the Prevention of Food Adulteration Act, 1954.The Indian Council of Medical Research acts as a advisory body on GM foods. The Ministry of Food Processing Industries is involved in developing new regulations for R&D of food processing industries. In addition to MoEF and DBT the Ministry of Agriculture is responsible for seeds policy.

Before Commercialization, GM crops undergo a series of detailed and specific safety assessment process, which focuses on the safety of product associated with the introduced gene and any other likely toxicological or anti-nutritional factors associated with the source of the novel gene and the product to which it was introduced. DBT had formulated Recombinant DNA Safety Guidelines in 1990 which were further revised in 1994 that covered areas of research involving GMOs. In 1998, DBT brought out separate guidelines for carrying out research in transgenic plants that is, “Revised Guidelines for Research in Transgenic Plants”. These also include guidelines for toxicity and allergenicity evaluation of such seeds, plants and plant parts. These guidelines cover development of transgenic plants and their molecular and field evaluation along with import and shipment of GM plants for research. The guidelines provide the basis for generating food safety information on such plants or their parts.

Acute and Sub-acute chronic toxicity tests have been included in the DBT Protocols12. Others are Sub-chronic Feeding Study, Protein Thermal Stability, Pepsin Digestibility Assay and Livestock Feeding Study. These test protocols are based on the “INTERNATIONAL BEST PRACTICES” have been adopted from the Codex Alimentarius Commission, Food and Agricultural Organization (FAO), Organisation for Economic Cooperation and Development (OECD) and the International Life Sciences Institute guidelines and modified as per requirements13.

Review Committee on Genetic Manipulation (RCGM) decides on the actual tests and protocols on a case by case basis. This statutory body had a task to ensure that the R&D activities are carried out in a safe and sound manner. It comprises of 29 experts from multi-disciplinary fields. The development of GM crops (including imports for research) at the lab stage, contained multi-location trials, and protocols for the biosafety studies requires prior approval of the RCGM. Based on the results of the contained field trials and the biosafety assessment studies, RCGM makes its recommendations to the GEAC.

An approval of the GEAC is mandatory to conduct large-scale field trials to assess safety, efficiency and the agronomic benefits. The result of the contained field trials and the large scale field trials are then evaluated by the State Agricultural Monitoring Committee (MEC) before recommendations on the efficacy of the transgenic are made to the GEAC. The GM crops for large scale trials are also evaluated under the Indian Council of Agricultural and Research (ICAR) testing system.

In addition to that all institutions involved in any work related to the development, use of such plants are required to set up an Institutional Biosafety Committee which has an expert nominated by the Department of Biotechnology. The GEAC takes into account the findings of the biosafety studies and the agronomic evaluation by MEC and ICAR before according approval for the environmental release of the crop. Thus, the GEAC is the apex statutory body to evaluate environmental risk versus societal benefits before release of modified organisms. Any company involved in the development of GM crop has to undertake extensive biosafety assessment which includes environmental safety assessment as well as food and feed safety assessment.

PROBLEMATIC AREAS

The existing regulatory regime seems to suffer from following problems:

Technocentric Approach: The roots of this approach lies in the scientific revolution of the 16th to 18th centuries, which acted as a precursor to the enlightenment14. In fact extreme legal positivism models itself on the objectivist-positivist approach of modern science15. In terms of man-made laws, the development of biotechnologies in general and particularly genetically modified products has prompted the promulgation of laws at national levels. The core of the legal regime is a requirement that a risk assessment be carried out by those who wish to obtain a license to import, acquire, release or market them, thereby introducing a PRECAUTIONARY ELEMENT. In assessing the risk of Genetically Modified crops the GEAC is advised by committees16. Difficulties exist, however, with the centrality of risk assessment in this regime. In particular the quantitative approach to risk assessment presupposes that the risks posed by the release of such crops and food can be identified and measured. The reality is that scientific opinions diverge in their views on the seriousness of the risks in this, an area of extreme uncertainty. Thus the present approach is resolutely TECHNOCENTRIC such that law draws upon a belief in a rational and objective approach to identifying and assessing risk and dealing with environmental problems. The present day ‘risk society’ is one which creates manufactured risks, where science and technology creates as many uncertainties as they dispel. Thus, social costs, while sadistically quantifiable as risks, become difficult to guard against, anticipate or even calculate17. And as Jurgen Habermas has argued that the increasing tendency to define practical problems as technical issues threatens an essential aspect of human life; for technocratic consciousness not only justifies a particular class interest in domination, but also affects the very structure of human affairs18. The approach needs to be reviewed.

Low threshold: A news report published on 20th of April, 200919said that the process for GEAC approval for GM crops has been simplified. Hybrids which had to undergo different tests over a process of about five years can now get approval in just one year. Earlier, the RCGM of the Department of Biotechnology would first recommend confined field trial, contained field trial, multi-locational field trials and large scale field trials. It would then go GEAC for approval. The whole process would take about five years. But now only one year of testing will do for the approved event. The hybrid will be tested in state agricultural university fields, then go to GEAC which after approval pass it on to the state agriculture department for release to farmers. It must be mentioned here that although the test protocols claim that they are based on best international practices, they are many a times by passed and overlooked like for example, an incident in Indian Agricultural Research Institute, where GM brinjals were sown in an open plant with total disregard to possible hazards due to cross-pollination20. While lowering the threshold gives the impression that the regulatory regime is pro-industry and there is some unwritten understanding between the government and corporations and the common people are ignored and overlooked.

There is a need to “tidy up” the existing regime and methods and modes to gain public confidence had to be devised.

CONCLUSION AND SUGGESTIONS

Justice Michael Kirby had once said that:

Science and technology are advancing rapidly. If democracy is to be more than a myth or shibboleth in the age of mature science and technology and more than a tri-annual visit to the polling booth, we need a new institutional response21...

Democracy functions on the assumption that the people or their representatives have the information and the necessary understanding to form a judgement on the matter22. The need of the hour is that we must first decide what society wants and needs- then tailor our technology to help where it can. There is a need to fill this planning vacuum. There is a need to draw the public directly into the decision making process. It must be remembered that the Government and the industry have the responsibility of informing the public about new technologies, products, which will influence their choice of products. For that purpose new ways and channels had to be devised. More importantly public confidence in regulatory effectiveness need to be significantly improved and creation of an environment for the public to made a balanced judgement with respect to biotechnology.

The problem requires a more inclusive and deliberative laws and administration, particularly to allow for a range of values and non-expert voices to be expressed. There is a need to engage the public in order to foster greater understanding and responsiveness between society and science. There must be a trinity of- science, law and citizen- to act in collaboration and put their wisdom together. The scientific vision may still be insufficient by itself to guide the community. The law cannot guide the community without the expertise of science. The law and the science together cannot guide the community, because they need feedback from the concerned citizen23. It will not be for the law people to solely determine the issues of health, environment and corporate dependence and neither it is the scientist alone who function away from the glare of publicity and the reach of social controls. Rather it is all three.

What is happening is that when people face what nothing in their past has prepared them for they grope for words to name the unknown, even when they can neither define nor understand it. Parallel to the growth of technology is the growth of the corporate giants which owe them, giving an additional dimension- the combination of technology with economic strength.  This is giving birth to the- CRISIS OF CONFIDENCE and the DANGER BELIEF in the society.

The point is that Law is the community’s bastion against power. Its strength lies in its ability to control powerful forces in any society. Science has been growing at a pace where we are lead to BRINK SITUATIONS the stage where two or more steps more would take all mankind over the brink. In that situation it will be too late to attempt to impose controls or to slow down the rate. The first and the most foremost task before the regulatory regime is as said by German Philosopher Hans Jonas’ is to identify “what we must avoid at all cost”, is to be determined by “what we must preserve at all cost24the latter can only be known ensuring the involvement of the community and a need to decentralise, and establish an accountable, challengeable regime which is open to criticism. Thus, the duty lies upon the law and policy makers to alert the public and regulate the technology. A great responsibility also falls on the community to engage with them in a manner which is informed and mature. After all, scientists are at least no better and no worse than the society of which they are a part25. Mature responses are urgently needed from all sides if the goods the genetics offers is not to be outweighed by bad.

  1. See Report of the select committee of the House of Lords on EC Regulation of Genetic Modification in agriculture (198-99) HL Paper 11 II (London, 1999); Royal Commission on Environment Pollution, 13th Report, The Release of Genetically Engineered Organisms to the Environment, Cmnd. 720 (London, 1989) cf. Jane Holder, New Age: Rediscovering Natural Law, in “Reasoning in Ethics and Law: The Role of Theory, Principles and facts”, ed. Alert W. Musschenga, WIm J. Van Der Steen, Ashgate, (1999). []
  2. See M. B. Rao, Manjula Guru, ‘Biotechnology, IPRs and Biodiversity’, Pearson, Longman, 1st Ed. 2007 at p.32. []
  3. “FEED A HUNGRY WORLD”,in Neil D, Hamilton, “Legal Issues Shaping Society’s Acceptance of Biotechnology and Genetically Modified Organisms”, 6 Drake J. Agric. L. 81, Spring 2001. []
  4. R.B. Stewart and M. Martinez, ‘International Aspects of Biotechnology: Implications for Environmental Law and Policy’ (1989) 1 Journal of Environmental Law, 157 at 158. []
  5. See for example, J. E. Losey, L. S. Rayor, and Y. Carter, ‘Transgenic Pollen Harms Monarch Larvae’ (1999) Nature, 20 May, 1999, which summarized research carried out at Cornell University on the effects of genetically modified Bt. Maize on species such as the caterpillars of the Monarch Butterfly: the results showed that 44 percent of the original population fed with the GM Bt. Maize had died and those which survived exhibited stunted growth. []
  6. See www.monsanto.com []
  7. See the legal interpretation of the risk of a release in R. v. Secretary of State for the Environment and Ministry of Agricultural Fisheries and Food, ex parte Watson [1999] Env. LR 310 which concerned the trial planting of GM maize on land adjoining the applicant’s organic farm. Cf. Jane Holder Supra Note 1 at p. 155 []
  8. Which views that GM organisms are bad for the environment and bad for our health, J. Morris and R, Bate, Fearing Food: Risk, Health and the Environment (Oxford, 1999) cf. Jane Holder, supra note 1. []
  9. See Jane Holder Supra Note 1. []
  10. Study Material, NLIU year 2009; BioSpectrum Volume 7, Issue 1 January 2009 at p.48 []
  11. For a reference to the Cartegana Protocol refer to M.B. Rao, Manjula Guru, Supra Note 2 at p.175-202. []
  12. Biotechnology study Material, National Law Institute University, Bhopal, 2009. []
  13. Biotechnology Study Material,  Law Institute University, Bhopal,  2009 []
  14. Cf Jane Holder Supra Note 1 []
  15. See C. G. Weeramantry, “Justice Without Frontiers: Protecting Human Rights in the Age of Technology”, Vol. II, Kluwer Law International []
  16. Like GEAC, MEC. []
  17. Biotechnology Study Material NLIU, 2009 []
  18. See David Held, Introduction to Habermas, Sociology, Giddens, at p.403. []
  19. See “GM HYBRID APPROVAL MADE EASY”, The Indian Express, April 20, 2009 on p.2. []
  20. See, Biotechnology and Contemporary Law, V. S. Rekhi, S. A. Abbas Rizvi, Ghayur Alam, Biotechnology Study material NLIU, p.32 []
  21. Kirby, M., Reform the Law, 1983, Oxford: OUP, pp.238-39. []
  22. See Weeramantra Supra Note 20 at p.27. []
  23. See Weeramantry, Supra Note 20 at p.9 []
  24. See Issues in medical law and ethics. []
  25. Roger Brownsworth, Margaret Llewelyn, ed. , Law and Human Genetics: Regulating a Revolution , Oxford, 1998 []

Share this post:

Recent Posts