Tuesday, February 2, 2010

THE BT BRINJAL CASE: OVERHAULING THE REGULATORY SYSTEM MUST BE THE FIRST STEP

Suman Sahai
The Minister for Environment and Forests, Sri Jairam Ramesh deserves congratulations for the effort he is making to hear the public’s views on Bt brinjal. The range of public concerns that are being expressed by diverse stakeholders in different parts of the country will help form the Minister’s opinion about GM crops and the regulatory system in general.

According to the legal framework on GMOs, the 1989 Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro organisms, Genetically Modified Organisms and Cells, (and subsequent amendments), the statutory authority to take decisions on the release of GMOs, rests with the Genetic Engineering Approval Committee (GEAC) which is India’s apex decision making body.

In the case of Bt brinjal however, the GEAC has taken the unorthodox step of referring the matter to the government for a final decision. After declaring itself satisfied with the bio safety data on Bt brinjal and giving it clearance in principle, the GEAC has passed the ball into the government’s court. This appears to have been done because the GEAC recognizes that there is opposition to GM crops as well as a trenchant criticism of the manner in which the GEAC itself and the rest of the regulatory system conducts itself, its lack of transparency and its refusal to engage with the public’s concerns.

Gene Campaign had filed a Public Interest Litigation (PIL) in the Supreme Court in 2004, asking for an improved regulatory system incorporating among other things, technical competence, transparency and the involvement of the public in decision making. The case is dragging through the Supreme Court in its sixth year with no signs of any resolution. In the meantime GEAC has preempted everything and given clearance for the cultivation of Bt brinjal. It took this decision despite the fact that there is neither a labeling system in place, nor a law on liability in this country. If some harm were to come from the commercialization of Bt brinjal, either to farmers ( poor crops or contamination of organic crops) or to consumers who ate the vegetable, there is no law according to which the Mahyco seed company could be held responsible and made to pay compensation and recall the offending brinjal from the fields, mandis, retail shops and vendors.

In the absence of a liability law, the Mahyco company would go scot free even if its product were to inflict damage. In the absence of a labeling law , (India’s official position is for mandatory labeling), the consumers would have no way of telling whether they were eating Bt brinjal or not. The freedom of choice guaranteed by the Consumer Protection Act of India has been taken away by the GEAC with its decision to allow Bt brinjal to be commercialized before a system of labeling has been put in place.

The GEAC’s actions, taking a decision in favor of the Mahyco company, at the same time passing the buck to the government to face the public’s opprobrium, reeks not just of cowardice but also manipulation. Quite apart from this unseemly action, a statutory body cannot simply shirk its responsibilities and pass the onus onwards when it does not want to be the bad guy, yet, step in aggressively to take decisions when it thinks it can get away with it. For this reason alone, the GEAC should be disbanded and another structure set up reflecting new scientific developments in the field and principles of good governance.

However it happened, by getting involved, Sri Ramesh has taken the initiative and given himself the opportunity to do something really useful and important. He could do a great public service by forcing an overhaul of the legal framework governing GMOs in India. The Minister should set up a committee including scientists from different disciplines, legal and technical experts, as well as public interest groups. This can be anchored in the Law Ministry particularly since after an evaluation done by them some years ago, they had declared that the current Rules could not with stand a legal challenge.

The mandate of the review committee should be to improve the regulatory system on GMOs, modernize it according to the current stand of knowledge, plug the loopholes and tighten the system to make it inclusive, technically competent and transparent. This would lay the foundation of a system that would enable the development of safe and relevant technologies serving the public interest. A stringent, transparent regulatory system would not allow dubious, poorly tested products to be foisted on the public. Because of the weak and ambiguous nature of the Rules of 1989, agencies wanting the release of their products can avail of shortcuts and pliant regulators assist in this indefensible activity.

Questions of utility and safety will continue to arise till the legal framework and processes remain ad hoc and arbitrary. The following require the attention of the review committee:


  1. Improve the overall technical competence of the GEAC. The head of GEAC must be a technically competent person, not whoever happens to be posted as Additional Secretary in the Ministry of Environment and Forests.

  2. Divide GEAC into an advisory body of experts from diverse science and social science fields and a statutory body of technically trained people who will do biosafety testing along the lines recommended by the advisory body for each crop variety.

  3. Commercial release of GM crops should be held back till a proper regulatory framework with appropriate systems is in place. Research should continue.

  4. India must develop a new, stand alone Gene Technology legislation with like other countries have done. We have copied the American system of parking our regulation under the Environmental Protection Act although our situation is entirely different.

  5. A thorough Needs Assessment must constitute the first step before starting research on GM crops. Is Bt brinjal really needed? Which problem in agriculture does the transgenic crop attempt to address ? Are there alternative approaches? Has conventional breeding failed to solve the problem? GM seeds require testing, are expensive and raise safety concerns. The GM approach must be justified , not undertaken just because the Bt gene is available for licensing.

  6. If the Bt gene is to be used, its use must be selective, only where it will have a clear advantage over other approaches. Currently almost 40 % of Indian transgenic research is based on the Bt gene. Overuse of the Bt gene and the planting of Bt crops in all crop seasons will ensure faster build up of resistance in the pest and collapse of the Bt strategy of pest control.

  7. Invest adequate resources in biosafety testing and monitoring at various stages. Public sector agencies complain they get research grants for research on transgenics but not for risk assessment.

  8. Create structures to enable public participation in decision making on GMOs. Do this after a stakeholder dialogue to determine the levels and nature of public participation.

  9. The regulatory system must have an unequivocal requirement for assessing the socioeconomic impact of a new transgenic crop on traditional agricultural systems, agro biodiversity and the traditional knowledge of communities. This is required by the Biosafety Protocol.

  10. There must be an unambiguous definition of what will constitute ‘Confidential Business Information’. Barring this, all other biosafety data must be available for public scrutiny.

  11. India must invoke the Precautionary Principle ( as other countries like China, Mexico and Peru have done) and not allow transgenic version of crops for which it is a Center of Origin, most importantly for rice but also other crops like brinjal.

  12. Crops in which India has trading interests, like rice, specially basmati rice, soybean, tea, spices etc must not be genetically engineered since this will result in lost export markets.

  13. The program to genetically engineer medicinal plants must be stopped. These will be unacceptable in the international market. It is highly likely that rearranging of the genetic material could result in changes in the constitution and profile of plant metabolites that confer the healing properties.

  14. Unless the advantage of hybrid vigor can be clearly demonstrated, transgenic crops should be produced as true breeding varieties, not hybrids. This will enable farmers to save seed for planting the next crop and not being dependent on the company.

  15. The Herbicide Tolerance trait must not be permitted in India . As a chemical approach to controlling weeds, it will displace agriculture labor, especially women, who earn wages from weeding and other farm activities. Application of herbicides will destroy the surrounding biodiversity which is used by the rural poor as supplementary food, fodder and medicinal plants. It will also make it impossible to practice mixed farming.

  16. A clear protocol of mandatory biosafety tests must be prescribed crop wise for agencies producing transgenic crops, so that tests are comprehensive and standardized.

  17. A transparent and independent biosafety testing facility must be established under the supervision of scientists in the public sector to verify the data submitted by agencies developing transgenics. The same facility should be available to consumers wanting to have foods tested to confirm the presence of GM ingredients.

  18. A state of the art testing facility for food safety testing and a roster of tests that must be conducted, is urgently required. Our current food safety testing procedures are ad hoc and highly inadequate.

  19. A system of post release monitoring must be in place before permitting commercial release of GMOs. This will allow the monitoring of long term impacts of the GMO on the environment , human and animal health.

  20. Provisions must be made for labeling before any GM food is introduced in the market. This must be preceded by a public education exercise so that the label is not merely a colored sign on the package but offers the opportunity for informed choice to the consumer. Labeling to make any sense, will have to be preceded by a system for segregation, traceability and Identity Preservation of GM crops.

  21. The country must enact a law on Liability and Redress before allowing commercial release of GM foods, to put in place provisions for compensation, damage control and recall of the offending GMO.

  22. Before any approval is given to a transgenic crop, a risk –benefit analysis should be conducted with public participation.

Dr Suman Sahai has a Ph. D in genetics and has several years of research and teaching experience at the Universities of Alberta, Chicago and Heidelberg. She can be reached at mail@genecampaign.org and http://www.genecampaign.org/

4 comments:

  1. Dear Dr. Sahai,

    Thanks for clarifying in such simple words the most complex debate happening in the country currently. As I understand, you have covered all the points as far as policy, new regulations with regard to indigenous agrodiversity is concerned.

    I think community in general understand the pros and cons of it but may be helpless since this is market driven and political forces behind the BT concept and strategy.

    Sarita

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  2. The suggestion of dividing GEAC into an advisory body with experts from science and social science fields and making it responsible to do biosafety testing is a good/ relevant one. All the GM products whether generated by private or public enterprises can be ultimately tested out through experiments on biosafety aspects by a statutory body rather than the statutory body depending on the experimental data generated by the institutions producing GM crops.This will surely bring credibility to the experiments and more responsibility. Similarly, as suggested, transgenics need to be opted when it alone can offer a feasible solution and not as a panacea for all problems of agriculture.

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