The Fly Ash on Indian Biotechnology from the European Commission’s Policy

The recent passing of a new legislation by the European Commission lifting the de facto moratorium on the commercialization genetically engineered organisms (GEOs, GMOs) in Europe, resulted in a sigh of relief, that was stifled midway, on account of the largely impractical regulations associated with it. The Ministers for Agriculture of the member countries have endorsed the new regulations. Most of these regulations relate to segregation and labeling of GE products and have not much to do with science or biosafety.

The EC’s de facto moratorium of the past six years prevented commercial releases of GEOs in Europe, and hampered research on them. Both private investment and expertise largely moved over to the US. Nevertheless, over 200 traits were identified for transgenic technology in various crops in the EU countries. By the end of June 2003 the EC received 64 reports of studies on biosecurity and yield performance of transgenic crops, ready for commercialization, from the member countries.

Belying the hope for a rational climate from the EC, the new policy turned out to be a pyrrhic victory to the pro-tech lobby.   What is more perplexing is that the stringent regulations were framed ignoring overwhelming evidence, much of which originated from Europe itself, on the safety of GE crops.   In 2001, the EC released results of a 15-year study, costing US $ 64 million, and involving more than 400 research teams and 81 projects.   This report concluded that GE products pose no more risk to human health or the environment than conventional crops.   The Strategy Unit of Cabinet Office of UK has also released a new report on the costs and benefits of GE crops.   In addition, the recent GM-Nation report involving 16,000 interviews, in 15 cities and in 11 languages, is considered as the most balanced set of recommendations and conclusions to go forward with the commercialization of GE crops.   So far, extensive and intensive research in the US, Australia and elsewhere, on the probable risks of GE technology, has not brought out any adverse effects and none of the fears expressed by anti-tech activists were proved even marginally.    Such overwhelming evidence should have been sufficient to soften up on GEO regulations by the EC.
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The silver lining is the EC’s stand that public authorities cannot ban farmers from planting genetically modified crops.   The EC also published guidelines for the development of strategies and practices to ensure the co-existence of GE crops with conventional and organic farming.   This will provide some support to those farmers in the EU, who want to embrace the technology, and takes some wind out of the sails on anti-tech activists in other countries.

Biosecurity regulations should be objective to the extent of ensuring biosafety and environmental safety. A strict compliance of must be enforced. But the regulations must themselves be based in science, risk specific, rational and practical. While the scientific community is reasonably clear and reassured on biosecurity issues, the objective of the whole regulatory process is to reassure the public on the safety of GE products. This objective largely remains unachieved, without appropriate public awareness and education programmes about the purpose, benefits and risk mitigation related to GEOs. Public education is the critical need of the hour to save the public from being misguided by the negative propaganda of vested interest groups.

Too rigid and impractical regulations will result in either no product getting into commercialization thus denying the potential benefits to the public or the regulations becoming lackadaisical. It would be akin to the statutory warning on cigarette packets, which every smoker sees but ignores it. If a product is bad in the public interest it should be banned altogether. Such a step requires a strong conviction, courage and political will, which in the context of GEOs, is totally absent. Merely making noises and creating scenes, when one does not have the responsibility of being answerable for actions, is quite a convenient situation, for the rabble-rousers.

The new regulations of the EC will certainly put the member countries at a lot of disadvantage in the matter of GEO development and deployment. This will also result in infringement of certain regulations of the WTO. These consequences would not be confined to the EU countries, but have a telling effects on the Asian and African countries, with major export interest in the agriculture sector.

Even now, several member countries of the EU have not fully complied with their responsibilities. The EC has recently decided to take eleven countries to the European Court of Justice, for failing to adopt and notify national legislation implementing the EU law on the deliberate release of genetically modified organisms (GMOs) into the environment. This is in addition to several other infringements by member countries.

Having spent enormous amounts of money and time on developing and testing several transgenic products, the defaulting member countries are naturally wary of the effects of the new stringent rules they have to pass and implement under the new guidelines of the EC.

Spain would suffer most from EC’s rigid regulations, as 34 out of the 64 European projects, came from Spain. Of these 34 reports, 18 are on rice (15 on the yield increase and three on abiotic stress), 14 on maize and one on gene stacked (Cry 1F/Cry 1Ac) cotton. France has 16 GEOs, Germany six, while others have one to three transgenics, ready for commercial release, once (and if) the green signal comes from the EC. Left to the respective countries, the stringency of the biosecurity regulations each country makes, would depend much on the economic stakes at risk for that particular country.

Infringement of safety regulations does not seem to be confined to just any one country or continent. A fifth of the Bt maize farmers appear to have flouted federal regulation, by planting refuge at either below-regulation levels (19 per cent) or much worse even without any refuge at all (13 per cent), in the Midwest US. Several Indian farmers, who cultivated Mahyco/Monsanto’s Bollgard Bt-cotton, planted less than regulatory requirement of refuge and in some cases no refuge at all. The obvious reason is there for all to see. If one makes impractical and scientifically untenable regulations, they will be defied or not complied with in its entirety. Market forces have their own strange ways of breaking them or circumventing them. This has happened time and time again in all spheres of economic activity, and agriculture is no exception.

Biotechnology in India and other developing countries has suffered serious damage from the past policy of the EC. It is not that EU dictates policy on GEOs to the developing countries, but its policy has repercussions on agricultural trade and development. Anti-technologists and the Greens take advantage of EC’s stringency. They have already twisted EC’s de facto moratorium into a virtual ban. The refusal of USAID by Zimbabwe, a fall out of EC’s policy, was repeated in India. When the public, and even the regulatory bodies, repeatedly hear that “Europe has banned GEOs”, naturally doubts and fear rule the roost. Vested interest from different quarters used this position to advantage. We cannot derive much happiness from the recent lifting of the de facto moratorium by the EC, since the anti-tech activists would now shift their position into demanding for regulatory procedures including labeling, as rigid or even stricter than those imposed by the EC on its member countries. This will have serious consequences for the developing countries that have no infrastructure, expertise and financial resources, to comply with such regulations. In fact, several activists in Indian have demanded an absurd and scientifically unwarranted regulatory regimen, including an outright ban on GEOs. Such postures had an unfortunate effect on the functioning of the Genetic Engineering Approval Committee (GEAC), the highest regulatory authority in India. The GEAC has used the Precautionary Principle more often than most regulatory bodies, and has been making inexplicable and irrational decisions on the release of GE crops in India.

India can certainly find a sensible position between the rigid policy of the EC and the rather lax policy of China or some of the African countries. India has the means to handle GEOs in a rational manner, provided its scientific community, rather than its bureaucracy, frames and implements policy. This is possible only if there was political will to prevent inter-continental and multi-national corporate politics, which mainly operate in the garb of anti-tech postures, from interfering with decision-making. Decisions should be timely, rational, consistent and transparent. Regulations should be based in science and made in relevance to India’s crops and conditions. All stakeholders must be a party to the process of making policy and regulations. This is the only way to save Indian agriculture and give the farmers the benefits of a promising technology.

Professor C Kameswara Rao and Dr S Shantharam, Foundation for Biotechnology Awareness and Education, Bangalore, India. E-m: krao@vsnl.com, sshantharam@biologistics.us