The report of the Task Force on Application of Agricultural Biotechnology on the development of a biotechnology policy has been received as a step in the right direction.
AT long last the framework for a much-needed biotechnology policy is ready. The Task Force on Application of Agricultural Biotechnology, under the chairmanship of the agricultural scientist Dr. M.S. Swaminathan, has submitted its report to the Union Agriculture Ministry. The report has been hailed variously as "unique" and "balanced" and as an attempt to "streamline the cumbersome regulatory process, steering it away from ad hocism". The recommendations are seen as a step in the right direction even by its critics.
The Task Force was set up in May 2003 to examine the potential and problems of biotechnology applications, particularly genetically modified (GM) crops. The thrust was on evolving a long-term policy on the use of agricultural biotechnology and setting up an independent and professional watchdog, the National Biotechnology Regulatory Authority (NBRA), to generate public confidence in the use of genetically modified organisms (GMO). The panel emphasises the vital role of the regulatory mechanism in generating public, political, professional and commercial confidence.
The policy on biotechnology, the report points out, should provide the direction for research and development based on social, economic, ecological, ethical and gender equity issues; devise a system for commercialisation of transgenics or genetically modified organisms; and formulate a clear policy on GM food. Swaminathan said: "The bottom line of the policy should be the economic well-being of farm families, food security of the nation and the health security of consumers." According to him, protection of the environment and security of national and international trade in farm commodities are equally important.
There is an urgent need for a transparent process for research on GM crops and for their approval and use. As per the Task Force's blueprint, the NBRA (with two wings, one for food and agriculture and the other for medical and pharmaceutical applications) will achieve just that by cutting through red tape and being answerable to Parliament. But until the NBRA is set up, the release, notification and registration of transgenic crops for commercial cultivation should be directly under the Ministry of Agriculture, specifically the Indian Council of Agricultural Research (ICAR), it says.
The report criticises the existing process of clearance as "lengthy and cumbersome". To hasten this process, the report suggests: "Once an extant/transgene has been declared bio-safe, its derivatives need not always be evaluated for bio-safety again. Such derivative crop varieties can be evaluated on the basis of large-scale field trials by the ICAR and released after satisfactory VCU [value for cultivation and use] trials." But the panel is for a "transparent and truthful risk-benefit analysis of GMOs on a case-to-case basis". It proposes that the powers of the Genetic Engineering Approval Committee (GEAC) - now responsible for commercial approvals - be limited to the granting of environmental clearances.
The Task Force suggests that until the NBRA is set up, the powers of approval for laboratory and field trials for bio-safety should rest with the Review Committee on Genetic Manipulation (RCGM), while the multi-locational farmer's field trials (through the All India Coordinated Research Project) should be the responsibility of the ICAR and the company (in the case of private research) concerned. The Monitoring-cum-Evaluation Committee (MEC) should report to the GEAC on bio-safety and environmental issues, while the Agriculture Ministry and the ICAR should monitor the GMOs, post-release.
Describing farmers and consumers as the best judges of the efficacy of GM seeds and food based on yield improvements and cost savings, the panel recommends that they be given "complete information" on the benefits and risks associated with GM crops.
The panel's attempt to strike a balance between the industry's profit motive, the farmers' interest and the public's concerns is noteworthy. It focusses on the adoption of GM varieties (which allows the farmer to save and re-use seeds), and not just hybrids. It lays stress on a strong liability regime and seeks insurance schemes for farmers, sponsored by the government and corporations. It advocates the segregation and labelling of GM foods for consumer benefit. The panel believes that linkages between organic and biotech farming should be studied and seeks to set up a process of registration of GM seeds.
Significantly, the Task Force has identified the weaknesses in the existing system and suggested a mechanism for regulation. The existing regulatory authority, the GEAC, is a multi-disciplinary body headed by an Additional Secretary-level official of the Ministry of Environment and Forests. The last three years have seen six chairmen come and go, much to the consternation of the industry. Hence the Task Force's thrust on setting up an independent and transparent regulatory authority.
The report also suggests the setting up of a biotechnology regulatory advisory board in each State and biotechnology risk assessment and communication committee in each district to ensure the prevention of illegal proliferation of GM seeds. These boards and committees are to liaise with the NBRA.
With regard to the selection of crops for developing transgenics, the panel points out that the deciding factor should be issues of national interest, such as external trade. The importance of the traditional basmati rice in the international market is a case in point. The panel also suggests labelling and traceability norms for GM products, establishing codex norms in GM foods, and the protection of organic farming zones and agro-biodiversity sanctuaries from the effects of cross-pollination of GM crops.
The panel wants data gathered "on the impact of transgenics on biodiversity in crop fields", venture capital assistance for the transgenic crops industry and private-public sector alliance for the production and marketing of GM seeds.
Further, the report suggests that the Seeds Act and the environment laws to deal with possible illegal proliferation of GM seeds be strengthened. It favours mandatory registration of all released seeds and proposes a single-window information centre on all aspects of bioethics and biosafety.
According to the report, the transgenic approach should be considered as complementary and resorted to when other options to achieve the desired objectives are either not available or not feasible. It also encourages the government to give out all details on transgenic seeds resistance to pests and diseases. An important recommendation of the panel is that the government should provide an additional Rs.1,200 crores over the remaining three years of the Tenth Five-Year Plan for biotechnology-related programmes to strengthen surveillance mechanisms and to set up an NBRA.
The Task Force recommends that the international guidelines created by the Food and Agriculture Organisation-World Health Organisation Codex Commission to assess and manage the health risks posed by GM foods should be closely followed and safety assessments conducted on all GM foods before giving them marketing approval.
According to the report, there are regions in India that represent either primary or secondary centres of genetic diversity in such major crops as rice. These areas should be conserved for posterity as "agro-biodiversity sanctuaries" and "organic farming zones" (see box). It also recommends the development of safety mechanisms to check inadvertent passage of unwanted genetic material in the plant-animal-human food chain.
THE Task Force report, as can be expected, has drawn its share of criticism. While appreciating the panel's broad concerns, the Delhi-based environment activist Dr. Vandana Shiva said: "What is needed for GM crops is a GEAC plus a stronger health regulation by the Health Ministry and agro- and socio-economic regulation by the Agriculture Ministry."
Dr. Suman Sahai, convener of Gene Campaign, welcomed the need for "overhauling the regulatory system from its present appalling state". While agreeing that the Task Force has generally taken the right direction, she criticised the recommendation that once a transgene is tested for biosafety in a particular crop it need not undergo tests when implanted in other crops. "This," she said, "is a dangerous suggestion."
A former regulator for GM crops in the United States Dr. Sivramiah Shantharam, though welcoming the Swaminathan panel's suggestion to set up an autonomous regulatory authority for GM crops, said: "I am not certain how autonomous it would be under the aegis of the ICAR, which itself is an organ of the Union Ministry of Agriculture. There is a serious conflict of interest with the ICAR as it will also be an applicant for regulatory clearance." Shantharam further said: "The Swaminathan panel also leaves environmental clearance with the GEAC. This is not practical. How can the regulatory body give commercial clearance without having the authority for environmental clearance? Both the decision-making powers must vest with one body."
Dr. Ashesh Tayal, scientific adviser to Greenpeace India, criticising the panel recommendations, said that the report was for giving a blanket approval to gene constructs and rejected the need of evaluating each application of the construct in different uses. He said it was accepted that new genes work differently in different species and environments and their impact can vary dramatically. They must be regulated on a case-by-case basis, according to him on the panel's recommendation for the conservation of biodiversity and organic zones coexisting with GM crop zones, Tayal said: "Environmental realities will not permit such a coexistence without contamination."
The panel's recommendation for a single-window clearance by the NBRA is unique as such an arrangement does not exist anywhere else. Even in the U.S., there is a three-tier process. Some experts seem to doubt the efficacy of a single-window system of clearance. User and promoter agencies the world over are not vested with the powers of clearance. But the Task Force recommends vesting the powers of clearance with the ICAR and the Agriculture Ministry, which are also promoter agencies.
For all the criticism, the report certainly provides a broad framework for the development of an agriculture biotechnology policy to be evolved. It will probably be a year before the Union Cabinet gets around to deliberating on the report. Until then, all stakeholders should engage in a dialogue to build consensus over the NBRA.
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