NOTE: Devastating account of how and why India's GM regulation is failing so badly.
EXTRACT: Last year, public outcry over lack of biosafety tests on Bt Brinjal [eggplant, aubergine] led to the formation of an expert committee to evaluate the biosafety data. Surprisingly, no such evaluations are being carried out for other food crops that are being considered for trials in the field. The reasons for this are not difficult to figure out. Many GEAC members, who are expected to take objective decisions, are themselves developers of GM crops and members of bodies sponsored by the biotech industry (see box). This is why the GEAC never penalises any biotech company for violation of norms and inadequate biosafety tests.
REGULATING GM CROPS
GEAC's poor record of regulation
India Together, 19 August 2007
How does one countenance a regulator that does not adhere to the law of the land and is also unable to protect the interest of one group against another? The Genetic Engineering Approval Committee [GEAC], says Bhaskar Goswami, itself needs to be regulated to ensure it plays a balanced role.
Many GEAC members, who are expected to take objective decisions, are themselves developers of GM crops and members of bodies sponsored by the biotech industry. A media advisory from the Centre for Sustainable Agriculture earlier this year noted many conflicts of interest.
Dr. C D Mayee, co-Chair of the GEAC and the DBT nominee, is also a Board member of ISAAA an international network funded by biotech majors such as Monsanto, Bayer and Dupont.
Dr T V Ramanaiah, Ex-Member-Secretary, Review Committee on Genetic Manipulation, had personally approved hundreds of GM crop field trials that have happened in India so far. He has quit his post in the DBT and has joined Pioneer HiBred International as their Biotech Regulatory Affairs Manager.
Dr Deepak Penthal (University of Delhi), Dr Akhilesh Tyagi (UD-South Campus), Dr B M Khadi (CICR), Dr P Anand Kumar (National Research Centre of Plant Biotechnology) and Dr Rakesh Tuli (National Botanical Research Institute) were others identified as holding (or having held) regulatory roles despite a personal interest in the development of GM varieties.
Under the Right to Information Act, Greenpeace had asked the Department of Biotechnology [DBT] to release all data related to biosafety assessment of GM crops. DBT refused, claiming this is proprietary information. On appeal, the Central Information Commission directed DBT to release the information, but DBT argued that given the volume of material involved, it could only be scrutinised at the MoEF, and that too in the presence of a GEAC representative. Finally, at the latest hearing at the Supreme Court on August 1, the government counsel agreed to share the information and said that GEAC will put all information on its website. That has still not happened, however.
16 August 2007 - Reforms in India are expected to replace control and licensing with regulations that will benefit both industry and the people. The report card on the performance of the Genetic Engineering Approval Committee (GEAC), however, shows no evidence of this balance. Instead, what we find is an evident and inherent bias in favour of industry, while farmers and consumers have been left on the margins.
Set up by the Ministry of Environment and Forests as an inter-ministerial body, the GEAC is meant to regulate research, testing and commercial release of genetically modified (GM) crops, foods and organisms. Considering the controversies surrounding the acceptance of GM foods and crops, and knowing the worldwide opposition to GM foods, the GEAC was expected to play a judicious role that goes beyond commerce. But recommendations and decisions from its last 79 meetings show that the nodal agency has swept under the carpet serious concerns about human and animal safety, as well as environmental contamination. Working in tandem with the biotech industry, the GEAC is turning India into a dumping ground for untested and risky GM crops and food.
Bt Cotton, the only commercially grown GM crop in India, was approved for cultivation in 2002. Since then, the GEAC has bent the rules to protect the interest of biotech companies. Beginning with three hybrids of Mahyco-Monsanto in 2002, it has now approved 135 GM cotton varieties of 16 companies. Despite calls for caution, many GM food crops like okra, rice, corn and brinjal are on the GEAC's menu this year.
There are principally three fronts on which the GEAC has failed.
Enforcing rules for trials:
Call it incompetence or connivance, the fact is that the GEAC has been unable to enforce rules and regulations governing GM crop trials. Under the 1989 Rules of the Environment Protection Act, the GEAC is the only body which is authorised to permit trials of GM crops. In 1998, the states governments of Andhra Pradesh and Karnataka protested against illegal Bt cotton trials being carried out by Mahyco-Monsanto. These trials were permitted by the Department of Biotechnology (DBT), which is a violation of the 1989 Rules. Instead of disciplining the DBT, the GEAC declared that these trials are meant for 'experimentation and research' and therefore the permission is valid!
The regulator has failed to control the illegal proliferation of Bt Cotton across the country since 2001. It has itself violated the Environment Protection Act by allowing trials in states where State Biotechnology Coordination Committees and District Level Biotechnology Committees have not been formed. The State governments and farmers are not informed of these trials. In fact, the GEAC itself is not aware of the locations of all the trials and, naturally, monitoring is inadequate. No wonder some farmers who were involved in the field trials of GM food crops even sold the produce after harvest. Such reports on contamination of the food supply chain as well as neighbouring fields have poured in from various parts of the country, but have rarely been discussed in the GEAC meetings
Carrying out biosafety tests:
Last year, public outcry over lack of biosafety tests on Bt Brijal led to the formation of an expert committee to evaluate the biosafety data. Surprisingly, no such evaluations are being carried out for other food crops that are being considered for trials in the field. The reasons for this are not difficult to figure out. Many GEAC members, who are expected to take objective decisions, are themselves developers of GM crops and members of bodies sponsored by the biotech industry (see box). This is why the GEAC never penalises any biotech company for violation of norms and inadequate biosafety tests.
Meanwhile serious health impacts are being reported from the field. More than 12,000 sheep were killed last year in Andhra Pradesh after grazing in Bt Cotton field. An alarmed Director of the State's Animal Husbandry Department urged the GEAC to carry out rigorous biosafety tests and also asked farmers not to graze their animals in Bt cotton fields. Yet the GEAC brushed aside these concerns.
Biotech developers have argued that there is no proven cause-and-effect relationship between Bt toxins and the deaths of these animals; the toxin is intended to affect insects with alkaline stomachs, not mammals which have acidic stomachs. However, there is empirical evidence that cellulose-rich livestock feed makes the stomach alkaline and results in the toxin surviving longer. There is also some evidence of toxin-induced impacts on neurological systems of animals.
Prior to this, cotton workers in Madhya Pradesh had reported allergic reactions to Bt cotton. Bt Cotton farmers in Punjab have also reported skin allergies among workers engaged in harvesting. None of these have been investigated by the GEAC.
One-sided inputs for decisions:
Inserting an alien gene into a plant might pose serious health risks to humans and animals, which is why rigorous biosafety tests are essential. Unmindful of this, the GEAC relies on the data produced by the biotech companies instead of independent research by government agencies. This data is treated as proprietary information and is neither peer-reviewed not put in the public domain for scientists to evaluate. When the Indian Council for Medical Research can make clinical trial data on biomedical and health-related studies public, why cannot the same yardstick be applied to GM crops and food? This is nothing but suppression of science and a cover-up strategy.
Not just biotech companies, but influential traders of agricultural commodities too are being patronised by the GEAC. Running the risk of rejection of contaminated rice by Europe, Basmati exporters lobbied hard and brought in a ban on GM rice trials in the Basmati belt, but not for the rest of the country where paddy is cultivated. Despite a ban on import of GM food, import of GM soybean oil has been going on for years with the knowledge of the government. Further, despite knowing that testing facilities and protocols for GM presence have yet to be developed, imports of GM food have been permitted provided they are labeled. Clearly, trade interests of private companies scores over safety of farmers' and consumers.
Failure of the regulatory mechanism has evoked strong reactions from some states. The Agriculture Ministers of Kerala and Orissa have announced that they will not allow any GM trials in their states. Farmers' movements have uprooted and burnt fields of GM rice in Haryana and Tamilnadu for violation of GEAC norms. Officials from the states of Uttar Pradesh, Chattisgarh, and West Bengal have written to the Centre pointing out irregularities during field trials on GM brinjal, okra and rice. Yet the GEAC has ignored all calls to exercise caution.
While hearing an appeal on safety of GM products, the Supreme Court, through its order on 8 May 2007, clearly upheld the importance of biosafety. However, the GEAC during its subsequent meetings has deliberately misinterpreted the decision and approved fresh field trials. That even the Supreme Court's order is not considered sacrosanct by the GEAC is a clear indicator of things to come.
A regulator that does not adhere to the law of the land and is also unable to protect the interest of farmers and consumer itself needs to be regulated. There is an urgent need for an autonomous body, which includes all stakeholders, to regulate the GEAC. The health and environmental risks associated with GM crops are too serious to be disregarded.
16 Aug 2007
Bhaskar Goswami is with the New Delhi based Forum for Biotechnology and Food Security.