Report bares serious lacunae with transgenics' regulation

The report of a committee set up by the Indian Council of Agricultural Research (ICAR) in January 2012, headed by Prof S K Sopory to look into the curious case of Monsanto’s gene ending up in public sector-developed Bt cotton is being seen as fair and thorough by many; there is also a view that the inquiry process left out some key players and that ICAR is shielding some of its own.

The report is indeed a scathing indictment on public sector research and ICAR headquarters’ functioning, raising questions related to capabilities, scientific ethics and integrity. Accountability questions also arise, given that taxpayers’ funds are being used for such public sector research.

Importantly, the Sopory committee report also points to serious shortcomings with transgenics’ regulation in the country. It reinforces observations of the Technical Expert Committee (TEC) set up by the Supreme Court in a PIL related to GMOs. The TEC has pointed out flaws with regard to examination of biosafety data by our regulators, for instance. The fact that this Monsanto event-contaminated-desi Bt cotton passed through regulatory evaluation even without a presentation to the apex regulatory body is an illustration. TEC pointed out the need for removing conflicts of interest. Sopory committee report shows that crop developers in the case of Bikaneri Bt cotton were sitting in the regulatory body approving their own products; what’s more, the committee says that information about contamination appeared to be known to scientists involved but was not revealed in the regulatory process!
One of the crucial issues that emerges from the Sopory committee report is that pertaining to the stand of the ministry of agriculture (MoA) in the Supreme Court in an important hearing in the GMOs PIL, which is tantamount to perjury. Pushing the ministry of environment & forests, which holds the mandate and authority for regulation of GMOs to the back seat, the MoA argued on behalf of the Union of India that open air field trials are essential for India’s food security (which is a fallacious argument) and that everything is ‘robust’ and ‘adequate in terms of global best practices’ when it comes to our regulation of GMOs. The MoA claimed what it did in the court, despite having in its hands the Sopory committee report clearly pointing to matters of serious concern with regard to transgenic research and regulation in the country.

Another important issue arising from the report is that related to contamination. The BNBt case is a real life illustration demonstrating the potential of ‘contamination’. The committee’s conclusion that contamination either in the form of outcrossing or admixture had occurred in UAS-Dharwad raises two pertinent points: one, the threat of contamination does exist admittedly; two, this possibility then exists for all future field trials and products in the R&D pipeline too.

Patent infringement

‘Contamination’ in the transgenics world brings in claims by large MNCs like Monsanto (holding IPRs on many related products and processes), of infringement on proprietary technology – in the current instance, a commercialised product was withdrawn from the market. Elsewhere, accidental contamination of a Canadian farmer’s crop with Monsanto’s ‘trait’ was judged as patent infringement! IPRs in the case of transgenics, coupled with contamination possibilities, will allow for larger markets for big corporations like Monsanto, edging out others: this has a direct bearing on farmers’ livelihoods and rights. Contamination in another context also has implications for trade security, as the LibertyLink rice case in the USA demonstrates.  Coming to other regulatory issues, the committee report clearly shows that regulation had not insisted on event selection prior to different stages of testing of BNBt cotton. They found that the integrated DNA has re-arranged itself significantly. The experts in the committee point out that this has implications on the effectiveness and stability of the event – read it as implications for farmers’ livelihoods ultimately. Further, the report points out that event-specific primers were not developed which are required for regulatory studies also.

The desi Bt cotton fiasco raises important questions around our research priorities, capabilities and accountability for such research investment decisions and results. Ironically, there was never anything desi or indigenous about the technology as it was a transgenic event obtained from a Canadian scientist by ICAR, with the latter deciding to unethically flout MTA norms subsequently to appropriate the technology as its own and call it ‘indigenous Bt’ technology.

The committee report is not just an indictment of how public sector transgenic research in this case has happened (claiming capabilities that do not exist for such research for instance, posing ethical and accountability questions given that precious taxpayers’ funds are being spent), but also of general research standards and quality in the country (how proposals are written, how even normal breeding guidelines are not followed, how project management takes place, etc.). The NARS has itself to blame if the public today is demanding accountability and rigour. If they do not set the house right now, the public sector scientists would be writing their own epitaph through reports like the Sopory committee’s.

Meanwhile, the MoA’s objections and arguments against the TEC report have given a curious twist to the GMOs’ controversy in India, since it was expected that the government would actually pick up important recommendations to make our regulation rigorous and trustworthy. It was after all a TEC whose constitution and ToR was jointly agreed to by the petitioners and respondents. It is as though the government adamantly wants to continue with its unscientific, lackadaisical and unaccountable regulatory regime. Why, one wonders!

(The writer is associated with Alliance for Sustainable & Holistic Agriculture)