In 2008, a reputed environmental NGO presented evidence to the Genetic Engineering Appraisal Committee (GEAC, then called the Genetic Engineering Approval Committee) of the presence of illegal genetically modified (GM) plants (GM plants that grow inadvertently due to seeds left behind without proper post harvest disposal), in the field after the trial crop was harvested. This happened with a field trial of GM rice in Jharkhand. After receiving the report and discussing it in its meeting, the GEAC warned the NGO for having taken samples outside the country (without permission) for testing for contamination. But the GEAC did not think it necessary to take any action against the crop developer company whose field trial resulted in the contamination. So the violator was not penalised, the complainant who reported the violation was put in the dock. This is in a nutshell, the story of GM crop field trial regulation in India.
Why are open air field trials a threat?
Genetic modification of living organisms is a living, uncontrollable, irreversible and unpredictable technology. Once out in nature, we can’t completely control the movement of pollen or seeds or prevent cross pollination, and thereby, contamination. This could seriously impact agro-biodiversity. Open air field trials of GM crops are fraught with risks as these are tantamount to releasing unapproved GMOs (Genetically Modified Organisms) into the environment. These trial plants, in most instances, allowed to grow to full maturity, produce fruits and flowers and can easily cross pollinate with non-GM plants, thereby contaminating the native gene pool. India is considered to be one of the mega biodiversity hotspots of the world. Carrying out open air GM crop trials in this geography is a threat to this vast native gene pool, which is the store house of our food security. Violations during field trials compound these risks manifold.
Norms and guidelines of field trials
The rules under the Environment Protection Act 1989 guide the handling of GMOs. The apex regulatory body is the GEAC. Research on genetically modified crops in labs and fields began in the mid 1990s and Indian regulators for GM crops have been approving field trials (FTs) for various genetically modified crops since then. Open air field trial approval was granted for a genetically engineered tree (GM rubber) in 2011. There are protocols and procedures laid down for carrying out field trials; these suffer from the shortcoming of not being comprehensive or rigorous enough and the problem is further aggravated by indifferent and lackadaisical implementation. The attitude of the regulators is akin to that of GM crop/tree developers (not surprising as many members in the regulatory body are GM crop developers and the body sorely lacks ecologists, biodiversity experts, social scientists or ethicists). Minutes of the GEAC meetings reveal that almost all applications that come up for scrutiny have been given a go ahead.
Norms have been laid down by the GEAC, the apex biotechnology regulator of India, for handling trials of GMOs. According to the regulators, these are broadly classified as contained (conducted within laboratories, green houses or net houses) and confined trials. The so called ‘confined trials’ are further classified as Biosafety Research level-1 trials (BRL-1) and Biosafety Research Level-11 trials (BRL-11). The term ‘confined trials’ is a misnomer as these are carried out in the open air in fields and farms and can cross pollinate surrounding non-GM crops and also get mixed up, thereby posing a threat to non-GM crops. According to the guidelines, these so called ‘confined’ trials have to be carried out maintaining reproductive isolation, adhering to post harvest land use restrictions, regular site monitoring after getting the relevant permissions and so on. However, in practice, almost every one of the laid down norms have been violated and continue to be violated.
How good is the regulation?
The regulatory oversight is cursory at best; the regulatory monitoring bodies have with the exception of one instance, never identified any violations. This is not surprising as RTI (Right to Information) queries have revealed that in many instances, site monitoring visits are neither a surprise nor done in time or at adequate intervals, and many a time visits are not even carried out. The violations that have been brought to the notice of the regulator are the ones identified by civil society and concerned public. RTIs have also revealed that in no instance of field trials are tests carried out by the regulator to establish if contamination has taken place as a result of the trial. This is in violation of the Supreme Court order which states that there should be a protocol for testing of contamination, and testing should be done.
Since the last one year, the GEAC has decided to make the whole regulatory process even more opaque. They do not reveal any details of field trial applications received, which field trials have been approved, and where and when the trials will be carried out. Earlier, as mandated by its own rules and directives from the Supreme Court and the Central Information Commission (CIC), the GEAC used to put the complete agenda and minutes of its meetings, and biosafety data on the Environment Ministry website. All the field trial approval letters were also in the public domain.
None of this information is available in the public domain anymore and the secrecy makes it impossible for public to even know about what is happening, violating our fundamental right to know about how our food supply is being impacted without our informed consent. Most decisions emanating from the regulators have leaned towards less transparency, more secrecy and easing norms for approval of field trials. The secrecy also leads to greater concerns about biosafety threats from field trials and approvals of GM crops.
Violation is the norm!
Violations during field trials of GM crops have been a recurring theme right from the beginning (since GM crop research began). These include the absence of statutory bodies at the state and district level that are supposed to regulate and monitor the FTs, use of unapproved GM seeds, improper handling during trials and post-harvest, and the absence of even basic trial protocols. Below are brief details about some cases of field trial violations that have come to light. Having said that, there would be many more cases where violations have gone unrecorded, since monitoring and oversight is almost non-existent.
One of the fundamental problems with GM crop developers and unfortunately, even with the regulators in India is the fact that they function on the premise that GMOs are safe, whereas, the approach should be one of abundant caution. The role of the regulatory bodies is to ensure whether the GMO in question is needed at all, and if so, is the safety of the GMO beyond doubt.
In India, the violations of GM crop trials begin with the regulatory apparatus itself. Theoretically, there are two bodies at the state level empowered to monitor field trials. In many states, these bodies, the State Biotechnology Coordination Committee (SBCC) and the District Level Committee (DLC), do not even exist. Even where they exist, they are only on paper and are nowhere in the picture when field trials are approved and carried out.
Sometimes, the regulatory process is a mockery. In 2011, the GEAC approved field trials for rubber trees based on protocols for a single season crop, and here the regulatory process was reduced to a cut and paste exercise. Enquiries revealed that the GEAC had not even formulated protocols for field trials of genetically engineered trees. The regulator did not respond to the complaint; fortunately, the trials got stalled due to other reasons.
Conflict of interest within the regulator is another serious concern. One such case is of Bikaneri Narma Bt cotton (public sector GM cotton), where the promoters/developers of the Bikaneri Narma were also members of the GEAC at the time the proposal for field trials and commercial approval was under consideration. The whole approval of Bikaneri Narma Bt cotton turned out to be a fiasco with the finding that the gene has been contaminated by MON531 (possibly during field trials or afterwards, nobody seems to know), a gene owned by Monsanto. Similarly, in the case of GM rice developed by the University of Kolkata, the spouse of the principal developer was a member of GEAC and made some suggestions regarding isolation distance for the field trials. Currently, the process for considering GM mustard for approval is underway in the GEAC and the colleague of the developer of GM mustard is part of the deliberations. Such conflict of interest is in violation of the basic tenets of ethical, effective and meaningful regulation.
As we have seen, when violations are reported, the regulator turns against the complainant or ignores it, but hardly ever takes action against the violating company/entity. In 2011, a Greenpeace team (along with the local media) visited trial fields in Bijapur where FT of GM maize of Monsanto was carried out. They found viable corn cobs lying around making it feasible for volunteer GM plants to sprout, the farmer was allowed to harvest the refuge plants, plant residue was not disposed off safely, and cattle were found grazing in the field (all of this amplifies the risks and is expressly prohibited). The company had entered into a seasonal lease instead of a long lease (as stipulated) and there was no DLC in Bijapur. Video evidence was submitted to the GEAC. A few months later, the GEAC set up its own investigation. Disregarding the evidence as well as a report from the state government, they concluded that everything was done as per procedures laid down.
Earlier, field trials of GM crops were allowed in farmers’ fields and the farmers were not even aware that these were trial plants. In the case of GM okra (in 2006), evidence exists that the farmer had harvested the okra and sold the trial crop (unapproved GMO) in the local market for human consumption. The same has happened with Bt brinjal and Bt rice trials, where the test crops were eaten by humans and animals and sold in the market. After many such instances were reported, the Supreme Court directed that open air field trials were to be allowed only inside University campuses and on long lease lands. The risk involved with this is that agricultural university campuses are the repository of our valuable germplasm and these trials pose a serious risk to the germplasm collections. For example, a field trial for GM rice was approved at Chinsurah Rice Research Centre campus in West Bengal, that has a repository of hundreds of varieties of traditional rice.
The one instance where the regulator-appointed monitoring team identified a violation was in the case of GM maize trial of Monsanto carried out in UAS Dharwad, in 2011. The monitoring team pointed out in their report that an unauthorised GM seed (NK603, a herbicide tolerant GM maize) was used in the trial. The company had not sought permission to use it and GEAC had in another case explicitly prohibited the use of NK603. Despite the report from its own monitoring team, no action was taken by the GEAC. The cavalier attitude of the apex regulator has been a recurring problem with regard to violations in the case of GM field trials. The above mentioned instances are but the tip of the iceberg.
According to documents obtained by the DNA newspaper through RTI, it was revealed that in the last six years, only 39 out of the 133 field trials conducted were monitored, leaving the rest as potential threats to human health and biodiversity. Further, even in these 39 cases, monitoring was far less than stipulated, one site visit as against four, no post-harvest visit done, and so on. However, the Environment Ministry, under which the regulator is housed, consistently claims in the Parliament and outside that our GM regulatory system is stringent and among the best in the world!
Stop open air field trials
There is no independent, scientific monitoring of field trials. The trials are shrouded in secrecy and there are no liability mechanisms, as observed above, no action is taken against violators. In view of the serious risks and threats involved in open air field trials of GM crops, the various problems experienced till now, and the violations that take place and the gaping holes in the regulatory mechanism, both the Parliamentary Standing Committee on Agriculture (2013) and the majority report of the Technical Expert Committee ( 2013) appointed by the Supreme Court have recommended a moratorium on open air field trials of GM crops until the regulatory and oversight mechanism is made fool proof.
The impact of release of genetically modified organisms is irreversible and unpredictable and the precautionary principle enshrined in the Cartagena Protocol is meant to deal with the consequences of such risks. Unfortunately, the developers of this technology and in our case even the GM regulators, instead of being guided by the precautionary principle have chosen to throw caution to the winds, posing a serious threat to human and animal health, biodiversity and ecological sustainability.