India has 'inadequate regulatory regime' for appraisal risk management of GMOs

By Bharat Dogra* 
As the many-sided risks and harms of GM crops are so serious, obvious and well-established, it is only to be expected that any completely unbiased appraisal and regulatory system will not allow their approval and spread. Hence it is an important part of the big business agenda of dominating world food and farming via GM crops to weaken the appraisal systems of various developing countries in particular so that GM crops can gain entry despite their huge risks. Hence it is not surprising that several senior scientists of India and world have repeatedly criticized the regulatory processes and systems relating to GM crops and foods.
The latest of these exposures regarding the weaknesses of the regulatory system and its glaring violations has been released by the Coalition for a GM-Free India (CGMFI) in the specific context of “serious deficiencies, lapses and violations in GM mustard appraisal and approval.” This report has put together 15 examples of the “violations of statutory regulations and serious procedural infirmities with regard to GM mustard appraisal and approval in India.”
While focussing on GM mustard, this report nevertheless recalls that some of these violations were applicable to other GM crops like Bt cotton and Bt brinjal too – in the case of Bt brinjal, these kind of egregious violations and compromises were incidentally made the grounds for the Government of India to impose an indefinite moratorium on the environmental release/commercial cultivation of Bt brinjal.

Fait accompli, before formal approval?

This is a very important part of the report. Here CGMFI presents a clear sequence of events which clearly violates proper procedures, as shown in the following:

• Government of India gives an undertaking in July 2017 in the Supreme Court that it will not create a situation of fait accompli with regard to any decision with GM mustard.
• Genetic Engineering Appraisal Committee (GEAC), the statutory regulatory body, gives a “recommendation” for environmental release of GM mustard on 18th October 2022 in its 147th meeting.
• Seeds are picked up by ICAR functionaries from the crop applicant CGMCP of Delhi University on October 22nd 2022 and delivered to Directorate of Rapeseed-Mustard Research (DRMR) for planting.
• Formal approval letter is issued only on October 25th 2022.
• Seeds are dispatched to eight centres and six of them plant GM mustard before the Court hears the matter on November 3rd 2022.

GM HT mustard did not undergo even the limited testing that Bt brinjal underwent: 

The CMGFI report has drawn attention to the fact that in India, while brinjal is grown on about 6-7 lakh hectares, mustard is grown on around 80 lakh hectares. With this oilseed contributing the largest share of domestic production of oil, this report laments, GM mustard was not tested even to the limited extent to which Bt brinjal got tested.
Explaining this in detail, this report says that in the case of Bt brinjal, pollen flow studies were done for 3 years in two locations. In the case of GM mustard, it was one location and one season. When it came to soil impact studies, in Bt brinjal, it was 4 years in all, and included impacts on earthworms and collembola populations. In the case of GM mustard, it did not include earthworm and collembola populations. When it comes to health safety testing, GM mustard did not undergo (a) mucous membrane irritation test, or (b) primary skin irritation test, or (c) allergenicity test in rats, or (d) feeding studies on fish or (e) rabbits or (f) broiler chicken or (g) goats or (h) dairy cows; whereas such tests were done in the case of Bt brinjal. Some tests were done over more seasons and more locations in the case of Bt brinjal.
The reason for this irresponsible compromise in testing and appraisal, this report suggests, could be a US-AID supported project implemented in India, in the name of “harmonisation” of regulation, which resulted in dilution of testing in the regulatory regime.
Many studies that were prescribed and done for Bt brinjal were not conducted for GM HT mustard. This dilution happened despite the fact that mustard is grown in far larger area than Brinjal in India, despite the fact that it is not just mustard seeds that are consumed but its leaves and flowers also, and despite the fact that significantly more livelihoods are directly dependent on mustard crop, when compared to Brinjal. The tests done on Bt brinjal revealed its lack of safety as per independent public scrutiny. Government is clearly avoiding that distinct possibility arising with GM mustard too, by limiting the testing drastically.

No (independent) health expert participated in GM mustard appraisal:

In effect, a herbicide tolerant crop which was never tested as a HT crop, was given health clearance without adequate consultation of independent health experts, despite the known health hazards of GM and HT crops and associated herbicides.
GM mustard was never tested as a ht crop: The CGMFI report states, “India does not have any guidelines and protocols for testing of HT crops, even as the petitioners are arguing that HT crops should be completely banned and while the Union of India is proceeding forward with approvals.”

Parental lines did not undergo even the limited tests that DMH-11 was put through:

Similarly, this report tells us, parental lines have not undergone even the limited testing that DMH-11 hybrid has been subjected to, whereas in hybrid technology, these parental lines have to be maintained and multiplied separately. No data of biosafety or seed setting/yields has been presented of ‘experimental seed production’ data generated, which would have certainly used herbicide Glufosinate Ammonium, and its environmental and health impacts. This, despite the fact that seed production trials have been permitted.

Statutory regulatory guidelines and protocols violated, when it comes to GM mustard testing:

The petitions in the Supreme Court are mainly centred around the regulatory regime being inadequate in India. In that sense, the existing statutory guidelines and protocols are narrow in their scope. However, even these limited guidelines and protocols were violated in GM mustard testing, the report tells us.
India has an inadequate regulatory regime for appraisal and risk management of GMOs. In the case of GM mustard, the guidelines and protocols of even this limited regime were violated. This can be seen in the case of environmental safety testing, as well as food safety/health safety testing. Additionally, even in the agronomic evaluation of GM mustard, the laid-down conditions and protocols were not followed.

Conflict of interest in the regulatory regime:

Several such cases have been pointed out on the CGMFI report.

Conflict of interest is also reflected in who designs test protocols and who does the testing:

In the case of GM mustard itself, an RTI reply from Delhi University shows that test protocols were all evolved by the crop developer/applicant. Even without the RTI reply from Delhi University, GEAC meeting minutes also reflect that regulator asks the applicant to evolve test protocols. (134th meeting minutes and 135th meeting minutes).
This report referring to legal cases says the Learned Bench was interested in knowing if industry does safety studies itself. Yes, is the reply. In the case of this GM mustard too, most studies were done by the crop developer.
All test protocols for GM mustard testing were evolved by the crop developer itself. Further, 8 of the tests that were done to prove safety and efficacy of GM mustard were done by the applicant itself. Only 5 other studies were done by other agencies. Members of these other agencies were also closely connected to study protocol designing, or conducting of tests and even appraisal of the results later on.

GEAC kept prescribing tests to be undertaken on gm mustard, but when the applicant sought exemption, kept agreeing to the requests for exemption and changed its own recommendations repeatedly:

There are at least four instances, this report tells us, when GEAC (or its sub-committee) in its meeting minutes would have recorded that some study or the other is to be undertaken by the applicant, but that study does not actually get done, in this entire GM mustard story.
Several studies were prescribed by GEAC to be undertaken on GM mustard. However, the crop developer sought exemption from doing these studies, and with or without actually taking a decision on exemption, GEAC straightaway moved into approving GM mustard for environmental release!

Faulty compositional analysis made the basis for not undertaking other studies; biosafety dossier never published on the regulators’/MOEFCC website, despite Supreme Court orders, CIC orders, GEAC meeting minutes and specific assurances on the same:

Making public the entire biosafety dossier is one good way of ensuring that regulatory compromises in the form of conflict of interest or unscientific testing of any kind can be clearly addressed, by independent appraisal of the data submitted by the applicant. It was such independent scientific scrutiny that brought to light the serious deficiencies in the case of Bt brinjal. It is with a clear malafide intent that the GM mustard biosafety dossier has been kept hidden by the regulators, despite their own commitment to publish the dossier.

GM HT mustard approval clearly ignores regulatory incapabilities -- there is nothing like “conditional approval for environmental release prior to commercial release” in Indian regulatory regime:

Regulatory capabilities are clearly lacking with GEAC, as well as regulators under other statutes, to ensure farmer-level compliance of regulations or conditions laid down by GEAC. The clear attempt to criminalise farmers is also condemnable. In such a case, conditional approvals are just an abdication of the responsibility of the regulators. Further, if GM mustard has been released for further testing, the applicable guidelines and protocols are that of “confined field trials”, and this cannot be termed as “Conditional Approval for Environmental Release Prior to Commercial Release”.

Cartagena Protocol on Biosafety violated in various ways:

India is a signatory to the Cartagena Protocol on Biosafety, an international agreement under the Convention on Biological Diversity.
Several key provisions of the Cartagena Protocol on Biosafety have not been operationalised in the Indian regulatory regime. There are no mechanisms for fixing liability for damages, nor redressal for such damages or losses. No guidelines and protocols have been instituted to include Socio Economic Considerations into the appraisal mandate given to the regulatory body. In fact, GEAC’s lack of understanding of the Precautionary Principle, which is the cornerstone for the Cartagena Protocol, is very apparent.
GEAC is an appraisal committee and not an approval committee: In 2010, Government of India, through a Gazette Notification renamed Genetic Engineering Approval Committee to Genetic Engineering Appraisal Committee. This happened after widespread public consultations, including soliciting of views of state governments, during the Bt brinjal environmental release debates and as per the Union of India’s moratorium decision.
After being renamed as an Appraisal Committee, from being an Approval Committee, Genetic Engineering Appraisal Committee (GEAC) itself knows that it is not the competent authority for approving GM mustard. This is reflected in its meeting minutes as well as submissions in the Supreme Court. However, GEAC issued the approval letter to GM mustard crop developer, and this is invalid.

Agriculture is a state subject – GM mustard being thrust even when state governments have opposed this transgenic food crop:

This is a very important point emphasized by the CGMFI. This report tells us that many state governments have come out in vocal opposition against GM mustard and wrote to the Central Government again and again, voicing concerns and opposition against GM mustard. This includes states like Rajasthan, Madhya Pradesh, Delhi, Bihar, Haryana, West Bengal, Tamil Nadu, Kerala, Andhra Pradesh etc. Most state governments which grow mustard on a large scale did not even allow field trials, while Rajasthan destroyed a field trial close to its harvest stage. However, this approval for Environmental Release of GM mustard, given by GEAC, is ignoring such opposition from state governments which are stating a policy position that they have taken. This is outright against the Constitutional Authority vested in state governments over both Agriculture and Health, which are state subjects. It is also surprising that when a regulatory regime can take cognisance of the right of state government when it comes to field trials (Ref: GEAC’s 116th meeting), it would not do so when it comes to ‘environmental release’! 

GEAC’s approval of GM mustard environmental release clearly ignores and bypasses the constitutional authority that state governments have been vested with, when it comes to Agriculture and Health. What is even more surprising is that GEAC takes into account the rights of state governments when it comes to Field Trials, but is choosing to ignore the same when it comes to Environmental Release, despite stated policy positions of state governments against GM crops.

The attempt to contaminate first, and get regulatory approval later is routine:

As this report states, the biotech industry’s strategy of “contaminate first, get approval subsequently” is notorious the world over. In India too, Bt cotton was given a regulatory clearance after illegal cultivation was discovered on a large scale, following leakage of seeds from field trials. Now, there is talk about giving regulatory clearance to HT cotton. In the case of GM mustard too, biosafety norms related to confined field trials got violated; this was also a violation of Supreme Court Orders, in fact. Biosafety norms were violated in Bathinda trial in 2014-15; alert civil society groups complained but there was no action from GEAC. Here, the 08.05.2007 Orders of Hon’ble Supreme Court got breached.

Conclusion:

Approval of GM HT mustard in fact demonstrates total failure of India’s limited biosafety regulations and also showcases the serious deficiencies in the regulatory regime. Public Health and Environmental Safety have been seriously compromised in GM mustard approval. State Governments’ Constitutional authority over agriculture has been bypassed and violated – States have not even been consulted, the way they were in the case of Bt brinjal. India, a signatory to the Cartagena Protocol on Biosafety, has also violated international commitments in the approval of GM mustard. Indian Government and regulators have clearly ignored and neglected the Supreme Court’s Technical Expert Committee’s science-based recommendation to ban HT crops in India, apart from banning transgenics in those crops for which we are the Centre of Origin and/or Diversity.
The CGMFI derserves widespread appreciation for preparing and releasing this very timely report on many-sided glaring violations of procedures and protocols relating to GM mustard.
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*Active in reporting food safety and environmental issues for several years