“Union Environment Ministry’s response vindicates our evidence and pointers on serious regulatory compromises in India’s appraisal and approval of GM mustard”: Coalition
“Govt. should respond to each point with evidence, if regulatory processes were indeed correct and robust – we challenge the Ministry to do so”
New Delhi, January 8th 2023: In a brief reply put out today, the Coalition for a GM-Free India stated that the Union Environment Ministry’s (reported) response to the Coalition’s report vindicates and reinforces what the report showcased, in terms of serious violations with regard to India’s appraisal and approval of GM mustard. In fact, there is nothing new that has been shared in the Ministry’s response to some media outlets, other than recycling of inane, defensive statements that have already been made in the past, and a further obfuscation and dilution attempt of regulatory mandate and responsibility of Genetic Engineering Appraisal Committee (GEAC), the apex regulatory body for gene technologies in India. “It is clear that the Government has no evidence to proffer of sound regulatory processes run. We challenge the Ministry of Environment to respond to each point with evidence, if regulatory processes were indeed correct and robust”, said the Coalition.
The Coalition’s report showcased more than 15 instances of how there have been lapses in the processes and procedures adopted for GM mustard appraisal and approval – these can be broadly categorised to include (a) regulatory infirmities and violations that go against India’s Constitution, (b) not adhering to India’s international commitments under the Cartagena Protocol, (c) taking up illegal processes that are not permissible under the 1989 Rules (of Environment Protection Act 1986) that govern statutory regulation of gene technologies in the country, (d) violating the limited guidelines and protocols that exist, (e) ad-hoc and arbitrary regulatory decision-making about tests to be done and exempted, and (f) defying Supreme Court and Central Information Commission Orders. The Coalition’s report also showed that India’s regulatory regime is ridden with conflict of interest, and is devoid of specific scientific protocols that are required for testing HT crops.
Importantly, the regulatory processes related to GM mustard chose to defy the key unanimous recommendations of the Supreme Court-appointed original and independent expert committee members, including the Government-nominated experts – that of banning HT crops in India, and that of not dabbling with transgenic technology in crops for which India is the Centre of Origin/Diversity.
While the Coalition report was put out through a Press Conference on the 6th of January 2023, the Union Ministry of Environment chose to respond on a plain page document (without any letterhead and signatures) on a weekend on the 7th of January 2023. While the Coalition had no way of verifying the authenticity of the document shared by several journalists, it is nevertheless choosing to put out a response.
“The Ministry of Environment is digging itself deeper into the regulatory muck and obfuscation that GM mustard is surrounded by, with its unscientific and disingenuous responses. For instance, if environmental release of GM mustard is subject to clearance from FSSAI, where is such clearance right now, whereas GM mustard has already been planted? What does MoEFCC want to do with the ICMR guidelines of 2008 for food safety assessment under the EPA statutory regulatory regime, if they want to put the onus on FSSAI? As another example from the response from the Ministry, the safety studies listed clearly show that they were with three proteins, which means that parental lines which will have two proteins each were not tested separately as distinct GMOs in themselves. The Ministry response also admits to many other points made by the Coalition, through evasive and unconnected responses. It is clear that the public response through our report, to Union of India’s falsehoods, has provided accurate information to the citizens of India, and it is hoped that the Union of India will not mislead the Court in the next hearing at least”, said the Coalition in a press release today.
The Coalition highlights, through the following points, the fact that the Government of India, through its response, is actually admitting clearly to most of the issues flagged by the Coalition’s report.
- The fact that GM mustard did not go through the testing that Bt brinjal went through is clear from the reply from the Environment Ministry. The list of studies performed on GM mustard is part of the Ministry’s Reply. As can be clearly seen (Ref: Microsoft PowerPoint – Presentation to GEAC May 22 2006Brijal.ppt [Read-Only] (moef.gov.in)), Acute Oral Toxicity Study in Rats, Mucous Membrane Irritation Test in Female Rabbits, Primary Skin Irritation Test in Rabbits, Assessment of allergenicity of protein extract using Brown Norway Rats, Response on growth performance of common carp with Bt brinjal as a dietary feed ingredient, Chemical Fingerprinting of alkaloids, Subchronic feeding studies using New Zealand White Rabbit, Effect on performance and health of broiler chickens, Subchronic feeding studies in goats, Feeding studies in lactating crossbred dairy cows were not done on GM mustard, whereas they were done in the case of Bt brinjal.
- Ministry response confirms that no Health Expert participated in the appraisal of GM mustard: The Ministry response does not refute the fact that Dr B Sesikeran did not participate in the 2016 Sub-Committee’s 3 meetings; and that the 2022 Expert Committee does not have any health expert nominated at all. The ICMR representative is not present when GM mustard is finally cleared on October 18th 2022, based on the Expert Committee’s recommendations. In response to the evidence presented about health expert absence, from the Government’s own documents, GEAC/MoEF are discussing about Environmental Risk Assessment Guidelines of 2016!! It is worth remembering that the 1989 Rules’ Preambles show that the competent authorities for regulation have been created “with a view to protecting the environment, nature and health, in connection with the application of gene technology..” (emphasis added). (Ref.: Rules-for-the-manufacture-use-import-export-and-storage-1989.pdf (geacindia.gov.in)). GM mustard seeds are GMOs when they are sold for consumption, and GEAC cannot say that the conditional approval for environmental release is subject to the clearance from Food Safety and Standards Authority of India. There are two issues here: One, GEAC itself is supposed to assess health safety since the regulatory regime under EPA has the 2008 ICMR guidelines (which themselves are narrow and challenged), since the mandate of the 1989 Rules requires this to be so (Ref: Microsoft Word – Coverpage.doc (geacindia.gov.in)); further, where is the FSSAI clearance, based on what testing and regulatory provisions and without such clearance from FSSAI, why were GM mustard seeds planted?
- Ministry response admits that there are no HT crop testing guidelines and protocols in India, and that GM mustard did not get tested as a HT mustard: Government shied away from showing where HT crop testing guidelines and protocols were. Instead of responding to that point, MoEF is busy showing that GM mustard cannot be termed a HT crop, while admitting that HT trait will be used during hybrid seed production. If that is so, why was GM mustard not tested as a HT crop, and if it has to be tested, where are the guidelines and protocols? The Coalition has pointed correctly to the regulatory compromise made here.
- Parental Lines have not undergone the tests required, and should have been treated as distinct GMOs, with separate dossiers and applications – MoEF response is an admission to the fact that this did not happen: MoEF response shied away from stating the tests undertaken ONLY on parental lines, and gave a list of tests done on parental lines and DMH-11. The list also shows that tests were with three proteins which means the hybrid offspring (parental lines will have two proteins each, different from each other). This itself is an avoidance of the response needed on this point, and admits to the accuracy of the Coalition’s evidence on the matter.
- Limited statutory guidelines and protocols that constitute the sum total of India’s regulatory regime have not been met, as clearly reflected in the Ministry response: The Government’s response is a dead give-away and a clear admission that the statutory guidelines and protocols were not adhered to. It is another matter that these guidelines and protocols are not adequate and do not constitute a robust regulatory regime. The response says that ICAR guidelines will be used for evaluation of DMH-11 now – if evaluation is to happen now, why was an environmental release approval already given? Why are claims on India’s edible oil import bill decline being made? If this is about testing and trials of GM mustard, why are the Confined Field Trials guidelines and protocols not being deployed?
- In response to the matters raised on Conflict of Interest, MOEF is choosing to bring up issues of Confidentiality Agreement!: It appears that similar to the gag order issued by ICAR, MoEF wants to remind regulators about some confidentiality agreement. The central point of conflict of interest has not been responded to at all. The fact that Dr Akshay Pradhan has indeed participated as a GEAC member on an application that was put in by his Centre, where he is also a developer, is the reality, and is not being denied by the MoEF response. Further, no explanation has been provided as to why GEAC was reconstituted in 2014 to bring in Dr Akshay Pradhan, when GEAC (which is constituted for 3 years each time) was created only some months earlier in 2013. By the circumventing of the correct replies to the issues raised by the Coalition, MoEF is admitting to its guilt related to a faulty regulatory body.
- State Governments’ Constitutional Authority being trampled upon: MoEF’s response clearly shows that the conditional environmental release is notionally and ostensibly for breeding of new lines, and for seed production and testing, all of which are to be done under guidelines related to Confined Field Trials, and not to be done with “environmental release”. This itself is a big regulatory violation. And any planting of GMOs in any state requires state government No Objection Certificate. This has not been done, nor have consultations been held with state governments (while for Bt brinjal, Union Environment Ministry wrote to the Chief Ministers of all states for eliciting their views and analysis). The Coalition was right in pointing out that the approval of GM mustard is against the letter and spirit of India’s constitution.
Similar are the other evasive and beside-the-point replies to very specific points of regulatory compromise that were raised by the Coalition for a GM-Free India, and the very replies are an admission from the Government of India on its culpability on these matters. This includes violations with regard to Cartagena Protocol and India’s international commitments. The biosafety dossier that was made available to the public of 3500+pages was not allowed to be photocopied or photographed, with responses expected from the memory of any person looking into the data. What has been presented in our report cannot be termed as “hair-splitting”, and rigorous scientific regulation requires the regime to be improved to fulfil its key mandate of protecting our environment and health from the risks of gene technologies and for socio-economic considerations to be addressed, for guidelines and protocols to be adhered to, for independent comprehensive long term scientific appraisal to be taken up, for conflict of interest to be avoided in regulatory decision-making and public participation to be institutionalised, for needs and alternatives assessment to precede any processing of any application, for State Governments’ policy positions to be respected, and for a liability and redressal regime to be put into place. The Coalition also clarifies that on the point of seeds reaching DRMR on October 22nd 2023 itself, it had relied on the DRMR Director’s media bytes where he shared this information to credible media outlets. It is apparent from the MoEFCC’s response that numerous serious regulatory violations and infirmities plague GM mustard approval, and the Coalition asks the Union of India to stop perpetrating falsehoods in the Supreme Court.
