Govt of India 'compromising' on mandate to regulate gene technologies, protect nature

Counterview Desk 
In a letter sent to the Union Ministry of Environment, Forests and Climate Change (MoEFCC) and other related ministries and departments, the Coalition for a GM-Free India has raised "serious concern" over the guidelines notified for Genome Edited Organisms, in which major exemptions from regulations have been offered to certain categories of Genome Edited Organisms/Plants and products.
A letter signed by Sridhar Radhakrishnan and Kapil Shah, co-convenors of the NGO network, addressed to Union Minister for Environment, Forest & Climate Change Bhupender Yadav, said, the Office Memorandum, dated May 17, 2022 of the Department of Biotechnology, Ministry of Science & Technology about Safety Assessment Guidelines, which follows the Office Memorandum dated March 30, 2022 of the MoEFCC, said, the move "essentially amounts to entry of risky GMOs through the backdoor.

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Coalition for a  GM-Free India is a national volunteer-driven platform of hundreds of organisations and individuals working on issues related to agriculture, health, conservation of biodiversity, appropriate technology, food safety and empowerment of farmers. We are deeply concerned about the regulatory deficiencies in India when it comes to gene technologies and their deployment in our farming systems/environment and realise that these affect citizens, their health, livelihoods and environment. The lack of capability and the apathy of our regulators and the regulatory regime is well-established in the case of large-scale proliferation of illegal GMOs in the country. The regulators now seem to be proceeding with creating unscientific and unacceptable regulatory regimes when it comes to Genome Edited Plants, leading to more hazards.
Through a mere Office Memorandum, MoEFCC has issued guidelines that have no legal or scientific validity, in the exemptions accorded to certain types of gene edited plants. What the MoEFCC has done essentially amounts to entry of risky GMOs through the backdoor, a policy decision that was brought in through an Office Memorandum. A policy decision pushed in as an Office Memorandum is objectionable and unacceptable. The DBT which earlier prepared grounds for this, rushed in to create Safety Assessment Guidelines which were issued on 17th May 2022. What has been done is blatantly illegal.
GUIDELINES WITH EXEMPTIONS ARE ILLEGAL: The EPA 1989 Rules require regulation of all applications of gene technologies, with a view to protect the environment, nature and health. Rule 2 (3) clearly says that the Rules shall also apply to new gene technologies, apart from those referred to in Rule 3 (ii) and (iv). Under Rule 3 (iv), Genetic Engineering is correctly described in a manner that Genome Editing is also undoubtedly included in the same. Therefore, there is no question of giving exemptions to particular kinds of Genome Edited Plants from the regulatory purview of the 1989 Rules.
Invoking Rule 20, when the very purpose of regulation under the 1989 Rules is defeated, is clear abdication of responsibility by the Ministry of Environment, Forest and Climate Change and is illegal. Rule 20 says that the Ministry can exempt an occupier handling a particular micro-organism / genetically engineered organism from Rules 7-11. This is meant for narrow and specific exemptions, that too with necessity justified. This Rule is not meant to exempt all occupiers handling any GM organism in present and future produced by a particular gene technology (genome editing in the current instance). The MoEFCC cannot take this non-existent exemption power on itself to keep out SDN1 and SDN2 GMOs from regulation. Rule 20 also clearly mentions “wherever necessary”, and there is no justification available or proffered by the MoEFCC to bring in Rule 20 to create exemptions here.
SCIENTIFIC REALITY OF SDN1 AND SDN2: Some basic scientific facts are important to note here, given that biosafety implications are the same or similar, when it comes to need for risk assessment as well as the need to apply the Precautionary Principle. This is the case irrespective of whether a gene edited plant is SDN1 or SDN2 or SDN3 and exemptions are unjustifiable. This decision on exemptions is unscientific, irresponsible and risky, because the assumptions underlying the understanding of SDN1 and SDN2 GMOs by MoEFCC are ignoring scientific evidence that already exists, and are assumptions that could turn out to be false or incorrect.
SDN1 is supposed to involve gene deletion or disruption, while SDN2 is supposed to involve gene alteration using a DNA repair template. The riskiness in these techniques is not just about introduction of foreign genes or not. It is about small intended changes using gene editing techniques resulting in large and unintended consequences, that can include toxicity or allergenicity of gene-edited plants. Complex unpredictable changes can result even from SDN1 and SDN2. It is therefore not just about the risk of the end product, but the risks of the applied gene technological procedures that result in intended and unintended changes.
There is existing scientific evidence that clearly documents unexpected, unintentional and risky biochemical changes occurring in Gene Edited organisms including of SDN 1 and SDN 2 applications. Some relevant references are being given as an Annexure to this letter. This increasing body of scientific research shows how genome editing of various kinds (not just SDN3) results in a lot of unintended on-target/near-target/off-target effects (importantly, in SDN1/SDN2 plants too). This includes unintended insertions/deletions/mutations/DNA rearrangements. Without the necessary regulatory oversight, how will regulators and the public know about such changes? Who will be responsible for the resultant risk implications?

Further, it is worth noting that even these two exempted techniques can end up creating “transgenic” GMOs. SDN1 can end up accidentally introducing whole foreign plasmids or fragments thereof, if the gene editing tool is introduced as plasmids. SDN1, therefore, can potentially be an unplanned or unexpected transgenic GMO. In SDN2 too, there is a high probability of the repair template DNA getting incorporated into the host genome. This would mean that in addition to the intended repair, the repair template DNA can get integrated at the edit site or off-target location. There are real life examples of such transgenic GMOs being detected by alert regulators, while the applicants ignored the same knowingly or unknowingly. This detection required whole genome long-read DNA sequencing, and not just checking of whether the intended change has occurred. But if SDN1 and SDN2 are deregulated, who will check? How then will regulators find out whether SDN1 and SDN2 are transgenic GMOs or not?
In February and March 2020, we have submitted detailed scientific reasons for not exempting any gene technology applications from the purview of regulation – these inputs have been completely ignored. As you might be aware, equating the risks associated with Gene Editing with other genetic modification, the European Court of Law ruled that new techniques to modify genetic material in plant or animal cells must undergo the same safety checks for their impacts on the environment and human health as existing GMOs. To fulfil legal and Constitutional mandate towards its citizens, Government of India should adopt a similar approach, and not allow risky GMOs of the SDN1 and SDN2 kind to circumvent regulatory checks.
Through this letter, we demand that:

• Government of India withdraw the OM dated 30th March 2022 of exemption of certain gene-edited plants from regulatory purview, immediately; the DBT guidelines for safety assessment, dated 17th May 2022 should also therefore ensure that all gene edited plants are regulated fully and comprehensively.
• All gene edited plants and other organisms should be on par with regulatory requirements for other GMOs which themselves need improvements in the regulatory regime. Government should ensure that all gene technologies are regulated in a scientific, comprehensive, independent and transparent fashion.
• The very mandate of regulation of gene technologies, to protect the safety of our food, as well as protect nature, the environment and our freedom of choice, cannot be compromised by the Government of India. Indian Constitution puts such an onus on the regulators under law, and it falls on the Government to ensure the same. We look forward to your response immediately.