Govt of India 'ignores' GMO regulation, 'overlooks' Constitutional process

Counterview Desk
Dr Narasimha Reddy Donthi, independent public policy expert, in a letter to Nareshpal Gangwar, additional secretary, Ministry of Environment, Forest and Climate Change (MoEFCC), New Delhi, has expressed “seriously concern” that a recent office memorandum (OM) has sought to exempt certain types of gene-edited plants from the country's genetically modified organism  (GMO) regulations, without any reason or basis or representation.
Dr Reddy regretted, “Such a serious decision, with an impact scale of unimaginable proportions, in terms of time and ecology, is being pushed through an ordinary office memorandum”, insisting, “This is circumvention of the processes enshrined in Indian Constitution, which has defined democratic participation in matters of critical importance.”
Stating that the exemption from regulation is a policy decision and has legal implications, he demanded immediate withdrawal the OM, insisting, the government should take a "strong stand against any attempts to exclude new GMOs from the existing regulation.”

Text:

Ref: Office Memorandum, dated 30th March, 2022, F. No. C-12013/3/2020-CS-III, Ministry of Environment, Forest and Climate Change
Sub: Exemption of the Genome Edited plants falling under the categories of SDN1 and SDN2 under the provisions of the Rules, 1989
Dear Sri Nareshpal Gangwar ji,
With reference to the above notification, we are seriously concerned about the future of regulation of gene-edited plants in India. This office memorandum has exempted certain types of gene-edited plants from the country's GMO regulations, without any reason or basis or representation. Such a serious decision, with an impact scale of unimaginable proportions, in terms of times and ecology, is being pushed through an ordinary office memorandum. This is circumvention of the processes enshrined in Indian Constitution, which has defined democratic participation in matters of critical importance. Exemption from regulation is a policy decision and has legal implications. Regulation and regulatory processes are bound by law. Exemption from law also has equal importance, if not more.
Through a mere Office Memorandum, government has initiated a major shift in regulatory action. This is in fact a shift in policy. Policy change cannot be brought in through a OM. This OM does not even explain properly and appropriately how this separate 'regulation' will be effective. It is a sinister attempt to dilute GM regulation, no doubt.
Biosafety implications are valid or same for SDN1, SDN2 and SDN3. This OM is attempting to grade biosafety. When gene-editing is a scientist-led process, dependent regulators cannot differentiate, unless we have transparency and independent verification mechanisms.
Importantly, this change in rules will go beyond allowing gene-edited plants without any “foreign” genes to be subjected to a weaker regulatory process or no regulation. The OM referred does not explain further, apart from unhooking these two categories. If we understand correctly, with this OM, two categories of gene-edited products -- in which genes are either disrupted to make them non-functional or altered to change the function of their protein product but not where a gene from another organism has been deliberately inserted -- will escape being regulated as GMOs. Categorisation of gene-editing plants into these three categories is not supported by science. This is unscientific, irresponsible, and based on assumptions that could turn out to be false, because a) gene editing doesn’t have to involve foreign genes to be risky and b) the types of gene-editing that will escape regulation can in fact introduce foreign genetic material.
SDN1 (as defined) results in normal nucleotide gene sequence disruption eventually resulting in partial or entire gene disruption. The omnigenic model of genes which is now starting to be understood for plants and humans that genes operate in networks not through isolation. That is edits in even a single gene can alter core biochemical pathways in the plant in unpredictable ways. Not only that, tissue culture which is used in genome editing as well, have also been found to cause mutations too. The Agrobacterium infection at times used for SDN-1 has been seen to increase mutations in genome editing as well.

The text in Draft Document on “Genome Edited Organisms: Regulatory Framework and Guidelines For Risk Assessment” stating ‘In rare cases, single base pair mutation(s) might result in the introduction of novel trait (e.g., Herbicide tolerance) which might pose additional biosafety concerns’ itself admitted the issue with leaving SDN-1 as unregulated. The statement in the draft document admitting that ‘currently available nucleases used for genome editing experiments are not completely error-free and therefore exhibit some offtarget effect(s) /un-intentional genetic changes at other than the target location during the genome editing process’ states the same. There is indeed an increasing body of scientific research showing how genome editing results in lot of unintended on-target/near-target/off-target effects as well in animals, humans and plants. This includes unintended insertions/deletions/mutations/DNA rearrangements as well.
Without the necessary regulatory checks, the regulators and the public won’t even know of such changes. It is for this reason that countries like New Zealand and the EU countries -- known to have stronger biosafety regulations -- have not left SDN-1 from genetic modification regulations.
This OM also opens up possibility of exemption of gene-edited plants under false pretences. GMOs claimed to contain no foreign DNA may get exempted from GMO regulatory processes under false pretences. According to a correspondence article by South Korean scientists published in Nature Biotechnology, in 2016, this has happened. In the article, the authors cite the case of the gene-edited non-browning mushroom. Earlier in the same year, the USDA exempted the mushroom from regulatory oversight on the basis of claims by the developer that it was "transgene-free" and had "no foreign DNA" integrated into its genome. But the authors point out that the approved mushroom "may still contain tiny fragments of foreign DNA in its genome". Deregulation of certain classes of gene-edited GMOs is based on the hypothetical – and, it now appears, mostly false – assumption that they do not contain any foreign DNA.
Rather than short-read sequencing (as is generally done by developers), whole genome longread DNA sequencing must be done to ensure all unintended changes are spotted. In addition, transcriptomics, metabolomics and proteomics analyses must be done to detect any unintended functional and compositional changes too.
Through this letter, we demand that

• Government of India and GEAC to withdraw this OM of exemption, immediately.
• Government should take a strong stand against any attempts to exclude new GMOs from the existing regulation.
• Government and decision-makers should ensure mandatory safety checks, regulatory transparency and exclude GMOs in food.

It is important that regulators guarantee the safety of our food, as well as protect nature, the environment and our freedom of choice. Indian Constitution puts such an onus on the regulators under law.
We look forward to your response immediately.
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