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Christmas came early for Big Biotech companies and their allied seeds multipliers as the Ministry of Environment, Forest and Climate Change (MoEFCC) has recently, through an office memorandum, excluded the new generation genetically modified (GM) plants – also known as genetically edited (GE) plants – from the ambit of India’s biosafety rules.
This means that Big Biotech companies will be able to by-pass India’s stringent genetic approval framework for their new generation of genetically modified organisms (GMOs). The end result will be a small step for agri-innovation, but a giant leap for corporate control over seeds and plants through patents. But how will this happen?
Before looking at the patent question, let’s look at the law.
All GMOs in India, as per the Environmental Protection Act, 1986, and the subsequent Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms/Genetically Engineered Organisms or Cells, 1989 (‘Rules, 1989’ for short), must be approved by the Genetic Engineering Appraisal Committee (GEAC), which has very unique set of approval mechanisms. Yet, somehow, two classes of gene edited plants – SDN 1 and SDN 2 – have been relegated to a less stringent regulatory process, perhaps to speed up approvals for the new GE product.
We must keep in mind that these are a newer generation of GMOs. The question which therefore arises is, why are their approvals being subjected to a lower standard?
India’s Rules, 1989 were drafted with the aim of protecting the environment, nature and the health of the people from the harmful affects of gene technology and micro-organisms. At that time, genetic engineering technologies were in their early stages; that is, gene-modification with one gene from another organism, and so on.
But our world has transformed over the past 40 years. Now, GE crops derived by using tools like CRISPR and the like are the latest generation of GMOs that are created by modification (that is, gene splicing/editing) of the genomic structure. Often, plant genomes are edited using artificial means and fused with foreign genomes too. Of course, this is not possible naturally and while it could potentially help accelerate plant breeding, it is generally consider a con.
This tool has the power to make a rose lose its redness forever; or our mustard its pungency, with one wrong edit.
In the post-Wuhan leak investigation and ‘gain-of-function’ world, we are well aware that things could go wrong. We need to be more caution on genetic tech regulation. Furthermore, should we allow these technologies to enter our food system based on a corporation’s own biosafety data? Nope. Without third party data and audits, rely on corporations’ biosafety data poses a big risk.
Barring the US, these technologies are regulated as ‘GM technology’ in the European Union (EU) and other parts of the world. The EU-led regulatory mechanism treats the new generation of GMOs, produced through CRISPR and other gene-editing technologies, as GM food.
The Court of Justice of the European Union (CJEU) ruled in 2018 that crops produced from by using genetic material editing techniques ought to be regulated in the same way as GMOs. That means all regulatory process, as well as labelling, are the same. Of course, lobby groups are actively trying to reverse this decision. But the EU is holding out strong against pressure from Big agriculture (Ag) and Biotech companies.
The Indian market, however, is very lucrative for them.
With the current memorandum, India is clearing opening the castle gates for deregulation. Keep in mind that the Food Safety and Standards Association of India (FSSAI) has already brought out a notification to not label GMO products having less than 1% GM content as GM foods.
We are blindly trying to emulate the US’s policies and are helping foreign companies bypass the regulatory process. Various experts have raised biosafety concerns as GE crops can disrupt evolution in nature and lead to genetic contamination; the fact that they have not been proven to increase productivity or yield notwithstanding.
Farmers across the world have also resisted GE crops as they will lead to further consolidation by corporate giants, especially in the Global South. Mexico is a good example. But seeds companies maintain that this technology is good for industry and farmers.
Coming back to the question of Intellectual Property Rights (IPR) and patents; firstly, these are patented technologies which profit a handful of corporations. There are also concerns about ‘seed sovereignty’ as corporations can now, by editing one gene within the genome, claim a patent on entire species. India could be thrown into serious IPR turmoil once some of these varieties are let out in the open. This would undermine millions of years of evolution and the collective efforts of our ancestors to co-evolve a species.
But how does this nexus work? This questions is dealt with in Bertram Verhaag’s documentary film, Percy Schmeiser – David Versus Monsanto. There are many examples of how, in the past, Big Ag and Big Biotech companies have claimed entire harvests of farmers because their seeds randomly pollinated said farmers’ fields. What prevents these companies from extracting these illegal royalties? Given that India is a biodiversity hotspot, are we willing to risk our biological heritage for potential corporate profits?
Next, we come to public health. There are studies on both sides of the fence; some claiming the dangers and some, the benefits of eating GM foods. But one thing is for certain; that the world’s wealthiest people eat organic and not GM food.
Almost all of Europe has banned GM foods. Then why the urgency to have them in India? When life term studies are not conducted for GM crops, how can we conclude they are safe? This issue was also raised by the parliamentary standing committee on GM crops, headed by Renuka Chowdhary.
Taking cognisance of the aforementioned problems, what Indian policy makers should do is stop passing the buck and take responsibility. We need to conduct independent studies to verify the efficiency of this technology, which would include third-party-led long-term studies on biosafety and environmental and health affects.
Moreover, a special committee needs to be formed to deliberate on the IPRs of GE crops; how they impact farmers and how the issue would play out with the existing Protection of Plant Varieties and Farmers’ Rights Authority (PPVFR) patent laws.
There are also trade issues, as many countries don’t except GM or GE foods. If pollination and unintended gene transferring takes place in the open environment, India could be looking at losing its agriculture exports too. India is a major source of non-GM food exports. If GE crops spread, we could soon lose that tag and risk losing a major chunk of our agri-exports forever. And because there genes would be in the open environment, the spread can never be curtailed. It’s an irreversible process.
Given India’s murky genetic contamination history with Herbicide Tolerant (HT) Bacillus Thuringiensis (BT) cotton, India should carefully conduct trials for gene-edited crops. Gene-editing is a new technology; we aren’t certain of its long-term affects on human and environmental health.
India should aim to create new, progressive laws at are aligned with Indian patent laws and take into account independent science, rather than be influenced by lobbying or propaganda.