- India has exempted crops with certain kinds of genetic modifications from the regulations previously imposed on the commercialisation of all genetically modified crops.
- The new policy – expedient but unscientific – exempts crops with simple tweaks to genes that are already 'natural' to the plant but that have not had any 'foreign' DNA added.
- Regulatory discrimination against these crops means some new useful varieties will remain proscribed and unavailable except through the stealth practices of farmers.
- The difference between these categories is determined by the presence of a foreign gene, but the term 'foreign' has many connotations, none meaningful in the current context.
- Flawed regulation is not the only problem related to genetically engineered crops in India, but the differentiation based on foreignness is a new and unsound addition to the list.
India has a long and dubious record of regulating genetically altered crops for agriculture. While the nation began at the same time as many other countries with the same ambitious goals – to deploy new genetic engineering tools to address agricultural vulnerabilities – it has fallen behind. Only one crop, modified with molecular techniques – pest-resistant cotton – has been approved by regulators.
In an attempt to expand farmers' access to genetically engineered crops, in March of this year, the Indian government exempted crops with certain kinds of genetic modifications introduced by genome editing (also known as gene editing) from the cumbersome and time-consuming regulations previously imposed on the commercialisation of all crops genetically modified with molecular techniques.
Specifically (and as explained in more detail below), the new policy exempts crops with simple tweaks to genes that are already 'natural' to the plant but that have not had any 'foreign' DNA added. This approach may be expedient but it is not scientifically sound.
Bt cotton and Bt brinjal
Genetically modified cotton came first to India because of its economic importance and environmental externalities. Specifically, Bt cotton was the first product in the country modified with modern molecular genetic techniques. However, it sparked fierce political debate instigated by internationally visible but misguided activists.
'Bt' is shorthand for Bacillus thuringiensis, a bacterium found mainly in the soil that produces proteins toxic to some insects, especially the cotton bollworm. The genes that express these proteins were introduced by recombinant DNA technology – a.k.a. gene splicing – into the genome of various crop plants to protect them from pests.
Bt cotton soon became ensnared in spurious societal battles around neo-colonialism, the purported evils of Monsanto, organic agriculture and farmers' suicides. It was officially regulated and socially stigmatised as a 'GMO', short for 'genetically modified organism'. After 10 years, it remains India's only approved genetically engineered crop.
The Indian versions of insect-resistant Bt-cotton proved highly successful in controlling the bollworm that had ravaged cotton crops. They contained only one transgene, or a gene introduced from an unrelated organism, for one trait – and for only a single species of bollworm. Yet, because of the presence of this single newly introduced gene, this first successful application of molecular genetic engineering in Indian agriculture was subjected to a long and costly development process.
Herbicide tolerance as a weed-control trait also proved popular, although it was never approved and therefore its cultivation was, and is, illegal.
At the same time, farmers' demand in underground markets moved the transgenic frontier forward in a poorly regulated and awkward way. Farmers vote with their ploughs, and many officials lack the knowledge and/or the incentives to contest illegal plantings.
The biggest flaw in India's cumbersome and poorly understood regulatory system emerged vividly with the introduction of a second genetically engineered crop candidate: Bt brinjal, a staple of some of the world's poorest rural populations.
Brinjal in India is attacked by a boring insect larva (Leucinodes orbonalis) that is susceptible to the same protein as the cotton bollworm. But as with cotton, there is no naturally occurring gene in the brinjal family tree that conventional breeding could utilise. This is why researchers introduced the Bt gene into a brinjal variety, thus rendering it a transgenic organism.
Brinjal is not extensively traded internationally but is very important for small farmers' income and both local and national consumption. There is also no environmentally acceptable, effective alternative for farmers to use as insecticides against brinjal pests.
Field trials of the transgenic brinjal cultivars were extremely promising, even compared to the successes of Bt cotton. The fact that the transgene and the cultivars were both indigenous also suggested that the variety would be nationally acceptable in a way that Bt cotton couldn't be.
The Genetic Engineering Approval Committee of India approved Bt brinjal – but it was vetoed in 2010 by the then-environment-minister, Jairam Ramesh. It has since been stuck in regulatory limbo in India. During this time, India donated the genetic event EE1 to Bangladesh and the Philippines.
After EE1 was introduced into Bangladeshi varieties of eggplant and tested, the government approved them and they have been extremely successful. Interestingly, some of the altered brinjal has 'spread' to India, and is found growing happily in India but on an unknown scale and unapproved by bureaucrats.
Both Bt cotton and Bt brinjal in India tell the same story: that advances for farmers unavailable through conventional, pre-molecular plant-breeding techniques have proved useful – not panaceas but incrementally beneficial, trait by trait, with more in the pipeline. However, the regulatory system is slow, unscientific, inconsistent and obstructionist. Its concerns often reflect more urban politics and the blandishments of activists than farmers' interests.
Nonetheless, there is hope that the most recent advances in the seamless continuum of genetic modification of plants represented by genome editing will fare better. These techniques allow genetic material to be added, removed or altered at specific locations in the genome.
The best known of these techniques is CRISPR-Cas9. This system is faster, cheaper, more precise and more efficient than earlier genome editing methods. It is also more democratic, by being less dependent on the political heft and huge resources of the multinational plant science corporations. Innovation is thus often centred in universities and individual research teams.
This said, if genome editing is to live up its potential, its regulation will need to be scientifically defensible and risk-based.
This is why the UK has reconsidered its highly prohibitive stance on molecular genetic engineering. Even the generally anti-genetic engineering EU is discussing a revised legal framework that incorporates genome editing. Consistent with this global trend, in March 2022, India announced that it would exempt certain categories of genome-edited crops from regulatory oversight.
As part of this, it has categorised genome-edited alterations as SDN-1, SDN-2 and SDN-3. (SDN stands for 'site-directed nuclease,' consistent with the mechanism of action of CRISPR-Cas9.)
Variants made using SDN-1 and SDN-2 involve simply tweaking particular traits that already exist in a genome – whereas SDN-3 involves the insertion of genes from external, or foreign, sources. So making brinjal resistant to insect predators by introducing genes from B. thuringiensis would put it in the SDN-3 category.
India has announced that SDN-1 and SDN-2 will be regulated as non-genetically engineered organisms, as there are no distinguishable sequence changes made between them and those resulting from conventional crop breeding. SDN-3, however, which involves the incorporation of a foreign DNA sequence, will continue to be heavily regulated.
This approach to regulation is unscientific and short-sighted. It has no demonstrated connection to enhanced risk. Instead, the SDN categories are based simply on considerations of how 'close to nature' the new constructions are. Bt cotton, which was introduced to India over 20 years ago and has transformed India's economy, will be classified as an SDN-3 crop – as will Bt brinjal. So as such, the latter looks set to remain stuck in the regulatory quagmire it has been in since the beginning of its development.
There is no scientific rationale for a regulatory policy that distinguishes SDN-3 crops from SDN-1 and -2 crops. The difference between these categories is determined by the presence or absence of a foreign gene, but the term 'foreign' has many connotations, none of which is meaningful for regulation in the current context.
Through advances in genome sequencing, we now know that 'foreign' genes – i.e. genes that originated in an unrelated organism – are present in many crop plants. They may be thought of as 'natural GMOs'. From sweet potato to several species of grass, genes from unrelated organisms have found their way into the most unexpected places.
What matters from a risk – and therefore regulatory – perspective is not the source of a gene but its function and its effect on phenotype
A construct that results from the addition of a foreign gene via molecular techniques should not be held to a different standard or subjected to a more stringent regulatory regime – unless the modification could in some way increase risk.
Baseless regulatory discrimination against transgenic – i.e. SDN-3 – crops means that some new varieties that could drastically improve the fortunes of resource-poor people and environmentally vulnerable places will, for practical purposes, remain proscribed and unavailable except through the stealth practices of farmers.
The regulatory policies of the governments of India, the EU and many other countries fail this test of scientific logic. The regulation of molecular genetic engineering has been based more on political considerations than on sound science, and as such cripples progress.
Flawed regulation is not the only problem related to genetically engineered crops in India. Another is the chronic lack of transparency about agricultural technology generally and genetic engineering in particular. Data that supports government policies and specific regulatory decisions have been consistently and conspicuously lacking from government sources. That stokes public suspicion about incompetence or even corruption.
That is unfortunate and puzzling, because there is plenty of evidence they could cite. We have more than 20 years of data on commercialised genetically engineered crops worldwide. It is very clear that they are as safe as, or in some cases safer than, crops from other breeding methods. Put another way, there is no evidence that the use of molecular genetic engineering techniques confers unique or incremental risks.
The European Academies Science Advisory Council said in 2013, "There is no valid evidence that [genetically engineered] crops have greater adverse impact on health and the environment than any other technology used in plant breeding." Even the WHO – a component of the notoriously risk-averse UN – agrees: it said in a 2014 report that
... [genetically engineered] foods currently available on the international market have passed safety assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved.
Literally hundreds of other analyses by governmental and professional groups have echoed these findings.
Genome editing is both a continuation of plant modifications humans have depended on for millennia and a promising new frontier. Nevertheless, striking a balance between too little and much caution is not difficult, given the great precision and predictability of newer molecular techniques. Science shows the way, and politicians and regulators everywhere should follow it.
Henry I. Miller is a physician and molecular biologist and a senior fellow at the Pacific Research Institute. He was the founding director of the FDA's Office of Biotechnology and a consulting professor at Stanford University's Institute for International Studies. Kathleen L. Hefferon teaches microbiology at Cornell University. Ronald Herring is emeritus professor of government and International Professor of agriculture and rural development at Cornell University.