Proactive or Sinister? Experts Divided on Govt's Relaxation of Gene Editing Regulations

While plant scientists feel that the government’s move will help develop high-yield, disease-resistant crops, activists and policy experts have objected to the change being introduced through an office memorandum, which the public cannot raise objections against.

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Kochi: Over two decades after they were first introduced, farmers now cultivate nearly 20 different genetically modified (GM) crops on around 192 million hectares worldwide.

India joined the GM bandwagon in 2002. We now grow ‘Bt Cotton’ on around 12 million hectares. Bt Cotton contains a ‘foreign’ gene – from a bacterium – that helps the plant produce toxins to ward off pests.

But debates have raged over the disadvantages of GM organisms, such as the health risks they could pose to people. India has not approved any other GM crop for use since Bt Cotton.

However, in a move that might open up India to more GM crops, the Union Environment Ministry on March 30 permitted the development of plants whose genes have been edited using specific methods that do not involve inserting foreign DNA.

According to plant scientists, this “proactive” step by the government will help develop higher yielding crop varieties or those resistant to diseases. However, activists and policy experts are crying foul over the introduction of this change through an office memorandum (which the public cannot register objections against).

Moreover, the permitted methods of gene editing could still cause unintended changes in the plants’ genomes, even if it does not involve inserting foreign DNA, they said. However, others argue that as India stares at low yields due to several factors including heatwaves caused by climate change, genetically edited crops may be the best way out.

Also read: With New MoEFCC Memo, Are Indian Policy Makers Supporting ‘Big Biotech’?

It’s all about genes

After scientists developed the first GM organism in the early 70s, there’s been no looking back. In 1987, American scientists developed Bt Cotton by inserting specific bacterial genes (from the bacterium Bacillus thuringiensis, hence ‘Bt’) into the genome of the cotton plant. These genes from the ‘foreign’ bacterium help the plant produce a specific toxin which wards off bollworms, a kind of moth larvae that feed on cotton fruit and drastically affect crop yields.

According to government data, adopting Bt Cotton in India has increased yields from around 8 million bales in 2002 to around 34 million in 2017, reported Down to Earth. The Indian government and plant breeding scientists, therefore, call Bt Cotton a runaway success.

However, activists and scientists have been vocal about its cons. For example, scientists found in 2018 that the cotton bollworm is fast building a resistance to Bt Cotton in Telangana and Andhra Pradesh. Bt Cotton yields have also stagnated, according to another study. Moreover, economic factors, such as high input costs and low farmer incomes, have linked Bt Cotton to farmer suicides in India.

Tampering with genes, clearly, is tricky business. So India’s ‘Rules 1989’ (Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells Rules, 1989) lays down regulations to govern GM organisms in light of biosafety. Such organisms have to meet several criteria – such as being approved by the Genetic Engineering Approval Committee (GEAC) under the Environment Ministry – before experimental field trials can be conducted and the organisms can be released into natural systems.

Today, however, scientists can alter plant genomes without introducing another organism’s gene into them. With latest ‘gene-editing’ methods, for instance, scientists can target a specific gene – already existing within the genome of a plant – and alter or ‘edit’ it to bring about a desired quality, such as pest or heat resistance.

These are called ‘Site-Directed Nuclease’ (SDN) techniques. In gene edits that involve SDN1 and SND2 techniques, scientists edit a specific gene without inserting foreign DNA (they cleave the genome, tweak a gene and repair it using the same plant’s DNA). In the SDN3 technique, however, repairs are made using foreign DNA. This technically makes plants developed using SDN3 genetically modified.

Also read: For Genetically Engineered Crops, India Is No Country for Regulation

New rules

The Environment Ministry has used this difference in methodology to exclude some gene-edited plants from the country’s existing biosafety rules. As per an office memorandum (OM) dated March 30, gene-edited plants developed using SDN1 and SDN2 techniques – which do not introduce foreign DNA into the plants – will be exempted from Rules 1989. 

“It’s a very important and proactive decision by the government,” said A.K. Singh, director of the ICAR-Indian Agricultural Research Institute, New Delhi. “Genome editing is a powerful tool which helps alter the gene in a very targeted manner without making changes to the [rest of the] genome.”

This ability to target only a specific gene – through modern technologies such as CRISPR – has been a “dream” for plant scientists. Since there are no biosafety concerns, this does not require regulation, he said. 

According to him, the move to exempt such gene-edited plants from regulations will address problems of nutrition (such as fortifying crops with vitamins), crop resistance to abiotic and biotic stresses, and crop quality.

Scientists had already expressed their disappointment over the government dragging its feet on approving norms related to gene-editing over the past two years. The GEAC had sent draft guidelines in this regard to states last year, but scientists had felt that this could delay the process drastically.

In October last year for instance, agricultural experts under the banner of the India Agriculture Advancement Group International (IAAG) wrote to Prime Minister Narendra Modi urging him to hasten the process.

Era of OMs

Activists, on the other hand, are crying foul over two aspects of the move. Firstly, this change in regulation has been introduced through an OM, which people cannot voice objections against. Public policy expert Narasimha Reddy Donthi called it a “sinister attempt” to dilute India’s GM regulations and a “circumvention of the processes enshrined in [the] Indian constitution, which has defined democratic participation in matters of critical importance”.

“Through a mere Office Memorandum, [the] government has initiated a major shift in regulatory action,” he wrote in his letter addressed to officials at the Environment Ministry. “This is, in fact, a shift in policy. Policy change cannot be brought in through [an] OM.”

This, incidentally, is not the first time that the Environment Ministry is introducing changes to regulations through OMs. It made changes to the Environment Impact Assessment (EIA) Notification 2006 through an OM in April and in early May, it used another OM to permit some coal mines to increase production by up to 50%, without a fresh EIA or public consultation.

Another major cause for concern is that the specific methods of gene-editing that are being permitted could still cause unintended changes in the plants’ genomes, even if it does not involve inserting foreign DNA, Reddy told The Wire. Indeed, numerous studies including this one point to this drawback of gene-editing techniques, including CRISPR.  

Such off-target genetic changes could occur, but that happens in natural plant breeding processes as well, commented Singh. In such cases, scientists discard the plants after observing them for two-three generations. Gene-edited plants, too, can be screened at this level, he added.

According to Singh, such gene-edited crop varieties will improve crop quality, production as well as the crops’ adaptation to both abiotic stressors (such as droughts and floods) and biotic ones. Such crop characteristics are crucial to cope with extreme events triggered by climate change, such as the recent heatwave that affected wheat production in northwest India. Studies show that emerging gene editing applications aimed at crop improvement could help adapt to the impacts of climate change.