The Department of Biotechnology (DBT) has issued guidelines easing norms for research into genetically modified (GM) crops and circumventing challenges of using foreign genes to change crops profile.
The ‘Guidelines for Safety Assessment of Genome Edited Plants, 2022’ exempt researchers who use gene-editing technology to modify the genome of the plant from seeking approvals from the Genetic Engineering Appraisal Committee (GEAC), an expert body of the Environment Ministry. The GEAC evaluates research into GM plants and recommends, or disapproves, their release into farmer fields. The final call however is taken by the Environment Minister as well as States where such plants could be cultivated. The Environment Ministry too has sanctioned this exemption.
The GM plants that have usually come for such scrutiny are those that involve transgenic technology or introducing a gene from a different species into a plant, for instance BT-cotton, where a gene from soil bacterium is used to protect a plant from pest attack.
The worry around this method is that these genes may spread to neighbouring plants, where such effects are not intended and so their applications have been controversial. Despite several kinds of transgenic crops having been researched and approved by scientific committees, none, save BT-cotton, has made it to fields because of stringent opposition from environmental activists as well as farmer organisations.
The DBT, whose mandate is to promote biotechnology, in the guidelines, says the document is a “... road map for the development and sustainable use of genome editing technologies in India, specifying the biosafety and/or environmental safety concerns, and describing the regulatory pathways to be adopted while undertaking the genome editing of plants.”
Several approaches
Genome editing involves the use of technologies that allow genetic material to be added, removed, or altered at particular locations in the genome. Several approaches to genome editing have been developed. A well-known one is called CRISPR-Cas9, which is short for clustered regularly interspaced short palindromic repeats and CRISPR-associated protein 9.
Just as foreign genes can be used to add properties to plants, gene editing too can be used to make plants express properties not native to them.
The guidelines say that all requirements that researchers must adhere to to develop transgenic seeds will apply to gene-edited seeds except clauses that require permission from the GEAC.
‘Unintended consequences’
Environmentalist groups have opposed this exception for gene-edited crops. “Gene editing is included in genetic engineering. Therefore, there is no question of giving exemptions to particular kinds of genome edited plants from the regulatory purview,” said a letter from Coalition for a GM-free India to Environment Minister Bhupendra Yadav. Gene editing techniques, the letter alleges, involves altering the function of genes and can cause “large and unintended consequences” that can change the “toxicity and allergenicity” of plants. “Without the necessary regulatory oversight, how will regulators and the public know about such changes? Who will be responsible for the resultant risk implications?” their letter queries. They have demanded that these exemptions be withdrawn.
N. Raghuram, Professor, Biotechnology, at Guru Gobind Singh University, New Delhi, said there were a great many similarities in the techniques employed in transgenic technology and gene-editing technology. “Gene-editing is getting quite popular in biotechnology labs across the country. Gene editing can address some of the fears around the use of ‘foreign genes’ but it can only be used to express genes already present in a plant’s genome that are not manifest. But more importantly, it is not about technology but about how plants developed thus are sold or made available to farmers.”