Rules relaxed for some gene-edited plants, organisms

The changes, approved by the Union ministry of environment and forest on Wednesday, follow recommendations from the department of biotechnology and the department of agriculture, research and education.

New Delhi: A key change in rules notified on Wednesday will allow genome-edited plants, or organisms without any “foreign” genes to be subjected to a different regulatory process than the one applied to genetically engineered products — a move likely to add to a polarising debate around technologies such as CRISPR.

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One scientist working with GM technologies said the changes will exempt two categories of genome-edited products — in which genes are tweaked but not inserted from another organism — from being treated as transgenic products.

Approved by the Union ministry of environment and forest on Wednesday, the changes follow recommendations from the department of biotechnology and the department of agriculture, research and education.

“SDN1 and SDN2 genome-edited products free from exogenous introduced DNA be exempted from biosafety assessment in pursuance of rule 20 of the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically engineered Organisms or Cells Rules 1989,” the new rule, issued through an office memorandum, states.

Gene-editing technologies, such as CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), allow scientists to go deep into a genetic sequence and precisely alter its traits, just like a word-editing software. Their use in gene-editing has been controversial in some instances.

There are three categories of gene-editing: SDN1, SDN2 and SDN3. The first two, which largely involve “knocking off” or “overexpressing” certain traits in a genome without any insertion of gene material from outside, will be covered by the new changes. The third, which involves insertion of foreign genes, will be treated as GMO. SDN stands for Site-directed Nuclease and refers to the practice of cleaving DNA strands to effect the subsequent genome editing.

“With this, India now has a separate regulatory process for such technologies that takes them out of the purview of Genetic Engineering Appraisal Committee or GEAC,” said Bhagirath Choudhary of the South Asia Biotechnology Centre, which advocates GM technologies.

GEAC is the final technical body that certifies a GM product as safe for commercial release.

SDN1 and SDN2 types of genome editing are currently being used in Indian labs for breeding new crops, and imparting traits including resistance to diseases and drought, Choudhary said.

“This is unscientific and risky. Genome editing as per Environmental Protection Act 1989 rules has to be regulated fully by GEAC and not selectively,” Kavitha Kuruganti of the Alliance for Sustainable and Holistic Agriculture.

BT Cotton is India’s only transgenic crop approved for commercial cultivation. Gene-editing technologies such as CRISPR are being intensively used to experiment in areas of biomedicine, especially in the US and China.

The previous United Progressive Alliance government had banned the commercial release of BT Brinjal, and no new GM product has been approved by the Narendra Modi government.