India's apex biotechnology regulatory body, the Genetic Engineering Appraisal Committee (GEAC), has cleared the environmental release of genetically modified mustard seeds. The development allows the environmental release and subsequent evaluation and propagation of three transgenic mustard lines - Bn 3.6 containing barnase and bar genes, Modbs 2.99, containing barstar and bar genes, and the high-yielding Dhara Mustard Hybrid 11 (DMH-11).

The move clears the way for commercial cultivation of GM mustard, although it is expected to take up several years for the required regulatory clearances before the crop can be grown by farmers across the country. All three mustard events have been developed by the University of Delhi's Centre for Genetic Manipulation of Crop Plants (CGMCP). The approval is valid for four years.

The favourable regulatory response follows the examination of scientific evidence involving the barnase, barstar and bar genes, with a committee constituted by the GEAC concluding that neither system poses an adverse impact on honeybees and other pollinators. Upon release, Bn 3.6 and Modbs 2.99 are to be used for developing new parental lines and hybrids under the supervision of the Indian Council of Agricultural Research (ICAR), with the GEAC noting that field demonstration studies involving the two GM events are to be conducted within two years of its decision being communicated. As far as DMH-11 is concerned, the environmental release will focus on seed production and testing, prior to the event being cleared for commercial release.

Mixed signals

Industry watchers deem the development to be significant, especially as India has long had a contentious relationship with GM technologies, particularly in food crops. The country's regulations governing transgenic crops are largely considered as vague and ambiguous, with the authorities often issuing contradictory signals.

India has only ever permitted the entry of insect-resistant Bt cotton, with the government clearing Bayer legacy business Monsanto's Bollgard I cotton for cultivation in 2005. While efforts were undertaken to commercialise Bt aubergines and GM mustard in the past, formal clearances were never accorded to either crop.

Following years of indecisiveness, the GEAC gave its assent to field trials of 12 crop lines, including mustard, in 2014. Acting on the rare headwind, a team from the CGMCP developed the high-yielding GM mustard, DMH-11, in 2016. While the regulator issued a safety assessment report in its favour the same year following initial public comments, the Supreme Court stalled the commercial roll out and asked the government to seek public opinion before allowing farming activities.

In May 2017, the GEAC again issued a positive recommendation to the Ministry of Environment, suggesting that DMH-11 could be debuted for mass cultivation. But a formal clearance was held back following the death of then Environment Minister, Anil Dave. Subsequently, in November 2018, the Supreme Court directed the government to clarify its stance on the matter.

In 2020, the Ministry of Agriculture seemed to pin the inordinate delay on the University of Delhi, claiming that the release is pending as the GEAC has advised the University to "generate complete safety assessment data on environmental bio-safety, especially effects on beneficial insect species", but that "no such request is pending in the matter". The response also noted that progress could not be made on the commercialisation of Bt aubergines after the Supreme Court of India-appointed technical expert committee recommended a ten-year moratorium on GM crops in 2013.

Shift in policy

In April this year, the Indian Ministry of Environment, Forest and Climate Change decided to exempt products derived through two gene editing techniques, site directed nuclease (SDN)-1 and SDN-2, from the purview of the country's regulations governing genetically modified organisms. The move allows such products to circumvent biosafety assessments undertaken by the GEAC, besides reassigning the jurisdiction of these products to India's Seeds Act, in lieu of the Environment Protection Act.

Following the new rule, requests for approval of SDN1 and SDN2 gene-edited products are to be treated differently from their transgenic counterparts, as both techniques involve "knocking off" or "overexpressing" certain traits within a gene without introducing new genetic material. However, products derived through SDN-3 will still be considered as GMOs as the process involves the introduction of foreign genes.

India is reportedly leveraging SDN-1 and SDN-2 gene editing to breed new crop varieties and develop traits such as disease resistance and drought tolerance.

A Crop Science Market Reporting analysis of the GM crop situation in India can be read here.

Posted 07 November 2022 by Akashpratim Mukhopadhyay, Senior Journalist, Crop Science Market Reporting, S&P Global Commodity Insights

This article was published by S&P Global Commodity Insights and not by S&P Global Ratings, which is a separately managed division of S&P Global.