India issues ruling favorable to gene editing

By Alex Martin

On March 31, the Ministry of Environment, Forest and Climate Change of India revised its rules concerning the applications of gene editing in agriculture. The ruling states gene editing will be excluded from the GMO classification.

The ruling concerns a regulation called the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms of Cells, dated December 5, 1989. The Ministry recommended that genome edited products under the labels SDN1 and SDN2 “free from exogenous introduced DNA” be exempted from biosafety assessments located within Rule 20 of the document.

In laymen’s terms, gene edited products with the classifications SDN1 or SDN2 will not be treated as other transgenic products. This potentially opens the door to new techniques, such as CRISPR, to be used in plant breeding.

“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, an advocate for GM technologies, in a news article to the Hindustan Times.

Others are reacting favorably to the decision as well.

For gene edited plants to be released as a new variety, they will still be subject to further development and evaluation, per the Ministry of Environment, Forest and Climate Change’s release.

Gene Editing Globally

India isn’t the only country relaxing its rulings on gene editing. In addition, the UK released a Statutory Instrument on March 14 which makes it easier to conduct trial research on gene edited plants as well.

“This legislation will enable UK plant breeders to continue their established world-leading research and development which brings crucial new varieties to farmers,” said Sam Brooke, CEO of the British Society of Plant Breeders in a release. “Using this new technology will help to contribute to agricultural productivity, which is vital in these challenging times.”

The excitement around new breeding techniques, including gene editing, are ramping up globally. But regulations are working to catch up to the excitement.

“It’s an exciting and critical time for us to think, from a regulatory perspective, about how we’re going to bring new products to market,” said American Seed Trade Association (ASTA) Vice President for Scientific Affairs and Policies Fan-Li Chou during a special episode of Seed Speaks during the ASTA CSS & Seed Expo. “We need to have regulatory approaches that fit the purpose and that are science-based and risk proportionate and adjusts as we accumulate more scientific knowledge.”