Can easing regulatory norms for gene-edited crops compromise bio-safety?

The government’s pathbreaking order on relaxing some of the stringent regulations for certain types of genome-edited crops issued on Wednesday could open a Pandora’s box with a section of the civil society fearing that it might lead to compromising biosafety standards and interference with natural gene of plants.

The civil society also feelsthat the opportunistic interpretation of the Environment Protection Act-Rules made by the Ministry of Environment and Forest while granting relaxation for genome edited crops need Supreme Court intervention.

However, scientists and experts working in the area clarified that the order does not completely exempt genome edited final products from regulatory oversight but instead does away with a need to get additional clearances for specified processes.

Which in itself is huge and could open the door for more advanced research on plant genetics, given that getting smooth and quick regulatory clearance for scientific research on plant genetics has been a tricky issue in India for long.

Sources said the matter has been pending for final approval for a long time with various government departments and it is after months of careful deliberation that the official order was passed yesterday by the Ministry of Environment and Forest.

The order exempted SDN1 and SDN2 genome edited plants from Rules 7-11 of the Environment Protect Act (EPA) for manufacture, use or import or export and storage of hazardous microorganisms or genetically engineered organisms or cells rules-1989.

SDN 1, SDN 2 and SDN 3 are three methods of genome editing in crops.

In the first two (SDN 1 and SDN 2), an underlying gene can be suppressed or overexpressed while in the third (SDN3), a foreign gene can be used in a targeted manner which is akin to genetic modification in some respects as both use foreign material.

The Centre in its order has eased the regulatory process for the first two while keeping it intact for the third.

With the order, it has also tried to differentiate between genetic editing crops and genetically modified ones.

A basic and fundamental difference between Genetically Modified Crops and Gene edited ones is that in the former the final product (which is a crop variety like BT cotton) has foreign genes, while in gene edited plants, there is no additional foreign gene.

The order will promote and foster higher levels of research and development and ultimately lead to commercial cultivation of crops resistant to biotic and abiotic stresses and with nutritional superiority.

Recently, China too approved guidelines for genome editing that will spur research into crops that have high yields and are resistant to pests and climate change.

“It would be wrong to say that complete regulatory control is being exempted for SDN 1 and SDN 2 genome edited crops. They will have to get themselves registered with the review committee of Genetic Modification under Department of Bio-Technology which it is fairly satisfied that the product is free from any foreign gene can then waive off other regulatory clearances required for developing on gene editing from the Genetic Engineering Appraisal Committee (GEAC),” Bhagirath Choudhary, Founder Director of the South Asia Biotechnology Centre (SABC) said.

Choudhury clarified that similar exemptions were also given by the ministry of environment and forests in 2006 for rDNA pharma products from the GMO regulatory system after primary evaluation by a review committee of the Department of Bio-Technology.

These pharma products are subsequently regulated by the Drug Controller General of India (DGCI).

“I feel that biosafety issues need to be properly addressed before any such regulatory oversight is relaxed. This is because even in gene editing where no foreign material is used, we are tampering with the natural gene,” Dr G V Ramanjaneyulu, executive director of the Centre for Sustainable Agriculture (CSA) told Business Standard.

He said whether a gene is engineered using outside material or inside material, both are problematic and bio-safety concerns might be different for both but should not be completely overlooked.

 "This is clearly a development that is taking some risky gene technological products out of the purview of regulation, and a way of bypassing resistance against r-DNA technologies. The imprecision in genome editing is well-documented, even though it is being called a precise technology," Kavitha Kuruganti from the Alliance for Sustainable and Holistic Agriculture (ASHA) said.

Difference between Genetically Modified and Gene Edited Organisms

Genetically Modified Organism (GMO)	Genome Edited Organism (GED)
Addition of foreign gene/transgene	Free from foreign gene/transgene
Random insertion	Site specific/targeted insertion

Stringent & onerous regulatory system Follow conventional regulatory system in many countries Unpredictable & long safety assessment & costly regulation Time bound, short time-to-market & supportive of public bred/edited crops