Centre rebuts claims that statutory regulations were violated during GM mustard appraisal

The Union Environment Ministry on Saturday rebutted the claims made by activists that statutory regulations were violated during the appraisal and approval of GM mustard in India, saying the product was conditionally cleared only after stakeholder consultation.

The Coalition of GM-free India, a group of NGOs opposing genetically modified crops, had on Friday released a report alleging that no (independent) health expert ever participated in GM mustard appraisal.

In a response issued on Saturday, the ministry said: "The Assessment of Food and Environmental Safety (AFES) report prepared by the sub-committee in 2016 with regard to the biosafety dossier of GM mustard was uploaded on the ministry's website for inviting comments by the public for a period of 30 days (from September 5 to October 5, 2016).

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"Further, the entire dossier was also made available for review by the public in the ministry's office for the same duration," it said.

"The conditional environmental release of GM mustard has been granted after stakeholder consultations as prescribed in the Environmental Risk Assessment (ERA) guidance documents (Guidelines for the ERA of Genetically Engineered Plants, Risk Analysis Framework, Stakeholder's guide) of 2016. The conditional approval for environmental release is subject to the clearance from the Food Safety and Standards Authority of India," it said.

Responding to the coalition's allegation that the Directorate of Rapeseed Mustard Research had received the seeds on October 22 last year before the formal approval was given on October 25, the ministry said the environmental release of GM mustard was recommended in the 147th meeting of the GEAC held on October 18 last year.

"The letter of approval for environmental release of GM mustard was issued on October 25 after the approval was granted by the central government and the seeds were sent to the ICAR-Directorate of Rapeseed Mustard Research (DRMR) on October 29," it said.

The coalition had also claimed that GM mustard did not get tested as a herbicide-tolerant (HT) crop because there are no regulatory guidelines and protocols for HT crops.

The ministry said the use of the terminology 'herbicide tolerant' for GM mustard that has been granted environmental release is "not appropriate."

"The herbicide tolerant (HT) trait present in GM mustard is a selection marker for experimental use during the development phase followed by use during the production of mustard hybrid seed for the purpose of identifying genetically modified (GM) plants," it said.

Countering the claim that the GM mustard approval ignored the fact that agriculture is a state subject, the ministry said Biosafety Research Level-I and Biosafety Research Level-II trials of GM mustard were conducted after obtaining the no-objection certificates from state governments.

Responding to the coalition's claim that the GEAC "kept agreeing" to the requests of "the applicant" for an exemption from tests, the ministry said the applicant was advised to undertake field demonstration studies of GM mustard in 2018 with a view to generate additional data on honey bees and other pollinators.

It said a letter was received from Prof Deepak Pental, the man behind GM mustard, in May 2022, indicating that GM technology deployed for the development of mustard has been well tested and used for more than 20 years in Canada, the US, and Australia. "References indicated no untoward effect of the technology has been reported with respect to honey bees."

"Comments were sought from the Department of Biotechnology (DBT) and Department of Agriculture Research & Education (DARE) on the letter received from Prof Pental. Both DBT and DARE opined that GEAC recommendation regarding the environmental release of GM mustard may be reconsidered," the ministry said.

It said the GEAC, in its 146th meeting held on August 25, 2022 had constituted an expert committee to examine the matter which recommended the environmental release of GM mustard and its further evaluation by the Indian Council of Agricultural Research (ICAR) along with post-release monitoring with respect to honey bees.

The GEAC recommended the environmental release of GM mustard based on the recommendation of the expert committee.

"To generate scientific evidence in Indian agro-climatic situation and also as a precautionary mechanism, the field demonstration studies with respect to the effect of GE mustard on honey bees and other pollinators, as recommended in the 136th GEAC meeting, shall also be conducted post-environmental release, simultaneously by the applicant, within two years under the supervision of ICAR, as per ICAR guidelines and other extant rules/guidelines/regulations and the report be submitted to the GEAC," the ministry said.

In October, the environment ministry allowed the environmental release of the Dhara Mustard Hybrid (DMH-11) developed by the Delhi University for its seed production and testing before its commercial release. At present, Cotton is the only GM crop allowed for cultivation in India.

Before the testing could start, the coalition approached the Supreme Court seeking its directions to stop the trials. The next date of hearing on the matter is January 10.

According to activists and farmers, GM mustard is a herbicide-tolerant crop and toxic chemicals sprayed on the plant would impact the health of the people consuming it. They also argue that it is environmentally unsustainable and does not suit Indian agricultural conditions.

In December, the government had told Parliament that extensive studies carried out on toxicity, allergenicity, compositional analyses, field trials, and environmental safety of GM mustard lines versus their non-transgenic comparators provided evidence that DMH-11 was safe for cultivation, food, and feed use.

It also said farming technologies like GM crops is important to ensure food security and reduce reliance on imports and that it has not found any evidence of decline in honey production in the country due to GM cotton.