Plant Variety Protection

GM Mustard: Of the Lack of Transparency and ‘Confidentiality’ of Biosafety Data


gm_mustard_rv_moor_2999756fThe Central Information Commission (CIC) directed the Environment Ministry to release all data relating to the bio-safety of GM Mustard by an order in April following a RTI application filed by Ms. Kavitha Kuruganti (the ‘Appellant’). The application sought information regarding the field trials of GM Mustard, which the Ministry refused to disclose on grounds of confidentiality.

The Ministry is yet to comply with the order in question, but on Tuesday released a safety assessment report stating that GM Mustard technology was found to be safe for human and animal consumption, and didn’t pose any threats to biodiversity. The report, though comprehensive in its 133 pages is unlikely to satisfy activists who demand that the raw data be released. The report did however raise a cautionary note calling for more studies on whether GM Mustard would harm honey bees and honey production in mustard growing areas, as well as call for the monitoring of insects and other organisms near mustard fields. The Genetic Engineering Appraisal Committee (GEAC) has additionally stated that it will only take a final decision on the commercialisation after it receives comments from stakeholders and the general public by the 5th of October, 2016.

With the GM Mustard debate heating up in the country, political parties are now rallying against its implementation. It’s difficult for this not to bring up a sense of déjà vu, with the Bt. Brinjal controversy having happened not so long ago. If GM Mustard is approved, it will be the first transgenic food crop to be commercially cultivated in India, as GM Cotton is the only genetically modified variety marketed at the moment. Until last week, the only data that had been released by the Ministry was the ‘gist’ of the minutes of the meeting conducted by the GEAC, and they had maintained that all data would be disclosed only after clinical trials had taken place.

RTI filed for the disclosure of data

The Appellant stressed that the Ministry could not claim that the GM Mustard data was confidential, as this was a matter of overriding public interest, relying on Divya Raghunandan v. Department of Biotechnology. She sought that the following information be shared in the public domain: the entire biosafety dossiers, and raw data submitted by the crop developer, the notices and agenda for all meetings of the regulators, as well as the full minutes of the meetings. She contended that full data is to be released at every stage – especially as it was in public interest to release biosafety data before the next stage of trials commenced. Such sharing of data, coupled with public scrutiny is what pointed out biosafety issues with Bt. Brinjal. The Appellant uses Bt. Brinjal as an example, showing that the Supreme Court had then held that the regulators were wrong in concluding that the crop was safe of consumption; and contends that it is precisely for this reason that data relating to GM crops be made available at every stage.

Direction of the Commission

The CIC largely agreed with the Appellant, holding that the ‘excuses’ forwarded by the Respondents were not sustainable, and did not fall within the purview of the RTI Act. The Commissioner was clear in stating that if they saw fit to disclose a ‘gist’ of the minutes of the meeting, there was no exception under the RTI Act that gave them the authority to limit the disclosure of the full minutes. The CIC further dismissed the Ministry’s arguments of releasing biosafety information only after it had been proved to be correct – holding that they were under the obligation to share the information, irrespective of the outcome of the clinical trials.

Two Sections of the RTI Act were highlighted by the CIC. They held that the Ministry was under the obligation to publish this information on its own accord as is mandated in Section 4 – to ‘publish the procedure followed in the decision making process, including channels of supervision and accountability’. Therefore, the minutes of the meeting results of the clinical trials and all available information about GM Mustard were directed to be released in public interest.

In order to determine whether such biosafety data was indeed in public interest, the Commission turned to Rules 7 & 14 of the ‘Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro Organisms Genetically Engineered Organisms or Cells’. On a combined reading, the CIC concluded that genetically engineered organisms or cells are recognised by the Government to be potentially hazardous to public health, and that full compliance with the rules would be a matter of public interest.

Section 8(1) of the RTI Act provides exemptions to disclosure of information, and the relevant exception in this scenario is if the information ‘includes commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party, unless the competent authority is satisfied that larger public interest warrants the disclosure of such information.The CIC did not expound on the possibility of trade secrets in GM Mustard, but felt that there was no need for the same as the public interest requirement had been met.

The aversion to genetically modified foods is disappointing, and one can only hope that GM Mustard doesn’t go the same way as Bt. Brinjal did. Step one to making sure that its introduction is the right step for the country to take would be to comply with CIC’s order, and make biosafety data more available to be able to promote public discourse. This, coupled with the conclusion of adequate trials and safeguards might go a long way in removing the stigma surrounding biotechnology products in the country.

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Inika Charles

Inika is a fifth year student at National Law University, Jodhpur, and is on the founding Board of Editors of the Journal of Intellectual Property Studies. She has a strong interest in Intellectual Property, and is fascinated with the intersection of IP with Technology and Media law. You can contact her at [email protected], or on Twitter: @inikacharles

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