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A Law Unto Itself by Lola Nayar, Chandrani Banerjee

* Main aim is to create asingle-window clearing-house for GM foods/crops
* Planned regulatory authority to have overarching powers over state governments, existing laws
* No room for farmers or civil society in approval process
* Penal action for raising objection without scientific evidence
* No independent risk assessment of data submitted to the authority
* No provision for revoking approvals, inadequate liability clause
* No informed choice for consumers through mandatory labelling

The surcharged debate over GM (genetically modified) crops and food has blundered into ominous terrain. Do civil society and scientists have the right to question government decisions on deployment of GM crops and foods? If a new draft bill for setting up a national biotechnology regulatory body goes through Parliament in its present form, exercising this right could be at the protesters’ peril. In plainspeak, that’s imprisonment for a minimum of six months and a fine to boot.

That’s what Section 63 of the third revised draft of the Biotechnology Regulatory Authority of India Bill proposes for those questioning the safety of GM crops without scientific evidence or record. “It is clearly meant to harass civil society groups concerned about the application of this hazardous technology,” says Kavitha Kuruganti of Kheti Virasat Mission. Her concern: the bill proposes a regime that rests on narrow risk assessment procedures and that too without any independent testing mechanism.

Plans to place the new draft bill in Parliament during the budget session is moving at a fast pace even as the prime minister seeks to bring about a rapprochement between his ministers of agriculture, science and technology, HRD and environment on promoting GM crops to boost food security. But fissures among the scientists and political decision-makers make it tough going. “These are the type of bills that either create controversy or get passed silently in Parliament because it involves huge business interests of corporates and MNCs,” warns constitutional expert Rajeev Dhawan.

Even environment minister Jairam Ramesh is unhappy. “There is a fundamental flaw in the bill...it overrides the Environment Protection Act, 1986. The way it is presently crafted is unacceptable,” says Jairam. Actually, there’s not much time to sort things out. After vetting, and incorporating changes suggested by the law ministry, the draft bill was sent this month to the cabinet secretary, who referred it to a committee of secretaries. The ministries have time till the end of February for their feedback. “By early March the draft bill would have taken a final shape for seeking cabinet approval,” Dr M.K. Bhan, secretary, Department of Biotechnology (dbt)—which is framing the draft—told Outlook.

Charges that the draft bill is draconian are unpalatable to Bhan, who stresses, “Nobody is trying to keep civil society out of the system.” Law minister Veerappa Moily assures, “There will be no adverse impact on the scientific community. If they have concerns, they will be heard.” He further clarified that “we are just administrators. We will see to the execution while they (the scientific community) will help formulate the policy”.

However, despite being part of the initial consultation process, many scientific, legal and environmental experts are questioning aspects of the draft bill. Some say many of the clauses are detrimental to the public and environment.

Strongly opposing the idea of “gagging scientists and whistle-blowers” instead of providing them protection, agricultural scientist M.S. Swaminathan feels that apart from the proposed regulatory body there should be multiple layers of scrutiny as in the US. Besides the US Environment Protection Agency, the Food and Drug Administration, and the Agriculture Plant Health Inspection Service, strict liability laws act as deterrents for erring companies in the US.

The first breakthrough in GM technology was achieved in 1953 but the scientific community imposed a voluntary moratorium for two decades. Though restrictions have been eased as regulatory frameworks evolved, many countries remain cautious—Australia and China among others have lately imposed some curbs. The UK, the first to pass GM laws, is among nations that have ensured public interest representation in the process. In the case of companies seeking to keep some information confidential, they have to give proper justification.

Some of these issues have not been properly framed in the draft bill, say experts. A major flaw is that “nowhere has the compliance to the Cartagena Protocol on Bio-safety (of which India is a signatory) been brought in,” says Suman Sahai of Gene Campaign. “Instead, we have a completely ad-hoc approach.” On another front, civil activist and Supreme Court lawyer Sanjay Parikh is upset that a suggestion for a three-tier approach for scientific risk assessment, clearance and monitoring has been overlooked. Instead, there is no clarity on parameters of risk assessment, the functions of the regulatory authority and the product ruling committee.

How will this all pan out? Swaminathan—who headed the taskforce that in 2004 recommended setting up a regulatory authority—remains hopeful that greater climate change literacy and GM awareness due to incidents over the past three months will get reflected in the regulatory body. “I hope all these churning of views will help us set up a regulatory body that will ensure bio-safety, health, crop safety, security of farmers’ income and trade security (like with basmati),” says the agriculture scientist.

That’s important, because debates on climate change and GM crops have eroded public faith in scientists and in science. Bhan, a paediatrician before taking charge of dbt, rues the fact that scientists, including himself, are seen as being on the other side and not part of society. He contends, “Policy should be decided as a society but products can only be assessed through a competent, science-based, transparent regulatory system.”

All this does serve up an aura of disquiet, but it’s not surprising that things have come to such a pass. Like the Bt brinjal moratorium—when public and scientific communities’ voices found space—it is crucial that health and bio-safety concerns are addressed before the bill becomes law. But science or no science, the “draconian” parts of the bill highlights a greater need for debate and thought. Let’s not rush this through.