India's biotech regulatory authority - too much power, no checks
2.States' entry ruffles GM lobby
NOTE: Anyone who's watched the pitiful performance of India's current apex regulatory authority for GM crops, the GEAC, over the past few years, may have thought things could hardly get any worse, but now a regulatory body (the BRAI) is being proposed that actually makes the GEAC look good!
1.In the wrong ministry?
Latha Jishnu, Jyotika Sood
Down to Earth, September 30 2011
*Biotech Regulatory Authority will have too much power, no checks
*Wrong ministry overseeing the regulation
*Centralised, narrow authority; no checks on its power
*States have no say although agriculture is their domain
*No interface with biodiversity and plant protection laws
*Excessively secretive, negates people's right to information
FEW laws have been embraced as wholeheartedly by industry as BRAI or the Biotech Regulatory Authority of India Bill, 2011. Yet to be introduced in Lok Sabha [the Indian parliament], following a last-minute hitch, the proposed law has received the full support of the Association of Biotech Led Enterprises (ABLE) and other leading organisations that campaign for the promotion of biotechnology primarily for one reason: a single-window mechanism that will streamline the regulatory processes.
"It is a visionary step forward," finds V Ram Kaundinya, chairperson of ABLE-AG, the agriculture interests section of the lobby group. "Once BRAI comes into place we are sure we will have a more science-based, predictable and consistent regulatory policy environment, so critical to take the agri-industry to the next level." BRAI will replace the current regulator, the Genetic Engineering Appraisal Committee (GEAC), which operates under the Environment Protection Act's rules of 1980.
Industry says it does not have any quibbles with the Bill because, as Kaundinya points out, it "takes good care to ensure the authority is filled with people of reputed scientific and academic calibre". The Bill was to have been introduced in the monsoon session of Parliament by Science and Technology minister Vilasrao Deshmukh. But it was delayed apparently on the account of objections from some Congress MPs. It is learned that ruling party MPs had pointed out that the Bill was not "implementable" in its current form because of the inherent conflict between different regulators in the pharmaceuticals sector. But this apart, there has been widespread criticism of where the law is being housedin the Science and Technology ministry.
This is clear conflict of interest, say farmers' representatives, public health organisation and anti-GM activists. As one MP emphasises, "This is, perhaps, the reason for the skewed form of the Bill which propagates biotechnology, although in a regulated manner, instead of focusing on biosafety." Most critics of the proposed law believe it should be reworked jointly by the ministries of environment and forests, health and agriculture, specially since developed countries have brought biotechnology regulations under the rules of health and environment ministries.
To verify if such criticism was valid Down To Earth did a quick survey of biotech regulatory laws elsewhere and found that in most countries regulators did indeed come under the laws of these two ministries. Here is how it works in three developed countries:
CANADA: The world's third largest producer of genetically modified organisms (GMOs) has different pieces of legislation governing biotechnology and GMOs but all decisions are primarily with the environment ministry, guided by the Canadian Environmental Protection Act. It also consults with Health Canada (ministry). As for regulation of foods derived from biotechnology, all decisions are the mandate of Health Canada.
THE UK: Here, the regulations are monitored by the Department for Environment, Food and Rural Affairs (DEFRA). The Environmental Protection Act (EPA) is the primary legislation that gives the DEFRA secretary of state powers to control the release of GMOs. The Genetically Modified (Deliberate Release) Regulations 2002 supplements the EPA.
AUSTRALIA: The Gene Technology Act of 2000 is a national scheme for the regulation of GMOs which includes legislation in every state and territory and by the federal government. The Office of the Gene Technology Regulator is part of the Commonwealth Department of Health and Ageing. It comprises some 50 scientific and legal staff who monitor compliance with policy. Its primary concern is to protect the health of people and the environment.
Arjula Reddy, co-chairperson, GEAC, puts his finger on the critical difference between the current and proposed regulator when he says "BRAI is based on single-window clearance system, while GEAC has a wider participation of scientists and experts from all relevant fields and a nominee appointed by the Supreme Court to ensure that all issues are addressed properly." However, "the flip side is there will be full time regulators with specific budget and well established mechanisms for evaluation, monitoring and post-release surveillanc," Reddy concedes. But with a final draft yet to be formulated, ruling party sources say that the government may be forced to take into account valid criticism based on experience elsewhere.
2.States' entry ruffles GM lobby
Latha Jishnu, Jyotika Sood
Down to Earth, September 30 2011
*Biotech firms object to states getting a say in approving GM crop trials
BIOTECH companies in the agriculture sector have taken to a publicity blaze in recent months, splashing advertisements that extol the “inherent safety” of genetically modified (GM) crops along with organising a series of farmer meets and press conferences aimed at promoting transgenic technology as the “powerful and safe” way to improve farming and the environment.
The lead player in this is ABLE or the Association of Biotech Led Industries, which is “the collective face of the Indian biotech industry,” and its ginger group on agriculture, known as ABLE-AG. There is also the Foundation for Biotechnology Awareness & Education (FBAE), headed by biotechnologist Chavali Kameswara Rao, which seeks to create scientific awareness about modern biotechnology and the benefits of transgenic technology. Three developments have triggered this blitz.
The first is that the normal stream of approvals accorded to trials of GM crops in India has been reduced, although not to a trickle but substantially this year, with the regulator, the Genetic Engineering Appraisal Committee (GEAC), forced to bring the states into the contested terrain of approvals. This comes in the wake of a complaint made by Bihar Chief Minister Nitish Kumar to the then Minister for Environment and Forests (MoEF) Jairam Ramesh that he had been kept out of the loop of approvals given to the Indian subsidiary of global seed giant Monsanto. The company had been conducting field trials of maize in a surreptitious manner, Kumar said (see 'Who is Watching GM crops', Down To Earth, May 1-16, 2011). Since then GEAC has been insisting on a no objection certificate (NOC) from states before companies can initiate field trials. This, says ABLE-AG chairperson V Ram Kaundinya, is not required by the law. "We are creating GEACs in every state, a second tier of scrutiny
approval process and leading to delays." Industry's complaint is that they have lost kharif 2011 because of such delays (see 'States may not have the competence'). As per MoEF sources, about 25 NOCS are yet to come in with only three states, Andhra Pradesh, Haryana and Gujarat, having given the permission. However, GEAC co-chairperson Arjula Reddy says, "There may be unintended delays but that is the rationale of our job. The trials coming up these days for approval are mostly for food crops, like maize and fruits. One has to be extra cautious."
As to creating a second level of scrutiny, Reddy says there was no way of keeping the states out after chief ministers of several states wrote to Ramesh that they did not want GM technology in their states. "Agriculture is a state subject so the provision for NOCs came about so that the states can also have a say," Reddy says. In any case, he points out that the law requires "states to have district and state-level biotechnology committees, comprising scientists and officials, whose mandate is to monitor trials. So I think NOCs should not be a big problem."
The second development is that GEAC itself has been preoccupied by policy issues raised earlier by ABLE-AG and the National Seeds Association of India, forcing it to shelve the approval process at its monthly meetings in Delhi. Besides, violation of rules by Mahyco also took up some of its time. Since January few approvals have been given to biotech companies barring in July when 23 of the 25 applications for event selection and field trials that came before the regulator were approved; the rest two were shelved.
August, too, would have seen considerable activity since 16 applications for approval were listed in the agenda of the meeting held on the 10th. The decisions are yet to be approved by new Minister for Environment and Forests Jayanthi Natarajan. However, it is the third factor, the incipient introduction of the Biotech Regulatory Authority of India (BRAI) Bill in the Lok Sabha that has charged up the campaign by Rao and FBAE. Rao's crusade to clear the "misconceptions” about the safety of biotech crops has picked up in recent weeks. He has roped in selected farmers to call for the expeditious clearance of the Bill and the setting up of BRAI, which will replace GEAC (see 'In the wrong ministry?' [item 1 above]). According to a press note issued after the mid-August meeting in Mumbai, Rao alleged that vested interests are misleading the public, media and policy makers, and that this is dangerous. "Biotech crops undergo rigorous safety assessments following international and national guidelines and no verifiable cases of harm have occurred." All of which will not take away from the fact that state NOCs will remain part of the process.