NEWS FROM INDIA
1. BRAI Bill - Can a regulator be a promoter?
2. Madhya Pradesh opposes BRAI Bill, says it encroaches on state domain
3. Kerala ban on GM crops to stay, says Minister
4. Saying No to Monsanto - Indian patent office rejects biotech seed giant's claim
1. Can a regulator be a promoter?
Business standard, July 10 2013
The stated objective of the Biotechnology Regulatory Authority of India Bill to "promote" the safe use of modern biotechnology is a serious distortion of the need for regulation in this sphere
The controversy around genetically modified organisms (GMOs) in our food and farming rages on with claims and counterclaims emerging constantly. Do we need GMOs? Are they safe? Do they permit sustainable use of resources? Will they uphold farmers' rights over seed resources and lead to viable livelihoods? Would they imply trade security?
In India, we do not have an express statute to regulate GMOs. Currently, the Environment Protection Act (EPA)'s 1989 rules govern the regulation of this controversial technology. The government is now proposing a single-window, fast-track clearance system in the form of a Biotechnology Regulatory Authority to be set up through a statutory framework. A Bill called the Biotechnology Regulatory Authority of India (BRAI) Bill, 2013, was tabled in the Lok Sabha on April 22, 2013 by the minister for science & technology.
The proposed Biotechnology Regulatory Authority will have just a handful of technocrats taking all the decisions, whereas the current apex regulator, the Genetic Engineering Appraisal Committee, is a multi-ministerial body representing various interests.
Moreover, the objective of the Bill is to "promote" the safe use of modern biotechnology, which is a serious distortion of the very need for regulation in this sphere. The technology is already being promoted through existing policies and schemes related to the research & development on GMOs. The fact that the ministry of science & technology (a promotional ministry) proposes to house the regulator is an objectionable conflict of interest.
Another matter to note is that this Bill has been proposed because of India's commitments in the Convention on Biological Diversity. The nodal ministry in this case is the ministry of environment & forests, not science & technology.
The Bill ignores the fact that the need for regulation of modern biotechnology arises because of the many acknowledged risks associated with this living, irreversible technology - and that the mandate for protecting biosafety lies with the ministries for environment & forests and for health & family welfare. The 1989 rules of the EPA, for instance, have been created with a "view to protect our health, environment and nature from risks of GMOs". There is a large body of independent scientific evidence that showcases the numerous adverse implications of GMOs. The Bt brinjal episode, where the government acknowledged the many lacunae in its initial clearance, has highlighted many more reasons to distinguish regulation from promotion. In this context, there is no justification for the government to make "promotion" - safe or otherwise - the objective of this Bill, moving away from the current protective regulatory approach.
Apart from the faulty objective, the BRAI Bill has other problematic clauses. For instance, through an "expediency clause", the Union government proposes to take under its control regulation "in public interest", denying any decision-making space for state governments, other than an advisory role. A clause related to Confidential Commercial Information seeks to bypass the Right To Information Act, 2005, despite Supreme Court orders in the past that brought all biosafety data of Bt brinjal into the public domain.
In the BRAI Bill, regulation is seen as only a technical affair, neglecting the fact that GMOs have implications beyond biosafety. There is no provision for an assessment of needs or alternatives nor independent or long-term testing. The narrow, centralised decision-making mechanisms (three full-time and two part-time technical experts constituting the Authority) are a cause for worry, with an additional clause that says no proceeding shall be invalidated by any vacancy in the Authority! There are no mandatory public consultations built in, despite India being a signatory to the Cartagena Protocol on Biosafety, which has an Article on this.
In fact, most of the problematic aspects of the Bill can be traced back to the "promotion" objective and not the "protection" objective for regulation. For instance, the expediency clause in this Bill stands in stark contrast to other regulatory bills in the agriculture sector.
In its unanimous report to the Parliament in August 2012, the Parliamentary Standing Committee on Agriculture, which studied the earlier version of the BRAI Bill, said: "The government has been for some years now toying with the idea of a Biotechnology Regulatory Authority. The Committee feels that regulating biotechnology is too small a focus in the vast canvas of biodiversity, environment, human and livestock health, etc. and a multitude of other such related issues. [It has], therefore, already recommended… setting up of an all encompassing Bio-safety Authority through an Act of Parliament, which is extensively discussed and debated amongst all stakeholders, before acquiring shape of the law…".
The latest curious twist to this Bill is that it has been referred to the Department Related Standing Committee on Science and Technology, Environment and Forests. This despite the science & technology minister's recommendation that this Bill be referred to a joint committee of both Houses in response to a growing demand for its withdrawal, to be replaced by a Biosafety Protection Bill and in acknowledgement of the fact that this Bill spans issues beyond science and technology. The committee has set a deadline of 30 days for public feedback and civil society groups around the country are asking the committee to extend the deadline.
The Bt brinjal episode in India saw some improvements in India's regulatory decision-making, even if they were made in a specific, narrow context. The government's moratorium was based on views and analysis gathered from a large cross section of society. One witnessed transparency with biosafety data, public participation, upholding of federal spirit, emphasis on independent analysis and need for independent long-term testing, questioning of the very need for a given GM product and so on. The BRAI Bill, however, seeks to undo all of this.
The government needs to withdraw the BRAI Bill and bring in a Biosafety Protection Bill, through the ministry of environment & forests. The M S Swaminathan-led Task Force on Agricultural Biotechnology (2004), that was accepted by the government, said the bottom line for regulatory policy should be: "the safety of the environment, the well-being of farming families, the ecological and economic sustainability of farming systems, the health and nutrition security of consumers, safeguarding of home and external trade and the biosecurity of the nation". The BRAI Bill should follow that broad philosophy too.
2.MP govt opposes BRAI Bill, says it encroaches on state domain
Business Standard, July 14 2013
*Says the Bill seeks to encroach upon state domain as agriculture is purely a state subject
Bhopal - The Madhya Pradesh government has reiterated its stand opposing Biotechnology Regulatory Authority of India (BRAI) Bill, and said that it would not allow the centre to encroach its domain.
Agriculture minister Ramkrishna Kusmaria said the Bill seeks to encroach upon state domain as agriculture is purely a state subject. The Bill violates the very spirit of Indian constitution and federal polity, he added. "There are laws in India which need to be implemented in a proper way, the centre should exercise upon implementing those laws. We do not need a bio-regulatory bill. We need a bio-safety law," Kusmaria said.
On May 1, Kusmaria wrote to Union Science minister Jaipal Reddy in protest and said this bill was anti-farmer. "It (BRAI Bill) overrides states' authority over agriculture and in lieu the Centre wants to limit us to play only an advisory role?" he asks and asserted, "In no case we will allow it."
The bill envisages states in the form of a state biotechnology regulatory advisory committee in agriculture matters. Kusmaria has strong objection on certain sections of the Bill. "They want entire domestic intellectual properties in agriculture matters to be controlled by few international corporations and we would not let it happen," the Minister said, "We have larger acreage in organic farming and is rising. In no case we will allow field trials of genetically modified organisms (GMOs) in the State," he added.
Madhya Pradesh, for the last five years, has given encouraging results in organic farming with 40,000 hectares of land under the cover. Also, use of organic manure and gradual discontinuation of chemical fertilizers is on the rise across the state, particularly in Hoshangabad, Harda, Sagar, Damoh, and Jabalpur districts. Madhya Pradesh still produces non-GMO soya and wheat although seed contamination cannot be ruled out. State, known as soya bowl of India, has nearly 15 million hectare of land of which 11-12 million is arable.
3.Ban on GM crops to stay, says Minister
Express News Service, 9 July 2013
The Genetic Engineering Appraisal Committee (GEAC) has waved through a private proposal for genetic engineering in rice crops in the state, but the State Government will stick to the ban it had imposed on Genetically Modified (GM) crops within the state, Agriculture Minister K P Mohanan said on Monday.
Replying to questions in the Assembly, Mohanan said that Bayer Bio Science Pvt Ltd, based in New Delhi, had received the go-ahead from the GEAC to conduct genetic engineering trials in paddy fields in the state.
GEAC is the agency, under the Ministry of Environment and Forests (MoEF), which evaluates applications for conducting GM trials in the country. However, Kerala has banned GM trials within its borders, the Minister said. The State Govt’s policy is that use and experimentation of GM crops need not be allowed within the state. Kerala being a biodiversity-rich state, the government’s intention is to preserve it as a biodiversity hotspot and GM-free zone, the Agriculture Minister said in a reply to questions by G S Jayalal, C Divakaran, E S Bijimol, and K Ajith.
4.Saying no to monsanto
Down To Earth, JulY 31 2013
*The Indian patent office has once again rejected the biotech seed giant’s claim for a method to produce stress-tolerant transgenic plants
ON the trail of rice a couple of years ago, I discovered the fascinating social ecology, agronomy and history of this crop through some amazing people—farmers, breeders, scientists and conservers. There’s a special bond they have for this foodgrain which they nurture with as much passion as it nourishes them, linking the ancient story of Nature’s munificence and ravages with the current challenges of climate change and the hunt for food security.
Among the many obsessive rice growers I’ve met is Natabar Sarangi, a retired school teacher who found his life’s calling in maintaining his cherished collection of around 350 indigenous rice varieties on a tiny farm in his native village of Narisho in Odisha. Then there is the singular Debal Deb who was then guarding his priceless hoard of some 700-odd land races in West Bengal from all kinds of threats, specially drought and corporate predators. He was rescued and brought to Odisha by another lover of traditional agriculture, Debjeet Sarangi who runs a small outfit promoting sustainable agriculture. For them, the richness of the past holds the promise of the future.
And there are the many scientists in public research laboratories who have made ready the seeds to combat the ominous vagaries of climate change. Such as scientists from the Central Soil Salinity Research Institute in Karnal who have developed several salt tolerant varieties of rice, wheat, mustard and gram and maize hybrids with increased drought tolerance. Sarangi and Deb have dozens of rice varieties that are resistant to the worst threats that climate and soil can inflict: drought, floods, and salinity. All of these are given away freely to those in need— farmers recovering from super-cyclones, normal floods and drought, or anticipating these calamities.
Why am I writing about men such as these when the title of the column says it’s about Monsanto failing to get a patent for its stress-tolerant transgenic plant? This piece, of course, is about the July 5 decision of the Intellectual Property Appellate Board (IPAB) upholding the decision of the Controller of Patents to reject all of Monsanto’s claims. But reading the order, I remembered, quite suddenly, Sarangi giving away a 50 kg bag of Sohra and Nadia Phulo rice seeds to farmers from a severely drought-affected area of the state.
It was the wisdom of the ages that he was readily sharing with farmers. There was no question of a trait fee or a royalty, charges that biotech companies generously slap on to the cost of the transgenic seeds they purvey. For reference: Monsanto has earned royalty of over Rs 2,000 crore for the genetically engineered (GE) Bt cotton it has been selling in India since 2002. That’s in addition to the high cost of the Bt hybrids themselves.
What was Monsanto’s claim that IPAB rejected? It had sought to patent “methods for enhancing stress tolerance in plants and methods thereof”, a description that was later amended to “A method of producing a transgenic plant with increased heat tolerance, salt tolerance, or drug tolerance.”
Specifically, it said the invention relates to a method of increasing the biotic and abiotic stress tolerance of plants through a DNA molecule that expresses a cold shock protein (CSP) within the cell of the said plant. The Patent Office in its rejection last year had said the following:
i) the claims lack inventive step; ii) that the structure and function of CSP was already known in cited prior art and is obvious to persons skilled in plant technology to make transgenic plant; (iii) it is mere application of already known process in producing plants tolerant to heat, salt and drought conditions and that such claims fall within the scope of Section 3(d) of the Patents Act which bars patent protection for new use of a known process.
More important, it also said that such claims were not patentable under Section 3(j) as claims also include essential biological process of regeneration and selection and includes growing of plant in specific stress condition.
This section says plants and animals in whole or part cannot be patented along with essentially biological processes for production or propagation of plants and animals.
In all, Monsanto had made 20 claims in its original application. It had contended that the role of CSP genes was not clearly known even in bacteria leave alone in predicting that the same would induce drought, salt and temperature tolerance in plants. But IPAB dismissed its claims and upheld the decision of the patent office.
To readers familiar with India’s patent law this might ring a bell. These are the same grounds on which pharma giant Novartis was denied a patent for its Glivec cancer drug. It was the very same Section 3 (d) that felled the drug MNC and made global headlines. It might do so once again.
But I am wondering. Can we be sure that these prohibitively expensive GE plants will be more tolerant to extreme stress than the traditional varieties of Deb and Sarangi?