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POLICY & REGULATION: Indian BRAI Bill - the recipe for a corrupt autocratic system



                                  PART 1


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TITLE:   BRAI BILL - BULLDOZING PUBLIC OPINION

SOURCE:  Business Standard, India

AUTHOR:  Raghuvansh Prasad Singh

URL:     http://www.business-standard.com/india/news/raghuvansh-prasad-singh-brai-bill-bulldozing-public-opinion/449406/

DATE:    17.09.2011

SUMMARY: "The problems with the current proposal of the regulatory system starts with the conflicting interest in which ministry is tabling the Bill, the ministry of science and technology that also has the mandate to promote GM crops in the country. The Bill also proposes to have an appellate tribunal that is the sole forum for redressal. This is a scary situation in which the promoter himself becomes the regulator, prosecutor and the judge. This is the recipe for a corrupt autocratic system."

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BRAI BILL - BULLDOZING PUBLIC OPINION

The author represents the Vaishali constituency of Bihar in the Lok Sabha and is a member of the Rashtriya Janata Dal. He was Union cabinet minister for rural development in the first United Progressive Alliance Cabinet

The government has finalised the draft of the Biotechnology Regulatory Authority of India (BRAI) Bill. A close reading of the draft shows that, on the one hand, this Bill intends to provide single-window clearance to genetically-modified (GM) crops promoted by multinational seed companies; on the other, it ignores the possible risks and threats to our agriculture, health and environment from this controversial technology.

The nation saw a widespread debate on Bt brinjal, the first GM food crop to have been considered for commercial cultivation in the country. Public consultations organised during that debate clearly highlighted the objections and concerns of all sections of society, including scientists, on GM foods in general and Bt brinjal in particular.

Twelve state governments, including the largest brinjal-cultivating states ? West Bengal, Bihar and Odisha ? expressed their concerns with regard to this novel and unnatural GM food crop. The government responded rightly to the diverse voices all around and placed a moratorium on the commercial release of Bt brinjal on February 9, 2010.

Despite the moratorium, there have been many efforts in the past several months to overlook the legitimate concerns over GM crops and this proposed regulatory system called BRAI is one such significant effort.

A hasty move in the wrong direction

The fact that the draft of the Bill was not put in the public domain and the haste with which the Bill was listed for tabling ? it was given to the MPs just a few hours before its scheduled introduction in the Lok Sabha on August 17 ? makes it clear that the government is in no mood for an informed debate either inside or outside Parliament on BRAI. It was thanks to the raging anti-corruption debates in the Lok Sabha that the Bill could not be introduced by the ministry of science and technology.

The problems with the current proposal of the regulatory system starts with the conflicting interest in which ministry is tabling the Bill, the ministry of science and technology that also has the mandate to promote GM crops in the country. The Bill also proposes to have an appellate tribunal that is the sole forum for redressal. This is a scary situation in which the promoter himself becomes the regulator, prosecutor and the judge. This is the recipe for a corrupt autocratic system.

One of the biggest issues with the current regulatory system, with the Genetic Engineering Appraisal Committee (GEAC) as the nodal agency, was that it overrules the constitutional role of state governments in policy decisions regarding agriculture and health. After almost 13 years of existence and resistance to it, the GEAC recently amended its rules to give state governments the decision-making power on the approval of field trials, which is the first level of open release of GM crops. The proposed BRAI seeks to reverse this and take control of decisions related to any open releases of GM crops, be it for experiments or for commercialisation. This is clearly an unconstitutional move since agriculture and health, two sectors that would be impacted by GM crops, are under the state list of the Indian Constitution and states should have a role in deciding anything that has an impact on these sectors.

Adding to the unconstitutionality is the powers that have been given to the five-member Biotechnology Regulatory Authority to override the provisions in the Right to Information Act, 2005.

The provisions laid out in Section 2, Section 28, Section 70 and Section 77 of this Bill undermine the fundamental right to freedom of speech and expression, and the right to life, by violating the provisions and protection of the RTI Act. And by preventing civil courts to have jurisdiction on any matter under the Act.

Anti-farmer and anti-people

This draft Bill clearly intends to circumvent opposition to GM and to facilitate the monopolisation of our seed sector by multinational seed giants like Monsanto. Besides having the wrong mandate, the proposals are completely sidestepping the precautionary approach and not addressing all the serious shortcomings of the existing regulatory regime. The BRAI proposal does not talk about the mandate of protecting India?s environment and health from the risks of modern biotechnology, which should be the primary mandate for any regulatory regime.

Given the growing concern in the country about the impact of GM crops to our health, our farmers livelihoods and food and seed sovereignty, it is high time that the government recognises it. Instead of coming up with such cantankerous legislations as the BRAI Bill to promote risky technologies like genetic modification, it should go after real solutions that are economically, socially and environmentally sustainable.

In the light of public concern on GM crops and such blatant violations of constitutional rights in the current BRAI Bill version, the prime minister should not let his science and technology minister introduce the BRAI Bill in Parliament without widespread public consultations.



                                  PART 2

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TITLE:   IN THE WRONG MINISTRY?

SOURCE:  Down To Earth, India

AUTHOR:  Latha Jishnu & Jyotika Sood

URL:     http://www.downtoearth.org.in/content/wrong-ministry

DATE:    30.09.2011

SUMMARY: "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, following a last-minute hitch, the proposed law has received the full support of the Association of Biotech Led Enterprises 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."

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IN THE WRONG MINISTRY?

Biotech Regulatory Authority will have too much power, no checks

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, 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 housed?in the Science and Technology ministry.

Basic flaws

- 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

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.



                                  PART 3

------------------------------- GENET-news -------------------------------

TITLE:   STATES? ENTRY RUFFLES GM LOBBY

SOURCE:  Down To Earth, India

AUTHOR:  Latha Jishnu & Jyotika Sood

URL:     http://www.downtoearth.org.in/content/states-entry-ruffles-gm-lobby

DATE:    30.09.2011

SUMMARY: "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 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."

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STATES? ENTRY RUFFLES GM LOBBY

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 
 over the 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??). 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 guideline
 s 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.

V RAM KAUNDINYA, chairperson of the Association of Biotech Led Enterprises?Agriculture Group (ABLE? AG), the industry lobby, is finding the going tough as government brings in a new level of biosafety assessment for GM crops. In an interview to Down To Earth, KAUNDINYA talks frankly about the industry?s view of states getting a role in regulation

ABLE-AG has been complaining about the delays in approvals

The first part is that the no objection certificate (NOC) by a state is not required by the law. What we are saying is once you introduce an element which is not as per the policy, you are introducing elements which are outside the control of everyone. The second part is, we are creating a Genetic Engineering Appraisal Committee (GEAC) in the states. It is becoming a second scrutiny.

So what is the problem?

We are not sure whether at the state level people have the necessary skills. It becomes more of a political decision than a scientific one. The delays are happening. NOCs have now come from two to three states. The other problem is some of the states have expressed their desire to be GM-free.

Are you saying it is not going to be easy for industry?

The procedure now is that each state has to give an NOC for each trial. It is a humongous task because there are 100 trials happening all put together. The state needs a team that should have time to go through the applications and decide whether to give permission. We believe kharif 2011 is gone and there were no trials.

What is causing the delay?

States want to look at the details?of the trait, its characteristics and the crop in which it will be introduced. Basically they want to go through the data which we submit to GEAC. It is a sort of duplication. But in some matters they may not have the competency to do that. They may have scientists from agricultural universities who can check some aspects but not all. This is a delay barrier rather than a value-added feature.

What is the reason for this new rule? Is it because of anti-GM activism?

Apparently it is a decision due to objections raised by Bihar Chief Minister Nitish Kumar, followed by states like Kerala saying they do not want GM. It could be an opposition to a particular country or to a particular company.

Is this the result of an anti-MNC campaign?

We need more communication about what biotechnology is, what its benefits are. A lot of information is floating around in the media which is not right. Right now 50 event selection trials are going on in more than 10 crops. Most of these trials, 50 per cent, are by public institutions. There are many Indian companies working on this. This logjam is hurting Indian companies more than MNCs which have the capacity to withstand the delays.

You said something about trying to meet Nitish Kumar?

We have to find a convenient time to meet him. We have met officers, we have briefed them. But everybody says it Is a political decision so industry has to meet him.

Have you sought scrapping of the NOC rule?

We have represented to all the three ministries?agriculture, environment and science and technology. We have not had any success so far.