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Drop the National Biotechnology Regulatory Authority Proposals of Department of Biotechnology


From: Deccan Development Society <ddshyderabad@gmail.com>

Date: Jul 31, 2008 4:24 PM

Subject: Sub: Drop the National Biotechnology Regulatory Authority Proposals of Department of Biotechnology.

To: manmohan@sansad.nic.in, pmosb@pmo.nic.in

Respected Sir,

The proposed National Biotechnology Regulatory Authority bill being contemplated by your Government, is an extraordinary piece of legislation on an issue that critically affects every citizen of this country either directly or indirectly, which should have been subjected to an intensive democratic debate from all quarters of this country.

However, we earnestly feel that it has not been given a chance for a detailed discussion and is being hurriedly pushed through. A huge number of farmers' associations, civil society groups, and consumer organizations who are seriously concerned about the impact of biotechnology on agriculture, human and livestock health and welfare, and its environmental impact, are feeling shortchanged because the proposed legislation has certain serious shortcomings and following
objectionable clauses.

The institutional mechanism of decision-making in the NBRA, with a 4-member committee consisting of scientists taking all decisions is undemocratic and authoritarian (Section 11(1)). It has been found time and again that even a broad-based and inter-ministerial body like the Genetic Engineering Approval Committee (GEAC) is unable to address all stakes and concerns during decision-making. Even though the NBRA proposals talk about various committees and offices to be set up, all of them have been given only an advisory role and the narrow 4-member 'Products Ruling Committee' clearly is not bound by the advice and recommendations of all these various units and committees.

The NBRA denies and violates the constitutional right of state governments over their agriculture. There is not only no role allowed for state governments in decision-making under the NBRA, there is a
denial of their state level mechanisms and regulations over their agriculture pertaining to biotechnology. This is completely unconstitutional (Section 25, 33(2)).

As per the provisions of Section 31 the NBRA is allowed to amend the first schedule, and this defeats the very purpose of a separate legislation for regulation and takes away the power of the elected
parliamentarians over this law

The over-riding effect of the NBRA on other existing regulations is a matter of serious concern. It tramples upon the Biological Diversity Act, for instance. (Section 29)

The NBRA proposals do not contain any clauses related to conditional approvals, for a limited period, subject to review and revoking of approvals. It appears that an approval would be valid for all time to
come, irrespective of other considerations!

There are no provisions in the NBRA for liability, redressal and remediation. As we know from past experience from across the world, even confined trials could involve losses and damages related to
contamination and recalls which will cost a lot in terms of redressal and remediation. NBRA makes no mention of making the GM developer liable for redressal and remediation.

Even the penalty clauses have been left to be evolved in the Rules. Section 16 related to penalties and offence; an offence is narrowly defined to include only offenders "who knowingly fail to comply" and
leaves room for misuse.

Under Section (8), no wrongful decision of the NBRA can be invalidated and leaves room to justify almost anything.

The NBRA proposals don't talk about any mandatory prior informed public consent in its decision-making; this is a violation of the principle enshrined in the Cartagena Protocol. The NBRA proposes to make only decisions of the body public, but not the bases on which decision-making took place; it also does not talk about how public will be involved in decision-making. All of this will only reinforce the current non-credible, opaque functioning of regulators.

The NBRA seems to negate and discount the existing systems of seed assessment and regulation by having over-arching and over-riding decision-making authority.

The NBRA seeks to make amendments to the Food Safety & Standards Act with regard to clauses that govern GM foods' regulation. The proposal to alter the definition of GM foods under the FSSA is obviously a way to scuttle the labeling regime of GM foods and this is objectionable.

The Appellate Tribunal proposed to be set up under the NBRA is not acceptable in its constitution and is not broad based to include farmers' and consumers' representatives. Further, an appeal to be filed
within 30 days is unreasonable - given that GM technology is unpredictable and any appeals mechanism cannot be time-bound with such technologies. Further, bar on judicial reviews on decisions taken by the Appellate Tribunal is objectionable (Section 20(2), (4), 26).

In the wake of the above objections, a single-window, fast-track clearance system proposed in the NBRA draft is not at all necessary and actually leaves much space for unscientific, undemocratic and corrupt functioning with very little checks and balances.

We are very doubtful about the unbiased functioning of the proposed set up of NBRA under the Department of Biotechnology, which has a blind mandate to promote the Biotechnology as the panacea for all the problems. 

As you know, a recent United Nations report pointed out the lack of biosafety capabilities in India (like in many other countries) especially with regard to bio-terrorism with the use of biotechnology.
In this context, it would be disastrous to go in for a single-window, fast-track clearance system in the form of NBRA, just to appease the biotech industry at the expense of the security, health and environment of the nation.

In fact, till date, there has been no conclusive evidence in India that GE crops are beneficial to human and cattle health. On the contrary, there have been a large number of studies and experiences reported from all over the country which indicate that genetic engineering in agriculture, as evidenced from Bt cotton cultivation, has given rise to huge pest problems, soil toxicity and human health problems.

To mention a few, the resurgence of sucking pests on Bt cotton, the huge incidence of mealy bugs in Punjab, AP and Vidarbha, an alarming rise of root rot disease from 2% in 2002, the year Bt cotton was introduced in AP, to 40% in 2007, and  five years later, the early evidences of the development of the resistance by     bollworms to the Bt cotton, the death of thousands of small ruminants and allergic reactions to farm labourers who worked on Bt cotton fields have already been recorded evidences in India.

While this is the Indian reality vis-a-vis the impact of genetic engineering on a non-edible crop, it would be extremely dangerous to go ahead with a Bill that will open up the doors for a string of
genetically engineered food crops that are waiting in the queue for clearance with the Indian government. Highly respected scientists such as Dr P M Bhargava,  former Director of the Centre for Cellular and Molecular Biology, Hyderabad and a recipient of the Padma Vibhushan, have openly raised questions about the way biosafety issues have been sidelined by the Indian genetic engineering regulators. Similar apprehensions have been expressed by leading environmental scientists such as Dr Vandana Shiva and Dr Suman Sahai. A number of concerned scientists and environmentalists as well as farmers and consumer organisations have also been questioning the way biosafety has become a casualty in the aggressive push for GM trials as well as the commercial
approval being considered by the Government of India, under the relentless pressure exerted by the biotech industry.

In the wake of this situation, we demand that the proposed NBRA be dropped immediately in the larger public interest. India being a basket of biodiverse species and genera, should not hurry for proposals such as NBRA which, in the long run ruthlessly destroy our diverse genetic base,
and make us vulnerable to all kinds of threats especially in the wake of bioterrorism.

As a people oriented democratic country, we should raise up to the occasion and learn from across the world's intense scientific processes like the IAASTD (International Assessment of Agricultural Science & Technology for Development) are concluding that Genetically Modified crops and foods are not the way forward and that ecological agriculture is the way forward. Any proposal like the NBRA would therefore be unwise and incongruous and we urge you to intervene and get the current
proposals dropped immediately.


Sd/[by more than 100 organizations/individuals - first few given as examples]

1.P V Satheesh
Director, Deccan Development Society, 101, Kishan Residency, Street No-5, Begumpet, Hyderabad-16, AP

2.S Kiran
South Against genetic Engineering, Hyderabad

3.A Giridhar Babu
AP Alliance for Food Sovereignty, Zaheerabad

4.C Jayasri
Andhra Pradesh Coalition in Defense of Diversity, Hyderabad

5.C Suresh Kumar
Millet Network of India, Hyderabad



8.P.S.Ajay Kumar