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Final Draft of Legislative Drafting 1 Dr. RAM MANOHAR LOHIYA NATIONAL LAW UNIVERSITY Submission of the Final Draft in the B.A. LLB (Hons.) (IXth Semester) Course in Legislative Drafting. On the topic- “The Biotechnology Regulatory Authority of India Bill, 2013 : A critical analysisSUBMITTED BY SUBMITTED TO Rohit kannojia Mrs. Seema Siddiqui Roll No. 109 Faculty of Law B.A. LL.B (Hons.) Dr. RMLNLU IX Sem. Sec. B.

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Final Draft of Legislative Drafting

1

Dr. RAM MANOHAR LOHIYA NATIONAL LAW UNIVERSITY

Submission of the Final Draft in the

B.A. LLB (Hons.) (IXth Semester) Course in Legislative Drafting.

On the topic-

“The Biotechnology Regulatory Authority of India Bill, 2013 : A critical analysis”

SUBMITTED BY SUBMITTED TO

Rohit kannojia Mrs. Seema Siddiqui

Roll No. 109 Faculty of Law

B.A. LL.B (Hons.) Dr. RMLNLU

IX Sem. Sec. B.

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Table of Contents

Acknowledgement

Abstract

Research Methodology

Introduction

Issues involved with the GM Crops

(i) Contamination of traditional varieties and threat to Gene Pool diversity

(ii) Threat to livestock of farmers

(iii) Issue of increased immunity in pests and in turn increased input crop value

(iv) Issue of testing and labelling and consumers right to know and to have choice

(v) Why promotion to only GM framing why not organic farming...

(vi) Conflict of interests in BRAI

(vii) What will be the impact on the export, if India will produce GM crops because as

we know GM and non GM cannot co-exist and if we chose GM over traditional

crops than what would be its effect on trade...

(viii) Compensation for the farmers who suffer loss because of GM crops and Issue of

need of increased toxicity tests

Some Disconcerting Features Of The BRAI Bill

Flaws in the BRAI Bill

Need of a liability provision in the BRAI Bill

Critical Analysis of Conflicting/Contradicting Provisions Of The BRAI Bill

Suggestions for Amendments In The Proposed BRAI Bill

GM promise is a fool’s paradise

Conclusion

Bibliography

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Acknowledgement

First of all, I would to thank my teacher of the Seminar Paper “Legislative Drafting”,

Mrs. Seema Siddiqui who helped me in suggesting the topic of the project and providing

every bit of help that I asked her for and also showing the way in which to proceed and how

to go about the project.

I would also like to thank my parents, friends and others who helped me immensely at every

step and gave every possible bit of help that I needed in preparing the project and making it

look presentable in a good way.

I would also like to thank the library staff of Dr. RMLNLU who provided me with books that

I needed in making and preparing the project and other pieces of information and help that

was required. At last I would like to sincerely thank God who gave me the much needed

strength and power to go ahead with the project and make it in a presentable way.

Yours Faithfully,

Rohit kannojia

IXth Semester, Sec –B

Roll No- 109

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Abstract

India’s agricultural future looks bleak as the Biotechnology Regulatory Authority of India

(BRAI) Bill 2013 is scheduled to pass by Indian parliament. This highly controversial

bill calls for the formation of a new regulatory body that is the ultimate authority on the

introduction of Genetically Modified (GM) crops in India.

This body makes a mockery of both consumer protection as well as farmer rights, as it

stipulates that the body will be made up of five members based within the Department of

Biotechnology (DBT), the very body that funds GM crop research in the country. To add to

the irony, the DBT is also the main agency for channelizing funds from foreign governments

to GM crop development projects.

This bill now allows biotechnology companies to bulldoze the Environment Ministry as well

as state governments. This single-window clearance body unconstitutionally denies state

government’s authority over agriculture and health issues as the bill explicitly states that the

final decision related to GM crops will be taken by the Union government. This is

convenient, as several states’ Chief Ministers have already expressed severe doubts over the

contents of the bill.

Their worries are not baseless. The bill makes provision for open-air field trials of GM crops

that have previously been banned, and allows non-accredited labs to conduct bio-safety

assessment tests. Even more worryingly however, it overrides the RTI (Right to Information

Act 2005) that was formulated to allow transparency of governance in the first place, and

prevents consumers from accessing information about the safety of these new crops.

This research paper will critically analyse the provisions in the BRAI bill which are in

conflict with The Constitution Of India or with other Acts in existence.

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Research Methodology

Aim of the project

This project aims to critically analyse the current “Bio technology Regulatory Authority Bill,

2013” and to examine the circumstances that whether there is really need of such a law in

our country.

AIMS:

To critically analyse the provisions of the proposed bill.

To Discuss the circumstances and Need of such law.

To analyse the impact and application of such law in India.

Hypothesis

BRAI is not a comprehensive piece of legislation it violates the federal structure of the

country and encroaches upon the state government’s domain. It doesn’t provide for issues

like Safe manufacturing and processing of GMO, Liability in case of hazard to ecosystem,

Application of RTI etc. It does not ensure transparency in an important issue which will

affect almost 65% population of the country.

Research questions

The problem with the BRAI, Bill is that it left several important issues unaddressed and the

issues and areas of interest which have been covered are not comprehensive enough to cover

all aspects of particular area there are several questions remain even after the introduction of

the bill some of them are :-

(1) Flawed risk assessment method of genetically modified organisms.

(2) Contamination of traditional Food varieties and threat to Gene Pool diversity?

(3) Issue of testing and labelling and consumers right to know and to have choice.

(4) There is no liability provision in the current Bill for any potential leakage and

contamination.

(5) Proposed Bill will create monopoly in the field of GM organisms.

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(6) State government’s domain has been violated and it is against the federal structure of

the country.

(7) Issue of transparency.

Scope of research

In my project till now I have tried to study all possible areas where the proposed BRAI Bill

can have some effect as like the possible conflict between centre and state government

domain, issues like safety standards for health issues and environmental safety, non

applicability of RTI , impact of MNC and their vested interest in opening up of Indian market

for GM crops. With the progress of study I will try to incorporate other important areas in my

research work.

Nature of Research

Analytical, Perspective, Critical and Descriptive Research. The research has been based upon

the various laws related to environment and GM technology.. A much critical and analytical

research has opened the scope of perspective and descriptive methodology to be employed.

Limitations of Research

The only limitation is that there is not much printed literature available on this topic and i

have to study most of the things form online resources. I wanted to know more about Indian

perspective on this issue but as it is a new topic not much literature available on it although

scientific material related to the GMO is available but not much legal material is available on

this matter.

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Introduction

One of the biggest concerns of 21st century is the constant growth of the corporate power.

India’s agricultural future looks bleak as the Biotechnology Regulatory Authority of India

(BRAI) Bill 2013 is scheduled to pass by Indian parliament. This highly controversial

bill calls for the formation of a new regulatory body that is the ultimate authority on the

introduction of Genetically Modified (GM) crops in India. This body makes a mockery of

both consumer protection as well as farmer rights, as it stipulates that the body will be made

up of five members based within the Department of Biotechnology (DBT), the very body that

funds GM crop research in the country. To add to the irony, the DBT is also the main agency

for channelling funds from foreign governments to GM crop development projects. The

Biotechnology Regulatory Authority of India Bill, 2013 proposed by the ministry of Science

and Technology makes it clear that the corporate greed is slowly but surely overshadowing

the human need.

This bill now allows biotechnology companies to bulldoze the Environment Ministry as well

as state governments. This single-window clearance body unconstitutionally denies state

government’s authority over agriculture and health issues as the bill explicitly states that the

final decision related to GM crops will be taken by the Union government. Several states’

Chief Ministers have already expressed severe doubts over the contents of the bill.1

Their worries are not baseless. The bill makes provision for open-air field trials of GM crops

that have previously been banned, and allows non-accredited labs to conduct bio-safety

assessment tests. Even more worryingly however, it overrides the RTI (Right to Information

Act 2005) that was formulated to allow transparency of governance in the first place, and

prevents consumers from accessing information about the safety of these new crops.

This bill if passed can bluntly violate the fundamental rights given to the citizens of this

country. In my project work I have tried to critically analyse the provisions in the BRAI bill

which are in conflict with The Constitution of India or with other Acts in existence.

1 Report No. 37 of Committee on Agriculture of 15

th Lok Sabha, Ministry of Agriculture (Department of

Agriculture and Cooperation) on the topic of “Cultivation of Genetically Modified Food Crops – Prospects and

Effects”.

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Issues involved with the GM Crops

(i) Contamination of traditional varieties and threat to Gene Pool diversity

GM crops and other biotechnology products are not the panacea. They have severe effect on

the traditional crop verities. At present there is a lot discussion going on about the

introduction of Bt Brinjal a GM crop but the thing which we must keep in mind is that we

have 2,200 varieties of Brinjal. If we allow GM Brinjal, all our varieties will get

contaminated and vanish as has happened in cotton. Parliamentary standing committee

pointed out this in its report. In that report it is mentioned that when the committee members

visited Yavatmal in Vidarbha, they asked farmers why they were growing Bt cotton if the

input costs were high and profits were low. They said they had no other option as alternate

seeds were no longer available. Initially a 450 gm packet of Monsanto’s Bt cotton seeds was

sold at Rs 1,700. Then after the Andhra Pradesh government challenged this in court, it was

brought down to Rs.750 per packet but the royalty of Rs.250 per packet paid to Monsanto

that developed the seed. Last year, a packet was sold between Rs.1,200 to Rs.2,000 because

of the monopoly of this private seed company. An artificial scarcity was created and the price

was hiked.2

This will happen in Bt brinjal too if it is allowed. The pertinent question about

the introduction of this GM technology is that if our quest is for food security then why must

we select this technology which has nothing to do with food security? The only motive

behind this is profit for the seed companies.

Unlike the situation in 1960s, the Technical Expert Committee of Supreme court has statted

in its report that, there is no desperate shortage of food and India is in a reasonably food

secure position. It recommended that the release of GM crops in country like India which is a

centre of origin or diversity as in Bt brinjal should not be allowed. (Philippines Supreme

Court has recently banned open field trials of Bt Brinjal.) Urging the government to accept

the recommendations based on sound-science, justice and principle of sustainability”, the

Committee said “vested interests must not be allowed to prevail.3

2 Bt Cotton or Better Cotton? By Kunal Datt, published by Centre for Civil society 3 Accept expert panel report on GM crops: forum by Gargi Parsai,

http://www.thehindu.com/news/national/accept-expert-panel-report-on...

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(ii) Threat to livestock of farmers

GM crops have adverse effects on the livestock of farmers. After conducting field study in

Vidarbha and Areas of Gujarat where cotton is chief cash crop, by the Parliamentary standing

committee it recommended re-evaluation of all research findings in Bt cotton seeds in the

light of latest studies that highlighted inexplicable changes in the organs and tissues of Bt-

cotton seed-fed lambs. This is serious issue of concern and must be addressed appropriately

before going forward in favour of GM crops.

(iii) Issue of increased immunity in pests and in turn increased input crop value

Acquired immunity in various species of pests is serious problem and must be considered.

GM technology cannot be the monopoly of one company, as in the case of Bt cotton. The

benefits that were assured from Bt cotton cultivation are not coming because new pests have

appeared. Farmers have to use more pesticide and chemical fertilizers, as a result of which

there has been an increase in input costs and reduction in profit margins leading to farmer’s

indebtedness and suicides.4

(iv) Issue of testing and labelling and consumers right to know and to have choice

This is another major weakness in proposed law. There is only a Food Lab in Kolkata under

the Ministry of Health and that too is not well-equipped. The new Food Safety and Standards

Authority of India (FSSAI) is supposed to do quality testing for GM crops but it is not ready.

Also government must enact a legislation to protect the rights of consumers. Today,

consumers have no rights and no means to know which imported food contains GM. There

should be compulsory testing and labelling of GM food entering the country.5

(v) Why promotion to only GM framing why not organic farming...

Do we really need the GM farming as we have attained the self reliance in food productivity

and problem of hunger in our country is just because of the improper distribution of the food 4 GM crops are no way forward by Satyarat Chaturvedi, http://www.thehindu.com/opinion/lead/gm-crops-are-

no-way-forward/a... 5 “Operationalizing the Regulation of Genetically Modified Foods in India” by Food Safety and Standards

Authority of India , FDA Bhawan, Kotla Road, New Delhi-110 002

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and not because of the less production of the food. In fact india is just going to launch biggest

food distribution program of world thorugh its food security ordinance.

Recalling the green revolution, that farmers have enhanced grains production since

Independence to such an extent that today the godowns were overflowing with grains. There

is no storage capacity. “Still half the land in the country is waiting to be exploited. There is

was no irrigation facility. If the government provides water for irrigation, then farmers can

raise production even higher.6

Important question is that “Do we really need GM farming” because if the aim is to achieve

Food Security than that can also be done with organic farming. Why government is promoted

only GM farming and not organic farming. As compared to GM farming organic farming is

cheap and effective it has no adverse impact on environment too. Also for organic farming

government does not need to establish heavy executive machinery for regulation stakes are

low in organic farming as compared to GM farming.

(vi) Conflict of interests in BRAI

Due to the dearth of biotechnology scientists in the country, the same scientists were found to

develop technologies as well as assess, evaluate and approve them. The BRAI will approve

any GM crop on the basis of its own assessments as the apex regulatory body. After

approving the crop, it was also responsible for evaluating its own decision to approve the

crop. This led to a conflict of interest within the regulatory process. To avoid such a conflict,

speedy evaluation of reports on GM crops should be done by an agency other than the BRAI,

such as the Council of Scientific and Industrial Research.7

6 Policy brief for Parliamentarians the biotechnology regulatory Authhority of india (BRAI) Bill 2013: A threat

to our food and farming published by Centre for legislative Research and advocacy ,Greenpeace policy brief

series no. 19, 2013 June – august

7 Report No. 37 of Committee on Agriculture of 15th

Lok Sabha, Ministry of Agriculture (Department of

Agriculture and Cooperation) on the topic of “Cultivation of Genetically Modified Food Crops – Prospects and

Effects”.

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(vii) What will be the impact on the export, if India will produce GM crops

because as we know GM and non GM cannot co-exist and if we chose GM

over traditional crops than what would be its effect on trade...

Many European countries do not allow GM crops. India’s food grains are primarily supplied

to European countries especially rice; it is chief export of India to these countries.

The report of Technical expert committee (TEC) of Supreme Court illustrates one possible

hazard posed by GM crops, saying that “in 2011-12, India was the largest exporter of rice in

the world. If the rice is contaminated with GM rice, then essentially India stands to lose the

entire European market. The total value of rice export from India worldwide is about Rs.

14000 crore. If the value is small and much less than projected benefits, that is one thing, but

if it is high then it could do grave damage. To the best of TEC’s knowledge this possibility

has not been considered by regulatory bodies when allowing development of transgenic rice

in India, which is presently in full swing and there are several applications before Genetic

Engineering Approval Committee.”8

(viii) Compensation for the farmers who suffer loss because of GM crops and Issue

of need of increased toxicity tests

Technical Expert Committee has also pointed out that there was no mechanism for the

payment of compensation to the farmers whose product could be affected and that there was

no statutory method in place to address these issues. It further said: “The TEC is of the view

that the policy of delegating responsibility by leaving the choice of site selection for field

trials to the applicant and also allowing the work to be sub contracted is contrary to the basic

safety requirements, and is most likely to lead to violation of the conditions of safety.”

Additional toxicity tests comprising long term and intergenerational studies should be added

to the existing requirement that needs to be met before field trials can commence, said the

Committee. It noted that the existing requirement stops at sub-chronic studies.9

8 “Put a stop to GM crop field trials for 10 years” By J. Venkatesan,

http://www.thehindu.com/todays-paper/tp-national/put-a-stop-to-gm-cro...

9 GM crops are no way forward by Satyarat Chaturvedi, http://www.thehindu.com/opinion/lead/gm-crops-are-

no-way-forward/a...

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Some Disconcerting Features Of The BRAI Bill

“... the 20th century has been characterized by three developments of great political

importance: The growth of democracy, the growth of corporate power, and the growth of

corporate propaganda as a means of protecting corporate power against democracy.”10

o The move of Government of India to introduce the Biotechnology Regulatory Authority of

India Bill, 2009 in the current session of Parliament is a perfect example of the growth of

corporate propaganda as a means of protecting corporate power against democracy. The

BRAI11

Bill has a number of most disconcerting provisions that cause profound concerns

among all of us who are demanding a democratic debate on the need to bring in genetic

engineering technology into the arena of food and farming in India.

o In the wake of the BT Brinjal controversy12

in the nation, which has steered a nationwide

public debate over the safety and viability of Genetically Modified13

food, the mad rush to

introduce the bill becomes more so clandestine. The direction in which the debate moved

the national consensus has put the cat among the genetically engineered pigeons and

hence, the surprising hurry on part of our government, almost bordering on obscenity does

not take a Sherlock Holmes to gauge the real reason for this urgency.

o It is pertinent to be noted that significant investment has already been made by private and

public organisations in developing BT crops14

, especially some biotech corporate giants

have huge stakes in the manufacturing and cultivation of GM foods. Any delay in the

launch of GM foods in the market will cause huge loss to these corporations and

organisations, which is imminent due to the recent spur of protests and debates all over the

country. Thus, in a blatant portrayal of corporate favouring policy, this ominous piece of

legislation has been drafted by Department of Biotechnology of the Ministry of Science

10

Alex Carey; Australian social scientist, quoted by Noam Chomsky in World Orders: Old and New

11Biotechnology Regulatory Authority of India

12After huge outcry of scientists and farmers, a moratorium was put on release of the genetically modified

Bt-Brinjal, after several public consultations by the current Environment Minister Jairam Ramesh across

the country.

13Genetically modified organisms (GMOs) can be defined as organisms in which the genetic material (DNA)

has been altered in a way that does not occur naturally. The technology is often called “modern biotechnology”

or “gene technology”, sometimes also “recombinant DNA technology” or “genetic engineering”. It allows

selected individual genes to be transferred from one organism into another, also between non-related species.

Such methods are used to create GM plants – which are then used to grow GM food crops.

14 Crops cultivated using biotechnological methods

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and Technology to stifle the voice of democracy and establish an autocratic authority

which will completely strip the citizens of their right to participate in making the decisions

on what they grow and eat through an undemocratic, secretive system that cannot be

challenged under the laws of the country.

o Therefore this Anti-state, flawed bill which has been presented in the parliament would

create a monopoly in the field of GM organisms since the Regulatory body proposed

would have the final arbitrary authority in relation to anything falling under this ambit.

The bill clearly gives an edge to the investing companies by emphasizing on one time

clearance to these organisms and by overlooking the consumers. Hence, this bill must not

be passed unless the required amendments are made. This issue should be seriously

considered by the government and must conduct thorough investigations on GM crops

before letting companies enter into our country.15

o This bill now allows biotechnology companies to bulldoze the Environment Ministry as

well as state governments. This single-window clearance body unconstitutionally denies

state government’s authority over agriculture and health issues as the bill explicitly states

that the final decision related to GM crops will be taken by the Union government.

o The bill makes provision for open-air field trials of GM crops that have previously been

banned, and allows non-accredited labs to conduct bio-safety assessment tests. Even more

worryingly however, it overrides the RTI (Right to Information Act 2005) that was

formulated to allow transparency of governance in the first place, and prevents consumers

from accessing information about the safety of these new crops.16

o After the open-ended moratorium imposed on the introduction of Bt brinjal, the industry

has been aggressively pushing for a tougher regulatory regime that minimises the role of

the general public. The proposed BRI Act came in handy. The 2009 version of the bill,

which was leaked out, and caused enough public uproar, actually sought to muzzle

opposition (Section 63) to GM by seeking to impose fines and imprisonment on voices

raising concerns on GM crops. After the outrage died down, another version of the bill has

been put in public domain. In my understanding, the grip of the GM-promoting

15

“BRAI sparks cry”

http://mla.prsindia.org/media/articles-citing-prs/brai-sparks-cry-2071/ 16 Policy brief for Parliamentarians the biotechnology regulatory Authhority of india (BRAI) Bill 2013: A threat

to our food and farming published by Centre for legislative Research and advocacy ,Greenpeace policy brief

series no. 19, 2013 June – august

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companies will be further strengthened if the draft Biotechnology Regulatory Authority of

India (BRAI) Act is passed by the Parliament in its present form.

o 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.

Flaws in the BRAI Bill

Firstly many failed to understand the motive behind this bill being proposed by the ministry

of science and technology when the issue is regarding food, environment etc. Even

overlooking that, it doesn’t take a brainy head or technical knowledge to spot some hilarious,

or rather seriously flawed provisions which are unconstitutional ‘ab initio.’

It is hereby submitted that the bill is driven by the Department of Biotechnology and it ought

to know as a matter of technical prudence that biotechnology covers some 30 areas, of which

many need to be regulated. These areas include stem cells, nano-biotechnology, biological

warfare, vaccines, bioinformatics, organ transplantation, and new drug delivery systems, new

materials such as spider silk and bacterial ropes, plant-based traditional drug formulations,

and assisted reproductive technologies. However, the proposed bill is confined to Genetically

Manipulated Organisms (GMOs) and their products only and makes an omission regarding

other areas. Should it not, therefore, have been called a GMO Regulatory Authority instead of

a Biotechnology Regulatory Authority? It is glaring error to equate biotechnology with

genetic engineering alone and thus the nomenclature of the authority sends a wrong signal.

Also, it is highly dubious as to the unbiased functioning of the proposed set up of BRAI

under the Department of Biotechnology, which has a blind mandate to

promote Biotechnology as the panacea for all problems.17

17 Status of GM crops in India: Research and Regulatory System by S.R. Rao , Advisor Department of

Biotechnology Ministry of Science and Technology Government of India

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Further, the objective of any proposed bill should be to fill a defined void. There is already a

regulatory procedure in place for GMOs and their products, involving the Review Committee

on Genetic Manipulation (RCGM) of the DBT and the Genetic Engineering Approval

Committee18

(GEAC) of the Ministry of Environment and Forests. Therefore, it should first

be determined if anything is wrong with the present system and then an attempt should be

made to correct the existing system. Only if this is not possible should a new bill be

considered. The authorities concerned should state what part of the existing procedures is

undesirable and how the proposed bill will correct it. However, unfortunately or rather

deliberately no such problem or hindrance has been accounted for, in the objective of the bill.

For example, the present system does not prescribe any penalty for contamination of a non-

GMO farm by GMOs in an adjoining farm. The proposed bill is silent on such problems.

A key concern appears to be the lack of guidelines in the BRAI Bill - the principles that

will shape the functioning of the regulatory authority in deciding the bio-safety of GM

crops. The functions and powers of the BRAI are to regulate transport, import,

manufacture and research of organisms related to biotechnology as specified in Schedule I

of the proposed BRAI legislation. The BRAI will look at impacts on human and animal

health as well as environment. The issues of social justice, inter-generational equity,

impact of genetic pollution (beyond environmental impacts) and political economy of these

decisions don't figure in this mandate. BRAI is designed to preclude the public's right to

grow, own, trade, transport, share, feed and eat each and every food that nature makes.19

The layout and provisions of the structure clearly shows that BRAI is not going to be a

regulatory authority but merely an APPROVAL agency. There will be no representation of

major stakeholders such as farmers, civil society groups, scientists’ et al in the proposed

authority. What the government wants to set up in place of the Genetic Engineering

Approvals Committee (GEAC), the apex regulatory body with representation from several

ministries, is a (3+2) member regulator that will act as single-window clearing house for

all GM commercial applications, with the processing of such applications as its primary

18

Set up under the Environment Protection Act. Presently, it is the apex committee under Ministry of

Environment Forest for approval of GMOs & products thereof. 19 Report No. 37 of Committee on Agriculture of 15

th Lok Sabha, Ministry of Agriculture (Department of

Agriculture and Cooperation) on the topic of “Cultivation of Genetically Modified Food Crops – Prospects and

Effects”.

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mandate.

The institutional mechanism of decision-making in the BRAI, with a (3+2) member

committee consisting of scientists taking all decisions is undemocratic and authoritarian. 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 BRAI proposals talk about various

committees and offices to be set up, all of them have been given only an advisory role and

the narrow (3+2) member 'Products Ruling Committee' clearly is not bound by the advice

and recommendations of all these various units and committees.

Therefore, it would be disastrous to go in for a single-window, fast-track clearance system

in the form of BRAI, which actually leaves much space for unscientific, undemocratic and

corrupt functioning with very little checks and balances, just to appease the biotech

industry at the expense of the security, health and environment of the nation.20

Need of a liability provision in the BRAI Bill

Another primary concern for stakeholders is that in the draft Bill htere is no provision for

Liability in cases of disaster or any mishappening occurred because of GM crops many civil

society groups demanding that one such provision must be included in the draft bill to fix

liability of multinational corporations. When after the report of TEC of SC govt. Put a

moratorium on field trials of GM crops many social activists supported this. Kavitha

Kuruganti of the Kheti Virasat Mission said that it was an “extremely positive” development.

“During the moratorium period the government should put in place a liability provision in the

Environment Protection Act which makes a GM crop developer solely liable for any potential

leakage and contamination.”

One of the concerns raised strongly by those opposing GM crops in India is that many

important crops like rice, brinjal, and mustard, among others, originated here, and introducing

genetically modified versions of these crops could be a major threat to the vast number of

domestic and wild varieties of these crops. In fact, globally, there is a clear view that GM

crops must not be introduced in centres of origin and diversity. India also has mega

biodiversity hotspots like the Eastern Himalayas and the Western Ghats which are rich in

20

Supra note 19

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biodiversity yet ecologically very sensitive. Hence it will only be prudent for us to be careful

before we jump on to the bandwagon of any technology.21

There is a essential need that the government should now put in place a robust framework

of protocols that was independent from the companies which seek approvals. “It is important

to note that 10 States [have] said ‘no’ to Bt brinjal. It is time now to allow States to define

their own agriculture policies.”22

Critical Analysis Of Conflicting/Contradicting Provisions Of The BRAI

Bill

Let us analyze some provisions of the aforementioned bill which shall shed some light on the

flawed policy of the government and the grave repercussions which may occur in case of the

bill becoming an act.

Section 2 of the bill states,

“It is hereby declared that it is expedient in the public interest that the

Union should take under its control the regulation of organisms, products and

processes of modern biotechnology industry.”

This section clearly violates the federal structure as provided in the constitution of

India as it purports to snatch away all power and control of the States over their

agriculture issues and vest it in the Union. Agriculture is an exclusive state subject

enumerated under List II of 7th

Schedule of the constitution.23

The BRAI denies and

violates this constitutional right of state governments over their agriculture. There

is not only no role allowed for state governments in decision-making under the

BRAI, there is a denial of their state level mechanisms and regulations over their

agriculture pertaining to biotechnology. This is completely unconstitutional. The

Bill envisages only an advisory role through the State Biotechnology Regulatory

Advisory Committee. The ACT will override all laws made by the State

21 GM crops are no way forward by Satyarat Chaturvedi, http://www.thehindu.com/opinion/lead/gm-crops-are-

no-way-forward/a... 22 A wise decision: Swaminathan By Gargi Parsai,

http://www.thehindu.com/news/national/a-wise-decision-swaminathan/a...

23 Article 246 of the constitution of India

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Government and will gain exclusive control over item24

specified in list II of VIIth

Schedule without actually going in for an amendment. Hence the union taking an

absolute control over this subject is a concern to the federal system followed in the

country.

Section 63(1) of the bill states,

“Whoever, himself or by any other person on his behalf, conducts field trials with

organisms or products specified in Part I or Part III of Schedule I, in contravention of

section 34 shall be punished with imprisonment for a term which shall not be less

than six months but which may extend to one year and with fine which may extend to

two lakh rupees.”

Section 3(g) defines “clinical trial” means systematic study of any new organism or

product specified in Schedule I for the purpose of generating data for discovering or

verifying its clinical, pharmacological (including pharmacodynamic and

pharmacokinetic) biological, or, adverse effects with the objective of determining

safety, efficacy or tolerance of that organism or product.”

This section gives the regulatory body all the authority to punish a person who

conducts ‘clinical experiments’ on GM crops. The punishment is of 6 months which

can be up to 1 year and with fine which can be up to two lakh rupees. Under this

section, no wrongful decision of the BRAI can be invalidated and this leaves room to

justify almost anything. Such a provision will inarguably give rise to a lot of arbitrary

and unreasonable decisions due to lack to accountability.

Section 63(1) bashes anyone who conducts clinical trials in order to determine the

safety and efficacy of GM organisms by imposing heavy penalty and languishing

jail terms on them. This is meant to harass civil society groups and scientists who

are voicing their concern on this technology. There is no penalty if someone

promotes GMOs without safety tests, but there is a penalty if someone wishes to

inform the public about the hazards of GMOs.

24

Item 14; Agriculture, including agricultural education and research, protection against pests and prevention of

plant diseases

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Section 63 directly stab the fundamental rights to death. The rationality behind the

above mentioned section are not understood since in this section you will be

punished if you found ‘conducting experiments.’ It should be noted that

experiments over GM Crops previously proved that they are hazardous in nature.

So considering this, curtail one’s right in expressing his concern over this issue or

enlightening the civil society on the same is intolerable.

Section 81of the bill states,

“Save as otherwise provided, the provisions of this Act shall have effect,

notwithstanding anything inconsistent therewith contained in any other law for the

time being in force or in any instrument having effect by virtue of any law other

than this Act.”

This is one of the most disconcerting and disturbing provisions of the bill. Apart

from hitting at the federal structure on agriculture and health issues, the BRAI will

impinge on, if not override, other laws like the better designed Biological Diversity

Act which gives equal play to the states and Union government.

In schedule II of the bill, certain amendments have been proposed to the already

existing legislations so as to confer complete monopoly over regulation of GM food

on the BRAI. These amendments have been deftly crafted in order to ensure

unquestioned working of the authority which leaves much scope for arbitrary and

capricious decisions. They are:

DRUG ACT25

: After section 37, the following section shall be inserted, namely:

37A. “Nothing contained in this section shall apply to the genetically modified or

engineered organisms or any matter or thing connected with it to which are

covered under the Biotechnology Regulatory Authority of India Act, 2013.”

FOOD SAFETY ACT26

: In section 13, in sub-section (3), in clause (c), the words

“organisms and”; shall be omitted.Section13 provides for appointment of Scientific

Panel on “Genetically Modified Organisms.”The Power of the Food Safety and

25

The Drugs and Cosmetics Act, 1940.

26Food Safety and Standards Act, 2006

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Standards Authority of India under Ministry of Health, to have scientific panel on

GMO will be taken away.

Sections 24 and 27 :

These provisions of the bill are in seeming conflict with one or the other

regulation. Sections 24 and 27 which relate to the procedure for risk assessment for

the research, transport, import of organism and product and the procedure for grant of

authorisation for manufacture or use of organisms and products, respectively.

The larger issue with the BRAI is that risk management is almost absent from its

agenda. Not only is there is no stipulation for revocation of approval by the authority

to prevent any possible harm to the environment or public health, there are also no

strong provisions for liability. Missing here, are express clauses for redressal or

compensation and measures for remediation and clean up in the event of an ecological

disaster. With a heavy cloud of suspicion still lurking upon on the safety of GM food,

this omission is almost criminal.

Also, It is not clear whether the Product Rulings Committee will be the final arbiter of

risk assessment or whether its reports will form the basis for such evaluation by the

risk assessment unit. But, of more concern is the fact that independence, impartiality

or autonomy of this five-member body can be easily undermined.

Section 75:

Under this section the Central government is allowed to give directions to the

regulatory authority, allowing it to "interfere with matters that are scientific and

technical in nature."

Biotechnology being a highly technical field, this kind of interference is prima

facie unjustified and smells of foul play on part of the government.

Section 27 of the bill states,

(1) In case an application to be submitted under sub-section (1) of section 24

or sub-section (1) of section 27 require the disclosure of confidential commercial

information, such information shall, notwithstanding anything contained in the Right

to Information Act, 2005, be retained as confidential by the Authority and not be

disclosed to any other party.

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(2) If the Authority is satisfied that the public interest outweighs theb disclosure of

confidential commercial information or such disclosure shall not cause harm to any

person, it may refuse to retain that the information as confidential commercial

information.

And Section 3(h) defines: “confidential commercial information” means, -

(i) a trade secret or any other information which has a commercial or other

value which would be, or could reasonably be expected to be, destroyed or

diminished if such information was disclosed; or

(ii) such other information which relates to lawful commercial or financial

affairs of a person, organisation or undertaking dealing with organisms or

products specified under Part I or Part II or Part III of Schedule I which, if

disclosed, could adversely affect such person, organisation or undertaking.

This means that the Regulatory body is the final authority in deciding what is

confidential and what is not. This would lead to arbitrariness and the whole concept of

‘transparency’ is pushed against the wall. The regulating body would have the full

freedom to give or restrict information according to its whims and fancies which is

frightening.Though the earlier bill proposed in 2008 doesn’t have anything regarding

the RTI Act, 2005, the present bill dealt with this issue in detailed and even managed

to violate it in Toto. . The bill if passed would make the regulating body an

exceptional case by having the final say w.r.t RTI claims, unlike the traditional way

followed by the other bodies where the PIO first scrutinizes the question raised by the

applicants and is answered only if it is in public interest.

This provision is clearly meant to give undue and unfettered discretion to the

authority to cite any information sought as confidential commercial information and

refuse to disclose it. There is scant regard accorded to public interest and BRAI has

been conferred with power to operate on its whims and fancies. This will clearly open

room for arbitrariness and unreasonable actions, without any checks and balances

whatsoever. BRAI will be an exceptional case by having the final say, unlike the

traditional way followed by the other bodies where first the PIO scrutinizes the

question raised by the applicants under RTI and is answered accordingly.

What is more frightening is the fact that, we cannot go to normal courts to challenge

any decision of the BRAI. The BRAI will set up its own Appellate Tribunal which

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22

will have the jurisdiction to hear arguments on the issues concerning biotechnology. If

one wants to appeal against the decisions of this Tribunal, the only court we can go to

is the Supreme Court of India. This is certainly the surest way of disempowering the

citizen activists of the country.

.Section 61 and 62:

These provisions of the bill are penal clauses which intend to fix liability of

the defaulters and violators. Both these provisions are very weak and vague to a large

extent, which will give rise to a lot of difficulty in fixing liability. There are way too

many deliberate loopholes and punishing violators would be a remote possibility.

First of all, if any violation regarding the safety and quality of GM food occurs, it has

to be a criminal wrong and therefore the procedure should be governed by Criminal

Procedure. However, strangely in the bill a civil procedure has been suggested though

it would be a criminal wrong. This is completely unjustified and drafted in order to

provide cushion to large corporations. Another glaring error is that the offences have

not been made cognizable. This means that even in case of a food catastrophe no

F.I.R. could be registered and arrests made without getting orders from the court.

Further, there is no provision for penalty for concealment of information and for

concealment or misrepresentation about safety of GE products. This is monstrous

considering the fact that anyone who spreads information about the safety of GM

food27

will be put behind bars but a person who conceals information about its ill

effects and hazards gets immunity.

Another serious omission is that there is no provision for class action in the bill. It

is quite pertinent to note that various other countries with similar legislations have a

class action provision contemplating the contingency that a lot of people may suffer

due to consumption of GM foods.

The BRAI proposals don't talk about any mandatory prior informed public consent in

its decision-making which is a violation of the principle enshrined in the Cartagena

Protocol28

to which India is a signatory. The BRAI proposes to make only decisions

27

Section 63 of the Draft bill 28

Article 23: 1. The Parties shall:(a) Promote and facilitate public awareness, education and participation

concerning the safe transfer, handling and use of living modified organisms in relation to the conservation and

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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. In the BRAI, the

people who will decide what organisms can be permitted, imported and field-trialled

will be a group of three who will all be composed of scientists in the area of

biotechnology or medicine or industrial science. It has no place for environmentalists,

farmers or food consumers. Thus, all our rights to decide for ourselves what we farm

and what we eat will be snatched away from us. All of this will only reinforce the

non-credible, opaque and arbitrary functioning of the regulatory authority.

Suggestions For Amendments In The Proposed BRAI Bill

1. A Standing Committee with functional autonomy must be set up to advise on the

social and economic implications of implementing GM technology.

2. It must provide for a consultative and participatory process to prioritise crops and

traits for genetic improvement through biotechnology with the goal of addressing the

needs of small farmers and Indian agriculture. Accordingly, the bill must provide for

the setting up of a statutory National Bioethics Commission.

3. The BRAI will be the sole regulating agency on biotechnology in India; it will be the

body to which the data from field trials and large-scale evaluation trials will be

presented. It, therefore, stands to reason that the BRAI should be a technically

competent body, strong on Risk Assessment and Risk Management of GM crops as

also on Monitoring. It is recommended that people skilled in Bio-safety Assessment,

Environmental Assessment and Environmental Impact Assessment, should staff this

Authority. A person of the highest technical competence and integrity who has

experience in the regulation of GM crops should head the body.

sustainable use of biological diversity, taking also into account risks to human health. In doing so, the Parties

shall cooperate, as appropriate, with other States and international bodies; (b) Endeavour to ensure that public

awareness and education encompass access to information on living modified organisms identified in

accordance with this Protocol that may be imported. 2. The Parties shall, in accordance with their respective

laws and regulations, consult the public in the decision-making process regarding living modified organisms and

shall make the results of such decisions available to the public, while respecting confidential information in

accordance with Article 21.

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4. There should be provision for a mandatory cost-risk-benefit analysis conducted in

public, before giving approval for a GM product. The law must have sections

providing for post- market surveillance and monitoring of GM products.

5. The Bill should put in place protocol for vastly improved food safety tests and

mechanisms for long term monitoring of human health (post GM food release).It

should also have a stringent protocol to assess environmental and ecological impact.

6. The Bill must contain a provision requiring an annual review of all decisions on GM

products to be presented to Parliament.

7. The Bill should incorporate provisions ensuring that the Authority functions in a

democratic and transparent manner and that it is answerable to the Inter- Ministerial

Advisory Board and the National Biotechnology Advisory Council (NBAC).

8. The draft legislation totally excludes NGOs and other scientific bodies from any

consultations and aspects of decision making or implementation of biotechnology.

The bill has two clauses which provide an interface with the public. Neither is in the

nature of public participation but merely informing the public about field and clinical

trials, regulatory decisions. There is no provision for ensuring that the public is

provided with all information supplied by the applicant to the national competent

authority, including the risk assessment report. There is also no provision for public

consultation. Excluding provisions for public participation is in violation of India’s

commitment in the Cartagena Protocol on Biosafety. Article 23 of the Protocol

requires public consultation and participation in decision-making.

9. The BRAI, BILL must include socioeconomic considerations in the risk assessment of

genetically modified organisms. Current risk assessment procedure as per Cartagena

protocol is very narrow. It should be more rigorous. Inclusion of factors such as

weeds developing resistance to weedicides (when used in conjunction with crops

protected against weedicides through genetic modification), which is currently

excluded from the Protocol, was an absolute necessity. There were also other external

factors such as health effects that needed to be included in the risk assessment.

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Questions like whether the whole plant or the just the genetically modified protein

should be subjected to assessment needed examination. “It is not good enough to just

test it like a chemical.” Impact of GM crops on traditional farming, farmers’ incomes

and welfare, cultural practices, community well being, traditional crops and varieties,

rural employment, indigenous peoples, food security, trade etc should also be

considered to attain a holistic approach of risk assessment.29

10. The NBRA must include a stringent provision for liability and redress. The Swiss

Gene Technology Law has a legal framework which provides for strict conditions for

the release of GMOs and a strong liability regime. Austria’s Law of Genetic

Engineering, Finland’s Gene Technology Act, 1995, the German Genetic Engineering

Act, the Gene Technology Act, 1993 of Norway are other examples of legislation

which have provided for a domestic liability and redress regime.

GM promise is a fool’s paradise30

According to a report by eminent scientists comprising the Independent Science Panel, “The

consistent finding from independent research and on-farm surveys since 1999 is that GM

crops have failed to deliver the promised benefits of significantly increasing yields or

reducing herbicide and pesticide use. GM crops have cost the United States an estimated $12

billion in farm subsidies, lost sales and product recalls due to transgenic contamination...The

instability of transgenic lines has plagued the industry from the beginning, and this may be

responsible for a string of major crop failures.”

“Till date, there are only four major commercialised GM crops (soya, maize/corn, cotton and

canola/oilseed rape) most of which (soya, corn, canola) are used primarily as animal feed. All

29 ‘Consider socio-economic factors for GM crops assessment’by Roy Mathew

wwww.thehindu.com/sci-tech/science/consider-socioeconomic-fact/

30 Traditional breeding outperforms genetic engineering

Bharat Dogra, http://www.thehindu.com/sci-tech/agriculture/traditional-breeding-outp...

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were commercialised in the late 1990s. Since then, no other commercially viable GM crop

application has made it to market, especially due to farmers not accepting other GM crops

(such as wheat, potatoes, and rice) for negative economic reasons (lack of buyers, loss of

export markets).”

“...The basic problem is that GM as employed in agriculture is conceptually flawed, crude,

imprecise and poorly controlled technology, that is incapable of generating plants that contain

the required multiple, co-ordinately regulated genes that work in an integrated way to respond

to environmental challenges.”

There are some unique risks involved in GM technology and these are related to food

security, farming systems and bio-safety impacts which are ultimately irreversible these risks

are severe because once GM will introduced in fields they will affect all existing crops the

effect of this is irrevocable. The GM transformation process is highly mutagenic leading to

disruptions to host plant genetic structure and function, which in turn leads to disturbances in

the biochemistry of the plant. This can lead to novel toxin and allergen production as well as

reduced/altered nutrition quality.

In Gujarat, while yields of Bt cotton increased for some years, this was mainly due to the

impact of good weather, improvement in water conservation and irrigation as well as more

facilities provided for Bt crops. In the very first year of Bt cotton's commercial cultivation in

India (2002-03), Andhra Pradesh’s Agriculture Department concluded a study on 3,709

farmers growing Bt cotton. As many as 71 per cent of them reported low yields with Bt

cotton.

In Madhya Pradesh, the average yield of cotton between 1996-2002 (before the introduction

of Bt cotton) was 612.7 kg/ha. However, in the six years after the introduction of Bt cotton,

average cotton yield was reduced to 518.3 kg/ha. Above all, it needs to be emphasised that

any claim of a possible rise in yield of a crop can turn out to be entirely baseless if the safety

of the crop is not assured.

The Independent Science Panel have said in its conclusion after examining all aspects of GM

crops: “GM crops have failed to deliver the promised benefits and are posing escalating

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problems on the farm. Transgenic contamination is now widely acknowledged to be

unavoidable, and hence there can be no co-existence of GM and non-GM agriculture. Most

important of all, GM crops have not been proven safe. On the contrary, sufficient evidence

has emerged to raise serious safety concerns, which if ignored, could result in irreversible

damage to health and the environment. GM crops should be firmly rejected now.”

Conclusion

While BT Cotton is currently the only GM crop grown in India on a large-scale, there are 56

GM crops under trial. The new BRAI body will be more of a promoter of these crops than a

regulator. We cannot risk another GM crop disaster in a country where over 50% of the

population relies on agriculture. India is often touted as the world’s largest democracy. If this

is true in practice, the BRAI Bill should be scrapped immediately. At the same time its not

understandable that when the United States can have a three-window regulatory system in

place for GM crops (although not perfect) why does India have to rush through with a single-

window clearance house?

Further, the BRAI setup will replace the current regulatory regime which is governed by the

Environment Protection Act’s 1989 Rules to protect health, environment and nature from

risks of biotechnology. This protective attitude should also be adopted in the BRAI Act and

the Ministry of Environment and Forests and the Ministry of Health and Family Welfare

should be the nodal agency in regulatory biotechnology. In addition, several committees are

envisioned in the bill but all of them have been accorded advisory role with the five-member

panel being supreme.

This will be a scary situation in which the promoter himself becomes the regulator,

prosecutor and the judge. This is the recipe for a corrupt autocratic system. It will have

disastrous consequences for Indian Agriculture, which still relies heavily on traditional

technologies. It will take the control of food from the farmer and give it to multinational

corporations, who will enslave our agriculture. Given the growing concern in the country

about the impact of GM crops to our health, our farmer’s 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.

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When Science and Polity become handmaids of Commerce - and unsuspecting citizens

become choice less guinea pigs - Quo Vadis?

Hence to conclude, it is an ominous piece of legislation and should be vociferously opposed

on all counts. It is brazen, undemocratic, anti-human rights and unconstitutional and if passed

would be a blot on Indian democracy and fraud on the people of this country.

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Bibliography

Books Referred

“EU Biotechnology Law & Practice: Regulating Genetically Modified & Novel Food

Products” Published by Brian Sheridan published by Palladian Law Pub., 2001

“Governing the Transatlantic Conflict over Agricultural Biotechnology by Joseph

Murphy and Les levidow” Published by Taylor & Francis

Documents referred

Report No. 37 of Committee on Agriculture of 15th

Lok Sabha, Ministry of

Agriculture (Department of Agriculture and Cooperation) on the topic of “Cultivation

of Genetically Modified Food Crops – Prospects and Effects”.

Policy brief for Parliamentarians the biotechnology regulatory Authhority of india

(BRAI) Bill 2013: A threat to our food and farming published by Centre for

legislative Research and advocacy ,Greenpeace policy brief series no. 19, 2013 June –

august

GMO Regulations, International Trade and the Imperialism of Standards by Mauro

Vigani, Valentina Raimondi and Alessandro Olper.

“Nip this in the bud” by Aruna Rodrigues published in The Hindu

Bt Cotton or Better Cotton? By Kunal Datt, published by Centre for Civil society

Status of GM crops in India: Research and Regulatory System by S.R. Rao , Advisor

Department of Biotechnology Ministry of Science and Technology Government of

India

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“Operationalizing the Regulation of Genetically Modified Foods in India” by Food

Safety and Standards Authority of India , FDA Bhawan, Kotla Road, New Delhi-110

002

Websites Referred

‘Consider socio-economic factors for GM crops assessment’by Roy Mathew

wwww.thehindu.com/sci-tech/science/consider-socioeconomic-fact/

‘Developing nations lack biosafety norms to test GM crops’

www.thehindu.com/sci-tech/energy-and-environment/developing-n

‘Genetically modified crops no panacea for food security’, interview of basudev

Acharia, http://www.thehindu.com/opinion/interview/genetically-modified-crops...

“Put a stop to GM crop field trials for 10 years” By J. Venkatesan,

http://www.thehindu.com/todays-paper/tp-national/put-a-stop-to-gm-cro...

A wise decision: Swaminathan By Gargi Parsai,

http://www.thehindu.com/news/national/a-wise-decision-swaminathan/a...

Accept expert panel report on GM crops: forum by Gargi Parsai,

http://www.thehindu.com/news/national/accept-expert-panel-report-on...

Bt Brinjal poses a risk to health, environment: Greenpeace report,

http://www.thehindu.com/sci-tech/energy-and-environment/bt-brinjal-p...

Bt Brinjal: Note by Ministry of Environment and Forests: Ministry of

Environment and Forests Decision on Commercialisation of Bt-Brinjal,

http://www.thehindu.com/news/national/bt-brinjal-note-by-ministry-of-...

Centre opposes moratorium on GM field trials By J. Venkatesan,

http://www.thehindu.com/news/national/centre-opposes-moratorium-o...

Global scientists back 10-year moratorium on field trials of Bt food crops by

Gargi Parsai, http://www.thehindu.com/sci-tech/agriculture/global-scientists-back-10...

GM crops are no way forward by Satyarat Chaturvedi,

http://www.thehindu.com/opinion/lead/gm-crops-are-no-way-forward/a...

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GM crops should go back to the lab by Devinder Sharma,

http://www.thehindu.com/opinion/op-ed/gm-crops-should-go-back-to-th...

Nip this in the bud By Aruna Rodrigues,

http://www.thehindu.com/opinion/lead/nip-this-in-the-bud/article50129...

Scientists and farmers groups write to Supreme Court on TEC report on GM

crops, http://www.thehindu.com/news/national/scientists-and-farmers-groups-...

Stop Bt. Brinjal, farmer leaders urge Manmohan

Gargi Parsai, http://www.thehindu.com/news/national/stop-bt-brinjal-farmer-leaders-...

“BRAI sparks cry”

http://mla.prsindia.org/media/articles-citing-prs/brai-sparks-cry-2071/

Traditional breeding outperforms genetic engineering

Bharat Dogra, http://www.thehindu.com/sci-tech/agriculture/traditional-breeding-outp...