DR.

RAM MANOHAR LOHIYA NATIONAL LAW UNIVERSITY

LUCKNOW

LEGISLATIVE DRAFTING (SEMINAR)

FINAL DRAFT

ON:

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

SUBMITTED TO: SUBMITTED BY :

Dr. SHASHANK SHEKHAR SAURAV SINGH

ASSISTANT PROFESSOR B.A.LL.B. (B) X SEM.

Dr. RMLNLU Enroll- 150101119

1
 ACKNOWLEDGEMENT

A major research project like this is never the work of anyone alone. Firstly, I would like to

thank respected Asst. Professor SHASHANK SHEKHAR SIR, for giving me such a golden

opportunity to show my skills and capability through this project.

This project is the result of the extensive ultrapure study, hard work and labour, put into to make

it worth reading. This project has been completed through the generous co-operation of various

persons, especially my seniors, who, in their different potentials helped me a lot in giving the

finishing touch to the project.

This project couldn’t be completed without the help of my university’s library Dr. Madhu

Limaye Library and its internet facility.

‘I am glad to have made it’

Thanking You........

2
 TABLE OF CONTENTS

a) ABSTRACT
b) AIM OF THE PROJECT
c) HYPOTHESIS
d) SCOPE OF RESEARCH
e) NATURE OF RESEARCH
f) LIMITATIONS OF RESEARCH
g) INTRODUCTION
h) ISSUES INVOLVED WITH THE GM CROPS
i) SOME DISCONCERTING FEATURES OF THE BRAI BILL
j) FLAWS IN THE BRAI BILL
k) NEED OF A LIABILITY PROVISION IN THE BRAI BILL
l) CRITICAL ANALYSIS OF CONFLICTING/CONTRADICTING PROVISIONS OF THE BRAI
BILL
m) SUGGESTIONS FOR AMENDMENTS IN THE PROPOSED BRAI BILL
n) GM PROMISE IS A FOOL’S PARADISE
o) CONCLUSION

3
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.

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.

 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?

4
(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.
(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.

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

5
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 could 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.

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
(ii) Threat to livestock of farmers

1
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”.
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...

6
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 Btcotton 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 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

4
GM crops are no way forward by Satyarat Chaturvedi, http://www.thehindu.com/opinion/lead/gm-crops-areno-
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
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
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
(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

SOME DISCONCERTING FEATURES OF THE BRAI BILL

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”.
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-areno-
way-forward/a...

8
“... 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
 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 BRAI 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.
 In the wake of the BT Brinjal controversy11 in the nation, which has steered a nationwide public
debate over the safety and viability of Genetically Modified 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.
 It is pertinent to be noted that significant investment has already been made by private and public
organisations in developing BT crops12, 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 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.13
 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.
 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

10
Alex Carey; Australian social scientist, quoted by Noam Chomsky in World Orders: Old and New
11
After 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
12
Crops cultivated using biotechnological methods
13
“BRAI sparks cry” http://mla.prsindia.org/media/articles-citing-prs/brai-sparks-cry-2071/

9
 transparency of governance in the first place, and prevents consumers from accessing
information about the safety of these new crops. 14
 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 companies will be further strengthened if the draft
Biotechnology Regulatory Authority of India (BRAI) Act is passed by the Parliament in its
present form.
 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.15
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

14
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
15
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

10
Manipulation (RCGM) of the DBT and the Genetic Engineering Approval Committee 16 (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. 17
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 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. 18

16
8Set up under the Environment Protection Act. Presently, it is the apex committee under Ministry of Environment
Forest for approval of GMOs & products thereof.
17
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”.
18
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”.

11
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 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. 19
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.” 20

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.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 Government and will gain exclusive control over item 21 specified in list II of
19
GM crops are no way forward by Satyarat Chaturvedi, http://www.thehindu.com/opinion/lead/gm-crops-areno-
way-forward/a...
20
A wise decision: Swaminathan By Gargi Parsai, http://www.thehindu.com/news/national/a-wise-decision-
swaminathan/a..
21
Item 14; Agriculture, including agricultural education and research, protection against pests and prevention of
plant diseases

12
 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.

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 81 of 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 ACT22 : 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

22
The Drugs and Cosmetics Act, 1940.

13
 matter or thing connected with it to which are covered under the Biotechnology Regulatory
Authority of India Act, 2013.”

FOOD SAFETY ACT23: 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 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.
(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, -

23
Food Safety and Standards Act, 2006

14
 (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 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 food24 will be put behind bars but a person who
conceals information about its ill effects and hazards gets immunity.

24
Section 63 of the Draft bill

15
 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 Protocol 25 to which India
is a signatory. The BRAI 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. 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.

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.

25
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 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.

16
 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.

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.26
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.

26
‘Consider socio-economic factors for GM crops assessment’by Roy Mathew wwww.thehindu.com/sci-
tech/science/consider-socioeconomic-fact/

17
GM PROMISE IS A FOOL’S PARADISE27
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 commercialized GM crops (soya, maize/corn, cotton and
canola/oilseed rape) most of which (soya, corn, canola) are used primarily as animal feed. All 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 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

27
Traditional breeding outperforms genetic engineering Bharat Dogra, http://www.thehindu.com/sci-
tech/agriculture/traditional-breeding-outp...

18
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 singlewindow 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.
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.

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

19
  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

 “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...

20
  GM crops are no way forward by Satyarat Chaturvedi,
http://www.thehindu.com/opinion/lead/gm-crops-are-no-way-forward/a...

 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...

------------------------------------------------------------------------------------------------------------------------------

21