Rohit Legislative Drafting FD

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 I ndia 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.


2
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 fools paradise

Conclusion

Bibliography


3

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


4
Abstract
Indias 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
governments 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.


5
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 governments domain. It doesnt 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.

6
(6) State governments 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.


7
Introduction
One of the biggest concerns of 21st century is the constant growth of the corporate power.
Indias 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
governments 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.


8
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 Monsantos 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...


9
(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 farmers
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


10
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
th
Effects.


11
(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. Indias 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 TECs 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
no-way-forward/a...


12
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
BRAI
11
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 controversy
12
in the nation, which has steered a nationwide
public debate over the safety and viability of Genetically Modified
13
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 crops
14
, 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
11
Biotechnology Regulatory Authority of India
12
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.
13
Genetically 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

13
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 governments 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


14
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 doesnt 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


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 Manipulation (RCGM) of the DBT and the Genetic Engineering Approval
Committee
18
(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
th
Effects.


16
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

17
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 7
th
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
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

18
Government and will gain exclusive control over item
24
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


19

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 ones 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 ACT
25
: 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 ACT
26
: 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.
26
Food Safety and Standards Act, 2006


20
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.

21
(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 doesnt 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

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
food
27
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
Protocol
28
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

23
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.


24

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 Indias
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.

25
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. Austrias Law of Genetic
Engineering, Finlands 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 fools paradise
30

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 assessmentby 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...


26
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 Pradeshs 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

27
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 worlds 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 Acts 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 farmers livelihoods and food and seed
sovereignty, it is high time that the government recognises it. Instead of coming up with such
cantankerous legislations as the BRAI Bill to promote risky technologies like genetic
modification, it should go after real solutions that are economically, socially and
environmentally sustainable.

28
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.


29
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
th
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


30
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 assessmentby 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...


31
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...

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