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Thursday, January 5, 2012

Biotechnology Regulatory Authority of India Bill: Unconstitutional, unethical, unscientific

http://www.thehindu.com/opinion/lead/article2752711.ece?homepage=true

December 28, 2011
Unconstitutional, unethical, unscientific
Pushpa M. Bhargava

The Biotechnology Regulatory Authority of India Bill, if passed, will
adversely affect agriculture, health of humans and animals, and the
environment, causing unparalleled harm.

It is now widely accepted that the existing procedure in India (and
even elsewhere) for regulation of genetic engineering technology is
faulty and insufficient. It was for this reason that Jairam Ramesh,
then Minister for Environment and Forests, put an indefinite
moratorium on the open release of genetically engineered Bt brinjal,
which was approved by the Genetic Engineering Approval Committee of
the Ministry on October 14, 2009.

The Biotechnology Regulatory Authority of India (BRAI) Bill, proposed
to be put up to Parliament, claims to take care of the deficiencies in
the existing system of approval of genetically modified (GM) crops. As
it turns out, the Bill is unconstitutional, unethical, unscientific,
self-contradictory, and not people-oriented. It suffers from greater
flaws and deficiencies than the present system. If passed, it will
seriously and adversely affect agriculture, health of humans and
animals, and the environment, causing unparalleled harm.

BRAI will consist of three full-time and two part-time members. It
will have three divisions, each headed by a Chief Regulatory Officer.
It will be supported by a Risk Assessment Unit, an Enforcement Unit, a
Monitoring Office, a Product Ruling Committee, an Environmental
Appraisal Panel, Scientific Advisory Panels, an Inter-ministerial
Governing Board, a Biotechnology Advisory Council, and State
Biotechnology Regulatory Advisory Committees. These bodies would
consist mostly of bureaucrats who are likely to have little knowledge
of the highly complex issues that arise in today's biotechnology. No
civil society participation is proposed anywhere. Even the proposed
Biotechnology Regulatory Appellate Tribunal will not accept complaints
from civil society, in spite of the fact that the Bill directly or
indirectly affects every citizen. It is not even clear which
department of the Government of India will service BRAI. The Convener
of the Selection Committee for members of BRAI will be from the
Department of Biotechnology (DBT), which is a vendor of genetic
engineering (the technology that BRAI is supposed to regulate) in the
country. The Bill says the members of BRAI will be persons of
integrity. There is, however, no requirement of integrity for members
of any of the other committees mentioned above!

The Bill is unconstitutional as agriculture is a State subject, and it
takes away from the State government the authority to take decisions
on GM plant products. In this connection, it is noteworthy that more
than 10 States cutting across political affiliations formally told Mr.
Ramesh in 2009-2010 that they would not permit Bt brinjal to be
released in their territories.

No public consultation

Article 28 of the Bill states the information declared by BRAI
"confidential commercial information" will not come under the RTI Act,
and there is no way civil society can challenge its decision to
declare any information confidential. In spite of the fact that BRAI
encompasses activities that would virtually affect every Indian, there
is no mention in the Bill of public consultation.

Articles 81, 86 and 87.2, which allow BRAI to override any existing
law in the areas covered by BRAI, contradict Article 86, which says
"the provisions [of BRAI] shall be in addition to, and not in
derogation of, any other law for the time being in force."

The definition of modern biotechnology in Article 3 (r) is absurd as
it excludes a large number (over 25) of areas such as peptide
synthesis, immuno-technology, tissue culture, stem cells and
nano-biotechnology that are an integral part of today's biotechnology.
Not only that, it would make techniques that are used in everyday
research in modern biology such as isolation or sequencing of DNA and
the PCR technique illegal, unless approved by BRAI in every specific
case. So every university in the country teaching these extremely
widely used techniques will have to get BRAI permission for teaching
them to undergraduate and postgraduate students.

Funnier is the inclusion in Schedule I (which lists organisms and
products "which should be regulated by the Authority") of cloned
animals, DNA vaccines, and stem cell-based products. There is no
mention of them in the main text of the Bill. Schedule 1 also includes
"products of synthetic biology for human or animal use." I have been
in the business of modern biology for six decades and seen the modern
biological evolution from very close quarters with more than 20 of my
friends having won Nobel prizes but, for the life of me, I cannot make
out what is meant by "products of synthetic biology."

In fact, if one strictly followed item 2(d) of Schedule 1, no organ
transplantation would be possible in the country without BRAI
permission!

One would also have expected that the Bill, if it was people-oriented,
to state the procedure to be adopted before approval of a GM product.
The first step should be to determine the need for the product through
a socio-economic survey and analysis. If there is need, then one
should determine if there are cheaper, better and well-established
alternatives such as smart or molecular breeding, organic agriculture,
or use of Integrated Pest Management or bio-pesticides in the case of
GM products containing a foreign pesticidal gene. If it is concluded
that there is no alternative to, say, a GM crop, one would need to
state a mechanism for deciding what tests the GM crop would need to
undergo, and a statement of who will do the tests to ensure public
credibility. There is no provision in the Bill for an independent
testing laboratory for GM crops, in which civil society would have
confidence.

No mention of mandatory labelling

There is no mention of mandatory labelling of GM food products, and
there is no protection provided to, say, farmers whose fields growing,
for example products of organic agriculture, get contaminated with a
GM product of the neighbouring farm.

Article 62 under "Offences and Penalties" is unprecedented. It implies
that anyone making a statement about a GM crop which BRAI decides is
false or misleading, shall be punished with imprisonment for a term
which may extend up to three months and also with a fine which may
extend to Rs. 5 lakh. BRAI will not be obliged to state the basis of
its decision which is not challengeable by any member of civil
society. The Bill thus assumes that all the wisdom of biotechnology
lies with the five members of the Authority, and what thousands of
leading scientists say will cut no ice with the members of BRAI.

One may justifiably ask why this Bill. The reasons are clear. Food
business is the biggest in the world. Whosoever controls it will
control the world. To control food production, one needs to control
just seed and agrochemicals production. This is what a handful of
multinational seed companies, which are also producers of
agrochemicals such as pesticides and weedicides, are attempting to do
through patented GM crops. These companies are located in the United
States, and liaise closely with the U.S. government.

In fact, one of the biggest quarrels between the U.S. and Europe is
that Europe, by and large, does not allow GM crops and requires
appropriate labelling of all food products that contain more than 0.9
per cent of GM material. No such labelling is required in the U.S.
where, therefore, a person today does not know if he is consuming GM
food.

Till a few years ago, there was no significant opposition to GM crops
in India. In fact, the mechanism set up by the Government of India,
ostensibly to regulate GM products, largely worked as a vendor of GM
products, serving the interests of seed and agrochemical MNCs.

But, then, people of India became wiser and better-informed.
Consequently, against all odds and expectations of the MNCs, and of
the U.S. government and the rulers in India, we had an indefinite
moratorium on Bt brinjal, and the opposition to GM crops became a
force to reckon with. Some components of the existing regulatory
system have also begun to assert themselves. As of today, at least
five States (Bihar, Madhya Pradesh, Kerala, Karnataka and Himachal
Pradesh) have formally declared that they will not allow field trials
and/or open release of any GM crop. So, the present system had to be
disabled, and roadblocks to fulfilling the ambition of the U.S. and
the seed MNCs removed. What better way to achieve this than by BRAI —
so the government thought. But, I believe, the GoI has again
underestimated the collective wisdom of the people of India!

(Pushpa M. Bhargava is former Vice-Chairman, National Knowledge Commission.)

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