1. REVIEWING THE
BRAI BILL 2012
“Wrong Bill by the wrong people, for the wrong reasons”
Dr. G. V. Ramanjaneyulu, Centre for Sustainable Agriculture

2. DEBATE AROUND GENETICALLY MODIFIED (GM)
CROPS
• GM technology is fraught with imprecision and unpredictability.
• A living technology which released into the environment is
uncontrollable and unreliable.
• It is a controversial technology whose safety is not yet established
conclusively and there is growing scientific evidence on the lack of
safety.
• A majority of countries around the world have not opted for this
technology, more than 16 years after the introduction of the first GM
crop , nearly 75% of the cultivation happens in 3 countries (USA, Brasil
and Argentina).

3. THREATS OF GM CROPS IN THE INDIAN SCENARIO
• Seed Sovereignty: GM crops are patented products and hence would lead to
the control of seeds and our agriculture by a select few multinational
companies.
• Loss in Bio- diversity: The introduction of GMOs in our agriculture
encourages mono cropping and destroys agro diversity and also impacts the
environment by destroying plant and animal diversity
• The loss of seed sovereignty and agro diversity by GM crops will effect
the food security of India
06/07/12

4. • BT COTTON: This is the only commercialised GM crop in India. This has been
controversial since its introduction due to its potential to impact the liveilhood
of our farmers our seed sovereignty and our agro ecosystems. After a decade of
Bt cotton the claims of reduced use of pesticide and increase in yield and
improve farmers livelihoods have been proven false, especially in states like
Maharashtra.
• BT BRINJAL: When the current regulatory system approved the first GM food
crop, Bt Brinjal, the nation saw massive opposition across sections of society due
to the potential harm to health, biodiversity, corporate control of our seed and
agriculture. Taking into account these varied concerns, the then Min of Env &
Forests put Bt Brinjal under an indefinite moratorium.
• The debate which is happening across the world is grounded on the
various scientific studies which points at the potential harm to health
and environment from environmental release of GM crops.

5. NEED FOR REGULATING GM CROPS
• There is an inherent risk involved in modern biotechnology and its
products, the regulatory system should be to safeguard the health of
the citizens, the environment and consider the various social,
economic and cultural aspects.
• In India, unlike in many countries, there is no express statutory
regulatory regime governing the regulation of transgenics.
• In India, the Environment Protection Act’s 1989 Rules govern the
regulation as of today. And as it was seen with the Bt Brinjal debate
they are infamous for their lack of independence and scientificity.

6. BACKGROUND ON THE PROPOSED BIOTECHNOLOGY REGULATORY
AUTHORITY OF INDIA (BRAI) BILL 2012
• In 2003-04 the task force set up by Min of Agriculture headed by Dr MS
Swaminathan recommended an independent regulatory authority. They
recommended that the bottom line for any biotechnology regulatory policy
should be the safety of the environment, the well being of farming families, the
ecological and economic sustainability of farming families, the health and nutrition
security of consumers, safeguarding of home and external trade and the biosecurity
of the nation.
• In 2008, the Dept of Biotech floated the National Biotechnology Regulatory
Authority (NBRA) bill for the first time and it was severely criticised and objected
to when they held public consultations.
• Another version this time called BRAI was created in 2009 and leaked in media in
March 2010- there was again opposition to the Bill.
• After the debate in 2010, no other version of the BRAI Bill was available for public
debate and suddenly in the Monsoon Session of 2011 it surfaced, the government
tried to introduce the Bill in Parliament both in monsoon and winter session of
2011 and budget session of 2012 but failed due to continuing opposition inside and
outside the parliament .

7. CRITIQUE OF THE BRAI BILL 2012
• The main reason why the BRAI Bill is controversial is due to its proposal
to create a single window regulatory system which is unscientific,
undemocratic, non-transparent, and centralised, that will lower the bar
for approval of GMOs in the country.
• A close analysis of the Bill reveals that there is an urgent need to
question several aspects of the Bill and to reconsider the mechanism
proposed.
• Bill drafted to meet India’s international obligations under the
Convention on Biological Diversity 1992 and the Cartagena Protocol
on Biosafety 2000, and Nagoya – Kuala Lumpur supplementary
protocol 2010 on Liability and redress and falls significantly short on
these accounts.
• It does not conform with several principles which form the core of
Indian and international environmental jurisprudence- absolute liability
for hazardous and dangerous activities, polluter pays principle,
precautionary principle and effective public participation

8. WEAK JUSTIFICATION FOR SETTING UP BRAI AND INTRODUCING THE BILL
• The Preamble to the Bill nor the Statement of Objects and Reasons
explain how the new authority would be better than the existing
regulatory system under the 1989 Rules.
• It does not acknowledge the concerns that have been raised with regard to
the 1989 Rules.
• India is under obligation to ensure that its domestic laws are in
compliance with the provisions of the Cartagena Protocol. The BRAI Bill
does not take a precautionary approach contained in Principle 15 of the
Rio Declaration on Environment and Development.
• The Bill takes a promotional approach to modern biotechnology and its
products

9. CONFLICT OF INTEREST
The BRAI Bill has been proposed by the Department of
Biotechnology (DBT) and will be located under the
Ministry of Science and Technology which has a mandate
to promote modern biotechnology and especially GMOs in
the country. In this situation the promoter of
biotechnology will play a major role in constituting the
sector regulator and also assisting in its functioning.

10. ROLE OF STATE GOVERNMENTS
The current BRAI Bill reduces the role of the State Governments to a
recommendatory capacity in the form of the State Biotechnology
Regulatory Advisory Committee.
In the 111th meeting, the GEAC had decided to give State
Governments the decision making power in respect to GM crop food
trials The GEAC/RCGM would issue the approval letter only on
receipt of NOC from the State Department of Agriculture. However
the BRAI Bill does not give any power to the State Governments to
reject the introduction of any GMOs.

11. INADEQUACIES IN THE COMPOSITION OF STATUTORY
COMMITTEES/COUNCILS
The qualifications of persons who can be appointed as
members of the proposed BRAI are limited and exclude those
representing social sciences, anthropology, public health,
economics etc.

12. INDEPENDENT LONG-TERM ASSESSMENT OF
BIOSAFETY OF GMOs MISSING
The BRAI Bill does not provide for independent long term
assessments, in fact it allows the applicant to undertake the
biosafety assessments itself which would then be reviewed
by suspect in such a scenario as the applicant is an
interested party.

13. NEED ASSESSMENT OF A PRODUCT MISSING
The procedure for authorization for research, transport,
import, manufacture or use of GM products is missing a very
critical step- an assessment of the very need of the specific
GMO and whether it will be an additional benefit to the
society and whether other ecologically socially and
economically sustainable alternatives exist.

14. LIMITED DISCLOSURE OF INFORMATION
The BRAI Bill has provisions to curtail the application
of the RTI Act, 2005. The bill leaves the decision on
whether any information including those critical ones
like the bio-safety assessment data should be given to
public to the authority. This could lead to non
transparent system as in the case of Bt Brinjal approval
process.

15. PARTICIPATION OF THE PUBLIC IN DECISION MAKING
CURTAILED
• The BRAI Bill provides for public participation in the decision making process at
only one stage- when an application for authorization for manufacture or use of
organisms and products specified under the Clause 27(5).
• It does not clearly state how these comments would be sorted and responded to
be before making any decision.
• The Bill does not provide any other opportunity to the public to raise its concerns
and to seek clarification.
• There is no provision for public participation/ seeking public comments before
authorization is given for conducting clinical trials or field trials which are also
environmental releases of GMOs. Since these open trials could lead to escape of
GMOs and potential contamination of our seeds, food and biodiversity public
opinion on this should be sought.

16. NEED FOR A NEW GRIEVANCE REDRESSAL MECHANISM
The BRAI Bill proposes the setting up of a Biotechnology
Regulatory Appellate Tribunal (BRAT). Any person aggrieved
by a decision/ order or directions of the BRAI may file an
appeal in the Tribunal. A pertinent question arises as to
whether there is actually a need for a separate Appellate
Tribunal for Biotechnology at all, given the fact that the
National Green Tribunal is functional and has a wide
jurisdiction.

17. DILUTED STANDARDS OF LIABILITY
• The penalty for providing inaccurate/ incorrect risk
assessment is not high enough to be effective deterrent.
• The BRAI Bill is not in conformity with the principle of
absolute liability.
• The Bill does not adopt the polluter pays principle. There is
no discretion granted to the deciding authority to grant
compensation for the harm caused and to direct payment of
costs for restoration of the environment.

18. It is crucial that before the Government of India
decides to table the BRAI Bill in the Parliament,
there is a rigorous public debate and
engagement with all stakeholders to suitably
amend the provisions of the Bill.

19. WHAT WE NEED………..
A Biosafety Protection statute, instead of the proposed BRAI
Bill, to instill confidence in all citizens about the intent of the
government. Such a statute should have as its cornerstones:
You need to elaborate on the cornerstones
• Long Term Biosafety Assessment of any new technology or
the products there of
• Need Assessment of the technology or the product there of
• Detterent Liability
• Transparency in processes of decision making
• Public Participation in decision making

20. NEED FOR REAL SOLUTIONS
• The government needs to stop promoting GM crops
which is a false solution, instead the real solution lies in
ecological farming for food security, livelihood security
and ecological sustainability.
• An example of ecological farming is Non Pesticidal
Management (NPM) practiced by millions of farmers in
Andhra Pradesh. This eco- friendly innovative approach
does not rely on the use of chemical pesticides or GM
crops.
• This initiative involved rediscovering traditional practices
and contemporary grass root innovations supplemented
by strong scientific analysis
06/07/12