REVIEWING THE

BRAI BILL 2012

“Wrong Bill by the wrong people, for the wrong reasons”

Dr. G. V. Ramanjaneyulu, Centre for Sustainable Agriculture

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).

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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

• 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.

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.

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 .

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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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