REVIEWING THEBRAI 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).
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
• 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 REGULATORYAUTHORITY 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 INTERESTThe BRAI Bill has been proposed by the Department ofBiotechnology (DBT) and will be located under theMinistry of Science and Technology which has a mandateto promote modern biotechnology and especially GMOs inthe country. In this situation the promoter ofbiotechnology will play a major role in constituting thesector regulator and also assisting in its functioning.
ROLE OF STATE GOVERNMENTSThe current BRAI Bill reduces the role of the State Governments to arecommendatory capacity in the form of the State BiotechnologyRegulatory Advisory Committee.In the 111th meeting, the GEAC had decided to give StateGovernments the decision making power in respect to GM crop foodtrials The GEAC/RCGM would issue the approval letter only onreceipt of NOC from the State Department of Agriculture. Howeverthe BRAI Bill does not give any power to the State Governments toreject the introduction of any GMOs.
INADEQUACIES IN THE COMPOSITION OF STATUTORY COMMITTEES/COUNCILSThe qualifications of persons who can be appointed asmembers of the proposed BRAI are limited and exclude thoserepresenting social sciences, anthropology, public health,economics etc.
INDEPENDENT LONG-TERM ASSESSMENT OFBIOSAFETY OF GMOs MISSINGThe BRAI Bill does not provide for independent long termassessments, in fact it allows the applicant to undertake thebiosafety assessments itself which would then be reviewedby suspect in such a scenario as the applicant is aninterested party.
NEED ASSESSMENT OF A PRODUCT MISSINGThe procedure for authorization for research, transport,import, manufacture or use of GM products is missing a verycritical step- an assessment of the very need of the specificGMO and whether it will be an additional benefit to thesociety and whether other ecologically socially andeconomically sustainable alternatives exist.
LIMITED DISCLOSURE OF INFORMATIONThe BRAI Bill has provisions to curtail the applicationof the RTI Act, 2005. The bill leaves the decision onwhether any information including those critical oneslike the bio-safety assessment data should be given topublic to the authority. This could lead to nontransparent system as in the case of Bt Brinjal approvalprocess.
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 MECHANISMThe BRAI Bill proposes the setting up of a BiotechnologyRegulatory Appellate Tribunal (BRAT). Any person aggrievedby a decision/ order or directions of the BRAI may file anappeal in the Tribunal. A pertinent question arises as towhether there is actually a need for a separate AppellateTribunal for Biotechnology at all, given the fact that theNational Green Tribunal is functional and has a widejurisdiction.
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 Indiadecides to table the BRAI Bill in the Parliament,there is a rigorous public debate andengagement with all stakeholders to suitablyamend 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
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