WHAT’S WRONG WITH THE BRAI BILL 2013?
(Bill copy at: http://www.prsindia.org/billtrack/the-biotechnology-regulatory-authority-of-india-bill-2013-
2709/; Detailed critique at: http://indiagminfo.org/?page_id=82 and Legal assessment available at: http://
www.greenpeace.org/india/Global/india/report/BRAI-Critique-Report.pdf)
1. PROMOTION CANNOT BE REGULATION: BRAI Bill makes promotion of modern biotechnology as its objective (“A bill to promote the safe use of modern biotechnology…..”). For promoting modern biotechnology, there are already policies and schemes in place and this does not need a regulatory statute. Regulation of modern biotechnology is necessary because it poses risks to environment and health; ‘Biosafety protection’ should therefore be the central function of regulation, which is not the case with BRAI Bill. The existing regulatory regime through EPA 1989 Rules have biosafety protection as the basis for regulation. There is no reason why BRAI Bill should be otherwise.
2. WRONG MINISTRY TABLING THE BILL & HOUSING THE AUTHORITY: The BRAI Bill preamble expressly refers to the UN Convention on Biological Diversity (CBD) and the Cartagena Protocol on Biosafety (2003) as reasons for the Bill being necessary. The nodal Ministry for the CBD is Ministry for Environment & Forests and it is not clear why the Ministry of S&T has tabled the Bill. Further, the Ministry of Science & Technology is a promoter of modern biotechnology, spending crores of rupees for R&D in this field. Promoters cannot be regulators, as it constitutes an inherent conflict of interest.
3. EXPEDIENCY CLAUSE FOR UNION’S CONTROL UNJUSTIFIED: The constitutional authority of state governments over their Agriculture is violated through an Expediency Clause (‘2. Declaration as to expediency of control by Union’). Such an expediency clause is glaringly absent with other regulatory bills like Seeds Bill and Pesticides Management Bill in agri-sector and has no justification to be included here, esp. after the authority of state governments is being asserted in regulatory practice.
4. NARROW, CENTRALISED DECISION-MAKING BODY: India at present has a multi-ministerial, broadbased regulatory body called Genetic Engineering Appraisal Committee. At a time when Bt brinjal was approved by the regulators in October 2009, only to be later overturned by the Govt of India’s moratorium decision in February 2010 after obtaining scientific and other feedback on the matter, GEAC was a 31-member body. This is just to point out that even such a body went wrong in its decision. Against this backdrop, it is surprising that BRAI is being proposed as a narrow, centralized, 5-member decisionmaking body (3 full time and 2 part-time, at that!). The BRAI Bill further states that no proceeding shall be invalidated merely by reason of any vacancy in the Authority (Sec. 13), which means that just a couple of people can also end up taking decisions!
5. BYPASSING RTI ACT: Right to Information is sought to be bypassed by the BRAI Bill in the garb of Confidential Commercial Information (Sec. 28 (1)). Biosafety data cannot be confidential commercial information and Supreme Court Orders in a PIL related to GMOs have already set a precedent for this.
6. AGRI BIOTECH TASK FORCE RECOMMENDATION NEGLECTED: BRAI Bill does not conform to the bottomline for regulation recommended by the Task Force on Agricultural Biotechnology, whose report was accepted by the Government of India in 2004. This Task Force 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 systems, the health and nutrition security of consumers, safeguarding of home and external trade and the biosecurity of the nation”. BRAI Bill does not reflect this.
7. REGULATION NARROWED DOWN TO TECHNICAL PARAMETERS: The Biotechnology Regulatory Authority is being shaped only around a technical framework, that too in a narrow biosafety framework. Regulation of transgenics is however beyond the purview of biosafety too (trade security, intellectual property rights, rural livelihoods etc.). This once again is retrograde compared to the regulatory system today.
8. TOOTHLESS ENVIRONMENT APPRAISAL PANEL: Under Section 26 of BRAI Bill, an Environment Appraisal Panel is proposed, which is a mechanism brought in under pressure from the then Environment Minister. However, this has been rendered into a toothless body by Section 27 (4).
9. NO INDEPENDENT LONG TERM TESTING REGIME LAID DOWN: The BRAI Bill does not make independent, long term testing a mandatory part of regulation, despite the Bt brinjal moratorium decision resting on the need for such testing. Further, the BRAI Bill does not make biosafety testing precede open air trials, even though environmental release in such trials is essentially of unknown, uncharacterized organisms.
10. LACK OF DEMOCRATIC FUNCTIONING: The BRAI Bill does not have anything related to mandatory public consultations, though this is enshrined in the Cartagena Protocol to which India is a signatory.
11. GRAM SABHAS/BIODIVERSITY MANAGEMENT COMMITTEES FIND NO RECOGNITION: The BRAI Bill has no acknowledgement of constitutional authority of PRIs/Gram Sabhas over their natural resources, nor of BMCs under the Biological Diversity Act, in its decision-making mechanisms.
12. NO NEED ASSESSMENT OR ASSESSMENT OF ALTERNATIVES BUILT INTO REGULATION: The BRAI Bill has no provision for need assessment or assessment of alternatives to precede any processing of applications. Nor does it lay down any schedules for prohibiting GMOs in particular areas or particular kind of GMOs or even transgenic technology in particular crops. This is contrary to the recommendations of Agri Biotech Task Force which was accepted by the Government of India.
13.NO RISK MANAGEMENT PLANS: The BRAI Bill has no mechanisms for reviewing and revoking approvals. No risk management mechanisms are built into this proposed legislation.
14. WEAK PENAL CLAUSES: The BRAI Bill has no liability regime worth the name laid down.
15.APPEAL MECHANISMS PROBLEMATIC: The Appeal mechanisms are limiting while the potential problems are many.
WHAT DOES INDIA NEED INSTEAD?
India needs a Biosafety Protection Legislation. Any regulatory regime around GMOs should have the primary mandate of protecting health of people and the environment from the risks of modern biotechnology and should also realize that transgenic technology is being actively rejected by citizens and governments all over the world and is not a fait accompli. It should necessarily have the following components as cornerstones of the legislation:
• Precautionary Principle as the central guiding principle
• Going in for GM option only in case other alternatives are missing and only if proven safe, including in the long-term
• Separating out very clearly the phases of contained research and deliberate release and distinct regulatory mechanisms for both, in a sequential fashion
• No conflict of interest to be allowed anywhere in the regulation and decision-making
• Transparent functioning: information disclosure and public/independent scrutiny
• Democratic functioning including public participation.
• Risk assessment – (a) prescribing rigorous, scientific protocols and asking the crop developer to take up studies and then do independent analysis of the dossier supplied by the crop developer and evaluate/review of the same; (b) to also take up independent testing by having all facilities and institutional structures in place for the same and evaluating the results
• Risk management – including monitoring, reviewing, revoking of approvals
• Liability – including penal clauses, redressal and remediation; Liability Regime to cover both crop developers and regulators
• Labeling regime for informed choices covering traceability requirements, including for imports
• Oversight and appellate mechanisms that are simple, affordable and accessible by affected parties and ones who can approach in public interest, without time limit set
• Given India’s federal structure with Agriculture as a state subject, special clauses to allow state governments to form their own regulatory systems and mechanisms; similarly, protection of the constitutional authority of Gram Sabhas over their natural resourcesThe recommendation that India needs a Biosafety Protection Authority and not a BRAI was already made by the Parliamentary Standing Committee on Agriculture in a unanimous report that it tabled in August 2012 on GM crops, after a detailed study of the current regulatory regime as well as regulatory structures in other countries and the BRAI Bill 2011 version.
WE REQUEST THE S&T STANDING COMMITTEE TO ALSO RECOMMEND THAT THE BRAI BILL BE WITHDRAWN, TO BE REPLACED BY A BIOSAFETY PROTECTION BILL, TO BE BROUGHT IN BY THE MINISTRY OF ENVIRONMENT & FORESTS.