[Bill] The Biotechnology Regulatory Authority of India Bill

[Ranjith]

The Biotechnology Regulatory Authority of India Bill, 2013:

It was introduced in the Lok Sabha on April 23, 2013 by the Minister for Science and Technology, Mr. S. Jaipal Reddy.  The Bill aims to promote the safe use of modern biotechnology by enhancing the effectiveness and efficiency of regulatory procedures.  Biotechnology Regulatory Authority: The Bill establishes the Biotechnology Regulatory Authority of India.  It will consist of a chairperson, two full time members, and two part time members. Functions of the Authority: The functions of the Authority shall include regulating the research, transport, import, containment, environmental release, manufacture and use of organisms and products of modern biotechnology.  The Authority has the power to call for information, conduct an inquiry and issue directions for the safety of products or processes of modern biotechnology. Field trials for certain organisms or products cannot be conducted unless the Authority permits them as aiding the development of modern biotechnology such as genetically engineered plants, animals used in food or any animal clones that can be applied in agriculture, fisheries or food products.  It will not apply to the clinical trials of drugs, under the Drugs and Cosmetics Act, 1940, and food or food additives or any material under the Food Safety and Standards Act, 2006.   The Authority will not disclose confidential commercial information made available in an application to the Authority.  However, the Authority may disclose it in public interest or if this disclosure will not harm any person. Divisions under the Authority: Regulatory divisions of the Authority have been created for the implementation of safety assessment procedures and processes.  The divisions are: (i) agriculture, forest and fisheries, (ii) human health and veterinary products, and (iii) industrial and environmental applications.  A Risk Assessment Unit will appraise applications for proposed research, transport or import of an organism or product, before final approval is granted.  The Product Rulings Committee will make recommendations to the Authority for the manufacture or use of organisms or products.  The Environmental Appraisal Panel will make recommendations on environmental safety of organisms and products.  Other bodies: An Inter-Ministerial Governance Board has been established to promote inter-ministerial or departmental co-operation for the effective discharge of the functions of the Authority. A Biotechnology Advisory Council will render strategic advice to the Authority regarding developments in modern biotechnology and their implications in India.  State level body: A State Biotechnology Regulatory Advisory Committee will act as a nodal agency between the state government and the Authority with regard to the regulation of modern biotechnology. Appellate Tribunal: A Biotechnology Regulatory Appellate Tribunal will hear appeals against the decisions, orders or directions of the Authority.  The Tribunal will consist of a full-time chairperson, who has been a judge of the Supreme Court of India or a Chief Justice of a High Court, and five part time expert members. Penalties under the Bill: The Bill imposes a penalty for providing false information (imprisonment for three months and fine extending to Rs five lakh) and conducting an unapproved field trial (imprisonment for six months to one year and a fine extending to Rs two lakh).

CONFLICT OF INTEREST

• The BRAI Bill is seen as a quick one-stop clearing house to benefit GM corporations as a committee of just five scientists will be empowered to clear their patented technology for use in the whole country, contrary to the unanimous concerns of the Parliamentary Standing Committee on Agriculture(PSCA) and the well-reasoned, science-based recommendations of the Technical Expert Committee(TEC) appointed by SC.
• The Bill has a mandate to promote biotechnology in the country. The PSCA as well as the TEC state explicitly the need to remove conflict of interest from the regulatory body.
• The TEC recommends that the regulatory body be located in the MoEF and the Ministry of Health and Family Welfare. The BRAI under the MoST will clearly result in a conflict of interest.
• Recently, the Coalition for a GM-Free India published a book containing abstracts of more than 400 scientific studies detailing the adverse impacts of GM crops on health and environment.

 

LIABILITY AND REDRESSAL

• While the Bill specifies offences and penalties, there is a need to integrate the principle of ‘absolute liability’ and the ‘polluters pay principle’, as penalties laid down are too weak to deter violations. A special legislation needs to be enacted in respect of liability and redress for damage from GMOs.
• One of the reasons for the moratorium on Bt brinjal in 2010 was opposition from 10 State governments. Under the Constitution, agriculture is a state subject. However the Bill seeks to override the authority of State governments.
• The BRAI Bill also goes against the 73^rd  and 74^th  amendment which focus on decentralisation of power and responsibilities to panchayats so as “to enable them to function as institutions of self-government”.
• The 11th Schedule (Article 243G) as introduced by the amendment, gives a detailed list of functions to be performed by PRIs. The very first point specifies ‘Agriculture, including agricultural extension’. The BRAI bypasses them, violating the letter and spirit of the Constitution.
• It is thus evident that the BRAI Bill is regressive in nature, and falls short on a number of fronts. It neither conforms to international agreements and protocols, nor does it include fundamentally important recommendations made by the TEC and the PSCA.x
• For this reason the Bill needs to be withdrawn, and an all-encompassing bio-safety legislation needs to be drawn up.

 

 

Reference:

http://www.prsindia.org/billtrack/the-biotechnology-regulatory-authority-of-india-bill-2013-2709/

http://www.thehindubusinessline.com/opinion/no-brai-bill-please/article5052683.ece