[Sci-Tech] The Biotechnology Regulatory Authority of India Bill, 2013

The Biotechnology Regulatory Authority of India Bill, 2013

• Bill will set up an independent authority
• Authority will regulate products and processes of Biotechnology and certify that the product is safe
• Regulation
• Research
• Trails
• Manufacture
• Transport including import and export
• Use
• Bill doesn’t specify for any liability, the tribunal and the court will decide the liability
• Biotechnology
• Is about manipulation of genetic structure of organisms. This results in change in specific traits
• Ex: Bt Cotton which produces an insecticide that kills certain pests that eat it or production of synthetic insulin for human consumption
• Currently biotechnology is regulated by
• Ministry of Environment and Forests
• Department of Biotechnology under Ministry of Science and Technology
• Biotechnology is governed under the rules of The Environmental Protection Act 1986

How BRAI will work / the institutional setup?

• Field trials of the modified products (which could be organisms) will only be conducted after permission from BRAI
•  For a drug or vaccine with elements of biotechnology, the Central Drugs Standard Control Organisation (CDSCO) will forward the application to BRAI to assess whether it is safe to proceed with a clinical trial. Clinical trials will continue to be regulated by the CDSCO under the Drugs and Cosmetics Act, 1940.
• The Bill amends the Food Safety and Standards Act, 2006, which regulates the manufacture, import, sale and distribution of food items. The amendment mandates that food items with elements of biotechnology have to be approved by BRAI as safe for human consumption
• BRAI will not disclose confidential commercial information made available to it in an application for authorisation. This is regardless of anything contained in the Right to Information Act, 2005.
• BRAI will comprise of three units:
• Risk Assessment Unit (RAU): The RAU will undertake science - based safety assessments of the applications (applications seeking authorisation for research, transport, import, manufacture or use of products and organisms of biotechnology)
• Product Rulings Committee (PRC): the report of the RAU will be forwarded to the PRC and the PRC will make recommendations regarding the safety of the product or organism
• Environmental Appraisal Panel (EAP): BRAI may refer an application to the EAP, in case of products or organisms having an environmental impact
• BRAI will constitute an Enforcement Unit consisting of monitoring officers for enforcing its decisions
• the three regulatory divisions
• agriculture, forest and fisheries
• human health and veterinary products
• industrial and environmental applications
• Each of these will be headed by a Chief Regulatory Officer (CRO)
• Disputes will be heard at Biotechnology Regulatory Appellate Tribunal
• Tribunal will have civil jurisdiction
• Appeal against the tribunal will be made in Supreme Court
• Tribunal will consist of 1 judicial member and 5 technical members having expertise in Biotechnology

Biotechnology Regulation Present Scenario

• Biotechnology has its benefits and drawbacks
• Benefits of this technology include the introduction of characteristics such as drought resistance, pest resistance, or high iron content in a plant
• Risks include adverse impact on the health of organisms that consume these products, and the environment and biodiversity.
• Any regulatory structure for the sector will need to balance the benefits with the risks and ensure the safe use of biotechnology
• The Bill envisages an independent scientific risk assessment to be undertaken by experts in the field of biotechnology.
• Comparison of the current regulatory approval system under the 1989 rules with the regulatory approval system proposed under the Bill

Parameter	Current	BRAI 2013 Bill
Kind of Authority	Govt departments give approval	Independent statutory body gives approval
Activities regulated	Trails Manufacture Transport including import and export Use	Research Trails Manufacture Transport including import and export Use
Oversight of the research process	Every entity conducting research needs to setup Institutional Biosafety Committee	Statutory body will do
Approval Bodies	Final approval by Genetic Engineering Appraisal  Committee (GEAC)	Single regulator comprising of a number of units such as the RAU, PRC and EAP
Regulatory divisions	No provision	Three divisions: (i)                  agriculture, forests and fisheries; (ii)                human health and veterinary; and (iii)               industrial and environmental applications
Assessment of environmental impact	GEAC approves proposals for release of products into the environment including field trials	EAP
Qualification of regulators	Ministry officials and representatives of government scientific/technical bodies	Individuals with scientific expertise in the area of biotechnology
Monitoring and enforcement body	No provision	Enforcement Unit will enforce decisions of BRAI and ensure compliance with rules and regulations
State and district level bodies	State body investigates and takes action for violation of law through the State Pollution Control Board. District committee monitors safety regulations in installations engaged in the use of such products	State body is the nodal agency for interaction between the state government and BRAI. No provision for district level body.
Public participation	No provision	Decisions of BRAI will be made public and public scrutiny will be invited
Judicial body	Authority to be notified by MoEF. National Green Tribunal (NGT) has jurisdiction in some cases.	Appeals to be heard by the Biotechnology Regulatory Appellate Tribunal.

International Regulations

• The Convention on Biological Diversity and the Cartagena Protocol on Biosafety mandate rigorous scientific regulation to ensure safe use of biotechnology
• In USA and Canada, the government departments of agriculture, health, environment and food regulate biotechnology. Both countries use existing laws and agencies rather than creating a specialised regulatory mechanism.
• Australia has set up an independent regulator

Determination of Liability

• The primary function of liability regimes is to provide compensation to affected parties and incentivise the industry to minimise the risks of adverse impact. There are different types of liability regimes. In some cases, liability is specified in a law (statutory liability). In other cases, courts decide that the polluter should compensate
• The Bill does not specify any liability regime. Therefore, it will remain open to the courts to determine the general civil liability arising out of any adverse impact of modern biotechnology.
• The Nagoya Supplementary Protocol has stated that countries should have a liability regime for living modified organisms
• USA and Canada have not specified any liability
• Australia and Norway in its statute regulating biotechnology, has specified strict liability for genetically modified organisms

Recommendation of Various Committees

Swaminathan Task Force on Agriculture

• An autonomous regulatory commission should be created with expertise in Biotechnology and Biosafety
• Work of the committee (testing, evaluation and approval) should be scientific
• Agriculture is a state subject, a state body should be there to bring cohesiveness with the centrl body

CD Mayee Committee on Bt-Cotton

• Regulatory Committee should have technical expertise
• Agriculture is a state subject so state agricultural department and institutions as universities should be involved in testing, evaluation, approval and monitoring of field trials

Mashelkar Committee on Recombinant Drugs

• Overlap in approval process of GEAC and Drugs Controller General of India has led to ambiguity
• An independent regulator is needed

Supreme Court on Agriculture

• Independent regulatory system is required
• Regulators should implement a robust scientific review mechanism through a dedicated and qualified team
• Mandatory consultation should be held with states to seek permission for field trials. Most of the responsibility for the maintenance and operation at the field level should be given to the states.

Controversy

• Though the Bill brings the regulation of biotechnology under the powers of the Union. So, the states are objecting that Union is trying to infringe the state’s right for example in case of agriculture. The Centre claims that the states will still have the powers to intervene in issues like GM technology as agriculture is something that belongs to the State list
• The draft Bill attempts to bypass the Right to Information Act (RTI) under the garb of being “Confidential Commercial Information”. Activists say that biosafety information cannot be confidential and the Supreme Court has already set a precedent for this in the Bt Brinjal case. RTI has time and again helped activists and civil society expose or get information on field trials of GMOs at various areas, which will be impossible if BRAI becomes law.
• Conflict of Interest: The ministry of Science and Technology, which is in charge of promoting genetically modified organisms in India like it promotes any other science and technology venture, is the regulating authority as the draft Bill proposes to set up the BRAI under the ministry. Activists view that as a clear case of conflict of interest. The Bt Brinjal file sailed through various ministries, including science and technology, without a hitch. It was stalled by the environment ministry alone. Now the government is trying to give a fast track single window clearance for genetically modified organisms through this Bill
• Deviation from Task Force Report: The task force on agricultural biotechnology, headed by M S Swaminathan, laid six cornerstones. They include well being of farming families, economic and environmental sustainability, bio-security and trade security. None of these has been taken into account while drafting the Bill.