Biosafety Regulatory Framework in India
Anil Kumar Bhushan, Manager Biotech Consortium India Limited, New Delhi
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Biosafety Protecting human & animal health and environment from the possible adverse effects of the products of modern biotechnology
Precautionary Approach is adopted for assessment of Biosafety
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Objectives of Regulations To facilitate & regulate Modern biotechnology work at different stages to achieve the objectives of biosafety.
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BIOSAFETY REGULATIONS & GUIDELINES * International: Cartagena Protocol on Biosafety OECD Guidelines * Country specific: USA, EU, Canada, Australia, Egypt, Japan, China, Philippines, Thailand, India, Pakistan, etc. 4
GENETICALLY MODIFIED ORGANISMS (GMOs) AND r-DNA PRODUCTS GOVERNED BY
Environment (Protection) Act, 1986 Came into force from 23.05.1986
Rules, 1989 on GMOs Notified on 05.12.1989 Came into force from 01.10.1993
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TRANSGENIC CROPS ARE ALSO GOVERNED BY ¾Industries (Development & Regulation) Act, 1951 - New Industrial Policy & Procedures, 1991 ¾ Seeds Act, 1966 ¾ Seeds Rules, 1968 ¾ Seeds (Control) Order, 1983 ¾ Seeds Policy, 1988, 2002 ¾ Protection of Plant Varieties and Farmers’ Rights Act, 2001 6
The Indian Environment (Protection) Act (EPA), 1986 ¾ Came into force from 23.5.1986. ¾ Provides protection and improvement of Environment. ¾ “Environment” includes water, air and land and the interrelationship, which exists among and between water, air and land, and human beings, other living creatures, plants, microorganism and property
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Some Important Sections of EPA Section -15 ¾ Whoever fails to comply with or contravenes the act or any
rules can be punished with imprisonment for a term up to 5 years, or with a fine up to Rs. 1,00,000 or with both. ¾ If failure or contravention continues beyond one year, the
offender may be punishable with imprisonment which may extend up to 7 years.
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Rules for the Manufacture, Use / Import / Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells (Rules 1989) * Notified in exercise of powers under sections 6,8 & 25 of the EPA, 1986 on 5thDec’89. * Rules are came into force from 01.10.1993.
Application of Rules : *
Manufacture, import and storage of microorganisms and Gene-technological products.
* Genetically engineered organisms, microorganisms and cells and correspondingly to any substances and products and food stuffs, etc. * Sale, any kind of handling, exportation, importation, production, manufacture, processing, storage, drawing off, packaging, repackaging of GMOs and drugs & pharmaceuticals, food stuffs etc. from GMOs and Gene technology products. 9
Agencies Involved in Rules,1989 of EPA 1986 GOVERNMENT OF INDIA Min. of Environment
Applicant
Large Scale Imports, Production and Release
GEAC
SBCC
DLC
Dept. of Biotechnology
RCGM
IBSC
PI/ Applicant
Monitoring -cumEvaluation Committee
Preparation of guidelines, protocols, R&D work, limited experimental field trials and imports for R&D. 10
COMPETENT AUTHORITIES 1.
Recombinant DNA Advisory Committee (RDAC)
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Review Committee on Genetic Manipulation (RCGM)
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Institutional Biosafety Committee (IBSC)
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Genetic Engineering Approval Committee (GEAC)
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State Biotechnology Co-ordination Committee (SBCC)
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District Level Committee (DLC)
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RECOMBINANT DNA ADVISORY COMMITTEE (RDAC) Main functions Review developments in Biotechnology at National and International level. Recommend suitable and appropriate safety regulations for India in r-DNA research, use and applications.
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INSTITUTIONAL BIOSAFETY COMMITTEES Regulatory Objective To examine competence of institutions to undertake R&D involving r-DNA work. To oversee and ensure adherence to r-DNA biosafety guidelines . To act as a nodal point for interaction with regulatory bodies
Functions Approve r-DNA proposals involving use of Risk Group I & II organisms. Examine & recommend to RCGM proposals involving Risk Group III and above organisms. To recommend to RCGM the import/ exchange of GMOs, vectors, gene constructs, plasmid etc. for research purpose. Inform RCGM about the facilities including containment facilities at R&D and production site. Prepare emergency plan according to biosafety guidelines and to inform DLC, SBCC and GEAC.
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REVIEW COMMITTEE ON GENETIC MANIPULATION Regulatory Objective
Functions
To examine the competence of the institutions to undertake r-DNA proposals.
Approve r-DNA proposals involving use of Risk Group III and above organisms.
To monitor safety related aspects in respect of ongoing research projects and activities related to rDNA work and ensure compliance of biosafety guidelines.
Permit import/ exchange of GMOs, vectors, gene constructs, plasmid etc. for research purpose.
Bring out biosafety guidelines with respect to activities involving r-DNA work in research and large-scale applications including industry. To stipulate/ recommend additional safeguards in specific cases.
Approve protocols for conduct of small scale field /pre-clinical trials. Approve containment facilities at R&D facilities. Recommend to GEAC the adequacy of containment facilities for production work.
To lay down procedures restricting or prohibiting production, sale, import and use of GMOs.
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GENETIC ENGINEERING APPROVAL COMMITTEE Regulatory Objective
Consider environmental release of GMOs based on Risk vs. Benefit analysis where benefit >> pre determined environmental risk. Stipulate/ recommend additional safeguards in specific cases. Stipulate procedures for restriction or prohibition, production, sale, import and use of GMOs for applications under EPA;
Functions
Approve containment facilities for use of GMOs involving more than 20 l fermentation capacity. Approve activities involving large-scale use of GMOs (Phase-III clinical trials/large scale field trials of transgenic crops) prior to commercialization. Approve import of GMOs for large-scale use/ commercialization. To permit the use of GMOs and products thereof for commercial use.
Authorize agencies or persons to have powers to initiate punitive actions under EPA on defaulters.
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STATE BIOTECHNOLOGY CO-ORDINATION COMMITTEE (SBCC) Main functions Powers to inspect, investigate and to take punitive action in case of violations of statutory provisions through the State Pollution Control Board or the Directorate of Health etc. To review periodically the safety and control measures in various institutions handling GMOs. To act as nodal agency at State level to assess the damage, if any, due to release of GMOs and to take on site control measures. 16
DISTRICT LEVEL COMMITTEE (DLC) Main functions To monitor the safety regulations in installations. Have powers to inspect, investigate and report to the SBCC or the GEAC about compliance or non compliance of r-DNA guidelines or violations under EPA. To act as nodal agency at District level to assess the damage, if any, due to release of GMOs and to take on site control measures. 17
r-DNA GUIDELINES
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“ Recombinant DNA Safety Guidelines”
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“ Revised Guidelines for Safety in Biotechnology”
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“ Revised Guidelines for Research in Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts ”
1999
“Guidelines for Generating pre-clinical and Clinical data for r-DNA based Vaccines, Diagnostics and other Biologicals”
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Protocol for development of Transgenic crops Institutional Biosafety Committee (IBSC) Examination & forwarding applications for approval of RCGM
Review Committee on Genetic Manipulation (RCGM) Green house experiments, contained field trials, toxicity and allergenicity studies
Farmer’s Field trials by Company
ICAR trials
Monitoring-cum- Evaluation Committee (MEC)
Review Committee on Genetic Manipulation (RCGM)
Genetic Engineering Approval Committee (GEAC) Evaluation of data and Environmental clearance of the event/ gene
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APPEAL AND EXEMPTION MECHANISMS Appeal to National Environment Appellate Authority: Any person aggrieved by the decision of GEAC/ SBCC to appeal within 30 days
Exemption: The MoEF wherever necessary may exempt an occupier handling particular GMOs from the provisions of 1989 rules (7-11).
INITIATIVES TAKEN FOR STRENGTHENING THE REGULATORY SYSTEM z
GEAC meetings are held 2nd Wednesday of every month since February 2004. and RCGM meetings are being held 4th Tuesday of every month.
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Project Proponents are being given opportunity for personal hearing.
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For ensuring transparency, decision taken in the GEAC along with status of pendency of the applications are posted on MoEF Website from April 2004.
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Inter-Ministerial Task Force under Chairmanship of Dr. M.S. Swaminathan was set up, with Secretaries of MoEF, Agriculture, DBT as members, besides independent experts. MoEF has constituted a sub-Committee under the Chairmanship of Dr C D Mayee, Chairman ASRB, and Co-Chair GEAC, to look into the existing processes, protocols and other related issues and give recommendation for rationalization of the same.
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CONCLUSIONS
All GMOs and r-DNA products are controlled commodities under the Rules- 1989 OF EPA- 1986.
Biosafety regulations required to assess the safety of transgenic crops before its release in to environment
Biosafety concerns need to be addressed in a scientific manner
Biosafety Regulations are being reviewed continuously
Familiarity with the Rules & Procedures is essential for all the stake holders
The EPA/Rules, 1989 to provide safe products to the society on existing scientific knowledge. 22
THANK YOU
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