Strengthening biosafety compliance among public sector institutions in India: A SABP Initiative. Dr. Vibha Ahuja, Chief General Manager, BCIL

Transcription

1 Strengthening biosafety compliance among public sector institutions in India: A SABP Initiative Dr. Vibha Ahuja, Chief General Manager, BCIL

2 Structure of presentation Biosafety Regulations in India South Asia Biosafety Programme:Key contributions ICAR Biosafety Awareness and Compliance Readiness Project 2

3 Biosafety Regulations in India India s biotechnology regulatory system is primarily based on the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/ Genetically Engineered Organisms or Cells, 1989 (Rules, 1989) notified under the Environment (Protection) Act,

4 Coverage of 1989 Rules The 1989 Rules cover the entire spectrum of activities relating to research, development and use of Genetically Modified Organisms (GMOs) and their products. The Rules are implemented by Ministry of Environment,Forest and Climate Change, Department of Biotechnology and State Governments through six statutory bodies. 4

5 Statutory Bodies 1. The Recombinant DNA Advisory Committee (RDAC). Advisory 2. Institutional Biosafety Committee (IBSC) 3. Review Committee on Genetic Manipulation (RCGM) 4. Genetic Engineering Approval Committee (GEAC) Approval 5. State Biotechnology Coordination Committee (SBCC) 6. District Level Committee (DLC) Monitoring

6 BIOSAFETY GUIDELINES FOR GE CROPS Contained Use (DBT) Recombinant DNA Safety Guidelines, 1990 Recombinant DNA Safety Guidelines and Regulations, 1994 Revised Guidelines for Research in Transgenic Plants, 1998 Confined Field Trials (MoEF&CC and DBT) Guidelines for Conduct of Confined Field Trials of Regulated GE Plants, 2008 Standard Operating Procedures (SOPs) for CFTs of Regulated, GE Plants, 2008 Guidelines for Monitoring of Confined Field Trials of Regulated GE Plants, 2008 Food Safety Assessment (DBT and ICMR) Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008 (Updated in 2012) Protocols for Food and Feed Safety Assessment of GE Crops, 2008 Environmental Safety Assessment (MoEF&CC anddbt) Guidelines for Environmental Risk Assessment (ERA) of GE Plants, 2016 Risk Analysis Framework, 2016 ERA of GE Plants: A Guide for Stakeholders, 2016

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8 South Asia Biosafety Program: A capacity building initiative A program that works to facilitate implementation of transparent, efficient and responsive biosafety regulatory frameworks. The model for SABP involves a long-term commitment to building relationships with both the government and relevant stakeholders in the country. Active in India and Bangladesh since 2005, Funded by the United States Agency for International Development (USAID) and implemented by International Life Sciences Institute (ILSI- RF) and International Food Policy Research Institute based in Washington with support from in-country partners. Partners with many other international and national organizations 8

9 SABP in India Worked on various aspects, confined field trials, food safety assessment, environmental safety assessment and biosafety compliance SABP has worked cooperatively with many partners: Indian Council of Medical Research Department of Biotechnology Ministry of Environment, Forests and climate change Indian Council of Agricultural Research and Research institutions and universities Activities include preparation of resource documents,supportfor preparation of guidance documents, training workshops etc. 9

10 SABP Newsletter Published monthly Content from India and Bangladesh Distributed to >20000 individuals and organizations Content from other SAARC countries also included

11 Annual South Asia Biosafety Conference 1 st conference in New Delhi in Annual SABC organized in India,Srilanka and Bangladesh Agenda, report and presentations can be viewed at SABP and SABC websites 11

12 Development of GMOs in India Investments have made by both public and private sector since last two decades in research and development to develop GE crops with a variety of traits as well as biopharmaceuticals including similar biologics. Several key organizations from both public and private sector are actively involved in research and development of GMOs.

13 Development of GE plants by ICAR Indian Council of Agricultural Research (ICAR) is an autonomous organization under the Ministry of Agriculture and Farmers Welfare, Government of India. Agricultural Biotechnology is a key research area in ICAR. ICAR institutes actively involved in development of GE plants for which ICAR has invested significant time and resources in R&D. ICAR also serves as an expert organization that provides scientific expertise to regulatory bodies on biosafety. A trusted source to address questions of science and safety that may arise from central or state governments or from the public more generally.

14 Need for Biosafety Compliance Development process of GE plants essentially needs to follow Biosafety Regulations and guidelines Biosafety compliance is a critical requirement for translating research to farms Generate data for submission to regulatory Authorities Instill public confidence for ensuring safety of final products

15 Biosafety Capacity in ICAR ICAR institutions (or more commonly individual scientists) addressed biosafety on an ad hoc basis Most ICAR institutes have IBSCs, but staff training to ensure compliance with biosafety requirements was not consistent across the organization There was no centralized resource for biosafety guidance for transgenic research Need for a biosafety program coordinated across all institutions Questionnaire based survey used to plan a project on Biosafety Awareness and Compliance Readiness jointly by ICAR, SABP and BCIL

16 Objectives To enhance ICAR s institutional capacity in biosafety To implement a biosafety program coordinated across institutions instead of individual ICAR institutions to address biosafety on an ad hoc basis

17 Participating Institutions Indian Institute of Vegetable Research, Varanasi Indian Institute of Millets Research, Hyderabad Central Potato Research Institute, Shimla Indian Institute of Pulses Research, Kanpur Directorate of Rapeseed Mustard Research, Bharatpur Indian Institute of Horticultural Research, Bangalore National Research Centre on Plant Biotechnology, New Delhi Indian Institute of Rice Research, Hyderabad Indian Institute of Oilseeds Research, Hyderabad Central Institute for Cotton Research, Nagpur

18 Project Outline Step 1: A nodal point for coordination in biosafety at ICAR HQ Step 2: Establish network of biosafety officers Step 3: Build cross-icar programs/practices/processes

19 Range of Activities Designation of Institutional Biosafety Officers (IBOs) Technical training workshops: Highly specific workshops for 20 IBOs Information through Biosafety Portal E-learning platforms to promote self directed, technical training in risk assessment and risk management. Invited lectures, conduct of workshops in participating institutions and international exposure/engagement

20 Responsibilities of IBOs Document developm ent, managem ent Undertake training on biosafety Develop and implement training at home institution Support IBO Auditing Work with colleagues to ensure compliance with legal requirements, institutional policies and practices related to biosafety Training Serve on the IBSC and act as liaison between the IBSC and institutional personnel Expected to be a resource for pan ICAR Biosafety Compliance

21 Steps in development of GM crop Gene discovery & proof of concept IBSC Guidance & SOPs for contained R&D Gene & construct optimization IBSC Guidance & SOPs for contained R&D Event characterization & selection Guidance & SOPs for contained R&D and CFTs Advanced testing & regulatory submission Guidance & protocols for FS and ERA Multiplication Guidance for variety registration & breeder seed production Distribution of new variety QMS ICAR Compliance Pilot Project

22 Activities so far Six workshops for IBOs One Webinar ICAR Biosafety Portal E learning programme for IBSCs Invited lectures in participating institutions ICAR SOPs prepared for contained research and posted; Crop-specific SOPs for CFTs under preparation

23 Topics covered in workshops Indian Regulatory System, Structure and coordination, Responsibilities of competent authorities Concepts of risk assessment and risk management Role of IBOs in risk management- Training, auditing, compliance Development of SOPs for lab and Greenhouse Work Introducing ICAR Biosafety Portal Practical considerations for implementing effective stewardship in a public sector research institute Importance and key features of crop specific SOPs for effective biosafety compliance Compliance management programme for confined field trials

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31 Preparation of Guidance Documents ICAR Standard Operating Procedures for Working with Genetically Engineered Plants in Contained Facilities ICAR Guidance for Conducting Research with Regulated, Genetically Engineered Plants in Contained Greenhouses and Screen Houses ICAR Record of Containment ICAR Record of Facility Inspection ICAR Record of Greenhouse and Screen House Operations

32 Activities by IBOs in Institutions :Examples Implementation of SOPs for lab/greenhouse safety Workshop conducted for students on sensitization of Biosafety and lab safety issues Discussions held in local language on general biosafety issues to non-research employees working in glass house and lab Regular interactions with various PIs who are involved GE work and share Biosafety related documents Contd/

33 Activities by IBOs in Institutions: Examples Inter institutional knowledge sharing Documented the GE work event wise in the institute Integrated biosafety into daily operations and promoted safe work practices to ensure appropriate containment and to prevent exposure to any harmful biological materials Testing laboratory equipment related to biological safety, such as biosafety cabinets and autoclaves, and maintaining database for testing and certification records.- IBOs displayed mobile numbers for contact in any emergency like including spills, accidental releases, vandalism, and theft

34 Posters displayed at Institutions

35 Proposed activities for 2018 ICAR crop specific SOPs prepared to date to be approved ; post on ICAR Biosafety Portal How to conduct biosafety compliance audits Development of standardized curriculum for audit training workshops Training of IBOs in auditing best practices IBOs audit own and each others institutions IBO and PI joint training in dossier development Survey of status of GE plant development in ICAR Best practices in regulatory dossier development Application processes e.g., CFTs, food/feed safety, cultivation Data and information requirements; preparing study reports Regulatory milestones and submission time lines etc.

36 Acknowledgements Dr Morven Mclean, Executive Director, ILSI Research Foundation Dr Andrew Roberts, Deputy Director,ILSI Research Foundation Dr P.Chakarborty, Asstt Director General,Indian Council of Agriculture Research 36

37 Thank You for your attention!