Indian Experience in Environmental safety Assessment of GM crops lessons learnt and future outlook

Transcription

1 Indian Experience in Environmental safety Assessment of GM crops lessons learnt and future outlook Regulatory Frame work S.R.RAO, RAO Advisor, Department of Biotechnology. Ministry of Science & Technology Government of India Public concerns PUBLIC POLICY Science of risk assessment

2 Indian Regulatory System IBSC s Recombinant DNA Safety Guidelines, 1990 EPA Act 1986 Rules 1989 RCGM Revised guidelines for research in transgenic plants & guidelines for toxicity and allergenicity evaluation of transgenic seeds, plants and plant parts, 1998 Standard Operating Procedures for confined field trials 2008 Guidelines for the conduct of confined field trials of regulated, GE crops, 2008 GEAC Guidelines and protocols for food and feed safety assessment of GE crops, 2008

3 Constitution of GEAC ( 31 members) Chairman : Member convener : Scientific agencies/institutions 1.CCMB 2.CSIR 3.ICAR 4.DBT 5.BARC 6.ICMR Environment and forests Environment and forests Regulatory agencies 6Director General of Health services 7Central pollution control board 8Directorate of plant protection 9Food safety & standards Authority of India Ministries Independent Members Environment & Forests Universities 11. Industry CSIR Institutes 12. Agriculture 24 ICAR Institutes 13. Commerce 25 Consumer 14. External affairs 26 Social science 15.Health & Family welfare 27 Law 16. food processing industry Supreme Court - Observers

4 VARIOUS GENES/EVENTS OF Bt COTTON UNDER CULTIVATION AND EVALUATION IN INDIA Approved Events MON 531(cry1Ac gene), MON (cry1ac & cry2ab genes), GFM Cry 1A (cry1ab y cry1ac), ) JK-1 (cry1ac) CICR (cry1ac) Events Under Biosafety Evaluation AS PER OLD GUIDLINES AS NEW GUIDLINES Round-up Ready Flex (RRF) cry1ac & cry2ab genes (Event MON15985) & CP4 EPSPS genes (Event MON 88913) WideStrike (cry1ac & cry1f genes) Event and Event ) JK Stack- cry1ac (Event -1) and cry1ec (Event-24) cry1c (Event 9124)

5 Post release conditions of Bt cotton approval Period of validity of approval -three years To look for the incidence of sucking pests on these hybrids and carry out artificial screening for CLCV resistance and submit its report to the GEAC. (only for north zone) Planting of refugia (20%) for which each packet of seeds of the approved varieties should also contain a separate packet of the seeds of the same non-bt cotton variety, which is sufficient for planting in the refuge defined above.

6 Commercialization of Bt cotton boosted its growth, However slow inseveral key other crops, Yields of select crops in India, (Indexed : 1991 yields = 100) CAGR Wheat Rice Pulses Soybeans Sugar cane Cotton Source: Ministry of agriculture website : % 1.40% 1.18% 0.60% 0.19% Wheat, rice, pulses etc. are largely varietal crops (non hybrid) No existing business models for private sector work in non -hybrid crops Strong R&D, supported by PPP led business models needed to encourage private R&D 6

7 Population of sucking pests, bollworms and natural enemies Mean number of pests/natural enemies over the season IPM Non-IPM Insect pest Standard week# Bt MECH-162 Non- Bt MECH-162 CC CC Sucking pests* Whiteflies ª 0.15ª 0.24 b 0.29 b Jassids ª 0.07ª 0.14 b 1.97 c Thrips ª 4.56ª 5.98 b c Aphids ª 3.50ª b c Bollworms** American bollworm eggs ª 0.12ª 0.08 b 0.17 c American bollworm larvae ª 0.06 b 0.05 b 0.09 c Spotted bollworm larvae ª 0.01ª 0.03 b 0.06 c Natural enemies ** Green lacewign eggs ª 0.37ª 0.61 b 0.26 c Ladybird beetle adults ª 1.23ª 2.06 b 0.69 c Means with at least one letter common are not significantly ifi different. # Standard week 30 corresponds to July. 8 Number of insects/three leaves, ** Number of insects/plant. Bambawale( 2006)

8 Story of Bt brinjal debacle within same regulatory framework and for same gene Bt Non Bt Non Bt Cash benefit of Rs 64,800 per ha and Rs 3,000 crore to our nation

9 Biosafety evaluation of Bt brinjal - the first food crop : Confined field trials to study pollen flow and growth, aggressiveness and weediness, Biochemical properties, toxicity and allergenicity : Data on the effect of Bt brinjal on soil microflora efficacy against FSB, pollen flow and chemical Composition

10 Environmental Safety Approach for Biotechnology Crops Introduced Trait(s) Environmental Safety Modified Plant l Ecological impact of the trait(s) Similarity to proteins or traits in conventional varieties Potential non-target toxicity Potential for resistance Outcrossing impacts l Ecological impact of the plant Similarity to conventional varieties Potential weediness Expression profile Potential ecological impacts Carefully evaluate the new and confirm no unintended adverse effects

11 Some concerns in public consultations Some concerns in public consultations for Commercial release of Bt Brinjal

12 Resistance development and its management are serious concerns There is a need for a consolidated report on ecology, biology genetics and population dynamics and simulation i models dl areto be developed d for post release risk management 3/06/2010 Hyderabad

13 In the context of Section 45 Codex on location and conduct of field trials ----It was concluded current standards formulated do not match global standards

14 Rich agri-biodiversity of brinjal should be conserved and preserved before we permit the extinction of the gifts of thousands of years of natural evolution and human selection

15 The Final diagnosis

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17 Lessons learnt.. Regulatory Frame work Public concerns PUBLIC POLICY Science of risk assessment

18 Strategic risk management requires : For an integrated action : Identifying i environmental effects of proposed actions Considering alternatives, including the best practicable environmental option Specifying appropriate mitigation measures To contribute to environmentally sustainable development by: Anticipating and preventing environmental impacts at source Early warning of cumulative effects and global risks Establishing safeguards based on principles i of sustainable development Achieve environmental protection and sustainable development by: Consideration of environmental effects of proposed strategic actions Identification of the best practicable environmental option Early warning of cumulative effects and large-scale changes To integrate t the environment into sector-specific decision i making by: Promoting environmentally sound and sustainable proposals Changing the way decisions are made Source: Adapted from Abaza et al [2009].

19 The adoption of a variety of new regulatory approaches and concepts, decision making processes and educational frames over the last three decades can be interpreted as an attempt to improve social acceptability of the process of science and technology governance. Based on this comparative However, neither research, the introduction it is argued of non-standard that models scientific methodology and precautionary policy, of public noracceptance participatory of decision making, nor increased scientific technological controversial education science-based are likely to significantly improve social acceptance products of must sciencealso and take technology into governance. Such reforms may shift the account focus of the ongoing state s policy ability debates, to but do not lead to closure. define the range of public debate as a key overall parameter of In consequence, public more research attitude formation is needed on the complex relationship between acceptance, trust, t information and participation, the implications of non-standard methodology in regulatory decision making, as well as the different interpretations that stakeholders may give to key regulatory concepts.

20 Way forward Biology documents Human resources with skills Regulatory science Modeling agro-ecosystems Roster and network of ERA experts Effective regulation is an essential component of any innovation process Serious re-evaluation of the existing regulatory framework in the light of accumulated evidence and experience

21 POLICY INTERVENTION GOVERNMENT OF INDIA Two specific expert groups i.e. M. S. Swaminathan Task Force on Agriculture Biotechnology and Mashelkar Task Force on Recombinant Pharma constituted by the Ministry of Agriculture and the Ministry of Environment and Forests recommended the establishment of an autonomous, statutory and professionally led National Biotechnology Regulatory Authority. Setting up NBRA will require the promulgation of new legislation, namely the: Biotechnology Regulatory Authority of India Act, 2011 or the BRAI Act. Existing mechanisms may continue till a full-fledged body is created with the required infrastructure and fully functional autonomy.

22 METHODOL0GY ADOPTED BY DBT FOR ESTABLISHMENT OF BRAI Step 1 Review of the structure and governance of other autonomous agencies in India Review of international models for the regulation of biotechnology Review of India s international obligations pertinent to the BRAI s mandate Step 2 Step 3 Step 4 Development of a model for the BRAI that addresses: 1. Scope of the regulatory mandate of the BRAI 2. Structure of the BRAI: programs and operations 3. Legal framework and other issues Preparation of a preliminary establishment plan for the BRAI. Stakeholder interviews to obtain feedback on the preliminary plan. Preparation of a revised, draft plan incorporating stakeholder feedback. Preparation of draft legislation for establishing the BRAI Step 5 Consultative process with various stakeholders

23 PROCESS OF TAKING FORWARD BRAI BILL Preparation of draft Bill and establishment plan through a consultative process. High level advisory committee to review and recommend. Placing on the DBT s websites and advertisements in leading newspapers for comments. Consultation with state governments for consensus and feed back Six countrywide consultation meetings with various stakeholders in Delhi, Chennai, Bangalore, Hyderabad, d Mumbai and Kolkata. Special consultation with Media & legal experts. Finalization of the draft Bill and establishment plan. Inter-ministerial consultation Roundtable with international regulators (USA, Canada, Australia, Philippines) the bill is now ready for introduction in parliament

24 KEY FEATURES OF BRAI BILL, 2011 The proposed statutory independent regulator that is the Biotechnology Regulatory Authority of India (BRAI) would be a nodal agency of the Government of India to ensure comprehensive safety assessment of organisms and products of modern biotechnology. Commercialization of biotechnology products in agriculture and healthcare would be subject to all other laws whether Central or State, for the time being in force and rules and regulations made thereunder. The organizational plan of the Authority also provides The organizational plan of the Authority also provides collaborative arrangements, co-ordination and mechanisms with other existing regulatory agencies.

25 MANDATE AND STRUCTURE OF BRAI BRAI shall be an independent, autonomous, statutory agency to regulate the research, transport, import, manufacture and use of organisms and products of biotechnology. BRAI shall consist of a Chairperson, two whole time members and two part time members to be appointed by the Central Government. The members shall have expertise in the fields of molecular biology, healthcare, agriculture and environment biotechnology.

26 C O M M U N I C A T I O N Legislation Rules & procedures Guidelines Elements of Biotech regulatory System SOPs Biosafety Review Process People MULTIDISCIPLINARY HUMAN RESOURCE I N F R A S T R U C T U R E Notified Testing Labs T Monitoring Cells Field sites

27 ORGANIZATION STRUCTURE OF BRAI Inter-Ministerial Governing Board Chairperson, BRAI and two whole time and two part time members Environment Appraisal Panel Economic Analysis Unit

28 Challenges Human resource for risk assessment review, management and communication at all levels State of art Laboratories ( new or Existing ) to meet future challenges of technology complexities Continual education and research resources for regulation

29 Consult Our Web site For more information