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Barry delivery vit a Barry delivery vit a Presentation Transcript

  • Navigating the Regulatory System: Lessons Learned from Golden Rice Gerard Barry IRRI Program 4 Leader - Rice and Human Health International Rice Research Institute (IRRI) Delivering Vitamin A Crops: a Visible Nutrient Tuesday, 4:00-6:00PM
  • Outline • Update on Golden Rice • Progress for the regulatory phase • Howdy‟s 3 questions • Farmer and consumer acceptance
  • Golden Rice in 1999/2000 Polished rice now contained meaningful levels of -carotene, the plant-produced precursor of vitamin A. Golden Rice (GR) could be used in food-based approaches, and complement others, in reducing the persistent problem of Vitamin A Deficiency in rice-dependent populations The „Golden Rice‟ technology was developed by Potrykus (ETH) and Beyer (ALUF) and was funded by the Rockefeller Foundation, the Swiss Federal Institute of Technology, the European Union, and the Swiss Federal Office for Education and Science.
  • Golden Rice – New Materials New GR1 and GR2 were developed by Syngenta as part of their then-commercial pipe-line and were donated for use by the Golden Rice Network when Syngenta decided not to pursue this trait as a commercial product. GR1 – 2004 GR2 - 2005 SGR1 SGR2 2000 2004-2005
  • Carotenoid Biosynthetic Pathway in GR2 Carotenes IPP DMAPP GGPP (C20) The sugar-based Genes Phytoene synthase added Maize PMI gene was Phytoene (C40) into used as the Golden Phytoene desaturase desaturation selectable marker Bacterial source Rice Lycopene (C40) and their source cyclization - carotene - carotene Xanthophylls -cryptoxanthin canthaxanthin -cryptoxanthin zeaxanthin lutein astaxanthin -carotene/other provitamin A carotenoids are converted to Vitamin A as needed in the body.
  • Progress on Golden Rice T-DNA insert • Six GR2 events in Kaybonnet, a US variety (Paine et al. 2005) – All single-locus, and single insert – Carotenoid levels up to 25 ug/g (screen-house samples) – Event-specific markers to assist back-crossing into varieties for the Philippines, India, Bangladesh and elsewhere. • Only one event will be released/go through regulatory approval • The final event and lines will be chosen on the bases of: – retained level of -carotene (product performance). – agronomic performance (farmer needs)
  • GLOBAL AREA OF BIOTECH CROPS Million Hectares (1996 to 2009) 200 “Trait Hectares” 180 Total Hectares 25 Biotech Crop Countries Industrial 160 Developing 140 120 100 80 60 40 20 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 A record 14 million farmers, in 25 countries, planted 134 million hectares (330 million acres) in 2009, a sustained increase of 7% or 9 million hectares (22 million acres) over 2008. Source: Clive James, 2010.
  • Biotech Crop Countries and Mega-Countries, 2009 2010
  • Some of the contexts in which Golden Rice will undergo further development • Vitamin A Deficiency remains a very large problem in many countries • The leading countries have policies conducive to the use of modern biotechnology for national development. • A number of the leading countries have approved GM crops for commercial production: • India (cotton) -5 events (~ 300 varieties/hybrids) • Philippines (maize) – 5 events (52 crop/traits for food/feed/processing; LY038) • Indonesia – 1 (temporary approval) • China – 7 (diverse crops) • Local GM food crop products are in advanced development in India, Bangladesh, Indonesia, and the Philippines • There is a lot GM rice activity, worldwide – China has issued a biosafety certificate for Bt (insect resistant) rice; final variety trials underway (also for improved processing maize) – Bt rice in India is entering large scale biosafety, pre-commercial trials
  • Philippines • Interaction with national regulatory system • Development and submission of data for regulatory review
  • “A fully integrated approach to the hazard assessment and characterization of all elements involved in producing a new GM variety” Adapted from: König et al., 2004. Food and Chemical Toxicology 42: 1047-1088 Donor, Transgene(s) Characterization of Safety Assessment of Parent Crop and Delivery Process Gene Product(s) New GM Crop/Food Identity, Phenotypic & Description of Structure, Identity Identity, Phenotypic & Agronomic Performance Donor and Characterization Agronomic Performance Geographical Description of Mode of Action/ Compositional Distribution Vector DNA Specificity Analysis Transgene Delivery Nutritional History of Safe Use Toxicity Process Analysis Compositional Characterization of Safety Analysis Allergenicity Analysis Introduced DNA (Animal Studies) Characterization of Insertion Site
  • “A fully integrated approach to the hazard assessment and characterization of all elements involved in producing a new GM variety” Adapted from: König et al., 2004. Food and Chemical Toxicology 42: 1047-1088 Donor, Transgene(s) Characterization of Safety Assessment of Parent Crop and Delivery Process Gene Product(s) New GM Crop/Food Identity, Phenotypic & Description of Structure, Identity Identity, Phenotypic & Agronomic Performance Donor and Characterization Agronomic Performance Geographical Description of Mode of Action/ Compositional Distribution Vector DNA Specificity Analysis Transgene Delivery Nutritional History of Safe Use Toxicity Process Analysis Compositional Characterization of Safety Analysis Allergenicity Analysis Introduced DNA (Animal Studies) Characterization of Insertion Site Not event-specific; documents can be produced early OECD Consensus documents
  • Consultations on science-based risk assessment of Golden Rice in the Philippines • Initial consultations organized by the Department of Agriculture in 2004/2005 • Three meetings held • Minutes of these meetings and edits of the Application Form recorded decisions on what was in/out (i.e., no non-target insect studies) • Process completed in 2010
  • Bringing the process to a close • Two reviews/briefings held in June/July 2010 – Bureau of Plant Industry Biotech Core Team, Department of Agriculture – Bureau of Animal Industry Biotech Core Team, Department of Agriculture – Biotechnology Coalition of the Philippines – Biotech Policy Group, Undersecretariat for Policy, Department of Agriculture – Science and Technology Review Panel members – Biosafety Resource Network – PhilRice – IRRI
  • Comparative Safety Assessment Approach for GMOs Underlying assumption: • Traditionally cultivated crops have gained a history of generally accepted use (environment/consumer/animals) • These crops can therefore serve as a baseline for the environmental and food/feed safety assessment of GM crops European Food Safety Authority Stakeholder Consultation “Conventional Counterpart” - means a related plant variety, its components and/or products for which there is experience of establishing safety based on common use as food. Codex Alimentarius Guideline for the Conduct of Food Safety Assessment from Recombinant-DNA Plants (CAC/GL 45-2003)
  • “A fully integrated approach to the hazard assessment and characterization of all elements involved in producing a new GM variety” Adapted from: König et al., 2004. Food and Chemical Toxicology 42: 1047-1088 Donor, Transgene(s) Characterization of Safety Assessment of Parent Crop and Delivery Process Gene Product(s) New GM Crop/Food Identity, Phenotypic & Description of Structure, Identity Identity, Phenotypic & Agronomic Performance Donor and Characterization Agronomic Performance Geographical Description of Mode of Action/ Compositional Distribution Substantially equivalent, except Vector DNA Specificity Analysis for the intended changes… Transgene Delivery Nutritional History of Safe Use Toxicity Process Analysis Compositional Characterization of Safety Analysis Allergenicity Analysis Introduced DNA (Animal Studies) Characterization of Insertion Site
  • “A fully integrated approach to the hazard assessment and characterization of all elements involved in producing a new GM variety” Adapted from: König et al., 2004. Food and Chemical Toxicology 42: 1047-1088 Donor, Transgene(s) Characterization of Safety Assessment of Parent Crop and Delivery Process Gene Product(s) New GM Crop/Food Identity, Phenotypic & Description of Structure, Identity Identity, Phenotypic & Agronomic Performance Donor and Characterization Agronomic Performance Geographical Description of Mode of Action/ Compositional Distribution Vector DNA Specificity Analysis Transgene Delivery Nutritional History of Safe Use Toxicity Process Analysis Compositional Characterization of Safety Analysis Allergenicity Analysis Introduced DNA (Animal Studies) Characterization of Insertion Site OECD Consensus documents
  • Suggested Nutritional and Compositional Parameters to be Analysed in Rice Matrices for Food Use Parameter Bran oil Rice flour Paddy Rice Proximate Analysisa X X Minerals X Vitamins X Amino Acids X X Fatty Acids X X X Phytic Phosphorus X Amylose Content X X a Proximate includes protein, fat, total dietary fibre, ash and carbohydrates. OECD Consensus Document on Compositional Considerations for New Varieties of Rice (Oryza Sativa): Key Food and Feed Nutrients and Anti-Nutrients. August 2004 http://appli1.oecd.org/olis/2004doc.nsf/linkto/env-jm-mono(2004)15
  • Suggested Nutritional and Compositional Parameters to be Analysed in Rice Matrices for Feed. Parameter Paddy Rice/Bran Straw Whole Plant Proximate Analysis1 X X X Amino Acids X Calcium X X X Phosphorus X X X Phytic Phosphorus X 1 NDF (neutral detergent fibre) and ADF (acid detergent fibre) should be substituted for crude fibre. OECD Consensus Document on Compositional Considerations for New Varieties of Rice (Oryza Sativa): Key Food and Feed Nutrients and Anti-Nutrients. August 2004 http://appli1.oecd.org/olis/2004doc.nsf/linkto/env-jm-mono(2004)15
  • Administrative Order No. 8, Series of 2002 Importation and Release into the Environment of Plants and Plant Products Derived from the Use of Modern Biotechnology Department of Agriculture
  • POLICY ON RELEASE FOR PROPAGATION “No regulated article shall be released for propagation unless: (i) a Permit for Propagation has been secured from BPI; (ii) it can be shown that based on field testing conducted in the Philippines, the regulated article will not pose any significant risks to the environment; (iii) food and/or feed safety studies show that the regulated article will not pose any significant risks to human and animal health; and, (iv) [If the regulated article is a pest-protected plant, it has been duly registered with the Fertilizer and Pesticide Authority.]”
  • Applicant Within 90 days APPROVED Grace period BPI of 60 days to from acceptance DENIED correct Process & evaluate defects within 5 days of receipt For evaluation on risk assessment STRP Shall submit report w/n 30 days Bureau of Sufficient in In all instances Agricultural NO YES BAFPS and Fisheries Form & Product Substance? Shall submit report w/n 30 days Standards If pest-protected plant FPA Shall submit report w/n 30 days If intended as APPLICATION TO feed BAI Shall submit report w/n 30 days RELEASE FOR For conduct of Applicant PROPAGATION public consultation Applicant shall publish Public Info Sheet in 2 newspapers, and invite comments w/in 30-day period.
  • International Acceptance of Food Safety Data/Assessments 1. The food safety assessment of the GM product must be carried out according to the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment from Recombinant-DNA Plants (CAC/GL 45-2003). 2. Because of the nutritional enhancement in the Golden Rice trait, adherence to the Annex 2: Food Safety Assessment from Recombinant-DNA Plants Modified for Nutritional or Health Benefits is also critical
  • Outline Timeline for GR2 Approval
  • Golden Rice and Howdy’s 3 Questions • Target level? – +50% of EAR – +50% of RDA (IRRI unpublished) • Bioavailable? – Bioconversion = 3.8:1 (Tang et al., 2009) – Bioefficacy studies planned for 2011 - 2013 • Acceptance? – Qualitative and environmental scanning completed – Quantitative studies underway (IRRI unpublished) – Bioefficacy studies planned for 2011 - 2013
  • GR nutritional data - completed and planned Funds Where Trial Complete Published NIH USA Adult β-c bioconversion (10g butter) √ √ NIH/SF USA Adult β-c bioconversion (5g, 0g butter) √ NIH/SF China Adult β-c bioconversion (10g, 5g, 0g oil) √ NIH China Child β-c bioconversion (10g oil) √ Future China Child β-c bioconversion/bioefficacy (10g oil) 2011 Grant USDA USA Adult β-c bioconversion/bioefficacy 2011 Future Philippines Clinical Adult β-c bioefficacy 2013 Grant Future Philippines Community Adult β-c bioefficacy 2013 Grant Future Philippines Study of long term population benefit Post 2014 Grant Source: Rob Russell and IRRI
  • Consumer acceptance activities • Rice taste panel (2011; 2012) • Consumer taste panel (2011; 2013) • Consumer research – Focus Group Discussion (2009) – Consumer Survey (2010)
  • PhilRice Golden Rice Team PROJECT LEADER Antonio A. Alfonso, Ph.D. BREEDING Gerald B. Ravelo, Ph.D. Nelson S. Garcia, MSc. Jean J. Somera, MSc. Emilie O. Espejo Eleanor S. Avellanoza MILLING AND SENSORY: Marissa Romero, Ph.D. PILOT SEED PRODUCTION: Marlon Labuguen, MSc. COMMUNICATION AND PROMOTION: Andrei Lanuza, MSc.
  • Thank you www.irri.org g.barry@cgiar.org www.harvestplus.org