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Barry delivery vit a

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Barry delivery vit a

  1. 1. 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
  2. 2. Outline • Update on Golden Rice • Progress for the regulatory phase • Howdy‟s 3 questions • Farmer and consumer acceptance
  3. 3. Golden Rice in 1999/2000 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. 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
  4. 4. Golden Rice – New Materials 2000 2004-2005 SGR1 SGR2 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
  5. 5. IPP DMAPP GGPP (C20) Phytoene (C40) desaturation Lycopene (C40) - carotene - carotene cyclization Carotenes zeaxanthin -cryptoxanthin astaxanthin canthaxanthin Xanthophylls Phytoene synthase Maize Phytoene desaturase Bacterial source -cryptoxanthin lutein Carotenoid Biosynthetic Pathway in GR2 Genes added into Golden Rice and their source -carotene/other provitamin A carotenoids are converted to Vitamin A as needed in the body. The sugar-based PMI gene was used as the selectable marker
  6. 6. Progress on Golden Rice • 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) T-DNA insert
  7. 7. 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. GLOBALAREA OF BIOTECH CROPS Million Hectares (1996 to 2009) 25 Biotech Crop CountriesTotal Hectares Industrial Developing “Trait Hectares” 0 20 40 60 80 100 120 140 160 180 200 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
  8. 8. Biotech Crop Countries and Mega-Countries, 2009 2010
  9. 9. 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
  10. 10. • Interaction with national regulatory system • Development and submission of data for regulatory review Philippines
  11. 11. “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 Parent Crop Donor, Transgene(s) and Delivery Process Characterization of Gene Product(s) Safety Assessment of New GM Crop/Food Identity, Phenotypic & Agronomic Performance Geographical Distribution History of Safe Use Compositional Analysis Description of Donor Description of Vector DNA Transgene Delivery Process Characterization of Introduced DNA Characterization of Insertion Site Structure, Identity and Characterization Mode of Action/ Specificity Toxicity Allergenicity Identity, Phenotypic & Agronomic Performance Compositional Analysis Nutritional Analysis Safety Analysis (Animal Studies)
  12. 12. “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 Parent Crop Donor, Transgene(s) and Delivery Process Characterization of Gene Product(s) Safety Assessment of New GM Crop/Food Identity, Phenotypic & Agronomic Performance Geographical Distribution History of Safe Use Compositional Analysis Description of Donor Description of Vector DNA Transgene Delivery Process Characterization of Introduced DNA Characterization of Insertion Site Structure, Identity and Characterization Mode of Action/ Specificity Toxicity Allergenicity Identity, Phenotypic & Agronomic Performance Compositional Analysis Nutritional Analysis Safety Analysis (Animal Studies) Not event-specific; documents can be produced early OECD Consensus documents
  13. 13. 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
  14. 14. 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
  15. 15. 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)
  16. 16. “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 Parent Crop Donor, Transgene(s) and Delivery Process Characterization of Gene Product(s) Safety Assessment of New GM Crop/Food Identity, Phenotypic & Agronomic Performance Geographical Distribution History of Safe Use Compositional Analysis Description of Donor Description of Vector DNA Transgene Delivery Process Characterization of Introduced DNA Characterization of Insertion Site Structure, Identity and Characterization Mode of Action/ Specificity Toxicity Allergenicity Identity, Phenotypic & Agronomic Performance Compositional Analysis Nutritional Analysis Safety Analysis (Animal Studies) Substantially equivalent, except for the intended changes…
  17. 17. “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 Parent Crop Donor, Transgene(s) and Delivery Process Characterization of Gene Product(s) Safety Assessment of New GM Crop/Food Identity, Phenotypic & Agronomic Performance Geographical Distribution History of Safe Use Compositional Analysis Description of Donor Description of Vector DNA Transgene Delivery Process Characterization of Introduced DNA Characterization of Insertion Site Structure, Identity and Characterization Mode of Action/ Specificity Toxicity Allergenicity Identity, Phenotypic & Agronomic Performance Compositional Analysis Nutritional Analysis Safety Analysis (Animal Studies) OECD Consensus documents
  18. 18. 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
  19. 19. 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
  20. 20. 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
  21. 21. “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.]” POLICY ON RELEASE FOR PROPAGATION
  22. 22. APPLICATION TO RELEASE FOR PROPAGATION Applicant BPI Sufficient in Form & Substance? STRP For evaluation on risk assessment For conduct of public consultation Process & evaluate within 5 days of receipt YESNO APPROVED DENIED Within 90 days from acceptance Applicant shall publish Public Info Sheet in 2 newspapers, and invite comments w/in 30-day period. Grace period of 60 days to correct defects Shall submit report w/n 30 days BAFPS FPA BAI If pest-protected plant In all instances If intended as feed Shall submit report w/n 30 days Shall submit report w/n 30 days Shall submit report w/n 30 days Applicant Bureau of Agricultural and Fisheries Product Standards
  23. 23. 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
  24. 24. Outline Timeline for GR2 Approval
  25. 25. 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
  26. 26. 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 Grant China Child β-c bioconversion/bioefficacy (10g oil) 2011 USDA USA Adult β-c bioconversion/bioefficacy 2011 Future Grant Philippines Clinical Adult β-c bioefficacy 2013 Future Grant Philippines Community Adult β-c bioefficacy 2013 Future Grant Philippines Study of long term population benefit Post 2014 Source: Rob Russell and IRRI
  27. 27. Consumer acceptance activities • Rice taste panel (2011; 2012) • Consumer taste panel (2011; 2013) • Consumer research – Focus Group Discussion (2009) – Consumer Survey (2010)
  28. 28. PhilRice Golden Rice Team MILLING AND SENSORY: Marissa Romero, Ph.D. PILOT SEED PRODUCTION: Marlon Labuguen, MSc. COMMUNICATION AND PROMOTION: Andrei Lanuza, MSc. 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
  29. 29. Thank you www.harvestplus.org www.irri.org g.barry@cgiar.org

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