Golden Rice and Transgenic Strategies Progress and Implications'

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Golden Rice and Transgenic Strategies - Progress
and Implications.

• Gerard Barry
• Golden Rice Network Coordinator
• HarvestPlus Rice Crop Team Leader
• Head of the Intellectual Property Management Unit
• International Rice Research Institute

Harvesting Health Farming for More Nutritious
Foods Through Agricultural Technologies
HarvestPlus Biofortification Challenge Program
2004 ASA-CSSA-SSSA International Annual
Meetings Division A-6 International Agronomy
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Chronic Undernutrition among Children
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Rice in the Asian Diet(FAOSTAT 2001and 1999)
Total Calories/cap/day 2000 3000 Rice
contributes 30-75 of the Calories
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Estimated Annual Number of Child Deaths
Precipitated by Vitamin A Deficiency (Asia)
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Basic Carotenoid Biosynthetic Pathway
Carotenes
IPP
DMAPP
GGPP (C20)
Phytoene synthase Plant source
Phytoene (C40)
desaturation
Phytoene desaturase Bacterial source
Lycopene (C40)
(Lycopene cyclase) Bacterial source
cyclization
a - carotene
b - carotene
Xanthophylls
b-cryptoxanthin
canthaxanthin
a-cryptoxanthin
zeaxanthin
lutein
astaxanthin
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Carotenoid profile of Golden Rice

• Transgenic
• Control

?-carotene
lutein
b-cryptoxanthin
a-carotene
Rai et al (unpublished data)
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Organization of the Golden Rice Network
Philippines International Rice Research
Institute, National Rice Research Institute
(PhilRice) Vietnam Cuu Long Delta Rice Research
Institute Germany University of Freiburg India
Department of Biotechnology India, Directorate of
Rice Research, Indian Agricultural Research
Institute, University of Delhi - South Campus,
Tamil Nadu Agricultural University, Agricultural
University Pantnagar, University of Agricultural
Sciences Bangalore, Chinsurah Rice Research
Station Bangladesh Bangladesh Rice Research
Institute China Huazhong Agricultural
University, Chinese Academy of Sciences, Yunnan
Academy of Agricultural Sciences Indonesia
Agency for Agricultural Research Development
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The contexts in which Golden Rice will undergo
regulatory review

• VAD remains a very large problem in the lead
  countries India, China, and the Philippines.
• These countries have approved GM crops for
  commercial production India and Philippines 1
  each China 6.
• GM rice has been approved for commercial sale in
  USA, and expected soon for import in EU
• Expect that prior to Golden Rice
• 2(3?) GM rice products will be commercialized
• 2(?) GM products substantially equivalent,
  except for the intended changes/ nutritionally
  enhanced will be commercialized
• There is a lot GM rice activity, worldwide.
• Some changes in the regulatory systems may have
  occurred by then

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Estimated Annual Number of Child Deaths
Precipitated by Vitamin A Deficiency (Asia)
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VAD in China current situation

• The deaths of over 20,000 children each year from
  increased susceptibility to infection.
• Cause vitamin A deficiency
• Approximately 12 of China's children growing up
  with lowered immunity, leading to frequent ill
  health and poor growth.
• Cause vitamin A deficiency (the prevalence of
  vitamin A deficiency in children under 6 is
  estimated at 12).

Vitamin Mineral Deficiency A damage assessment
report for China. Micronutrient Initiative and
UNICEF 2004
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VAD in China

• Resp. for 7.5 of estd. deaths of children 6-59
  mo. old
• 206, 000 deaths over the past ten years.
• Halving the prevalence would have saved 49,000
  child lives.
• the western provinces (28 of the pop.) lt50
  of deaths
• ...most of deaths avoided with Vitamin A
  supplementation were among children with
  sub-clinical forms

Only population-wide interventions to reduce the
prevalence of sub-clinical deficiency are likely
to have any significant impact on the problem...
Ross et al. (2003) Biomedical and Environmental
Sciences 16, 187-193. Source data Lin et al.,
2002 Survey on Vitamin A deficiency in children
under 6-years in China. Chinese Journal of
Preventative Medicine 36 (5) 315-319
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Prevalence of Vitamin A Deficiency (VAD) by
RegionPhilippine Nutrition Facts and Figures
(National Nutrition Survey, 1998)
Children, 6 Mos to 5Y Pregnant Women
Lactating Women
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Trends in the Prevalence of Vitamin A Deficiency
(by Age, and by Physiological State 1993
1998)
Philippine Nutrition Facts and Figures (National
Nutrition Survey, 1998)
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LLRICE06, LLRICE62Adapted from original
documents at http//agbiosafety.unl.edu/
Rice lines LLRICE06 and LLRICE62 tolerant to
glufosinate ammonium, the active ingredient in
phosphinothricin herbicides (Basta, Rely,
Finale, and Liberty) The gene encoding the
enzyme phosphinothricin-N-acetyltransferase (PAT)
was isolated from the common aerobic soil
actinomycete, Streptomyces hygroscopicus. LLRICE06
and LLRICE62 were tested in field trials to show
that they did not exhibit weedy characteristics,
or negatively affect beneficial or non-target
organisms, and were not expected to impact on
threatened or endangered species. The
nutritional composition of rice was found to be
equivalent to conventional varieties. Assays were
completed for anti-nutritional factors normally
concentrated in the bran fraction of rice, such
as phytic acid, trypsin inhibitor, and lectins.
Summary of Regulatory Approvals Country Environm
ent Food and/or Feed United States 1999
2000 EU Pending (Food/Feed)
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Number of Transgenic Rice Field Test Applications
Worldwide (USDA and OECD databases, January
2004)
Tests have also been conducted in China 1000
(1995-2003) India 5 (2003-2004) Philippines 1
(2003) Korea 5? (1999- ) Colombia 1
(2001?) Costa Rica 1 (2002?) Based on pers.
commun. secondary and tertiary sources
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European Network on Safety Assessment of
Genetically Modified Food (ENTRANSFOOD)
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
• Draft guidance document for the risk assessment
  of genetically modified plants and derived food
  and feed. 25 May 2004, Brussels
• http//www.efsa.eu.int/consultation/483/presentati
  on_gmo_03_intro_hak_may20041.pdf
• Reports published in Food and Chemical
  Toxicology, 42 (7) 2004

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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
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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
OECD Consensus documents crop and composition
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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
Substantially equivalent, except for the intended
changes
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The contexts in which Golden Rice will undergo
regulatory review

• The same one event will be advanced in all
  countries
• Some countries may advance the same varieties at
  the same time.
• The introduced genes are from a plant and a soil
  bacterium
• The event will be marker-free or use the PMI
  system, will have single-locus, single intact
  insert, genome location mapped
• Ex ante assessments of contribution to reduction
  in VAD will be based on actual data

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Carotenoid profile of Golden indica (BR29) rice
(pre- and post-cooking)
?-carotene

• Transgenic
• Control

• Transgenic
• Control

?-carotene
lutein
b
lutein
a
a-carotene
a-carotene
B-cryptoxanthin
B-cryptoxanthin
(a) grains without cooking (b) grains
cooked in excess water
Rai et al (unpublished data)
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• Thank you!