Biosafety Aspect of Biotechnology Product

Program for Biosafety Systems – http://pbs.ifpri.info/
Biosafety Considerations for Crops Improved
Using Modern Biotechnology
Jeff Stein
Asia Coordinator & Biosafety Advisor
Program for Biosafety Systems
Indonesia – 2014

Facts Summary
• Thousands of safety studies conducted over 20 years
– Studies follow accepted protocols
• Regulations based on international guidelines with
consideration for local implementation
• Safety is an integrated part of the product
development process
• Farmers have benefited

Plant Breeding and Biotechnology
Commercial
Cultivar
Improved
Commercial
Cultivar
Desirable genes are directly
Desired Gene transferred in a precise way.
Genes from plant
breeding

Claims About GM Crops
 GM crops/foods require no regulatory approvals
 Reduces biodiversity: harm birds, butterflies, amphibians,
marine ecosystems, soil organisms
• Creates ‘superweeds’
• Pollutes water resources
• Eliminates habitat
• Causes birth defects , embryonic deaths, hormone disruption,
and organ damage in animals
• Causes allergic reactions, intestinal disease, & autism

Benefits of Agbiotech: Supporting Evidence
A Meta-Analysis of the Impacts of GM Crops
Wilhelm Klümper & Matin Qaim,
Georg-August-University of Goettingen, Goettingen, Germany
http://dx.plos.org/10.1371/journal.pone.0111629.
Analysed 147 original studies conducted internationally
over the last 20 years
• 37% reduction in pesticide use
• 22% increase in crop yields
• Farmer profits >68% increase
• Yield & profit gains are higher in developing countries

Impact of GM Crops on Biodiversity
Janet Carpenter
GM Crop 2:1, 7-23 (2011) Landes Bioscience
• Analysed data from 15 years of peer reviewed literature (155 references)
from across the globe
• Conclusions:
– Increased yields: habitat preservation
• Reduced pressure to convert land to agriculture
– Significant reduction in pesticide use
• Improved worker safety & reduction in water pollution
– Reduced impact on biodiversity
• Preservation of non-target organisms and natural bio-control agents (IPM)
– Reduced soil erosion due to conservation tillage practices
– Use of environmentally benign herbicides

GM crops: Global Socio-economic and Environmental Impacts
Graham Brookes & Peter Barfoot
PG Economics Ltd, UK
• Based on a considerable volume of peer reviewed about economic and
other reasons behind farm level crop biotechnology adoption & with the
environmental impacts associated with the changes.
• Conclusions:
– Higher yields & profits
– Use of conservation tillage = reduced labor & energy costs
– Exceptional weed control
– Worker safety improved due to reduced pesticide use
– Improved harvest quality

Ag Biotech Regulatory Approvals
Herbicide tolerant Soybean (13 products approved)
Insect & Herbicide-tolerant Corn (>52 products approved)
Insect & Herbicide-tolerant Cotton (20 products approved)
Argentina Australia Brazil China EU Japan
Mexico Paraguay Philippines Russia Romania Taiwan
U.S. Uruguay Japan Korea Taiwan UK
Argentina Canada Brazil China EU Japan
Mexico Paraguay Philippines S. Africa Romania Taiwan &
Vietnam
U.S. Uruguay Japan Korea Columbia El Salvador
Argentina Australia Brazil China EU Japan
Mexico Burkina Faso India S. Africa Canada Columbia
U.S. Philippines
http://www.isaaa.org/gmapprovaldatabase/
http://www.cera-gmc.org/GMCropDatabase

Harmonized Biosafety Elements
Nations assess the safety of GM crops similarly
• Food & feed safety considerations
⁻ Toxicity
⁻ Allergenicity
⁻ Nutritional composition
• Environmental safety
⁻ Potential for the crop to become a weed
⁻ Impact of gene flow into sexually compatible wild or weedy species
⁻ Impact to non-target organisms - biodiversity

Administration of Regulatory Process: Canada
Health Canada
• Responsible for assessing food safety
•Directives consistent with international standards
• Toxicity, allergenicity, and nutrient composition
Canadian Food Inspection Agency
•Responsible for environmental safety issues
• Directives consistent with those used by international authorities
• Product performance, weediness, gene flow, non-targets, etc

Administration of Regulatory Process: Argentina
Secretariat of Agriculture, Livestock, & Fisheries
Biotechnology Directorate - environment
 CONABIA: National Advisory Committee
 Members: academics, industry, gov’t, professional associations
 Conduct risk assessment comparing GM crop with traditionally bred crops
National Service Agrifood Health & Quality (SENASA) - food
 CTA-UOGM: Technical Advisory Committee on GMOs
 Members: industry, civil society, producers, manufacturers
 Reviews safety and nutritional aspects of the GM food

Administration of Regulatory Process: U.S.A.
Integrated (coordinated) framework involves three federal
agencies to address biotech product safety
USDA: Environmental safety & protection of US agriculture
EPA: Environmental, food and feed safety
FDA: Feed and food safety

Have Regulators Responded to these Claims?
 Investigation of claims of harmful effects is a top priority for
regulatory agencies
 A combination of internal staff and external experts are tasked to
investigate the claim within a very narrow time frame
• Regulatory agencies have the authority to remove products from
the marketplace if a claim has been found to be scientifically
valid
In ~20 years, regulators have concluded that there
is NO scientific basis for any of the harmful CLAIMS reported
from the planting or eating of GM crops.

Safety is assessed at every stage in
the development and farmer use
of GM Crops
Lab
Greenhouse
Confined Field
Trials
General
release
Full safety
assessment

Biosafety - Integrated into the Product
Development Process
Development Phase Biosafety Activity
Gene selection/cloning (6 mos) *allergenicity
Transformation (12 mos) *unintended phenotypes
*integrity of DNA insert
Greenhouse studies(12 mos) *unintended phenotypes
Field trials (36 mos) *agronomic assessment
*impact to environment
*gene stability
Biosafety Assessment (30mos) *Mammalian toxicity
*nutrient composition
*environmental risk

Food Safety Assessments for GM Crops

Foundation of Safety Assessments
• Elements derived from expert consultations
– FAO
– WHO
– OECD
– United States Food and Drug Administration
– International Life Sciences Institute
– Codex Alimentarius Commission
http://www.fao.org/fileadmin/user_upload/gmfp/docs/CAC.GL_45_2003.pdf

1

Food Safety Considerations
• Three categories of safety assessments based on
international standards established by expert teams.
Mammalian Toxicity
Allergenic Potential
Nutritional Composition

FAO – WHO Decision Tree for Allergies

Allergy Assessment Results

Food Safety: Nutritional Analysis
As per International Standards (Codex):
 Examine levels of key nutrients and anti-nutrients
that are
 Established to be significant contributors to the human or animal
diet
 The targeted nutrient levels in the GM crop are
compared to
 a non-GM (conventional) counterpart
 values from the literature

OECD Consensus Documents
www.oecd.org
– Oilseed Rape (Brassica napus)
– Potato (Solanum tuberosum subs. Tuberosum)
– Wheat (Triticum aestivum)
– Rice (Oryza sativa)
– Soybean (Glycine max)
– Sugar Beet (Beta vulgaris)
– Maize (Zea mays subs. mays)
– Sunflower (Helianthus annus)
– Papaya (Carica papaya)
– Oyster Mushroom (Pleurotus spp.)
– Chili, Hot & Sweet Peppers (Capsicum annuum)
– Cotton (Gossypium spp.)
– Bananas and plantains (Musa spp.)
– Sugarcane (Saccharum ssp)

Series on Harmonisation of Regulatory Oversight in Biotechnology
No. 56
CONSENSUS DOCUMENT ON THE BIOLOGY OF SUGARCANE (Saccharum spp.)
JT03348639
http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(201
3)22&doclanguage=en
OECD Consensus Documents

Environmental Risk Assessments
Focus in 3 Areas
 What is the potential for the GM crop to have adverse effects on non-target
organisms?
 Does the GM crop exhibit any greater weed-like characteristics compared to its
non-GM counterpart?
 If potential for gene flow into wild/weedy species exists, what is the potential for
the novel trait to increase their weediness characteristics?

Environmental Risk Considerations
JT03348639
SECTION III - ORIGIN AND CULTIVATION .......................................................................................... 19
3.1 Centre of diversity and domestication ............................................................................................ 19
3.1.1 Geographic distribution............................................................................................................. 19
3.1.2 Commercial hybrid cultivars ..................................................................................................... 20
3.2 Cultivation ...................................................................................................................................... 21
3.2.1 Commercial propagation ........................................................................................................... 21
3.2.2 Scale of cultivation ................................................................................................................... 22
3.2.3 Cultivation practices ................................................................................................................. 24
3.3 Crop improvement .......................................................................................................................... 28
3.3.1 Breeding .................................................................................................................................... 29
3.3.2 Genetic modifications ............................................................................................................... 31

JT03348639
SECTION V - DEVELOPMENT ................................................................................................................. 37
5.1 Reproductive biology ..................................................................................................................... 37
5.1.1 Asexual reproduction ................................................................................................................ 37
5.1.2 Sexual reproduction .................................................................................................................. 37
5.2 Pollen dispersal and pollination ...................................................................................................... 38
5.3 Fruit/Seed development and dispersal ............................................................................................ 38
5.4 Seed germination ............................................................................................................................ 39
5.5 Vegetative growth .......................................................................................................................... 40

JT03348639
SECTION IX - WEEDINESS ...................................................................................................................... 57
9.1 Weediness status on a global scale ................................................................................................. 57
9.2 Control measures ............................................................................................................................ 58
SECTION X - HYBRIDISATION ............................................................................................................... 59
10.1 Intraspecific crossing ................................................................................................................ 59
10.2 Natural interspecific and intergenic crossing ............................................................................ 59
10.2.1 Natural interspecific crossing................................................................................................ 60
10.2.2 Natural intergenic crossing ................................................................................................... 60
10.3 Crossing under experimental conditions ................................................................................... 61
10.3.1 Species in Saccharum complex ............................................................................................. 61
10.3.2 Species outside Saccharum complex .................................................................................... 62

Conclusions
• Safety assessments of biotech crops were developed by teams
of international experts in:
– toxicology,
– genetics,
– molecular biology, and
– agricultural science
• The risk / safety assessment process has been built and tested
over nearly 20 years of cultivation across the world
– Across many environments
– Using improvements in safety assessment technology
• XXXX studies concluded GM crops are:
– Providing substantial economic benefits to small & large-scale farmers,
– Safe for human and animal consumption, and
– reducing agriculture’s environmental footprint

Thanks

Biosafety Aspect of Biotechnology Product

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