biosafety aspect of biotechnology product

Program for Biosafety Systems – http://pbs.ifpri.info/

Biosafety Considerations for Crops Improved Using Modern Biotechnology

Jeff SteinAsia 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

transferred in a precise way.Desired Gene

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

http://isaaa.us5.list-manage1.com/track/click?u=90d9912fca3d624d294e24b28&id=3c4f1932c4&e=fa5edbb8b5



Impact of GM Crops on BiodiversityJanet 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 ImpactsGraham 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 ApprovalsHerbicide 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. Philippineshttp://www.isaaa.org/gmapprovaldatabase/http://www.cera-gmc.org/GMCropDatabase

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


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


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

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 Documentswww.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)

http://www.oecd.org/


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(2013)22&doclanguage=en

OECD Consensus Documents

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2013)22&doclanguage=en


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

Environment

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biosafety systemsindonesia

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reduced pesticide

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evidenceimpact of gm

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