Role of GMO Detection Methods in Trade - Impacts,...
Transcript of Role of GMO Detection Methods in Trade - Impacts,...
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Global Detection Methods and Reference Materials Symposium
Anne Bridges, AACC Intl
CropLife International, 15th - 16th October 2015
Minneapolis, Minnesota, U.S.A
Role of GMO Detection Methods in Trade - Impacts, Implications
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formerly the American Association of Cereal Chemists
• Global association of more than 2,000
scientists and food industry professionals from 70 countries
• Working to advance the understanding and knowledge of grain science Wheat, barley, rye … oats, rice, corn Pulses, ancient grains
• Product development, research, leadership, education, analytical methods, superior technical service, and advocacy
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Trade – description
• What is trade – USA 2014 exports total = $1,402,282 x 106
USA export agriculture = $150,466 x 106 = 11 % of Total *
USA import agriculture = $38,734 x 106
• Obligations of export and buyer
• Managed – by contract
• What components of agriculture trade can be measured? e.g. Quality, Food Safety, Contaminants, GMOs
• Sampling and Testing is important - Sampling is critical
• Test methods – speed, precision and accuracy
• Need the same result everywhere
* US Economic Research Service
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Codex Alimentarius - trade
• The C O D E X A L I M E N T A R I U S international food standards, guidelines and codes of practice contribute to the safety, quality and fairness of this international food trade. Consumers can trust the safety and quality of the food products they buy and importers can trust that the food they ordered will be in accordance with their specifications.
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Top 30 U.S.A. Agricultural Sources, 2012-14 average
Source: USDA Economic Research Service
Exports
Imports
USA Agriculture Trade
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World Grain System Characteristics • Most grain used for food, feed or processing is shipped
by bulk handling systems
• Bulk system is characterized by high volumes which achieve lower costs (economy of scale)
• Most of the world grain is used as feed – 72% of world corn production
– 60% of world oilseed production
• Specialty programs (value added rice, sweet corn, non GMO) need to function within this bulk handling infra structure
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Quality Attributes Protein, Ash, Moisture,
Oil Profile etc(Validated Methods)
Contamination
Sampling and Testing
3rd party analysis/audits
Standards (Regulations and Safety)
Management
Timing
Cost (terms/conditions)
International Contracts and Regulations
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Supply Chain
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Bulk Handling of Grain - USA
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Sampling and testing at each transfer – to grain contract
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In 2013, GMO crops were grown, imported and/or used in field trials in 70 countries
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Regulatory requirements are not harmonized globally Data requirements differ between countries
• Most are based on Codex Guideline for the Conduct of
Food Safety Assessment of Foods Derived from rDNA
Plants
• Some go beyond the Codex requirements
• Some trading blocks have very defined requirements
• Some countries are cooperating on assessments
• Politics can hold up or prevent approval
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Regulatory requirements are not harmonized globally Countries have differing approaches to regulating biotech products
• Single events vs. stacked events
• Food, Feed or Processed Food labelling
• Import for laboratory use
• Movement between states
• Authorized versus unauthorized events
• LLP policies How does testing fit into the regulatory framework?
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GMOs - categories, conditions and relative impact on trade • Approval process
• Risk assessment
• Labeling policies
• Traceability requirements
• Coexistence guidelines
• Membership in international agreements
• Exclusion of unapproved events
Ref. GMO Regulations, International Trade and the Imperialism of Standards Mauro Vigani, Valentina Raimondi and Alessandro Olper DOI: 10.2139/ssrn.1571202
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GMOs - categories, conditions and relative impact on trade • Approval process
• Risk assessment
• Labeling policies
• Traceability requirements
• Coexistence guidelines
• Membership in international agreements
• Exclusion of unapproved events
Ref. GMO Regulations, International Trade and the Imperialism of Standards Mauro Vigani, Valentina Raimondi and Alessandro Olper DOI: 10.2139/ssrn.1571202
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How does testing fit into a regulatory framework?
Some countries
Generally, testing for ‘GMO’ is not required…
• because biotech derived crops and their products are not considered substantially different from the conventional counterparts
• and most corn, soy, canola and cotton are Biotech-derived.
In these countries, testing is carried out only for export and specialist markets (such as organic, or produced without GMOs)
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How does testing fit into a regulatory framework?
In other countries
Generally testing for GMOs or proof of lack of GMO is required even if the GMO cannot be detected (e.g. oils)
Although some countries exclude these products
• these countries are generally importers of food
In these countries, testing is carried out on imports as they come into the country, and in some cases on processed foods
Some actively seek cases of non-compliance
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GMOs - categories, conditions and relative impact on trade • Approval process
• Risk assessment
• Labeling policies
• Traceability requirements
• Coexistence guidelines
• Membership in international agreements
• Exclusion of unapproved events
Ref. GMO Regulations, International Trade and the Imperialism of Standards Mauro Vigani, Valentina Raimondi and Alessandro Olper DOI: 10.2139/ssrn.1571202
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Labeling policies
• A label is not required or is just at proposal stage
• Voluntary GMO labelling
• Mandatory GMO label without threshold or with threshold >= 5%
• Mandatory GMO label with threshold <= 0.9%
• Countries declared GMO free
• Challenge - what determines the threshold?
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Is there a safety or scientific basis for thresholds – at what level?
• Labeling thresholds at 0.9%
– It is “less than 1%”
• 0 % threshold for LLP
– Does it consider the safety of the technology?
– Or the limits of sampling?
– Or the cost of testing to zero?
Market verses Safety
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GMOs - categories, conditions and relative impact on trade • Approval process
• Risk assessment
• Labeling policies
• Traceability requirements
• Coexistence guidelines
• Membership in international agreements
• Exclusion of unapproved events
Ref. GMO Regulations, International Trade and the Imperialism of Standards Mauro Vigani, Valentina Raimondi and Alessandro Olper DOI: 10.2139/ssrn.1571202
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Traceability requirements
• A GMO traceability process or an IP system is not required
• GMO traceability process is at proposal stage, or an IP system is in place
• Mandatory GMO traceability
• Countries declared GMO free
• Challenge to testing
• Oils and fats, sugar etc.
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GMOs - categories, conditions and relative impact on trade • Approval process
• Risk assessment
• Labeling policies
• Traceability requirements
• Coexistence guidelines
• Membership in international agreements
• Exclusion of unapproved events
Ref. GMO Regulations, International Trade and the Imperialism of Standards Mauro Vigani, Valentina Raimondi and Alessandro Olper DOI: 10.2139/ssrn.1571202
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Introduction of New Events Accelerating • In the first 13 years, 30 events were
commercialized
• In 2009-2015, it was expected that 90 events would be commercialized *
Examples: by 2015, 24 corn and 17 soybean events
• These events will be used in stacked products and are treated as new events by some regulatory systems
• Brazil 2012: 33 approved traits
• 5 soybean, 18 maize, 9 cotton, 1 bean * Stein & Rodríguez-Cerezo 2010
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Changes in origin of event development and commercialisation • By 2015, a number of commercial events will come
from South America and Asia and some will be for domestic markets/cultivation
• Asynchronous approvals are likely to increase
– Increased emergence of regionally approved events
– Zero Tolerance Policy becomes more of a problem
• Pragmatic Low Level Presence thresholds will be important in order to avoid major trade disruptions
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Argentina announcement - 05 Octubre 2015
• soybean resistant to drought • potato resistant to virus PVY
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Low Level Presence (LLP) • Refers to incidental small amounts of
biotech material that has been authorised in at least one country of cultivation, but is not authorised in the importing country
• Contributing factors
– Asynchronous approvals
– Unpredictable and politicized regulatory frameworks
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Global trade • Seed is used to produce grain and other agricultural
commodities
• Traded around the world
• Different regulatory systems and approvals
• Different detection methods and thresholds
• Harmonised approach to testing can help global trade
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Thank you
http://www.gipsa.usda.gov/fgis/commgallery/gr_srw.aspx