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<strong>Use</strong> <strong>of</strong> <strong>the</strong> <strong>ILSI</strong> <strong>Crop</strong> <strong>Composition</strong><br />

<strong>Database</strong><br />

Philip Brune<br />

Syngenta <strong>Crop</strong> Protection, LLC<br />

<strong>ILSI</strong> <strong>Crop</strong> <strong>Composition</strong> <strong>Database</strong> Working Group<br />

<strong>ILSI</strong>-Brasil Workshop, Brasília, Brasil, 6 November 2012


Outline<br />

• The role <strong>of</strong> compositional analysis in <strong>the</strong> safety<br />

assessment<br />

• <strong>ILSI</strong> <strong>Crop</strong> <strong>Composition</strong> <strong>Database</strong><br />

– Overview<br />

– Data acceptance requirements for quality samples<br />

– Extracting data from <strong>the</strong> database<br />

– Future plans


The Role <strong>of</strong> <strong>Composition</strong>al<br />

Analysis in <strong>the</strong> Safety Assessment:<br />

• Mode <strong>of</strong> action<br />

• Agronomic evaluation<br />

• <strong>Composition</strong>al analysis<br />

• Protein expression studies<br />

• Allergenicity assessments<br />

• Specific toxicity studies<br />

<strong>Composition</strong>al analysis provides<br />

information that is used in <strong>the</strong><br />

overall safety assessment <strong>of</strong> <strong>the</strong><br />

novel food/feed<br />

3


The Importance <strong>of</strong> <strong>Crop</strong> <strong>Composition</strong><br />

Why should food crops be analyzed?<br />

• <strong>Crop</strong> plants and <strong>the</strong>ir commodities such as oil,<br />

protein, and starch are <strong>the</strong> raw materials for <strong>the</strong><br />

manufacture <strong>of</strong> food products<br />

• Nutrients derived from food crops are essential for<br />

normal growth and development<br />

• <strong>Composition</strong>al analysis helps to ensure a safe and<br />

plentiful food supply


<strong>Composition</strong>al Analysis Study<br />

• Are <strong>the</strong>re differences between <strong>the</strong> GM crop and its non-GM<br />

comparator?<br />

– Key components selected for analysis (represent appropriate<br />

nutritional components and components <strong>of</strong> major metabolic<br />

pathways)<br />

• – Organization for Economic Co-operation and Development (OECD)<br />

guidance documents<br />

• How similar is <strong>the</strong> GM crop to what is considered to be <strong>the</strong><br />

conventional “safe” crop?<br />

– Substantial equivalence<br />

– Deviations beyond natural range may indicate fundamental changes in<br />

<strong>the</strong> plant (fur<strong>the</strong>r evaluation may be needed)<br />

5


Assessing Biological Relevance<br />

“The statistical significance <strong>of</strong> any observed differences<br />

should be assessed in <strong>the</strong> context <strong>of</strong> <strong>the</strong> range <strong>of</strong><br />

natural variations for that parameter to determine its<br />

biological significance.”<br />

Codex Alimentarius. 2003. Guideline For The Conduct Of Food Safety<br />

Assessment Of Foods Derived From Recombinant-DNA Plants.<br />

CAC/GL 45-2003.<br />

6


Characterization <strong>of</strong> Natural Variability<br />

in Biochemical <strong>Composition</strong><br />

• The interaction <strong>of</strong> crop genetic background with <strong>the</strong><br />

environment results in natural variability in <strong>the</strong> levels <strong>of</strong><br />

components<br />

• Natural variability must be considered when comparing<br />

biotech to conventional crops<br />

• An understanding <strong>of</strong> <strong>the</strong> natural variability in compositional<br />

analytes enhances <strong>the</strong> scientific basis for <strong>the</strong> concept <strong>of</strong><br />

substantial equivalence


<strong>ILSI</strong> <strong>Crop</strong> <strong>Composition</strong> <strong>Database</strong> (CCDB)<br />

• Task Force convened by <strong>ILSI</strong> <strong>International</strong> Food<br />

Biotechnology Committee (IFBiC) in 2001<br />

• Members <strong>of</strong> <strong>the</strong> Working Group:<br />

» Bayer <strong>Crop</strong>Science<br />

» BASF<br />

» Covance, Inc.<br />

» Dow AgroSciences<br />

» Monsanto<br />

» Pioneer/DuPont<br />

» Syngenta


<strong>ILSI</strong> <strong>Crop</strong> <strong>Composition</strong> <strong>Database</strong> (CCDB)<br />

A comprehensive public database that provides<br />

information on <strong>the</strong> natural variability in<br />

composition <strong>of</strong> conventionally-bred crops<br />

www.cropcomposition.org<br />

9


<strong>Database</strong> Overview<br />

– 3 crops (maize, soy, cotton) - conventional<br />

– 3 tissues (forage, seed/grain)<br />

– 94 unique analytes<br />

– 10 years (1995 to 2005)<br />

– 3000 samples; 115000 data points<br />

– Meta-data (method, country, location, year,<br />

variety, source)<br />

10


Versions <strong>of</strong> <strong>the</strong> <strong>Database</strong><br />

• Version 1.0 - Released 2003<br />

• Version 2.0 - Released 2004<br />

• Version 3.0 - Released 2006<br />

• Version 4.0 - Released 2010<br />

• Version 4.1 - Released 2011<br />

• Version 4.2 - Released 2011<br />

11


<strong>Database</strong> Improvements<br />

Version 3.0 Version 4.0<br />

Language Perl Java<br />

Hardware Early 2004 Late 2008<br />

GUI* Outdated Simple, Intuitive<br />

Speed 5 – 10 min 2 – 5 sec<br />

Units <strong>of</strong> measure Limited Flexible<br />

Data preview No Yes<br />

LOQ No Yes<br />

Data output Monitor Monitor, PDF, CSV<br />

*Graphical <strong>Use</strong>r Interface<br />

*Alba, R. et al., 2010, J. Food Comp. Analysis<br />

12


Data Acceptance Criteria<br />

• Samples used for analysis<br />

– Sample from a single plot at one location from a single<br />

controlled field trial (no averaging <strong>of</strong> values)<br />

– Location <strong>of</strong> <strong>the</strong> plot<br />

– Year <strong>of</strong> production and sample collection<br />

– Variety grown<br />

– Date <strong>of</strong> planting, harvesting, sample collection (not<br />

submitted as part <strong>of</strong> <strong>the</strong> data)


Data Acceptance Criteria<br />

• Analysis <strong>of</strong> samples<br />

– All data points are associated with a referenced method<br />

using certified or historically verified standards<br />

– Validated methods<br />

• list method and year <strong>of</strong> publication, provide references for<br />

modifications<br />

– Accredited / certified labs or labs experienced with <strong>the</strong><br />

specific methodology<br />

– Quality control checks in place<br />

– Records and data retained at least 5 years after submission


Natural Variability in Conventional Maize<br />

Total fat and Crude protein in conventional maize grain (v4.0). The<br />

analytes were measured in more than 1100 grain samples and <strong>the</strong><br />

data were binned prior to plotting <strong>the</strong> histograms. (Alba et al. 2010)<br />

15


Usage Statistics in 2010-2011<br />

Visitors/day: ~150 (unique)<br />

Page views/visit: ~6<br />

Busiest Days: Mondays & Fridays<br />

16


Relevance <strong>of</strong> <strong>Database</strong> to <strong>Use</strong>rs<br />

• Considered a valuable resource by:<br />

– Government Agencies<br />

– Scientific / Academic Institutions<br />

– FAO Food and Nutrition Division<br />

– OECD Task Force for <strong>the</strong> Safety <strong>of</strong> Novel Foods and<br />

Feeds<br />

– <strong>ILSI</strong> Task Force on Improved Nutrition <strong>Crop</strong>s<br />

17


Extracting Data From <strong>the</strong> <strong>Database</strong><br />

How to access <strong>the</strong> <strong>ILSI</strong> <strong>Crop</strong> <strong>Composition</strong><br />

<strong>Database</strong> (CCDB) and how to navigate through<br />

<strong>the</strong> different screens<br />

www.cropcomposition.org


Welcome Page (Screen 1)


Primary Search Criteria (Screen 2)


Summary <strong>of</strong> Search Results (Screen 3)<br />

More<br />

Below


Summary <strong>of</strong> Search Results (Screen 3)<br />

More<br />

Below


Summary <strong>of</strong> Search Results (Screen 3)<br />

More<br />

Below


Summary <strong>of</strong> Search Results (Screen 3)<br />

More<br />

Below


Summary <strong>of</strong> Search Results (Screen 3)


Report Options (Screen 4)


Report Output (Screen 5)<br />

(Summary Report)


Report Options (Screen 4)


Report Output (Screen 5)<br />

(Detailed Report)


Summary <strong>of</strong> Search Results (Screen 3)


Report Output (Screen 5)<br />

(Detailed Report)


Primary Search Criteria (Screen 2)


Summary <strong>of</strong> Search Results (Screen 3)


Summary <strong>of</strong> Search Results (Screen 3)


Summary <strong>of</strong> Search Criteria (Screen 3)


Summary <strong>of</strong> Search Criteria (Screen 3)<br />

Click on each<br />

to remove<br />

OR:<br />

Click here to begin new search


CCDB Search (Screen 5)


Report Options (Screen 4)


Report Output (Screen 5)<br />

(Tabular Report)


Future Plans<br />

• Better functionalities (Version 5.0)<br />

– Data upload tools<br />

– Curator interface tools<br />

• Complete upload <strong>of</strong> data for maize, soybean, and<br />

cotton (Version 5.0)<br />

• Add new crops, tissues, analytes<br />

examples: canola, wheat, rice, sugar beet, potato<br />

www.cropcomposition.org


Publications<br />

• Ridley et al, 2004 (Ridley, W.P., Shillito, R.D., Coats, I., Steiner,<br />

H-Y, Shawgo, M., Phillips, A., Dussold, P., Kurtyka, L, 2004.<br />

Development <strong>of</strong> <strong>the</strong> <strong>International</strong> <strong>Life</strong> Sciences Institute<br />

<strong>Crop</strong> <strong>Composition</strong> <strong>Database</strong>. Journal <strong>of</strong> Food <strong>Composition</strong><br />

and Analysis 17, 423-438.)<br />

• Alba R, Phillips A, Mackie S, Gillikin N, Maxwell C, Brune P,<br />

Ridley W, Fitzpatrick J, Levine M, Harris S (2010).<br />

Improvements to <strong>the</strong> <strong>International</strong> <strong>Life</strong> Sciences Institute<br />

crop composition database. J. Food <strong>Composition</strong> and<br />

Analysis 23:741-748.

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