TSD FMD DIOO QACD IT. National Grain Center

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3 TSD FMD DIOO QACD IT National Grain Center

4 Operational Research and Development

5 Composition of the Biotechnology and Analytical Services Branch (BASB) Biotechnology Lab BASB Commodities Testing Lab Reference Labs

6 Development of GIPSA s Biotechnology Laboratory In 2001, the marketing structure of the U.S. grain industry had undergone significant changes GIPSA developed additional voluntary testing and process verification programs USDA sought public comment re: how USDA can best foster grain marketing in an evolving arena

7 GIPSA Biotechnology Lab Programs and Functions I. Administer Global Proficiency Program II. GE Rapid Test Kit Verification Program I. Respond to Inadvertently Released Products: a. Starlink corn b. Bt10 corn c. LL601 rice d. FP967 flaxseed e. RR wheat IV. Research related to detection/quantification methods and objective analysis of grain

8 Benefits of GIPSA s Biotech Proficiency Program Improves the consistency and reliability of testing for GE traits in grains No methods or reference material specified or provided Both protein and DNA-based methods acceptable First sample round disseminated in February 2002

9 Development of Proficiency Challenge Samples GIPSA receives new trait Grind GE and non-ge grain Gravimetric fortification Blend using V-blender Extract DNA Quantify DNA Gel Electrophoresis PCR Aliquot samples Mail to recipients

10 GIPSA s Biotechnology Proficiency Program Program Organizations 22 registered organizations in registered organizations in 2015 Continent Africa 1 Asia 17 Europe 35 North America 18 South America 7

11 GE Products Affect our Grain Marketing Needs To distinguish biotech from conventional crops, we need tests that are: Accurate Reliable Cost-effective Market compatible

12 GE Rapid Test Kits Facilitate Testing Throughout the Grain-Handling System

13 Supports industry s demand for accurate and reliable test kits Provides increased consumer confidence Confirms test kit performance claims GIPSA s Biotech Test Kit Program

14 1. Manufacturer submits data package supporting their claims. 2. GIPSA staff reviews submitted data. 3. If the data package is complete and claims of the kit are supported by the data, GIPSA conducts performance verification. 4. If kit passes GIPSA performance testing, a certificate of performance (COP) is issued.

15 Control Samples 120 independent analyses, using three different test lots, 40 samples for each lot. All test results must be negative for the GE protein of interest. Fortified Samples 120 independent analyses, using three different test lots, 40 samples for each lot, at the claimed detection threshold. All test results must be positive for the GE protein of interest.

16 Herculex RW EV 3272 LL and RR Corn/Soy GIPSA- Approved Test Kits MON MIR 162 MON MON863

17 Supports evolving technology Addresses consumers desire for increased testing Analyzes accuracy and precision between different methods GIPSA s Biotech Test Kit Program 17

18 1. Detection and quantification of trait 2. Confirmation of DNA-based detection methods 3. Multiplex and simplex PCR method verification 4. Design and implementation of proficiency program 5. Varietal ID, protein detection, and method optimization for tissue samples

19 Syngenta trait which contains VIP3A protein that is toxic to pests Deregulated for food and feed use in 2008 GIPSA approved a rapid test kit for detection of the protein in corn in 2009 Limit of detection for the two test kits commercially available are 1/400 and 1/1000 kernels

20 Highly processed matrix No reference materials No PCR method available No rapid test kit currently approved

21 GIPSA Biotechnology Lab Determine if Envirologix rapid test kit detects MIR162 protein Determine if Romer rapid test kit detects MIR162 protein Determine if PCR method detects DNA Technical Assistance to DIIA and FAS

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