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The Advisory Committee for Biotechnology and 21st Century Agriculture (AC21)

The Advisory Committee for Biotechnology and 21st Century Agriculture (AC21) Accuracy for Quantitative Testing of Biotechnology Derived Grains Steven N. Tanner, Director, Technical Services Division December 5, 2003. GIPSA and Biotechnology. Facilitate U.S. grain markets

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The Advisory Committee for Biotechnology and 21st Century Agriculture (AC21)

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  1. The Advisory Committee for Biotechnology and 21st Century Agriculture (AC21) Accuracy for Quantitative Testing of Biotechnology Derived Grains Steven N. Tanner, Director, Technical Services Division December 5, 2003

  2. GIPSA and Biotechnology • Facilitate U.S. grain markets • When testing is needed, ensure reliability and credibility of testing for transgenic grains and oil seeds

  3. USDA/GIPSA Proficiency Program • Improve the reliability of testing for biotechnology events • 86 organizations now participating • Corn events: T25, CBH351, MON810, GA21, E176, Bt11 and NK603; TC1507 and MON863 to be added in FY 2004 • Soybeans: Glyphosate tolerance

  4. USDA/GIPSA Proficiency Program Global Program AreaFeb 2002Nov. 2003 Africa 0 1 Australia 0 1 Asia 1 8 Europe 5 39 South America 1 10 North America 15 27 Total Participants 22 86

  5. USDA/GIPSA Proficiency Program • Voluntary participation • Participant anonymity • Offered quarterly • Qualitative and quantitative • Results on GIPSA’s biotechnology web page

  6. USDA/GIPSA Proficiency Program Observations General Observations • Participants use protein and DNA-based tests • Qualitative results correct > 90 % of the time Quantitative Sample Results: • Average results were lower than target level • Coefficients of variation (CV’s) ranged from ~30 to >100 % • False negatives/positives were < 10 % except at lowest levels (i.e., 0.1 %)

  7. Relative Measurement Variability AnalyteSTD*CV (%)* 1 ppb 0.45 45 1 ppm 0.16 16 1 % 0.04 4 DNA-Based Testing** STD RangeCV Range 0.1 % 0.06-0.50 80-190 1.5 % 0.50-1.15 42-93 5.0 % 1.12-4.20 36-90 *Horwitz predicted values **Actual values reported in Proficiency Program (% by wt)

  8. Testing Challenges • Methods - Patent Protection/Intellectual Property - Limited official protein-based methods - No globally recognized methods for conventional or real time PCR • Reference Materials - Limited availability - No general agreement (seed, grain, plasmids, etc.)

  9. Addressing the Challenges • International Collaboration of Quantitative Methods • Real Time PCR Techniques • DNA Isolation Procedures • DNA Quantitation Technologies • International Reference Materials: GIPSA and NIST Workshop on June 27, 2003

  10. GIPSA/NIST Workshop Recommendations • Protein and DNA reference materials • Matrix reference materials • Global convention for expressing results

  11. Key Organizational Cooperation • USDA GIPSA • NIST • Life Science Organizations • Institute for Reference Materials and Measurements (IRMM/Europe) • National Research Council (NRC/Canada) • National Food Research Institute (NFRI/Japan) • International Organizations (Codex, ISO, CEN, AOAC-I, AACC, and AOCS)

  12. USDA Biotechnology Webpage www.usda.gov/gipsa/ biotech/biotech.htm

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