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Increasing IR-4 Laboratory Output

Increasing IR-4 Laboratory Output. Emy Pfeil, Chair Laboratory Scientific Review Committee. IR-4 Laboratory Vision Statement. To Provide High-Quality Residue Data for Incorporation into IR-4 Petitions for Minor-Use Registrations . New Challenges.

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Increasing IR-4 Laboratory Output

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  1. Increasing IR-4 Laboratory Output Emy Pfeil, Chair Laboratory Scientific Review Committee

  2. IR-4 Laboratory Vision Statement • To Provide High-Quality Residue Data for Incorporation into IR-4 Petitions for Minor-Use Registrations

  3. New Challenges • Recover the Data Output Lost by the Closing of the Northeast Residue Laboratory • Average of 2-3 More Studies (17 Field Trials) / Lab • Merge into a Floating 30-Month Timeline • Match Industry Submission Time-Tables • Coordinate with EPA Petition Review Time-Slots • Coordinate with Bundled Project Submissions

  4. Objectives • Increase Residue Data Reporting Output • Incorporate Time-Line Flexibility into the Completion of the Residue Phase of IR-4 Studies • Maintain the Current Quality Level of the IR-4 Laboratory Data

  5. Today’s SituationImpediments to Increasing Output • Methods • Staffing • Space • Operating Funds • Equipment

  6. Methods • Enforcement Methods are Getting More Complex • IR-4 Studies More Involved • MS/MS Methods Increasingly the Norm

  7. Staffing • Need for More Bench Chemists/Analysts

  8. Space • Freezer Space • Limited Capacity • Running Out in Some Labs • Laboratory Space • Fume Hoods • Bench Space

  9. Operating Funds • Not Mentioned as a Problem by All Labs • Supply and Service Contract Costs Rise Annually

  10. Equipment • Changing Technology • Obsolescence - Nearing or at end of lifespan for manufacturer support - Reaching limits of sensitivity

  11. Today’s SituationWhat Do We Have • Inventory of Instrumentation and Other High-End Laboratory Equipment (Addendum to this Presentation) • Summary

  12. Current Instrumentation

  13. High-End Equipment & Services • All Labs Have Costly ($10-50K) Process-Related Equipment and Services. These include… • Accelerated Solvent Extractors • Gel Permeation Chromatography Systems • Food Choppers • Rotor/Stator Homogenizers • Analytical Balances • Refrigerated Centrifuges • High Purity N2 Generators (req'd. for HPLC-MS/MS systems) • High Purity Oil-Free Air Compressors (also for HPLC-MS/MS systems) • High Efficiency Rotary and Multi-position Evaporators • Instrument Service Contracts ($15-20K/year/instrument for HPLC-MS/MS)

  14. TomorrowWhat Do We Need to… • Maintain Current Levels of Output • Increase Output Levels * = Priority Items

  15. North Central Region Lab • * Additional HPLC-MS/MS • GC-MS/MS • Additional Bench Chemist / Analyst • Standardization of Procedures Throughout All Studies

  16. Southern Region Lab • * Additional HPLC-MS/MS • * Upgrade of GC/MS instruments • * Additional GC-MS/MS • 2 New Rotary Evaporators • New Analytical Balance

  17. Western Region Lab • * Additional HPLC-MS/MS (Agilent 6430) • * SPEX Geno-Grinder • Additional GC-MS/MS (Agilent)

  18. ARS Lab – Beltsville, MD * HPLC-MS/MS (Waters or Thermo) * GC-MS/MS (Thermo) Operating Funds Additional Bench Chemist/Analyst

  19. ARS Lab – Tifton, GA • * HPLC-MS/MS

  20. ARS Lab – Wapato, WA • ** HPLC-MS/MS • GC-MSD or * GC-MS/MS • Centrifuge

  21. Instrumentation:What Will It Cost? • New Research-Grade HPLC-MS/MS ($250-300K each) • New Research-Grade GC-MS/MS ($200-240K) • Other Needs (< $50K)

  22. How to Meet these Costs • PMC Leveraging / Lobbying Power • At IR-4 Headquarters • Stream-Lining the Size of Studies • Standardizing Procedures and Forms • Funding Increases • Congress/USDA-NPS Appropriations Level • PMC-Supported Funding

  23. Recommendations For Instrumentation Purchases • New, Used, Refurbished Equipment • All can be Financed or Leased • GSA Pricing • Multiple Instrument ‘Purchasing’ for All Programs • Instrument Leasing Programs • Lease to Own (~$100K/Instrument/Year) • Operating Lease (~$40K/Instrument/Year)

  24. Operating Lease • Renting for 3-5 years w/ the option to… • Return Instrument and Owe Nothing • Keep Instrument and Buyout Lease for the Fair Market Value (FMV) of the Instrument • Keep Instrument and Finance the FMV in Another Lease

  25. Addendum:Specific Laboratory Inventories and Current Serviceability Status

  26. Key to Symbols  Still Working Reliably  No Longer Reliable  Unsupported by Manufacturer for Service  Parts Limited or Unavailable from the Manufacturer PM = Preventative Maintenance

  27. North Central Region Lab - HPLC

  28. North Central Region Lab - GC

  29. North Central Region Lab • High-End Equipment • Dionex ASE 200 (pre-2000)  • Peak Scientific Nitrogen Generator (2007) 

  30. Southern Region Lab - HPLC

  31. Southern Region Lab - GC

  32. Southern Region Lab • High-End Equipment • RobotCoupe Food Processors, 10 & 23 qt (2009)  • 6 Omni Homogenizers (10-20 yrs old)  • Rotor/Stator Blender (2006) 

  33. Western Region Lab - HPLC

  34. Western Region Lab - GC

  35. Western Region Lab • High-End Equipment • Caliper Prelude GPC System (2003) (software) • Labconco Rapid Vac System (2009)  • Zymark TurboVap Workstation (~1993)

  36. ARS Lab – Beltsville, MD - HPLC

  37. ARS Lab – Beltsville, MD - GC

  38. ARS Lab – Beltsville, MD • High-End Equipment • AtlasCopco SF8FF Air Compressor (2005)  • ParkerHannifin NP2010 Nitrogen Generator (2001)  • Büchi Syncore Polyvap-Reactor Multi-Sample Evaporation / Reaction Module (2008)  • 2 Heidolf Laborata 4001 High-Efficiency REs (2007) 

  39. ARS Lab – Tifton, GA - HPLC

  40. ARS Lab – Tifton, GA - GC

  41. ARS Lab – Tifton, GA • High-End Equipment • Listing Not Provided

  42. ARS Lab – Wapato, WA - HPLC

  43. ARS Lab – Wapato, WA - GC

  44. ARS Lab – Wapato, WA • High-End Equipment • Peak NM20Z Nitrogen Generator (2003)  • 4 Rotary Evaporators (2 <6yrs, 2 ~1991)  • Grinders and Blenders (1993-2000)  • TurboVaps, Lg.& Low Vol. Units (15&7 yrs)  • Balances (analytical needs service) • BeckmanCoulter Refrigerated Centrifuge 

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