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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 l.jpg

Increasing IR-4 Laboratory Output

Emy Pfeil, Chair

Laboratory Scientific Review Committee


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IR-4 Laboratory Vision Statement

  • To Provide High-Quality Residue Data for Incorporation into IR-4 Petitions for Minor-Use Registrations


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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


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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


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Today’s SituationImpediments to Increasing Output

  • Methods

  • Staffing

  • Space

  • Operating Funds

  • Equipment


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Methods

  • Enforcement Methods are Getting More Complex

  • IR-4 Studies More Involved

  • MS/MS Methods Increasingly the Norm


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Staffing

  • Need for More Bench Chemists/Analysts


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Space

  • Freezer Space

    • Limited Capacity

    • Running Out in Some Labs

  • Laboratory Space

    • Fume Hoods

    • Bench Space


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Operating Funds

  • Not Mentioned as a Problem by All Labs

  • Supply and Service Contract Costs Rise Annually


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Equipment

  • Changing Technology

  • Obsolescence

    - Nearing or at end of lifespan for manufacturer support

    - Reaching limits of sensitivity


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Today’s SituationWhat Do We Have

  • Inventory of Instrumentation and Other High-End Laboratory Equipment (Addendum to this Presentation)

  • Summary



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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)


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TomorrowWhat Do We Need to…

  • Maintain Current Levels of Output

  • Increase Output Levels

    * = Priority Items


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North Central Region Lab

  • * Additional HPLC-MS/MS

  • GC-MS/MS

  • Additional Bench Chemist / Analyst

  • Standardization of Procedures Throughout All Studies


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Southern Region Lab

  • * Additional HPLC-MS/MS

  • * Upgrade of GC/MS instruments

  • * Additional GC-MS/MS

  • 2 New Rotary Evaporators

  • New Analytical Balance


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Western Region Lab

  • * Additional HPLC-MS/MS (Agilent 6430)

  • * SPEX Geno-Grinder

  • Additional GC-MS/MS (Agilent)


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ARS Lab – Beltsville, MD

* HPLC-MS/MS (Waters or Thermo)

* GC-MS/MS (Thermo)

Operating Funds

Additional Bench Chemist/Analyst



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ARS Lab – Wapato, WA

  • ** HPLC-MS/MS

  • GC-MSD or * GC-MS/MS

  • Centrifuge


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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)


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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


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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)


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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


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Addendum:Specific Laboratory Inventories and Current Serviceability Status


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Key to Symbols

 Still Working Reliably

 No Longer Reliable

 Unsupported by Manufacturer for Service

 Parts Limited or Unavailable from the Manufacturer

PM = Preventative Maintenance




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North Central Region Lab

  • High-End Equipment

    • Dionex ASE 200 (pre-2000) 

    • Peak Scientific Nitrogen Generator (2007) 




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Southern Region Lab

  • High-End Equipment

    • RobotCoupe Food Processors, 10 & 23 qt (2009) 

    • 6 Omni Homogenizers (10-20 yrs old) 

    • Rotor/Stator Blender (2006) 




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Western Region Lab

  • High-End Equipment

    • Caliper Prelude GPC System (2003) (software)

    • Labconco Rapid Vac System (2009) 

    • Zymark TurboVap Workstation (~1993)




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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) 




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ARS Lab – Tifton, GA

  • High-End Equipment

    • Listing Not Provided




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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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