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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

Increasing IR-4 Laboratory Output

Emy Pfeil, Chair

Laboratory Scientific Review Committee

ir 4 laboratory vision statement
IR-4 Laboratory Vision Statement
  • To Provide High-Quality Residue Data for Incorporation into IR-4 Petitions for Minor-Use Registrations
new challenges
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
objectives
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
today s situation impediments to increasing output
Today’s SituationImpediments to Increasing Output
  • Methods
  • Staffing
  • Space
  • Operating Funds
  • Equipment
methods
Methods
  • Enforcement Methods are Getting More Complex
  • IR-4 Studies More Involved
  • MS/MS Methods Increasingly the Norm
staffing
Staffing
  • Need for More Bench Chemists/Analysts
space
Space
  • Freezer Space
    • Limited Capacity
    • Running Out in Some Labs
  • Laboratory Space
    • Fume Hoods
    • Bench Space
operating funds
Operating Funds
  • Not Mentioned as a Problem by All Labs
  • Supply and Service Contract Costs Rise Annually
equipment
Equipment
  • Changing Technology
  • Obsolescence

- Nearing or at end of lifespan for manufacturer support

- Reaching limits of sensitivity

today s situation what do we have
Today’s SituationWhat Do We Have
  • Inventory of Instrumentation and Other High-End Laboratory Equipment (Addendum to this Presentation)
  • Summary
high end equipment services
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)
tomorrow what do we need to
TomorrowWhat Do We Need to…
  • Maintain Current Levels of Output
  • Increase Output Levels

* = Priority Items

north central region lab
North Central Region Lab
  • * Additional HPLC-MS/MS
  • GC-MS/MS
  • Additional Bench Chemist / Analyst
  • Standardization of Procedures Throughout All Studies
southern region lab
Southern Region Lab
  • * Additional HPLC-MS/MS
  • * Upgrade of GC/MS instruments
  • * Additional GC-MS/MS
  • 2 New Rotary Evaporators
  • New Analytical Balance
western region lab
Western Region Lab
  • * Additional HPLC-MS/MS (Agilent 6430)
  • * SPEX Geno-Grinder
  • Additional GC-MS/MS (Agilent)
ars lab beltsville md
ARS Lab – Beltsville, MD

* HPLC-MS/MS (Waters or Thermo)

* GC-MS/MS (Thermo)

Operating Funds

Additional Bench Chemist/Analyst

ars lab wapato wa
ARS Lab – Wapato, WA
  • ** HPLC-MS/MS
  • GC-MSD or * GC-MS/MS
  • Centrifuge
instrumentation what will it cost
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)

how to meet these costs
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
recommendations for instrumentation purchases
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)
operating lease
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
key to symbols
Key to Symbols

 Still Working Reliably

 No Longer Reliable

 Unsupported by Manufacturer for Service

 Parts Limited or Unavailable from the Manufacturer

PM = Preventative Maintenance

north central region lab29
North Central Region Lab
  • High-End Equipment
    • Dionex ASE 200 (pre-2000) 
    • Peak Scientific Nitrogen Generator (2007) 
southern region lab32
Southern Region Lab
  • High-End Equipment
    • RobotCoupe Food Processors, 10 & 23 qt (2009) 
    • 6 Omni Homogenizers (10-20 yrs old) 
    • Rotor/Stator Blender (2006) 
western region lab35
Western Region Lab
  • High-End Equipment
    • Caliper Prelude GPC System (2003) (software)
    • Labconco Rapid Vac System (2009) 
    • Zymark TurboVap Workstation (~1993)
ars lab beltsville md38
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) 
ars lab tifton ga41
ARS Lab – Tifton, GA
  • High-End Equipment
    • Listing Not Provided
ars lab wapato wa44
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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