Increasing IR-4 Laboratory Output

Emy Pfeil, ChairLaboratory 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

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

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 Methods Staffing Space Operating Funds Equipment

Methods

Enforcement Methods are Getting More Complex

IR-4 Studies More Involved MS/MS Methods Increasingly the

Norm

Staffing

Need for More Bench Chemists/Analysts

Space

Freezer Space Limited Capacity Running Out in Some Labs

Laboratory Space Fume Hoods Bench Space

Operating Funds

Not Mentioned as a Problem by All Labs

Supply and Service Contract Costs Rise Annually

Equipment

Changing Technology Obsolescence

- Nearing or at end of lifespan for manufacturer support - Reaching limits of sensitivity

Today’s SituationWhat Do We Have Inventory of Instrumentation and

Other High-End Laboratory Equipment (Addendum to this Presentation)

Summary

Current InstrumentationNumber of…. NCR SR WR BER TIR YAR

HPLCs MS/MS 2 2 4 1 1 1

 Other 2 1 - 2 - 1

GCsMS/MS - - - - - -

  MS or MSD 2 2 2 1 1 1

  Other 2 3 3 2 2 3

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)

TomorrowWhat Do We Need to…

Maintain Current Levels of Output

Increase Output Levels

* = Priority Items

North Central Region Lab

* Additional HPLC-MS/MS GC-MS/MS Additional Bench Chemist / Analyst Standardization of Procedures

Throughout All Studies

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

* Additional HPLC-MS/MS (Agilent 6430)

* SPEX Geno-Grinder Additional GC-MS/MS (Agilent)

ARS Lab – Beltsville, MD

* HPLC-MS/MS (Waters or Thermo)* GC-MS/MS (Thermo)Operating FundsAdditional Bench Chemist/Analyst

ARS Lab – Tifton, GA

* HPLC-MS/MS

ARS Lab – Wapato, WA

** HPLC-MS/MS GC-MSD or * GC-MS/MS Centrifuge

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

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 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

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

Addendum:

Specific Laboratory Inventories and Current Serviceability Status

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 Lab - HPLC

Waters MS/MS (2006)

Thermo-Finnigan MS/MS

(2002) (PM only)

Waters vwUVD (2000) (PM only)

Waters vwUVD(pre-2000)

(PM only)

North Central Region Lab - GC

Agilent MS (2004)

Agilent MS (2001) (PM only)

Agilent ECD/FPD(pre-2000)

Agilent NPD/FPD(pre-2000)

North Central Region Lab

High-End Equipment Dionex ASE 200 (pre-2000) Peak Scientific Nitrogen Generator

(2007)

Southern Region Lab - HPLC

Thermo TSQ Ultra MS/MS

(2006)

Thermo TSQ MS/MS (2002)

Hitachi Binary Pump Syst. with Dual vwUVD

(pre-1999)

Southern Region Lab - GC

HP 5890 II NPD/ECD(2005used

) (soon)

Agilent 6890/5973 EI MSD (1999) (software out of

date)

Agilent 6890/5973 EI/CE MSD

(1998) (software out of

date)

Agilent 6890 NPD/µECD (1998)

PerkinElmer Auto NPD/FPD (1995)

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 Lab - HPLC

Agilent 6430 MS/MS

(2009)

Agilent 6410B MS/MS

(2007)

2 Applied Biosystems API-2000 MS/MS

(1999 & 2000, one unit at

WSU)

(sensitivity an issue)

Western Region Lab - GC

Agilent 6890/5975B MSD

(2006)

3 Agilent 6890/5973 MSD

(1997, 1998 & 2004)

3 HP 5890s(mid 1980s to early 1990s)

Western Region Lab

High-End Equipment Caliper Prelude GPC System (2003)

(software)

Labconco Rapid Vac System (2009) Zymark TurboVap Workstation

(~1993)

ARS Lab – Beltsville, MD - HPLC

Waters 2695 PCR/FLD/PDA

(2007)

Waters 2695/Micromass Quattro Ultima MS/MS

(2001) (soon)

Agilent 1050 FLD/vwUVD (1997)

ARS Lab – Beltsville, MD - GC

Agilent 6890N NPD/FPD

(2005)

Shimadzu GC17/QP5050A MS

(2004) (software)

HP 5890 II NPD/ECD (1992)

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, GA - HPLC

Thermo-Finnigan TSQ Quantum MS/MS

(2003) (soon)

ARS Lab – Tifton, GA - GC

Agilent 6890 – ECD/MSD(2001)

Agilent 6890 – NPD/FPD(2001)

Perkin Elmer Auto ECD/NPD

(1993)

ARS Lab – Tifton, GA

High-End Equipment Listing Not Provided

ARS Lab – Wapato, WA - HPLC

Applied Biosystems API-2000 MS/MS

(2003) (operational status and sensitivity unreliable)

Agilent 1100 (1999)

ARS Lab – Wapato, WA - GC

3 Agilent 6890s(1999-2001)

(software)

Agilent 5973 MSD

(1999) (questionable for near long-term)

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