Increasing IR-4 Laboratory Output

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Transcript 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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Recover the Data Output Lost by the Closing of
the Northeast Residue Laboratory
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Average of 2-3 More Studies (17 Field Trials) / Lab
Merge into a Floating 30-Month Timeline
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Match Industry Submission Time-Tables
Coordinate with EPA Petition Review Time-Slots
Coordinate with Bundled Project Submissions
Objectives
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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
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Methods
Staffing
Space
Operating Funds
Equipment
Methods
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Enforcement Methods are Getting More
Complex
IR-4 Studies More Involved
MS/MS Methods Increasingly the Norm
Staffing
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Need for More Bench Chemists/Analysts
Space
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Freezer Space
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Limited Capacity
Running Out in Some Labs
Laboratory Space
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Fume Hoods
Bench Space
Operating Funds
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Not Mentioned as a Problem by All Labs
Supply and Service Contract Costs Rise
Annually
Equipment
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Changing Technology
Obsolescence
- Nearing or at end of lifespan for
manufacturer support
- Reaching limits of sensitivity
Today’s Situation
What Do We Have
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Inventory of Instrumentation and Other
High-End Laboratory Equipment
(Addendum to this Presentation)
Summary
Current Instrumentation
Number of….
HPLCs
GCs
NCR
SR
WR
BER
TIR
YAR
MS/MS
2
2
4
1
1
1
Other
2
1
2
-
-
-
-
1
MS/MS
-
-
MS or MSD
2
2
2
1
1
1
Other
2
3
3
2
2
3
High-End Equipment & Services
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All Labs Have Costly ($10-50K) Process-Related
Equipment and Services. These include…
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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…
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Maintain Current Levels of Output
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Increase Output Levels
* = Priority Items
North Central Region Lab
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* Additional HPLC-MS/MS
GC-MS/MS
Additional Bench Chemist / Analyst
Standardization of Procedures
Throughout All Studies
Southern Region Lab
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* Additional HPLC-MS/MS
* Upgrade of GC/MS instruments
* Additional GC-MS/MS
2 New Rotary Evaporators
New Analytical Balance
Western Region Lab
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* 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 Funds
Additional Bench Chemist/Analyst
ARS Lab – Tifton, GA
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* HPLC-MS/MS
ARS Lab – Wapato, WA
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** HPLC-MS/MS
GC-MSD or * GC-MS/MS
Centrifuge
Instrumentation:
What Will It Cost?
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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
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PMC Leveraging / Lobbying Power
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At IR-4 Headquarters
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Stream-Lining the Size of Studies
Standardizing Procedures and Forms
Funding Increases
Congress/USDA-NPS Appropriations Level
PMC-Supported Funding
Recommendations For
Instrumentation Purchases
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New, Used, Refurbished Equipment
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All can be Financed or Leased
GSA Pricing
Multiple Instrument ‘Purchasing’ for All Programs
Instrument Leasing Programs
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Lease to Own (~$100K/Instrument/Year)
Operating Lease (~$40K/Instrument/Year)
Operating Lease
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Renting for 3-5 years w/ the option to…
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Return Instrument and Owe Nothing
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Keep Instrument and Buyout Lease for the Fair
Market Value (FMV) of the Instrument
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Keep Instrument and Finance the FMV in Another
Lease
Addendum:
Specific Laboratory Inventories
and Current Serviceability Status
Key to Symbols
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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)
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Thermo-Finnigan MS/MS (2002)

(PM only)
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Waters vwUVD
(2000)
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(PM only)
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Waters vwUVD
(pre-2000)  
(PM only)

North Central Region Lab - GC
Agilent MS
(2004)
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Agilent MS
(2001)
 (PM only) 
Agilent ECD/FPD
(pre-2000)
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Agilent NPD/FPD
(pre-2000)

North Central Region Lab
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High-End Equipment
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Dionex ASE 200 (pre-2000) 
Peak Scientific Nitrogen Generator (2007) 
Southern Region Lab - HPLC
Thermo TSQ Ultra MS/MS
(2006)
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Thermo TSQ MS/MS
(2002)
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Hitachi Binary Pump Syst.
with Dual vwUVD
(pre-1999)
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Southern Region Lab - GC
HP 5890 II NPD/ECD
(2005 )
 (soon)
Agilent 6890/5973 EI MSD
(1999)
(software out of
Agilent 6890/5973 EI/CE MSD (1998)
(software out of
Agilent 6890 NPD/µECD
(1998)
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PerkinElmer Auto NPD/FPD
(1995)

used
date)
date)
Southern Region Lab
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High-End Equipment
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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)
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Agilent 6410B MS/MS
(2007)
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2 Applied Biosystems
API-2000 MS/MS
(1999 &
2000
(sensitivity an issue)
, one unit at WSU
)
Western Region Lab - GC
Agilent 6890/5975B MSD (2006)
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(1997, 1998 &
3 Agilent 6890/5973 MSD
2004)
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3 HP 5890s
(mid 1980s to
early 1990s)

Western Region Lab
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High-End Equipment
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Caliper Prelude GPC System (2003) 
Labconco Rapid Vac System (2009) 
Zymark TurboVap Workstation (~1993)
(software)
ARS Lab – Beltsville, MD - HPLC
Waters 2695 PCR/FLD/PDA
(2007)
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Waters 2695/Micromass
Quattro Ultima MS/MS
(2001)
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Agilent 1050 FLD/vwUVD
(1997)

(soon)
ARS Lab – Beltsville, MD - GC
Agilent 6890N NPD/FPD (2005)
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Shimadzu
GC17/QP5050A MS
(2004)
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HP 5890 II NPD/ECD
(1992)

(software)
ARS Lab – Beltsville, MD
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High-End Equipment
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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
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High-End Equipment
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Listing Not Provided
ARS Lab – Wapato, WA - HPLC
Applied
Biosystems
API-2000 MS/MS
(2003)
(operational status and
Agilent 1100
(1999)

sensitivity unreliable)
ARS Lab – Wapato, WA - GC
3 Agilent 6890s
(1999-2001) 
Agilent 5973 MSD
(1999)
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(software)
(questionable for near long-term)
ARS Lab – Wapato, WA
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High-End Equipment
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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 
BeckmanCoulter Refrigerated Centrifuge 
(analytical needs service)