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Procedures for Detection and Quantitation

Preliminary Draft Evaluation Criteria

September 30, 2005

At the June 21-22 meeting, you developed a list of "desirable characteristics" for the Technical Work Group to use in its initial analysis and evaluation of the technical merits of detection and quantitation procedures. You will see the results of this initial evaluation during this meeting.

You, as a Committee, also need to develop broad, policy-level criteria for evaluating a final package of detection and quantitation procedures to recommend to EPA. At the June meeting, you began the process of identifying these criteria by responding in your respective caucuses to the question, What does your interest group need from a final package of methodologies?

The table below presents the broad, policy-level criteria that each caucus identified as necessary in a final package of procedures. The facilitators have grouped these elements into three categories: those that must be met; those that are highly desirable; and those that are goals to work toward.

On September 30th, 2005, you will take the next steps to develop evaluation criteria for the package of recommendations as a whole.

Draft Evaluation Criteria based on Caucus Discussions, June 21, 2005
Caucus Must Be Met Highly Desirable Goals to Work Toward
States Address both detection and quantitation procedures Provide flexibility to implement use of detection and quantitation limits as public policy evolves Reward entities that strive to attain lower detection and quantitation limits where necessary (e.g., water quality)
States   Include protocols for advancement of technologies/sensitivity  
Environmental Laboratories Provide clear, consistent, technically-valid procedures to replace existing procedure in 40 CFR part 136 appendix B   Entice "non-compliant" laboratories to comply
Environmental Laboratories Provide guidance document (e.g., SW846 - method 5035A)   Be easy to use in a competitive environment
Environmental Community Provide confidence in detection and quantitation procedures at low enough levels to protect human health and the environment    
Environmental Community Give equal attention to false positives and negatives Choose procedure(s) that encourage more sensitive methods and equipmen  
Environmental Community Address matrices (e.g., sample interference)    
Environmental Community A procedure that reflects routine laboratory operation    
Industry Provide explicit definitions for a detection limit and a quantitation limit   Tailor different procedures for different regulatory uses
Industry Detection:
  • Must address false positives and false negatives
  • Reflective of routine performance
  • Define procedures for addressing matrix effects
   
Industry Quantitation suitable for regulatory compliance:
  • Explicit measurement quality objectives including precision and bias
  • Appropriate quality control procedures
  • Reflective of routine performance
   
Public Utilities Procedures that determine in an unambiguous and legally-defensible manner compliance with the Clean Water Act Procedures should apply to labs and analytical methods  
Public Utilities 40 CFR promulgated procedures that clearly define measurement quality objectives for different uses Procedures shouldn't preclude a qualified lab from conducting them Within reason, procedures should be driven by quality, not cost
Public Utilities Measurement quality objectives are needed for data quality indicators for both detection and quantitation    
Public Utilities Procedures allow assessment of ability to meet the measurement quality objectives on an ongoing, batch-by-batch basis
  • Calibration check at the quantitation limit with predetermined recovery rates
  • Method blank with maximum acceptable concentration as a percentage of the quantitation limit
   
EPA Be a complete, tested, understandable, written procedure    
EPA Include a statement of uncertainty level around detection and quantitation levels    
EPA Include a sense of method performance (QA/QC)    
EPA Include a procedure for validation and a procedure for laboratories    

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