Method for Organic Chemical Analysis of Municipal and Industrial Wastewater
Table of Contents
Chapter 1: Intoduction
1.1 Background
1.1.1 Statutory Authority
1.1.2 Current Office of Water Methods Approval Programs
1.2 The Streamlining Initiative
1.2.1 Streamlining Objectives
1.2.2 Benefits of Streamlining
1.2.3 Development of EPA's Streamlining Initiative
1.2.4 Implementation Issues
1.3 Propose of Guide
1.4 Content and Organization Issues
Chapter 2: Method Flexibility
2.1 Introduction
2.2 Existing Flexibility
2.3 Scope of Flexibility Provided by Streamlinging
2.3.1 Reference Method
2.3.2 Modificaitons to Front-end and Determinative Techniques
2.3.3 Method-Defined Analytes
2.3.4 Flexibility to Add New Target Analytes
2.3.5 New Methods, Screening Mehotds and Modified Methods
2.4 Controls on Flexibility
Chapter 3: Quality Control Requirements
3.1 introduction
3.2 Description of Tiers
3.3.1 Calibration Linearity
3.3.2 Calibration Verification
3.3.3 Absolute and Relative Retention Time Precision
3.3.4 Initial Precision and Recovery
3.3.5 Ongoing Precision and Recovery
3.3.6 Analysis of Blanks
3.3.7 Surrogate or Labeled Compound Recover
3.3.8 Matrix Spike and Matrix Spike Duplicate
3.3.9 Demonstration of Method Detection Limit
3.3.10 Reference Sample Analysis
3.4 Development of Quality Control Acceptance Criteria
3.4.1 Quality Control Acceptance Criteria Development for New Methods at Tier1
3.4.2 Quality Control Acceptance Criteria Development for New Methods at Tier2
3.4.3 Quality Control Acceptance Criteria Development for New Methods at Tier3
Chapter 4: Method Validation Requirements
4.1 Introduction
4.2 Summary of Validation Requirements
4.3 Description of Tier 1,2 and 3 Validation Studies
4.3.1 Tier 1 Validation Studies
4.3.2 Tier 2 Validation Studies
4.3.3 Tier 3 Validation Studies
4.4 Development of a Validatio Study Plan
4.5 Detailed Procedures for Conducting Tier 1,2 and 3 Validation Studies
4.5.1 Optional Preliminary Testing
4.5.2 Method Compilation
4.5.3 Method Detection Limit Study
4.5.4 Calibration
4.5.5 Initial Precision and Recovery
4.5.6 Field Sample Analyses
4.5.7 Ongoing Precision and Recovery
4.5.8 Calibration Verification
4.5.9 Contamination Level I Blanks
4.5.10 Surrogate or Labeled Compound Recovery
4.5.11 Absolute and Relative Retention Time
4.5.12 New Analytes
4.5.13 Further Validation Studies for New Methods
4.6 Validaation Study Report
4.6.1 Background
4.6.2 Study Design and Objectives
4.6.3 Study Implementation
4.6.4 Data Reporting and Validation
4.6.5 Results
4.6.6 Development of QC Acceptance Criteria
4.6.7 Data Analysis/Discussion
4.6.8 Conclusions
4.6.9 Appendix A - The Method
4.6.10 Appendix B - Validation Study Plan
4.6.11 Appendix C - Supporting Data
4.7 Reporting Validation Study Results
4.7.1 Reporting Validation Study Results for New Methods
4.7.2 Reporting Validation Study Results for Method Modifications
Chapter 5: Method Approval Process
5.1 Introduction
5.2 Pre-Submission Procedures
5.2.1 Method Development
5.2.2 Method Validation
5.2.3 Compilation of Information to Support Development of Preamble
5.2.4 Method Publication
5.3 Submission of Method Approval Application to EPA
5.4 EPA Review of Method Approval Application
5.5 Tier 1/Single-Laboratory Use Methods
5.6 Rulemaking Process
5.7 Proprietary Reagents, Instruments and Methods
Chapter 6: Assessing Method Equivalency
6.1 Introduction
6.2 Checking Completeness of the Method Validation Study Report Package
6.3 Assessing Equivalency Using the Checklists
6.4 Data Review Guidance
6.4.1 Standardized Quality Control
6.4.2 Details of Data Review
Chapter 7: Biological Methods
7.1 Introduction
7.2 New WET Methods
7.3 Modified WET MEthods
7.4 Validation Requirements
Appendices
Appendix A Acronyms and Symbols
Appendix B Glossary
Appendix C Current Method Flexibility
Appendix D Suggested Data Elements
Appendix E Equivalency Checklists
Appendix F Inorganic Criteria
Appendix G Bibliography
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