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Alternate Test Procedures
Draft Guide to Method Flexibility and Approval of EPA Water Methods
December 1996
This draft guidance document describes the principles and procedures for a comprehensive initiative to expand method flexibility and expedite approval of analytical methods for wastewater at 40 CFR parts 136. This initiative represents an effort to streamline EPA's water methods approval programs.
Federal Register Notice of Streamlining Proposal (March 28, 1997)
Complete document: Guide to Method Flexibility and Approval of EPA Water Methods (PDF) (248 pp., 862 K; About PDF)
- Chapter 1—Introduction
- Background
- The Streamlining Initiative
- Purpose of Guide
- Content and Organization of Guide
- Chapter 2—Method Flexibility
- Introduction
- Existing Flexibility
- Scope of Flexibility Provided by Streamlining
- Controls on Flexibility
- Chapter 3—Quality Control Requirements
- Introduction
- Description of Tiers
- Standardized Quality Control
- Development of Quality Control Acceptance Criteria
- Chapter 4—Method Validation Requirements
- Introduction
- Summary of Validation Requirements
- Description of Tier 1, 2, and 3 Validation Studies
- Development of a Validation Study Plan
- Detailed Procedures for Conducting Tier 1, 2, and 3 Validation Studies
- Validation Study Report
- Reporting Validation Study Results
- Chapter 5—Method Approval Process
- Introduction
- Pre-Submission Procedures
- Submission of Method Approval Applications to EPA
- EPA Review of Method Approval Applications
- Tier 1/Single-Laboratory Use Methods
- Rulemaking Process
- Proprietary Reagents, Instruments, and Methods
- Chapter 6—Assessing Method Equivalency
- Introduction
- Checking Completeness of the Method Validation Study Report Package
- Assessing Equivalency Using the Checklists
- Data Review Guidance
- Chapter 7—Biological Methods
- Introduction
- New WET Methods
- Modified WET Methods
- 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