1. Achieving Method Compliance with Innovative Technologies Tony Francis, PhD Principal, SAW Environmental tfrancis@sawenviro.com TCEQ – Environmental Trade Fair and Conference May 3-4, 2016

2. Background The EPA is the gatekeeper for determining approved and accepted methods for each environmental program. Analytical equipment manufacturers create new and innovative technologies leading to greater accuracy and precision. There is often lag time between current capabilities and method approval. Conflict between method requirements and technology sometimes occur.

3. Questions What drives innovation? How do methods change? What constitutes an acceptable method? How do laboratories and regulatory authorities confirm method compliance while allowing for the best technologies available?

4. What drives innovation? Technology, instrument, and reagent manufacturers are constantly creating new technologies and improve existing ones. For what purpose?

5. What drives innovation? Technology, instrument, and reagent manufacturers are constantly creating new technologies and improve existing ones. For what purpose?

6. What drives innovation? For increased accuracy and precision. This is an effective tool for science. Better technology, better data, and better decision making by the end user. Technology, instrument, and reagent manufacturers are constantly creating new technologies and improve existing ones. For what purpose?

7. How do methods change? Revisions to analytical methods (EPA, Standard Methods, ASTM, etc.) generally take a lengthy amount of time. The EPA’s Office of Science and Technology amended 40 CFR Part 136 (136.6) to add explicit authority to modify many steps of an approved CWA method without EPA approval. The EPA is tasked with approving methods for each environmental program (CWA, SDWA, RCRA)

8. How do methods change? Method modifications are generally not allowed for method-defined parameters (e.g., n-hexane extractable material (HEM) ) or methods for SDWA compliance. Cases like this require a revision of the method and/or acceptance under 40 CFR Part 141.

9. What constitutes an acceptable method? EPA Approved methods are evaluated and approved by the EPA and cited in the Federal Register and compiled in 40 CFR. EPA Accepted methods have been reviewed and accepted for use in compliance monitoring. Generally not published in the FR or CFR but usually have an acceptance letter. Instrument/reagent manufacturers will often “package” approved or acceptance method into kits.

10. How do laboratories and regulatory authorities confirm method compliance while allowing for the best technologies available? Confirming Method Compliance

11. Example: HEM analysis using Horizon Technology’s Oil and Grease Extractor (SPE-DEX) HEM is a performance based method. A note at the beginning of the method, EPA 1664A, states: “…it is the responsibility of the discharger/generator and laboratory to assure that results produced are equivalent to results produced by the procedure below." Confirming Method Compliance - HEM

12. Approved modifications do not necessarily imply any modification is allowed. Common, but unacceptable, changes to the method include: pH measurements, sample volume measurements, subsamples The laboratory must show, through proper QC, the results obtained are equivalent to the described procedure. Confirming Method Compliance - HEM

13. Example: Hach TNT Methods Packaged kits that contain all the reagents for a specific method in one box. Same chemistries as the approved EPA method (ammonia, phosphorus, COD) Confirming Method Compliance - TNT

14. Benefits include: Simplified procedure Consistency Traceability Obstacles include: Knowledge of method Troubleshooting Must verify system, batch, and matrix QC Confirming Method Compliance - TNT

15. Example: Perkin Elmer NexION 300Q mass spectrometer Can be used in Standard Mode, Collision Mode, or Reaction Mode depending on the interferences of the matrix. However, collision and reaction modes are not allowed for drinking water compliance (EPA method 200.8). Confirming Method Compliance - MS

16. Method requires mathematical interference correction equations rather than available technologies to suppress interferences. Laboratory must show the requirements of method 200.8 are met through Standard Mode. Confirming Method Compliance - MS

17. Conclusions Greater accuracy and precision drives innovation. Technologies often advance at a faster rate than methods can be revised. The EPA authorizes methods and modifications for each environmental program. When allowed, laboratories must confirm method compliance while utilizing the best technologies available through system, batch, and matrix QC.

18. Questions? Tony Francis, PhD SAW Environmental 801-999-8293 tfrancis@sawenviro.com