EPA Method 2431

This document (“protocol”) provides guidance on how the U.S. Environment Protection Agency (EPA) will evaluate certain test procedures under its National Alternate Test Procedure program for inclusion as a new, approved 40 CFR Part 136 method (“new method”). The protocol applies to new alternate test procedures (ATP) for measuring an organic or inorganic analyte for which there is already an existing Part 136 method when the new method uses a different determinative technique to measure the analyte.

The protocol outlines in substantial detail the kind of information and evidentiary showing EPA would expect is necessary to demonstrate the suitability of a new method for approval and inclusion in Part 136 (§ 136.4(c)). This protocol also includes guidance regarding obtaining approval of new methods for measurement of method-defined analytes or parameters (MDPs) that use a determinative technique that is different than the existing Part 136 methods.