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Method 301 provides a set of procedures that the owner or operator of an affected source subject to requirements under 40 CFR part 63 can use to validate an alternative test method to a test method required in 40 CFR part 63, or to validate a stand-alone alternative test method based on established precision and bias criteria. This method describes the minimum procedures that you must use to validate an alternative test method to meet 40 CFR part 63 compliance requirements. This method includes minimum procedures to determine and document systematic error (bias) and random error (precision) of measured concentrations from exhaust gases, wastewater, sludge, and other media. It contains procedures for ensuring sample stability if such procedures are not included in the test method. This method also includes optional procedures for ruggedness and detection limits. The EPA is finalizing revisions to existing Method 301. The revisions include editorial, technical, and consistency changes in the language, tables, and equations of Method 301. Technical revisions include the specification of when certain procedures in Method 301 are required and when they are optional, and consistency changes include a requirement for the same number of samples to be analyzed independent of the approach chosen to validate the alternative method. Other revisions include revising the language for the bias acceptance criteria and adding a correction factor equation for a site specific determination of bias, requiring ruggedness testing and determination of a detection limit when using Method 301 as validation for multiple sources, requiring the same number of samples when using a quadruplicate sampling system or analyte spiking to reduce the amount of uncertainty in statistical calculations, and updating limit of detection procedures to incorporate media specific data. Method 301 was originally published on December 29, 1992 [57 FR 61970], as a field validation protocol method. On March 16, 1994, Method 301 was included in 40 CFR 63.7 [59 FR 12430] to validate alternative test method requests. To date, subsequent revisions of Method 301 have not been changed to distinguish requirements for site-specific applications of the method versus a single validation for multiple sources. The EPA recognized that there were a number of ways Method 301 could be clarified while reviewing submitted data and answering questions from facilities, environmental labs, and technology vendors on the application and requirements of the method. The changes are intended to improve the readability of the method and ensure that required calculations and acceptance criteria for each of Method 301's three validation approaches are clear. The revisions to Method 301 were proposed on December 2, 2016.