| (a) The person submitting data to the agency is responsible for the quality of the data. (b) The person shall provide data that are of sufficient and documented quality to meet the program and project objectives. The data package, including the supporting quality control data generated by the laboratory, shall be available upon a reasonable request by the agency within and up to three years after submittal of the report. The project data quality objectives should be included in the APAR, unless a response action is self-implemented in which case the project data quality objectives should be included in the RACR. These data quality objectives should include, but are not limited to: (1) the rationale for the sampling design, including the number, type, location and intended use of samples; (2) the levels of required performance (e.g., assessment level, critical PCL, attenuation action level) and the applicable method quantitation limit in accordance with subsection (e)(3) of this section for each COC; and (3) the precision, accuracy, representativeness, comparability, and data completeness objectives for the project. (c) The report shall indicate the type of sample (e.g., composite or discrete sample) that was collected and the method or standard operating procedure by which it was collected. Samples shall represent the environmental media of the affected property being monitored or assessed. Field quality control shall be adequate to demonstrate that the COC is present or absent from the environmental media. (d) The person shall ensure that the laboratory selected to perform the analyses of samples has in place an adequate and documented quality assurance program and the capability to meet the project and measurement objectives. The laboratory's quality assurance program must be compliant with the requirements in Chapter 25 of this title (relating to Environmental Testing Laboratory Accreditation and Certification), as amended, by July 1, 2008. For data generated on or before July 1, 2008, the person shall ensure the laboratory's quality assurance program is consistent with: (1) the International Organization for Standardization (Guide 25: General Requirements for the Competence of Calibration and Testing Laboratories (ISO 25, 3rd edition, 1990)(, as amended, or (2) the quality standards outlined in the National Environmental Laboratory Accreditation Program, as amended. (e) The person shall ensure the data are generated by a laboratory performing the analytical methods that meet the intralaboratory performance standards for the method and that those performance standards are sufficient to meet the bias, precision, sensitivity, representativeness, comparability, and completeness, as specified in the project data quality objectives. (1) The bias of the method may be demonstrated through the use of reference materials, comparison to alternative methods, or spiked samples. (2) The precision of the method may be determined by evaluation of relative standard deviation or the relative percent difference through the use of replicate analyses. (3) In order to address sensitivity requirements, the person shall select a standard available analytical method that provides a method quantitation limit below the necessary level of required performance for purposes of assessment as well as demonstration of conformance with critical PCLs. If it is not possible to achieve a method quantitation limit below the necessary level of required performance, and the COC does not meet the conditions of §350.71(k) of this title (relating to General Requirements), then the person shall select the standard available analytical method that provides the lowest possible method quantitation limit for that COC. The executive director may require that the person demonstrate that a lower method quantitation limit is not achievable or is not practicable, using standard available analytical methods. (4) The method detection limit shall be verified after major instrument maintenance or major changes in instrumentation or instrument conditions. The person shall ensure that the laboratory has performed and has documented an initial demonstration of proficiency for the analysis of each COC and each method used, and has also demonstrated, in a scientifically valid manner, and has documented the method detection limit the laboratory can achieve. This demonstration and documentation shall be preparatory and method specific and include any cleanup method used. The method detection limit should be routinely checked for reasonableness. (5) The representativeness of the method may be demonstrated by the laboratory through the use of proper storage, preparation, and subsampling techniques. (6) The standard available method may either be a documented method from the U. S. EPA, American Society for Testing and Materials, other organizations nationally recognized as having scientifically acceptable methods, or the executive director, or a laboratory method that is completely documented in an appropriate Standard Operating Procedure. All methods derived by a laboratory must meet the quality control criteria recommended in U.S. EPA Test Methods for Evaluation of Solid Waste, Update III, as amended, unless the project and/or samples require less stringent quality control requirements than those recommended in U.S. EPA Test Methods for Evaluation of Solid Waste, Update III, as amended. Such projects or samples which require less stringent quality control shall be clearly identified and the rationale for lower levels of quality control shall be documented. (A) Application of the method shall include the use of instrument calibration that brackets the value reported or includes a low standard that is below the necessary level of required performance, unless the method quantitation limit has been determined to be the necessary level of required performance in accordance with §350.78(c) of this title (relating to Determination of Critical Protective Concentration Levels). The calibration range shall yield results which demonstrate that the sample reporting level has not exceeded the necessary level of required performance after correction for sample weight or volume. (B) Laboratory control samples must be used to demonstrate that the method can produce results for the COCs that meet the bias and precision requirements at or below the necessary level of required performance or at the method quantitation limit in a clean laboratory matrix. The matrix must be similar to the medium of the environmental samples. Results for a sample spike may be substituted for the laboratory control samples, if the bias and precision criteria have been met. (f) The person shall identify any data that may be affected by laboratory deviations from the analytical method or by the laboratory's performance not meeting the project-required and/or method-required quality control acceptance criteria. The person shall also identify any data that may be affected by improper field procedures. (g) The person shall be responsible for having all documentation readily available to demonstrate that the sample integrity has not been compromised and that an appropriate analytical method has been used, and shall provide all reasonable information requested by the executive director. (h) The person shall: (1) report all results (corrected for sample weight or volume, sample preparations, and/or laboratory adjustments) greater than the method detection limit that meet the qualitative identification criteria recommended in the analytical method used, and shall use a qualifier flag on all those results reported as greater than the method detection limit and less than the method quantitation limit; and (2) report all non-detected results as less than the value of the sample detection limit; or (3) report as otherwise requested by the executive director when such reporting as specified in paragraphs (1) and (2) of this subsection is not warranted. (i) When reasonably appropriate, the executive director shall require persons to perform confirmation analysis for tentatively identified compounds. |
