Current through Register Vol. 54, No. 45, November 9, 2024
Section 250.707 - Statistical tests(a) For regulated substances which are naturally occurring, the person shall compare the analytical results of background reference samples, that are representative of naturally occurring concentrations of regulated substances on the site, with the analytical results of the medium of concern onsite. For nonnaturally occurring regulated substances for which a known background condition exists, the person shall compare the analytical results of background reference samples, which are related to the migration of contaminants onto the site, with the analytical results of the medium of concern onsite. In addition, application of statistical tests for the background standard shall be as follows:(1) Soil. For soil, a person shall use one of the following statistical methods in subparagraphs (i)-(iii) and conditions relating to subparagraphs (i)-(iii) as described in subparagraphs (iv)-(vi) to demonstrate attainment of the background standard: (i) The person shall demonstrate that the highest measurement from the area of concern is not greater than the highest measurement from the background area. The Department may accept insignificant variances in numbers. The minimum number of samples to be collected is ten from the background reference population and ten from each distinct area of contamination.(ii) The Department may accept the use of a combination of the Wilcoxon rank-sum test (equivalent to the Mann-Whitney U test) and the quantile test for data from two populations. The application of these tests shall meet the criteria in subparagraphs (iv) and (vi).(iii) The Department may accept other appropriate statistical methods that meet the requirements of subparagraphs (iv)-(vi).(iv) For nonparametric and parametric methods under subparagraphs (ii) and (iii), the false-positive rate for a set of data applied to a statistical test may not be greater than 0.20. The minimum number of samples to be collected is ten from the background population and ten from each distinct area of contamination.(v) For parametric methods under subparagraph (iii), the censoring level for each nondetect (ND) shall be the assigned value randomly generated that is between zero and the limit related to the PQL.(vi) For nonparametric and parametric methods under subparagraphs (ii) and (iii), the application of a statistical method shall meet the criteria in subsection (d).(2) Groundwater for known upgradient release of a regulated substance. (i) The Department may accept the use of the nonparametric tolerance intervals that are applied in accordance with the procedures in subparagraphs (ii)-(vi) and (viii)-(x).(ii) The upgradient concentration shall be determined by sampling in a background reference well shown on the basis of characterization to exhibit the highest concentration and by demonstrating that the groundwater is representative of concentrations in groundwater that are migrating onto the site.(iii) The background reference well shall be sampled over a period of eight quarters to provide eight samples.(iv) From these eight samples, the highest concentration for each regulated substance shall be selected as the upper tolerance limit.(v) In each onsite well, eight samples shall also be collected during the same eight-quarter period.(vi) The upper tolerance limit shall be met in each onsite well. The maximum of data collected from each onsite well shall be at or below the upper tolerance limit.(vii) In lieu of subparagraphs (iv)-(vi), the Department may accept a retesting strategy using nonparametric prediction limit in accordance with current EPA guidance (EPA, Office of Solid Waste Management Division. "Statistical Analysis of Groundwater Monitoring Data at RCRA Facilities;" Addendum to Interim Final Guidance, EPA, Washington, D. C. June 1992). For each regulated substance, the highest concentration of the eight background reference samples shall be selected as the upper prediction limit, as determined by the most current EPA guidance.(viii) The application of a statistical method for groundwater background standard shall meet the criteria in subsection (d).(ix) For parametric methods, the censoring level for each nondetect (ND) shall be the assigned value randomly generated that is between zero and the limit related to the PQL.(x) In lieu of eight-quarter sampling in subparagraphs (iii) and (v), the Department may allow the eight samples to be taken during a period of four quarters, or less with written approval from the Department if the following criteria can be met: (A) There is adequate spatial monitoring of the plume upgradient of the property on which the release occurred which indicates a stable plume condition.(B) Parameters affecting the fate and transport of regulated substances within the plume have been fully evaluated.(C) Coefficient of variation for the eight samples collected over a 4-quarter period may not exceed 1.0 for metals and 2.0 for organic compounds.(D) The age of the plume is sufficiently well known to permit a judgement to be made regarding its stability and remediation of the souirce associated with the upgradient contamination is not currently or has not recently occurred.(3) Background groundwater conditions due to naturally occurring or areawide contamination. (i) To use this subparagraph for areawide contamination, the person performing remediation shall demonstrate to the Department, in writing, that the site conditions are due to areawide contamination and shall obtain the Department's approval to use this subsection.(ii) A minimum of 12 samples shall be collected from any combination of monitoring wells, including upgradient locations, if all data collected is used in determination of background concentrations.(iii) The same number of samples shall be collected within and representative of the area of groundwater contamination (plume) onsite as were collected in the upgradient sampling for each sampling event.(iv) The samples from the upgradient wells and the wells in the plume onsite shall be collected during the same sampling event.(v) Sampling may be accelerated so that all sampling events occur in as short a period of time as possible so as not to result in serial correlation in the data.(vi) The resulting values may be used with appropriate nonparametric or parametric methods to compare the two populations.(vii) The sampling results in the plume onsite may not exceed the sum of the background arithmetic average and three times the standard deviation calculated for the background area.(viii) The application of a statistical method for groundwater background standard shall meet the criteria in subsection (d).(ix) For parametric methods, the censoring level for each nondetect (ND) shall be the assigned value randomly generated that is between zero and the limit related to the PQL.(b) The following statistical tests may be accepted by the Department to demonstrate attainment of the Statewide health standard. The statistical test for soil shall apply to each distinct area of contamination. The statistical test for groundwater will apply to each compliance monitoring well. Testing shall be performed individually for each regulated substance identified in the final report site investigation as being present at the site for which a person wants relief from liability under the act. The application of a statistical method must meet the criteria in subsection (d). (1) For soil attainment determination at each distinct area of contamination, subparagraph (i), (ii) or (iii) shall be met in addition to the attainment requirements in §§ 250.702 and 250.703 (relating to attainment requirements; and general attainment requirements for soil). (i) Seventy-five percent of all samples, which shall be randomly collected in a single event from the site, shall be equal to or less than the Statewide health standard or the limit related to PQLs with no individual sample exceeding ten times the Statewide health standard.(ii) As applied in accordance with EPA approved methods on statistical analysis of environmental data, as identified in subsection (e), the 95% UCL of the arithmetic mean shall be at or below the MSC.(iii) For sites with a petroleum release where full site characterization, as defined in § 250.204(b) (relating to final report), has not been done in association with an excavation remediation, attainment of the Statewide health standard shall be demonstrated using the following procedure: (A) For sites regulated under Chapter 245 (relating to administration of the storage tank and spill prevention program) where there is localized contamination as defined in the document "Closure Requirements for Underground Storage Tank Systems" (DEP technical document 2530-BK-DEP2008), samples shall be taken in accordance with that document.(B) For sites not covered by clause (A), including all sites being remediated under an NIR under this chapter, samples shall be taken from the bottom and sidewalls of the excavation in a biased fashion that concentrates on areas where any remaining contamination above the Statewide health standard would most likely be found. The samples shall be taken from these suspect areas based on visual observation and the use of field instruments. If a sufficient number of samples has been collected from all suspect locations and the minimum number of samples has not been collected, or if there are no suspect areas, the locations to meet the minimum number of samples shall be based on a random procedure. The number of sample points required shall be determined in the following way: (I) For 250 cubic yards or less of excavated contaminated soil, five samples shall be collected.(II) For each additional 100 cubic yards of excavated contaminated soil, one sample shall be collected.(III) For excavations involving more than 1,000 cubic yards of contaminated soil, the remediator shall identify the number and locations of samples in a confirmatory sampling plan submitted to the Department. The remediator shall obtain the Department's approval of the confirmatory sampling plan prior to conducting attainment sampling.(IV) Where water is encountered in the excavation and no obvious contamination is observed or indicated, soil samples collected just above the soil/water interface shall be equal to or less than the applicable Statewide health MSC determined by § 250.308(a)(2)(ii) (relating to soil to groundwater pathway numeric values).(V) Where water is encountered in the excavation and no obvious contamination is observed or indicated, a minimum of two samples shall be collected from the water surface in the excavation.(VI) For sites where there is a release to surface soils resulting in excavation of 50 cubic yards or less of contaminated soil, samples shall be collected as described in this clause, except that two samples shall be collected.(C) All sample results shall be equal to or less than the applicable Statewide health MSC as determined using Tables 1-4 and 6 in Appendix A.(D) A vapor intrusion analysis is not necessary if the requirements of § 250.707(b)(1)(iii) are met in addition to the following: (I) At least one soil sample is collected on the sidewall nearest an inhabited building within the appropriate proximity distance to a potential vapor intrusion source and there are not substantially higher field instrument readings elsewhere.(II) Observations of obvious contamination and the use of appropriate field screening instruments verify that contamination has not contacted or penetrated the foundation of an inhabited building.(III) Groundwater contamination has not been identified as a potential vapor intrusion concern.(2) For groundwater attainment determination at each compliance monitoring well, subparagraph (i) or (ii) shall be met in addition to the attainment requirements in § 250.702 and § 250.704 (relating to general attainment requirements for groundwater). (i) Seventy-five percent of all samples collected within each monitoring well over time shall be equal to or less than the Statewide health standard or the limit related to PQLs with no individual sample exceeding both of the following: (A) Ten times the Statewide health standard on the property.(B) Two times the Statewide health standard beyond the property boundary.(ii) As applied in accordance with EPA approved methods on statistical analysis of environmental data, as identified in subsection (e), the 95% UCL level of the arithmetic mean shall be at or below the Statewide health standard.(3) In addition to the statistical tests identified in paragraphs (1) and (2), a person may use a statistical test that meets the requirements of subsection (d) to demonstrate attainment.(c) To demonstrate attainment of the site-specific standard, a person may use a statistical test identified in subsection (b)(1)(ii) and (2)(ii) where the 95% UCL of the arithmetic mean is below the site-specific standard or a statistical test that meets the requirements of subsection (d). The attainment test and the methodology used in the risk assessment to evaluate exposure concentrations shall be the same.(d) Except for the statistical methods identified in subsections (a)(1)(i) and (b)(1)(i) and (2)(i), a demonstration of attainment of one or a combination of remediation standards shall comply with the following: (1) When statistical methods are to be used for demonstration of attainment of Statewide health or site-specific standards, the null hypotheses (Ho) shall be that the true site arithmetic average concentration is at or above the cleanup standard, and the alternative hypothesis (Ha) shall be that the true site arithmetic average concentration is below the cleanup standard. When statistical methods are to be used to determine that the background standard is exceeded, the null hypothesis (Ho) shall be that the background standard is achieved and the alternative hypothesis (Ha) shall be that the background standard is not achieved.(2) A statistical method chosen shall comply with the following performance standards: (i) The underlying assumptions of the statistical method shall be met, such as data distribution.(ii) The statistical method shall be recommended for this use in Department-approved guidance or regulation and shall be generally recognized as appropriate for the particular remediation implemented at the site.(iii) Compositing cannot be used with nonparametric methods or for volatile organic compounds.(iv) For parametric methods, the censoring level for each nondetect shall be the assigned value randomly generated that is between zero and the limit related to the PQL.(v) Tests shall account for seasonal and spatial variability as well as temporal correlation of data, unless otherwise approved by the Department.(vi) Tests used to determine that the background standard is exceeded shall maintain adequate power to detect contamination in accordance with current EPA guidances, regulations or protocols.(vii) For the limits relating to the PQLs, Statewide health and site-specific standards, the false-positive rate for a statistical test may not be greater than 0.20 for nonresidential and 0.05 for residential.(viii) Statistical testing shall be done individually for each regulated substance present at the site.(3) The following information shall be documented in a final report when a statistical method is applied: (i) A description of the statistical method.(ii) A clear statement of the applicable decision rule in the form of statistical hypotheses for each spatial unit and temporal boundary including the applicable statistical parameter of interest and the specific cleanup standard.(iii) A description of the underlying assumptions of the method.(iv) Documentation showing that the sample data set meets the underlying assumptions of the method and demonstrating that the method is appropriate to apply to the data.(v) Specification of false positive rates and, in addition for the background standard, specification of false negative rates.(vi) Documentation of input and output data for the statistical test, presented in tables or figures, or both, as appropriate.(vii) An interpretation and conclusion of the statistical test.(e) The references identified in subsection (b)(1)(ii) and (2)(ii) are as follows:(1) EPA, Office of Policy, Planning and Evaluation, Methods for Evaluating the Attainment of Cleanup Standards, Volume 1: Soils and Solid Media, EPA 230/02-89-042, Washington, D. C. 1989.(2) EPA, Office of Solid Waste Management Division, Test Methods for Evaluating Solid Waste, SW-846 Volume II: Field Methods, EPA, November 1985, Third Edition.(3) EPA, Office of Solid Waste Management Division, Statistical Analysis of Groundwater Monitoring Data at RCRA Facilities, Interim Final Guidance, EPA, Washington, D.C., April, 1989.(4) EPA, Office of Solid Waste Management Division, Statistical Analysis of Groundwater Monitoring Data at RCRA Facilities, Addendum to Interim Final Guidance, EPA, Washington, D.C., June, 1992.(5)40 CFR 264 and 265 (relating to standards for owners and operators of hazardous waste treatment, storage, and disposal facilities; and interim status standards for owners and operators of hazardous waste treatment, storage, and disposal facilities).The provisions of this §250.707 amended November 23, 2001, effective 11/24/2001, 31 Pa.B. 6395; amended January 7, 2011, effective 1/8/2011, 41 Pa.B. 230; amended November 19, 2021, effective 11/20/2021, 51 Pa.B. 7173.The provisions of this §250.707 amended under sections 104(a) and 303(a) of the Land Recycling and Environmental Remediation Standards Act (35 P.S. §§ 6026.104(a) and 6026.303(a)); and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
This section cited in 25 Pa. Code § 250.702 (relating to attainment requirements); 25 Pa. Code § 250.703 (relating to general attainment requirements for soil); 25 Pa. Code § 250.703 (relating to general attainment requirements for soil); and 25 Pa. Code § 250.704 (relating to general attainment requirements for groundwater).