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COMMONWEALTH OF PENNSYLVANIA

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PA Bulletin, Doc. No. 96-1362a

[26 Pa.B. 3985]

[Continued from previous Web Page]

   Remedial investigations should be designed, to the extent known, based on knowledge of the site, historical activities at the site and chemicals used at the site. Performance standards are provided for those factors to be taken into account when investigating soil and groundwater contamination. These performance standards also address the data quality and reporting requirements for sampling and analysis activities. Copies of all laboratory data are required to be included in the report, regardless of whether the data has been eliminated from consideration by the person performing the remediation. Further guidance on the information required in the remedial investigation can be found in the Manual.

   If the municipality has requested the development of a community involvement plan, any public comments and the response to those comments must also be included in all plans and reports submitted under the site-specific standard.

   8.  Section 250.408.  Risk assessment report.

   The risk assessment report must describe the potential risks, or adverse affects, posed to humans and other ecological receptors under both current and planned future use of the site in the absence of any cleanup taking place and the methodologies and supporting documentation that are used to develop any site-specific cleanup levels and those levels will be proposed in a cleanup plan for the site.

   9.  Section 250.409.  Cleanup plan.

   The site-specific standard is the only one of the three standards which requires Department approval of the cleanup plan prior to implementation. The plan must describe those alternatives which were evaluated and the alternative which the remediator is proposing to implement, along with an analysis of how these alternatives were evaluated using the remedy selection criteria of section 304(j) of Act 2. The plan shall also include site maps, results of any treatability or small scale studies which were used to assist in the remedy evaluation process, a final design of the proposed remedy and a post-remediation care plan which addresses monitoring and maintenance of any continued treatment and any utilized engineered or institutional controls. Further technical guidance on the information needed in the cleanup plan can be found in the Manual.

   When the cooperation of a third party is necessary in order for the remediator to implement the remedy, the plan must also include documentation that cooperation has been obtained. This provision would be relevant in cases including extension of water supplies, installation of home treatment units for water supply wells and water use restrictions on other properties.

   10.  Section 250.410.  Final Report.

   Final reports submitted under the site-specific standard must contain the information necessary to document that the remedy, as approved by the Department in the cleanup plan, was implemented. This information must also include confirmation sampling and analysis methods, and documentation of compliance with any necessary post-remediation care requirements required by the approved cleanup plan.

Subchapter E.  Special Industrial Areas

   Special incentives were provided by Act 2 to encourage the cleanup and reuse of orphan sites and sites located in an enterprise zone. These incentives include streamlined cleanup requirements that apply only to the portions of the property that would prevent the property from being occupied for its intended purpose. While off-property releases must be investigated, the threats posed from these off-property areas are not required to be addressed by persons entering into SIA agreements. These incentives are only available to persons who did not cause or contribute to the contamination at the site and are only available for certain sites that have been used for industrial purposes.

   A baseline remedial investigation must be conducted prior to entering into a SIA agreement. The investigation will be the basis for establishing a person's liability protection for contamination at the property. Protection can only be given for contamination identified in this investigation; therefore, it would be in the remediator's best interest to conduct a thorough investigation.

   Section 250.502.  Eligibility determinations.

   This section identifies what a person must demonstrate in order for a property to qualify as an SIA.

   Section 250.503.  Remediation requirements.

   A person remediating an SIA must prepare a work plan that is reviewed and approved by the Department. Once approved, the work plan, which describes the baseline remedial investigation, is implemented. The baseline remedial investigation should be based on historical information and knowledge about the property, with environmental sampling on those areas of the property believed to be potentially contaminated. The investigation must identify existing contamination that poses an immediate, direct or imminent threat to public health or the environment which is inconsistent with the intended reuse of that portion of the property.

   The results of the baseline remedial investigation must be reported in a baseline environmental report that is submitted to the Department for approval. The report must include a remediation plan that addresses all immediate, direct and imminent threats to public health and the environment which would prevent the property from being occupied for its intended purpose. Subsection (d)(4) describes, at a minimum, what constitutes an immediate, direct or imminent threat. For those areas not included in the reuse plans, the report must address how access will be limited for workers and trespassers.

   Subsection (e) requires a person to enter into a Consent Order and Agreement with the Department, based on the baseline environmental report, in order to qualify for liability protection.

   Subsection (f) requires a person to notify the Department about any change in the use of the property from the use identified in the cleanup plan. These changes may result in the need for further remediation of the site if there are any immediate, direct or imminent threats.

   The municipality may request the development of a public involvement plan for properties going through the SIA process. If requested, public comments and the remediators' response to those comments must be included along with the baseline environmental report.

Subchapter F.  Exposure and Risk Determinations

   1.  Section 250.602.  Risk assessment procedures.

   Risk assessments may be conducted using either the methodologies utilized in development of the statewide health standards or the most recent EPA or ASTM guidelines. The assessment must define unacceptable risks to both humans and ecological receptors. The risk assessment must include the following components: identification of contaminants of concern and their concentration levels; an exposure assessment to identify pathways of concern and to determine the appropriate exposure assumptions; a toxicity assessment which evaluates toxicity of contaminants based on the oral reference dose for systemic toxicants and cancer slope factor for carcinogens; and a risk characterization which quantifies risk and determines whether the current site conditions meet the protection goals of Act 2.

   2.  Section 250.603.  Exposure factors for site-specific standards.

   This section explains which exposure factors should be used to perform an exposure assessment. Based on a recommendation of a subcommittee to SAB, the proposed regulations state that site-specific exposure factors shall be used and shall be clearly justified by supporting data. If site-specific exposure factors are not used, the exposure assessment must be based on the standard exposure factors used to develop the statewide health standards.

   3.  Section 250.604.  Fate and transport modeling requirements for exposure assessments.

   This section explains which models may be used to estimate site-specific, soil-to-groundwater leaching potential for organic contaminants. The soil-to-groundwater model in the statewide health standards, § 250.307(a)(2), may be used in site-specific exposure assessment. Because the model was based on a number of assumptions, SAB recommended and the Department agreed that only the values of Koc, water-filled soil porosity, dry soil bulk density, fraction organic carbon and the dilution factor in the model may be varied based on site-specific measurements.

   This section also recognizes that many fate and transport models and methods are available in EPA and ASTM guidelines. To ensure the proper application of groundwater models, the Department requires that EPA or ASTM quality assurance/quality control criteria, such as model verification, model calibration and model validation shall be followed.

   4.  Section 250.605.  Sources of toxicity information.

   When conducting the toxicity assessment, this section establishes sources of toxicology data that are acceptable for use and a hierarchy within these sources for selection of the most appropriate oral reference dose and cancer slope factor. This is the same protocol which was used to select the toxicity values used in generation of the statewide health standards.

   If no toxicity data is available in any of these defined sources, a person may use the background standard or may meet one of the following:  (1)  develop chemical-specific toxicity values in accordance with EPA guidance and based on published, peer-reviewed scientific literature or develop toxicity values from appropriately justified surrogates for the Department's review in the risk assessment report; or (2)  use the minimum threshold MSC as the site-specific standard, with an assumed risk of 1 × 10-5 for purposes of calculating cumulative risk for the regulated substances identified in Appendix A, Table 4.

   5.  Section 250.606.  Development of site-specific standards.

   If an unacceptable risk is identified through the risk assessment, a person may choose to eliminate the pathway or implement a remedy which abates the risks posed by that pathway to the protection levels established for site-specific standard remedies.

   Specific factors are provided for the assessment of risks posed by contaminated soil, contaminated groundwater in an aquifer, nonaquifer groundwater and ecological receptors. These factors include consideration of the fate and transport of released regulated substances through the environment, natural conditions that may affect this fate and transport, specified exposure pathways, current and future land use and the effectiveness of institutional or legal controls placed on the use of the land.

   6.  Section 250.607.  Risk assessment of remediation alternatives.

   This section explains that a risk assessment of remedial alternatives must evaluate long-term risks remaining after completion of the remediation and short-term risks that may be posed to the community, workers or the environment during the implementation of the remediation. The degree of uncertainty associated with the risk must be discussed in the risk assessment.

Subchapter G.  Demonstration of Attainment

   1.  Section 250.701.  Scope.

   This section describes the scope of the subchapter for demonstration of attainment. The subchapter clarifies what information and procedures are necessary to demonstrate attainment with the cleanup standards, where a release of a regulated substance has occurred.

   The section clarifies that the concentration of a regulated substance is not required to be less than the standard relating to the PQL, in accordance with § 250.7(a)--(d), for purposes of demonstrating attainment. The section also clarifies that attainment must be demonstrated at the points of compliance indicated by each subchapter pertaining to a cleanup standard.

   2.  Section 250.702.  Attainment requirements.

   This section explains that attainment will apply to the horizontal and vertical extent of soil and water identified as contaminated. SAB recommended, and the Department agreed, that the areas defined as contaminated are those areas that exceed the cleanup standard selected. Where separate zones of contamination exist on a property from multiple releases, attainment applies to each individual separate zone.

   This section also identifies what is required to be included in a final report to demonstrate attainment. The report must include a demonstration that the cleanup standard has been met, based on an analysis of data through the application of statistical tests and must include a demonstration of a statistical trend analysis, knowledge of the plume stability or other acceptable method that shows that the standard will not be exceeded at the point of compliance. For attainment of the site-specific standard, a demonstration of pathway elimination, if applicable, and a demonstration that the site does not exceed the least protective risk level provided for in Act 2 must be provided.

   3.  Section 250.703.  General attainment requirements for soil.

   This section explains that the data collected to demonstrate attainment of a cleanup standard for soil must be random, both horizontally and vertically, over the areal extent which was shown to be contaminated above the selected cleanup standard during the site characterization. This data varies spatially and is used to determine statistically whether or not attainment has been demonstrated. This data is not the same as the data used to characterize the site. The data is collected specifically for the determination of attainment. The number of samples needed is dependent on the site of the area.

   SAB recommended a general distinction between sites which are less than and those equal to or greater than 125 cubic yards. This figure was determined by the size of a pit (15 feet by 15 feet by 15 feet deep). In order to correspond with statistical methods used to demonstrate attainment, a minimum of eight sampling points are required for soil volumes less than 125 cubic yards. A minimum of 12 sampling points are required for soil volumes equal to or greater than 125 cubic yards.

   4.  Section 250.704.  General attainment requirements for groundwater.

   This section explains that a sufficient number of sampling points needed to demonstrate attainment with a cleanup standard must be installed, based on site-specific conditions, such as geologic characteristics, the size of the contaminated area, the number of aquifers impacted and whether contamination extends off the property. The data collection and statistical analysis for attainment must be performed for each individual well.

   In order to represent a valid conclusion, the number of samples used for analysis is dependent on the statistical test chosen. SAB identified and recommended a statistical test which is not data intensive or restrictive. In general, a minimum of eight quarters of groundwater data is needed to account for variability over time. SAB recommended, and the Department agreed, that only four quarters of data may need to be collected for cleanups resulting from recent spills or other conditions in which enough information exists to make scientifically sound assumptions regarding the source and the extent of the plume. In cases where vertical migration of contamination is significant or where more than one aquifer has been impacted, clusters of wells will be required at each point of compliance. A cluster consists of wells drilled and open to a specific vertical interval of interest.

   5.  Section 250.705.  Demonstration of attainment of surface water and air quality standards.

   This section requires that applicable State and Federal laws and regulations related to surface water and air must be met to demonstrate attainment with surface water and air media.

   6.  Section 250.706.  Statistical tests.

   This section specifies the requirements for using and applying statistical tests to demonstrate attainment. The statistical tests may also be used to establish background concentrations at a site, as required by the background standard subchapter. The statistical test used to establish background must correspond with the statistical test used to demonstrate attainment.

   The proposed regulations allow a person to choose between SAB's 75%/10x statistical test, a 95% UCL of the mean statistical test or other methods that meet specified performance standards for demonstrating attainment with the statewide health and site-specific standard. For the background standard in soil, a person may use a nonparametric UTL combined with the Wilcoxon rank-sum test or other methods that compare the population of analytical results of background samples with a population of the medium of concern and meet specified performance standards. For the background standard in groundwater, a person may use the nonparametric Tolerance Intervals, a retesting strategy using nonparametric Prediction Limits in accordance with EPA guidance or other statistical methods that meet specified performance standards. A nonparametric statistical test compares distributions rather than parameters and is intended to apply to a large class of distributions rather than a single distribution. A parametric statistical test estimates parameters, such as arithmetic average, and tests hypotheses concerning them. The assumptions generally specify the form of distribution.

   Except for SAB's 75%/10x test, the other tests identified in the proposed regulations are well documented in Federal guidances. The 95% UCL of the mean test is a parametric statistical procedure for determining whether the mean (average) concentration in the area of concern attains the cleanup standard. If the 95% upper confidence limit of the mean value is below the cleanup standard, the area of concern would be considered clean.

   The 75%/10x test was developed by SAB. This test requires that 75% of all samples collected for attainment purposes must be equal to or less than the standard with no individual sample exceeding ten times the standard. This test requires that a sufficient number of samples be collected in the field to provide an acceptable result in the test. Therefore, SAB recommended that a minimum of eight samples must be collected in order to reduce the false positive rate in the test. A false positive conclusion means that the statistical finding that the standard has been met is not representative of the overall field conditions at the site. To substantially reduce the false positive rate, SAB recommended the use of a minimum of eight samples in groundwater and a minimum of eight samples in soil equal to or less than 125 cubic yards.

   The attainment subcommittee of SAB evaluated six different tests or decision rules using statistical simulation:

   (1)  SAB 75%/10x test.

   (2)  SAB 75% test without 10x cap.

   (3)  A PaDEP statistical procedure for determining with 95% confidence (alpha=0.05) whether 75% of the site is less than the cleanup standard (the 75th percentile test).

   (4)  The PaDEP 75th percentile test in paragraph (3) with 10x cap.

   (5)  Upper 95% confidence limit of the mean value must lie below the cleanup standard (95% UCL).

   (6)  Wilcoxon Signed Rank test (alpha=0.05) of null hypothesis that population median equals cleanup standard versus alternative hypothesis that population median is below the cleanup standard.

   The tests were evaluated using log normal distributions with coefficients of variation (Cv) ranging from 0.5 to 4.0 and 5 to 40 samples.

   After a series of computer simulations, the Attainment Subcommittee had the following basic conclusions:

   (1)  With 5 samples, the 75%/10x test has somewhat indeterminate behavior, including an unacceptable high false positive rate (evaluated where 50% of the site remains contaminated).

   (2)  Despite its method, the 75%/10x test is not a test of whether 75% of a site is truly below the cleanup standard. With 10 to 20 samples, the 75%/10x test behaves more like a test of whether the population mean or median is below a cleanup standard. That is, its power curves are similar to those of the 95% UCL and the Wilcoxon Signed Rank test, which are testing the location of the mean and median, respectively. The power curve shows the change of probability to declare that the site attains cleanup standards as a function of the extent of cleanup.

   (3)  For sample distributions with lower variance (Cv=1), the power of the 75%/10x test is relatively insensitive if more than 10 samples are taken. Higher sample sizes improve the power of traditional tests as expected, while the power of the 75%/10x test remains relatively constant.

   (4)  For sample distributions with higher variance (Cv>1), the power of the 75%/10x test decreases as more than 10 samples are taken. With higher variances, the 10x cap begin to limit the probability of concluding ''clean'' because the probability of encountering a large value above the 10x cap increase quickly with sample size. Higher numbers of samples then become a penalty. This is an undesirable characteristic, because it penalizes a more thorough effort to demonstrate verification.

   (5)  The 75th percentile test has typical lower power than the other rules, since it is a true test of whether 75% of the site is below the cleanup standard, then rises quickly.

   (6)  With five samples, the 75th percentile test is a ''no exceedance'' rule. The 95% UCL and the Wilcoxon are essentially the same, since even one exceedance in five samples is usually enough to prevent the upper confidence limit or rank test from concluding ''clean.'' With 10 or more samples, the cleanup under the 75th percentile test would leave less of the site above the numeric standard than the cleanup would leave under the 95% UCL of the mean test or SAB 75%/10x test.

   The attainment subcommittee of SAB concluded that for numbers of samples in the 10--12 range, SAB ad hoc decision test (75%/10x) performed the best of the six methods examined, in determining when actual attainment was reached at a site. An alternative considered was a parametric test--the 95% upper confidence limit (UCL) of the mean test used by EPA. Because the 95% method generally requires much more data to be as sensitive, and because the 75%/10x appeared to statistically determine when a site was ''clean,'' the SAB recommended the use of the 75%/10x test with a 2x limit off property. The Department included both the 75%/10x and the 95% UCL of mean tests as options for the user. In addition, other methods can be proposed based on performance requirements of this section. The background determination was treated as comparison of range distributions between the background area and the area of attainment determination. The Department specifically requests comments on the use and efficacy of the 75%/10x statistical test.

   7.  Section 250.707.  Post-remediation attainment.

   This section applies to remediations that require the use of engineering or institutional controls to attain and maintain a cleanup standard beyond the time a final report is reviewed and approved by the Department. Implementation of a post-remediation care plan is required if engineering or institutional controls are needed to demonstrate attainment with a cleanup standard.

F.  Benefits and Costs

   Executive Order 1996-1 requires a cost/benefit analysis of the proposed regulations.

Benefits

   The proposed regulations provide significant benefits to the public, local government and the private sector. The public and local government are notified of plans to remediate sites, by the person who intends to perform the remediation, prior to the initiation of the cleanup. In the past, this notice was not required. In addition, for cleanups that involve the site-specific standard or SIAs, a person who is remediating a site must publish the availability of the opportunity for a municipality to become involved in the remediation and reuse plans for the site.

   These proposed regulations will encourage the voluntary cleanup and reuse of contaminated sites, restoring these sites to safe and productive uses, while promoting additional employment and tax revenues to distressed communities. The reuse of these sites will also reduce industrial development of greenfields sites.

Compliance Costs

   The Department does not anticipate new compliance costs associated with the proposed regulations. Costs to remediate contaminated sites should be reduced based on the availability of a release of liability for compliance with the cleanup standards. Act 2, however, does impose fees for the submission of plans and reports that are reviewed by the Department. These fees will be collected by the Department and will be used to implement the provisions of Act 2, including implementation of these regulations.

Compliance Assistance Plan

   Act 2 establishes an Industrial Sites Cleanup Fund, which is administered by the Department of Commerce. (Editor's Note: The Community and Economic Development Enhancement Act, Act 58 of 1996, created the Department of Community and Economic Development as the successor agency of the Department of Commerce.) The fund provides financial assistance to persons who did not cause or contribute to contamination on a property used for industrial activity and who propose to undertake a voluntary cleanup of the property.

   The Department has developed a technical guidance manual for the land recycling program. The Manual provides detailed, technical information on how to comply with Act 2 and the proposed regulations.

Paperwork Requirements

   The paperwork required by these proposed regulations is based on statutory requirements. Act 2 requires an NIR and final reports for all remediations. In addition, Act 2 requires the preparation of remedial investigation reports, risk assessment reports and cleanup plans for remediations that will attain the site-specific standard. For the remediation of special industrial areas, Act 2 requires the preparation of a work plan and a baseline remedial investigation report. Also, a person undertaking the reuse of a special industrial site is required to enter into an agreement with the Department based on the baseline remedial investigation report. The reports are an important aspect of the cleanup program because releases of liability will be based on the Department-approved reports that identify contamination and demonstrate compliance with a cleanup standard. The proposed regulations do not require additional paperwork.

G.  Pollution Prevention

   Pollution prevention approaches to environmental management often provide environmentally sound and longer-term solutions to environmental protection because pollution is prevented at the source. Generally speaking, pollution prevention refers to measures taken to avoid or reduce the generation of all types of pollution at their points of origin. These proposed regulations will be applied after the pollution has been generated and a person is remediating the property. It should be noted, however, that these proposed regulations are intended to encourage the reuse of contaminated sites and prevent the generation of pollution at a site that is not contaminated.

H.  Sunset Review

   These proposed regulations will be reviewed in accordance with the sunset review schedule published by the Department to determine whether the regulations effectively fulfill the goals for which it was intended.

I.  Regulatory Review

   Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), the Department submitted a copy of the proposed rulemaking on August 2, 1996, to the Independent Regulatory Review Commission (IRRC), and the Chairpersons of the Senate and House Environmental Resources and Energy Committees. In addition to submitting the proposed regulations, the Department has provided IRRC and the Committees with a copy of a detailed regulatory analysis form prepared by the Department in compliance with Executive Order 1996-1, ''Improving Government Regulations.'' A copy of this material is available to the public upon request.

   If IRRC has objections to any portion of the proposed regulations, it will notify the Department within 30 days of the close of the public comment period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for the Department, the Governor and the General Assembly to review these objections before final publication of the regulations.

J.  Public Comments

   Written Comments--Interested persons are invited to submit comments, suggestions or objections regarding the proposed regulation to the Environmental Quality Board, P. O. Box 8477, Harrisburg, PA 17105-8477 (express mail:  Rachel Carson State Office Building, 15th Floor, 400 Market Street, Harrisburg, PA 17105-2301). Comments received by facsimile will not be accepted. Comments, suggestions or objections must be received within 60 days of publication in the Pennsylvania Bulletin. Interested persons may also submit a summary of their comments to the Board. The summary shall not exceed one page in length and must also be received within 60 days following publication in the Pennsylvania Bulletin. The one-page summary will be provided to each member of the Board in the agenda packet distributed prior to the meeting at which the final regulations will be considered.

   Electronic Comments--Comments may be submitted electronically to the Board at RegComments@A1.dep.state.pa.us. A subject heading of the proposal must be included in each transmission. Comments submitted electronically must also be received by the Board within 60 days following publication in the Pennsylvania Bulletin.

K.  Public Hearings

   The Board will hold three public hearings for the purpose of accepting comments on this proposal. They will be held at 1 p.m. on the following dates:

September 17, 1996Ramada Inn--Allentown
1500 McArthur Road
Whitehall, PA
September 23, 1996Sheraton Inn--Pittsburgh North
910 Sheraton Drive
Mars, PA
October 3, 1996Holiday Inn
334 Arsenal Road (I-83, Exit 9E)
York, PA

   Persons wishing to present testimony at a hearing are requested to contact Sharon Freeman at the Environmental Quality Board, P. O. Box 8477, Harrisburg, PA 17105-8477, (717) 787-4526, at least 1 week in advance of the hearing to reserve a time to present testimony. Oral testimony is limited to 10 minutes for each witness. Witnesses are requested to submit three written copies of their oral testimony to the hearing chairperson at the hearing. Organizations are limited to designating one witness to present testimony on their behalf at each hearing.

   Persons with a disability who wish to attend the hearing and require an auxiliary aid, service or other accommodation in order to participate should contact Sharon Freeman at (717) 787-4526, or through the Pennsylvania AT&T Relay Service at (800) 654-5984 (TDD) to discuss how the Department may accommodate their needs.

JAMES M. SEIF,   
Chairperson

   Fiscal Note: 7-300. No fiscal impact; (8) recommends adoption.

Annex A

TITLE 25.  ENVIRONMENTAL PROTECTION

PART I. DEPARTMENT OF ENVIRONMENTAL PROTECTION

Subpart D. ENVIRONMENTAL HEALTH AND SAFETY

ARTICLE VI. GENERAL HEALTH AND SAFETY

CHAPTER 250.  ADMINISTRATION OF LAND RECYCLING PROGRAM

Subch.

A.  GENERAL PROVISIONS
B.  BACKGROUND STANDARDS
C.  STATEWIDE HEALTH STANDARDS
D.  SITE-SPECIFIC STANDARDS
E.  SIA STANDARDS
F.  EXPOSURE AND RISK DETERMINATIONS
G.  DEMONSTRATION OF ATTAINMENT

Subchapter A.  GENERAL PROVISIONS

Sec.

250.1.Definitions.
250.2.Application of remediation standards.
250.3.Management of contaminated media.
250.4.Groundwater determinations.
250.5.Aquifer determinations.
250.6.Current use and future use of aquifer groundwater.
250.7.Standards related to PQLs.
250.8.Public notice by applicant.
250.9.Public participation.
250.10.Fees.
250.11.Publication.
250.12.Applicability to solid waste facilities.
250.13.Measurement of regulated substances in media.

§ 250.1.  Definitions.

   The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

   ASTM--American Society for Testing and Materials.

   Act--The Land Recycling and Environmental Remediation Standards Act (35 P. S. §§ 6026.101--6026.909).

   Anisotropy--The variability of a physical property based on direction, for example, variation in permeability in relation to direction of groundwater flow.

   Enterprise zone--An area specially designated as an enterprise zone under requirements determined by the Department of Community Affairs or its successor agency for this responsibility.

   Heterogeneity--Nonhomogeneous structure, composition and physical properties.

   MCL--Maximum contaminent level.

   MSC--Medium-specific concentration.

   NIR--Notice of Intent to Remediate.

   NPDES--National Pollution Discharge Elimination System.

   PQL--Practical quantitation limit.

   Property--A parcel of land defined by the metes and bounds set forth in the deed for that land.

   Risk assessment--A process to quantify the risk posed by exposure of a human or ecological receptor to regulated substances. The term includes baseline risk assessment, development of site-specific standards and risk assessment of the remedial alternatives.

   SIA--special industrial area--A property where there is no financially viable responsible person to perform remediation on property located within an enterprise zone and where the property was used for industrial activity.

   Site--The extent of contamination originating within the property boundaries and all areas in close proximity to the contamination necessary for the implementation of remediation activities to be conducted under the act.

   TF--Transfer factor.

   Volatile compound--A chemical compound with a Henry's Law constant >1x10-5 atm-m3/mol and a molecular weight <200 g/mol.

§ 250.2.  Application of remediation standards.

   (a)  A person who is required to perform a site remediation under an enforcement action of the Department shall meet the following:

   (1)  Select one or a combination of the background standards contained in Subchapter B (relating to background standard), statewide health standards contained in Subchapter C (relating to statewide health standards) and site-specific standards, contained in Subchapter D (relating to site-specific standards).

   (2)  Demonstrate compliance with one of the standards in paragraph (1) by meeting the requirements of the act and this chapter.

   (b)  To qualify for liability protection under the act, a person conducting remediation shall comply with this chapter and the act. Administrative and procedural requirements for remediations listed in subsection (a)(1) and (2) shall be used in lieu of those requirements listed in this chapter to qualify for liability protection under the act.

   (1)  Persons remediating sites placed on the Pennsylvania Priority List shall comply with the Hazardous Sites Cleanup Act (35 P. S. §§ 6020.101--6020.1305), except for the cleanup levels which are set by the act.

   (2)  Persons remediating releases from storage tanks regulated under the Storage Tank and Spill Prevention Act (35 P. S. §§ 6021.101--6021.2104) shall comply with the requirements of the corrective action process, contained in Chapter 245, Subchapter D (relating to corrective action process for owners and operators of storage tanks and storage tank facilities and other responsible parties), except for the cleanup levels which are set by the act.

§ 250.3.  Management of contaminated media.

   (a)  Contaminated media removed for reuse, treatment or disposal shall be managed in accordance with the Solid Waste Management Act (35 P. S. §§ 6018.101--6018.1003), The Clean Streams Law (35 P. S. §§ 691.1--691.1001), the act of July 13, 1988 (P. L. 525, No. 93) (35 P. S. §§ 6019.1--6019.6), known as the Infectious and Chemotherapeutic Waste Law, the Air Pollution Control Act (35 P. S. §§ 4001--4015) and the regulations promulgated thereunder.

   (b)  The Department may waive procedural and operating requirements for onsite remediation activities based on a written demonstration of the criteria in section 902 of the act (35 P. S. § 6026.902).

§ 250.4.  Groundwater determinations.

   For the purpose of meeting groundwater standards, water and substances contained within it in a suspended or aqueous phase are contaminated media and substances that are in a separate phase are waste. The Department may require removal of waste during a remediation conducted under the act. The Department may waive procedural and operating requirements for onsite remediation activities based on a written demonstration of the criteria in section 902 of the act (35 P. S. § 6026.902).

§ 250.5.  Aquifer determinations.

   To qualify as groundwater in an aquifer, the water shall be in a geological formation, a group of formations or part of formations that exist beneath the site and the formation shall meet one of the following conditions:

   (1)  The geological formation or part of a formation is capable of supplying a developed spring or typically constructed well drilled in the formation with a yield of water year round in an amount greater than 200 gallons/day.

   (2)  The geological formation or part of a formation is supplying an existing developed spring or typically constructed well, regardless of quantity or quality, for drinking water or agricultural use.

§ 250.6.  Current use and future use of aquifer groundwater.

   (a)  Current drinking or agricultural use of groundwater in an aquifer, at the time contamination was discovered, shall be protected.

   (b)  Under the Statewide health standard, an aquifer under a site will be considered to be currently planned for future use and under the site-specific standard, an aquifer under a site will be considered to be available for probable future use if the following apply:

   (1)  The water for a present or future private water supply or public water supply system can be expected to rely on the groundwater in the vicinity of the site where contamination could reasonably migrate.

   (2)  The background quality of the water is of a quality that it could be used for drinking water or agricultural purposes, or both, with reasonable treatment--for example, point of use treatment.

   (3)  There are no other factors, such as local ordinances or deed restrictions, or similar prohibitions that exist on consumption, that reasonably would prevent the use of groundwater in the vicinity of the site where site contamination could reasonably migrate.

§ 250.7.  Standards related to PQLs.

   (a)  The PQLs shall be selected from the PQLs specified by the EPA as estimated quantitation limits (EQLs) in the most current version of the EPA RCRA Manual SW-846 (U. S. EPA, 1990. Test Methods for Evaluating Solid Waste, Physical/Chemical Methods. Third Edition. Office of Solid Waste and Emergency Response) for soil listed as ''low level soil'' and for groundwater listed as ''groundwater'' in accordance with the following:

   (1) For inorganic compounds, the PQLs under this chapter shall be the values listed for methods associated with analysis by Inductively Coupled Plasma (ICP) with the following exceptions:

   (i) For lead, cadmium, arsenic and selenium, values listed for the atomic absorption graphite furnace methods for water shall be used.

   (ii) Mercury shall be the value listed for the cold vapor method.

   (2) For organic compounds, the PQLs shall be the EQLs listed for the GC/Mass spec methods--for example, Method 8240 for volatile organic compounds.

   (b)  In cases where EQLs set by the EPA have a health risk that is greater (less protective) than the risk levels set in sections 303(c) and 304(b) and (c) of the act (35 P. S. §§ 6026.303(c) and 6026.304(b) and (c)), the MSC levels under the statewide health standards shall be used to demonstrate attainment.

   (c)  If an MCL or lifetime health advisory level (HAL) exists for a regulated substance, the MCL or lifetime HAL will be the standard regardless of whether it is higher or lower than the PQL.

   (d)  Nothing in this section restricts the selection of valid and generally accepted methods to be used to analyze samples of environmental media.

§ 250.8.  Public notice by applicant.

   (a)  Public notice shall be initiated by the applicant through an NIR. For remediations proposing the use of a site-specific standard or, for remediations under an SIA agreement, the public and the municipality where the site is located shall be provided a 30-day period, in the NIR, in which the municipality may request to be involved in the development of the remediation and reuse plans for the site.

   (b)  The remedial investigation report, the risk assessment report and the cleanup plan, prepared under a site-specific remediation, may not be submitted to the Department until after the initial 30-day public and municipal comment period following the submission of the NIR has expired.

   (c)  The baseline remedial investigation report, prepared under an SIA remediation, shall be submitted after the initial 30-day public and municipal comment period has expired.

§ 250.9.  Public participation.

   (a)  The publication date of the summary of the NIR in a newspaper of general circulation in the area of the site shall initiate the 30-day public and municipal comment period during which the municipality can request to be involved in the development of the remediation and reuse plans for a site being remediated to a site-specific standard or for remediation at an SIA.

   (b)  The person proposing remediation shall be responsible for developing and implementing a public involvement plan if the following circumstances exist:

   (1)  The remediation involves a site-specific standard or an SIA cleanup.

   (2)  A municipality, through its official representatives, has requested, in writing, to be involved in the development of the remediation and reuse plans within the 30-day public and municipal comment period identified in the notice to the municipality and the newspaper notice.

   (c)  If a public involvement plan has been initiated, the person proposing remediation shall, at a minimum, provide:

   (1)  Public access at convenient locations for document review.

   (2)  Designation of a single contact person to address questions from the community.

   (3)  A location near the remediation site for any public hearings and meetings that may be part of the public involvement plan.

   (d)  If a public involvement plan has been requested, it shall be submitted with one of the following:

   (1)  A remedial investigation report under a site-specific remediation.

   (2)  A baseline environmental report under an SIA cleanup.

§ 250.10. Fees.

   (a)  Except for the resubmission of a site-specific standard final report, resubmission of a cleanup plan, remedial investigation, risk assessment or final report will require payment of the appropriate fee identified in the act for each resubmission.

   (b)  The Department will disapprove a plan or report that is submitted without the appropriate fee.

§ 250.11.  Publication.

   The Department will publish a notice of its final actions on plans and reports in the Pennsylvania Bulletin.

§ 250.12.  Applicability to solid waste facilities.

   (a)  A release of a regulated substance at a solid waste facility which did not receive waste after the applicable trigger date in subsection (d) shall be remediated in accordance with this chapter and the act. The standard shall be attained at the point of compliance as determined in accordance with this chapter and the act.

   (b)  A release of a regulated substance at a solid waste facility which did not receive waste prior to the applicable trigger date in subsection (d) shall be remediated to background, as that term is defined in the act. Background shall be attained at the appropriate monitoring points as determined under the applicable hazardous, residual or municipal waste regulations.

   (c)  A release of a regulated substance at a solid waste facility, including an expansion, which received waste on or before, and after, the applicable trigger date in subsection (d) shall be remediated to one or a combination of the remediation standards in the act. In regard to hazardous waste facilities, the remedy selected shall also comply with the Resource Conservation and Recovery Act (42 U.S.C.A. §§ 6091--6986). The standard shall be attained at appropriate monitoring points as determined under the applicable hazardous waste, residual waste or municipal waste regulations.

   (d)  As used in this section, ''applicable trigger date'' means:

   (1)  July 26, 1982, for hazardous waste facilities.

   (2)  July 4, 1992, for residual waste facilities.

   (3)  April 9, 1988, for municipal waste facilities.

   (e)  Nothing in this section affects any closure requirements in the applicable hazardous, residual and municipal waste regulations contained in Subpart D, Articles VII--IX (relating to hazardous waste management; municipal waste; and residual waste management) other than those that set forth levels for releases of regulated substances that the facility shall achieve in contaminated media.

§ 250.13.  Measurement of regulated substances in media.

   (a)  For measuring regulated substances in soil and sediments, analyses shall be performed on a dry weight basis.

   (b)  For metals in soil, analyses shall be performed on total metals, except for hexavalent and trivalent chromium, which analyses shall be performed individually.

   (c)  For groundwater, samples for metals analysis shall be field filtered and field acidified in accordance with the most current version of the EPA RCRA Manual SW-846.

Subchapter B.  BACKGROUND STANDARD

Sec.

250.201.Scope.
250.202.Establishing background concentrations.
250.203.Points of compliance.
250.204.Final report.

§ 250.201.  Scope.

   This subchapter sets forth requirements and procedures for a person selecting the background standard, as provided in § 250.2 (relating to application of remediation standards).

§ 250.202.  Establishing background concentrations.

   (a)  Background concentrations shall be established using one of the following:

   (1)  A person chooses the default background concentrations based on standards relating to the PQLs described in § 250.7 (relating to standards related to PQLs).

   (2)  A person establishes background concentrations based on a remedial investigation.

   (b)  The background concentrations will be determined using analysis of samples of regulated substances present at the property but not related to any release at the property. If all areas on the property are affected by a release, background shall be determined at points off the property in accordance with § 250.204(f)(6) and (7) (relating to final report).

   (c)  Background concentrations shall be determined by a methodology that is statistically valid and consistent with the methodology used to demonstrate attainment.

§ 250.203.  Points of compliance.

   (a)  For attainment of a background groundwater standard, the point of compliance shall be throughout the contaminant plume, including areas of the plume that are outside the property boundary.

   (b)  For attainment of a background soil standard, the point of compliance shall be throughout the area of the soil that has become contaminated as a result of releases on the property.

   (c)  For attainment of a surface water quality standard, the following points of compliance shall be used:

   (1)  For point source discharges, compliance shall be measured at the point of discharge in accordance with limits specified in the NPDES permit.

   (2)  For purposes of determining compliance with surface water quality standards from a diffuse groundwater discharge, the person shall estimate the expected instream regulated substance concentrations, using mass balance techniques for groundwater/surface water mixing at design flow conditions. If the results indicate that surface water quality standards are being achieved, no action is required. If results indicate that surface water quality standards are not being achieved, further remedial action will be required. In the case of special protection waters, point source and diffuse discharges shall meet the applicable regulations and achieve water quality that does not preclude uses existing prior to the contamination from this source.

   (3)  For purposes of complying with surface water quality standards in a spring, the point of compliance is the point of discharge to the ground surface.

   (d)  For the emission of regulated substances to outdoor air, the point of compliance for any applicable air quality standard shall be as specified in the air quality regulations in Subpart C, Article III (relating to air resources).

§ 250.204.  Final report.

   (a)  For sites remediated under the background standard, the person conducting the remediation shall submit a final report to the Department which documents attainment of the selected standard. The final report shall include site characterization information in subsections (b)--(e). The site characterization shall be conducted in accordance with scientifically recognized principles, standards and procedures. The level of detail in the investigation and the methods selected shall sufficiently define the rate, extent and movement of contaminants. Interpretations of geologic and hydrogeologic data shall be prepared by a professional geologist licensed in this Commonwealth.

   (b)  As derived from specific knowledge of the subject property, historic use of the subject property or regulated substance usage information regarding the subject property, an appropriate number of sample locations should be investigated from the identified media of concern to characterize the nature and composition of the contaminants including the following:

   (1)  Source characterization or development of a conceptual site model.

   (2)  The vertical and horizontal extent of contamination above the selected standard within each media of concern.

   (3)  The direction and rate of contaminant movement within each media of concern.

   (4)  A determination of the appropriate remedial technology for each media of concern.

   (c)  Descriptions of sampling and decontamination methodologies and analytical quality assurance/quality control procedures should be included within a Sampling and Analysis Plan and Quality Assurance Plan. Copies of soil and geologic boring descriptions and as-built construction drawings of wells used for site characterization should be included in the report. Copies of laboratory analytical results and applicable laboratory quality control results should be included within the report, including historical data and data eliminated from consideration based on data validation protocols. Analytical results should be presented within the report in table form.

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