PROPOSED RULEMAKING
ENVIRONMENTAL QUALITY BOARD
[ 25 PA. CODE CH. 250 ]
Administration of the Land Recycling Program
[50 Pa.B. 1011]
[Saturday, February 15, 2020]
The Environmental Quality Board (Board) proposes to amend Chapter 250 (relating to administration of Land Recycling Program). This rulemaking is proposed under 25 Pa. Code § 250.11 (relating to periodic review of MSCs), which requires that the Department of Environmental Protection (Department) review new scientific information that relates to the basis of the Statewide health standard medium-specific concentrations (MSC) at least 36 months after the effective date of the most recently promulgated MSCs and to propose to the Board any changes to the MSCs as necessary. In addition to updating the existing MSCs, this proposed rulemaking would add MSCs for three new contaminants, namely Perfluorooctanoic Acid (PFOA), Perfluorooctane Sulfonate (PFOS) and Perfluorobutane Sulfonate (PFBS). These contaminants are within the Per-fluoroalkyl and Poly-fluoroalkyl Acid (PFAS) family of compounds for which the United States Environmental Protection Agency (EPA) has published toxicological data. This proposed rulemaking would also clarify several other regulatory requirements.
This proposed rulemaking was adopted by the Board at its meeting on November 19, 2019.
A. Effective Date
This proposed rulemaking would go into effect upon final-form publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information contact Michael Maddigan, Environmental Group Manager, Land Recycling Program, P.O. Box 8471, Rachel Carson State Office Building, Harrisburg, PA 17105-8471, (717) 772-3609; or Robert ''Bo'' Reiley, Acting Director, Bureau of Regulatory Counsel, Rachel Carson State Office Building, P.O. Box 8464, Harrisburg, PA 17105-8464, (717) 787-7060. Information regarding submitting comments on this proposed rulemaking appears in Section J of this preamble. Persons with a disability may use the Pennsylvania AT&T Relay Service by calling (800) 654-5988 (voice users). This proposed rulemaking is available on the Department's web site at www.dep.pa.gov (select ''Public Participation,'' then ''Environmental Quality Board'').
C. Statutory Authority
This proposed rulemaking is authorized under sections 104(a) and 303(a) of the Land Recycling and Environmental Remediation Standards Act (Act 2) (35 P.S. §§ 6026.104(a) and 6026.303(a)), which direct the Board to adopt and amend periodically by regulation Statewide health standards for regulated substances for each environmental medium, including any health-based standards adopted by the Federal government by regulation or statute, and health advisory levels (HAL), and which direct the Board to promulgate appropriate mathematically valid statistical tests to define compliance with Act 2, and other regulations as necessary to implement the provisions of Act 2; and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20), which authorizes the Board to formulate, adopt and promulgate rules and regulations that are necessary for the proper work of the Department.
D. Background and Purpose
Section 250.11 requires that the Department review new scientific information that is used to calculate MSCs under the Statewide health standard and propose appropriate changes at least every 36 months following the effective date of the most recently promulgated MSCs. The Board's most recently promulgated MSCs became effective upon publication in the Pennsylvania Bulletin at 46 Pa.B. 5655 (August 27, 2016). These proposed changes, based on new information, would protect public health and the environment and would provide the regulated community with clear information regarding the requirements of Act 2 and Chapter 250 related to the remediation of contaminated sites.
In addition to updating Chapter 250 MSCs, this proposed rulemaking would include changes that would add groundwater and soil MSCs for three compounds in the PFAS family—PFBS, PFOS and PFOA. The proposed standards for these three chemicals are based on data in toxicological studies published by the EPA. Under Act 2, the Department has directly incorporated the EPA's 2016 HALs regarding PFOS and PFOA as groundwater MSCs and has used the data developed by the EPA for those HALs to calculate soil MSCs for both compounds. With respect to PFBS, the Department is proposing soil and groundwater standards based on a 2014 EPA Provisional Peer-Reviewed Toxicity Value (PPRTV).
Finally, this proposed rulemaking would clarify a number of procedural issues related to the administrative requirements of Act 2. In particular, this proposed rulemaking would clarify requirements for remediators and municipalities regarding public participation and public involvement plans, update requirements for acceptable ''practical quantitation limits'' related to the precision of laboratory testing, update requirements for professional seals from professional geologists or engineers, provide resources to calculate MSCs, and clarify the proper submission of various reports related to the Act 2 Site-Specific Standard.
This proposed rulemaking would impact any person addressing a release of a regulated substance at a property, whether voluntarily or as a result of an order by the Department. This proposed rulemaking would not impact any particular category of person with additional or new regulatory obligations. Under Act 2, a remediator may select the standard to which to remediate. To complete a remediation, the remediator must then comply with all relevant remediation and administrative standards.
As noted previously, this proposed rulemaking will not singularly affect one specific industry or person. This proposed rulemaking will impact the owners and operators of storage tank facilities that have had a release of a petroleum or hazardous substance. There are approximately 12,000 storage facilities in this Commonwealth. Some of these facilities are owned or operated, or both, by small businesses. Because of the broad potential reach of this proposed rulemaking, it is not possible to identify specifics on the types and numbers of small businesses that could potentially be affected by property contamination. In addition, Act 2 and Chapter 250 are unique from other statutes and regulations because they do not create permitting or corrective action obligations. Instead, Act 2 and Chapter 250 provide remediators with options to address contamination and any associated liability that arises under other statutes. For example, adding PFOS to the Chapter 250 Appendix does not create any liability or obligation related to PFOS. Instead, a person's liability arises under The Clean Streams Law (35 P.S. §§ 691.1—691.1001) while Act 2 and Chapter 250 provide that person the means to resolve their Clean Streams Law liability and to address the contamination. In this way, Act 2 and Chapter 250 do not create new obligations that will impact a particular category of person like a new permitting obligation or corrective action regulation would.
The soil numeric values represent a proposed decrease for approximately 83% of the values and an increase for 17% of the values. For groundwater, the proposed changes reflect a decrease for approximately 92% of the values and an increase in approximately 8% of the values. Lowering the values may indicate a more stringent cleanup is required at a site and increasing the values may indicate a less stringent cleanup is required at a site. These proposed changes reflect updated information related to exposure limitations to these substances and recognize that a higher or lower standard is better representative of those substances' exposure thresholds.
The number of completed remediations vary each year. On average, remediators apply the Act 2 remediation standard to approximately 800 contaminated properties across this Commonwealth. Generally, any cost related to a given site remediation depends in large part on which regulated substances are being remediated and what the specific soil and groundwater conditions are at the site.
The Department worked with the Cleanup Standards Scientific Advisory Board (CSSAB) during the development of this proposed rulemaking. The CSSAB, which was established by section 105 of Act 2 (35 P.S. § 6026.105), consists of persons representing a cross-section of experience, including engineering, biology, hydrogeology, statistics, medicine, chemistry, toxicology and other related fields. The purpose of the CSSAB is to assist the Department and the Board in developing Statewide health standards, determining the appropriate statistically and scientifically valid procedures and risk factors to be used, and providing other technical advice as needed to implement Act 2. During CSSAB meetings on August 1, 2018, February 13, 2019, June 12, 2019, and October 29, 2019, CSSAB members were given the opportunity to review and provide feedback on draft regulatory amendments to Chapter 250. The Department worked with the CSSAB to resolve concerns and agreed to evaluate additional suggestions during the next review cycle for this proposed rulemaking. Following these presentations and discussions, the CSSAB issued a letter related to the proposed regulatory amendments included in this proposed rulemaking. Specifically, the CSSAB noted concern related to the MSCs for vanadium.
A listing of CSSAB members and minutes of CSSAB meetings are available on the Department's web site at www.dep.pa.gov (select ''Public Participation,'' then ''Advisory Committees,'' then ''Cleanup and Brownfields Advisory Committees,'' then ''Cleanup Standards Scientific Advisory Board'').
E. Summary of Regulatory Requirements
§ 250.1. Definitions
This proposed rulemaking would add a definition for the term ''MDL—Method detection limit'' because both ''method detection limit'' and ''MDL'' are used in Chapter 250 but are not defined. The proposed definition is consistent with the EPA's definition in (U.S. EPA Office of Water Publication EPA 821-R-16-006, 2016).
This proposed rulemaking would amend the definition of ''volatile compound'' to match the description in Section IV, Appendix IV-A.1 of the Department's Land Recycling Program Technical Guidance Manual (TGM) and to match the EPA's definition in their OSWER (Office of Solid Waste and Emergency Response) Technical Guide for Assessing and Mitigating the Vapor Intrusion Pathway from Subsurface Vapor Sources to Indoor Air (OSWER Publication 9200.2-154, 2015). The current definition excludes naphthalene as well as several other semi-volatiles that are considered volatiles in the vapor intrusion section of the TGM. The Department's TGM is available at https://www.dep.pa.gov/Business/Land/LandRecycling/Standards-Guidance-Procedures/Guidance-Technical-Tools/Pages/Technical-Guidance-Manual.aspx.
§ 250.4. Limits related to PQLs
Proposed amendments to this section would update the references and procedures for determining the practical quantitation limit (PQL) and would remove confusing and outdated language. Improvements in laboratory instrument technology and the removal of PQLs and estimated quantitation limits (EQL) from revised laboratory methods resulted in the need to update this section.
§ 250.6. Public participation
The proposed amendments to § 250.6(c) would clarify that if a public involvement plan (PIP) has been initiated, the public has a right to be involved in the development and review of the remedial investigation report, risk assessment report, cleanup plan and final report consistent with section 304(o) of Act 2 (35 P.S. § 6026.304(o)), regarding community involvement, and outlines the necessary measures to involve the public.
The proposed amendments to § 250.6(d) would help to ensure that the Department and the municipality requesting the PIP are notified of the submission of the PIP and receive copies of the PIP. These proposed amendments necessitate the removal of § 250.6(d)(1) and (2) because it no longer makes sense to include them in subsection (d). These subsections were also removed because they are already discussed in Chapter 250 in the final report requirements section for the site-specific standard in § 250.411(e) (relating to final report) and remediation requirements section for special industrial area (SIA) sites in § 250.503(f) (relating to remediation requirements). Finally, these two subsections were removed because the current Chapter 250 regulations require that the public involvement plan be submitted with the remedial investigation report or baseline environmental report. The proposed change is necessary because the Department needs notice of PIPs in advance of receipt of those reports.
§ 250.10. Measurement of regulated substances in media
The proposed amendments to § 250.10(d) would change the references from the Groundwater Monitoring Guidance Manual to reference the most current version of Appendix A of the TGM or an alternative method that appropriately measures regulated substances in groundwater.
§ 250.12. Professional seal
This proposed new section mirrors language from § 245.314 (relating to professional seals) of the storage tank regulations, requiring that reports submitted to the Department which include professional geologic or engineering work be sealed by a professional geologist or engineer.
§ 250.304. MSCs for groundwater
Under subsection (c), the EPA publication number has been revised.
Under subsection (g), this proposed rulemaking would list additional sources of aqueous solubility information to support the new compounds proposed to be added to the MSC tables in this proposed rulemaking. The following aqueous solubility sources are proposed be added to subsection (g):
19. ATSDR (Agency for Toxic Substances and Disease Registry). 2015. Toxicological Profile for Perfluoroalkyls. Draft for Public Comment. Agency for Toxic Substances and Disease Registry, Public Health Service, U.S. Department of Health and Human Services, Atlanta, GA. Accessed May 2016. http://www.atsdr.cdc.gov/ToxProfiles/tp200.pdf.
20. Hekster, F.M., R.W. Laane, and P. de Voogt. 2003. Environmental and toxicity effects of perfluoroalkylated substances. Reviews of Environmental Contamination and Toxicology 179:99—121.
21. HSDB (Hazardous Substances Data Bank). 2012. U.S. National Library of Medicine, Bethesda, MD. Accessed May 2016. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB.
22. Kauck, E.A., and A.R. Diesslin. 1951. Some properties of perfluorocarboxylic acids. Industrial & Engineering Chemistry Research 43(10):2332—2334.
23. SRC (Syracuse Research Corporation). 2016. PHYSPROP Database. Accessed May 2016. http://www.srcinc.com/what-we-do/environmental/scientific-data bases.html.
24. OECD (Organisation for Economic Co-operation and Development). 2002. Hazard Assessment of Per- fluorooctane Sulfonate (PFOS) and its Salts. ENV/JM/RD (2002) 17/FINAL. Report of the Environment Directorate, Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology, Co-operation on Existing Chemicals, Paris, November 21, 2002.
§ 250.305. MSCs for soil
Under subsection (c), a minor correction to a cross-reference is proposed.
The proposed amendments to § 250.305(g) would alleviate confusion as to the need to evaluate the soil-to-groundwater pathway for compounds that have secondary maximum contaminant levels (SMCL) and either a primary Maximum Containment Level (MCL) or a HAL. These proposed changes would also allow for the determination of soil MSC values for substances with SMCLs but no toxicological information in Appendix A, Table 5B, of Chapter 250. This determination would be based on the physical capacity of the soil to contain a regulated substance as described in § 250.305(b). This proposed change, along with other proposed changes to subsection (g), would result in the ability of remediators to determine soil MSCs for chloride and sulfate that also incorporate impacts to ecological receptors as described in § 250.311(a)—(f) (relating to evaluation of ecological receptors).
§ 250.306. Ingestion numeric values
Due to new information published by the EPA in Exposure Factors Handbook 2011 Edition, EPA/600/R-090/052F, the residential groundwater ingestion rate would increase from 2 liters a day (L/day) to 2.4 L/day. This proposed amendment would result in additional changes to other exposure factors listed in the table and footnotes in § 250.306(d). Formatting errors in the table footnotes in this section would also be corrected. Some of the equations in the footnotes contain brackets that should not be confused with brackets used to delineate changes proposed in the proposed rulemaking. Bolded text within bolded brackets represents text to be deleted while unbolded brackets encompass existing text not proposed for removal.
Proposed amendments to § 250.306(e) would update the models used to calculate blood lead levels that are applied to the corresponding lead numeric value calculations. The new model references would also be updated in this subsection.
§ 250.307. Inhalation numeric values
A proposed amendment to the equation in § 250.307(g)(1) would add a ''× 24 hr/day'' multiplier to the numerator. This component was inadvertently omitted from this equation in the previous rulemaking.
§ 250.308. Soil to groundwater pathway numeric values
In section § 250.308(a)(2)(ii), the word ''standard'' would be replaced with ''generic numeric value'' to avoid the implication that the 1/10th value is always the soil MSC for saturated soil and to avoid the implication that the comparison process should be bypassed.
§ 250.311. Evaluation of ecological receptors
Amendments to § 250.311(b) are proposed to directly reference the proposed changes to § 250.305(g) and to reference the physical capacity of the soil to contain a regulated substance as described in § 250.305(b).
§ 250.402. Human health and environmental protection goals
Proposed amendments to § 250.402(d) would resolve confusion and ensure the correct application of § 250.311(e) to protect ecological receptors under the site-specific standard.
A proposed amendment to § 250.402(d)(3) would correct and replace the reference to § 230.311(f) with § 250.311(f).
§ 250.404. Pathway identification and elimination
Under subsection (a), proposing to add the words ''Department or'' to allow for the use of Department guidance in identifying exposure pathways.
§ 250.409. Risk assessment report
Proposed amendments to § 250.409(1) would clarify that an approved remedial investigation report is needed in advance of submitting an approvable risk assessment report when the reports are submitted separately. This proposed amendment is part of a clarification regarding the appropriate sequence of reports submitted under Subchapter D (relating to the site-specific standard), including a proposed new section for ''combined reports,'' in § 250.412 (relating to combined reports), described as follows.
§ 250.410. Cleanup plan
A new proposed subsection (d) would remove any ambiguity regarding the need for a cleanup plan in situations in which a remedy is already present. The current language in subsection (d) would be moved into a newly created subsection (e).
§ 250.412. Combined reports
This newly proposed section would explain that prior approval of a remedial investigation report is not necessary when combined with either a risk assessment report or a cleanup plan. This proposed section is necessary as a result of the changes made to § 250.410 (relating to cleanup plan).
§ 250.503. Remediation requirements
The proposed amendments to § 250.503(e) would clarify that a revised baseline environmental report, not just a new remediation plan, may need to be submitted when land use changes from nonresidential to residential at a SIA site.
§ 250.603. Exposure factors for site-specific standards
The proposed amendment to § 250.603(a) would update the citation of the 1992 version of the EPA's Final Guidelines for Exposure Assessment to EPA's 2011 Exposure Factors Handbook.
§ 250.605. Sources of toxicity information
The proposed updates to § 250.605(a)(3) would add the EPA's Office of Pesticide Programs Human Health Benchmarks for Pesticides and the EPA's PPRTV Appendix databases to the toxicity value source hierarchy.
§ 250.707. Statistical tests
The term ''Statewide health standard'' would be changed to ''MSC'' in the proposed amendment to § 250.707(b)(1)(ii) for clarification.
A new clause (D) would be added to § 250.707(b)(1)(iii) clarifying when or whether a vapor intrusion analysis is necessary for sites with small petroleum releases where full site characterization is not performed.
Appendix A, Tables 1—7
Proposed amendments to the ''Medium-Specific Concentrations'' tables would update the MSCs for certain regulated substances. Updates to footnotes would be necessary to help explain some of the changes to the MSCs. Numeric values would be calculated for several new substances, including PFOS, PFOA and PFBS in groundwater and soil, and total polychlorinated biphenyls in soil. Ingestion-based numeric values would all decrease slightly due to the proposed increase in water ingestion rate under § 250.306(d) from 2 L/day to 2.4 L/day. Other proposed numeric value changes would mostly be attributed to updates in toxicity values in Tables 5A and 5B. However, proposed corrections to the numeric value calculation process would also cause some numeric values to change.
The proposed update to the definition of a ''volatile compound'' would cause some of the values to change because the new definition would include the consideration of Henry's law constant and molecular weight. Additionally, some of the numeric values changes would be due to rounding adjustments. When the Department calculates the numeric MSC values for inclusion in Chapter 250, some values are rounded during one of the early calculation steps instead of at the end of the calculation. To be consistent, the rounding procedure would now be changed so that all rounding occurs at the final value calculation step. Elimination of the rounding of transfer factors would also cause changes to the numeric values. Transfer factors used for the calculation of inhalation numeric values from soil are calculated and listed in Table 5A. The transfer factors currently in Table 5A were rounded inconsistently. To be consistent with the other proposed rounding corrections, these values would no longer be rounded because they are calculated and used in the early stages of the numeric value calculation process.
In the proposed amendments, information would be updated on the ''Threshold of Regulation Compounds'' table (Table 6) by the removal of compounds that would have numeric values calculated on other tables.
Proposed amendments to the ''Default Values for Calculating MSCs for Lead'' table (Table 7) would update the input parameters for use in the Integrated Exposure Uptake Biokinetic (IEUBK) Model for Lead in Children for residential exposure. Proposed amendments for nonresidential exposure would update the model input parameters for the Adult Lead Model. References for both models would also be updated. These proposed amendments would result in updates to the lead residential and nonresidential direct contact values provided in Table 4A.
F. Benefits, Costs and Compliance
Benefits
In enacting Act 2, the General Assembly found and declared among its policy goals that ''[p]ublic health and environmental hazards cannot be eliminated without clear, predictable environmental remediation standards and a process for developing those standards,'' that ''[a]ny remediation standards adopted by this Commonwealth must provide for the protection of public health and the environment,'' and that ''[c]leanup plans should be based on actual risk that contamination on the site may pose to public health and the environment, taking into account its current and future use and the degree to which contamination can spread offsite and expose the public or the environment to risk.'' See 35 P.S. § 6026.102 regarding declaration of policy.
To effectuate this, the General Assembly authorized the Board and the Department to develop standards and methods to effectuate those goals. 35 P.S. §§ 6026.104 and 6026.303. The Department's regulatory structure, as authorized under Act 2 and as implemented by Chapter 250, provides those important benefits articulated in the General Assembly's declaration of policy.
The amendments to the MSCs in this proposed rulemaking would serve both the public and the regulated community because they would provide MSCs based on the most up-to-date health and scientific information for substances that cause cancer or have other toxic effects on human health. The Board first published Chapter 250 regulations in 1997 at 27 Pa.B. 4181 (August 16, 1997). The General Assembly recognized, in section 104(a) of Act 2 (35 P.S. § 6026.104(a)), that these standards must be updated over time as better science becomes available and as the need for clarification or enhancement of the program becomes apparent.
Potential contamination of soil and groundwater from accidental spills and unlawful disposal can impact almost any resident of this Commonwealth. Many of the chemical substances addressed in this proposed rulemaking are systemic toxicants or carcinogens as defined under Act 2 and, in some cases, are widespread in use. Examples of substances that contain toxic or carcinogenic properties include gasoline and other petroleum products, solvents, elements used in the manufacture of metals and alloys, pesticides, and some dielectric fluids previously contained in transformers and capacitors. Releases of regulated substances not only pose a threat to the environment, but also could affect the health of the general public if inhaled or ingested. New research on many of these substances is ongoing and provides the basis for protection of the residents of this Commonwealth through site cleanup requirements.
Although most of the changes to soil numeric values in this proposed rulemaking would decrease the numeric values, 17% of the values would increase. Increases in values reflect updated information related to exposure limitations to the substances and acknowledge that a higher standard is better representative of those substances' exposure threshold.
An additional benefit of this proposed rulemaking would be the promulgation of soil and groundwater MSCs for PFOS, PFOA and PFBS. Establishing these MSCs would allow remediators to address groundwater and soil contamination and thereby lessen public exposure to the contaminants. This will also benefit remediators wishing to remediate contaminated sites, who tend to be owners, operators or purchasers—or their contractors—of properties and facilities including, or at or near, military bases, municipalities and other locations that used or stored fire-fighting foam. The EPA reports that contamination from these chemicals has also been associated with manufacturing textiles, food packaging, personal care products, and other materials such as cookware that are resistant to water, grease and stains. See Fact Sheet, EPA, PFOA & PFOS Drinking Water Health Advisories (November 2016) (available at https://www.epa.gov/sites/production/files/2016-06/documents/drinkingwaterhealth advisories_pfoa_pfos_updated_5.31.16.pdf).
Finally, remediators would benefit from the proposed amendments that clarify many of the administrative elements of Act 2, making for a more efficient and streamlined Act 2 remediation process.
The benefits of this proposed rulemaking are difficult to quantify because, unlike other statutory or permitting schemes, Act 2 does not prevent contamination but instead provides remediators with a variety of options to address sites that have already been contaminated. In that sense, this proposed rulemaking, consistent with Act 2, benefits the public because it can lead to more efficient and more expedient remediation and reuse of contaminated areas.
Compliance costs
Financially and economically, the Department believes that any potential impact to the regulated community would be insignificant. Under this proposal, the MSC values for many regulated substances are being amended for a variety of reasons. The two most common reasons for amendments are Federal agency (including the EPA and United States Department of Health Agency for Toxic Substances and Disease Registry) changes in toxicity values that are used in calculating MSC and a change in the EPA's underlying assumption of a person's average daily consumption of water from 2 L/day to 2.4 L/day. The soil numeric values represent a decrease for approximately 83% of the values and an increase for 17% of the values. For groundwater, the proposed changes reflect a decrease for approximately 92% of the values and an increase in approximately 8% of the values. Lowering the values may indicate a more stringent cleanup is required at a site and increasing the values may indicate a less stringent cleanup is required at a site. The number of completed remediations vary each year. On average, remediators apply the Act 2 remediation standard to approximately 800 contaminated properties across this Commonwealth. The Department does not expect that the proposed amendments would impact the number of remediations voluntarily completed or the number that must be completed as a result of Department enforcement actions.
The proposed amendments to Statewide health standard MSCs would not affect the cleanup options available to remediators under other cleanup standards. Persons conducting remediation under Act 2 may choose from three different cleanup standards: background, Statewide health or site-specific.
The Department does not expect that this proposed rulemaking, as it relates to new MSCs for PFOA, PFOS and PFBS, would create any additional costs. Act 2 does not create liability for, or the obligation to, address contamination for these and other chemicals. Instead, that obligation comes from other environmental statutes, including The Clean Streams Law (35 P.S. §§ 691.1—691.1001) and the Solid Waste Management Act (35 P.S. §§ 6018.101—6018.1003). Act 2 provides remediators with options to remediate contamination. Having these new MSCs would allow remediators to address PFOS, PFOA and PFBS groundwater and soil contamination. This would benefit the public by lessening public exposure to these contaminants.
Compliance assistance plan
The Land Recycling Program would disseminate information concerning these updates using the Department web site and e-mails to environmental consultants involved in the program.
Paperwork requirements
This proposed rulemaking would not result in any additional forms or reports, beyond those that are already required by Act 2 and Chapter 250.
G. Pollution Prevention
The Federal Pollution Prevention Act of 1990 (42 U.S.C.A. §§ 13101—13109) established a National policy that promotes pollution prevention as the preferred means for achieving state environmental protection goals. The Department encourages pollution prevention, which is the reduction or elimination of pollution at its source, through the substitution of environmentally friendly materials, more efficient use of raw materials and the incorporation of energy efficiency strategies. Pollution prevention practices can provide greater environmental protection with greater efficiency because they can result in significant cost savings to facilities that permanently achieve or move beyond compliance.
Act 2 encourages cleanup plans that have as a goal remedies which treat, destroy or remove regulated substances whenever technically and economically feasible. This proposed rulemaking would provide the necessary Statewide health standard MSCs for remediators to remove contamination or eliminate exposure, where appropriate. This proposed rulemaking reflects the most up-to-date science, especially as it relates to the characterization and removal of contamination that exceeds Act 2 MSCs. During the remediation of a contaminated site, potential sources of pollution are often removed to attain the Act 2 standards, eliminating or minimizing the potential for continued migration of the sources of pollution to other areas.
H. Sunset Review
The Board is not establishing a sunset date for this proposed rulemaking because it is needed for the Department to carry out its statutory authority.
I. Regulatory Review
Under Section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on January 27, 2020, the Department submitted a copy of these proposed amendments to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House and Senate Environmental Resources and Energy Committees. In addition to submitting the proposed amendments, the Department has provided IRRC and the Committees with a copy of a detailed regulatory analysis form prepared by the Department. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed regulations within 30 days of the close of the public comment period. The comments, recommendations or objections shall specify the regulatory review criteria that have not been met. The Act specifies detailed procedures for review of these issues by the Department, the General Assembly and the Governor prior to final publication of the regulations.
J. Public Comments
Interested persons are invited to submit written comments, suggestions, support or objections regarding this proposed rulemaking to the Board. Comments, suggestions, support or objections must be received by the Board by April 14, 2020.
Comments may be submitted to the Board online, by e-mail, by mail or express mail as follows. Comments submitted by facsimile will not be accepted.
Comments may be submitted to the Board by accessing eComment at http://www.ahs.dep.pa.gov/eComment.
Comments may be submitted to the Board by e-mail at RegComments@pa.gov. A subject heading of this proposed rulemaking and a return name and address must be included in each transmission.
If an acknowledgement of comments submitted online or by e-mail is not received by the sender within 2 working days, the comments should be retransmitted to the Board to ensure receipt.
Written comments should be mailed to the Environmental Quality Board, P.O. Box 8477, Harrisburg, PA 17105-8477. Express mail should be sent to the Environmental Quality Board, Rachel Carson State Office Building, 16th Floor, 400 Market Street, Harrisburg, PA 17101-2301.
K. Public Hearings
The Board will hold 3 public hearings for the purpose of accepting comments on this proposed rulemaking. The hearings will be held at 6 p.m. on the following dates:
March 17, 2020 Department of Environmental Protec-
tion
Southcentral Regional Office
Susquehanna Conference Rooms A & B
909 Elmerton Avenue
Harrisburg, PA 17110
March 18, 2020 Department of Environmental Protec-
tion
Southwest Regional Office
Waterfront Conference Rooms A & B
400 Waterfront Drive
Pittsburgh, PA 15222
March 25, 2020 Warminster Township Library
1076 Emma Lane
Warminster, PA 18974
Persons wishing to present testimony at a hearing are requested to contact 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 5 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 in need of accommodations as provided for in the Americans with Disabilities Act of 1990 should contact the Board at (717) 787-4526 or through the Pennsylvania AT&T Relay Service at (800) 654-5984 (TDD) or (800) 654-5988 (voice users) to discuss how the Board may accommodate their needs
PATRICK McDONNELL,
Chairperson
Fiscal Note: 7-552. 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
Subchapter A. GENERAL PROVISIONS
§ 250.1. Definitions.
* * * * *
MCL—Maximum contaminant level.
MDL—Method detection limit—The instrument-specific minimum measured concentration of a substance that can be reported with 99% confidence to be distinguishable from the method blank result.
MSC—Medium-specific concentration.
* * * * *
TF—Transfer factor.
Volatile compound—A chemical compound with either a boiling point less than 200° centigrade at 1 atmosphere or a Henry's law constant greater than or equal to 1 × 10-5 atm-m3/mol and a molecular weight less than 200 g/mol, where:
atm = standard atmosphere
m3 = cubic meter
mol = mole
g = gram
g/mol = molar mass
§ 250.4. Limits related to PQLs.
(a) The PQLs shall be selected from the PQLs or EQLs specified by the EPA [as 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:] EPA's drinking water or solid waste analytical methods.
[(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) If the PQL selected under subsection (a) is higher than the MCL or HAL for an organic regulated substance in groundwater, the PQLs shall be derived from the analytical methodologies published under the drinking water program in the most current version of Methods for the Determination of Organic Compounds in Drinking Water (U.S. EPA, 1988, Environmental Monitoring Systems Laboratory, EPA/600/4-88/039) If a PQL determined under this subsection is not below a HAL, the methodologies in subsection (c)(1) or (2) shall be used unless those quantitation limits are higher than the PQL determined under this subsection.
(c)] (b) For regulated substances when PQLs or EQLs set by the EPA exceed an MCL or HAL or 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)) [or] and for substances when no EQL has been established by the EPA, the [limits related to the] PQL shall be [the quantitation limits] established by the methodologies in paragraph (1) or (2).
(1) A level set by multiplying 3.18 by the published method detection limit (MDL) of the most recently approved EPA methodology.
(2) A level [representing the lowest calibration point that can consistently be determined to have a percent relative standard deviation (%RSD) of less than 30% or correlation coefficient of greater than 0.995 using reagent water] set by multiplying 3.18 by the instrument-specific MDL. If multiple instruments are used, then the PQL is set by averaging the instrument-specific MDLs and multiplying that value by 3.18.
[(d)] (c) For regulated substances which have no limits related to PQLs identified in subsection [(c)(1)] (b)(1) or (2), a person shall demonstrate attainment under the site-specific standard or the background standard.
[(e)] (d) When a minimum threshold MSC is used as a Statewide health standard, the minimum threshold MSC is the Statewide health standard regardless of whether it is higher or lower than a quantitation limit established by this section.
[(f)] (e) Nothing in this section restricts the selection of valid and generally accepted methods to be used to analyze samples of environmental media.
§ 250.6. Public participation.
* * * * *
(c) If a public involvement plan has been initiated, the person proposing remediation shall, at a minimum, [provide] include the following three measures in the plan to involve the public in the development and review of the remedial investigation report, risk assessment report, cleanup plan and final report:
(1) [Public] Provide public access at convenient locations for document review.
(2) [Designation of] Designate a single contact person to address questions from the community.
(3) [A] Use 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:] the person proposing the remediation shall notify the Department and submit the plan to the municipality and the Department prior to its implementation.
[(1) A remedial investigation report under a site-specific remediation.
(2) A baseline environmental report under an SIA cleanup.]
§ 250.10. Measurement of regulated substances in media.
* * * * *
(d) For groundwater where monitoring is being performed at a drinking water well, samples for metals analysis shall be field acidified and unfiltered in accordance with the most current version of [Groundwater Monitoring Guidance Manual] Land Recycling Program Technical Guidance Manual, Appendix A: Groundwater Monitoring Guidance, Department of Environmental Protection, [3610-BK-DEP1973] document number 261-0300-101, or in accordance with an alternative sampling method that accurately measures regulated substances in groundwater.
* * * * *
(Editor's Note: The following rule is proposed to be added and printed in regular type to enhance readability.)
§ 250.12. Professional seal.
Reports submitted to satisfy this subchapter containing information or analysis that constitutes professional geologic or engineering work as defined by the Engineer, Land Surveyor and Geologist Registration Law (63 P.S. §§ 148—158.2) must be sealed by a professional geologist or engineer who is in compliance with that statute.
Subchapter C. STATEWIDE HEALTH STANDARDS
§ 250.304. MSCs for groundwater.
* * * * *
(c) The MSCs for regulated substances contained in groundwater in aquifers used or currently planned to be used for drinking water or for agricultural purposes are the MCLs as established by the Department or the EPA in § 109.202 (relating to State MCLs, MRDLs and treatment technique requirements). For regulated substances where no MCL has been established, the MSCs are the Lifetime Health Advisory Levels (HAL) set forth in Drinking Water Standards and Health Advisories (DWSHA), EPA Office of Water Publication No. EPA [822-S-12-001 (April 2012 or as revised)] 822-F-18-001 (March 2018 or as revised), except for substances designated in the DWSHA with cancer descriptor (L) ''Likely to be carcinogenic to humans'' or (L/N) ''Likely to be carcinogenic above a specific dose but not likely to be carcinogenic below that dose because a key event in tumor formation does not occur below that dose.'' New or revised MCLs or HALs promulgated by the Department or the EPA shall become effective immediately for any demonstration of attainment completed after the date the new or revised MCLs or HALs become effective.
* * * * *
(g) The references referred to in subsection (f) are:
(1) Lide, D. R., ed. 1996. CRC Handbook of Chemistry and Physics, 77th Edition. CRC Press.
* * * * *
(18) Riddick, J. A., et al. 1986. Organic Solvents; Physical Properties & Methods of Purification. Techniques of Chemistry. 11th Edition. New York, NY: Wiley-Interscience.
(19) ATSDR (Agency for Toxic Substances and Disease Registry). 2015. Toxicological Profile for Perfluoroalkyls. Draft for Public Comment. Agency for Toxic Substances and Disease Registry, Public Health Service, U.S. Department of Health and Human Services, Atlanta, GA. Accessed May 2016. http://www.atsdr.cdc.gov/ToxProfiles/tp200.pdf.
(20) Hekster, F.M., R.W. Laane, and P. de Voogt. 2003. Environmental and toxicity effects of perfluoroalkylated substances. Reviews of Environmental Contamination and Toxicology 179:99—121.
(21) HSDB (Hazardous Substances Data Bank). 2012. U.S. National Library of Medicine, Bethesda, MD. Accessed May 2016. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB.
(22) Kauck, E.A., and A.R. Diesslin. 1951. Some properties of perfluorocarboxylic acids. Industrial & Engineering Chemistry Research 43(10):2332—2334.
(23) SRC (Syracuse Research Corporation). 2016. PHYSPROP Database. Accessed May 2016. http://www.srcinc.com/what-we-do/environmental/scientific-databases.html.
(24) OECD (Organisation for Economic Co-operation and Development). 2002. Hazard Assessment of Perfluorooctane Sulfonate (PFOS) and its Salts. ENV/JM/RD (2002) 17/FINAL. Report of the Environment Directorate, Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology, Co-operation on Existing Chemicals, Paris, November 21, 2002.
§ 250.305. MSCs for soil.
* * * * *
(c) For the residential standard, the MSC for regulated substances contained in soil is one of the following:
(1) The lowest of the following:
(i) The ingestion numeric value throughout the soil column to a depth of up to 15 feet from the existing ground surface as determined by the methodology in § 250.306 (relating to ingestion numeric values), using the appropriate default residential exposure assumptions contained in [§ 250.306(e)] § 250.306(d).
* * * * *
(g) A person conducting a remediation of soils contaminated with [a substance] one or more substances having a secondary MCL, but no toxicological properties listed in Appendix A, Table 5B, will not be required to comply with either the direct contact pathway or the soil-to-groundwater pathway requirements for those substances [to protect groundwater in aquifers for drinking water]. The substances shall be subject to the requirements of § 250.311(a) through (f) (relating to evaluation of ecological receptors) with respect to evaluation of ecological receptors.
§ 250.306. Ingestion numeric values.
* * * * *
(d) The default exposure assumptions used to calculate the ingestion numeric values are as follows:
| Residential |
|---|
| Term | Systemic1 | Carcinogens2,6 | Nonresidential
(Onsite Worker) |
|---|
THQ
| Target Hazard Quotient
| 1 | N/A | 1 |
RfDo
| Oral Reference Dose (mg/kg-day)
| Chemical-specific | N/A | Chemical-specific |
BW
|
Body Weight (kg)
Soil
Groundwater
|
15
80 | N/A
|
80
80 |
ATnc
|
Averaging Time for systemic toxicants (yr)
Soil
Groundwater
|
6
30 |
N/A
N/A |
25
25 |
Abs
| Absorption (unitless)3
| 1 | 1 | 1 |
EF
|
Exposure Frequency (d/yr)
Soil
Groundwater
|
250
350 |
250
350 |
180
250 |
ED
| Exposure Duration (yr)
Soil
Groundwater
|
6
30 |
N/A
N/A |
25
25 |
IngR
|
Ingestion Rate
Soil (mg/day)
GW (L/day)
|
100
[2] 2.4 |
N/A
N/A |
50
[1] 1.2 |
| Residential |
|---|
| Term | Systemic1 | Carcinogens2,6 | Nonresidential
(Onsite Worker) |
|---|
CF
|
Conversion Factor
Soil (kg/mg)
GW (unitless)
|
1 × 10-6
1
|
1 × 10-6
1
|
1 × 10-6
1
|
TR
| Target Risk
| N/A
| 1 × 10-5
| 1 × 10-5 |
CSFo
| Oral Cancer Slope Factor (mg/kg-day)-1
| N/A
| Chemical-specific | Chemical-specific |
ATc
| Averaging Time for carcinogens (yr)
| N/A
| 70
| 70
|
IFadj4
|
Ingestion Factor
Soil (mg-yr/kg-day)
GW (L-yr/kg day)
|
N/A
|
55
[1] 1.2
|
15.6
[0.3] 0.38
|
AIFadj5
| Combined Age-Dependent Adjustment
Factor and Ingestion Factor
Soil (mg-yr/kg-day)
GW (L-yr/kg-day)
| N/A
|
241
[3.23] 3.45 | N/A
|
CSFok
CSFol
| TCE oral cancer slope factor for kidney
cancer (mg/kg/day)-1
TCE oral cancer slope factor for
non-Hodgkin lymphoma and liver cancer (mg/kg/day)-1
| | 9.3 × 10-3
3.7 × 10-2 | |
Notes:
* * * * *
4 The Ingestion Factor for the residential scenario is calculated using the equation If[adj]adj = EDc × IRc/BWc + EDa × IRa/B[w]Wa, where EDc = 6 yr, IRc = 100 mg/day for soils and 1 L/day for groundwater, BWc = 15 kg, EDa = 24 yr, IRa = 50 mg/day for soils and [2] 2.4 L/day for groundwater, and BWa = 80 kg. The ingestion factor for the nonresidential scenario is calculated using the equation If[adj]adj = ED × IR/BW, where ED = 25 yr, IR = 50 mg/day for soils and [1] 1.2 L/day for groundwater, and BW = 80 kg.
5 The Combined Age-Dependent Adjustment Factor and Ingestion Factor (AIFadj) for the residential scenario is calculated using the equation AIFadj = [(ADAF<2 × ED<2) + (ADAF2-6 × ED2-6)] × IR[c]c / BW[c]c + [(ADAF[>]>6-16 × ED[>]>6-16 + (ADAF>16 × ED>[6-]16)] × IR[a]a / BW[a]a, where ADAF<2 = 10, ED <2 = 2 yr, ADAF2-6 = 3, ED2-6 = 4 yr, IR[c]c = 100mg/day for soils and 1 L/day for groundwater, BW[c]c = 15 kg, ADAF[>]>6-16 = 3, ED[>]>6-16 = 10 yr, ADAF>16 = 1, ED>16 = 14 yr, IR[a]a = 50 mg/day for soils and [2] 2.4 L/day for groundwater, and BW[a]a = 80 kg.
* * * * *
(e) The residential ingestion numeric value for lead in soil was developed using the [Uptake Biokinetic (UBK) Model for Lead (version 0.4)] Integrated Exposure Uptake Biokinetic (IEUBK) Model for Lead in Children, Windows®® version (IEUBKwin v1.1 build 11) 32-bit version developed by the EPA (U.S. Environmental Protection Agency. ([1990] February 2010) [Uptake Biokinetic (UBK) Model for Lead (version 0.4). U.S. EPA/ECAO. August 1990,] in lieu of the algorithms presented in subsections (a) and (b). Default input values are identified in Appendix A, Table 7. Because the [UBK] IEUBK model is applicable only to children, the nonresidential ingestion numeric value was calculated [according to the method developed by the Society for Environmental Geochemistry and Health (Wixson, B. G. (1991)). The Society for Environmental Geochemistry and Health (SEGH) Task Force Approach to the Assessment of Lead in Soil. Trace Substances in Environmental Health. (11-20), using the following equations:
using EPA's Adult Lead Methodology (ALM) in accordance with the guidance, exposure factors, equations, and spreadsheets provided in EPA's Recommendations of the Technical Review Workgroup for Lead for an Approach to Assessing Risks Associated with Adult Exposures to Lead in Soil (EPA-540-R-03-001, OSWER Dir # 9285.7-54, January 2003), OLEM Directive 9285.6-56 ''Update to the Adult Lead Methodology's Default Baseline Blood Lead Concentration and Geometric Standard Deviation Parameters'' (May 2017) and the associated June 14, 2017, version of the Calculations of Preliminary Remediation Goals (PRGs) for Soil in Nonresidential Areas U.S. EPA Technical Review Workgroup for Lead, Adult Lead Committee spreadsheets. Table 7 identi-fies each of the variables [in this equation] used to calculate the nonresidential ingestion numeric value for lead.
§ 250.307. Inhalation numeric values.
* * * * *
(g) For a regulated substance which is a carcinogen and is a volatile compound, the numeric value for the inhalation of volatiles from groundwater shall be calculated by using the appropriate residential or nonresidential exposure assumptions from subsection (h) according to the following equations:
(1) For regulated substances not identified as a mutagen in § 250.301(b):
MSC = TR × ATc × 365 days/year × 24 hr/day
_____________________________
IUR × ET × EF × ED × TF × CF
* * * * *
§ 250.308. Soil to groundwater pathway numeric values.
(a) A person may use the soil-to-groundwater pathway numeric values listed in Appendix A, Tables 3B and 4B, as developed using the methods contained in paragraph (1), (2) or (4), may use a concentration in soil at the site which does not produce a leachate in excess of the MSC for groundwater contained in Appendix A, Tables 1 and 2, when subjected to the Synthetic Precipitation Leaching Procedure (Method 1312 of SW-846, Test Methods for Evaluating Solid Waste, promulgated by the U.S. EPA), or may use the soil-to-groundwater pathway soil buffer criteria in subsection (b) or may use the soil-to-groundwater pathway equivalency demonstration in subsection (d).
* * * * *
(2) For organic compounds, a generic value determined not to produce a concentration in groundwater in the aquifer in excess of the MSC for groundwater as calculated by the equation in paragraph (3).
(i) For soil not in the zone of groundwater saturation, the generic value shall be calculated by the equation in paragraph (3).
(ii) For soil in the zone of groundwater saturation, the [standard] generic numeric value is 1/10th of the generic value calculated by the equation in paragraph (3).
* * * * *
§ 250.311. Evaluation of ecological receptors.
* * * * *
(b) For purposes of determining impacts on ecological receptors, no additional evaluation is required if the remediation attains a level equal to 1/10th of the value in Appendix A, Tables 3 and 4 or, for substances identified in § 250.305(g), 1/10th of the physical limitation identified in § 250.305(b), except for constituents of potential ecological concern identified in Table 8, or if the criteria in paragraph (1), (2) or (3) are met. Information that supports a determination that no additional evaluation is required shall be documented in the final report.
* * * * *
Subchapter D. SITE-SPECIFIC STANDARD
§ 250.402. Human health and environmental protection goals.
* * * * *
(d) If a person is using the site-specific standard to protect ecological receptors under this subchapter or [in accordance with § 250.311(e)] as a result of selecting § 250.311(e)(4) when ecological receptors cannot be evaluated under the Statewide health standard, the following shall be performed:
* * * * *
(3) Implementation of the selected remedy, which may include mitigation measures under § [230.311(f)] 250.311(f), that is protective of the ecological receptors.
§ 250.404. Pathway identification and elimination.
(a) The person shall use Department or Department-approved EPA or ASTM guidance to identify any potential current and future exposure pathways for both human receptors and environmental receptors identified in § 250.402 (relating to human health and environmental protection goals).
* * * * *
§ 250.409. Risk assessment report.
The risk assessment report shall conform to this subchapter and Subchapter F (relating to exposure and risk determinations), and shall include the following unless not required under § 250.405 (relating to when to perform a risk assessment):
(1) [A] Except when submitted in combination with a remedial investigation report, a risk assessment report that [describes] uses site characterization information from an approved remedial investigation report to describe the potential adverse effects, including the evaluation of ecological receptors, under both current and planned future conditions caused by the presence of regulated substances in the absence of any further control, remediation or mitigation measures.
* * * * *
§ 250.410. Cleanup plan.
* * * * *
(c) When a person proposes a remedy that relies on access to properties owned by third parties, for remediation or monitoring, documentation of cooperation or agreement shall be submitted as part of the cleanup plan.
(d) A cleanup plan is required when an institutional or engineering control is used as a remedy to address current and future exposure pathways or exposure pathways that existed prior to submitting an NIR.
(e) A cleanup plan is not required and no remedy is required to be proposed or completed if no current or future exposure pathways exist.
(Editor's Note: The following rule is proposed to be added and printed in regular type to enhance readability.)
§ 250.412. Combined reports.
A person does not need prior Department approval of a remedial investigation report if the remedial investigation report is submitted together with either a risk assessment report or a cleanup plan.
Subchapter E. SIA STANDARDS
§ 250.503. Remediation requirements.
* * * * *
(e) A person that changes the use of the property from nonresidential to residential, or changes the use of the property to create substantial changes in exposure conditions to contamination that existed prior to the person's reuse shall notify the Department of the changes and may be required to amend the baseline environmental report and implement a remediation plan to address any new imminent, direct or immediate threats to human health and the environment resulting from the changes.
* * * * *
Subchapter F. EXPOSURE AND RISK DETERMINATIONS
§ 250.603. Exposure factors for site-specific standards.
(a) A risk assessment for the site-specific standard shall use site-specific exposure factors under the EPA's [Final Guidelines for Exposure Assessment, 1992 (57 FR 22888—22938)] Exposure Factors Handbook: 2011 Edition, 2011 (EPA/600/R-090/052F) or exposure factors used in the development of the Statewide health standards identified in Subchapter C (relating to Statewide health standards).
* * * * *
§ 250.605. Sources of toxicity information.
(a) For site-specific standards, the person shall use appropriate reference doses, reference concentrations, cancer slope factors and unit risk factors identified in Subchapter C (relating to Statewide health standards), unless the person can demonstrate that published data, available from one of the following sources, provides more current reference doses, reference concentrations, cancer slope factors or unit risk factors:
(1) Integrated Risk Information System (IRIS).
(2) United States Environmental Protection Agency, National Center for Environmental Assessment (NCEA) Provisional Peer-Reviewed Toxicity Values (PPRTV).
(3) Other sources:
(i) Health Effects Assessment Summary Tables (HEAST)
(ii) Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles.
(iii) California EPA, California Cancer Potency Factors and Chronic Reference Exposure Levels.
(iv) EPA criteria documents, including drinking water criteria documents, drinking water health advisory summaries, ambient water quality criteria documents and air quality criteria documents.
(v) EPA Human Health Benchmarks for Pesticides (HHBP)
(vi) EPA PPRTV Appendix
(b) If no toxicity values are available from sources identified in subsection (a), the person may use the background standard or meet one of the following:
* * * * *
Subchapter G. DEMONSTRATION OF ATTAINMENT
§ 250.707. Statistical tests.
* * * * *
(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).
* * * * *
(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 [Statewide health standard] 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).
* * * * *
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