PROPOSED RULEMAKING
ENVIRONMENTAL
QUALITY BOARD
[ 25 PA. CODE CH. 250 ]
Administration of the Land Recycling Program
[44 Pa.B. 2980]
[Saturday, May 17, 2014]The Environmental Quality Board (Board) proposes to amend Chapter 250 (relating to administration of Land Recycling Program). The proposed rulemaking is intended to update the Statewide health standards based on current science, to correct errors and omissions, and to state how to provide to the Department of Environmental Protection (Department) information about notification that remediators are required to provide to municipalities and the public.
This proposed rulemaking was adopted by the Board at its meeting of February 18, 2014.
A. Effective Date
This proposed rulemaking will go into effect upon final-form publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information contact Troy Conrad, Program Manager, Land Recycling Program, P. O. Box 8471, Rachel Carson State Office Building, Harrisburg, PA 17105-8471, (717) 783-7816; or Robert ''Bo'' Reiley, Assistant Counsel, 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 AT&T Relay Service by calling (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This proposed rulemaking is available electronically on the Department's web site at www.dep.state.pa.us (DEP Search/Keyword: Environmental Quality Board).
C. Statutory Authority
The proposed rulemaking is being made primarily under the authority of sections 104(a) and 303(a) of the Land Recycling and Environmental Remediation Standards Act (act) (35 P. S. §§ 6026.104(a) and 6026.303(a)). Section 303(a) of the act directs the Board to promulgate Statewide health standards for regulated substances for each environmental medium, and the methods used to calculate the standards. Section 104(a) of the act authorizes the Board to adopt and amend regulations that may be needed to implement the act.
D. Background and Purpose
Section 250.11 (relating to periodic review of MSCs) requires the Department to review new scientific information that is used to calculate Medium-Specific Concentrations (MSC) used to demonstrate the Statewide health standard, and propose appropriate changes at least every 36 months. These changes serve the public as they are based on the most up-to-date health and scientific information. In addition, the changes in requirements serve the public and regulated community as they provide clear information on what is required to clean up contaminated sites. The proposed rulemaking was reviewed by the Cleanup Standards Scientific Advisory Board (CSSAB). The proposed rulemaking was discussed and supported unanimously, with one exception and one comment, at the CSSAB meeting on October 23, 2013.
E. Summary of Regulatory Requirements
§ 250.5. Public notice by applicant
Proposed amendments to this section would add the requirement that documented proof of the mailing of municipal notices and the arranging for publication of newspaper notices that are required under the act be submitted at the time the Notice of Intent to Remediate (NIR), plan or report is submitted to the Department. This will assure that the municipality and the public are notified of the NIR, plan or report in a timely fashion.
§ 250.7. Fees
Proposed amendments to this section would clarify that the Department may waive the fee for resubmission of a plan or report if the resubmission is related to correcting minor administrative or technical deficiencies.
§ 250.301. Scope
Proposed amendments to this section would add certain regulated substances to the list of substances classified as mutagens based on recently published scientific information.
§ 250.304. MSCs for groundwater
Prior to the January 2011 edition of the Drinking Water Standards and Health Advisories, the United States Environmental Protection Agency (EPA) Office of Water Publication No. EPA 820-R-11-002 (January 2011), when the EPA published both a Lifetime Health Advisory Level (HAL) and a 10-4 Cancer Risk concentration for a chemical, the Lifetime HAL concentration included an adjustment for cancer risk. Starting with the January 2011 edition of the Drinking Water Standards and Health Advisories, the EPA changed its Cancer Classification system and started publishing Lifetime HALs that did not include adjustments for cancer risk, even when a 10-4 Cancer Risk concentration was also published.
Proposed amendments to § 250.304(c) (relating to MSCs for groundwater) would clarify that a published Lifetime HAL concentration may not always be used as the MSC for substances that are designated as likely to be carcinogenic, if the Lifetime HAL does not include an adjustment for cancer risk. For these substances, a numeric value would be calculated based on the equations in §§ 250.306 and 250.307 (relating to ingestion numeric values; and inhalation numeric values). In that situation, the MSC would be the lower of the Lifetime HAL and the calculated value.
Proposed amendments to § 250.304(g) would include additional references regarding the determination of solubility values.
§ 250.306. Ingestion numeric values
Due to new information about the toxicology of trichloroethylene (TCE), proposed amendments to this section would add values for oral cancer slope factors for TCE and revise the formula for calculating the MSC for TCE.
Due to new information published by the EPA in the Exposure Factors Handbook 2011 Edition, EPA/600/R-090/052F, the average body weight and the associated ingestion factors would change.
§ 250.307. Inhalation numeric values
Due to new information relating to the toxicology of TCE, proposed amendments to this section would add values for inhalation unit risk for TCE and make changes to the formula for calculating the MSC for TCE.
Appendix A, Tables 1—6
Proposed amendments to Tables 1—4 would update the MSC for certain regulated substances. Information also would be updated on the ''Physical and Toxicological Properties'' tables and the ''Threshold of Regulation Compounds'' table.
F. Benefits, Costs and Compliance
Benefits
Consistent with § 250.11, the Department needs to update MSCs on a timely basis to assure that environmental response actions at contaminated sites are remediated using current scientific research and principles. This will ensure the protection of public health and the environment where it has been determined that lower MSCs for regulated substances are protective. This will also avoid unnecessary expense for those remediating property where it has been determined that higher MSCs for regulated substances are protective.
Compliance costs
This proposed rulemaking will affect owners, operators and purchasers of properties and facilities who volunteer, or are required to perform, remediation of contaminated sites. The proposed amendments are not expected to add any significant costs to the cleanup of contaminated sites under the act. Some cleanup standard concentration values will be lower and some will be higher. The net cost should be negligible.
Compliance Assistance Plan
The Department will disseminate information concerning this rulemaking using the Department's web site and e-mails to environmental consultants.
Paperwork requirements
Forms or reports are not required beyond those established by the act.
G. Pollution Prevention (if applicable)
During remediation of a contaminated site, potential sources of pollution are often removed to attain the standards in the act, thus eliminating or minimizing the potential for continued migration.
H. Sunset Review
These 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 they were intended.
I. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on April 28, 2014, the Department submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House and Senate Environmental Resources and Energy Committees. 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 rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Department, the General Assembly and the Governor of comments, recommendations or objections raised.
J. Public Comments
Interested persons are invited to submit written comments, suggestions or objections regarding the proposed rulemaking to the Board. Comments, suggestions or objections must be received by the Board by June 17, 2014. In addition to the submission of comments, interested persons may also submit a summary of their comments to the Board. The summary may not exceed one page in length and must also be received by the Board by June 17, 2014. The one-page summary will be distributed to the Board and available publicly prior to the meeting when the final-form rulemaking will be considered.
Comments, including the submission of a one-page summary of comments, may be submitted to the Board online, by mail or express mail as follows. Comments may be submitted online to the Board by accessing the Board's Regulatory Comment System at http://www.ahs.dep.pa.gov/RegComments. If an acknowledgement of comments submitted online is not received by the sender within 2 business 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. Comments submitted by facsimile will not be accepted.
E. CHRISTOPHER ABRUZZO,
Chairperson(Editor's Note: See 44 Pa.B. 2975 (May 17, 2014) for corrective amendments to §§ 250.306 and 250.307 and Appendix A, Tables 1, 3b, 5a and 5b).
Fiscal Note: 7-486. 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 § 250.5. Public notice by applicant.
* * * * * (e) Upon receipt of notice of a request for a nonuse aquifer designation, the municipality and community water supplier shall have 45 days to indicate to the Department and the remediator any information relevant to the requirements of § 250.303.
(f) Documented proof of the mailing of the municipal notices and arranging for the publication of newspaper notices, required under sec- tions 302(e), 303(h), 304(n) and 305(c) of the act (35 P. S. §§ 6026.302(e), 6026.303(h), 6026.304(n) and 6026.305(c)), shall be submitted at the same time the NIR, plan or report is submitted to the Department. A copy of the letter to the municipality with a United States Postal Service certified mail receipt, PS Form No. 3800, will be accepted as proof of mailing. A copy of the published text of the newspaper notice and the publication date will be accepted as proof of arranging for publication.
§ 250.7. Fees.
* * * * * (b) The Department will disapprove a plan or report that is submitted without the appropriate fee.
(c) The Department may waive the fee for resubmission of a plan or report if the resubmission is related to correcting minor administrative or technical deficiencies. The fee waiver is limited to the following:
(1) One time for each plan or report to correct administrative deficiencies if the corrections are made within 15 days of notice of the deficiencies by the Department.
(2) One time for each plan or report to correct technical deficiencies if the corrections are made within 60 days of notice of the deficiencies by the Department.
Subchapter C. STATEWIDE HEALTH STANDARDS § 250.301. Scope.
* * * * * (b) This subchapter sets forth generic Statewide health standards for regulated substances determined by the EPA to be mutagens. Tables 1—4 contain Statewide health standards based upon the methodology for mutagens in §§ 250.306 and 250.307 (relating to ingestion numeric values; and inhalation numeric values) for the following substances classified as mutagens:
Regulated Substance CAS Number Acrylamide 79-06-1 Benzo[a]anthracene 56-55-3 Benzidine 92-87-5 Benzo[a]pyrene 50-32-8 Benzo[b]fluoranthene 205-99-2 Benzo[k]fluoranthene 207-08-9 Chromium (VI) 18540-29-9 Chrysene 218-01-9 Dibenzo[a,h]anthracene 53-70-3 Dibromo-3-chloropropane, 1,2- 96-12-8 Dichloromethane 75-09-2 Indeno[1,2,3-cd]pyrene 193-39-5 Methylene bis(2-chloroaniline), 4,4`- 101-14-4 Nitrosodiethylamine, N- 55-18-5 Nitrosodimethylamine, N- 62-75-9 Nitroso-N-ethylurea, N- 759-73-9 Trichloroethylene (TCE) 79-01-6 Trichloropropane, 1,2,3- 96-18-4 Vinyl chloride 75-01-4 * * * * * § 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 [is the MCL] are the MCLs as established by the Department or the EPA [as established] in § 109.202 (relating to [state] State MCLs, MRDLs and treatment technique requirements) [and Health Advisory Levels (HALs) set forth in Drinking Water Standards and Health Advisories, EPA Office of Water Publication No. EPA 822-R-09-011 (October, 2009)]. For [a regulated substance] regulated substances where no MCL has been established, the [MSC is the lifetime HAL for that compound.] MSCs are the Lifetime Health Advisory Levels (HALs) 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), 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.
(1) For [a regulated substance] regulated substances where neither an MCL nor a lifetime HAL has been established and for substances designated in the DWSHA with cancer descriptor (L) or (L/N), the [MSC is] MSCs are the lowest concentration calculated using the appropriate residential and nonresidential exposure assumptions and the equations in §§ 250.306 and 250.307 (relating to ingestion numeric values; and inhalation numeric values). [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.]
(2) If the Lifetime HAL for a substance designated in the DWSHA with cancer descriptor (L) or (L/N) is less than the MSC calculated paragraph (1), then the Lifetime HAL shall be the MSC.
(d) For regulated substances contained in aquifers not used or currently planned to be used, the MSCs in Appendix A, Tables 1 and 2 are calculated by the following:
* * * * * (g) The references referred to in subsection (f) are:
* * * * * (11) Mabey, et al. 1982, Aquatic Fate Process Data for Organic Priority Pollutants, SRI. EPA Contract Nos. 68-01-3867, 68-03-2981.
(12) Yalkowsky, S.H. and R.M. Dannenfelser. 1992. Aquasol Database of Aqueous Solubility. Version 5. College of Pharmacy, University of Arizona—Tucson, AZ. PC Version.
(13) Estimate from Log Kow.
(14) Bennett, S.R., J.M. Bane, P.J. Benford and R.L. Pyatt. 1984. Environmental Hazards of Chemical Agent Simulants. CRDC-TR-84055, Aberdeen Proving Ground, MD.
(15) Munro, N.B. et al. 1999. The Sources, Fate, and Toxicity of Chemical Warfare Agent Degradation Products. Environ. Health Perspect. 107(12): 933-4.
(16) Monteil-Rivera, F., C. Groom and J. Hawari. 2003. Sorption and Degradation of Octahydro-1,3,5,7-Tetranitro-1,3,5,7-Tetrazocine in Soil. Environ.Sci. Technol. 37:3878-3884.
(17) Seidell, A. 1941. Solubilities of Organic Compounds. New York, NY. D. Van Nostrand Co. Inc.
§ 250.306. Ingestion numeric values.
* * * * * (b) For a regulated substance which is a carcinogen, the ingestion numeric value for that substance was calculated using the appropriate residential or nonresidential exposure assumptions from subsection (d) according to the following equations:
(1) For regulated substances not identified as a mutagen in § 250.301(b) (relating to scope):
MSC = TR x ATc x 365 days/year
_________________
CSFo x Abs x EF x IFadj x CF(2) For regulated substances identified as a mutagen, except for vinyl chloride and trichloroethylene, in § 250.301(b):
MSC = TR x ATc x 365 days/year
_________________
CSFo x Abs x EF x AIFadj x CF(3) For vinyl chloride:
MSC = TR
_____________________________________
[CSFo x Abs x EF x IFadj x CF / (ATc x 365 days/year)] + (CSFo x Abs x IRc x CF/BWc)(4) For trichloroethylene:
MSC = TR x ATc x 365 days/yr
___________________________
(CSFok x AIFadj + CSFol x IFadj) x Abs x EF x CF(c) For a regulated substance that has both an oral reference dose and an oral cancer slope factor, the ingestion numeric value is the lower of the two numbers as calculated by the equations in subsections (a) and (b).
(d) The default exposure assumptions used to calculate the ingestion numeric values are as follows:
Residential
Nonresidential Term Systemic1 Carcinogens2,6 (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
[70] 80N/A [70] 80
[70] 80ATnc 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/A25
25
IngR Ingestion Rate
Soil (mg/day)
GW (L/day)
100
2N/A
N/A
50
1
CF Conversion Factor
Soil (kg/mg)
GW (unitless)
1 x 10-6
1
1 x 10-6
1
1 x 10-6
1TR Target Risk N/A 1 x 10-5 1 x 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] IFadj4 Ingestion Factor
Soil (mg-yr/kg-day)
GW (L-yr/kg day)
N/A [57.1] 55
[1.1] 1
[17.9] 15.6
[0.4] 0.3AIFadj5 Combined Age-Dependent Adjustment Factor and Ingestion Factor
Soil (mg-yr/kg-day)
GW (L-yr/kg-day)
N/A [245] 241
[3.39] 3.23
N/A CSFok
CSFolTCE 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 x 10-3
3.7 x 10-2* * * * * § 250.307. Inhalation numeric values.
* * * * * (b) For a regulated substance which is a carcinogen, the following apply:
(1) For a volatile compound, the numeric value for inhalation from soil was calculated using the appropriate residential or nonresidential exposure assumptions from subsection (d) according to the following equation using TF for volatiles:
MSC = TR x ATc x 365 days/year x 24 hr/day x TF
_________________
IUR x ET x EF x ED x CF(2) For a regulated substance attached to particulates, the numeric value for inhalation from soil was calculated using the appropriate residential or nonresidential exposure assumptions from subsection (d) according to the equation in paragraph (1) using TF for particulates.
(3) For a regulated substance identified in § 250.301(b) (relating to scope) as a mutagen, except for vinyl chloride and trichloroethylene, the numeric value for inhalation from soil was calculated using the appropriate residential or nonresidential exposure assumptions from subsection (d) according to the following equation using the TF for volatiles or particulates:
MSC = TR x ATc x 365 days/year x 24 hr/day x TF
_________________
IUR x ET x EF x AED x CF(4) For vinyl chloride, the numeric value for inhalation from soil was calculated using the appropriate residential or nonresidential exposure assumptions from subsection (d) according to the following equation using the TF for volatiles:
MSC = TR
_____________________________________
[IUR x ET x EF x ED x CF / (ATc x 365 days/yr x 24 hr/d x TF)] + (IUR x CF x TF)(5) For trichloroethylene, the numeric value for inhalation from soil was calculated using the appropriate residential or nonresidential exposure assumptions from subsection (d) according to the following equation using the TF for volatiles:
MSC = TR x ATc x 365 days/yr x 24 hr/day x TF
_________________
(IURk x AED + IURl x ED) x ET x EF x CF(c) For a regulated substance which is both a systemic toxicant and a carcinogen, the inhalation numeric value is the lower of the two numbers as calculated by the equations in subsections (a) and (b).
(d) The default exposure assumptions used to calculate the inhalation numeric values for soil are as follows:
Residential Nonresidential Term Systemic1 Carcinogens2 (Onsite Worker) THQ Target Hazard Quotient 1 N/A 1 RfCi Inhal. Reference Concentration (mg/m3) Chemical-specific N/A Chemical-specific [ATnc] ATnc Averaging Time for systemic toxicants (yr) 30 N/A 25 TF Transport Factor (mg/kg)/(mg/m3)
Volatilization3
Particulate4
Chemical-specific
1 x 1010Chemical-specific
1 x 1010
Chemical-specific
1 x 1010ET Exposure Time (hr/day) 24 24 8 EF Exposure Frequency5 (d/yr) 250 250 180 ED Exposure Duration (yr) 30 [N/A] 30 25 CF Conversion Factor [1,000 µg/mg] N/A 1,000 µg/mg 1,000 µg/mg TR Target Risk N/A 1 x 10-5 1 x 10-5 IUR Inhalation Unit Risk (µg/m3)-1 N/A Chemical-specific Chemical-specific [ATc] ATc Averaging Time for carcinogens (yr) N/A 70 70 AED Combined Age-Dependent Adjustment Factor and Exposure Duration (yr)6 N/A 76 N/A IURk TCE inhalation unit risk for kidney cancer (µg/m3)-1 1 x 10-6 IURl TCE inhalation unit risk for both non-Hodgkin lymphoma and liver cancer (µg/m3)-1 3 x 10-6 * * * * * (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 x ATc x 365 days/year x 24 hr/day
_________________
IUR x ET x EF x ED x TF x CF(2) For regulated substances identified as a mutagen, except for vinyl chloride and trichloroethylene, in § 250.301(b):
MSC = TR x ATc x 365 days/year x 24 hr/day
_________________
IUR x ET x EF x AED x TF x CF(3) For vinyl chloride:
MSC = TR
_____________________________________
[(IUR x ET x EF x ED x TF x CF) / (ATc x 365 days/year x 24 hr/day)] + (IUR x TF x CF)(4) For trichloroethylene:
MSC = TR x ATc x 365 days/yr x 24 hr/day
___________________________
(IURk x AED + IURl x ED) x ET x EF x TF x CF(h) The default exposure assumptions used to calculate the inhalation numeric values for the inhalation of volatiles from groundwater are as follows:
Residential Nonresidential Term
Systemic1 Carcinogens2 (Onsite Worker) THQ Target Hazard Quotient 1 N/A 1 RfCi Inhal. Reference Concentration (mg/m3) Chemical-specific N/A Chemical-specific [ATnc] ATnc Averaging Time for systemic toxicants (yr) 30 N/A 25 ET Exposure Time (hr/day) 24 24 8 EF Exposure Frequency (d/yr) 350 350 250 ED Exposure Duration (yr) 30 30 25 TF Transfer Factor (L/m3)3 0.5 0.5 0.5 CF Conversion Factor N/A 1,000 µg/mg 1,000 µg/mg TR Target Risk N/A 1 x 10-5 1 x 10-5 IUR Inhalation Unit Risk (µg/m3)-1 N/A Chemical-specific Chemical-specific [ATc] ATc Averaging Time for carcinogens (yr) N/A 70 70 AED Combined Age-Dependent adjustment Factor and Exposure Duration (yr)4 N/A 76 N/A IURk TCE inhalation unit risk for kidney cancer (µg/m3)-1 1 x 10-6 IURl TCE inhalation unit risk for both non-Hodgkin lymphoma and liver cancer (µg/m3)-1 3 x 10-6 * * * * *
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