Presentation_ActionItem_02L-PFAS_July2024_Shelton

15A NCAC 02L .0202 Groundwater Quality Standards PFAS Rulemaking
Bridget Shelton
Division of Water Resources
July 2024 GWWMC
Jessica Montie
Division of Waste Management
Follow-Up Responses to Questions from May 2024 GWWMC Meeting
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•What are other states doing to regulate PFAS in groundwater?
•Response: The Interstate Technology Regulatory Council (ITRC) maintains a PFAS Water and Soil
Values Table (Microsoft Excel format) which can be accessed on their website at this link:
https://pfas-1.itrcweb.org/fact-sheets/
•Several states have guidance values, action levels, cleanup levels, standards, and promulgated rules
in place to regulate various PFAS in groundwater, including Alaska, Colorado, Connecticut, Florida,
Hawaii, Illinois, Iowa, Maine, Massachusetts, Michigan, Minnesota, Montana, New Hampshire, New
Jersey, Pennsylvania, Rhode Island, Texas, Vermont, and Washington. For example, Michigan has
established Cleanup Criteria in groundwater for PFOA, PFOS, PFNA, PFBS, PFHxS, PFHxA, and
HFPO-DA. Minnesota has established Health Risk Limits for groundwater for PFOA, PFOS, PFBA,
PFBS, PFHxS, and PFHxA.
•North Carolina is the only state in the Southeast Atlantic US with a PFAS manufacturer.
•What are the “traditional testing methods” for the PQL for legacy PFAS?
•Response: The testing method for groundwater is Method 1633, issued by the EPA in January 2024,
which includes 43 PFAS including PFOA and PFOS:
https://www.epa.gov/system/files/documents/2024-01/method-1633-final-for-web-posting.pdf
Follow-Up Responses to Questions from May 2024 GWWMC Meeting
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•Where are the manufacturers of PFAS?
•Response: North Carolina has one PFAS manufacturer. PFAS can also be released from
manufacturing operations that formulate raw material containing PFAS chemicals. Examples of
other industry categories that are potential PFAS sources include organic chemicals, plastics &
synthetic fibers; metal finishing; electroplating; electric and electronic components; landfills; pulp,
paper & paperboard; leather tanning & finishing; plastics molding & forming; textile mills; paint
formulating, and airports.
•What are the alternatives to PFAS in manufacturing, if PFAS are no longer able to be used?
•Response: This proposed amendment does not prohibit the use of PFAS in manufacturing. The
existing rule states that substances without a groundwater standard which are not naturally
occurring shall not be permitted in concentrations at or above the PQL. The existing rule requires
a manufacturer, formulator, or other permitted activity to prevent releases of PFAS into
groundwater that cause exceedances of the groundwater standards (either the PQL under the
existing rule or the proposed standards, if adopted). The proposed rule amendment does
not contain any requirements for the use of PFAS in manufacturing processes.
Follow-Up Responses to Questions from May 2024 GWWMC Meeting
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•What is the Department’s compliance and enforcement strategy and the burden on the State to
implement PFAS groundwater and surface water quality standards?
•Response: Groundwater standards are used as clean-up standards and to protect groundwater
as a resource. This rulemaking does not change the requirements and procedures for
addressing groundwater contamination, only the clean-up standard is proposed to be changed
from the current. For providing clarity to these compliance assistance processes, see Appendix
B of the attached Fiscal and Regulatory Impact Analysis (RIA).
•The strategy and the burden on the State would be the same under the existing groundwater
standards or the proposed groundwater standards. The RIA outlines which DEQ programs
implement groundwater quality standards and the impacts, which includes the potential for staff
time saved in the future, which could be redirected to other project/sites.
Outline
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•Groundwater Quality Standards Background
•Development of Groundwater Quality Standards
•Per-and Polyfluorinated Substances (PFAS)
•Proposed Groundwater Quality Standards for PFAS
•Regulatory Impact Analysis Summary
•Proposed Rulemaking Schedule and Action Item Request
Types of North Carolina Water Quality Standards
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Groundwater Standards
(protect resource)Surface Water Standards
(protect resource)
Drinking Water Standards
(treatment)
State Regulations Safe Drinking Water Act Clean Water Act
Impacts of Groundwater and Surface Water on Drinking Water Treatment Burden
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Groundwater in NC
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•Groundwater is the water that fills cracks and other openings in beds of
rocks and sand and is stored in underground reservoirs known as aquifers
•Groundwater supports approximately 50% of drinking water use in the state
•Public Water Supply Sites
•80% of approximately 2300 Public Water Systems rely on groundwater
as drinking water source
•Majority are smaller systems providing drinking water to rural
communities with fewer residents
•Private Drinking Water Wells
•25% of residents rely on groundwater sourced wells
Groundwater Quality Standards Rule
Title 15A NCAC Subchapter 02L – Groundwater Classifications and Standards
Section .0100: General Considerations
Section .0200: Classifications and Groundwater Quality Standards
.0201 Groundwater Classifications
.0202 Groundwater Quality Standards
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NC Groundwater Quality Standards
Federal Requirement No*
North Carolina Rule 15A NCAC 02L .0202
Population Human Adults
Target use Ingestion
Household use
Standard endpoints
Noncancer
Cancer
Aqueous taste and odor
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North Carolina Groundwater Quality Standards
•Maximum allowable concentrations which may be tolerated without creating a threat to human health or which would otherwise render the groundwater unsuitable for its intended best usage
•Best Usage: existing or potential source of drinking water supply for humans
•Protect groundwaters of the state as a resource for human consumption
•Groundwater supports approximately 50% of drinking water use in the state
•Implemented in various programs including site clean-ups, risk assessments, health evaluations, etc.
*Groundwater standards are used in Federal programs in NC (such as
Superfund, RCRA, etc.)
•Substances which are not naturally occurring and for which no
standard is specified shall not be permitted in concentrations at or
above the practical quantitation limit (PQL).
•Where the standard for a substance is less than the PQL, the
detection of that substance at or above the PQL constitutes a
violation of the standard.
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Groundwater Quality Standards Rule Language
15A NCAC 02L .0202 (b) and (c)
Practical quantitation limit or "PQL" means the lowest concentration of a
given material that can be reliably achieved by analytical technique
during routine laboratory analysis.
Established as the least of the following*:
1.Systemic/non-cancer threshold concentration
2.Concentration which corresponds to an incremental lifetime cancer
risk of 1 x 10-6 (one in a million)
3.Taste threshold limit value
4.Odor threshold limit value
5.Maximum contaminant level
6.National secondary drinking water standard
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Developing Groundwater Quality Standards
*15A NCAC 02L .0202 (d)
Groundwater Standards Calculation
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1. Noncancer/systemic
𝐺𝐺𝐺𝐺𝐺𝐺𝐺𝐺=𝑅𝑅𝑅𝑅𝑅𝑅× 𝐵𝐵𝐺𝐺× 𝑅𝑅𝐺𝐺𝑅𝑅𝐺𝐺𝑅𝑅𝑅𝑅
2. Cancer 𝐺𝐺𝐺𝐺𝐺𝐺𝐺𝐺=𝑅𝑅𝑅𝑅× 𝐵𝐵𝐺𝐺𝑅𝑅𝐶𝐶𝐶𝐶× 𝐺𝐺𝑅𝑅𝑅𝑅
Toxicity benchmarks
RfD = Chronic Oral Reference Dose
CPF = Carcinogen Potency Factor
or Cancer Slope Factor (CSF)
Exposure estimates
RSC = Relative Source Contribution
(0.1 for inorganics; 0.2 for organics)
BW = Body Weight = 70 kg (adult)
WCR = Water Consumption Rate =
2 L/day (adults)
RL = Risk Level = 1x10-6
The following references are used, in order of preference*:
1.EPA Integrated Risk Information System (IRIS)
2.EPA Drinking Water Health Advisories
3.Other EPA health risk assessment data
4.Other relevant, published health risk assessment data and
scientifically valid peer-reviewed published toxicological data
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*15A NCAC 02L .0202 (e)
Developing Groundwater Quality Standards cont.
Per- and Polyfluorinated Substances (PFAS)
•PFAS are a group of manufactured chemicals that are used to make
fluoropolymer coatings and products
•Perfluorinated compounds are chemicals of specific concern to North Carolina
•Widely produced and used; significant presence in NC
•Persist in the environment
•Bioaccumulate in humans, animals, and the environment
•Evaluated the available scientific data to develop groundwater standards for a
subset of PFAS compounds
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Background – NPDWR for Drinking Water
•March 2023 – EPA announced the proposed National Primary Drinking Water
Regulation (NPDWR) for six PFAS:
•PFOA, PFOS, PFNA,HFPO-DA,PFHxS, and PFBS
•April 2024 – Finalized NPDWR, establishing legally enforceable levels for
drinking water, called Maximum Contaminant Levels (MCLs), for six PFAS:
https://www.epa.gov/sdwa/and-polyfluoroalkyl-substances-pfas
Background- Previous GWWMC and EMC Presentations
2022-2023
•May 2022 EMC Meeting
•Information Item – Prevalence of PFAS
in NC, EPA actions, and regulations in
other states
•July 2022 EMC Meeting
•Information Item – PFAS Update
•July 2023 GWWMC Meeting
•Information Item – Groundwater Quality
Standards and PFAS Rulemaking
Update
•November 2023 EMC Meeting
•Information Item – Proposed PFAS
Toxicological Summaries
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2024
•January 2024 GWWMC Meeting
•Information Item – Affected Sources and
Anticipated Implementation Requirements;
Cost and Benefits Analysis Approach
•March 2024 GWWMC Meeting
•Information Item – Plan Implementation
Timeline; DWM Stakeholder Meetings
Overview and Feedback
•May 2024 GWWMC Meeting
•Information Item – Proposed Groundwater
Standards; Regulatory Impact Analysis
Overview
Proposed PFAS Compounds for Groundwater Standards Development
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PFAS Compound Acronym
1 Perfluorooctane sulfonic acid PFOS*
2 Perfluorooctanoic acid PFOA*
3 Hexafluoropropylene oxide dimer acid HFPO-DA (GenX)*
4 Perfluorobutane sulfonic acid PFBS*
5 Perfluorononanoic acid PFNA*
6 Perfluorohexane sulfonic acid PFHxS*
7 Perfluorobutanoic acid PFBA
8 Perfluorohexanoic acid PFHxA
*Regulated under the Safe Drinking Water Act in the form of MCLs and Hazard Index.
Why these PFAS Compounds?
1.All eight compounds have an available literature base and available health effects data to support the development of groundwater standards.
2.The literature bases for all compounds have been reviewed and evaluated by a federal agency.
3.All eight PFAS compounds have been detected in North Carolina’s environmental media.
4.There is a final EPA test method (Method 1633) available to measure these compounds in groundwater.
For full toxicological summary, see Appendix A documenting principal studies and health effects data
used, description of assigned toxicological values, and calculation of the numeric water quality criteria.
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PFAS
Compound Reference Critical Health
Effects
Toxicity Benchmarks
and Values Available^
1 PFOS 2023 EPA Toxicity Assessment+Developmental and
Cardiovascular effects RfD, CSF, MCL
2 PFOA 2023 EPA Toxicity Assessment+Renal cell carcinomas RfD, CSF, MCL
3 HFPO-DA
(GenX)
2021 EPA Human Health Toxicity
Assessment+Liver effects RfD, MCL
4 PFBS 2021 EPA Human Health Toxicity
Assessment+Thyroid effects RfD
5 PFNA 2021 ATSDR* Minimal Risk Level+Developmental effects RfD, MCL
6 PFHxS 2021 ATSDR* Minimal Risk Level+Thyroid effects RfD, MCL
7 PFBA 2022 EPA IRIS Assessment Liver and Thyroid effects RfD
8 PFHxA 2023 EPA IRIS Assessment Developmental effects RfD
Proposed Groundwater Standards for PFAS Compounds
See Appendix A for Details on Toxicological Summary and Derivation of the Standard
+Used as basis for EPA's PFAS National Primary Drinking Water Regulation​*ATSDR= Agency for Toxic Substances and Disease Registry^RfD: reference dose; CSF: cancer slope factor; MCL: Maximum Contaminant Level in drinking water
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Proposed Groundwater Standards for PFAS Compounds
15A NCAC 02L .0202 (b)(1):
Where the standard for a
substance is less than the
PQL, the detection of that
substance at or above the
PQL constitutes a violation
of the standard.
PFAS
Compound
Proposed 02L
.0202(h)
Standard (ng/L)
Existing 02L
Standard - PQL
(ng/L)
Compliance Level
Under Proposed
Rule (ng/L)
1 PFOS 0.7 4.0 PQL (4.0)
2 PFOA 0.001 4.0 PQL (4.0)
3 HFPO-DA
(GenX)10 5.0 10
4 PFBS 2,000 3.0 2,000
5 PFNA 10 4.0 10
6 PFHxS 10 3.0 10
7 PFBA 7,000 5.0 7,000
8 PFHxA 4,000 3.0 4,000
*PQLs were calculated using the method detection limits (MDLs) reported in EPA Method 1633, which were based on the national
Multi-Laboratory Validation Study of PFAS by Isotope Dilution LC-MS/MS Wastewater, Surface Water, and Groundwater.
Regulatory Impact Analysis
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•The attached Fiscal and Regulatory Impact Analysis (RIA) was approved by OSBM per G.S. 150B-21.4.
•Includes reason for rule amendment, fiscal analysis approach, cost and
benefits summary, and rule alternatives
•Supporting Information
•Appendix A – Toxicological Summary, Derivation of Groundwater Standards,
and Calculation Sheets
•Appendix B – Proposed Plan for Addressing PFAS Impacts to Groundwater
at DWM-Regulated Sites Under Existing Regulations
•Appendix C – Technical Memorandum Used to Determine PFAS Treatment
Cost for Groundwater
Regulatory Impact Analysis Summary
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•Impact Summary of rule amendment as compared to baseline (existing rule/absence of 02L groundwater standard/PQL):
•Benefit of regulatory certainty.
•No additional impacts to human health risks.
•No additional costs to regulated community, and potential for benefit in avoided costs in the future (potential substantial economic impact in benefits) for:
•Local government-owned sites;
•Private industry-owned sites;
•Inactive Hazardous Sites Fund (allowing funds to be redirected to other site priorities); and
•State government staff time (allowing staff time to be redirected to other priorities).
Potential Costs and Benefits from the Proposed AmendmentFor One Hypothetical DWM-Regulated Site
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( * ) Range of potential avoided assessment and remediation costs over time for one hypothetical DWM-regulated site, if a site fell under certain circumstances (see fiscal note in Attachment C).
Original Costs obtained were in November 2023 dollars, but have been escalated at 2.42% for CapEx and 2% for O&M. Table assumes Year 1 is 2026 per the DWM implementation schedule. Net Present Value (NPV) total is in 2024 dollars.
The year that remediation would have begun is site-specific. Remediation timeframe would also be site-specific, but annual avoided costs would continue until remediation would have been completed, if warranted under existing rules.
Category Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10
ADDED COSTS FROM PROPOSED AMENDMENT
Additional expenses to the regulated community to address
PFAS as compared to baseline/existing rule $0 $0 $0 $0 $0 $0 $0 $0 $0 $0
CHANGES TO HUMAN HEALTH IMPACTS FROM PROPOSED AMENDMENT
Changes to human health impacts as compared to
baseline/existing rule $0 $0 $0 $0 $0 $0 $0 $0 $0 $0
POTENTIAL BENEFITS TO REGULATED COMMUNITY FROM PROPOSED AMENDMENT *
Potential Avoided Future Capital Expenditures at One Hypothetical DWM-Regulated Site
• Construction of additional 1 to 4 Groundwater Wells for
either assessment monitoring or extraction, if needed
$13,054 to
$78,322 ------------------
• Treatment System Construction $156,858 to
$883,133 ------------------
Potential Avoided Future Annual O&M and Monitoring Expenses at One Hypothetical DWM-Regulated Site
• Adding PFAS Analysis to Routine Monitoring for 3-25
Wells, 1 or 2 Events
$2,303 to
$38,034
$2,349 to
$38,795
$2,396 to
$39,571
$2,444 to
$40,362
$2,493 to
$41,169
$2,543 to
$41,993
$2,594 to
$42,832
$2,645 to
$43,689
$2,698 to
$44,563
$2,752 to
$45,454
• Groundwater Well O&M (1 to 4 wells)$2,494 to
$9,975
$2,544 to
$10,175
$2,595 to
$10,378
$2,647 to
$10,586
$2,700 to
$10,797
$2,754 to
$11,013
$2,809 to
$11,233
$2,865 to
$11,458
$2,922 to
$11,687
$2,981 to
$11,921
• Treatment System O&M $59,428 to
$301,383
$60,617 to
$307,411
$61,829 to
$313,559
$63,065 to
$319,830
$64,327 to
$326,227
$65,613 to
$332,751
$66,926 to
$339,406
$68,264 to
$346,194
$69,629 to
$353,118
$71,022 to
$360,181
TOTAL QUANTIFIED BENEFITS TO REGULATED
COMMUNITY IN POTENTIAL FUTURE AVOIDED COSTS
AT ONE HYPOTHETICAL DWM-REGULATED SITE *
$208,670 to
$1,156,140
$65,510 to
$356,380
$66,820 to
$363,507
$68,156 to
$370,778
$69,519 to
$378,193
$70,910 to
$385,757
$72,328 to
$393,472
$73,774 to
$401,342
$75,250 to
$409,368
$76,755 to
$417,556
Ten -Year Net Present Value, 7% discount rate, 2024 dollars $604,975 to $3,323,557
Action / Responsibility Date
Stakeholder Meetings January and February 2024
GWWMC/EMC – Information items May 2022, July 2022, July 2023, November
2023, January 2024, March 2024, and May 2024
GWWMC – Decision to Approve Rule Text and RIA to go to EMC July 10, 2024
EMC – Decision to Approve Rule and RIA for Public Comment September 12, 2024
Public Comment Period October 15 – December 16, 2024
Earliest Date for Public Hearing October 30, 2024
EMC – Decision to Approve Hearing Officer’s Report and final RIA,
Adopt Rule March 2025
RRC - Approval of Rule April 2025
Proposed effective date May 1, 2025
Proposed Rulemaking Schedule
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Action Item Request
Approval to proceed to the EMC with request for public notice and
hearings for the proposed rule amendment to 15A NCAC 02L .0202
Groundwater Quality Standards and the associated Fiscal and
Regulatory Impact Analysis.
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Thank you
Groundwater Standards Calculations:
Bridget Shelton
Groundwater Quality Standards Coordinator, DWR
[e-mail]; (919)-707-9022
Human Health Impacts:
Frannie Nilsen, PhD
Environmental Toxicologist, DEQ
[e-mail]​; (919)-707-8217
Regulatory and Fiscal Impact Analysis and Rule Implementation:
Jessica Montie
Environmental Program Consultant, DWM
[e-mail]​;(919)-707-8247