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Rule2024-08547

Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances

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Published

May 8, 2024

Effective

July 8, 2024

Issuing agencies

Environmental Protection Agency

Abstract

Pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act ("CERCLA" or "Superfund"), the Environmental Protection Agency (EPA) is designating two per- and polyfluoroalkyl substances (PFAS)--perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers--as hazardous substances. The Agency reached this decision after evaluating the available scientific and technical information about PFOA and PFOS and determining that they may present a substantial danger to the public health or welfare or the environment when released. The Agency also determined that designation is warranted based on a totality of the circumstances analysis, including an analysis of the advantages and disadvantages of designation.

Full Text

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[Federal Register Volume 89, Number 90 (Wednesday, May 8, 2024)]
[Rules and Regulations]
[Pages 39124-39192]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-08547]

[[Page 39123]]

Vol. 89

Wednesday,

No. 90

May 8, 2024

Part III

Environmental Protection Agency

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40 CFR Part 302

Designation of Perfluorooctanoic Acid (PFOA) and
Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances;
Final Rule

Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Rules
and Regulations

[[Page 39124]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 302

[EPA-HQ-OLEM-2019-0341; FRL-7204-03-OLEM]
RIN 2050-AH09

Designation of Perfluorooctanoic Acid (PFOA) and
Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Pursuant to the Comprehensive Environmental Response,
Compensation, and Liability Act (``CERCLA'' or ``Superfund''), the
Environmental Protection Agency (EPA) is designating two per- and
polyfluoroalkyl substances (PFAS)--perfluorooctanoic acid (PFOA) and
perfluorooctanesulfonic acid (PFOS), including their salts and
structural isomers--as hazardous substances. The Agency reached this
decision after evaluating the available scientific and technical
information about PFOA and PFOS and determining that they may present a
substantial danger to the public health or welfare or the environment
when released. The Agency also determined that designation is warranted
based on a totality of the circumstances analysis, including an
analysis of the advantages and disadvantages of designation.

DATES: Effective July 8, 2024.

ADDRESSES: EPA has established a docket for this rulemaking under
Docket ID No. EPA-HQ-OLEM-2019-0341. All documents in the docket are
listed in <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>. Although listed, some
information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy. With the exception of such material, publicly available docket
materials are available electronically in <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

FOR FURTHER INFORMATION CONTACT: Sicy Jacob, Office of Emergency
Management (5104A), Environmental Protection Agency, 1200 Pennsylvania
Avenue NW, Washington, DC 20460; telephone number 202-564-8019; email
address: <a href="/cdn-cgi/l/email-protection#fc969d9f939ed28f959f85bc998c9dd29b938a">[email&#160;protected]</a> or Linda Strauss, Office of Superfund
Remediation and Technology Innovation, Environmental Protection Agency,
1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number
202-564-0797; email address: <a href="/cdn-cgi/l/email-protection#5724232536222424793b3e3933361732273679303821">[email&#160;protected]</a>.

SUPPLEMENTARY INFORMATION: Acronyms and Abbreviations: We use multiple
acronyms and terms in this preamble. While this list may not be
exhaustive, to ease the reading of the preamble and for reference
purposes, EPA defines the following terms and acronyms here:

AFFF Aqueous film-forming foam
ARARs Applicable or Relevant and Appropriate Requirements
ATSDR Agency for Toxic Substances and Disease Registry
CDC Centers for Disease Control and Prevention
CASRN Chemical Abstracts Service Registry Number
COC Contaminant of Concern
CDR Chemical Data Reporting
CERCLA Comprehensive Environmental Response, Compensation, and
Liability Act
CFR Code of Federal Regulations
DoD Department of Defense
DOE Department of Energy
EA Economic Analysis
ECF Electrochemical fluorination
EJ Environmental justice
EPA Environmental Protection Agency
EPCRA Emergency Planning and Community Right-to-Know Act
EU European Union
FAA Federal Aviation Administration
FDA Food and Drug Administration
FR Federal Register
ICR Information Collection Request
LEPC Local Emergency Planning Committee
MCL Maximum contaminant level
MCLG Maximum Contaminant Level Goals (MCLGs)
NAICS North American Industrial Classification System
NCP National Oil and Hazardous Substances Pollution Contingency Plan
NECI National Enforcement Compliance Initiative
NHANES National Health and Nutrition Examination Survey
NPDWR National Primary Drinking Water Regulation
NPL National Priorities List
NRC National Response Center
OMB Office of Management and Budget
PCBs Polychlorinated biphenyls
PFAS Per- and polyfluoroalkyl substances
PFOA Perfluorooctanoic acid
PFOS Perfluorooctanesulfonic acid
PFOSA Perfluorooctanesulfonamide
PHGs Public health goals
ppt parts per trillion
PRG Preliminary remediation goal
PRP Potentially responsible party
PRSC Post-Removal Site Control
PWS Public water system
RCRA Resource Conservation and Recovery Act
RFA Regulatory Flexibility Act
RfD Reference dose
RQ Reportable quantity
SAB Science Advisory Board
SDWA Safe Drinking Water Act
SERC State Emergency Response Commission
SNURs Significant New Use Rules
TEPC Tribal Emergency Planning Committee
TERC Tribal Emergency Response Commission
TRI Toxic Release Inventory
TSCA Toxic Substances Control Act
UCMR Unregulated Contaminant Monitoring Rule
UMRA Unfunded Mandates Reform Act
U.S. United States
WWTP Wastewater treatment plant

Table of Contents

I. Executive Summary
II. General Information
A. What action is the Agency taking?
B. What are the Direct Effects of this Action?
C. Does this action apply to me?
D. What is the Agency's Authority for taking this Action?
E. What are CERCLA's primary objectives, and how does it operate
to protect human health and the environment?
1. How does CERCLA authority and causes of action differ in key
respects between ``hazardous substances'' and ``pollutants or
contaminants''?
2. What response actions does CERCLA authorize?
3. What discretionary authority does CERCLA provide and how does
CERCLA prioritize cleanup actions?
4. What is the CERCLA cleanup process and what role does the
National Priorities List (NPL) play in it?
5. What is the process for identifying and selecting remedial
actions under CERCLA?
6. How does CERCLA's framework ensure that those responsible for
contamination pay for cleanup?
7. What enforcement discretion is available when exercising
CERCLA authority?
8. Why is understanding CERCLA's overarching provisions critical
to understanding the importance of this rulemaking to EPA's ability
to protect human health and the environment?
III. Background of this Rulemaking
A. Summary of Proposed Designation.
B. PFOA and PFOS Production and Use
C. EPA's PFAS Strategic Map
IV. Legal Authority
A. CERCLA section 102(a) Designation Considerations
B. Consistency with other methodologies for identifying CERCLA
hazardous substances.
C. CERCLA Section 102(a) and Cost Considerations.
V. PFOA and PFOS may present a substantial danger to the public
health or welfare or the environment when released into the
environment.
A. PFOA and PFOS Pose a Hazard.
B. Information about the fate and transport of PFOA and PFOS
demonstrate that they are Persistent and Mobile in the Environment.
C. Other Information Considered.
VI. The totality of the circumstances confirms that designation of
PFOA and PFOS as hazardous substances is warranted.
A. Advantages of designation

[[Page 39125]]

1. Designation enables earlier, broader, and more effective
cleanups of contaminated sites.
a. Designation opens up CERCLA's notification, response,
enforcement, and cost recovery authorities, which allows EPA to more
timely address contaminated sites.
b. The availability of CERCLA enforcement and cost recovery
authority ensures that polluters are financially responsible, which
is consistent with CERCLA.
c. EPA expects designation will increase Emergency Response and
Removal Actions for PFOA/PFOS.
d. EPA expects that shifting costs to PRPs to address PFOA/PFOS
contamination at NPL sites will make Fund money available for other
response work.
2. Designation Brings Broad Health Benefits
a. Qualitative potential benefits from decreased exposure after
addressing PFOA/PFOS contamination
b. Quantifiable health benefits of PFOA and PFOS exposure
reduction.
i. Quantified Developmental Effects
ii. Quantified Cardiovascular Effects
iii. Quantified Kidney Cancer Effects
iv. Estimated health benefits of PFOA and PFOS exposure
reduction.
c. Cost Estimates of Burden of PFAS-Related Disease
d. Environmental Justice (EJ) Analysis
e. Summary of health benefits resulting from the designation.
3. Property Reuse and Social, Economic, and Ecological Benefits
that may Result from Designation
4. Some facilities may adopt or improve best practices to
prevent future releases of PFOA and PFOS
B. Potential Disadvantages of Designation
1. Direct costs
2. Potential hardship for parties that did not contribute
significantly to contamination.
3. Potential litigation, liability, and uncertainty,
C. Results of Totality of the Circumstances Analysis
VII. Summary of Public Comments and Responses
A. Legal Authority
B. Operation of CERCLA
C. Toxicity, Human Health Effects/Mobility, Persistence,
Prevalence/Release into the environment
D. Effects of Designation
E. National Priorities List (NPL) Sites--Existing and Future
Contamination
F. Regulate PFAS as a class.
G. Managing PFOA and PFOS Contaminated Waste
H. Comments on Economic Assessment/Regulatory Impact Analysis
I. Enforcement
VIII. Summary of this Final Rule
A. Default Reportable Quantity
B. Direct Effects of Designating PFOA, PFOS, and their Salts and
Structural Isomers as Hazardous Substances
IX. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review, as
amended by Executive Order 14094: Modernizing Regulatory Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act (UMRA)
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
G. Executive Order 13045: Protection of Children from
Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations and Executive Order 14096: Revitalizing our Nation's
Commitment to Environmental Justice for All

References

I. Executive Summary

A. Overview

Pursuant to section 102(a) of the Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA), EPA is designating
perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS),
including their salts and structural isomers, as hazardous
substances.\1\ Each of the actions adding PFOA, PFOS, and their salts
and structural isomers, to CERCLA's hazardous substances list is
independent, and severable from the others. The Agency evaluated the
available scientific and technical information about those substances
and concluded that designation of each substance is warranted under the
criteria in section 102(a) because both PFOA and PFOS, and their salts
and isomers, may present substantial danger to public health or welfare
or the environment. Exercising its discretion with respect to when to
make a finding under section 102(a), EPA as part of its decision-making
process went beyond considering whether PFOA and PFOS ``may present a
substantial danger to public health welfare or the environment'' within
the meaning of section 102(a), and also performed an additional
analysis that weighed the advantages and disadvantages of designation,
including quantitative and qualitative benefits and costs. As part of
that additional discretionary analysis, EPA determined that the
advantages of designation outweigh the disadvantages. Among other
advantages, designation best serves CERCLA's two primary objectives--
the timely cleanup of contaminated sites and holding polluters
accountable for contamination they caused (i.e., the ``Polluter Pays''
principle). Designation provides necessary tools to address the
challenge of PFOA and PFOS contamination in the environment.
Designation will allow EPA to utilize all CERCLA's authorities, which
will enable EPA to address more sites, take earlier action, and to
expedite eventual cleanup. Designating PFOA and PFOS as CERCLA
hazardous substances is thus critical to addressing PFOA and PFOS
releases in the environment and to protecting public health.
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\1\ PFOA and PFOS are part of a group of human-made chemicals
known as per- and polyfluoroalkyl substances (PFAS). All references
to PFOA and PFOS in this notice include their salts and structural
isomers.
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B. ``May Present Substantial Danger to Public Health or Welfare or the
Environment''

EPA is taking final action on the proposed finding that both PFOA
and PFOS ``may present substantial danger to public health or welfare
or the environment'' when released into the environment after
considering the available scientific and technical information and
after considering comments on the proposed determination. Available
information indicates that human exposure to PFOA and/or PFOS is linked
to a broad range of adverse health effects, including developmental
effects to fetuses during pregnancy or to infants (e.g., low birth
weight, accelerated puberty, skeletal variations), liver effects (e.g.,
tissue damage), immune effects (e.g., antibody production and
immunity), and other effects (e.g., cholesterol changes). Both PFOA and
PFOS are known to be transmitted to the fetus via the placenta and to
the newborn, infant, and child via breast milk.
In addition, toxicity assessments in support of EPA's 2024 National
Primary Drinking Water Regulation for PFAS (2024a) indicate that PFOA
and PFOS may cause carcinogenic effects in humans and animals (Barry et
al., 2013; Bartell & Vieira, 2021; Goodrich et al., 2022; Shearer et
al., 2021; Vieira et al., 2013). In the final toxicity assessments, EPA
assessed the weight of the evidence for the available cancer data and
determined that PFOA and PFOS are Likely to Be Carcinogenic to Humans
consistent with the Guidelines for Carcinogen Risk Assessment (U.S.
EPA, 2005, 2024b, 2024c, 2024d). Additionally, in November 2023, the
International Agency for Research on Cancer (IARC) evaluated the
carcinogenicity of PFOA and PFOS and classified PFOA as carcinogenic to
humans (Group 1) and PFOS as possibly

[[Page 39126]]

carcinogenic to humans (Group 2b) (Zahm, et al., 2023).
The potential for adverse health effects is exacerbated by the fact
that PFOA and PFOS are persistent in the environment, which can cause
long-term exposure. PFAS, including PFOA and PFOS, are sometimes
referred to as ``forever'' chemicals because of their strong carbon-
fluorine bonds in the ``tail group'' that cause them to be extremely
resistant to degradation and to remain in the environment for long
periods of time. This means that the potential for human exposure
continues long after an immediate release has ended. PFOA and PFOS are
also highly mobile in the environment and can migrate away from the
point of initial release. Studies also show that PFOA and PFOS persist
in humans and animals (i.e., bioaccumulate) with estimated elimination
half-lives \2\ in humans ranging from about two to three years for PFOA
to four or five years for PFOS \3\ (ATSDR, 2021). Because PFOA and PFOS
can remain in the human body for these long durations, individuals who
have consistent ongoing exposures to elevated concentrations of PFOA
and PFOS (e.g., individuals exposed by drinking contaminated well
water) can have elevated concentrations of these compounds in their
bodies which may contribute to adverse health effects (Hall et al.,
2023; Hoffman et al., 2011; Kotlarz et al., 2020; Steenland et al.,
2009).
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\2\ Elimination half-life is the length of time required for the
concentration of a particular substance to decrease to half of its
starting dose in the body.
\3\ Data from two studies in Table 3-5 of ATSDR 2021 (Seals et
al., 2011 and Zang et al., 2013) were not included in EPA's estimate
of elimination half-life because their findings were significantly
different for the other studies, and may not be the most
representative.
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PFOA and PFOS are prevalent in the environment and can be found in
surface water, groundwater, soil, and air. PFOA and PFOS are prevalent
because they have been produced and used since the 1940s, were among
the most widely used of the PFAS constituents and persist in the
environment for a long time. PFOA and PFOS have historically been used
in a wide range of consumer products including carpets, clothing,
fabrics for furniture, packaging for food and cookware, and
firefighting foam, in addition to being used in a wide range of
industrial processes. See Designation of Perfluorooctanoic Acid (PFOA)
and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances,
87 FR 54415, 54417 (proposed Sept. 6, 2022) (hereinafter ``Proposed
Rule'' or ``Proposal'') (providing a brief history of PFOA and PFOS
production and use). Domestic production and import of PFOA has been
phased out by the companies participating in the 2010/2015 PFOA
Stewardship Program (U.S. EPA, 2023c). Some uses of PFOS are ongoing.
The sustained and broad use of PFOA and PFOS by industries means that
many sites may be contaminated with high levels of PFOA and PFOS.
Furthermore, these substances may still be released into the
environment through use and disposal of legacy products and through
limited ongoing uses.
PFOA and PFOS have been detected in the drinking water of millions
of Americans and are widely detected in surface water samples collected
from various rivers, lakes, and streams in the United States (ATSDR,
2021; Cadwallader et al., 2022; U.S. EPA, 2017, 2024a). This exposure
potential is exacerbated by their persistence and mobility in the
environment (Langenbach & Wilson, 2021). The prevalence of PFOA and
PFOS is further demonstrated by the fact that these chemicals were
detected in the blood of nearly all of the participants in the latest
U.S. Centers for Disease Control and Prevention's (CDC) National Health
and Nutrition Examination Survey (NHANES) for which data is available
from 2017-2018. (CDC, 2022). This information indicates widespread
though generally declining exposure to PFOA and PFOS in the U.S.
population. From 1999-2000 to 2017-2018, blood PFOS levels declined by
more than 85%. From 1999-2000 to 2017-2018, blood PFOA levels declined
by more than 70%. While serum concentrations of PFOA and PFOS in the
general population are declining, there is evidence that PFOA and PFOS
releases continue to result in elevated environmental concentrations
and the potential for human exposure. For example, under the 2018-2019
National Rivers and Streams Assessment (NRSA) PFOS was detected in 91%
of the 290 fish fillet composite samples analyzed, corresponding to
PFOS being detected in 92% of the sampled population of 41,099 river
miles (a statistically significant decrease of 6.7% from NRSA 2013-14)
(U.S. EPA, 2023i).
In consideration of the evidence of adverse effects to human health
and the environment from PFOA and PFOS exposure, their persistence and
mobility in the environment, and the significant potential for human
exposure due to their prevalence in the environment, EPA concludes that
PFOA and PFOS may present a substantial danger to public health or
welfare or the environment when released into the environment. EPA
further finds that populations located near highly contaminated sites
are of particular concern because they are at risk of a
disproportionately high potential of repeat exposure to PFOA and PFOS
as compared to the general population and across demographic
characteristics and repeated exposures increase the likelihood of
adverse health effects, as discussed further in the Preamble, Section
VI.A,2. d. For these reasons, designation of PFOA and PFOS as hazardous
substances is warranted.

C. ``Totality of the Circumstances'' Analysis

Along with concluding that PFOA and PFOS each, when released, ``may
present a substantial danger'' to public health or welfare or the
environment and therefore meet the statutory designation criteria, EPA
also exercised discretion to conduct an additional totality of the
circumstances analysis. The analysis looks to CERCLA section 102(a),
and its broader context, to help identify the information to weigh and
how to balance multiple considerations. In conducting the analysis as
to PFOA and PFOS, EPA identified and weighed the advantages and
disadvantages of designation relative to CERCLA's purpose alongside the
formal benefit-cost analysis, including quantitative and qualitative
benefits and costs, provided in the Regulatory Impact Analysis \4\
accompanying this final rule. That ``totality of the circumstances''
analysis confirmed EPA's conclusion that designation is warranted
because the advantages of designation outweigh the disadvantages.
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\4\ The RIA was conducted in a consistent manner with economic
principles and governmental guidance documents for economic analysis
(e.g., OMB Circular A-4 and EPA's Guidelines for Preparing Economic
Analyses) and summarized monetized costs and benefits. The RIA is a
neutral analysis tool that allows the federal government to consider
potential benefits and costs that may result from designation. It
does not consider whether designation is warranted.
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EPA considered how designation supports CERCLA's primary objectives
to clean up contaminated sites and ensure the ``Polluter Pays.'' EPA
concluded that designation best serves those objectives and that CERCLA
is the best tool to address the legacy of sites contaminated with these
substances and to address additional releases of these chemicals in the
future. EPA considered that designation would allow EPA to deploy the
full suite of CERCLA tools to identify, characterize, and clean up the
most contaminated sites expeditiously. It allows EPA to ensure that
those parties responsible for significant

[[Page 39127]]

contamination bear the costs of cleaning it up. The use of these
authorities will allow EPA to address more sites and to do so earlier
in time than it otherwise could in the absence of designation. The
ability to address more contaminated sites will provide meaningful
health benefits to the communities near these sites by reducing the
risk of exposure and the potential adverse health and environmental
effects associated with such exposure. EPA expects these cleanups will
have meaningful health benefits similar to health benefits typically
associated with CERCLA actions. EPA also considered the potential
quantifiable and qualitative costs and benefits of designation and the
comments expressing concerns about widespread liability and litigation
after designation. As explained below, EPA finds that the advantages of
designation outweigh the disadvantages and that designation is
warranted.
EPA's totality of the circumstances analysis considered the adverse
health impacts and environmental challenges posed by PFOA and PFOS
contamination. PFAS, including PFOA and PFOS, are a nationwide concern
because exposure to these chemicals is linked to significant adverse
human health impacts, they were in wide use, and they persist and are
mobile once released into the environment. CERCLA provides the tools
for addressing such contamination and provides a framework to allow
EPA, and other delegated Federal agencies,\5\ to make site-specific
determinations and response decisions to address instances of PFOA and
PFOS releases that pose unacceptable risk. Specifically, CERCLA
provides authority to respond to releases of hazardous substances
(including legacy releases). CERCLA's cleanup process is comprehensive
in that it can address contamination to air, water, groundwater, and
soil. EPA's CERCLA response authority also extends from initial
investigations to cleanup. No other statute that EPA administers
provides the breadth of authority to fully address highly contaminated
sites. Thus, CERCLA is the best authority to address existing
contamination to mitigate the disproportionate risk borne by
communities impacted by those sites. Furthermore, CERCLA is a liability
statute. The CERCLA cost recovery and enforcement provisions ensure
that those parties responsible for significant contamination can be
held accountable to pay for or conduct clean up. Designation is the
best way for EPA to effectuate CERCLA's objectives with respect to
releases of PFOA and PFOS.
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\5\ Executive Order 12580 (Jan. 23, 1987, as amended) delegates
CERCLA response authority to EPA, as well as the Secretaries of
Defense, Interior, Agriculture, Commerce, and Energy with respect to
releases from a facility or vessel under their jurisdiction, custody
or control and to the U.S. Coast Guard with respect to releases
involving the coastal zone, Great Lakes waters, ports, and harbors.
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EPA also considered whether designation is warranted considering
EPA's existing CERCLA authority, which allows the Agency to address
PFOA and PFOS as ``pollutants or contaminants.'' CERCLA's authority to
address pollutants or contaminants is much more circumscribed than the
authority to address hazardous substances. Specifically, CERCLA's
notification requirements for releases do not attach to pollutants or
contaminants; EPA cannot address a release of pollutants or
contaminants unless the Agency demonstrates that the release may
present an ``imminent and substantial danger''; CERCLA does not provide
cost recovery authority for actions taken solely in response to
releases or threats of releases of pollutants or contaminants; and
CERCLA authority to compel potentially responsible parties (PRPs) to
conduct or pay for response work does not extend to pollutants or
contaminants. Designating PFOA and PFOS as CERCLA hazardous substances
eliminates those limitations. Elimination of those limitations provides
meaningful advantages.
EPA also considered the advantages of designation. The most
significant direct costs associated with designation stem from the
requirement for facilities to report releases of PFOA and PFOS that
occur after designation. EPA determined these costs were fairly minimal
and reasonable in light of the benefits of release notifications.
Notification ensures transparency about new releases of PFOA and PFOS,
and it allows EPA and affected States and communities to immediately
evaluate a release and quickly respond, as necessary, to address risks
to human health or the environment. Without notice, EPA is less able to
obtain key information to help protect affected communities. Thus, the
notification requirement is an advantage that is necessary to
adequately protect the public from future releases. Designation also
allows EPA to streamline the Federal government's response authority to
address releases of PFOA and PFOS, which will allow EPA to take action
sooner. EPA can also begin the lengthy process of identifying,
characterizing, and cleaning up the most contaminated sites without
delay, either through enforcement or EPA-funded action.
Another key advantage to designation is that it best effectuates
the Polluter Pays principle underpinning CERCLA. Designation improves
equities by transferring costs of cleaning up PFOA and PFOS from the
Superfund (``the Fund''),\6\ which has been historically funded by
taxpayer dollars, to those responsible for contamination. Absent
designation, costs incurred for addressing PFOA and PFOS as pollutants
or contaminants are paid for by the Fund, rather than responsible
parties. Preservation of the Superfund is critical because the monies
in it are insufficient to clean up all the existing contamination
across the country from the more than 800 CERCLA hazardous substances
as well as additional/emerging pollutants and contaminants. The ability
to require PRPs to pay for PFOA and PFOS response costs means that more
money will be available in the Fund to address a multitude of
priorities, particularly at those sites where there is no viable PRP.
It also allows EPA to address more releases earlier than it otherwise
could absent designation. Further, cleanup to address PFOA/PFOS
supported by designation may allow for incidental cleanup of co-
contaminants, including other types of PFAS, which would also benefit
human and environmental health. Because contaminated sites often have
multiple contaminants of concern (``COCs''), the benefits from
addressing co-contaminants may be substantial for some sites to the
extent this occurs. It is critical to initiate more CERCLA actions to
address PFOA and PFOS contamination now because the process from
investigations to cleanups can take many years, if not decades. And,
because PFOA and PFOS are persistent in the environment and highly
mobile, further delay increases the extent of contamination,
potentially increasing the number of individuals exposed to these
substances, and also potentially increasing costs associated with
cleanup.
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\6\ Congress established the Hazardous Substances Trust Fund,
otherwise known as the Superfund, to provide funding to address
contamination. CERCLA also established liability for parties that
contributed to releases of hazardous substances, CERCLA section
107(a), which allows EPA to shift costs from the Fund to PRPs.
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EPA's ability to address PFOA and PFOS contamination through
enforcement and EPA-funded action means more communities will be
protected from disproportionate and unacceptable health risks,
including communities with environmental justice

[[Page 39128]]

(EJ) concerns. Published literature \7\ supports the conclusion that
certain communities with EJ concerns have a higher likelihood of
exposure to PFAS, including PFOA/PFOS. For more information, see RIA
Section 6.3 Impacts on Communities with EJ concerns: Analysis. Cleaning
up more sites with PFOA and PFOS contamination will help to decrease
their exposure to PFOA and PFOS, thus reducing their risk of
detrimental health effects, such as decreased immune response to
vaccination, decreased birthweight, increased total cholesterol, and
cancer. Cleaning up sites also promotes economic benefits, such as
improved property values and making land available for reuse. Improving
environmental quality can improve local economies by supporting local
business, such as recreation companies or industries that rely on
natural products like agriculture. Improved quality of natural
resources can also contribute to ecosystem services.\8\
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\7\ Northeastern University--The PFAS Project Lab, ``PFAS
Contamination Is an Equity Issue, and President Trump's EPA Is
Failing to Fix It'' October 31, 2019. Available at: <a href="https://pfasproject.com/2019/10/31/pfas-contamination-is-an-equity-issue-and-president-trumps-epa-is-failing-to-fix-it/">https://pfasproject.com/2019/10/31/pfas-contamination-is-an-equity-issue-and-president-trumps-epa-is-failing-to-fix-it/</a>.
Lee, Susan, Avinash Kar, and Dr. Anna Reade, Dirty Water: Toxic
``Forever'' PFAS Chemicals are Prevalent in the Drinking Water of
Environmental Justice Communities. Natural Resources Defense
Council, New York. 2021. <a href="https://www.nrdc.org/sites/default/files/dirty-water-pfas-ej-communities-report.pdf">https://www.nrdc.org/sites/default/files/dirty-water-pfas-ej-communities-report.pdf</a>
Stoiber, T., Evans, S., & Naidenko, O.V. (2020). Disposal of
products and materials containing per- and polyfluoroalkyl
substances (PFAS): A cyclical problem. Chemosphere 260, Accessed at:
<a href="https://doi.org/10.1016/j.chemosphere.2020.127659">https://doi.org/10.1016/j.chemosphere.2020.127659</a>.
\8\ Ecosystem services produce the life-sustaining benefits we
receive from nature--clean air and water, fertile soil for crop
production, pollination, and flood control.
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EPA also considered the quantitative and qualitative direct and
indirect costs and benefits evaluated in the RIA as part of its
totality of the circumstances analysis.\9\ EPA recognizes that
designation will lead to both direct and indirect costs. The only
quantifiable direct cost associated with designation is the
notification requirement, for releases of PFOA and PFOS at or above 1
pound within a 24-hour period. EPA estimates that the notification
requirement will cost $2,658 per release and that the total cost of the
notification requirement is not anticipated to exceed $1,630,000 per
year.\10\ Notification is critical to ensuring that new releases are
identified, evaluated, and addressed to the extent necessary to protect
human health and the environment. EPA considers both the individual and
total notification costs to be generally reasonable because of the
value notification provides to impacted communities and regulatory
agencies. Notification can avoid delays in evaluation of a new release.
This is particularly important for persistent and mobile substances
like PFOA and PFOS because early evaluation can determine whether the
release poses an unacceptable risk that requires a response before PFOA
and PFOA migrate away from the release. Such migration without
intervention can lead to an increase in both the scope of the
contamination and the costs necessary to address any identifiable
risks.
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\9\ The terms ``direct'' and ``indirect'' as used to describe
potential impacts of this rule are based on established definitions
used for analyses under the Regulatory Flexibility Act (RFA). EPA is
aware that ``direct'' and ``indirect'' costs have distinct
definitions for CERCLA purposes; those CERCLA-specific definitions
were not used for estimating costs for the purpose of designation.
Both EPA and SBA have applicable RFA guidance documents that were
considered in developing this rule. For this rule, reporting
requirements are direct effects because upon designation of PFOA and
PFOS as hazardous substances, entities that release a reportable
quantity within a 24-hour period are required to use established
procedures to report the release immediately by telephone and
provide a follow-up written report. Potential liability for response
costs for addressing PFOA and PFOS releases or threatened releases
is an indirect effect of designation. This is because CERCLA
response actions are not required by this rule, and are
discretionary and contingent upon a series of many site-specific
determinations. See RIA Section 1.4 Scope of Analysis and RIA
Section 6.2 Small Entity Analysis for more detail.
\10\ The designation may also result in minimal costs to federal
agencies associated with CERCLA section 120(h) notice requirements
when selling or transferring federally owned real property where
PFOA/PFOS may be present. Future federal property sales and
transfers involving property where PFOA and/or PFOS may be present
is unknowable and therefore such costs are unquantifiable.
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With respect to indirect costs, EPA considered the costs associated
with responding to releases of PFOA and PFOS at contaminated sites and
with responding to future releases, either through direct EPA action
with cost recovery or through enforcement. As stated above, EPA
considers the ability to use the full suite of CERCLA authorities--
including cost recovery and enforcement--to be an advantage of the
rule. Designation eliminates current barriers to timely cleanup of
contaminated sites and enables EPA to pursue parties responsible for
significant contamination, these are the parties that should bear the
costs of cleaning it up. When parties responsible for contamination are
required to bear the cost of cleanup, more resources are made available
to address additional cleanups. For example, EPA can compel a PRP to
take action to address PFOA and PFOS pursuant to CERCLA section 106(a),
which will then allow EPA to use Superfund monies and human resources
to address other releases at other sites. Further, every contaminated
site that is addressed can reduce the disproportionate burden borne by
some of the communities at risk of exposure to PFOA and PFOS from the
contamination. EPA's totality of the circumstances analysis included an
evaluation of the benefit-cost analysis in the RIA (including indirect
costs) as well as additional qualitative considerations related to
designation, such as how CERCLA functions.
EPA is required to take a measured approach in responding to
contamination. For instance, CERCLA ensures that costs are considered
when determining the remedy. In addition, EPA, as well as other Federal
agencies, have resource constraints that require CERCLA response
actions to be prioritized to address the most urgent and highest risks
as specified by the National Priorities List (NPL). The NPL is the list
of sites of national priority among the known releases or threatened
releases of hazardous substances, pollutants, or contaminants
throughout the United States and its territories. It is intended
primarily to guide EPA in determining which sites warrant further
investigation. Eligibility for the NPL includes identifying priority
sites based upon relative risk or danger that may be posed to public
health or welfare or the environment, considering the population, the
hazard potential of the hazardous substances at issue, the potential
for contamination of drinking water supplies, the potential for direct
human contact, the potential for destruction of sensitive ecosystems,
and the damages to natural resources that may affect the human food
chain when determining priority. Thus, CERCLA provides EPA with the
ability to identify the sites with the highest human health and
environmental risks and address those sites first, and the costs of
addressing contamination are considered relative to the risks the
contamination poses before a remedy is selected. before a remedy is
selected.
Between FY 2003 and FY 2022, only about four percent of all
contaminated sites added to EPA's Active Site Inventory were placed on
the NPL. Since 2013, EPA has, on average, added 11 sites \11\ per year
to the NPL, and EPA

[[Page 39129]]

does not expect the rate at which annual additions to the NPL occur to
increase as a result of this rule. Moreover, NPL listing does not
trigger any immediate actions, liability, or requirements for the
site.\12\
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\11\ This estimate is based on data from EPA's SEMS database
with respect to non-federal NPL sites. EPA determined that it was
appropriate to assess the designation's impact with respect to non-
federal NPL sites only, because federal sites are generally expected
to address PFOA and PFOS in the absence of designation consistent
with CERCLA section 104. As discussed in Chapter 2 of the RIA,
federal sites are addressing PFAS in the baseline as authorized by
CERCLA section 104 and corresponding Executive Orders, as required
by the NDAA, and consistent with federal facilities agreements under
CERCLA section 102(a). Therefore, EPA expects that federal sites
will address PFOA and PFOS contamination in the absence of the final
rule. With federal sites taking action to address PFAS in the
baseline, indirect impacts of the final rule will likely be related
to actions taken at non-federal sites. For additional context, since
FY 2000 EPA has added 8 federal sites to the NPL.
\12\ EPA considered the portion of non-federal NPL sites that
may be impacted by designation depending on site-specific
circumstances. Of final, proposed, or deleted non-federal NPL sites
that have been tested for PFOA and/or PFOS, an estimated 33.1% of
NPL sites have detectable levels of PFOA and/or PFOS. See Section
3.3 of the RIA for more details about this estimate. In evaluating
the designation's impact non-federal NPL sites, this estimate is
instructive and serves as a benchmark for assessing designation's
potential impact to those sites. There are currently 5 sites where
either PFOA or PFOS contributed to NPL listing.
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CERCLA ensures that the most significant releases that pose the
most risks to human health and the environment are prioritized, and
designation will allow EPA to ensure more sites are evaluated sooner,
thereby protecting more communities from PFOA and PFOS contamination.
In Chapter 5 of the Regulatory Impact Analysis (RIA) for this
rulemaking, EPA presents quantified potential response costs \13\ that
may occur after designation despite the uncertainty of future response
actions. Every site is unique and the extent of action necessary to
mitigate risks depends on many factors, which leads to uncertainties
regarding response activities and associated costs. Notwithstanding
these uncertainties, EPA used existing data to estimate response costs
for PFOA and PFOS. Specifically, EPA used response costs data for EPA-
lead response actions, potential costs associated with cleanup methods
and technologies available to address PFOA and PFOS, and information
about conditions at contaminated sites. EPA then used that data to
assess the incremental costs of cleanup associated with addressing
PFOA/PFOS contamination. Data available to EPA demonstrates that PFOA
and PFOS generally are not found in isolation; rather, those substances
are typically co-located or commingled with other ``contaminants of
concern'' that on their own support a remedy. The estimated incremental
costs to address PFOS and/or PFOS releases at NPL sites are those that
the Agency believes it would incur absent the designation, which can be
transferred to viable, liable parties as a result of designation. As
EPA's funds would then be used for additional fund-led efforts to
address contamination not addressed under the baseline, there will be a
net increase in spending on response activities. This ability to
transfer costs enables EPA to investigate and clean up additional NPL
sites to address potential risks posed by any of the more than 800
hazardous substances, including PFOA and PFOS. EPA estimated the
potential transfer of response costs associated with NPL sites range
from $10.3M to $51.7M per year (at a 2% discount rate), depending on
the cost premium associated with the response work to address PFOA and/
or PFOS in addition to other Contaminants of Concerns (COCs) \14\ at a
given NPL site. Because EPA would use these funds for additional fund-
led efforts to address contamination not addressed under the baseline,
the transfer of $10.3M to $51.7M would result in additional costs of
this same amount. Additionally, indirect costs associated with
potential enforcement actions that may result in additional response
activities for PFOA and PFOS at non-NPL sites are estimated to range
from $327,000 to $18,100,000 per year (at the 2% discount rate),
depending on the type of response actions taken at a given site. See
RIA Section.
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\13\ The term ``response'' may include actions including but not
limited to: site assessment, investigation, remedial action, and
removal action. See CERCLA section 101(25). For a description of
details on the differences between remedial and removal actions and
other response activities under CERCLA, please see Section 2.1 of
the RIA.
\14\ Contaminants of Concerns (COCs) are chemicals identified
during in-depth site studies (Remedial Investigation/Feasibility
Study) that need to be addressed by a cleanup action because they
pose a potential threat to human health or the environment.
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5.1 Indirect Costs and Transfers
EPA expects response costs to address PFOA and PFOS to represent an
incremental increase above the cost of addressing other substances at
NPL sites because, more often than not, PFOA and PFOS are likely to be
co-located with or commingled with other substances. EPA also expects
that costs to address PFOA and PFOS will fall within typical response
cost ranges for actions to address other hazardous substances. This is
because many of the same response and cleanup methods available, as
noted in the Interim Guidance on the Destruction and Disposal of
Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing
Perfluoroalkyl and Polyfluoroalkyl Substances--Version 2 (2024),\15\ to
address other hazardous substances can be used to address PFOA and PFOS
(e.g., dig and haul for soil and granulated activated carbon for
water). Moreover, EPA expects that response and cleanup costs may
decrease over time as associated methods improve. Finally, by
addressing PFOA and PFOS releases earlier, EPA can mitigate the spread
of contamination, which likely mitigates the costs of an otherwise more
wide-spread cleanup.
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\15\ Interim PFAS Destruction and Disposal Guidance; Notice of
Availability for Public Comment was published in the Federal
Register on April 16, 2024 (89 FR 26879) <a href="https://www.govinfo.gov/content/pkg/FR-2024-04-16/pdf/2024-08064.pdf">https://www.govinfo.gov/content/pkg/FR-2024-04-16/pdf/2024-08064.pdf</a>.
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EPA also considered liability and litigation that may arise after
designation. CERCLA is designed to ensure that those responsible for
contamination pay to clean it up. For PRPs that have significantly
contributed to contamination, imposing CERCLA liability is wholly
consistent with CERCLA and necessary to address the public health
threat posed by PFOA and PFOS. However, EPA also gave serious
consideration to potential liability for parties that have not played a
significant role in contamination. Those parties include entities that
did not generate PFOA- or PFOS-contaminated materials. EPA evaluated
CERCLA liability limitations, EPA's enforcement policies, settlement
protections for settling and non-settling parties, and parameters for
CERCLA lawsuits to resolve who should pay and how much. Those
mechanisms, combined with decades of historical practice, show that
CERCLA liability is not unlimited; enforcement is targeted; and
parties' ability to recover costs from other PRPs is constrained.
Although CERCLA's liability structure is broad, both the statute
and EPA enforcement discretion policies may constrain a party's ability
to secure reimbursement of response costs.\16\ CERCLA includes
liability exemptions as well as affirmative defenses against liability.
See, e.g., CERCLA section 101(10), 107(b), (d), (k). Parties must incur
response costs before they can recover those costs from other viable,
liable parties. And parties must prove that response costs incurred are
consistent with the National Contingency Plan, CERCLA's implementing
regulations. Id. section 107(a)(4)(B). EPA's enforcement authorities
and policies can serve as a deterrent for responsible parties to pursue
entities that did not contribute

[[Page 39130]]

significantly to contamination.\17\ EPA has a well-proven track record
of developing enforcement discretion policies that have been effective
and well-received.\18\ EPA's enforcement policies, such as its policy
regarding de minimis or de micromis parties and innocent landowner
policies, have proven to be useful tools in convincing responsible
parties not to pursue entities covered by these enforcement discretion
policies. Finally, the statute provides that a party that resolves its
potential liability with the United States or a State in a judicially
approved settlement is entitled to contribution protection--the ability
to block third-party claims for matters addressed in the settlement.
These liability limitations and mitigation tools are more fully
discussion in Section VI.B.2. EPA concludes that designation is not
expected to result in excessive litigation and that CERCLA will
continue to operate as it has for decades. Indeed, CERCLA's liability
framework, coupled with EPA enforcement policies, has operated in a
rational way for the more than 800 CERCLA hazardous substances already
within its purview, some of which are similar to PFOA and PFOS in terms
of ubiquity, mobility, and persistence. Heavy metals, such as arsenic
and chromium, are persistent, and in at least some places, prevalent in
the environment. Although EPA understands that designation will result
in new litigation regarding PFOA and PFOS releases for responsible
parties, forty years of CERCLA experience indicates that designation
should not result in unusual CERCLA liability or litigation outcomes
for parties who did not significantly contribute to the contamination
as a result of this designation, and, therefore, the potential for
litigation should not be a barrier to designation.
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\16\ Other Federal agencies including DOD, DOE, USDA, and DOI
have delegated CERCLA authority. EPA's policies apply only to EPA
and its exercise of enforcement discretion. Please note that EPA's
policies are not regulations and do not create new legal obligations
or limit or expand obligations under any Federal, State, Tribal or
local law.
\17\ CERCLA is designed to achieve the cleanup of contaminated
sites by ensuring that those responsible for the contamination pay
to clean it up, which EPA supports through its longstanding
``enforcement first'' policy. (``Guidelines for Using the Imminent
Hazard, Enforcement and Emergency Response Authorities of Superfund
and Other Statutes,'' 1982.) Furthermore, CERCLA's settlement
provisions are designed to support and achieve those outcomes by
making it efficient for EPA to secure clean up from those that have
significantly contributed to contamination. See, e.g. Section 122(a)
(``Whenever practical and in the public interest, . . . [EPA] shall
act to facilitate agreements . . . that are in the public interest
and minimize litigation.''); Section 122(g)(1) (allowing for
``expedited'' de minimis settlements for ``minor portions of the
response costs''). In practice, CERCLA's settlement parameters
incentivize PRPs that likely bare a large share of responsibility to
settle with EPA, which in turn can deter those same parties from
pursuing other PRPs. Ultimately, settlement is generally less
expensive than litigation and can serve as an effective mechanism
for achieving the true goal of CERCLA--that the parties most
responsible for contamination pay to clean it up.
\18\ While EPA's enforcement discretion policies themselves are
not regulations and do not create new legal obligations or limit or
expand obligations under any federal, state, tribal or local law,
such policies have influenced Congress to create new laws that have
been upheld by courts. The Small Business Liability Relief and
Brownfields Revitalization Act of 2002 (``Brownfields Amendments'')
illustrate how EPA's policies have influenced Congressional action.
The Brownfields Amendments amended CERCLA and promoted the cleanup,
reuse, and redevelopment of sites by addressing potential liability
concerns associated with contaminated, potentially contaminated, and
formerly contaminated properties. The Brownfields Amendments
provided important self-implementing liability limitations for
certain categories of landowners, enabling private parties to save
time and costs, in part, by reducing EPA involvement in most private
party transactions. EPA launched the Brownfields Initiative in the
1990s and developed guidance and tools to help further the
Initiative's goals to empower states, communities, and other
stakeholders to assess, safely clean up, sustainably reuse, and
prevent future brownfield sites. EPA's Brownfields Initiative
established a number of practices, policies, and guidances to
support cleanup and reuse at contaminated property. In 2002, many
elements of EPA's Brownfields Initiative were codified into CERCLA
by the Brownfields Amendments.
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EPA aims to further support reasonable liability and litigation
outcomes through the implementation of its CERCLA enforcement program.
EPA will continue to implement its ``Enforcement First'' policy
(``Guidelines for Using the Imminent Hazard, Enforcement and Emergency
Response Authorities of Superfund and Other Statutes,'' 1982)--in which
EPA aims to compel viable PRPs to conduct and pay for investigation and
cleanup before resorting to the Fund--which supports the Polluter Pays
principle. EPA has a proven track record of developing and applying
enforcement discretion policies that are effective and well-received by
the public and interested parties, and courts have sanctioned this
approach. Enforcement discretion policies historically have given EPA
the needed flexibility to offer liability comfort or protections when
circumstances warrant. For example, for more than 30 years, EPA has
maintained its ``Policy Towards Owners of Residential Property at
Superfund Sites,'' which generally provides that EPA will not take
action against residential property owners provided their own actions
do not cause a release that requires a response action.
Although EPA believes existing limitations in CERCLA coupled with
existing CERCLA enforcement policies mitigate concerns about liability
that may arise after designation, EPA recognizes that some parties that
do not bear primary responsibility for litigation may be sued and face
uncertain litigation costs as a consequence. EPA believes that the
statutory safeguards described above will likely limit this type of
litigation, or at a minimum, limit adverse outcomes. Even if litigation
costs are incurred by parties that do not bear primary responsibility,
EPA does not believe that these potential costs will outweigh the
substantial advantages from the rule.
While some commenters shared concerns that these mechanisms may not
mitigate concerns, these commenters did not support their concerns with
any specific data or evidence. Generally, in enforcement matters, the
facts, circumstances, and equities of a case help dictate which parties
the Agency will pursue. EPA, intends to develop a policy, consistent
with those limitations and policies, that explains EPA's priorities for
enforcement in the context of PFOA and PFOS releases.\19\ As EPA states
in the FY 2024-2027 National Enforcement and Compliance Initiatives
(NECI), the Agency expects to ``focus on implementing EPA's PFAS
Strategic Roadmap and holding responsible those who significantly
contribute to the release of PFAS into the environment . . . much as
[EPA] exercises CERCLA enforcement discretion in other areas.''.\20\
Available at <a href="https://www.epa.gov/system/files/documents/2023-08/fy2024-27necis.pdf">https://www.epa.gov/system/files/documents/2023-08/fy2024-27necis.pdf</a>.
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\19\ EPA received valuable public input that EPA is considering
in drafting a CERCLA PFAS enforcement discretion policy. EPA held
two public listening sessions in March 2023 and several stakeholder
meetings in 2023 with the agriculture sector, water sector, pulp and
paper sector, solid waste management sector, and NGOs to hear
stakeholder concerns regarding potential CERCLA PFAS enforcement
concerns.
\20\ <a href="https://www.epa.gov/enforcement/national-enforcement-and-compliance-initiatives">https://www.epa.gov/enforcement/national-enforcement-and-compliance-initiatives</a>.
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In sum, EPA's additional ``totality of the circumstances'' analysis
affirms that designation is warranted. The totality of the
circumstances analysis gave particular weight to the scientific basis
for designation--that PFOA and PFOS may present substantial danger when
released into the environment. EPA also concluded that designation best
addresses the problem posed by PFOA and PFOS in the environment,
particularly for those communities living in and around highly
contaminated sites, and that designation meaningfully furthers CERCLA's
purposes. Designation ensures that EPA has the full suite of CERCLA
tools necessary to address contamination and that EPA is able to take
more timely response actions, including those necessary to address
immediate risks. EPA's analysis shows that designation results in
quantitative and qualitative benefits, including significant health

[[Page 39131]]

benefits. EPA's analysis accounts for potential direct and indirect
costs that may result from designation. Direct costs, particularly for
release notifications, are minimal and reasonable in light of the
substantial benefits notification provides. EPA assessed the potential
for litigation and liability costs, particularly for parties that have
not significantly contributed to contamination. EPA was unable to
quantify those costs with reasonable certainty but conducted a
qualitative assessment of CERCLA's liability provisions and enforcement
policies to assess the potential magnitude of such costs. EPA's
analysis shows that designation should not result in excessive or
unreasonable liability and litigation outcomes. Rather, CERCLA will
continue to operate as it has for decades. EPA concludes that the
substantial advantages of designation outweigh potential disadvantages,
and that designation is warranted based on its additional totality of
the circumstances analysis.

D. Conclusion

EPA concludes that designation is warranted based solely on its
finding that PFOA and PFOS may present a substantial danger to the
public health or welfare or the environment when released into the
environment. Additionally, EPA believes designation is warranted based
on its totality of the circumstances analysis. The latest science is
clear: human exposure to PFOA and PFOS is linked to significant health
risks. CERCLA provides the tools necessary to address those risks posed
by significant contamination of PFOA and PFOS in the environment.
CERCLA is designed to target and prioritize sites that present
unreasonable risk to human health and the environment and serves those
communities that are most vulnerable to potential adverse health risks
from exposure. Designation eliminates barriers to cleanup and enables
EPA to secure more timely actions. It streamlines response authority,
provides a mechanism for parties to recover response costs from PRPs,
and makes available CERCLA enforcement authority to compel PRPs to
conduct or pay for cleanup. Designation also requires facilities to
notify Federal, State, local, and Tribal authorities, as well as
potentially injured parties, of significant releases. EPA considered
the potential costs that may arise after designation, including both
quantified and unquantified costs, and finds that they are outweighed
by the substantial advantages of designation. Further delay in
accessing CERCLA's complete suite of tools to address contamination
will allow PFOA and PFOS more time to migrate within the environment
and exacerbate existing contamination. Thus, designation best achieves
CERCLA's primary objectives--the timely cleanup of contaminated sites
and ensuring that those responsible for contamination pay to clean it
up. Designation will help protect communities near contaminated sites
from potential health risks. For all these reasons, discussed in detail
below, EPA concludes that designation of both PFOA and PFOS as CERCLA
hazardous substances is warranted under the statute.

II. General Information

A. What action is the Agency taking?

As proposed on September 6, 2022, EPA is designating PFOA and PFOS,
including their salts and structural isomers, as hazardous substances
under section 102(a) of CERCLA. See Designation of Perfluorooctanoic
Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous
Substances, 87 FR 54415 (Sept. 6, 2022). The list of hazardous
substances in Table 302.4 of 40 CFR part 302 is amended to include
PFOA, PFOS and their salts and structural isomers. (Note: EPA's CompTox
Chemicals Dashboard (<a href="https://comptox.epa.gov/dashboard/">https://comptox.epa.gov/dashboard/</a>) is a resource
that can be used to identify salts and structural isomers of PFOA and
PFOS. EPA periodically updates the CompTox Chemicals Dashboard to
include new information on PFAS, including PFOA and PFOS.)

B. What are the direct effects of this Action?

The designation of PFOA and PFOS, including their salts and
structural isomers, as hazardous substances, can trigger the
applicability of release reporting requirements under CERCLA sections
103 and 111(g), and accompanying regulations, and section 304 of the
Emergency Planning and Community Right-to-Know Act (EPCRA). Facilities
must report releases of hazardous substances at or above the reportable
quantity (RQ) within a 24-hour period. For PFOA and PFOS, a default
\21\ reportable quantity (RQ) of one pound is assigned to these
substances pursuant to CERCLA section 102(b). Therefore, consistent
with CERCLA section 103(a), any person in charge of a vessel or
facility is required, as soon as they have knowledge of any release
(other than a federally permitted release) of any PFOA, PFOS, their
salts or structural isomers from such vessel or facility in quantities
equal to or greater than the RQ of one pound or more within a 24-hour
period, to immediately notify the National Response Center (NRC) of
such a release. The reporting requirements are further codified in 40
CFR 302.6(a). <a href="https://www.ecfr.gov/current/title-40/chapter-I/subchapter-J/part-302/section-302.6">https://www.ecfr.gov/current/title-40/chapter-I/subchapter-J/part-302/section-302.6</a>.
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\21\ 42 U.S.C. 9602(b). <a href="https://www.govinfo.gov/content/pkg/USCODE-2021-title42/pdf/USCODE-2021-title42-chap103-subchapI-sec9601.pdf">https://www.govinfo.gov/content/pkg/USCODE-2021-title42/pdf/USCODE-2021-title42-chap103-subchapI-sec9601.pdf</a>.
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In addition to CERCLA 103(a), EPCRA section 304 requires facility
owners or operators to immediately notify their community emergency
coordinator for local emergency planning committee (LEPC) (or Tribal
emergency planning committee (TEPC)), if established, for any area
likely to be affected by the release and to notify the State Emergency
Response Commission (SERC) (or Tribal Emergency Response Commission
(TERC)) of any State or Tribal region likely to be affected by the
release of these substances. These entities may have specific release
reporting requirements under the State, Tribal, and local EPCRA
program. <a href="https://www.epa.gov/epcra/state-contact-information-epcra-section-304-emergency-release-notification">https://www.epa.gov/epcra/state-contact-information-epcra-section-304-emergency-release-notification</a>.
EPCRA section 304 also requires facilities to submit a follow-up
written report to their SERC (or TERC) and the LEPC (or TEPC) as soon
as practicable after the release. EPCRA section 304 requirements are
codified in 40 CFR 355.30 to 355.43. <a href="https://www.ecfr.gov/current/title-40/chapter-I/subchapter-J/part-355/subpart-C">https://www.ecfr.gov/current/title-40/chapter-I/subchapter-J/part-355/subpart-C</a>.
CERCLA section 111(g) requires that owners or operators of any
vessel or facility ``provide reasonable notice to potential injured
parties by publication in local newspapers serving the affected area''
of any release of these substances.
CERCLA section 120(h) requires Federal agencies that sell or
transfer real property to provide notice of the presence of hazardous
substances in certain circumstances. CERCLA section 120(h) also
requires Federal agencies to provide a covenant warranting that ``all
remedial action necessary to protect human health and the environment
with respect to any [hazardous substances] remaining on the property
has been taken before the date of such transfer, and any additional
remedial action found to be necessary after the date of such transfer
shall be conducted by the United States.''
As provided by CERCLA section 306, the Department of Transportation
(DOT) is required to regulate any substance added to the CERCLA list as
hazardous materials in accordance with the Hazardous Materials
Transportation Act (HMTA).

[[Page 39132]]

While these are the only direct, automatic requirements of
designating PFOA and PFOS as CERCLA hazardous substances, EPA has also
considered other, indirect impacts in the Regulatory Impact Analysis
(RIA) of the Final Rulemaking to Designate Perfluorooctanoic Acid
(PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous
Substances, available in the docket, including those that are expected
to facilitate cleanups and reduce human and environmental exposure to
these hazardous substances.

C. Does this Action apply to me?

The seven broad categories of entities that may potentially be
affected by this action include, but are not limited to: (1) PFOA and/
or PFOS manufacturers (including importers and importers of articles
that contain these substances); (2) PFOA and/or PFOS processors; (3)
manufacturers of products containing PFOA and/or PFOS; (4) downstream
users of PFOA and PFOS; (5) downstream users of PFOA and/or PFOS
products; (6) waste management facilities; and (7) wastewater treatment
facilities.\22\ (Note: PFOA and PFOS noted here include their salts and
structural isomers.) The following list of North American Industrial
Classification System (NAICS) codes identifies entities that may be
directly or indirectly affected by this action. It is not intended to
be exhaustive, but rather a guide to help readers determine whether
this action applies to them. Potentially affected entities may include:
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\22\ The proposed rule listed 5 broad categories of entities
potentially affected by this designation. This action separated two
of these categories to be clearer. Entities listed as downstream
product manufacturers and users of PFOA and/or PFOS products in the
proposed rule are split into two separate categories in the final
rule (see (4) and (5)). Entities listed as waste management and
wastewater treatment facilities in the proposed rule are split into
two categories in the final rule (see (6) and (7)).
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D. What is the Agency's authority for taking this action?

CERCLA section 102(a) authorizes the EPA Administrator to
``promulgate and revise as may be appropriate, regulations designating
as hazardous substances, . . . such elements, compounds, mixtures,
solutions, and substances which, when released into the environment may
present substantial danger to the public health or welfare or the
environment[.]'' CERCLA section 102(b) establishes a default RQ of one
pound for releases of designated hazardous substances. See Section IV
of this document for additional details on EPA's authority, including
statutory criteria.

E. What are CERCLA's primary objectives, and how does it operate to
protect human health and the environment?

CERCLA establishes broad Federal authority to address past,
current, and future releases or threat of releases of hazardous
substances and pollutants or contaminants. The statute's primary
objectives are to promote the timely cleanup of contaminated sites and
to ensure parties responsible for contamination bear site cleanup
costs. CERCLA is unlike traditional environmental statutes that
prospectively regulate, among other things, how facilities operate and
provide limitations on discharges, emissions, releases, or disposal of
certain chemicals into water, air, or land. Instead, CERCLA is designed
to address contamination already in the environment on a site-specific
basis, which includes evaluating the nature, extent, and risk to human
health and/or the environment from the release. CERCLA affords EPA
broad discretion as to whether or how to respond to a release. It
includes cost-shifting mechanisms and liability provisions that support
PRP cleanups rather than relying on the Fund.
1. How does CERCLA authority and causes of action differ in key
respects between ``hazardous substances'' and ``pollutants or
contaminants''?
For hazardous substances,\23\ CERCLA section 103(a) requires
reporting of releases. CERCLA requires any person in charge of a vessel
or facility to immediately notify the NRC when there is a release of a
hazardous substance in an amount equal to or greater than the RQ for
that substance. Notice given to the NRC under CERCLA serves to inform
the Federal Government of a release so that Federal personnel can
evaluate the need for a response pursuant to CERCLA and its
accompanying regulations, the National Oil and Hazardous Substances
Pollution Contingency Plan (NCP). (40 CFR part 300).
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\23\ CERCLA defines ``hazardous substance'' primarily by
reference to other environmental statutes (i.e., the Clean Water
Act, Solid Waste Disposal Act, Clean Air Act and the Toxic
Substances Control Act) and includes substances designated as
hazardous under CERCLA section 102. (CERCLA section 101(14)).
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CERCLA response authorities apply to releases or the threat of
releases into the environment of ``hazardous substances'' and/or
``pollutants or contaminants'' \24\; however, the CERCLA authorities
available to address each type of release differs. With respect to
hazardous substances, the Agency can conduct response actions if there
is a release or threatened release; however, for pollutants or
contaminants, EPA can only respond if it establishes that the release
may present an imminent and substantial danger. (CERCLA section
104(a)).
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\24\ CERCLA defines the term ``pollutant or contaminant'' to
include, ``but not be limited to, any element, substance, compound,
or mixture . . . which after release into the environment and upon
exposure, ingestion, inhalation, or assimilation into any organism .
. . will or may reasonably be anticipated to cause death, disease,
behavioral abnormalities, cancer, genetic mutation, physiological
malfunctions . . . or physical deformations.'' (CERCLA 104).
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In addition, CERCLA's cost recovery and some specific enforcement
authorities extend to hazardous substances but not pollutants or
contaminants. (CERCLA section 107(a), 106(a)). For hazardous
substances, EPA can recover all response costs (e.g., investigation and
cleanup costs) from PRPs the Agency incurs that are not inconsistent
with the NCP and require PRPs to conduct the response. CERCLA also
authorizes non-governmental entities (including private parties) who
conduct cleanup activities related to hazardous substance releases to
recover response costs from liable parties provided the costs incurred
are consistent with the NCP.
2. What response actions does CERCLA authorize?
CERCLA authorizes two types of response actions--removal and
remedial. (CERCLA section 101(25)). Removals include ``such actions as
may be necessary taken in the event of the threat of release,''
including those ``necessary to prevent, minimize, or mitigate damage to
the public health or welfare or the environment.'' (CERCLA section
101(23)). Removals are typically short-term response actions that may
be taken to address releases or threatened releases requiring prompt
action; they are limited in cost and duration unless specific criteria
are met. (CERCLA section 104(c)(1)). Remedial includes those actions
consistent with ``permanent remedy taken instead of or in addition to
removal actions in the event of a release or threatened release of a
hazardous substance into the environment, to prevent or minimize the
release of hazardous substances so that they do not migrate to cause
substantial danger to present or future public health or welfare or the
environment'' (CERCLA section 101(24)). Remedial actions (RAs) entail
longer-term and more complex cleanup actions designed to provide
permanent solutions to mitigate risks typically associated with chronic
exposures often not immediately life-threatening.

[[Page 39138]]

3. What discretionary authority does CERCLA provide and how does CERCLA
prioritize cleanup actions?
EPA has broad discretionary authority to decide on a site-specific
basis whether to respond to a release or threat of release and to
prioritize the order in which it undertakes response actions determined
to be necessary. (CERCLA section 105(a)(8)(A)). Site-specific decisions
take into consideration factors such as relative risk, hazard
potential, population at risk and the potential for drinking water
contamination. Those considerations are embodied in the NCP. (See,
e.g., 40 CFR 300.410, 300.415, 300.430).
4. What is the CERCLA cleanup process and what role does the National
Priorities List (NPL) play in it?
Before identifying an appropriate response action--removal or
remedial--EPA or another lead agency, may first identify a release,
investigate its scope and extent, and evaluate its potential risk to
human health and the environment. Superfund cleanups typically begin
with a preliminary assessment/site inspection, which includes reviews
of historical information and site visits to evaluate the potential for
a release of hazardous substances (CERCLA section 104(b); 40 CFR
300.410, 300.430(b)). After an initial investigation, EPA has several
options, including determining a release does not pose sufficient risk
to warrant further action and deciding that the release warrants a
CERCLA response action. EPA may also defer the site to the State where
it is located.
The NCP provides guidance on the process to determine whether to
undertake a removal or a remedial action. For removal actions, the NCP
provides that the lead agency may take such an action when it has
determined ``that there is a threat to public health or welfare'' based
on a set of factors such as actual or potential exposure to drinking
water supplies, the potential for hazardous substances to migrate, and
the availability of other appropriate Federal or State response
mechanisms to address the release. (40 CFR 300.415(b)). For remedial
actions, EPA first evaluates a site for consideration as an NPL site,
(40 CFR part 300 App. A); only sites added to the NPL are eligible for
Superfund monies to conduct remedial actions.
A site's addition to the NPL does not trigger any immediate action
but represents an initial step towards a site's potential long-term
remedy; NPL sites are among the Nation's worst contaminated sites. EPA
has placed on the NPL only about 3 percent of the 53,400 sites assessed
since the program's beginning in 1980.
5. What is the process for identifying and selecting remedial actions
under CERCLA?
EPA can only begin the process to identify potential remedial
actions after completing the careful and deliberate process to add a
site to the NPL. CERCLA and the NCP together prescribe a comprehensive
and detailed process for evaluating, selecting, and implementing
remedies, which includes State and community roles. (40 CFR 300.430).
The process' first step is conducting a remedial investigation and
feasibility study (RI/FS) to assess site conditions and to evaluate the
remedial alternatives identified. (40 CFR 300.430(a)(2)). Next, the NCP
mandates consideration of several factors by which to evaluate remedial
alternatives. (40 CFR 300.430(e)(9)). At a minimum, all eligible
remedies must be protective of human health and the environment and
comply with all applicable or relevant and appropriate requirements
(ARARs).\25\ (CERCLA section 121(a), (d); 40 CFR 300.430(f)(1)(i)(A)).
The alternatives satisfying these two threshold criteria are then
further evaluated against one another using balancing criteria,
including factors such as long-term effectiveness and permanence;
toxicity, mobility or volume reduction; implementability; cost; and
finally modifying criteria of State acceptance; and community
acceptance. (40 CFR 300.430(e)(9), (f)).
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\25\ ARARs may be waived under certain circumstances. (CERCLA
section 121(d)(4)).
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A remedial action's selection must include public review and
comment on the lead agency's preferred alternative as presented in a
proposed plan. (CERCLA section 117; 40 CFR 300.430(f)(2)). EPA
documents its selection of a remedy in a record of decision. (40 CFR
300.430(f)(1)(ii)).
A site's selected remedy then enters the remedial design (RD)/
remedial action (RA) stage in which the remedy is designed and
constructed, followed in some instances by an Operation & Maintenance
(O&M) period.\26\ (40 CFR 300.435(a), (f)). Five-year reviews (FYR)
\27\ are required at sites where completed remedial actions result in
any hazardous substances, pollutants, or contaminants remaining onsite.
(CERCLA section 121(c)). They also must be conducted where remedial
actions result in any hazardous substances, pollutants, or contaminants
remaining at the site above levels that allow for unlimited use and
unrestricted exposure after the initiation of the selected remedial
action. (40 CFR 300.430(f)(4)(ii)).
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\26\ O&M is an important component of a Superfund response,
ensuring that the remedy continues to perform as intended and
remains protective of human health and the environment. O&M
activities may include remedy operation, maintenance and monitoring,
as well as monitoring of impacted media and monitoring and
maintenance of implemented Institutional Controls (IC)s. ICs are
non-engineered instruments, such as administrative and/or legal
controls, that help minimize the potential for human exposure to
contamination and/or protect the integrity of a remedy by limiting
land or resource use. Examples include fishing restrictions, deed
restrictions, and the posting of warning signs outside of a
contaminated site.
\27\ Five-year reviews evaluate the implementation and
performance of a remedy to determine whether it remains protective.
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6. How does CERCLA's framework ensure that those responsible for
contamination pay for cleanup?
A critical CERCLA component is holding those responsible for the
contamination accountable to perform or pay for its cleanup. EPA's
preference, and one of CERCLA's main goals, is to have PRPs be
responsible for the cleanup of releases of hazardous substances. EPA
can compel a PRP to take action pursuant to a CERCLA enforcement
instrument. (CERCLA section 106). EPA can also perform the response
action using Fund money and then seek reimbursement of costs incurred
from liable parties in litigation, (CERCLA section 107(a)), or
subsequent cost recovery settlement (CERCLA section 122(a)). Under
CERCLA, potentially liable parties include: (1) current owners and
operators of facilities, (2) past owners and facility operators in
place at the time of hazardous substance disposal, (3) any person who
``arranged for disposal'' of that facility's hazardous substances, and
(4) any person that accepts hazardous substances for ``transport to
disposal or treatment facilities.'' (CERCLA section 107(a)(1)-(4)). If
found liable under the statute, a PRP is financially responsible for
the government's response costs incurred not inconsistent with the NCP
in addition to other categories of costs. (CERCLA section 107(4)(A)-
(D).

[[Page 39139]]

7. What enforcement discretion is available when exercising CERCLA
authority?
EPA has a proven track record of developing and applying
enforcement discretion policies that are effective and well-received,
and courts have sanctioned this approach. CERCLA's limitations and
EPA's enforcement discretion policies historically have given EPA the
needed flexibility to provide assurances when circumstances warrant.
Although CERCLA's liability scheme is broad, the statutory affirmative
defenses and EPA's enforcement discretion policies provide mechanisms
to narrow the scope of liability and focus on the significant
contributors to contamination.
Both the statute and EPA enforcement discretion policies may
constrain a party's ability to secure reimbursement of response costs.
CERCLA itself includes liability exemptions as well as affirmative
defenses against liability. See, e.g., CERCLA section 101(10), 107(b),
(d), (k). Additionally, parties must prove that response costs incurred
are consistent with the National Contingency Plan, CERCLA's
implementing regulations. Id. section 107(a)(4)(B). Parties must also
incur response costs before they can recover those costs from other
viable, liable parties. EPA's enforcement authorities and policies can
serve as a deterrent for responsible parties to pursue parties that did
not contribute significantly to contamination. EPA has a well-proven
track record of developing enforcement discretion policies that have
been effective and well-received by stakeholders. EPA's enforcement
policies, such as its policy regarding de minimis or de micromis
parties and innocent landowner policies, have proven to be useful tools
in convincing responsible parties not to pursue parties covered by
these enforcement discretion policies. Finally, the statute provides
that a party that resolves its potential liability with the United
States or a State in a judicially approved settlement is entitled to
contribution protection--the ability to block third-party claims for
matters addressed in the settlement. These liability limitations and
mitigation tools are more fully discussion in Section VI.B.2.
8. Why is understanding CERCLA's overarching provisions critical to
understanding the importance of this rulemaking to EPA's ability to
protect human health and the environment?
Understanding CERCLA's basic concepts, particularly its liability
scheme and CERCLA's authority to address hazardous substances (versus
its authorities to respond to pollutants or contaminants) are essential
to understanding this regulatory action's importance in protecting
human health and the environment. Designating PFOA and PFOS as
hazardous substances is an important step for EPA to take because it
makes available the full suite of CERCLA tools to address releases of
these substances. Designation provides a more streamlined path to
respond to PFOA and PFOS releases. It also makes available CERCLA
enforcement authority that EPA can use to compel PRPs to pay for or
conduct CERCLA response actions, rather than EPA using the Fund to
clean up. Designation is expected to expediate PFOA and PFOS cleanups,
and in turn, mitigate risks to public health and the environment from
these substances.

III. Background for This Rulemaking

A. Summary of Proposed Designation

On September 6, 2022 (87 FR 54415), EPA proposed to find that PFOA
and PFOS and their salts and structural isomers warrant designation as
hazardous substances pursuant to CERCLA section 102(a). EPA concluded
that significant evidence indicates that PFOA and PFOS may present a
substantial danger to public health or welfare or the environment when
released. (87 FR 54417, 54423). In reaching the proposed conclusion,
the Agency relied on a significant body of evidence showing that PFOA
and PFOS are persistent and mobile in the environment and that exposure
to such substances may lead to adverse health effects.
The Agency primarily relied on evidence concerning the hazard and
fate and transport, as well as other information that may be relevant
to whether the statutory criteria are met. EPA looked at scientific and
technical data regarding toxicity and toxicokinetics, chemical and
physical characteristics, and environmental prevalence of PFOA and PFOS
to support the proposed finding that these chemicals may present
substantial danger when released into the environment. See Proposed
Rule, 87 FR at 54423-29. In short, the evidence related to the chemical
and physical characteristics indicated that PFOA and PFOS are
persistent in the environment and that they bioaccumulate in both
humans and wildlife. The evidence also showed that PFOA and PFOS are
distinct from many other bioaccumulative chemicals because their water
solubility allows PFOA and PFOS to more readily migrate from soil to
groundwater; thus, their release into the environment has the potential
to contaminate both surface water and groundwater used as drinking
water sources.
Concerning the toxicity and toxicokinetics, both human and animal
studies supported a conclusion that exposure to PFOA and PFOS may cause
adverse health effects, including effects on the immune system, the
cardiovascular system, fetus development, and cancer. The evidence also
showed that PFOA and PFOS are prevalent in the environment because they
have been produced and used since the 1940s and are resistant to
degradation. The evidence showed that PFOA and PFOS are not only
prevalent in humans, but also prevalent in environmental media, wild
animals, livestock, and plants. EPA concluded that the prevalence of
these substances impacts the environment directly and increases the
likelihood of exposures that may lead to additional human exposure.
The adverse human health effects, mobility, persistence,
prevalence, and other information about PFOA and PFOS combined to
support EPA's proposed finding that these chemicals may present a
substantial danger to public health or welfare or the environment when
released such that designation of PFOA and PFOS as CERCLA hazardous
substances is warranted.

B. PFOA and PFOS Production and Use

PFOA and PFOS are part of a large family of human-made chemicals
known as PFAS that have been in use in the U.S. since the 1940s. PFAS,
including PFOA and PFOS, are used in industry and consumer products
because of their useful properties, including their resistance to
water, grease, and stains. These substances have been found in or used
in making a wide range of consumer products including carpets,
clothing, fabrics for furniture, and packaging for food and cookware
that are resistant to water, grease, or stains. They have also been
used for firefighting and various industrial processes. In terms of
their chemistry, they exist as linear and branched isomers, depending
on the methods by which they are produced. Both PFOA and PFOS have been
manufactured in numerous salt forms. Once dissolved in water, the salt
and the acid forms will dissociate into the respective ions. See
Proposed Rule, 87 FR at 54417 (providing a brief history of PFOA and
PFOS production and use).
Production and use of these chemicals have resulted in releases
into the

[[Page 39140]]

environment for many decades. Historic releases of PFOA and PFOS are
significant sources of environmental contamination and present ongoing
hazards to human health and the environment. Precursors of PFOA and
PFOS can be converted to PFOA and PFOS by microbes in soil, sludge, and
wastewater and through abiotic chemical reactions. PFOA and PFOS that
are deposited or created by the degradation of their precursors in
industrial and consumer waste or in a landfill without environmental
controls can discharge via leachates, groundwater pollution/migration,
and atmospheric releases.
PFAS have been detected in the ambient environment, in wildlife,
and in humans around the globe, and PFOA and PFOS were among the most
used PFAS from the beginning of their development in the 1940s (Blake &
Fenton, 2020; Calafat et al., 2007; Domingo & Nadal, 2019; Hanssen et
al., 2013; Olsen et al., 2017). The potential health risks associated
with PFAS were first recognized in occupationally exposed workers in
the 1980s and community level exposure concerns were first raised in
1998. Since that time, the U.S. government, including EPA, and many
other environmental and human health organizations both within the U.S.
and internationally have researched PFAS to determine the risks posed
by exposure to such chemicals. The additional evaluation since the late
1990s has added support for early concerns that exposure to PFAS may
present a risk and that exposure to long chain PFAS, such as PFOA and
PFOS, are of particular concern because of, among other things, their
prevalence in the environment, mobility, and resistance to degradation.
In response to the growing body of evidence concerning the
potential risks, Federal, State, and international agencies have taken
steps to mitigate exposure to PFOA and PFOS. For example, in 2016, the
FDA revoked a regulation that allowed the use of long chain PFAS in
food contact applications in the U.S.; the DoD added PFOA and PFOS to
its list of emerging chemicals of concern and is in the process of
requiring any of its new firefighting foam it purchases to be made
without PFAS per a January 2023 military specification; several States
have established groundwater cleanup standards for PFOA and/or PFOS;
and PFAS, including PFOA and PFOS, are addressed in several
international treaties.\28\
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\28\ See Proposed Rule, 87 FR at 54429-39 (providing a list of
regulatory and other PFAS related actions at EPA, other Federal
Agencies, states, and international agencies).
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Domestic production and import of PFOA has been phased out in the
United States by the companies participating in the 2010/2015 PFOA
Stewardship Program (U.S. EPA, 2023c, 2023d). Small quantities of PFOA
may be produced, imported, and used by companies not participating in
the PFOA Stewardship Program and some uses of PFOS are ongoing (U.S.
EPA, 2023a). The EPA Chemical Data Reporting (CDR) rule (see 40 CFR
721.9582) under TSCA requires manufacturers (including importers) to
report certain data about chemicals in commerce in the United States,
including information on PFOA and PFOS (subject to a 2,500-pound
reporting threshold at a single site). The last time PFOA and PFOS
manufacturing information was reported to EPA pursuant to CDR was in
2013 and 2002, respectively. The reports showed that these chemicals
were still being produced or used in those reporting years, however
manufacturers did not report PFOA and PFOS in excess of the reporting
limit in subsequent reporting cycles. However, 2020-2022 Toxic Release
Inventory (TRI) data show that PFOA and PFOS continue to be released
into the environment, which means that there are on-going uses of these
substances. Pursuant to TRI reporting requirements, regulated
facilities must report annually on releases and other waste management
of toxic chemicals that they manufacture, process, or otherwise use
above certain threshold quantities. The TRI reporting threshold for
PFOA and PFOS is 100 pounds. Between 2020 and 2022, TRI data on
releases \29\ of PFOA, PFOS, and their salts \30\ reported by 21
facilities amount to 71,411 lbs. In 2020, TRI data on releases of PFOA,
PFOS, and their salts reported by nine facilities totaled 1,706 lbs. In
2021 and 2022, reported releases increased to 24,351 lbs. and 45,384
lbs., respectively.\31\ PFOA is not produced domestically or imported
by the companies participating in the 2010/2015 PFOA Stewardship
Program. However, based on the TRI report, it is possible that PFOA may
still be produced domestically or imported by companies that did not
participate in the PFOA Stewardship Program and that PFOS may be as
well.
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\29\ Facilities are required to report total releases per year
of listed toxic chemicals into the environment (e.g., releases to
land on-site, discharges to receiving streams or water bodies,
etc.). <a href="https://www.ecfr.gov/current/title-40/part-372/subpart-E#p-372.85">https://www.ecfr.gov/current/title-40/part-372/subpart-E#p-372.85</a>(b)(14) (40 CFR 372.85(b)(14).
\30\ As of November 2023, the list of toxic chemicals under the
TRI program include 8 salts, as well as PFOA and PFOS, that are also
listed as CERCLA HSs in this final action.
\31\ In addition to these releases, the TRI also includes data
on PFOA and PFOS production-related waste. See U.S. Environmental
Protection Agency. Toxic Release Inventory (TRI) Search. Available
at: <a href="https://www.epa.gov/enviro/tri-search">https://www.epa.gov/enviro/tri-search</a>.
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Environmental contamination and resulting human exposure to PFOA
and PFOS are anticipated to continue for the foreseeable future due to
their past wide-scale manufacture and use, environmental persistence,
formation from precursor compounds, and continued limited domestic
production and use. Although PFOA and PFOS levels have been decreasing
in human serum samples since the phase out, they are still detected in
a high percentage of the U.S. population (NHANES). This indicates
humans are still being exposed to PFOA and PFOS.

C. EPA's PFAS Strategic Roadmap

EPA issued the PFAS Strategic Roadmap (Roadmap) in October 2021,
wherein the Agency recognized the potential dangers posed by exposure
to PFAS and committed to a comprehensive whole-of-Agency plan to
address PFAS (U.S. EPA, 2021a). EPA's integrated approach to PFAS is
focused on three central directives: (1) Research. Invest in research,
development, and innovation to increase understanding of PFAS exposures
and toxicities, human health and ecological effects, and effective
interventions that incorporate the best available science; (2)
Restrict. Pursue a comprehensive approach to proactively prevent PFAS
from entering air, land, and water at levels that can adversely impact
human health and the environment; and (3) Remediate. Broaden and
accelerate the cleanup of PFAS contamination to protect human health
and ecological systems. The Roadmap committed to an Agency-wide
approach, in which EPA would utilize the tools at its disposal to
urgently address PFAS and bring tangible health benefits to communities
impacted by PFAS. EPA identified a variety of authorities to address
PFAS, including the TSCA, the Safe Drinking Water Act (SDWA), CWA, and
RCRA, in addition to CERCLA. The Agency recognized that each authority
has a unique set of tools to address discrete and specific
environmental challenges posed by PFAS. Since 2021, EPA has taken
several actions to address PFAS contamination under the Agency's
various regulatory programs. Visit Agency's website at <a href="https://www.epa.gov/pfas/key-epa-actions-address-pfas">https://www.epa.gov/pfas/key-epa-actions-address-pfas</a>.

[[Page 39141]]

IV. Legal Authority

A. CERCLA Section 102(a) Designation Considerations

In this action, the Administrator is exercising his authority to
designate PFOA and PFOS as hazardous substances pursuant to CERCLA
section 102(a). CERCLA's definition of ``hazardous substances''
includes any substance designated pursuant to specified provisions in
select environmental statutes (CWA, RCRA, CAA, and TSCA) and ``any
element, compound, mixture, solution, or substance designation pursuant
to [CERCLA section 102]. CERCLA section 101(14).\32\ Section 102(a), in
turn, provides clear authority to designate hazardous substances in
addition to substances designated automatically through the operation
of CERCLA section 101(14). In relevant part, section 102(a) provides
that, ``[t]he Administrator shall promulgate and revise as may be
appropriate, regulations designating as hazardous substances, in
addition to those referred to in section 101(14), such elements,
compounds, mixtures, solutions, and substances, which when released
into the environment, may present substantial danger to the public
health or welfare or the environment. . . .'' The statutory language
delegates to EPA the authority to identify and weigh the scientific,
technical, and other factual information relevant to determining
whether a substance ``may present a substantial danger,'' and then
determine whether to promulgate regulations designating such
substances.
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\32\ The complete definition of ``hazardous substances'' is:
``(A) any substance designated pursuant to section 311(b)(2)(A) of
the Federal Water Pollution Control Act [33 U.S.C. 1321(b)(2)(A)],
(B) any element, compound, mixture, solution, or substance
designated pursuant to section 9602 of this title, (C) any hazardous
waste having the characteristics identified under or listed pursuant
to section 3001 of the Solid Waste Disposal Act [42 U.S.C. 6921]
(but not including any waste the regulation of which under the Solid
Waste Disposal Act [42 U.S.C. 6901 et seq.] has been suspended by
Act of Congress), (D) any toxic pollutant listed under section
307(a) of the Federal Water Pollution Control Act [33 U.S.C.
1317(a)], (E) any hazardous air pollutant listed under section 112
of the Clean Air Act [42 U.S.C. 7412], and (F) any imminently
hazardous chemical substance or mixture with respect to which the
Administrator has taken action pursuant to section 7 of the Toxic
Substances Control Act [15 U.S.C. 2606]. The term does not include
petroleum, including crude oil or any fraction thereof which is not
otherwise specifically listed or designated as a hazardous substance
under subparagraphs (A) through (F) of this paragraph, and the term
does not include natural gas, natural gas liquids, liquefied natural
gas, or synthetic gas usable for fuel (or mixtures of natural gas
and such synthetic gas).''
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Reading Section 102(a) in context, including the broader context of
CERCLA as a whole, EPA affirms the factors it proposed to evaluate for
determining what constitutes ``substantial danger'' and designating
hazardous substances under CERCLA section 102(a). 87 FR at 54421. To
inform its decision whether a substance, when released, may present
``substantial danger'' pursuant to CERCLA section 102(a), EPA considers
two primary factors: the potential harm to humans or the environment
from exposure to the substance (i.e., hazard), and how the substance
potentially moves, persists and/or changes when in the environment
(i.e., environmental fate and transport). EPA will then weigh this
information in deciding whether the substance, when released, may
present a substantial danger.
In deciding whether a substance presents potential harm to humans
or the environment from exposure to the substance (hazard), EPA may
consider such information as human health toxicity, including
carcinogenicity, neurotoxicity, developmental toxicity, reproductive
toxicity, and other adverse health effects. EPA may also consider
toxicity or adverse impacts to non-human organisms or ecosystems, such
as adverse effects to wildlife, aquatic life, or other natural
resources, including adverse impacts on populations of endangered or
threatened species or significant degradation of environmental quality
over broad areas. Additionally, EPA may consider chemical properties
such as combustibility, flammability, reactivity, or corrosiveness.
Regarding the environmental fate and transport of a substance, EPA may
consider whether a substance moves readily through the environment, and
whether it persists and/or changes in the environment.
In weighing this information, EPA will consider the degree or
magnitude of the danger posed based on the substance's hazard and
environmental fate and transport characteristics. The hazard that a
substance presents can be shown in a variety of ways. For example, it
could be toxic to humans or other organisms in the environment, or it
could exhibit a more physical hazard, such as corrosivity or
explosivity.
In assessing a substance's hazard if based on toxicity, EPA could
consider whether the substance may be acutely toxic (and thus lead to
an immediate health problem or even death) or may have chronic toxicity
(and thus lead to detrimental health effects after long-term exposure).
For example, there could be a substance that is acutely toxic but does
not move far from the point of release. This substance might pose
substantial danger due to its ability to immediately harm people and
other organisms at the point of release. As another example, there may
be a substance that exhibits chronic toxicity and is very persistent.
In this case, the substance might also pose substantial danger when
released because people and other organisms near the point of release
could be exposed to the substance over a long period of time,
potentially leading to adverse health effects. Designation may be
appropriate if the hazard and fate and transport, when taken together,
demonstrate there may be danger and the danger is substantial.
Hazard and environmental fate and transport are the primary factors
EPA will assess in evaluating whether to designate a substance under
section 102(a). However, EPA may also consider additional information
that could inform the degree of danger a substance may pose when
released. This includes, but is not limited to, information such as
frequency, nature, and geographic scope of releases (e.g., prevalence)
and likelihood of human exposure. For example, the Agency may review
accident history or other release data (e.g., TRI, UCMR) to determine
how frequently a substance is released or found in the environment, and
how or if the substance has caused any adverse health effects to the
public or the environment. Together with hazard and environmental fate
and transport, this additional information will inform EPA's conclusion
on whether a substance, when released, may present a substantial danger
to public health or welfare or the environment.
EPA interprets section 102(a) as requiring that, at a minimum,
there is a possibility the substance, when released into the
environment, presents substantial danger. EPA need not have certainty
that the substance poses a substantial danger or require proof of
actual harm when released into the environment. This reading of CERCLA
section 102(a) is consistent with the ordinary meaning of ``may'' which
is defined as a term ``used to indicate possibility or probability.''
Merriam-Webster (<a href="https://www.merriam-webster.com/dictionary/may">https://www.merriam-webster.com/dictionary/may</a>). It is
also consistent with the caselaw interpreting the term ``may'' in the
phrase ``may present an imminent and substantial endangerment'' under
RCRA, which has been construed as not requiring certainty. See ME.
People's Alliance v. Mallinckrodt, Inc., 471 F.3d 277, 288 (1st Cir.
2006) (noting that ``at least four of our sister circuits have
construed [section 7002(a)(1)(B)] expansively'' and that ``all four
courts have emphasized the preeminence of the word `may' in

[[Page 39142]]

defining the degree of risk needed to support [section 7002(a)(1)(B)'s]
liability standard'' and that certainty of harm is not required); Price
v. United States Navy, 39 F.3d 1011, 1019 (9th Cir. 1994) (reasoning
that the term ``may'' ``implies that there must be a threat which is
present now, although the impact of the threat may not be felt until
later'').
The information that EPA may consider in determining whether the
release of a substance may present a substantial danger is consistent
with the criteria that the Agency uses in implementing CERCLA through
the Hazard Ranking System (HRS) (U.S. EPA, 2023b). CERCLA section
105(a)(8)(A) requires EPA to set criteria for determining priorities
among releases or threatened releases throughout the United States for
the purpose of taking remedial and removal action, to the extent
practicable taking into account the potential urgency of such action.
The statute directs EPA to develop criteria based upon relative risk or
danger to public health or welfare or the environment, taking into
account to the extent possible the population at risk, the hazard
potential of the hazardous substances at such facilities, the potential
for contamination of drinking water supplies, the potential for direct
human contact, the potential for destruction of sensitive ecosystems,
the damage to natural resources which may affect the human food chain
and which is associated with any release or threatened release, and the
contamination or potential contamination of the ambient air which is
associated with the release or threatened release. EPA's regulations
establishing criteria for placing sites on the National Priorities List
are codified in EPA's Hazard Ranking System (HRS), 40 CFR part 300 App.
A. Ultimately, the HRS factors are consistent with the information EPA
considered in designating PFOA and PFOS under CERCLA section 102(a).
The standard that EPA has adopted for CERCLA section 102(a) is also
consistent with EPA's interpretation of similar statutory language.
See, e.g., CERCLA section 104(a) (allowing for response to pollutants
or contaminants that ``may present an imminent and substantial
danger'') and CERCLA section 106(a) (granting enforcement authority
``when there may be an imminent and substantial endangerment'').\33\
For example, CERCLA section 106(a) provides EPA with enforcement
authority when ``there may be an imminent and substantial
endangerment.'' EPA guidance provides that EPA should rely on
``scientific evidence and documentation'' to determine if conditions
may present an imminent and substantial endangerment (Breen et al.,
2001). This may include an evaluation of site-specific conditions that
provide a ``reasonable cause for concern that someone or something may
be exposed to a risk of harm by a release or a threatened release of a
hazardous substance.'' B.F. Goodrich Co. v. Murtha, 697 F. Supp. 89, 96
(D. Conn. 1988). ``Hazard'' and ``fate and transport'' are inherently a
part of that analysis, and courts have long examined such
considerations under CERCLA section 106(a). See, e.g., United States v.
Northeastern Pharmaceutical and Chemical Co., Inc., 579 F. Supp. 823,
832 (W.D. Mo. 1984), aff'd in part, rev'd in part, 810 F.2d 726 (8th
Cir. 1986) (examining toxicological properties, hazard, fate and
transport, as well as likelihood of exposure in determining whether
substances posed an ``imminent and substantial endangerment''); United
States v. E.I. du Pont de Nemours & Co., Inc., 341 F.Supp.2d 215, 247
(W.D.N.Y. 2004) (collecting cases and concluding endangerment exists
where, examining all impacts, ``there is reasonable cause for concern
that someone or something may be exposed to a risk of harm by a release
or a threatened release''); see also Cox v. City of Dallas, Tex., 256
F.3d 281, 300 (5th Cir. 2001) (examining hazard and fate and transport
posed from dangerous gases in concluding that old landfill ``may
present an imminent and substantial endangerment'' under RCRA).\34\
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\33\ These provisions concern enforcement and response actions
and apply to and require analysis of narrow, site-specific
circumstances relevant to a particular facility or person, and to a
specific event. As a result, the Agency conducts an assessment of
the particular situation at each site when it invokes those other
authorities. That purpose is distinct from the purpose of CERCLA
section 102(a), which requires a more generalized, non-site-specific
evaluation.
\34\ CERCLA section 106 sets forth a site-specific standard,
which differs from the general applicability of CERCLA section
102(a). The language between each section also slightly differs. The
phrase ``imminent and substantial endangerment'' in section 106 is
different from the phrase ``may present a substantial danger'' in
section 102. However, given the similar language, the factors that
courts have considered in analyzing whether a substance poses a
threat under section 106 are instructive to determining whether a
substance ``may pose a substantial danger'' under section 102.
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B. Consistency With Other Methodologies for Identifying CERCLA
Hazardous Substances

The two central factors that EPA considers in the context of CERCLA
section 102(a)--hazard, as well as fate and transport--are consistent
with other methodologies used for identifying CERCLA hazardous
substances. CERCLA's list of ``hazardous substances'' includes more
than 800 substances identified as hazardous or toxic by Congress or EPA
under the following specified environmental statutes:
<bullet> Clean Water Act section 311(b)(2)(A) hazardous substances;
<bullet> Resource Conservation and Recovery Act section 3001
hazardous wastes;
<bullet> Clean Water Act section 307(a) toxic pollutants;
<bullet> Clean Air Act section 112 hazardous air pollutants; and
<bullet> Toxic Substances Control Act section 7 imminently
hazardous chemicals.
See 40 CFR Table 302.4 (list of hazardous substances).
EPA has applied these authorities in a manner similar to how EPA is
interpreting and applying its authority under CERCLA section 102(a) in
this action. For this designation, under section 102(a), EPA evaluated
toxicity data to assess ``hazard'' from exposure to PFOA and PFOS.
Similarly, the statutes cited in CERCLA's definition of hazardous
substance consider toxicity in some fashion in their listing or
identification decisions. See RCRA section 3001 (providing that EPA's
criteria for listing RCRA regulated hazardous wastes take into account
``toxicity,'' along with other factors); CWA section 311(b)(2)(A) and
42 FR 10474, 10475 (March 13, 1978) (describing ``toxicological
selection criteria'' for hazardous substances designated under the CWA
section 311); CWA section 307(a) (providing CWA authority to list
``toxic pollutants'' taking into account ``toxicity of the
pollutant''); CAA section 112(b)(2) (providing CAA authority to
identify air toxics which ``present, or may present . . . a threat of
adverse human health effects (including . . . substances which are
known to be, or may reasonably be anticipated to be . . . acutely or
chronically toxic)); TSCA section 7 (providing TSCA authority to
identify a chemical substance or mixture as imminently hazardous when
it ``presents an imminent and unreasonable risk of serious or
widespread injury to health or the environment, without consideration
of costs or other non-risk factors.'').
EPA also evaluated data regarding the fate and transport of PFOA
and PFOS in the environment. This analysis focused primarily on the
chemical and physical characteristics of PFOA and PFOS, including
mobility, resistance to degradation, and persistence in the

[[Page 39143]]

environment. Similarly, the CWA, RCRA, and CAA provisions referenced in
CERCLA, also consider persistence and resistance to degradation in
their listing and identification decisions. See CWA section 307(a)
(providing that EPA may list toxic pollutants under the CWA that take
into account ``persistence and degradability,'' alongside toxicity);
RCRA section 3001 (providing that EPA's criteria for listing RCRA
regulated hazardous wastes take into account ``persistence and
degradability in nature,'' along with other factors); CAA section
112(b)(2) (identifying ``bioaccumulation'' as a consideration for
evaluating whether a pollutant may be identified as a hazardous air
pollutant under CAA).

C. CERCLA Section 102(a) and Cost Considerations

EPA proposed interpreting CERCLA section 102(a) as precluding the
consideration of cost in designating CERCLA hazardous substances. EPA
recognizes that, as a general matter, a statutory assessment of health-
and environmental-based criteria like the criteria in section 102 does
not typically allow for consideration of costs. See, e.g., Whitman v.
American Trucking, 531 U.S. 457, 471 (2001) (finding that public health
criteria provided in the Clean Air Act, interpreted in its statutory
and historical context and with appreciation for its importance to the
CAA as a whole, unambiguously bars cost considerations.''). EPA is not
resolving in this final action whether section 102 is best construed as
precluding or requiring consideration of costs in designating a
hazardous substance. It need not resolve this question here because
designation is appropriate under either construction. Specifically, as
discussed in Section V, examining only whether PFOA and PFOS may
present a substantial danger to public health or welfare or the
environment, without considering costs and benefits, EPA has concluded
that designation is warranted. In addition to the analysis of the
health- and environmental-based criteria, EPA also conducted a
totality-of-the-circumstances analysis, including an evaluation of
quantitative and qualitative benefits and costs of designation. This
additional analysis confirmed that designation is appropriate. In sum,
designation is warranted either by examining the health- and
environmental-based criteria alone or by examining these criteria along
with the broader totality of the circumstances.

V. PFOA and PFOS May Present a Substantial Danger to the Public Health
or Welfare or the Environment When Released Into the Environment

In evaluating hazard with respect to PFOA and PFOS, EPA considered
the substantial evidence, based on epidemiological and toxicological
studies, indicating that human exposure to PFOA or PFOS is linked to
adverse human health effects. Regarding environmental fate and
transport, EPA considered evidence that PFOA and PFOS migrate through
the environment from the point of release, that they persist in the
environment for long durations, and that they bioaccumulate in humans
and other organisms.
For PFOA and PFOS, EPA considered other relevant information about
the frequency, nature, and geographic scope of releases of the
substances (i.e., prevalence) demonstrating that these substances have
been widely detected in drinking water, surface water, wild animals,
and humans in the United States. This other information about the
prevalence of PFOA and PFOS is relevant to EPA's designation decision
because widespread detections of these substances in the environment
and people demonstrates a greater potential for communities to be
exposed to the substances at concentrations that could result in
adverse health effects. EPA weighed all of this information--hazard,
environmental fate and transport, prevalence--in evaluating the degree
or magnitude of danger posed. EPA concluded that PFOA and PFOS may
present a substantial danger when released because of the potential for
harm to human health, evidence of persistence and bioaccumulation, and
high likelihood of exposure.

A. PFOA and PFOS Pose a Hazard

EPA is confirming the proposed finding that exposure to PFOA and
PFOS may pose a hazard, after evaluating the available scientific and
technical information as well as public comments. There is evidence
from both epidemiological and animal toxicological studies that oral
exposure to either PFOA or PFOS has been associated with various
adverse health effects across many health outcomes. Numerous health
studies support a finding that PFOA and PFOS exposure can lead to
adverse human health effects, including cancer (testicular and kidney
for PFOA, liver cancer for PFOS), pregnancy-induced hypertension and
preeclampsia, and decreased immune response to vaccination (ATSDR,
2021). Toxicology studies suggest that PFOA and PFOS exposure is
associated with decreases in serum thyroid hormone levels \35\ and
adverse effects to the endocrine system (ATSDR, 2021; USEPA, 2024b;
2024c).
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\35\ Decreased thyroid hormone levels are associated with
effects such as changes in thyroid and adrenal gland weight, hormone
fluctuations, and organ histopathology (ATSDR, 2021; USEPA, 2024b;
USEPA, 2024c).
---------------------------------------------------------------------------

Based on studies of PFOA and PFOS, in 2021, EPA found that PFOA and
PFOS may have adverse effects on public health (''Announcement of the
Final Regulatory Determinations for Contaminants on the Fourth Drinking
Water Contaminant Candidate List,'' 2021). EPA determined that studies
indicate human exposure to PFOA and/or PFOS is linked to a broad range
of adverse health effects, including developmental effects to fetuses
during pregnancy or to infants (e.g., low birth weight, accelerated
puberty, skeletal variations), liver effects (e.g., tissue damage),
immune effects (e.g., antibody production and immunity), and other
effects (e.g., cholesterol changes). Both PFOA and PFOS are known to be
transmitted to the fetus via the placenta and to the newborn, infant,
and child via breast milk or formula made with contaminated water. Both
compounds were also associated with carcinogenic effects in human
epidemiological and long-term animal studies (NTP, 2020; U.S. EPA,
2016a, 2016b). In November 2023, the International Agency for Research
on Cancer (IARC) evaluated the carcinogenicity of PFOA and PFOS and
classified PFOA as carcinogenic to humans (Group 1) and PFOS as
possibly carcinogenic to humans (Group 2b) (Zahm, et al., 2023).
These adverse health effects of PFOA and PFOS were further
described in the final toxicity assessments and Final Maximum
Contaminant Level Goals (MCLGs \36\) for Perfluorooctanoic Acid (PFOA)
and Perfluorooctane Sulfonic Acid (PFOS) in Drinking Water (U.S. EPA,
2024b, 2024c, 2024d). These toxicity assessments indicate that PFOA and
PFOS are associated with adverse health effects at lower levels than
previously recognized. In the final toxicity assessments, EPA assessed
the weight of the evidence for the available cancer data and determined
that PFOA and PFOS are Likely to Be Carcinogenic to Humans consistent
with the Guidelines for Carcinogen Risk Assessment (U.S. EPA, 2005).
For PFOA, this determination is based on

[[Page 39144]]

the evidence of kidney and testicular cancer in humans and Leydig cell
tumors, pancreatic acinar cell tumors, and hepatocellular adenomas in
rats. (U.S. EPA, 2024c, 2024d). For PFOS, this determination is based
on the evidence of hepatocellular tumors in humans and rats, pancreatic
islet cell carcinomas in male rats, and mixed but plausible evidence of
bladder, prostate, kidney, and breast cancers in humans as described by
U.S. EPA (2024b, 2024d).
---------------------------------------------------------------------------

\36\ Maximum Contaminant Level Goal (MCLG)--the maximum level of
a contaminant in drinking water at which no known or anticipated
adverse effect on the health of persons would occur, allowing an
adequate margin of safety. (<a href="https://www.epa.gov/sdwa/how-epa-regulates-drinking-water-contaminants">https://www.epa.gov/sdwa/how-epa-regulates-drinking-water-contaminants</a>.)
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The EPA's 2024 PFOA and PFOS toxicity assessments prioritized the
following five health endpoint categories with the strongest weight of
evidence and indicating that oral PFOA and PFOS exposure is associated
with adverse health effects: immunological, hepatic, developmental,
cardiovascular, and cancer effects. This prioritization was based on
findings from conducting systematic review (including the study quality
evaluation, evidence synthesis and evidence integration) on the
available and relevant human epidemiological and animal toxicity
studies (U.S. EPA, 2024b, U.S. EPA, 2024c). EPA evaluated sixteen non-
cancer health outcomes as part of the 2024 toxicity assessments and, in
accordance with recommendations from the SAB {U.S. EPA, 2022,
10476098{time} and the IRIS Handbook {U.S. EPA, 2022, 10367891{time} ,
EPA's toxicity assessments prioritized the five categories of health
outcomes above with either evidence demonstrating or evidence
indicating associations between PFOA and PFOS exposure and adverse
health effects. Accordingly, to support EPA's finding in this final
rule that both PFOA and PFOS each individually pose a human health
hazard, EPA gave weight to immunological, hepatic, developmental,
cardiovascular, and cancer effects.
For this final rule, EPA considered a wide range of potential
health effects associated with exposure to PFOA and PFOS using five
comprehensive peer-reviewed Federal government documents that summarize
the recent literature on PFAS (mainly PFOA and PFOS) exposure and its
health impacts: (1) EPA's 2016 Health Effects Support Documents for
PFOA (U.S. EPA, 2016c); (2) EPA's 2016 Health Effects Support Documents
for PFOS (U.S. EPA, 2016d); (3) U.S. Department of Health and Human
Services Agency for Toxic Substances and Disease Registry's (ATSDR)
2021 Toxicological Profile for Perfluoroalkyls (ATSDR, 2021); (4) EPA's
2024 Final Human Health Toxicity Assessment for Perfluorooctanoic Acid
(PFOA) (U.S. EPA, 2024b); and (5) EPA's 2024 Final Human Health
Toxicity Assessment for Perfluorooctane Sulfonic Acid (PFOS), (U.S.
EPA, 2024c). Each source presents comprehensive, systematic reviews of
relevant, peer-reviewed literature on adverse health effects associated
with PFOA and PFOS. The EPA assessments were prepared by the Office of
Water.
Data from human and animal studies indicate that PFOA and PFOS are
well absorbed in the human body after being ingested and are
distributed throughout the body by binding to proteins. PFOA and PFOS
bioaccumulate in the human body as evidenced by the elimination half-
lives from about two to three years for PFOA and four to five years for
PFOS (ATSDR, 2021). There is no evidence that humans or animals are
able to break down these substances, and they can be distributed to
tissues throughout the human body and are not readily eliminated,
resulting in long elimination half-lives in the human body and
bioaccumulation. Available evidence supports urine as the primary route
of excretion in most species, though fecal elimination is prominent in
rats. In rats, hair is another route of elimination in both males and
females. In females, elimination pathways include menstruation,
pregnancy (cord blood, placenta, amniotic fluid, and fetal tissues) and
lactation (breast milk) (PFOA Toxicity Assessment 2024, PFOS Toxicity
Assessment 2024). Thus, PFOA and PFOS remain in the body after exposure
has ended and can potentially cause detrimental health effects even
after an initial exposure has ceased. Continued exposures to PFOA and
PFOS can lead to significantly elevated concentrations in the human
body and result in adverse health effects due to this bioaccumulation
(Ballesteros et al., 2017; Barry et al., 2014; Dhingra et al., 2016;
Frisbee et al., 2010; Gallo V et al., 2012; Hall et al., 2023; Hoffman
et al., 2011; Kotlarz et al., 2020; Savitz et al., 2012; Steenland et
al., 2009; Steenland et al., 2018a; Steenland et al., 2018b).
EPA's 2024 Final Human Health Toxicity Assessments for PFOA and
PFOS integrated the available data on absorption, distribution,
metabolism and elimination into the derivation of reference values for
PFOA and PFOS. Collectively the adverse health effects evidence
demonstrates that each PFOA and PFOS individually pose a human health
hazard, and the substantial body of evidence for several individual
adverse health effects also supports EPA's human health hazard finding
for each of these substances. A discussion of some of the detrimental
health effects follows.
Developmental Effects: Adverse developmental effects can increase
the likelihood of difficulties during labor through post-delivery.
Evidence indicates that exposure to PFOA and PFOS is likely associated
with developmental effects such as lower infant birth weight, lower
birth length, smaller head circumference at birth, and other effects
(Verner et al., 2015; U.S. EPA, 2016e; U.S. EPA, 2016f; Negri et al.,
2017; ATSDR, 2018; Waterfield et al., 2020; U.S. EPA, 2023b; U.S. EPA,
2024c). Research suggests that exposure to PFOA and PFOS is associated
with developmental effects, including decreased infant birth weight
(ATSDR, 2021; Negri et al., 2017; U.S. EPA, 2016c, 2016d, 2024b, 2024c;
Verner et al., 2015; Waterfield et al., 2020). Low birth weight is
linked to a number of health effects that may be a source of economic
burden to society in the form of medical costs, infant mortality,
parental and caregiver costs, labor market productivity loss, and
education costs (Behrman & Rosenzweig, 2004; Chaikind & Corman, 1991;
Colaizy et al., 2016; Institute of Medicine, 2007; Joyce et al., 2012;
Klein & Lynch, 2018; Kowlessar et al., 2013; Nicoletti et al., 2018).
Toxicity studies conducted in laboratory animal models demonstrate
that the developing fetus is particularly sensitive to PFOA- and PFOS-
induced toxicity. Some studies in laboratory animals indicate that
gestation and/or lactation periods are critical exposure windows that
may lead to developmental health effects including decreased offspring
survival, low birth weight, accelerated puberty and skeletal variations
(ATSDR, 2021; U.S. EPA, 2016c, 2016d). The embryo and fetus are exposed
prenatally to PFOA and PFOS through maternal blood via the placenta
(ATSDR, 2021). Several epidemiological studies of the association
between maternal serum PFOA/PFOS and birth weight have found evidence
for decreased body weight of infants exposed in utero (Chu et al.,
2020; Darrow et al., 2013; Dzierlenga et al., 2020; Govarts et al.,
2016; Negri et al., 2017; Sagiv et al., 2018; Starling et al., 2017;
Verner et al., 2015; Wikstrom et al., 2020; Yao et al., 2021). Other
developmental associations with PFOA and PFOS include small for
gestational age (SGA), decreased birth length, decreased head
circumference at birth, and other effects (ATSDR, 2021; Negri et al.,
2017; U.S. EPA, 2016c, 2016d, 2024b, 2024c; Verner et al., 2015;
Waterfield et al., 2020). Epidemiology evidence for SGA related to
PFOA/PFOS exposure was mixed; some studies reported increased risk of
SGA with PFOA/PFOS exposure, while other studies observed null results
(USEPA,

[[Page 39145]]

2024b; USEPA, 2024c). SGA is a developmental health outcome of interest
when studying potential effects of PFOA/PFOS exposure because SGA
infants have increased health risks during pregnancy and delivery as
well as post-delivery (Osuchukwu & Reed, 2022).
Cardiovascular Effects: Cardiovascular Disease (CVD) is one of the
leading causes of premature mortality in the United States (D'Agostino
et al., 2008; Goff et al., 2014; Lloyd-Jones et al., 2017). Changes in
total cholesterol and blood pressure are associated with changes in
incidence of CVD events such as myocardial infarction (i.e., heart
attack), ischemic stroke, and cardiovascular mortality occurring in
populations without prior CVD event experience (D'Agostino et al.,
2008; Goff et al., 2014; Lloyd-Jones et al., 2017). Evidence indicates
that exposure to PFOA and PFOS is likely associated with increased low-
density lipoprotein cholesterol (LDLC), total cholesterol, and high-
density lipoprotein cholesterol (ATSDR, 2021; U.S. EPA, 2024b, 2024c).
High levels of LDLC lead to the buildup of cholesterol in the arteries,
which can raise the risk of heart disease and stroke. Epidemiology
studies showed a positive association between PFOA or PFOS exposure and
LDLC or total cholesterol levels in children (U.S. EPA, 2024b, 2024c).
In particular, the evidence suggested positive associations between
serum PFOA and PFOS levels and LDLC levels in adolescents ages 12-18,
while positive associations between serum levels and LDLC levels in
younger children were observed only for PFOA (ATSDR, 2021). Other
epidemiology studies have generally found a positive association
between increasing serum PFOA and total cholesterol levels (ATSDR,
2021).
Cancer Effects: PFOA and PFOS are Consistent with the Guidelines
for Carcinogen Risk Assessment (U.S. EPA, 2005), EPA determined that
both PFOA and PFOS are Likely to Be Carcinogenic to Humans based on
sufficient evidence of carcinogenicity in humans and animals (U.S. EPA,
2024b, USEPA 2024c). Additionally, in November 2023, the International
Agency for Research on Cancer (IARC) evaluated the carcinogenicity of
PFOA and PFOS and classified PFOA as carcinogenic to humans (Group 1)
and PFOS as possibly carcinogenic to humans (Group 2b) (Zahm, et al.,
2023). For PFOA, cancer evidence in epidemiological studies is
primarily based on the incidence of kidney and testicular cancer, as
well as some evidence of breast cancer, which is most consistent in
genetically susceptible subpopulations or for particular breast cancer
types (U.S. EPA, 2024c). Epidemiology studies indicated that exposure
to PFOA was associated with an increased risk of renal cell carcinoma
(RCC) (ATSDR, 2021; California EPA, 2021; U.S. EPA, 2016d, 2024d). For
PFOS, the available epidemiology studies report elevated risk of liver
cancer, consistent with increased incidence of liver tumors reported in
long-term rat exposure studies. There is also mixed but plausible
evidence of bladder, prostate, kidney, and breast cancers in humans
after chronic exposure and evidence of pancreatic islet cell tumors in
rats (U.S. EPA, 2024b).
Liver Effects: High levels of the enzyme alanine transaminase (ALT)
in the bloodstream may indicate liver damage. Evidence indicates that
exposure to PFOS and PFOA is associated with increased liver enzymes
(U.S. EPA, 2024b; 2024c). Epidemiology data provides evidence of a
positive association between PFOS/PFOA exposure and ALT levels in
adults (ATSDR, 2021; U.S. EPA, 2024b, 2024c). Studies of adults showed
consistent evidence of a positive association between PFOA exposure and
elevated ALT levels at both high exposure levels and exposure levels
typical of the general population (U.S. EPA, 2024c). Associations
between increasing serum PFOA concentrations and elevations in
different serum enzyme levels were consistently observed in
occupational cohorts, high-exposure communities and the U.S. general
population that could indicate the potential for PFOA to affect liver
function (ATSDR, 2021). There is also consistent epidemiology evidence
of associations between PFOS and elevated ALT levels. A limited number
of studies reported inconsistent evidence on whether PFOA/PFOS exposure
is associated with increased risk of liver disease (U.S. EPA, 2024b).
Results reported in animal toxicological studies are consistent with
the observed elevated ALT indicative of hepatic damage in
epidemiological studies. Specifically, studies in rodents found that
oral PFOA or PFOS treatment resulted in biologically significant
alterations in levels of at least one serum biomarker of liver injury
(e.g., ALT) and evidence of histopathological alterations including
hepatocyte degenerative or necrotic changes.
Immune Effects: Proper antibody response helps maintain the immune
system by recognizing and responding to antigens. Evidence indicates
that exposure to PFOS and PFOA is associated with immunosuppression;
(U.S. EPA, 2024b; U.S. EPA, 2024c); epidemiology studies showed
suppression of at least one measure of the antibody response for
tetanus and diphtheria among people with higher prenatal, childhood,
and adult serum concentrations of PFOA (U.S. EPA, 2024c). Data
reporting associations between PFOA exposure and antibody response to
vaccinations other than tetanus and diphtheria are limited (ATSDR,
2021; USEPA, 2024c). Several epidemiological studies have shown a
relationship between increased PFOA and PFOS serum concentrations and
decreased response to vaccinations in children (Budtz-Jorgensen &
Grandjean, 2018; Grandjean et al., 2012; Grandjean, Heilmann, Weihe,
Nielsen, Mogensen, & Budtz-Jorgensen, 2017; Grandjean, Heilmann, Weihe,
Nielsen, Mogensen, Timmermann, et al., 2017; Timmermann et al., 2022;
Zhang et al., 2023). Epidemiology evidence suggests that children with
preexisting immunological conditions are particularly susceptible to
immunosuppression associated with PFOA exposure (U.S. EPA, 2024c).
Available studies supported an association between PFOS exposure and
immunosuppression in children, where increased PFOS serum levels were
associated with decreased antibody production (U.S. EPA, 2024b).
Studies reporting associations between PFOA or PFOS and
immunosuppression in adults are less consistent; there is a lack of
high confidence data. (U.S. EPA, 2024b).
In addition to the adverse health effects listed above, there was
suggestive evidence that exposure to PFOS and PFOA is associated with
the additional health effects summarized below.
Endocrine Effects: Elevated thyroid hormone levels can accelerate
metabolism and cause irregular heartbeat; low levels of thyroid hormone
can cause neurodevelopmental effects, tiredness, weight gain, and
increased susceptibility to the common cold. There is suggestive
evidence of a positive association between PFOA/PFOS exposure and
thyroid hormone disruption (ATSDR, 2021; U.S. EPA, 2024b, 2024c).
Toxicology studies in animals indicated that PFOA and PFOS exposure can
affect thyroid function \37\ (ATSDR, 2021; U.S. EPA, 2024b, 2024c).
Changes to serum thyroid hormone levels in animals lead to adverse
effects to the endocrine system (U.S. EPA, 2024b, 2024c). Despite
uncertainty around the applicability of animal studies in this area,
changes in serum

[[Page 39146]]

thyroid hormone levels in animals did indicate adverse effects after
PFOS and PFOA exposure that is relevant to humans (U.S. EPA, 2024b;
2024c).
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\37\ Decreased thyroid hormone levels are associated with
effects such as changes in thyroid and adrenal gland weight, hormone
fluctuations, and organ histopathology (ATSDR, 2021; U.S. EPA,
2024b, 2024c).
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Metabolic Effects: Leptin is a hormone that controls hunger, and
high leptin levels are associated with obesity, overeating, and
inflammation (e.g., of adipose tissue, the hypothalamus, blood vessels,
and other areas). Animal studies showed increases in serum leptin
levels in mice that were exposed to low levels of PFOA (ATSDR, 2021).
Based on a review of 69 human epidemiology studies, evidence of
associations between PFOS and metabolic outcomes appears inconsistent,
but in some studies, suggestive evidence was observed between PFOS
exposure and leptin levels (U.S. EPA, 2024b).
Reproductive Effects: Studies of the reproductive effects from
PFOA/PFOS exposure have focused on associations between exposure to
these pollutants and increased risk of gestational hypertension and
preeclampsia in pregnant women (ATSDR, 2021; U.S. EPA, 2024b, 2024c).
Gestational hypertension (high blood pressure during pregnancy) can
lead to fetal health outcomes such as poor growth and stillbirth.
Preeclampsia--instances of gestational hypertension where the mother
also has increased levels of protein in her urine--can similarly lead
to fetal problems and maternal complications. The epidemiology evidence
yields mixed (positive and non-significant) associations, with some
suggestive evidence supporting positive associations between PFOA/PFOS
exposure and both preeclampsia and gestational hypertension (ATSDR,
2021; U.S. EPA, 2024b, 2024c). A study of a community with high
exposure to PFOA observed an association between serum PFOA and risk of
pregnancy-related hypertension or preeclampsia, conditions that are
related to renal function during pregnancy (U.S. EPA, 2016d).
Musculoskeletal effects: Adverse musculoskeletal effects such as
osteoarthritis and decreased bone mineral density impact bone integrity
and cause bones to become brittle and more prone to fracture. There is
limited evidence from studies pointing to effects of PFOS on skeletal
size (height), lean body mass, and osteoarthritis (U.S. EPA, 2024b).
Epidemiology evidence suggested that PFOA exposure may be linked to
decreased bone mineral density, bone mineral density relative to bone
area, height in adolescence, osteoporosis, and osteoarthritis (ATSDR,
2021; U.S. EPA, 2024c). Evidence from four PFOS studies suggests that
PFOS exposure has a harmful effect on bone health, particularly
measures of bone mineral density, with greater statistically
significance of effects occurring among females (U.S. EPA, 2024b).
Taken together, the technical/scientific information above
demonstrate that both PFOA and PFOS individually are each associated
with considerable and varied adverse health effects.
EPA also considered potential effects on children's health. EPA's
Policy on Children's Health requires the Agency to consider early life
exposures (from conception, infancy, early childhood and through
adolescence until 21 years of age) and lifelong health consistently and
explicitly in all human health decisions through identifying and
integrating children's health data and information. As described
throughout this section, information on PFOA and PFOS shows exposure to
PFOA and/or PFOS is linked to adverse health effects relevant to
children. These adverse health effects include developmental effects to
fetuses during pregnancy or to infants, cardiovascular effects and
immune effects in children and endocrine and reproductive effects that
impact development. Suggestive evidence of associations found in human
epidemiological studies between PFOA and PFOS and adverse development
effects of include decreased infant birth weight (ATSDR, 2021; Negri et
al., 2017; U.S. EPA, 2016c, 2016d, 2024b, 2024c; Verner et al., 2015;
Waterfield et al., 2020). Animal studies have shown developmental
health effects including associations with decreased offspring
survival, low birth weight, accelerated puberty and skeletal variations
(ATSDR, 2021; U.S. EPA, 2016c, 2016d). Cardiovascular effects include
positive associations between serum PFOA and PFOS levels and LDLC
levels in adolescents ages 12-18 (ATSDR, 2021). Several epidemiological
studies have shown a relationship between increased PFOA and PFOS serum
concentrations and decreased response to vaccinations in children
(Budtz-Jorgensen & Grandjean, 2018; Grandjean et al., 2012; Grandjean,
Heilmann, Weihe, Nielsen, Mogensen, & Budtz-Jorgensen, 2017; Grandjean,
Heilmann, Weihe, Nielsen, Mogensen, Timmermann, et al., 2017;
Timmermann et al., 2022). There is suggestive evidence of a positive
association between PFOA and/or PFOS exposure and thyroid hormone
disruption (ATSDR, 2021; U.S. EPA, 2024b, 2024c). The epidemiology
evidence yields mixed (positive and non-significant) associations, with
some evidence suggesting positive associations between PFOA and/or PFOS
exposure and both preeclampsia and gestational hypertension which can
lead to fetal health outcomes such as poor growth, stillbirth and
maternal complications (ATSDR, 2021; U.S. EPA, 2024b, 2024c).
EPA also considered the hazards associated with salts and
structural isomers of PFOA and PFOS. The hazards associated with PFOA
and PFOS can be associated with their respective salts and both their
linear and branched isomers. Salts are deemed to have the same toxicity
as the commonly referenced acid versions because, once put in water
(and likewise when in the human body), the acid and salt forms will
dissociate to the ionic form. Further, many toxicity studies on PFAS
were often performed using the salt form. For example, while Emmett et
al. (2006) toxicity studies were performed on the acid version of PFOA,
Butenhoff et al. (2012) used the ammonium salt of PFOA. The potassium
salt of PFOS was generally used in animal toxicity studies such as
Ankley et al. (2004).
Additionally, PFOA and PFOS exist as linear and branched isomers,
and the linear and branched isomers have been found in environmental
media and in human sera. For example, in the last NHANES for which
results are available (2017-2018), branched PFOS was detected in 99% of
those sampled, while branched PFOA was found in 10%. Most animal
toxicity studies using isomeric mixtures do not state the ratio of
linear and branched isomers in the test material, and, therefore, it is
not feasible to distinguish the toxicity of the individual isomers.
However, in a few studies, including Butenhoff et al. (2012), Lau et
al. (2006), and Lou et al. (2009) for PFOA, and Ankley et al. (2004)
for PFOS, the authors stated that the PFAS test substance was not 100%
linear, and thus, any effects indicated in these studies can only be
associated with the isomeric mixture of linear and branched and not
specifically with linear isomers or branched isomers. Further, Loveless
et al. (2006) compared the toxicity of linear ammonium PFOA, branched
ammonium PFOA, and a mixture of linear and branched ammonium PFOA in
rodents and demonstrated that both linear and branched isomers exhibit
similar types of toxicity.

B. Information About the Fate and Transport of PFOA and PFOS
Demonstrate That They Are Persistent and Mobile in the Environment

Available information about the fate and transport of PFOA and PFOS

[[Page 39147]]

support EPA's conclusions that these substances remain in the
environment for many years (i.e., persistency) and that they can move
through air, land, and water (i.e., mobility) after release. Both PFOA
and PFOS are considered surfactants due to their chemical structures
that consists of a hydrophobic perfluorinated alkyl ``tail group'' and
a hydrophilic carboxylate (for PFOA) or sulfonate (for PFOS) ``head
group.'' Surfactants decrease the surface tension between two liquids
(i.e., oil and water), a gas and a liquid, or a solid and a liquid.
This attribute means they increase mixing and transport between soil
and groundwater or air and water, and thus PFOA and PFOS move between
environmental media more easily.
These chemicals are sometimes referred to as ``forever'' chemicals
because of their strong carbon-fluorine bonds in the ``tail group''
that cause PFOA and PFOS to be extremely resistant to degradation
through biological degradation and also through chemical degradation
(i.e., photooxidation and hydrolysis). Photooxidation describes the
process of oxidation through light exposure and hydrolysis describes
the chemical breakdown of compound due to reaction with water.
Degradation data from 3M for PFOA states ``Hydrolysis half-life >92
years @ pH 7 & 25 [deg]C (ammonium salt tested); Photolysis in water:
half-life > = 342 days; neither direct nor indirect photolysis in water
observed based on loss of PFOA; Biodegradation-OECD 301C, 28 days, 5%
BOD/ThOD; Biodegradation-Aerobic sludge, 18 days, no degradation
observed (ammonium salt tested); Biodegradation-Anaerobic sludge, 94
days, no degradation observed.'' Degradation date from 3M for PFOS
states ``Biodegradation-Anaerobic sludge, 105 days, no degradation
observed; Biodegradation-OECD 301C (MITI-I), 28 days, 0% BOD/ThOD (3M
2021).'' The resistance to degradation causes PFOA and PFOS to remain
in the environment for long periods of time. This means that the
potential for human exposure continues long after a release has ended.
PFAS are mobile in the environment and have been found in remote
locations, indicating they are widespread in the environment (Giesy &
Kannan, 2001). PFAS have been found in outdoor air at locations in the
United States, Europe, Japan, and over the Atlantic Ocean (ATSDR,
2021). PFOA and PFOS are water soluble and thus may be found in
groundwater and surface water (U.S. EPA 2024a). Further, PFOA and PFOS
have water-soil/sediment partition coefficients of 15-708 L/kg and 7-
120 L/kg, respectively (3M, 2021). These values are on the order of
many metals, indicating that PFOA and PFOS are fairly mobile and will
move from soil and sediment to water. Experimental data indicates in
the marine environment, where suspended solid concentrations are
generally low, PFOA and PFOS are mainly transported in the dissolved
phase rather than being adsorbed to suspended solids (Ahrens et al.,
2011). Their presence in the water column means that they will be
transported further and are available for long range transport and
bioaccumulation (Ahrens et al., 2011).
In a 2001 study investigating the global distribution of PFAS,
wildlife samples were collected on four continents including North
America and Antarctica and PFAS was found to be widely distributed on a
global scale.38 39 Over 30 different species had measurable
levels of PFOS (European Food Safety Authority, 2008; Giesy & Kannan,
2001). PFOA and PFOS have been shown to persist in humans and animals,
with estimated half-lives in humans ranging from about two to three
years for PFOA to four or five years for PFOS (ATSDR, 2021). Organisms
that are exposed to PFOA and PFOS cannot break them down inside the
body and excrete very little. Because PFOA and PFOS can remain in human
and animal bodies for long durations, individuals with consistent
ongoing exposures to PFOA and PFOS (e.g., individuals consistently
exposed by drinking contaminated water or eating contaminated food) can
have elevated concentrations of these substances in their bodies
(Bangma et al., 2017; Burkhard, 2021; Ng & Hungerbuhler, 2014).
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\38\ Global Distribution of Perfluorooctane Sulfonate in
Wildlife; John P. Giesy and Kurunthachalam Kannan; Department of
Zoology, National Food Safety and Toxicology Center, Institute for
Environmental Toxicology; Michigan State University.
\39\ <a href="https://www.efsa.europa.eu/en/efsajournal/pub/653">https://www.efsa.europa.eu/en/efsajournal/pub/653</a>.
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C. Other Information Considered

Other information that EPA considered includes, the frequency,
nature, and geographic scope of releases of these substances. This
information demonstrates that PFOA and PFOS are prevalent, including in
the U.S., and there is likelihood of exposure to humans and the
environment. PFOA and PFOS are prevalent throughout the environment
because of their widespread use since the 1940s in a wide range of
commercial and consumer products and because of their persistence.
Currently, the public can be exposed to PFOA and PFOS through a variety
of sources, including water, food, and environmental media. See
Proposed Rule, 87 FR at 54418-19 (Discussion on the uses of PFOA and
PFOS).
Major causes of PFOA and PFOS environmental contamination include
historical uses, limited ongoing uses, and ongoing uses of precursors.
These activities include past direct industrial discharges of PFOA and
PFOS to soil, air, and water and disposal of these substances or
products that contain these substances. Precursor chemicals can also
degrade to PFOA and/or PFOS (e.g., perfluorooctanesulfonamide (PFOSA)
can be transformed to PFOS in the environment). PFOA and PFOS
precursors can be converted to PFOA and PFOS, respectively, by microbes
in soil, sludge, and wastewater and through abiotic chemical reactions.
See Proposed Rule, 87 FR at 54426 (providing a brief history of sources
of PFOA and PFOS to the environment).
PFOA and PFOS have been detected in groundwater in monitoring
wells, private drinking water wells, and public drinking water systems
across the country. The most vulnerable drinking water systems are
those in close proximity to sites contaminated with PFOA and PFOS
(ATSDR, 2021). Under the third Unregulated Contaminant Monitoring Rule
(UCMR), EPA worked with the States and local communities to monitor for
six PFAS, including PFOA and PFOS, to understand the nationwide
occurrence of these chemicals in the U.S. drinking water provided by
public water systems (PWSs). Of the 4,920 PWSs with results for PFOA
and PFOS, PFOA was detected above the minimum reporting level (minimum
reporting level = 20 nanogram/liter (ng/L)) in 379 samples in 117 PWSs
serving a population of approximately 7.6 million people located in 28
States, Tribes, or U.S. territories. PFOS was found in 292 samples at
95 systems above the UCMR 3 MRL (40 ppt). These systems serve a
population of approximately 10.4 million people located in 28 States,
Tribes, or U.S. territories (U.S. EPA, 2017).
More recent available data collected by States show continued
occurrence of PFOA and PFOS in drinking water supplies in multiple
geographic locations throughout the country, as well as occurrences at
lower concentrations and significantly greater frequencies than were
measured under the UCMR3 (``PFAS National,'' 2023). PFOA and PFOS are
also widely detected in surface water samples

[[Page 39148]]

collected from various rivers, lakes, and streams in the United States.
Municipalities and other entities may use surface water sources for
drinking water and that creates an additional potential exposure
pathway to PFOA and PFOS.
PFOA and PFOS can reach soil due to atmospheric transport and wet/
dry deposition (ATSDR, 2021). These substances have been found in
outdoor air at locations across the globe around PFAS production
facilities and facilities that use PFAS. PFOA and PFOS have been
detected in surface and subsurface soils. Levels of PFOA and PFOS
generally increased with increasing depth at sampled locations (PFAS
manufacturing facilities), suggesting a downward movement of the
contaminants and the potential to contaminate groundwater (ATSDR,
2021).
PFOA and PFOS can be taken up by plants, as evidenced by their
presence in produce analyzed by the U.S. Food and Drug Administration
(2021). PFOA and PFOS have also been found in wild and domestic animals
such as fish, shellfish, alligators, deer, and avian eggs and in humans
(ATSDR, 2021). For example, PFOA has been found in snack foods,
vegetables, meat dairy products and fish, and PFOS has been found in
eggs, milk, meat, fish and root vegetables (Bangma et al., 2017; Falk
et al., 2012; Gewurtz et al., 2016; Holmstrom et al., 2005; Michigan
PFAS Action Response Team, 2021; Morganti et al., 2021; U.S. EPA,
2016a, 2016b; Wang et al., 2008; Wisconsin DNR, 2020).
There is a significant potential for human exposure to PFOA or PFOS
because of their persistence, mobility, and prevalence in the
environment (Langenbach & Wilson, 2021). PFOA and PFOS contamination in
the environment can lead to human exposure through ingestion of
contaminated water, plants, wild animals, and livestock. PFOA and PFOS
enter the drinking water supply from contamination in groundwater and
surface water sources for drinking water. Contaminated drinking water
or groundwater can also be used to irrigate or wash home-grown foods or
farm-grown foods, thereby providing another means for human exposure.
Human exposure can occur through the consumption of wild animals that
have been contaminated by environmental exposure. Several States have
issued advisories recommending that hunters and fishers avoid eating
deer, turkey, or fish due to high levels of PFOS detected in the
animals (MDIFW, 2023; Michigan PFAS Action Response Team, 2023; NCDHHS,
2023). Contaminated water also results in the contamination of
livestock such as beef, pork, poultry, etc. Susceptible populations,
such as women of reproductive age, pregnant and breastfeeding women,
and young children who eat fish may have increased exposure to PFOA and
PFOS due to bioaccumulation in fish (Christensen et al., 2017; FDA,
2021; U.S. EPA, 2019b). Food can also be contaminated through food
packaging made with these chemicals. However, in 2016, the Food and
Drug Administration revoked the regulations authorizing the remaining
uses of long-chain PFAS in food packaging (see 81 FR 5, January 4,
2016, and 81 FR 83672, November 22, 2016). Therefore, PFOA and PFOS
should not be in food packaging now. Humans can also be exposed through
incidental ingestion of contaminated soil and dust. Numerous studies
have shown that PFOA and PFOS can be found in residences, offices, and
other workplaces, and in consumer goods (Gaines, 2023; Hall et al.,
2020; Strynar & Lindstrom, 2008).
PFOA and PFOS have been detected in nearly all of the blood of the
participants in the NHANES. This indicates widespread exposure to these
PFAS in the U.S. population (CDC, 2022). As part of the continuous
NHANES, PFOA and PFOS were measured in the serum of a representative
sample of the U.S. population ages 12 years and older in each two-year
cycle of NHANES since 1999-2000, with the exception of 2001-2002. PFOA
and PFOS have been detected in 99% of those surveyed in each NHANES
cycle. As of the 2017-2018 data, PFOA and PFOS were still detectable in
99% of the population, although the mean concentrations of PFOA and
PFOS in the serum have been steadily decreasing since 1999-2000 (CDC,
2021; U.S. EPA, 2019a).
Communities drinking water or eating food contaminated with PFAS
can have significantly elevated blood levels of PFAS compared to
national average concentrations (Graber et al., 2019; Kotlarz et al.,
2020). Because PFOA and PFOS can remain in the human body and for long
durations, individuals who have consistent ongoing exposures to PFOA
and PFOS (e.g., those exposed by drinking contaminated water or eating
contaminated food) can have high concentrations of these compounds in
their bodies. Epidemiological studies measuring PFAS levels in humans
have noted that people living near contaminated sites have higher
concentrations of these chemicals than the general population and that
drinking water is an important contributor to exposure (Emmett et al.,
2006).
Conclusion
In light of the evidence regarding hazard and the fate and
transport of these chemicals, and consideration of the degree or
magnitude of danger posed, EPA concludes for several reasons described
above that PFOA and PFOS each may present a substantial danger when
released into the environment.\40\ Furthermore, the other information
EPA considered, such as environmental prevalence and the likelihood of
exposure, reinforce its conclusion. individuals living in communities
located near sites with high levels of PFOA and PFOS (e.g., sites where
PFOA and PFOS were manufactured or used in the manufacture of products)
are the populations (i.e., non-occupationally exposed populations) most
likely to be exposed to PFOA or PFOS and are thus more likely to
experience associated adverse health effects.
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\40\ EPA need only determine that PFOA and PFOS ``may present''
a substantial danger to designate as hazardous substances pursuant
to CERCLA. CERCLA section 102(a). Other actions taken by EPA,
pursuant to other statutory authorities, may require a different or
more stringent finding. The scientific and technical data that EPA
is relying on in this action may be relevant to those determinations
and may support a finding under a more stringent standard.
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At the same time, the mobility of PFOA and PFOS means that these
substances have the potential to migrate away from a highly
contaminated site into sources of drinking water, both groundwater and
surface water. And the mobility and persistence combine to create an
ever-expanding area of contamination if it is not contained and/or
cleaned up. The persistence, mobility, and prevalence of PFOA and PFOS
create more opportunities for exposure to humans and the environment,
thereby increasing the likelihood of adverse health effects and adverse
ecological burdens stemming from the toxicity of these compounds. See
Proposed Rule, 87 FR 54415. In sum, communities located near sites with
the highest concentrations of PFOA and PFOS are subject to a
disproportionately higher risk of exposure to those substances as
compared to the general population.
For all these reasons, EPA finds that both PFOA and PFOS, and their
salts and isomers, each may present a substantial danger to the public
health, or welfare, or the environment when released.

[[Page 39149]]

VI. The Totality of the Circumstances Confirms That Designation of PFOA
and PFOS as Hazardous Substances Is Warranted

Along with concluding that both PFOA and PFOS ``may present a
substantial danger,'' EPA also independently exercised its discretion
and conducted an additional ``totality of the circumstances'' analysis
to evaluate whether designation was warranted. The analysis looks to
the evidence showing that PFOA and PFOS ``may present a substantial
danger'' along with CERCLA section 102(a) and its broader context.
CERCLA section 102(a) and its broader context help identify the
information to weigh and how to balance multiple considerations. In
conducting the analysis as to PFOA and PFOS, EPA identified and weighed
the advantages and disadvantages of designation. This analysis included
consideration of the formal benefit-cost analysis, including
quantitative and qualitative benefits and costs provided in the
Regulatory Impact Analysis accompanying this final rule.
The totality of the circumstances analysis first considered the
evidence that both PFOA and PFOS may present a substantial danger to
public health or welfare or the environment when released, see CERCLA
section 102(a). Specifically, EPA examined the scientific basis for
designation. EPA gave the scientific evidence considerable weight. As
discussed in Section V above, PFOA and PFOS exposure has been connected
to a wide range of adverse human health and environmental effects. PFOA
and PFOS bioaccumulate in humans and animals, including the fish and
other wild animals we eat. And PFOA and PFOS are persistent and mobile
in the environment. If not addressed, PFOA and PFOS will continue to
migrate, further exacerbating exposure risk and potential cleanup
costs.
EPA then evaluated CERCLA section 102(a) in the broader context of
CERCLA. Section 102(a) provides EPA with health- and environmental-
based criteria to evaluate whether a substance can be designated as
hazardous. A hazardous substance designation, in turn, makes available
the full suite of CERCLA authorities. EPA examined the ways in which
designation serves CERCLA's express purposes and functions: ensuring
that the ``Polluter Pays'' for cleanup (CERCLA sections 107(a),
106(a)); allowing for timely cleanup of contaminated sites (CERCLA
sections 104, 106, 121); and authorizing response that protects human
health and the environment (CERCLA sections 104, 106, 121).
With these statutory purposes in mind, EPA considered the core
problem posed by PFOA and PFOS in the environment and whether
designating PFOA and PFOS as hazardous substances would meaningfully
improve EPA's ability to address the problem. EPA believes that the
likelihood of the public being exposed to PFOA and PFOS is high. The
science demonstrates that human exposure to these chemicals is linked
to a broad range of adverse health effects. These concerns apply
particularly to those communities living near former manufacturing
sites, where PFOA and PFOS were produced (and then widely used) since
the 1940s. As a result, communities may be exposed to existing
contamination at and near sites where those substances were
manufactured and used for decades. These contaminated sites have the
potential to disproportionately harm nearby communities and ecosystems.
Because of this potential risk, such sites need to be investigated,
evaluated for risk to human health and the environment, and cleaned up
as appropriate. EPA concluded that CERCLA is best suited to address the
problem posed by legacy PFOA and PFOS contamination.
EPA next considered whether the hazardous substances designation is
warranted considering EPA's existing authority that allows the Agency
to address PFOA and PFOS as CERCLA ``pollutants and contaminants.'' EPA
weighed how designation may promote cleanups that might otherwise be
delayed or not occur. EPA's current authority to is limited in
meaningful ways.\41\ This rule, however, will allow EPA to utilize the
full suite of CERCLA authorities and enable EPA to address more sites,
allow for earlier action, and expedite eventual cleanup. This is, in
large part, because EPA will be able to employ CERCLA's liability and
enforcement provisions to require parties responsible for significant
pollution to address existing contamination. As a consequence,
designation greatly expands societal resources available (both
financial and human capital) for investigation and cleanup that would
not be available absent designation.
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\41\ As described in Section II.E., CERCLA authority differs
with respect to ``hazardous substances'' and ``pollutants or
contaminants.'' Designation of PFOA and PFOS as ``hazardous
substances'' streamlines response authority, makes available cost
recovery authorities allowing parties to recover response costs from
PRPs, and makes available CERCLA enforcement authority to compel
PRPs to conduct or pay for cleanup. See CERCLA sections 104(a),
106(a), 107(a). Designation also requires facilities to notify
federal, state, local, and tribal authorities, as well as
potentially injured parties, of significant releases. See CERCLA
sections 103(a), 111(g); EPCRA section 304.
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EPA also weighed the quantitative and qualitative costs and
benefits evaluated in the RIA.\42\ EPA considered the estimated direct
and indirect monetized costs. These costs include direct costs to
comply with release notification requirements and indirect costs for
response actions, including potential costs for existing and future NPL
sites as well as potential costs that may arise from enforcement
actions taken at non-NPL sites. EPA also considered qualitative costs,
which are those that EPA could not quantify with reasonable certainty.
Qualitative costs encompass the potential costs of litigation and
liability. Although EPA was unable to quantify these potential costs,
EPA evaluated how designation may affect CERCLA liability and
litigation. EPA analyzed whether CERCLA's statutory provisions (e.g.,
liability limitations, cost recovery provisions and settlement
authorities) and existing enforcement discretion policies could
mitigate those potential costs. Next, in evaluating benefits, EPA
considered the quantified baseline benefits associated with
transferring response costs from EPA to PRPs as well as quantified
health benefits that may result from the designation. These health
effects include those associated with birth weight, cardiovascular
disease (CVD) and renal cell carcinoma (RCC)-avoided morbidity and
mortality associated with reductions in PFOA and/or PFOS. Unquantified
health benefits include health effects such as immune, liver,
endocrine, metabolic, reproductive, musculoskeletal, as well as certain
cancers such as combined hepatocellular adenomas and carcinomas.
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\42\ EPA conducted a Regulatory Impact Analysis (RIA) consistent
with E.O. 12866. The E.O. requires, among other things, that the
Agency quantify costs and benefits to the extent possible and that
it qualitatively address the costs and benefits that cannot be
quantified. The analyses required under the E.O. do not determine
the appropriate consideration of advantages and disadvantages for
EPA final actions. Instead, the EPA statute, in this case CERCLA,
must be evaluated to determine the intended benefits of the statute
as determined by it terms.
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EPA also considered the ways in which the accompanying RIA does not
fully capture the quantitative costs or benefits of the rule due to
data limitations. As discussed throughout this preamble, CERCLA
response actions are discretionary, contingent, and site-specific
determinations. Whether it is appropriate to take any action--such as
through CERCLA

[[Page 39150]]

response authority under section 104 or CERCLA enforcement authority
under section 106--is based on a myriad of factors and most importantly
whether the releases at the site pose unacceptable risk. Because EPA
cannot fully assess and characterize the magnitude and number of
instances where the rule would reduce impacts associated with PFOA or
PFOS exposure, the benefits are difficult to fully ascertain and
estimate with certainty. In addition, there is considerable uncertainty
regarding the cost of health burdens that may result from exposure to
PFOA or PFOS, and associated cost savings from reducing the incidence
of these burdens because of designation.
Relatedly, future response costs are also difficult to quantify due
to the site-specific nature of CERCLA. Unlike with benefits, though,
EPA concluded that it has sufficient information to reasonably estimate
anticipated future costs for NPL and non-NPL sites. EPA was able to
utilize existing data to estimate a high and low range for response
costs at these sites. As explained in Section VI.A, the investigative
and remedial technologies available to address PFOA and PFOS are, in
large part, the same remedial technologies used to address other
hazardous substances (e.g., the costs to pump and treat groundwater; to
dig and haul contaminated soil; or to provide alternative drinking
water). Therefore, EPA can use historic response cost information to
reasonably assess PFOA and PFOS response costs. EPA acknowledges,
however, that there remains uncertainty concerning the location and
number of sites that will be identified as needing remediation and the
extent of contamination at those sites. There is also uncertainty
regarding the potential incremental increase in cost (if any) of
addressing PFOA or PFOS at a site along with other COCs present.\43\
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\43\ Designation does not require any specific response actions
or confer liability. Whether response costs will be incurred is
wholly dependent on site-specific discretionary decisions. Before
taking any action, EPA evaluates the level of risk posed by any
given release.
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EPA concluded that a ``totality of the circumstances'' analysis is
a useful benchmark for assessing whether action is warranted under a
unique statute like CERCLA. Unlike other environmental statutes which
are premised on ``command and control'' regulation, CERCLA is a
remedial statute. It does not set prospective limits on the amount of
permissible contamination. Instead, CERCLA imposes financial liability
on those responsible for existing contamination that presents
unacceptable risk to public health and the environment. In many
instances (e.g., at NPL sites) cost considerations are evaluated on a
site-specific basis. A totality of the circumstances analysis best
reflects the advantages and disadvantages of designation and allows for
a more holistic assessment of designation.
The totality of the circumstances analysis is provided below.
Section VI.A discusses the numerous advantages of designation.
Designation allows EPA to deploy the full suite of CERCLA tools to
identify, characterize, and cleanup the most contaminated sites
expeditiously. It also allows EPA to hold responsible those parties
that have contributed to significant contamination so that they bear
the costs of cleaning it up. This, in turn, makes more resources
available, allowing for additional and/or earlier cleanups relative to
what could occur absent designation. These additional, earlier cleanups
will protect vulnerable populations and communities living near
contaminated sites. Further, these cleanups will have meaningful health
benefits similar to other CERCLA actions by reducing a broad range of
potential adverse human health effects. Thus, cleaning up PFOA and PFOS
contamination that is posing unacceptable risk to human health, or the
environment will improve quality of life and reduce health care
expenditures for the communities living in and around PFOA and PFOS
contaminated sites.
Section VI.B evaluates the disadvantages of designation such as
direct costs of the rule, the potential for the rule to create hardship
for parties that did not significantly contribute to contamination, and
the potential for uncertainty for PRPs. EPA estimates that direct
costs, particularly release notification costs, are fairly minimal. EPA
recognizes that some parties that do not bear primary responsibility
for contamination may be sued and face uncertain litigation costs. EPA
believes that CERCLA's liability limitations, coupled with EPA
enforcement discretion policies, should operate to minimize hardship
for parties that did not significantly contribute to contamination. EPA
expects that designation should not change CERCLA's liability framework
and that CERCLA will continue to operate as it has for decades (with
respect to the more than 800 existing hazardous substances) to resolve
who should pay for the cleanup and how much.
In Section VI.C, EPA explains the results of the totality of the
circumstances analysis to demonstrate that potential costs and
disadvantages are not unreasonable when weighed against the numerous
advantages of designation.

A. Advantages of Designation

EPA examined the advantages of designation, including its positive
impacts on public health, the Superfund program, local economies and
ecosystems, and the importance of shifting response costs to parties
responsible for significant contamination. Unlike other environmental
statutes which are premised on ``command and control'' regulation,
CERCLA is a remedial statute. It does not set prospective limits on the
amount of permissible contamination. Instead, CERCLA imposes financial
liability on those responsible for existing contamination that presents
unacceptable risk to public health and the environment. As a
consequence, benefits of the designation flow from CERCLA's liability
framework--which leads to more cleanups of existing contaminated
sites--rather than the prospective regulation of releases at regulated
sources.
Designating PFOA and PFOS as CERCLA hazardous substances eliminates
barriers to timely cleanup of contaminated sites, enables EPA to shift
responsibility for cleaning up certain sites from the Fund to PRPs, and
allows EPA to compel PRPs to address additional contaminated sites.
Ensuring the timely cleanup of sites, and that the parties responsible
for significant contamination bear the costs of cleaning it up, are the
primary objectives of CERCLA. EPA gave significant weight to these
considerations because, absent designation, the cleanup of PFOA and
PFOS contamination would be significantly hampered. PFOA and PFOS
contamination is widespread, and EPA's current authority is limited.
Earlier and more timely responses at contaminated sites will better
address the urgent public health issue of PFOA and PFOS contamination.
As discussed above in Section V, the latest science is clear: human
exposure to PFOA and PFOS is linked to a broad range of adverse health
effects. EPA gave significant weight to its finding that both PFOA and
PFOS may present substantial danger. The potential for harm to public
health is unabated if PFOA and PFOS remain in the environment, and
designation is necessary to facilitate swift action. EPA also gave
significant weight to the substantial health benefits--realized by
communities nationwide--that are expected to result from designation.
Earlier, expeditious response to PFOA

[[Page 39151]]

and PFOS releases will reduce exposure to PFOA and PFOS across the
country and will minimize the likelihood of adverse health effects,
particularly for sensitive groups such as pregnant woman and children.
As discussed supra in Section V, PFOA and PFOS exposure is linked to
serious health conditions, including cancer and cardiovascular disease.
Reducing PFOA and PFOS exposures can improve community health while
potentially saving Americans billions of dollars in health care and
other expenses. PFOA exposure alone has been estimated to have caused
billions of dollars of health care and other economic costs (Malits et
al., 2018). EPA also quantified certain potential health benefits
associated with reducing PFOA and PFOS exposure in private drinking
water wells. Designation allows for earlier, and additional, CERCLA
response activities to address areas with high levels of PFOA and PFOS
contamination, which translates to lower risk of adverse health effects
for the most exposed communities. Ensuring that EPA can utilize CERCLA
to the fullest extent is critical to address this serious public health
issue.
1. Designation Enables Earlier, Broader, and More Effective Cleanups of
Contaminated Sites
Designation of PFOA and PFOS as hazardous substances is critical to
EPA's ability to address the public health threats posed by PFOA and
PFOS in the environment. CERCLA imposes notification requirements and
potential liability on those that release hazardous substances and
makes available authorities that promote timely cleanup of hazardous
substances. This includes release notification under CERCLA section
103, response authority under CERCLA section 104, enforcement authority
under CERCLA section 106, and cost recovery under CERCLA section 107.
Thus, designation allows EPA to employ a broader suite of CERCLA
authorities to address contamination, which in turn allows EPA to
address more sites, enables earlier and more expeditious responses to
PFOA and PFOS releases, and makes available additional resources
allowing for cleanup of other COCs at NPL sites. It also provides EPA
with authority to pursue those responsible for the most significant
contamination so that they bear the financial responsibility for
cleaning it up.
a. Designation Opens Up CERCLA's Notification, Response, Enforcement
and Cost Recovery Authorities, Which Allows EPA to More Timely Address
Contaminated Sites
This action will make PFOA and PFOS subject to CERCLA's
notification, response, enforcement, and cost recovery authorities.
This is because those authorities either do not apply, or are limited,
with respect to pollutants or contaminants (which PFOA and PFOS are
currently).
A direct consequence of designating PFOA and PFOS as hazardous
substances is that, once designated, entities that release PFOA and
PFOS at or above the reportable quantity must provide notification of
the release. The requirements include notification to the National
Response Center for releases that meet or exceed the reportable
quantity, CERCLA section 103; newspaper notice to parties potentially
injured by a release, CERCLA section 111(g); and State, local, and
Tribal notice, as appropriate, for reportable releases, EPCRA section
304. These notifications allow EPA to assess whether CERCLA response
actions are necessary to mitigate risks to public health and the
environment and to respond promptly where response actions are
necessary. Swift action to address harmful releases can prevent further
migration of PFOA and PFOS from the source of the release and reduce
the need for more expensive, more expansive cleanup in the future.
Designation also allows EPA to streamline the Federal government's
response authority under CERCLA section 104 to address releases or
threatened releases using removal or remedial authority. Absent
designation, EPA (and other Federal agencies) can only address PFOA and
PFOS as pollutants or contaminants. This means that, for each
individual response, EPA (or another agency) needs to find that a
release, or threat of release, ``may present an imminent and
substantial danger to the public health or welfare.'' 42 U.S.C.
9604(a)(1). After designation, agencies will be able to respond to a
release or threatened release without first making this determination,
allowing for action sooner.
Designation also makes CERCLA's enforcement and cost recovery
authorities available for PFOA and PFOS. In the absence of designation,
CERCLA authority to compel PRPs to conduct or pay for response work
does not extend to ``pollutants or contaminants'' and CERCLA does not
provide cost recovery for actions taken solely in response to releases
or threats of releases of ``pollutants or contaminants.'' Having access
to these authorities will allow EPA to hold PRPs responsible for
addressing PFOA/PFOS contamination, which can lead to the timely
cleanup of more contaminated sites.
Designation will allow EPA to take enforcement actions against PRPs
under CERCLA section 106(a) when there may be an imminent and
substantial endangerment from an actual or threatened release of PFOA
or PFOS. EPA will be able to use CERCLA section 106(a) to compel PRPs
to take immediate action to start the time-consuming process of
investigating, scoping, and cleaning up PFOA and PFOS releases. This
authority also helps to ensure that PRPs are financially accountable
for releases of PFOA and PFOS by enabling EPA to compel PRPs to
undertake response action. This, in turn, enables earlier and more EPA
response work by diversifying EPA's options. Enforcement actions are
also complementary to Fund-financed response activities (``Guidelines
for Using the Imminent Hazard, Enforcement and Emergency Response
Authorities of Superfund and Other Statutes,'' 1982). EPA aims,
whenever possible, to seek cleanup by responsible parties prior to
recourse to either the Fund or litigation. This allows EPA to preserve
the valuable resources of the Fund to address as many priorities as
possible.
Enforcement authority contributes to timely response actions at the
most contaminated sites. Because PRPs, rather than EPA, are best
positioned to know the location and extent of potential contamination
at and from their facilities, PRP-led cleanups can be more efficient.
PRP-led cleanups can also be faster because EPA need not secure access
orders with PRPs if the PRP is conducting the response actions. Also,
EPA generally takes enforcement actions to address sites that pose the
highest relative risks; therefore, making enforcement authority
available supports EPA's ability to target and prioritize existing
sites where PFOA and PFOS releases pose substantial risk to public
health and the environment.
Additionally, designation will allow EPA to use CERCLA section 107
to recover costs expended by EPA to clean up PFOA and PFOS
contamination. CERCLA section 107 provides that liable parties are
responsible for the costs associated with responding to hazardous
substances. Liable parties under CERCLA include: (1) Current owners and
operators of facilities, (2) past owners and facility operators in
place at the time of hazardous substance

[[Page 39152]]

disposal, (3) any person who ``arranged for disposal'' of that
facility's hazardous substances, and (4) any person that accepts
hazardous substances for ``transport to disposal or treatment
facilities.'' (CERCLA section 107(a)). If a person is liable for a
release of hazardous substances, that person may be responsible to pay
for response costs, natural resource damages, and assessment costs, and
costs pertaining to certain health assessment or health effects
studies. CERCLA section 107(a)(4)(A)-(D).
b. The Availability of CERCLA Enforcement and Cost Recovery Authority
Ensures That Polluters Are Financially Responsible, Which Is Consistent
With CERCLA
This action will allow EPA to hold polluters responsible for
addressing significant contamination. After designation, EPA will have
authority under CERCLA section 106 to compel PRPs to take response
actions at their facilities. This may allow EPA to reach more sites
more quickly. After designation, EPA can also rely on authority under
CERCLA section 107 to recover costs expended by EPA to clean up PFOA
and PFOS contamination.
The availability of CERCLA enforcement authority to address PFOA
and PFOS releases aligns with the Polluter Pays principle, a central
objective of CERCLA, and is an important advantage of the rule. CERCLA
is specifically designed to hold responsible those parties that
contributed to dangers to human health and the environment by releasing
hazardous chemicals into the environment. See H.R. Rep. No. 99-253, pt.
3, at 15 (1985), as reprinted in 1978 U.S.C.C.A.N. 3038, 3038 (stating
that a goal of CERCLA is ``to hold responsible parties liable'' for
cleanup costs); H.R. Rep. No. 96-1016, pt 1, at 1 (1980) (acknowledging
that CERCLA establishes ``strict liability to enable the Administrator
to pursue rapid recovery of costs . . . and to induce [liable parties]
voluntarily to pursue appropriate environmental response actions . . .
.''). The ability to require liable parties to pay for cleanup is the
cornerstone of ensuring that sites are cleaned up to protect public
health from ``one of the most pressing environmental problems.'' See
H.R. Rep. No. 99-253, pt 1, at 54 (1986), as reprinted in 1986
U.S.C.C.A.N. 2835, 2836. In reauthorizing CERCLA, Congress acknowledged
that, ``[I]t is clear from the accumulating data on waste sites that
EPA will never have adequate monies or manpower to address the problem
itself. As a result, an underlying principle . . . is that Congress
must facilitate cleanups of hazardous substances by the responsible
parties . . . .'' H.R. Rep. No. 99-253 at 55. Consistent with these
legislative goals, this rule enables EPA to hold PRPs, particularly
those that have contributed significantly to PFOA and PFOS
contamination, financially responsible for addressing such
contamination. Designation also signals to the market that there is
value in the prevention of releases and mitigation of existing
releases.
EPA considered the additional costs that PRPs may face and
concluded that these potential costs do not outweigh the advantages of
designating PFOA and PFOS. Potential costs associated with CERCLA
enforcement actions that may occur after designation are difficult to
assess. Nonetheless, EPA used historical cost data to assess the
potential for additional costs to PRPs associated with response work at
non-NPL sites that may result from enforcement actions, see Chapter 5
of the RIA for more detail. EPA cannot ascertain with certainty the
number of sites that may be subject to a CERCLA enforcement action over
the next several years. Depending on the circumstances, EPA may
determine that authority provided under a different statute, such as
RCRA, SDWA, CWA, or TSCA, may be best suited to address the
environmental harm. In addition, the site could be referred to the
State for further action rather than EPA; or site activity could be
Fund-lead, which may occur when there is no viable PRP or when
immediate action is required. Should EPA proceed using CERCLA
enforcement, the scope of the enforcement action--including the
response activities required and the amount of time it may take to
implement them--is also difficult to estimate absent a preliminary
assessment of the scope of contamination at a specific site.
Ensuring that the PRPs responsible for significant contamination
bear the costs of cleanup is one of the express purposes of CERCLA and
can only be realized through designation. This is an important
advantage of designation. Bringing PFOA and PFOS into CERCLA's
liability framework is a critical and essential advantage of
designation, considering that PFOA and PFOS are prevalent in the
environment, threaten communities across the country, and PRPs are best
situated to address releases from their facilities. And while it cannot
be determined with specificity where or when enforcement and response
actions will occur, EPA attempted to estimate anticipated expenditures
to the best of its ability. Considering all of this together, EPA
concluded that designation achieves a principal objective of CERCLA--
the polluter pays. The payment of these costs by those responsible for
significant contamination represents an improvement in social welfare
as a result of the rule.
c. EPA Expects Designation Will Increase Emergency Response and Removal
Actions for PFOA/PFOS
EPA expects that designation will result in more removal actions,
including emergency actions, to address PFOA and PFOS releases, which
in turn may increase health benefits. These removal actions can be
taken by EPA (i.e., Fund-lead actions) or a PRP (i.e., PRP-lead
actions).\44\ Additional removal actions are expected to occur because
EPA prioritizes responses to hazardous substances and in particular
those with the greatest threat to human health, and EPA expects an
increase in State referrals, each of which are explained in turn.
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\44\ This section only discusses designation impacts on Fund-
lead removals. Designation impacts pertaining to PRP-lead actions,
including removal orders, are discussed in section VI.1.b.
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After designation, EPA expects to take more Fund-lead removal
actions for PFOA and PFOS contamination because existing limitations on
response authority and cost recovery will no longer apply. EPA's
removal program, although not limited to responses to hazardous
substance releases, prioritizes responses to hazardous substance
releases. This is in part because the removal budget is limited, and
the administrative burden for addressing hazardous substances is
reduced relative to addressing PFOA/PFOS as pollutants or contaminants.
Absent designation, to respond to PFOA or PFOS contamination utilizing
CERCLA section 104(a), the statute requires EPA to determine the
release or threat of release may pose an imminent and substantial
endangerment. The statute also does not allow EPA to cost recover for
actions exclusive to pollutants or contaminants. A hazardous substance
designation removes those statutory limitations, as EPA need not
demonstrate on a case-by-case basis that releases of hazardous
substances may pose an ``imminent and substantial endangerment.''
Designation thus enables additional Fund-lead removal actions to
address immediate risks.\45\

[[Page 39153]]

EPA can then later recover costs for cleanup of these substances.
Recovered costs for each removal action that EPA takes to address sites
contaminated with PFOA and/or PFOS are costs that would be shifted from
taxpayers to PRPs.
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\45\ When a removal action is appropriate, EPA should take
action ``as soon as possible,'' (40 CFR 300.415(b)(3)), and may
often choose to take a Fund-lead removal rather than pursing a PRP-
lead action through use of CERCLA enforcement authority. Negotiating
an enforcement order can be a time-consuming effort, which can in
turn delay a response. When immediate action is required, EPA will
use Fund dollars to initiate a removal and later cost recover.
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Removal actions to address PFOA and PFOS releases may also increase
as a result of State referrals, which often trigger a Fund-lead removal
action. States refer sites to EPA when they do not have the capacity,
technical expertise, or funding to take action under their own
authorities. EPA expects an increase in State referrals to EPA for PFOA
and PFOS removal actions because State budgets are limited. And because
State budgets are limited, Federal involvement may be the only
financially viable path toward responding to PFOA and PFOS releases.
EPA is not required to initiate a removal in response to referrals;
however, EPA must evaluate the need for removal actions as promptly as
possible after receiving the notification and determine the appropriate
response. (40 CFR 300.405(f)(1), 300.410(b)). EPA may determine that a
Fund-lead removal is the appropriate response or, if not, EPA may
continue monitoring the situation should EPA involvement be appropriate
at a later point in time.
EPA expects that removal costs for addressing PFOA and PFOS
releases will likely be roughly similar to removal costs for other
substances. The same response methods that exist for addressing other
hazardous substances are available for PFOA and PFOS. As one example,
in cases where PFOA and PFOS are contaminating drinking water, removal
actions would primarily focus on risk reduction for exposure to
contaminated drinking water. Methods of addressing exposure may include
granulated activated carbon, ion exchange, connecting customers to the
nearest public water system, and/or temporarily providing bottled
water. Any contamination left in place would be managed using post-
removal site controls \46\ or referred to a cleanup program (e.g.,
State, local, or the Superfund remedial program),\47\ dependent on
relative risk. EPA expects that Fund-led removal actions to address
PFOA and PFOS releases may range from $160,000 to $503,000 per site.
See RIA Chapter 5. Where PFOA and/or PFOS are the sole driver for
initiating a removal action, the cost estimate above represents the
estimated cost of the action. Where EPA may be responding to multiple
COCs, the cost of addressing PFOA/PFOS would represent an incremental
increase to the overall cost of response in addition to those other
COCs.
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\46\ Post-removal site control (PRSC) means ``those activities
that are necessary to sustain the integrity of a Fund-financed
removal action following its conclusion.'' (40 CFR 300.5). This may
include, for example, replacing water treatment system filters or
collecting leachate. Once field actions end, and all EPA resources
are demobilized, any additional actions required are PRSCs. PRSCs
continue until they are no longer necessary or until such time as a
PRP, state or local government, or EPA's remedial program implements
a remedy. (40 CFR 300.415(l)).
\47\ After EPA takes a removal action, it may be appropriate to
refer the site back to the state to maintain PRSCs. The NCP provides
that EPA should provide for PRSC, to the extent practicable, before
the removal action begins. (40 CFR 300.415(l)). EPA often
coordinates with states to obtain a commitment that the state will
maintain PRSCs after the removal ends. States may not have funding
to undertake the initial removal action, but often are able to
budget PRSC costs.
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An increase in removal actions for PFOA and PFOS releases is
expected to produce meaningful health benefits. Fund-lead removal
actions are the fastest way for EPA to respond to the most urgent
situations. Removal actions are typically quick responses to immediate
threats to eliminate or mitigate a threat to the public. Thus, EPA is
able to initiate a removal action more quickly than it can remedial
action--actions which often take decades to develop and implement.
Through removal actions, EPA can more quickly eliminate or mitigate
exposure pathways. For example, if it becomes known to EPA that a
resident's drinking water is contaminated with PFOA and PFOS above
risk-based levels, EPA can take action to eliminate that exposure
pathway by providing alternative drinking water or connecting the
resident to an alternative water source. Such actions mitigate the risk
of adverse health outcomes associated with chronic and cumulative
exposures to PFOA and PFOS. See Section VI.A.2 of this document,
discussion of health benefits.
d. EPA Expects That Shifting Costs to PRPs To Address PFOA/PFOS
Contamination at NPL Sites Will Make Fund Money Available for Other
Response Work
Through this action, EPA may compel viable PRPs to clean up PFOA/
PFOS contamination. EPA may thus conserve use of the Fund for
addressing other COCs or sites where there are no viable PRPs,
expanding EPA's ability to provide meaningful benefits for public
health and the environment across the country. Absent designation, EPA
would continue to spend Fund resources to clean up PFOA and PFOS
releases at non-Federal facility NPL sites under EPA's authority to
address PFOA and PFOS as ``pollutants or contaminants.'' Prior to this
rule, EPA evaluated PFOA and PFOS releases as pollutants and
contaminants as part of its process to identify potential NPL sites, in
its selection of a remedy, and in evaluation of the remedy. See supra--
Section II.E.4, 5. After designation, EPA will continue to evaluate
PFOA and PFOS releases as part of the Superfund process, but now EPA
can transfer these costs to PRPs--the entities responsible for the
contamination and associated hazards to human health and the
environment.\48\ Designation or not, EPA has been and will continue to
evaluate hazardous substances, pollutants or contaminants, at NPL sites
and, if necessary, address releases that present unacceptable risk to
human health or the environment. A major difference this designation
makes for NPL sites is who bears responsibility.
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\48\ As detailed in the RIA accompanying this rule, these ``cost
transfers'' from EPA to the PRP do not result in a net increase in
economic costs--rather, they just change ``who pays'' for these
cleanup costs.
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After designation, parties responsible for significant
contamination may bear liability. As discussed in Section VI.A.1.b.,
the transfer of costs from EPA to PRPs directly advances CERCLA's
objective that those that contributed to contamination bear the cost of
cleaning it up. While these cost transfers at NPL sites are an
important outcome of the designation, the designation itself does not
lead to greater response costs at particular NPL sites. Absent
designation, EPA wo

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