[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Proposed Rules]
[Pages 54415-54442]
[FR Doc No: 2022-18657]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 302

[EPA-HQ-OLEM-2019-0341; FRL-7204-02-OLEM]
RIN 2050-AH09

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Under the Comprehensive Environmental Response, Compensation,
and Liability Act of 1980, as amended (``CERCLA'' or ``Superfund''),
the Environmental Protection Agency (EPA or the Agency) is proposing to
designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic
acid (PFOS), including their salts and structural isomers, as hazardous
substances. CERCLA authorizes the Administrator to promulgate
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. Such a designation would
ultimately facilitate cleanup of contaminated sites and reduce human
exposure to these ``forever'' chemicals.

DATES: Comments must be received on or before November 7, 2022. Under
the Paperwork Reduction Act, comments on the information collection
provisions are best assured of consideration if the Office of
Management and Budget (OMB) receives a copy of your comments on or
before October 6, 2022.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OLEM-2019-0341, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov
(our preferred method). Follow the online instructions for submitting
comments.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, OLEM Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460.
     Hand Delivery or Courier: EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004.
The Docket Center's hours of operations are 8:30 a.m.-4:30 p.m.,
Monday-Friday (except Federal Holidays).
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the ``Public Participation''
heading of the SUPPLEMENTARY INFORMATION section of this document. For
further information on EPA Docket Center services and the current
status, please visit us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michelle Schutz, Office of Superfund
Remediation and Technology Innovation (5202T), Environmental Protection
Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone
number<PHONE_NUMBER>; email address: [email protected].

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, the EPA defines the
following terms and acronyms here:

ADEC Alaska Department of Environmental Conservation
AFFF Aqueous film-forming foam
APFO Ammonium perfluorooctanoate
ATSDR Agency for Toxic Substances and Disease Registry
CDC Center for Disease Control and Prevention
CDR Chemical Data Reporting
CERCLA Comprehensive Environmental Response, Compensation, and
Liability Act
CFR Code of Federal Regulations
COP-9 9th Conference of Parties
DoD Department of Defense
DOE Department of Energy
DNA Deoxyribonucleic acid
EA Economic Analysis
EALs Environmental action levels
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
FSANZ Food Standards Australia New Zealand
IARC International Agency for Research of Cancer
ICR Information Collection Request
ILs Initiation levels
LEPC Local Emergency Planning Committee
LHA Lifetime health advisories
MAC Maximum acceptable concentration
MCL Maximum contaminant level
MDH Minnesota Department of Health
mg/kg milligram per kilogram
mg/kg/day milligram per kilogram per day
MRL Minimal risk level
MSC Medium-specific concentration
NAICS North American Industrial Classification System
NCP National Oil and Hazardous Substances Pollution Contingency Plan
ng/g nanograms per gram
ng/L nanograms per liter
NHANES National Health and Nutrition Examination Survey
NJDEP New Jersey Department of Environmental Protection
NPL National Priorities List
NRC National Response Center
OMB Office of Management and Budget
PADEP Pennsylvania Department of Environmental Protection
PBI Proprietary business information
PCBs Polychlorinated biphenyls
PCL Protective concentration level
PER Perimeter Well Study
PFAS Per- and polyfluoroalkyl substances
PFBS Perfluorobutanesulfonic acid
PFDA Perfluorodecanoic acid
PFHpA Perfluoroheptanoic acid
PFHxA Perfluorohexanoic acid
PFHxS Perfluorohexanesulfonic acid
PFNA Perfluorononanoic acid
PFOA Perfluorooctanoic acid
PFOS Perfluorooctanesulfonic acid
PFOSA Perfluorooctanesulfonamide
pg/m\3\ picogram per cubic meter
PHGs Public health goals
POSF Perfluorooctanesulfonyl fluoride
ppt parts per trillion
PRG Preliminary remediation goal
PWS Public water system
RAGs Remedial action guidelines
RCRA Resource Conservation and Recovery Act
REACH Registration Evaluation, Authorisation and Restriction of
Chemicals
RFA Regulatory Flexibility Act
RfD Reference dose
RIDEM Rhode Island Department of Environmental Management
RML Regional removal management level
RQ Reportable quantity
RSL Regional screening level
SAB Science Advisory Board
SALs State action levels
SDWA Safe Drinking Water Act SERC State Emergency Response
Commission
SNURs Significant New Use Rules
TDI Tolerable daily intake
TEPC Tribal Emergency Planning Committee
TERC Tribal Emergency Response Commission
TRI Toxic Release Inventory
TSCA Toxic Substances Control Act
UCMR Unregulated Contaminant Monitoring Rule
UK United Kingdom
UMRA Unfunded Mandates Reform Act

UNEP United Nations Environment Programme
U.S. United States
U.S.C. United States Code
WQCC Water Quality Control Commission
WWTP Wastewater treatment plant

Table of Contents

I. Public Participation
    A. Written Comments
II. Does this action apply to me?
III. General Information
    A. Executive Summary
    B. What are PFOA and PFOS and how have they been used?
    C. What action is the Agency taking?
IV. Legal Authority
    A. Background
    B. Explanation of Criteria for Designation Decisions
    1. Factors To Be Considered Under Section 102
    2. CERCLA Section 102(a) Precludes Consideration of Cost
    a. Consistency With Case Law
    b. Consistency With Statutory Structure
    c. Indirect Costs
    d. Request for Comment
V. Designation of PFOA, PFOS, and Their Salts and Structural Isomers
as Hazardous Substances
    A. Introduction
    B. What is the evidence for designation of PFOA and PFOS as
hazardous substances?
    1. Chemical/Physical Characteristics
    2. Toxicity and Toxicokinetics
    3. Environmental Prevalence
VI. Effect of Designation
    A. Default Reportable Quantity
    B. Direct Effects of a Hazardous Substance Designation
    1. Reporting and Notification Requirements for CERCLA Hazardous
Substances
    2. Requirements Upon Transfer of Government Property
VII. Regulatory and Advisory Status at EPA, Other Federal, State and
International Agencies
    A. EPA Actions
    B. Actions by Other Federal Agencies
    C. State Actions
    D. Enforcement
    E. International Actions
VIII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review, and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    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

I. Public Participation

A. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OLEM-2019-
0341, at https://www.regulations.gov (our preferred method), or the
other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. The EPA may
publish any comment received to its public docket. Do not submit to
EPA's docket at https://www.regulations.gov any information you
consider to be Propriety Business Information (PBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about PBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    For further information and updates on EPA Docket Center services,
please visit us online at https://www.epa.gov/dockets.
    The EPA continues to monitor information carefully and continuously
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID-19.

II. Does this action apply to me?

    The purpose of this proposed rulemaking is to designate PFOA and
PFOS, including their salts and structural isomers, as hazardous
substances under CERCLA section 102(a). Upon designation, any person in
charge of a vessel or an offshore or onshore facility, as soon as they
have knowledge of any release of such substances at or above the
reportable quantity (RQ) must immediately report such releases to the
Federal, state, tribal and local authorities (CERCLA section 103(a),
Emergency Planning and Community Right-to-Know Act (EPCRA) section
304). The RQ for these designations is 1 pound or more in a 24-hour
period. Once EPA has collected more data on the size of releases and
the resulting risks to human health and the environment, the Agency may
consider issuing a regulation adjusting the reportable quantities for
these substances.
    The five broad categories of entities potentially affected by this
action include: (1) PFOA and/or PFOS manufacturers (including importers
and importers of articles); (2) PFOA and/or PFOS processors; (3)
manufacturers of products containing PFOA and/or PFOS; (4) downstream
product manufacturers and users of PFOA and/or PFOS products; and (5)
waste management and wastewater treatment facilities. The following
list of North American Industrial Classification System (NAICS) codes
is not intended to be exhaustive, but rather provides a guide to help
readers determine whether this action applies to them. Potentially
affected entities may include:

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                                      List of potentially affected U.S.
            NAICS code                       industrial entities
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488119............................  Aviation operations.
314110............................  Carpet manufacturers.
811192............................  Car washes.
325...............................  Chemical manufacturing.
332813............................  Chrome electroplating, anodizing,
                                     and etching services.
325510............................  Coatings, paints, and varnish
                                     manufacturers.
325998............................  Firefighting foam manufacturers.
562212............................  Landfills.
339112............................  Medical Devices.
922160............................  Municipal fire departments and
                                     firefighting training centers,
                                     including Federal agencies that
                                     use, trained with, and tested
                                     firefighting foams.
322121 and 322130.................  Paper mills.
325320............................  Pesticides and Insecticides.

324...............................  Petroleum and coal product
                                     manufacturing.
324110 and 424710.................  Petroleum refineries and terminals.
352992............................  Photographic film manufacturers.
325612............................  Polish, wax, and cleaning product
                                     manufacturers.
325211............................  Polymer manufacturers.
323111 and 325910.................  Printing facilities where inks are
                                     used in photolithography.
313210, 313220, 313230, 313240,     Textile mills (textiles and
 and 313320.                         upholstery).
562...............................  Waste management and remediation
                                     services.
221320............................  Wastewater treatment plants.
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III. General Information

A. Executive Summary

    EPA is proposing to designate two per- and polyfluoroalkyl
substances (PFAS)--specifically PFOA and PFOS including their salts and
structural isomers \1\ as hazardous substances because evidence
indicates that these chemicals may present substantial danger to public
health or welfare or the environment when released into the
environment. All references to PFOA and PFOS in this notice are meant
to include their salts and linear and branched structural isomers.
Linear and branched structural isomers of PFOA and PFOS maintain the
carboxylic acid and sulfonic acid functional groups, respectively, but
have different arrangements of the carbon atoms in the fluorinated
carbon chain.
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    \1\ All references to PFOA and PFOS in this notice are meant to
include their salts and linear and branched structural isomers.
Linear and branched structural isomers of PFOA and PFOS maintain the
carboxylic acid and sulfonic acid functional groups, respectively,
but have different arrangements of the carbon atoms in the
fluorinated carbon chain.
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    PFOA and PFOS have historically 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 are also used for firefighting at
airfields and in a number of industrial processes. PFOA and PFOS are
persistent and mobile in the environment, and exposure can lead to
adverse human health effects, including high cholesterol, changes in
liver enzymes, decreased immune response to vaccination, thyroid
disorders, pregnancy-induced hypertension and preeclampsia, and cancer
(testicular and kidney for PFOA, liver and thyroid cancer for PFOS). In
June 2022, EPA released interim updated health advisories for PFOA and
PFOS based on human epidemiology studies in populations exposed to
these chemicals. Based on the new data and EPA's draft analyses, the
levels at which negative health effects could occur are much lower than
previously understood when EPA issued the 2016 health advisories for
PFOA and PFOS (70 parts per trillion or ppt).
    EPA believes the totality of evidence about PFOA and PFOS described
here demonstrates that they can pose substantial danger to public
health or welfare or the environment. This level of evidence is more
than sufficient to satisfy the CERCLA section 102(a) standard. EPA
believes that this amount and type of evidence exceeds the minimum
required under CERCLA section 102(a).
    PFOA and PFOS are common contaminants in the environment because of
their release into the environment and their resistance to degradation.
PFAS generally, and PFOA and PFOS specifically, are sometimes referred
to as ``forever'' chemicals because their strong carbon-fluorine bonds
cause PFOA and PFOS to be extremely resistant to degradation in the
environment. PFAS are found in outdoor air at locations in the United
States, Europe, Japan, and over the Atlantic Ocean. PFAS are also found
in the artic snow and air.\2\
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    \2\ Scientific Reports (2016) Natural Poly-/perfluoroalkyl
Substances in Air and Snow from the Artic https://www.nature.com/articles/srep08912.
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    PFOA and PFOS are found worldwide in many environmental media and
in wildlife. For example:
     PFOA and PFOS are widely detected in surface water samples
collected from various rivers, lakes, and streams in the United States.
     PFOA and PFOS have been detected in surface and subsurface
soils.
     PFOA and PFOS have been detected in groundwater in
monitoring wells, private drinking water wells, and public drinking
water systems across the country. PFOA and PFOS have been found in wild
and domestic animals such as fish, shellfish, alligators, deer and
avian eggs.
    Environmental sources can include industrial, and inadvertent
municipal and agricultural discharges of PFOA and PFOS directly. PFOA
and PFOS precursors can be converted to PFOA and PFOS, respectively, 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, in a
landfill without environmental controls, can discharge via leachates,
groundwater pollution/migration and atmospheric releases.
    The principal worldwide manufacturers of PFOA and PFOS and related
chemicals phased out their production in the early 2000's although PFOA
and PFOS may still be produced domestically for certain uses and by
international companies that export treated products to the United
States. Environmental contamination and resulting human exposure to
PFOA and PFOS are anticipated to continue for the foreseeable future
due to its environmental persistence, formation from precursor
compounds, continued production by international manufacturers and
possible domestic production, and as a result of the large legacy
production in the United States. 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.\3\
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    \3\ CDC. (2021). National Health and Nutrition Examination
Survey: NHANES questionnaires, datasets, and related documentation.
Centers for Disease Control and Prevention. https://wwwn.cdc.gov/nchs/nhanes/Default.aspx.
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    The adverse human health effects, mobility, persistence,
prevalence, and other factors related to these PFAS combine to support
EPA's proposed finding that PFOA and PFOS, when released into the
environment may present substantial danger to the public health or
welfare or the environment and, as a result, warrant designation as
CERCLA hazardous substances.
    The potential dangers posed by PFOA and PFOS specifically, and more
generally by PFAS, have been recognized by numerous Federal, state, and
international governmental entities that have taken a wide variety of
actions to address these dangers to public health and welfare and the

environment. For example, the Department of Defense has been providing
alternative drinking water to local residents near military bases with
elevated PFOA and PFOS levels from DoD activities. Many states,
including California, Michigan, and Vermont have drinking water
standards for PFOA and PFOS. And numerous international bodies, such as
the European Union, and individual countries, such as Australia, China,
and Canada, have taken measures to address PFOA and PFOS. Designating
PFOA and PFOS as hazardous substances will add to the set of tools
already available under CERCLA to protect the public health and welfare
and the environment.
    If finalized, the direct effects of this proposed CERCLA
designation would include requiring that any person in charge of a
vessel or facility report releases of PFOA and PFOS of one pound or
more within a 24-hour period. This would give the Agency, state,
Tribal, and local governments, and the public a better understanding of
where releases occur and the quantities involved.
    In addition, when selling or transferring Federally-owned real
property, Federal agencies would be required to meet all of the
property transfer requirements in CERCLA section 120(h), including
providing notice when any hazardous substance ``was stored for one year
or more, known to have been released, or disposed of'' and providing 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.'' This would ensure that any entity receiving Federal land is
informed of the presence of PFOA or PFOS, and that these substances
will be addressed as required under CERCLA. There would also be an
obligation for DOT to list and regulate PFOA and PFOS as hazardous
materials under the Hazardous Materials Transportation Act (HMTA) (see
CERCLA Section 306(a)).
    In addition to those direct effects, if finalized, these
designations would provide some additional tools that the government
and others could use to address PFOA/PFOS contamination and, thus,
could facilitate an increase in the pace of cleanups of PFOA/PFOS
contaminated sites. Furthermore, there will likely be additional
response actions beyond those that are simply undertaken before
designating PFOA/PFOS a hazardous substance, although the quantity of
such an increase is indeterminable. The Federal government is already
authorized to cleanup PFOA/PFOS contamination under some circumstances,
including when it finds that a release may present an imminent and
substantial danger to public health or welfare. A faster pace of
cleanups would provide public health protection for affected
communities sooner and could reduce the cost of individual cleanups
(generally, the sooner contamination is addressed, the less it spreads
and the smaller the area that needs to be cleaned). The indirect,
downstream effects of these designations could include the following:
     EPA and other agencies exercising delegated CERCLA
authority could respond to PFOA and PFOS releases and threatened
releases without making the imminent and substantial danger finding
that is required for responses now.
     EPA and delegated agencies could require potentially
responsible parties to address PFOA or PFOS releases that pose an
imminent and substantial endangerment to public health or welfare or
the environment.
     EPA and delegated agencies could recover PFOA and PFOS
cleanup costs from potentially responsible parties, to facilitate
having polluters and other potentially responsible parties, rather than
taxpayers, pay for these cleanups.
     Private parties that conduct cleanups that are consistent
with the National Oil and Hazardous Substances Contingency Plan (NCP)
could also recover PFOA and PFOS cleanup costs from potentially
responsible parties.
    These impacts from the proposed rule will result in meaningful
public health benefits, including by increasing transparency around
PFOA/PFOS releases and offering additional tools that EPA and other
government agencies could use to conduct faster cleanups at
contaminated sites.\4\
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    \4\ See the Economic Assessment of the Potential Costs and Other
Impacts of the Proposed Rulemaking to Designate Perfluorooctanoic
Acid and Perfluorooctanesulfonic Acid as Hazardous Substances in the
rulemaking docket for a discussion of indirect benefits and costs.
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    In addition to this action, in 2022, the EPA will be developing an
advance notice of proposed rulemaking seeking comments and data to
assist in the development of potential future regulations pertaining to
other PFAS designation as hazardous substances under CERCLA.

B. What are PFOA and PFOS, and how have they been used?

    PFAS, including PFOA and PFOS, are human-made chemicals that have
been used in industry and consumer products since the 1940s because of
their useful properties, including their resistance to water, grease,
and stains. 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.\5\ In
considering toxicity and fate and transport processes, the salts are
deemed the same as the commonly referenced acid versions because, once
added to water, the salts dissociate to the component ions (there are
two ions, the cation and the anion). Hence, if any of the salt or acid
forms of PFOA or PFOS are released into the environment, the anionic
form will generally be found in environmental media; all references to
PFOA and PFOS in this preamble are meant to include all salts and
structural isomers.\6\
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    \5\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \6\ Ibid.
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    PFOA and PFOS have been produced within the United States (U.S.)
\7\ as well as imported. Although PFOA and PFOS production may be
ending in the United States, their continued use in certain
applications and persistence in the environment means that their
historical production and use will continue to be a concern in the
future.
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    \7\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
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    PFOA and PFOS can also be formed by chemical or biological
degradation from a large group of related PFAS (i.e., precursor
compounds).\8\ \9\ The nature of PFOA and PFOS (i.e., reactivity as
both a base and acid) has led to their use in a variety of manufactured
goods, industrial applications, or the environment, including the
following:
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    \8\ Ibid.
    \9\ UNEP. (2006). Report of the Persistent Organic Pollutants
Review Committee on the work of its second meeting. Addendum: Risk
profile on perfluorooctane sulfonate. Stockholm Convention on
Persistent Organic Pollutants. (UNEP/POPS/POPRC.2/17/Add.5). United
Nations Environment Programme. https://chm.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC2/POPRC2ReportandDecisions/tabid/349/Default.aspx.
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     Food packaging and preparation, including PFAS-containing
materials

(e.g., sandwich wrappers, and other paper and paperboard food
packaging) and processing equipment that uses PFAS. This can lead to
migration of PFAS into food that contacts such surfaces.
     Commercial household products, including stain- and water-
repellent fabrics, nonstick products, polishes, waxes, paints, and
cleaning products.
     Certain firefighting foams. PFAS can be found in
groundwater and surface water at airports, military bases and other
facilities where PFAS-containing firefighting foam was used for
training, incident response, or where foam was stored.
     Manufacturing and production, including chrome plating,
electronics manufacturing, textile manufacturing or oil recovery.
     Drinking water, typically because of localized
contamination associated with a specific facility (e.g., manufacturer,
landfill, wastewater treatment plant, firefighter training facility).
     Living organisms, including plants, animals and humans due
to the above-mentioned sources.
     Plating processes, such as a wetting agent/fume
suppressant.
     Non-stick cookware and food processing equipment.
     Processing aids in fluoropolymer production.
     Processing aids in textile coating applications.
     Insecticides.
     Certain types of adhesives.
     Cleaning products, such as carpet cleaners, auto washes
and electronics.
     Coating products, paints, varnishes and inks.
     Surfactants for oil extraction and mining.
     Photo lithography, photographic coatings
     Hydraulic fluids for aviation.\10\ \11\
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    \10\ U.S. EPA. (2014). Certain perfluoroalkyl sulfonates. U.S.
Environmental Protection Agency. Code of Federal Regulations. 40 CFR
721.9582. https://www.govinfo.gov/content/pkg/CFR-2014-title40-vol31/pdf/CFR-2014-title40-vol31-sec721-9582.pdf.
    \11\ Gl[uuml]ge, J; Scheringer, M; Cousins, IT; DeWitt, JC;
Goldenman, G; Herzke, D; Lohmann, R; Ng, CA; Trier, X; Wang, Z.
(2020). An overview of the uses of per-and polyfluoroalkyl
substances (PFAS). Environ Sci Process Impacts 22: 2345-2373.
https://www.ncbi.nlm.nih.gov/pubmed/33125022.
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     Certain explosives and pyrotechnics as binders and
oxidizers.
    The most common processes for making fluorinated chemicals,
including PFOA and PFOS, are electrochemical fluorination (ECF) and
telomerization. Production sites that produced PFAS by means of ECF
were located in the U.S., including Decatur, Alabama. International
production sites include Belgium (Zwijndrecht near Antwerp) and Italy
(Miteni in Vicenza)).
    Although PFOA and PFOS production may be ending in the United
States, their continued use in certain applications and persistence in
the environment means that their historical production and use will
continue to be a concern in the future.
    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. 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 (see 40 Code of
Federal Regulations (CFR) 721.9582).\12\ The EPA Chemical Data
Reporting (CDR) rule under the Toxic Substance Control Act (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.
However, Toxics Release Inventory (TRI) data for 2020 shows that small
amounts of PFOA and PFOS continue to be released into the environment.
Pursuant to TRI reporting requirements, facilities in regulated
industry sectors must report annually on releases and other waste
management of certain listed toxic chemicals that they manufacture,
process, or otherwise use above certain threshold quantities (100
pounds for PFOA and PFOS).
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    \12\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
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C. What action is the Agency taking?

    The EPA is proposing to designate PFOA and PFOS, including their
salts and structural isomers, as hazardous substances under section
102(a) of CERCLA.
    The designation of PFOA and PFOS, including their salts and
structural isomers, as hazardous substances, if finalized, would result
in a default RQ of one pound pursuant to CERCLA section 102. CERCLA
section 103(a) requires any person in charge of a vessel or facility,
as soon as they have knowledge of any release \13\ (other than a
federally permitted release) of a hazardous substance from such vessel
or facility in quantities equal to or greater than the RQ (one pound)
or more in 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). Section 304 of EPCRA (42 (United
States Code) U.S.C. 11004) also 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. 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. EPA published a guidance on July 13, 2010 (75 Federal Register
(FR) 39852) defining the phrase, ``as soon as practicable'' to be 30
days after a release. (Note: Some states or Tribal Nations provide less
than 30 days for submitting a follow-up report.) EPCRA section 304
requirements are codified in 40 CFR 355.30 to 355.43.\14\
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    \13\ See Office of Regulatory Enforcement, EPA, Enforcement
Response Policy for Sections 304, 311 and 312 of EPCRA and Section
103 of CERCLA at 12 (Sept. 30, 1999), available at https://www.epa.gov/enforcement/enforcement-response-policy-epcra-sections-304-311-312-and-cercla-section-103. See also https://www.epa.gov/epcra/definition-immediate-epcra-and-cercla-release-notification.
    \14\ For additional information on release reporting
requirements, see https://www.epa.gov/faqs/search/topics/emergency-planning-and-community-right-know-304487/topics/release-notification-epcra-304cercla-103-30450.
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    In addition, when Federal agencies sell or transfer real property
they must provide notice of the presence of hazardous substances in
certain circumstances as required by CERCLA section 120(h).
Furthermore, in certain circumstances, CERCLA 120(h) 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.''
    While these are the only direct and automatic consequences of
designating PFOA and PFOS hazardous substances for purposes of CERCLA,
there are other, indirect impacts described above that should
facilitate cleanups and reduce

human and environmental exposure to these hazardous chemicals.

IV. Legal Authority

A. Background

    CERCLA was enacted to promote the timely cleanup of contaminated
sites and to ensure that parties responsible for the contamination bear
the costs of such cleanups. CERCLA provides the Federal government with
the authority to respond to releases or threatened releases of
hazardous substances, and pollutants and contaminants in order to
protect public health, welfare, and the environment. The statute
confers considerable discretion upon the EPA in its exercise of these
authorities. Other than the reporting requirements in the statute,
CERCLA is not a traditional regulatory statute that prospectively
regulates behavior; rather it is remedial in nature, generally designed
to address contamination on a site-specific basis.
    CERCLA required a significant update to the NCP, which provides the
``procedures and standards for responding to releases of hazardous
substances, pollutants, and contaminants . . . .'' CERCLA section
105(a). The NCP is the blueprint for all aspects of the cleanup
process, from the discovery of releases of contaminants, to responding
to releases or threatened releases that require prompt response, and to
prioritizing and developing longer-term remedial actions.
    Once a Federal agency learns of a release or potential threat of a
release of a hazardous substance, pollutant and/or contaminant, CERCLA
authorizes response in one of three ways: by determining no action at
the Federal level is warranted; by undertaking a removal action (if the
situation presents a more immediate threat); or by assessing the
relative risk of the release to other releases via the NPL listing
process that is the first step towards a longer-term remedial action.
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.
EPA determines whether the site poses a threat to people and the
environment and whether hazards need to be addressed immediately or
additional site information will be collected. Federal entities other
than EPA that respond to releases or threatened releases of hazardous
substances, pollutants, or contaminants at Federal sites must similarly
act consistent with CERCLA and the NCP. Finally, private parties
responding to a release or threatened release at their facility must
act consistent with CERCLA and the NCP in order to maintain CERCLA
claims for recovery of response costs.
    The nature of the subsequent response action depends upon the site-
specific circumstances. Short-term ``removals'' are response actions
that EPA and other Federal agencies may take to address releases or
threatened releases requiring prompt action and are limited in cost and
duration unless specific criteria are met. Long-term ``remedial''
actions permanently and significantly reduce the risks associated with
releases or threats of releases that are serious and are typically
associated with chronic exposures, but not immediately life-
threatening. EPA can only conduct remedial actions at sites listed on
EPA's National Priorities List (NPL). Additions to the NPL undergo
notice-and-comment rulemaking. The NPL sites are among the worst
hazardous substance sites identified by EPA. Only about 3% of the
53,400 assessed sites have been placed on the NPL. If a site is placed
on the NPL, a Remedial Investigation/Feasibility Study is conducted to
assess risks posed by releases of a hazardous substance, pollutant, or
contaminant at the site by evaluating soil, surface water, ground
water, and other media, and waste samples, and to analyze potential
treatment methods or cleanup alternatives. EPA then summarizes those
alternatives and offers its recommendation in a Proposed Plan, which
undergoes a public comment process. The final decision on the cleanup
is memorialized in a Record of Decision, which is accompanied by a
responsiveness summary addressing the public comments. The specific
details of the cleanup are then planned in the Remedial Design and
finally carried out in the Remedial Action. Ultimately, the remedy must
be one ``that is protective of human health and the environment, that
is cost effective, and that utilizes permanent solutions and
alternative treatment technologies or resource recovery technologies to
the maximum extent practicable.'' CERCLA section 121(b)(1).
    CERCLA provides authority for response actions to address releases
of hazardous substances as well as releases of pollutants and
contaminants. The authority conferred by CERCLA with regard to
hazardous substances differs in a few respects from the authority with
regard to pollutants and contaminants. With respect to hazardous
substances, the Agency can conduct response actions if there is a
release or threatened release without having to establish an imminent
and substantial danger. In addition, the EPA can also recover costs
from potentially responsible parties and require potentially
responsible parties to conduct the cleanup themselves. CERCLA also
authorizes persons (including private parties) that conduct cleanup
activities that are consistent with the NCP to seek to recover cleanup
costs from potentially responsible parties. With respect to releases or
substantial threat of releases of pollutants and contaminants, EPA can
respond if the Agency finds that the release or threat of release may
present an imminent and substantial danger to the public health or
welfare, and, generally, cannot require a private party to pay for or
conduct the removal action.
    Accordingly, CERCLA already provides significant authority to
Federal agencies to address PFOA and PFOS releases because these two
chemicals are pollutants and contaminants. Nonetheless, designating
PFOA and PFOS as hazardous substances will likely increase the pace at
which cleanups occur because it will allow the Federal government to
require responsible private parties to address releases of PFOS and
PFOA at sites without other ongoing cleanup activities, and allow the
government and private parties to seek to recover cleanup costs from
potentially responsible parties assuming relevant statutory criteria
are met. As a result, risks from releases of PFOA and PFOS may be
mitigated.

B. Explanation of Criteria for Designation Decisions

    CERCLA section 101(14) sets out the definition of ``hazardous
substance.'' There are two ways that a substance may be defined as a
``hazardous'' substance under CERCLA. The first is automatic where the
substance is identified as hazardous or toxic pursuant to other
specified environmental statutes (e.g., chemicals listed as air toxics
by Congress or EPA under section 112 of the Clean Air Act). The second
is where the substance is designated as hazardous pursuant to CERCLA
section 102. In this action, the Administrator is exercising his
authority to designate under section 102.
1. Statutory Factors To Be Considered Under Section 102
    The EPA Administrator is authorized under CERCLA section 102(a) to
promulgate regulations designating as a hazardous substance:
    (1) ``such elements, compounds, mixtures, solutions, and
substances''
    (2) ``which, when released into the environment''

    (3) ``may present substantial danger''
    (4) ``to the public health or welfare or the environment.''
    The term ``hazardous substance'' is defined in section 101(14) of
CERCLA primarily by reference to other environmental statutes and
includes substances designated pursuant to CERCLA section 102. Pursuant
to CERCLA section 101(14) the term hazardous substance means (A) any
substances 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 substances 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 paragraphs (A) through (F) of this paragraph,
and the term does not include natural gas, natural gas liquids,
liquified natural gas, or synthetic gas usable for fuel (or mixtures of
natural gas and such synthetic gas).
    Because EPA has not exercised its authority under CERCLA section
102(a), it has not previously issued an interpretation of the standard
for designating hazardous substances.
    EPA proposes to interpret ``may present'' in the statutory language
as indicating that Congress did not require certainty that the
substance presents a substantial danger or require proof of actual
harm. In assessing whether a substance, when released, may present
``substantial danger,'' \15\ the EPA proposes to consider information
such as the following: the potential harm to humans or the environment
from exposure to the substance (i.e., hazard), and how the substance
moves and degrades when in the environment (i.e., environmental fate
and transport). To further inform its decision about whether the
statutory factors have been met, the Agency proposes to also consider
other information that may be relevant when evaluating releases of the
substance, such as the frequency, nature and geographic scope of
releases of the substances. The Agency proposes to weigh this
information to determine whether the substance, when released, may
present a ``substantial danger.''
---------------------------------------------------------------------------

    \15\ The EPA notes that the ``substantial danger'' language in
CERCLA section 102(a) is similar to language in other parts of
CERCLA but is interpreted in a different manner due to the contexts
in which the language appears. Those other provisions (see, e.g.,
CERCLA sections 104, 105, 106, and 128) concern enforcement and
response actions and apply to and require analyses of site-specific
circumstances relevant to a particular facility or person, and to an
event. By contrast, the statutory objectives associated with
designating hazardous substances under CERCLA section 102(a) warrant
a different implementation strategy because of its broader
applicability and analytical requirements. The standard for CERCLA
section 102(a) in this notice is based on the specific language and
purpose of section 102(a) and does not affect EPA's interpretations
of other CERCLA provisions. See Utility Air Regulatory Group v. EPA,
573 U.S. 302, 320 (2014) (finding that statutory terms, even those
that are defined in the statute, ``may take on distinct characters
from association with distinct statutory objects calling for
different implementation strategies.'').
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2. CERCLA Section 102(a) Precludes Consideration of Cost
    Given the specific standard Congress established for determining
whether a substance is hazardous (i.e., whether it ``may present
substantial danger to the public health or welfare or the
environment''), EPA proposes to interpret the language of CERCLA
section 102(a) as precluding the Agency from taking cost into account
in designating hazardous substances. Congress did not list cost as a
required or permissible factor, and none of the Congressionally-listed
statutory factors encompass a consideration of cleanup costs. Moreover,
as a matter of common sense and straightforward reading, determining
whether something is ``hazardous'' does not naturally lend itself to
considerations of cost. A substance is or is not hazardous based on
scientific and technical considerations. Subsequent determinations of
whether and how to address something hazardous may involve
considerations of cost, as CERCLA does in the context of response
actions, as discussed below.
a. Consistency With Case Law
    Reading CERCLA as precluding consideration of costs in hazardous
substance designations is consistent with relevant Supreme Court
precedent on cost consideration in rulemaking decisions. CERCLA section
102(a) is similar to Clean Air Act section 109(b)(1),\16\ which governs
EPA's setting of national ambient air quality standards (NAAQS) and
which the Supreme Court said precludes consideration of costs. Whitman
v. American Trucking, 531 U.S. 457 (2001). In his majority opinion,
Justice Scalia explained,
---------------------------------------------------------------------------

    \16\ ``National primary ambient air quality standards,
prescribed under paragraph (a) shall be ambient air quality
standards the attainment and maintenance of which in the judgment of
the Administrator, based on such criteria and allowing an adequate
margin of safety, are requisite to protect the public health. Such
primary standards may be revised in the same manner as
promulgated.'' 42 U.S.C. 7409(b)(1).

The EPA, ``based on'' the information about health effects contained in
the technical ``criteria'' documents compiled under section 108(a)(2),
42 U.S.C. 7408(a)(2), is to identify the maximum airborne concentration
of a pollutant that the public health can tolerate, decrease the
concentration to provide an ``adequate'' margin of safety, and set the
standard at that level. Nowhere are the costs of achieving such a
---------------------------------------------------------------------------
standard made part of that initial calculation.

American Trucking, 531 U.S. at 465.

    Similarly, CERCLA section 102(a) establishes a standard for
designation that is tied exclusively to whether the release of a
substance ``may present substantial danger to the public health or
welfare or the environment.'' 42 U.S.C. 9602(a). Congress did not
mention cost in this language that sets the standard for designation of
hazardous substances.
    Section 102(a)'s specific designation standard and its statutory
context differentiate it from the broader statutory standard in Clean
Air Act section 112(n)(1)(A), which the Supreme Court held requires EPA
to consider costs in determining whether to regulate air toxic
emissions from power plants in Michigan v. EPA, 576 U.S. 743 (2015).
Clean Air Act section 112(n)(1)(A) states, in part,

The Administrator shall regulate electric utility steam generating
units under this section, if the Administrator finds such regulation is
appropriate and necessary after considering the results of the study
required by this paragraph.

42 U.S.C. 7412(n)(1)(A). The Supreme Court explained that
``appropriate'' is a broad term that ``includes consideration of all
the relevant factors'' and when read in the context of Clean Air Act
section 112(n)(1)(A) requires ``at least some attention to cost.''
Michigan, 576 U.S., at 752. In particular, the Court pointed to a study
that was required by

the same paragraph (i.e., Clean Air Act section 112(n)(1)), and noted
both that Congress required that this study address cost (among other
factors), and that EPA said that study helped provide a ``framework''
for EPA's decision under Clean Air Act section 112(n)(1). Given this
context, in interpreting the Clean Air Act section 112(n)(1)'s
``appropriate and necessary'' standard for triggering regulation of air
toxics from power plants, the Court held that EPA must consider cost in
deciding whether to regulate power plants.
    The standard for designation in CERCLA section 102(a) is
significantly more circumscribed than the standard at issue in
Michigan. As noted above, in CERCLA section 102(a), Congress specified
a public health and welfare and environment standard governing EPA's
designation decisions that did not include cost. In these
circumstances, Michigan acknowledged that:

American Trucking thus establishes the modest principle that where the
Clean Air Act expressly directs EPA to regulate on the basis of a
factor that on its face does not include cost, the Act normally should
not be read as implicitly allowing the Agency to consider cost anyway.

Id. at 755-56. Because CERCLA section 102(a) specifies the standard
that EPA is to use, and it wholly relates to danger to public health,
welfare, or the environment, cost should not be read in as an
additional consideration. Furthermore, CERCLA section 102(a) is lacking
provisions that indicate Congressional intent to take cost into
account--unlike CAA section 112(n)(1), which had cost elements in
provisions that the Court and EPA said were relevant to interpreting
the ``appropriate and necessary'' standard.
    CERCLA section 102(a) does use the word ``appropriate'' (the
Administrator shall ``promulgate and revise as may be appropriate''
regulations designating hazardous substances), but significantly, the
word ``appropriate'' is not used in the context of what EPA should
consider when assessing whether a substance is hazardous. And as the
Michigan Court noted, ``appropriate and necessary'' does not always
encompass cost, context matters. See Michigan, 576 U.S. at 752. Under
CAA section 112(n)(1), the substantive standard is nothing more than
whether regulation is ``appropriate and necessary'' and, to the extent
Congress provided a contextual indication about the meaning of that
capacious phrase, it indicated that cost was relevant. In contrast,
under CERCLA section 102(a), the Administrator is to promulgate and
revise as may be appropriate regulations that accomplish the statutory
goal of designating hazardous substances--and the guidance Congress
provided was that the Administrator should look to specific criteria
that do not include cost. Thus, EPA's authority to designate a
substance as hazardous is tied solely to a finding that, when released,
the substance may present a substantial danger to public health or
welfare or the environment.
    In addition, the Court in both American Trucking and Michigan,
looked to the overall statutory scheme to determine whether cost should
be considered as part of the Agency's determination. The role of a
hazardous substance designation in the overall structure of CERCLA is
much closer to the role of a national ambient air quality standard in
the overall structure of the NAAQS program than it is to the role of
the appropriate and necessary finding in regulating air toxic emissions
from power plants.
    Under CERCLA, the only automatic, private party obligation that
flows from designation as a CERCLA hazardous substance under section
102(a) is the obligation to report releases (a relatively small cost).
As discussed above, designation does not lead automatically to any
response action obligations. CERCLA response actions, which include
investigations of hazardous substance releases and determining if
removal or remedial action is necessary, are contingent, discretionary,
and site-specific actions.\17\ EPA prioritizes the highest-risk sites
under CERCLA (and that listing process is open to public comment); the
process for selecting remedies includes public notice and comment (such
as on the remedial action objectives and the consideration of remedial
alternatives); and cost considerations, among other important factors
such as protectiveness, are part of CERCLA's site-specific cleanup
approach.
---------------------------------------------------------------------------

    \17\ As noted below in section IV.B.2.c. and the Economic
Assessment, the multiple, contingent, discretionary and site-
specific steps between designation of a hazardous substance and the
incurrence of cleanup costs contribute to the inability to quantify
costs at the designation stage. The uncertainty at this stage, when
contrasted with the greater certainty and explicit consideration of
costs during the later cleanup selection process, further supports
EPA's proposed interpretation that CERCLA precludes consideration of
costs when designating a hazardous substance.
---------------------------------------------------------------------------

    For both the hazardous substance designation in CERCLA and the
setting of a NAAQS, there are later steps in the program where cost can
be taken into account before specific requirements are imposed on
entities subject to the programs. In contrast, in Michigan, the Court
seemed to weigh heavily the fact that, if regulations are ``appropriate
and necessary'' under section 112(n)(1)(A), then, without regard to
cost, ``the Agency must promulgate certain minimum emission
regulations, known as floor standards.'' Michigan, 576 U.S., at 748.
    Furthermore, the designation of a hazardous substance under CERCLA
section 102(a) in some cases does not create new costs, but rather
allows costs to be shifted from the taxpayer to parties responsible for
pollution under CERCLA. Even in those circumstances, where the
government is able to transfer costs, a private party's ability to pay
response costs is taken into account under the statute and in EPA's
implementation of the statute.\18\
---------------------------------------------------------------------------

    \18\ See Memorandum from Susan Shinkman, Director, Office of
Civil Enforcement, and Cynthia Mackey, Director, Office of Site
Remediation Enforcement, US EPA (June 29, 2015) (Guidance on
Evaluating a Violator's Ability to Pay a Civil Penalty in an
Administrative Enforcement Action); Memorandum from Barry Breen,
Director, Office of Site Remediation Enforcement, US EPA (Sep. 30,
1997) (General Policy on Superfund Ability to Pay Determinations).
---------------------------------------------------------------------------

    The interpretation that section 102(a) precludes the consideration
of cost in designation decisions is also supported by the Court of
Appeals for the D.C. Circuit. In Utility Solid Waste Activities Group
v. EPA, 901 F.3d 414 (D.C. Cir. 2018), the D.C. Circuit, relying on
Michigan and American Trucking, upheld EPA's decision that it should
not have considered cost in establishing requirements under the
Resource Conservation and Recovery Act (RCRA) for disposing of coal
combustion residuals because the statutory standard only addresses
``adverse effects on health or the environment'' without mentioning
costs or including other language that could encompass cost.
    Based in part on Supreme Court decisions addressing statutory
interpretation and the D.C. Circuit's application of those decisions,
EPA proposes to interpret CERCLA section 102(a) as precluding
consideration of costs in hazardous substance designations.
b. Consistency With Statutory Structure
    The way CERCLA initially established the list of hazardous
substances shows that Congress did not intend for costs to be
considered in designation decisions. As noted above, CERCLA offers two
ways for a substance to be designated as hazardous. One is a finding
pursuant to CERCLA section 102. Another is the list of other statutory
provisions in CERCLA section 101(14) that identify hazardous and toxic
substances. In that section, Congress directed that the definition of

``hazardous substance'' includes all substances identified as hazardous
or toxic by Congress or EPA under other specified environmental
statutes:
     Clean Water Act section 311(b)(2)(A) hazardous substances;
     Resource Conservation and Recovery Act section 3001
hazardous wastes;
     Clean Water Act section 307(a) toxic pollutants;
     Clean Air Act section 112 hazardous air pollutants; and
     Toxic Substances Control Act section 7 imminently
hazardous chemical.

When EPA adds a substance or chemical for regulation under any of those
other statutory provisions, it also becomes a CERCLA hazardous
substance--without considering the resulting costs under CERCLA.
    In addition to the other statutory provisions listed above, CERCLA
section 101(14) also includes CERCLA section 102(a), which suggests it
should be interpreted in a manner similar to the other authorities on
the list. Under the other statutory provisions, that program's
compliance costs are not considered a factor or criteria in making
listing decisions,\19\ and the Agency proposes to interpret CERCLA
section 102(a) as similarly excluding consideration of cost.
---------------------------------------------------------------------------

    \19\ See, e.g., 42 U.S.C. 6921(a) (RCRA section 3001(a)); 42
U.S.C. 7412(b)(2) (Clean Air Act section 112(b)(2).
---------------------------------------------------------------------------

c. Costs
    While EPA proposes to interpret CERCLA section 102(a) as excluding
consideration of cost in a designation decision, the Agency is
soliciting comment on that interpretation and, if costs should be
considered, how they should be considered. See section IV.B.2.d. below.
    EPA has estimated parties' potential direct costs associated with
this designation decision (from reporting releases); they are
relatively small and would not impede a designation decision even if
the Agency were required to consider costs.
    It is impractical, however, to quantitatively assess the indirect
costs (for response actions) associated with a designation decision
because of the uncertainty about such costs at this early stage in in
the process. However, a qualitative discussion of indirect costs and
benefits, as well as details explaining the impracticality of
quantitative estimates are contained in the Economic Assessment of the
Potential Costs and Other Impacts of the Proposed Rulemaking to
Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as
Hazardous Substances.\20\ Possible indirect costs could arise from an
increased number of sites identified, assessed and/or remediated, and
from associated research and development. In addition, economic costs
could be offset by savings from faster and more efficient response
actions. Possible indirect benefits could include reduced health
effects such as cancer, immunological problems, high cholesterol, and
thyroid disorders resulting from earlier and greater numbers of
response actions due to release reporting, and application of enhanced
response authority.
---------------------------------------------------------------------------

    \20\ U.S. EPA (2022) Economic Assessment of the Potential Costs
and Other Impacts of the Proposed Rulemaking to Designate
Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as Hazardous
Substances.
---------------------------------------------------------------------------

    A designation alone does not require the EPA to take response
actions, does not require any response action by a private party, and
does not determine liability for hazardous substance release response
costs.
    Response actions are contingent, discretionary, and site-specific
decisions made after a hazardous substance release or threatened
release. They are contingent upon a series of separate discretionary
actions and meeting certain statutory and regulatory requirements, as
explained above. In addition, future discretionary decisions about
cleanup and response are difficult to quantify due to numerous,
significant uncertainties such as: (1) How many sites have PFOA or PFOS
contamination at a level that warrants a cleanup action; (2) the extent
and type of PFOA and PFOS contamination at/near sites; (3) the extent
and type of other contamination at/near sites; (4) the incremental cost
of assessing and remediating the PFOA and/or PFOS contamination at/near
these sites; and (5) the cleanup level required for these substances.
d. Request for Comment
    EPA proposes to interpret CERCLA section 102(a) as prohibiting the
Agency from considering cost as part of its decision to designate
hazardous substances, EPA is taking comment on its approach to the
consideration of costs, including: (1) Whether CERCLA section 102(a)
precludes, allows, or requires consideration of cost in designation
decisions, and, if so, (2) which costs and benefits of those discussed
in the EA should be considered, (3) whether additional benefits and
costs not identified in the EA should be considered, (4) if indirect
benefits and costs are considered, how they should be assessed in light
of the discretion and uncertainties described above, (5) how benefits
and costs could be incorporated into the designation decision, and (6)
whether designation would be justified if costs were to be considered
in the Agency's designation decision. In addition, the Economic
Assessment of the Potential Costs and Other Impacts of the Proposed
Rulemaking to Designate Perfluorooctanoic Acid and
Perfluorooctanesulfonic Acid as Hazardous Substances includes requests
for comments on several topics related to indirect costs that EPA does
not currently have robust information about. Please see Section ES-5 of
the Economic Assessment for specific details.

V. Designation of PFOA, PFOS, and Their Salts and Structural Isomers as
Hazardous Substances

A. Introduction

    The EPA is proposing to designate PFOA and PFOS as hazardous
substances because significant evidence indicates that they satisfy the
statutory criteria set forth in CERCLA section 102(a):
    (1) They are ``substances'' as described in section IV.B.;
    (2) They may be ``released into the environment'' as described in
section IV.B.;
    (3) They may present substantial danger as described in section V;
and
    (4) That danger is ``to the public health or welfare or the
environment'' as described in section V.
    While EPA acknowledges that the science regarding PFOA and PFOS
human health and environmental effects is still evolving, a significant
body of scientific evidence shows that PFOA and PFOS are persistent and
mobile in the environment, and that exposure to PFOA and PFOS may lead
to adverse human health effects. Assessments conducted by EPA, other
Federal, state, Tribal and international agencies, academia, non-profit
organizations and the private sector support the conclusion that PFOA
and PFOS warrant a hazardous substance designation. This conclusion is
based on the factors considered by EPA in this proposal, which, as
noted above, included the potential human health or environmental
hazards associated with exposure to PFOA and PFOS and the environmental
fate and transport of PFOA and PFOS. The evidence for concern about
PFOA and PFOS includes:

 Chemical/Physical Characteristics
 Toxicity and Toxicokinetics

 Environmental Prevalence

    Each of the above evidence categories are discussed in more detail
below. PFOA and PFOS hazardous substance designation would be
consistent with and supportive of many other actions taken by EPA,
other Federal agencies, states, Tribal Nations and international
bodies. These entities have set PFOA and PFOS benchmarks and standards
and have undertaken PFOA- and PFOS-based regulatory activities and
enforcement actions. Details are provided below.

B. What is the evidence for designation of PFOA and PFOS as hazardous
substances?

    A significant collection of evidence and actions support
designating PFOA and PFOS as hazardous substances under CERCLA section
102(a). EPA is proposing that, when released into the environment, PFOA
and PFOS may present substantial danger to the public health or welfare
or the environment. What follows are brief summaries and not a
comprehensive review of the available literature.
1. Chemical/Physical Characteristics
    PFOA and PFOS are persistent chemicals that bioaccumulate, and
exposure to PFOA and PFOS may cause adverse human health effects. PFOA
and PFOS are distinctive from many other bioaccumulative chemicals
because their water-solubility allows them to migrate readily from soil
to groundwater. If PFOA and PFOS are released into the environment,
they can contaminate surface water and groundwater used as drinking
water sources and persist for long periods of time, thereby posing a
direct threat to human health and the environment.
    PFOA is comprised of eight carbons, seven of which are fully
fluorinated, and the eighth carbon is part of a carboxylic acid group.
PFOA is considered a surfactant (i.e., a substance that tends to reduce
the surface tension of a liquid in which it is dissolved) due to its
chemical structure consisting of a hydrophobic perfluorinated alkyl
``tail group'' and a hydrophilic carboxylate ``head
group''.21 22 As a result of the head group, PFOA is water
soluble, which contributes to its tendency to be found in groundwater.
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    \21\ ChEBI. (2017). ChEBI:35549--perfluorooctanoic acid.
Chemical Entities of Biological Interest. European Molecular Biology
Laboratory, European Bioinformatics Institute. https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:35549.
    \22\ Lindstrom, AB; Strynar, MJ; Libelo, EL. (2011).
Polyfluorinated compounds: past, present, and future. Environ Sci
Technol 45: 7954-7961. https://www.ncbi.nlm.nih.gov/pubmed/21866930.
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    PFOA is produced and used mainly as ammonium perfluorooctanoate
(APFO), a salt of PFOA, that may include both linear and branched
isomers. APFO's isomeric composition depends on the manufacturing
processes used. The APFO that is produced through the perfluorooctyl
iodide oxidation process, commonly called telomerization, is >99
percent linear, and the APFO that is produced by the ECF process is >70
percent linear with the remaining <30 percent a mixture of branched
isomers.23 24 As a result, there are different PFOA
structural isomers that may be released and found in the environment.
Analytical chemistry methods used to detect and measure PFOA may
measure the different isomers separately.
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    \23\ European Commission. (2015). Analysis of the risks arising
from the industrial use of perfluorooctanoic acid (PFOA) and
ammonium perfluorooctonate (APFO) and from their use in consumer
articles. Evaluation and risk reduction measures for potential
restrictions on the manufacture, placing on the market and use of
PFOA and APFO. (TOX08.7049). European Commission, Enterprise and
Industry Directorate--General. https://ec.europa.eu/docsroom/documents/13037/attachments/1/translations/en/renditions/pdf.
    \24\ Buck, RC; Franklin, J; Berger, U; Conder, JM; Cousins, IT;
de Voogt, P; Jensen, AA; Kannan, K; Mabury, SA; van Leeuwen, SP.
(2011). Perfluoroalkyl and polyfluoroalkyl substances in the
environment: terminology, classification, and origins. Integr
Environ Assess Manag 7: 513-541. https://www.ncbi.nlm.nih.gov/pubmed/21793199.
---------------------------------------------------------------------------

    PFOS has a fully fluorinated eight-carbon linear or branched tail,
with a hydrophilic sulfonate functional head group attached to the
carbon tail. PFOS is manufactured from perfluorooctanesulfonyl fluoride
(POSF), which is produced through ECF. This process results in linear
and branched isomers of PFOS.\25\ PFOS is often produced as its
potassium salt. Like PFOA, PFOS is water soluble, which is why it can
be found in groundwater.
---------------------------------------------------------------------------

    \25\ OECD. (2002). Hazard assessment of perfluorooctane
sulfonate (PFOS) and its salts. Environment Directorate, Joint
Meeting of the Chemicals Committee and the Working Party on
Chemicals, Pesticides and Biotechnology, Co-operation on Existing
Chemicals. (ENV/JM/RD(2002)17/FINAL. JT00135607). Organisation for
Economic Co-operation and Development. https://www.oecd.org/env/ehs/risk-assessment/2382880.pdf.
---------------------------------------------------------------------------

    As noted above, PFOA and PFOS contain carbon atoms bonded to
fluorine atoms. These carbon-fluorine bonds are strong, causing PFOA
and PFOS to be extremely resistant to degradation in the environment
(including biodegradation, photolysis and hydrolysis) and, thus, likely
to persist for long periods of time.26 27
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    \26\ U.S. EPA. (2016). Drinking water health advisory for
perfluorooctanoic acid (PFOA). (EPA822R16005). U.S. Environmental
Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_health_advisory_final_508.pdf.
    \27\ U.S. EPA. (2016). Drinking water health advisory for
perfluorooctane sulfonate (PFOS). (EPA822R16004). U.S. Environmental
Protection Agency. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_health_advisory_final_508.pdf.
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    These chemical and physical characteristics of PFOA and PFOS, when
viewed in combination with the information that follows, supports this
proposed designation of these chemicals as CERCLA hazardous substances.
2. Toxicity and Toxicokinetics
    Exposure to PFOA and PFOS is associated with a variety of adverse
human health effects. Human studies have found associations between
PFOA and/or PFOS exposure and effects on the immune system, the
cardiovascular system, human development (e.g., decreased birth
weight), and cancer. EPA continues to conduct extensive evaluations of
human epidemiological and experimental animal study data to support the
development of a PFAS National Primary Drinking Water Regulation. In
November 2021, EPA released draft updated health effects analyses for
PFOA and PFOS; these analyses are undergoing Science Advisory Board
(SAB) review. EPA evaluated over 400 peer-reviewed studies published
since 2016 and used new approaches, tools, and models to identify and
evaluate the information. Based on the new data and draft analyses, the
levels at which negative health effects could occur are much lower than
previously understood when EPA issued the 2016 Health Advisories for
PFOA and PFOS (70 ppt).
    The following discussion is based on information and conclusions
from the EPA 2016 Health Effects Support Documents for PFOA \28\ and
PFOS \29\ and other published peer reviewed science. The weight of
scientific evidence presented in the Health Effects Support Documents
for PFOA \30\ and

PFOS \31\ and supporting documents for the Regulatory Determination 4
process \32\ supports the conclusion that exposure to PFOA and PFOS can
lead to adverse human health effects. As part of the final Regulatory
Determination 4 process, the Agency concluded that exposure to PFOA and
PFOS may have adverse health effects.\33\
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    \28\ U.S. EPA. (2016). Health effects support document for
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency,
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \29\ U.S. EPA. (2016). Health effects support document for
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
    \30\ U.S. EPA. (2016). Health effects support document for
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency,
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \31\ U.S. EPA. (2016). Health effects support document for
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
    \32\ U.S. EPA. (2021). Final regulatory determination 4 support
document. (EPA815R21001). U.S. Environmental Protection Agency.
    \33\ Ibid.
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    Data from human and animal studies indicate that PFOA and PFOS are
well absorbed via the oral route and are distributed throughout the
body by noncovalent binding to serum albumin and other plasma proteins.
PFOA and PFOS are slowly eliminated from the human body as evidenced by
the half-life of 2.1-10.1 years for PFOA and 3.3-27 years for PFOS.\34\
Because of their resistance to metabolic degradation, PFOA and PFOS are
eliminated from mammals primarily unchanged.
---------------------------------------------------------------------------

    \34\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
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    Human epidemiology studies observed associations between PFOA
exposure and high cholesterol, changes in liver enzymes, decreased
immune response to vaccination, thyroid effects, pregnancy-induced
hypertension and preeclampsia, low birth weight, and cancer (testicular
and kidney).\35\ Epidemiology studies have generally found a positive
association between increasing serum PFOA and total cholesterol levels
in PFOA-exposed workers and residents of high-exposure communities. In
addition, associations between increasing serum PFOA concentrations and
elevations in serum levels of alanine aminotransferase and gamma-
glutamyl transpeptidase were consistently observed in occupational
cohorts, high-exposure communities and the U.S. general population.
This could indicate the potential for PFOA to affect liver function. A
decreased response to vaccines was found to be associated with PFOA
exposure in studies in adults in a highly exposed community and in
studies of children in the general population. 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. An association
between increasing maternal PFOA or cord blood PFOA concentrations and
decreasing birth weight was seen in several studies.\36\
---------------------------------------------------------------------------

    \35\ Ibid.
    \36\ U.S. EPA. (2016). Health effects support document for
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency,
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
---------------------------------------------------------------------------

    Numerous epidemiology studies have examined occupational
populations at large-scale PFOS production plants in the United States
and the residential populations living near the PFOS production
facilities to evaluate the association between increasing PFOS
concentrations and various health outcomes. Data also suggest
associations between higher PFOS levels and increases in total
cholesterol and high-density lipoproteins, decreases in female
fecundity and fertility, in addition to decreased offspring body
weights and negative effects on other measures of postnatal growth.
Evidence of an association between PFOS exposure and cancer is less
conclusive.\37\
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    \37\ U.S. EPA. (2016). Health effects support document for
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
---------------------------------------------------------------------------

    Perfluoroalkyl acids are transferred to the fetus during pregnancy
and to breast milk through distribution due to their slow elimination
from the human body through excretion.\38\ 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 animal models 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.39 40 41
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    \38\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \39\ Ibid.
    \40\ U.S. EPA. (2016). Health effects support document for
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency,
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \41\ U.S. EPA. (2016). Health effects support document for
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
---------------------------------------------------------------------------

    Numerous animal toxicity studies for PFOA and PFOS are available
and provide information about the potential for similar effects in
humans. Animal studies and epidemiology studies indicate that PFOA and
PFOS are well absorbed orally; absorption may also occur via the
inhalation and dermal routes. Absorbed PFOA and/or PFOS are widely
distributed in the body, with the highest concentrations typically
found in the blood, liver and/or kidney. Across species, the highest
extravascular concentrations of PFOA and PFOS are found in the liver,
however, PFOA and/or PFOS have also been detected in many other tissues
(e.g., lung, kidney, spleen and bone). Though not readily, PFOS can
cross the blood-brain barrier and has been detected at low levels in
the brains of humans and rodents.42 43 44
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    \42\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \43\ U.S. EPA. (2016). Health effects support document for
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency,
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \44\ U.S. EPA. (2016). Health effects support document for
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
---------------------------------------------------------------------------

    PFOA and PFOS in blood bind to plasma albumin and other plasma
proteins. Absorbed PFOA and PFOS are not metabolized and are eliminated
by excretion primarily in urine. Active transport mechanisms mediate
renal tubular reabsorption and secretion of PFOA and PFOS. Some
excretion occurs through cord blood in pregnant women, and through
lactation and menstrual blood loss. Although PFOA and PFOS are found in
the bile of humans, they are reabsorbed from the bile and thus, fecal
excretion is substantially lower than urinary excretion; levels in
fecal matter represent both unabsorbed material and that discharged
with bile.45 46 47 48 49
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    \45\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \46\ U.S. EPA. (2016). Health effects support document for
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency,
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \47\ U.S. EPA. (2016). Health effects support document for
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
    \48\ NJDWQI. (2017). Appendix A: Health-based maximum
contaminant level support document perfluorooctanoic acid (PFOA).
New Jersey Drinking Water Quality Institute, Health Effects
Subcommittee. https://www.state.nj.us/dep/watersupply/pdf/pfoa-appendixa.pdf.
    \49\ NJDWQI. (2018). Appendix A: Health-based maximum
contaminant level support document perfluorooctane sulfonate (PFOS).
New Jersey Drinking Water Quality Institute, Health Effects
Subcommittee. https://www.state.nj.us/dep/watersupply/pdf/pfos-recommendation-appendix-a.pdf.

---------------------------------------------------------------------------

    For PFOA, oral studies of short-term (subchronic) and chronic
duration are available in multiple species including monkeys, rats and
mice. The animal studies report developmental effects, liver and kidney
toxicity, immune effects and cancer (liver, testicular and pancreatic).
The developmental effects observed in rodents include decreased
survival, delayed eye opening, reduced ossification, skeletal defects,
altered puberty (delayed vaginal opening in females and accelerated
puberty in males) and altered mammary gland development.
    For PFOS, numerous animal studies are available in multiple species
including monkeys, rats and mice. Short-term and chronic exposure
studies in animals demonstrate increases in liver weight, changes in
cholesterol, hepatic steatosis, lower body weight and liver
histopathological changes. One- and two- generation rodent toxicity
studies also show decreased pup survival and body weights.
Additionally, developmental neurotoxicity studies in rodents show
increased motor activity, decreased habituation and increased escape
latency in the water maze test (tests spatial learning and memory)
following in utero and lactational exposure to PFOS. Gestational and
lactational exposures were also associated with higher serum glucose
levels and evidence of insulin resistance in adult offspring. Evidence
suggests immunological effects in animal models.50 51
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    \50\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \51\ U.S. EPA. (2016). Health effects support document for
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
---------------------------------------------------------------------------

    The International Agency for Research on Cancer (IARC) concluded
that PFOA is possibly carcinogenic to humans.\52\ Study findings are
mixed. While a mutagenic mode of action has not been established for
PFOA or PFOS, studies indicate that PFOA (the more extensively studied
of the two compounds) can induce deoxyribonucleic acid (DNA)
damage.\53\ In 2016, the EPA determined there is suggestive evidence
that PFOA and PFOS may contribute to tumor development in
humans.54 55 Epidemiology studies show an association
between exposure to high levels of serum PFOA and testicular and kidney
cancer in humans; two chronic bioassays in rats 56 57 also
support the finding that PFOA is tumorigenic (i.e., capable of
producing tumors).\58\ Epidemiology studies establishing a correlation
between PFOS exposure and the incidence of cancer are limited; however,
a chronic toxicity and carcinogenicity study in rats provides some
evidence of tumorigenicity.\59\
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    \52\ IARC. (2021). Agents classified by the IARC monographs,
volumes 1-129. List of classifications. International Agency for
Research on Cancer. https://monographs.iarc.who.int/list-of-classifications.
    \53\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \54\ U.S. EPA. (2016). Health effects support document for
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency,
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \55\ U.S. EPA. (2016). Health effects support document for
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
    \56\ NTP. (2020). NTP Technical report on the toxicology and
carcinogenesis studies of perfluorooctanoic acid (CASRN 335-67-1)
administered in feed to Sprague Dawley (Hsd:Sprague Dawley[supreg]
SD[supreg]) rats. (NTP TR 598). Research Triangle Park, NC: National
Toxicology Program. https://ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/tr598_508.pdf?utm_source=direct&utm_medium=prod&utm_campaign=ntpgolinks&utm_term=tr598.
    \57\ Butenhoff, J.L.; Kennedy, G.L.; Chang, S.; Olsen, G.W.
(2012). Chronic dietary toxicity and carcinogenicity study with
ammonium perfluorooctanoate in Sprague Dawley rats. Toxicology 298:
1-13.
    \58\ U.S. EPA. (2016). Health effects support document for
perfluorooctanoic acid (PFOA). U.S. Environmental Protection Agency,
Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
    \59\ U.S. EPA. (2016). Health effects support document for
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection
Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
---------------------------------------------------------------------------

    This information does not reflect recent scientific data that has
been collected to support EPA's ongoing PFAS National Primary Drinking
Water Regulation. The Agency's draft new analyses, released in November
2021 for independent scientific review by the EPA Science Advisory
Board (SAB), indicate that negative health effects may occur at much
lower levels of exposure to PFOA and PFOS than previously understood
and that PFOA is likely carcinogenic to humans. The draft documents
present EPA's initial analysis and findings with respect to this newly
available updated information.60 61 Following SAB peer
review, the final documents will be used to inform the development of
Maximum Contaminant Level Goals and ultimately a National Primary
Drinking Water Regulation for PFOA and PFOS. While this preliminary
data was not used for this proposal, it appears to support designating
PFOA and PFOS as hazardous substances.
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    \60\ U.S. EPA. (2021). Proposed approaches for deriving maximum
contaminant level goals for PFOA in drinking water. (EPA822D21001).
U.S. Environmental Protection Agency.
    \61\ U.S. EPA. (2021). Proposed approaches for deriving maximum
contaminant level goals for PFOS in drinking water. (EPA822D21002).
U.S. Environmental Protection Agency.
---------------------------------------------------------------------------

    In sum, studies have shown that exposure to PFOA and PFOS is
associated with numerous and varied adverse effects to human health.
This evidence plays a major role in the EPA's proposal to designate
PFOA and PFOS as hazardous substances.
3. Environmental Prevalence
    PFOA and PFOS are common contaminants in the environment because of
their release into the environment since the 1940s and their resistance
to degradation. PFOA and PFOS are found in many environmental media and
in wildlife worldwide, including in remote polar regions. As an
example, the polar bear, the top predator of arctic marine ecosystems,
bioaccumulates high concentrations of PFAS (especially PFOS), which may
be harmful to their health.\62\
---------------------------------------------------------------------------

    \62\ Tartu, S.; Bourgeon, S.; Aars, J.; Andersen, M.; Lone, K.;
Jenssen, B.M.; Polder, A.; Thiemann, G.W.; Torget, V.; Welker, J.M.;
Routti, H. (2017). Diet and metabolic state are the main factors
determining concentrations of perfluoroalkyl substances in female
polar bears from Svalbard. Environ Pollut 229: 146-158. https://www.ncbi.nlm.nih.gov/pubmed/28587979. Tartu et al. (2017) found that
the concentration of PFAS increased with the trophic level of female
polar bears, which is consistent with other studies showing
biomagnification of PFAS in Arctic marine ecosystems.
---------------------------------------------------------------------------

    Environmental sources can include direct industrial discharges of
PFOA and PFOS to soil, air, and water. Precursors 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. PFOA and
PFOS that are deposited, created by the degradation of their precursors
in industrial and consumer

waste, in a landfill without environmental controls can discharge via
leachates, groundwater pollution/migration and atmospheric
releases.63 64 65 The discharge of aqueous film-forming foam
(AFFF) starting in the 1970s is also an important source for some
locations. AFFF is a foam containing many PFAS, including PFOA and
PFOS, which is effective at extinguishing petroleum fueled fires. PFAS,
including PFOA and PFOS, were found in the soil and groundwater where
AFFF was used to fight fires or for training and storage. Concrete
where AFFF has been repeatedly discharged, such as for training
activities, can absorb PFAS, including PFOA and PFOS, and then release
PFAS to groundwater and soils during precipitation events.\66\
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    \63\ Lindstrom, A.B.; Strynar, M.J.; Libelo, E.L. (2011).
Polyfluorinated compounds: past, present, and future. Environ Sci
Technol 45: 7954-7961. https://www.ncbi.nlm.nih.gov/pubmed/21866930.
    \64\ Buck, R.C.; Franklin, J.; Berger, U.; Conder, J.M.;
Cousins, I.T.; de Voogt, P.; Jensen, A.A.; Kannan, K.; Mabury, S.A.;
van Leeuwen, S.P. (2011). Perfluoroalkyl and polyfluoroalkyl
substances in the environment: terminology, classification, and
origins. Integr Environ Assess Manag 7: 513-541. https://www.ncbi.nlm.nih.gov/pubmed/21793199.
    \65\ Oliaei, F.; Kriens, D.; Weber, R.; Watson, A. (2013). PFOS
and PFC releases and associated pollution from a PFC production
plant in Minnesota (USA). Environ Sci Pollut Res Int 20: 1977-1992.
https://www.ncbi.nlm.nih.gov/pubmed/23128989.
    \66\ Baduel, C.; Paxman, C.J.; Mueller, J.F. (2015).
Perfluoroalkyl substances in a firefighting training ground (FTG),
distribution and potential future release. J. Hazard Mater 296: 46-
53. https://www.ncbi.nlm.nih.gov/pubmed/25966923.
---------------------------------------------------------------------------

    Industrial uses that have led to PFOA and PFOS in the soil and
groundwater include, but are not limited to, chrome plating facilities
where PFAS were used as a wetting agent/fume suppressant and industries
where textiles and other materials are coated with PFAS. PFAS
manufactured for use as a stain or water repellant may be released from
these facilities into the air and wastewater.\67\
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    \67\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
---------------------------------------------------------------------------

    The principal worldwide manufacturers of PFOA and PFOS and related
chemicals phased out their production in the early 2000's. PFOA and
PFOS may still be produced domestically for certain uses and by
international companies that import treated products to the United
States.\68\ Some uses of PFOS are ongoing, such as use as a component
of a photoresist substance, including a photo acid generator or
surfactant, or as a component of an anti-reflective coating, used in a
photomicrolithography process to produce semiconductors or similar
components of electronic or other miniaturized devices. Environmental
contamination and resulting human exposure to PFOA and PFOS are
declining, but are anticipated to continue for the foreseeable future
due to their environmental persistence, formation from precursor
compounds, continued production primarily by international
manufacturers and their long history of production in the United
States.\69\
---------------------------------------------------------------------------

    \68\ Ibid.
    \69\ (ATSDR) Per- and Polyfluoroalkyl Substances (PFAS) and Your
Health U.S. Department of Health and Human Services, Centers for
Disease Control and Prevention, Agency for Toxic Substances and
Disease Registry. https://www.atsdr.cdc.gov/pfas/health-effects/us-population.html.
---------------------------------------------------------------------------

    Wastewater treatment plants (WWTPs) may receive wastewater that
contains PFOA, PFOS or their precursors, from a variety of sources,
including industries that manufacture or use these PFAS and their
precursors. Some companies may operate onsite wastewater treatment
facilities, but typically they are not designed to remove PFAS. PFOA
and PFOS are the most widely detected PFAS in wastewater, and generally
treatment units at conventional WWTPs do not remove PFAS
efficiently.\70\ Certain PFAS can be volatilized into the atmosphere
from wastewater treatment plant operations, such as aeration
chambers.71 72 Although effluent discharged to receiving
water bodies may contain PFOA or PFOS, much of these substances may
concentrate in the WWTP biosolids. Biosolids are also commonly applied
to land as fertilizers or soil amendments but can also be sent to a
landfill. The use of biosolids on farmland and home gardens can lead to
the uptake of PFOA and PFOS in the food chain, as acknowledged by the
U.S. Food and Drug Administration (FDA).\73\ Biosolids from wastewater
treatment plants and some industrial wastewater that is land applied
are also potential sources of contamination.74 75
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    \70\ Rainey, M.; Beecher, N. (2018). PFAS in wastewater
residuals. National Pretreatment & Pollution Prevention Workshop &
Training. North East Biosolids & Residuals Association. https://www.nacwa.org/docs/default-source/conferences-events/2018-pretreatment/18pret-m-rainey.pdf?sfvrsn=2.
    \71\ Ma, R.; Shih, K. (2010). Perfluorochemicals in wastewater
treatment plants and sediments in Hong Kong. Environ Pollut 158:
1354-1362. https://www.ncbi.nlm.nih.gov/pubmed/20153098.
    \72\ Ahrens, L.; Shoeib, M.; Harner, T.; Lee, S.C.; Guo, R.;
Reiner, E.J. (2011). Wastewater treatment plant and landfills as
sources of polyfluoroalkyl compounds to the atmosphere. Environ Sci
Technol 45: 8098-8105. https://www.ncbi.nlm.nih.gov/pubmed/21466185.
    \73\ Genualdi, S.; deJager, L.; South, P.; Sheehan, J.; Begley,
T. (2019). Investigation of PFAS concentrations in US food products.
Center for Food Safety and Applied Nutrition, Food and Drug
Administration. In SETAC Europe 29th annual meeting 26-30 May 2019
(pp. 357). Helsinki, Finland: Society of Environmental Toxicology
and Chemistry.
    \74\ NJDWQI. (2018). Appendix A: Health-based maximum
contaminant level support document perfluorooctane sulfonate (PFOS).
New Jersey Drinking Water Quality Institute, Health Effects
Subcommittee. https://www.state.nj.us/dep/watersupply/pdf/pfos-recommendation-appendix-a.pdf.
    \75\ NJDWQI. (2017). Appendix A: Health-based maximum
contaminant level support document perfluorooctanoic acid (PFOA).
New Jersey Drinking Water Quality Institute, Health Effects
Subcommittee. https://www.state.nj.us/dep/watersupply/pdf/pfoa-appendixa.pdf.
---------------------------------------------------------------------------

    PFAS have been found in outdoor air at locations in the United
States, Europe, Japan, and over the Atlantic Ocean.\76\ Concentrations
are not generally correlated with rural or urban environments, but
rather, around PFAS production industries and industries that use PFAS.
Mean PFOA levels ranged from 1.54 to 15.2 picograms per cubic meter
(pg/m\3\) in air samples collected in the urban locations in Albany,
New York, Fukuchiyama, Japan, and Morioka, Japan and in the rural
locations in Kjeller, Norway, and Mace Head, Ireland. However, higher
mean concentrations (101-552 pg/m\3\) were measured at the urban
locations in Oyamazaki, Japan, and Manchester, United Kingdom (UK), and
semirural locations in Hazelrigg, UK. Maximum reported concentrations
at Oyamazaki and Hazelrigg were 919 and 828 pg/m\3\, respectively.
Thus, there is no correlation between higher concentrations and urban
versus rural locations; rather, high concentrations in certain
locations may be attributable to a specific industrial plant.\77\
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    \76\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://www.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=1117&tid=237.
    \77\ Ibid.
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    PFOA and PFOS are widely detected in surface water samples
collected from various rivers, lakes, and streams in the United
States.\78\ Therefore, municipalities and other entities that use
surface water sources for drinking water may face challenges treating
and removing PFOA and PFAS from their finished drinking water. The most
vulnerable drinking water systems are those in close proximity to sites
contaminated with PFOA and PFOS.\79\ Levels of these substances in
surface water are declining since the major U.S.

producers phased out these two substances.\80\
---------------------------------------------------------------------------

    \78\ Ibid.
    \79\ Ibid.
    \80\ Ibid.
---------------------------------------------------------------------------

    PFOA and PFOS have been detected in surface and subsurface soils.
Levels of PFOA and PFOS generally increased with increasing depth at
sampled locations, suggesting a downward movement of the contaminants
and the potential to contaminate groundwater.\81\ PFAS can be
inadvertently released to soils when biosolids are applied as
fertilizer to help maintain productive agricultural soils and stimulate
plant growth.\82\ PFOA and PFOS have been detected in both biosolids
and biosolid-amended soils. PFAS can also reach soil due to atmospheric
transport and wet/dry deposition.\83\
---------------------------------------------------------------------------

    \81\ Ibid.
    \82\ Ibid.
    \83\ Ibid.
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    PFOA and PFOS have been detected in groundwater in monitoring
wells, private drinking water wells, and public drinking water systems
across the country. The EPA worked with the states and local
communities to monitor for six PFAS, including PFOA and PFOS, under the
third Unregulated Contaminant Monitoring Rule 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 were detected above the minimum reporting level
(minimum reporting level = 20 nanogram/liter (ng/L)) in 117 PWSs.
Detections exceeded above the MRL for PFOS (MRL = 40 ng/L) at 95
PWSs.\84\
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    \84\ U.S. EPA. (2017). The third Unregulated Contaminant
Monitoring Rule (UCMR 3): Data summary, January 2017.
(EPA815S17001). U.S. Environmental Protection Agency, Office of
Water. https://www.epa.gov/sites/default/files/2017-02/documents/ucmr3-data-summary-january-2017.pdf.
---------------------------------------------------------------------------

    As previously stated, PFOA and PFOS are common contaminants in the
environment because they and their precursors have been produced and
released into the environment since the 1940s, and they are resistant
to degradation. In addition to being found in groundwater, surface
water, soil, sediment, and air, they have been found in wild and
domestic animals such as fish, shellfish, alligators, deer and avian
eggs; and in humans.\85\ 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.86 87 88 89 90 91 92 93 94 95 In one study
investigating the global distribution of PFAS, wildlife samples were
collected on four continents including North America and Antarctica.
Wildlife sampled included marine mammals, birds, and polar bears. Only
a few samples contained PFOA in concentrations greater than the limit
of quantification. However, over 30 different species had measurable
levels of PFOS. The study reported PFOS concentrations in mink liver in
the midwestern U.S. ranging from 970-3, 680 nanograms per gram (ng/g),
river otter liver in northwestern U.S. from 34-990 ng/g, brown pelican
liver in Mississippi from 290-620 ng/g, and lake whitefish eggs in
Michigan waters from 150-380 ng/g.96 97
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    \85\ ATSDR. (2021). Toxicological profile for perfluoroalkyls:
final. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, Agency for Toxic
Substances and Disease Registry. https://www.atsdr.cdc.gov/pfas/health-effects/us-population.html.
    \86\ U.S. EPA. (2016). Drinking water health advisory for
perfluorooctanoic acid (PFOA). (EPA822R16005). U.S. Environmental
Protection Agency, Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_health_advisory_final_508.pdf.
    \87\ U.S. EPA. (2016). Drinking water health advisory for
perfluorooctane sulfonate (PFOS). (EPA822R16004). U.S. Environmental
Protection Agency. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_health_advisory_final_508.pdf.
    \88\ Holmstrom, K.E.; Jarnberg, U.; Bignert, A. (2005). Temporal
trends of PFOS and PFOA in guillemot eggs from the Baltic Sea, 1968-
2003. Environ Sci Technol 39: 80-84. https://www.ncbi.nlm.nih.gov/pubmed/15667078.
    \89\ Wang, Y.; Yeung, L.W.Y.; Yamashita, N.; Taniyasu, S.; So,
M.K.; Murphy, M.B.; Lam, P.K.S. (2008). Perfluorooctane sulfonate
(PFOS) and related fluorochemicals in chicken egg in China. Chinese
Science Bulletin 53: 501-507.
    \90\ Gewurtz, S.B.; Martin, P.A.; Letcher, R.J.; Burgess, N.M.;
Champoux, L.; Elliott, J.E.; Weseloh, D.V.C. (2016). Spatio-temporal
trends and monitoring design of perfluoroalkyl acids in the eggs of
gull (Larid) species from across Canada and parts of the United
States. Sci Total Environ 565: 440-450. https://www.ncbi.nlm.nih.gov/pubmed/27183458.
    \91\ Morganti, M.; Polesello, S.; Pascariello, S.; Ferrario, C.;
Rubolini, D.; Valsecchi, S.; Parolini, M. (2021). Exposure
assessment of PFAS-contaminated sites using avian eggs as a
biomonitoring tool: A frame of reference and a case study in the Po
River valley (Northern Italy). Integr Environ Assess Manag 17: 733-
745. https://www.ncbi.nlm.nih.gov/pubmed/33764673.
    \92\ Michigan.gov. (2021). Michigan PFAS Action Response Team:
Fish and wildlife. PFAS in deer. Michigan Department of Environment,
Great Lakes, and Energy. https://www.michigan.gov/pfasresponse/
0,9038,7-365-86512_88981_88982_,00.html.
    \93\ Wisconsin DNR. (2020). DNR And DHS issue do not eat
advisory for deer liver in five-mile area surrounding JCI/TYCO site
in Marinette. Wisconsin Department of Natural Resources. https://dnr.wisconsin.gov/newsroom/release/37921.
    \94\ Falk, S.; Brunn, H.; Schroter-Kermani, C.; Failing, K.;
Georgii, S.; Tarricone, K.; Stahl, T. (2012). Temporal and spatial
trends of perfluoroalkyl substances in liver of roe deer (Capreolus
capreolus). Environ Pollut 171: 1-8. https://www.ncbi.nlm.nih.gov/pubmed/22868342.
    \95\ Bangma, J.T.; Reiner, J.L.; Jones, M.; Lowers, R.H.;
Nilsen, F.; Rainwater, T.R.; Somerville, S.; Guillette, L.J.;
Bowden, J.A. (2017). Variation in perfluoroalkyl acids in the
American alligator (Alligator mississippiensis) at Merritt Island
National Wildlife Refuge. Chemosphere 166: 72-79. https://www.ncbi.nlm.nih.gov/pubmed/27689886.
    \96\ Giesy, J.P.; Kannan, K. (2001). Global distribution of
perfluorooctane sulfonate in wildlife. Environ Sci Technol 35: 1339-
1342. https://www.ncbi.nlm.nih.gov/pubmed/11348064.
    \97\ EFSA. (2008). Perfluorooctane sulfonate (PFOS),
perfluorooctanoic acid (PFOA) and their salts Scientific Opinion of
the Panel on Contaminants in the Food chain. EFSA Journal 6.
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    PFOS bioaccumulates in animals. A fish kinetic bioconcentration
factor for PFOS has been estimated to range from 1,000 to 4,000.\98\
The time to reach 50% clearance of PFOS in fish has been estimated to
be around 100 days.\99\ Bioaccumulation has been demonstrated for fish,
birds, crustaceans, worms, plankton, and alligators, among
others.100 101 102
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    \98\ Ibid.
    \99\ Ibid.
    \100\ Bangma, J.T.; Reiner, J.L.; Jones, M.; Lowers, R.H.;
Nilsen, F.; Rainwater, T.R.; Somerville, S.; Guillette, L.J.;
Bowden, J.A. (2017). Variation in perfluoroalkyl acids in the
American alligator (Alligator mississippiensis) at Merritt Island
National Wildlife Refuge. Chemosphere 166: 72-79. https://www.ncbi.nlm.nih.gov/pubmed/27689886.
    \101\ Ng, C.A.; Hungerbuhler, K. (2014). Bioaccumulation of
perfluorinated alkyl acids: observations and models. Environ Sci
Technol 48: 4637-4648. https://www.ncbi.nlm.nih.gov/pubmed/24762048.
    \102\ Burkhard, L.P. (2021). Evaluation of published
bioconcentration factor (BCF) and bioaccumulation factor (BAF) data
for per- and polyfluoroalkyl substances across aquatic species.
Environ Toxicol Chem 40: 1530-1543. https://www.ncbi.nlm.nih.gov/pubmed/33605484.
---------------------------------------------------------------------------

    PFOA bioaccumulates as well, but not to the same degree as
PFOS.\103\
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    \103\ https://setac.onlinelibrary.wiley.com/doi/epdf/10.1002/etc.5010.
---------------------------------------------------------------------------

    The prevalence of PFOA and PFOS in environmental media, wild
animals, livestock, and plants not only affects the environment but can
also lead to human exposure. PFOA and PFOS can also 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. Wild animals
are contaminated through environmental exposure, and some wild animals
are caught or hunted and eaten by humans, thus, increasing human
exposure. Contaminated water also results in the contamination of 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.104 105 106
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    \104\ U.S. EPA. (2019). Fish and shellfish program newsletter.
(EPA823N19002). U.S. Environmental Protection Agency. https://www.epa.gov/sites/production/files/2019-04/documents/fish-news-mar2019.pdf.
    \105\ FDA. (2021). Testing food for PFAS and assessing dietary
exposure. U.S. Food and Drug Administration. https://www.fda.gov/food/chemical-contaminants-food/testing-food-pfas-and-assessing-dietary-exposure.
    \106\ Christensen, K.Y.; Raymond, M.; Blackowicz, M.; Liu, Y.;
Thompson, B.A.; Anderson, H.A.; Turyk, M. (2017). Perfluoroalkyl
substances and fish consumption. Environ Res 154: 145-151. https://www.ncbi.nlm.nih.gov/pubmed/28073048.

---------------------------------------------------------------------------

    Human exposure is confirmed by measurements of PFOA and PFOS that
were detected in human serum as part of the continuous National Health
and Nutrition Examination Survey (NHANES), a program of the CDC. 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.
However, the mean concentrations of PFOA and PFOS in the serum have
been steadily decreasing since 1999-2000.107 108
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    \107\ CDC. (2021). National Health and Nutrition Examination
Survey: NHANES questionnaires, datasets, and related documentation.
Centers for Disease Control and Prevention. https://wwwn.cdc.gov/nchs/nhanes/Default.aspx.
    \108\ U.S. EPA. (2019). EPA's per- and polyfluoroalkyl
substances (PFAS) action plan. (EPA823R18004). U.S. Environmental
Protection Agency. https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=P100W32I.txt.
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    Taken together, this information illustrates the prevalence of PFOA
and PFOS in water, soil, air, plants, and animals worldwide due to its
transportability and persistence. This widespread distribution of these
PFAS significantly contributes to the EPA's proposed finding that PFOA
and PFOS, when released into the environment may present substantial
danger to the public health or welfare or the environment.
    EPA's proposal to designate PFOA and PFOS, and their salts and
structural isomers, as hazardous substances under CERCLA section 102(a)
is based on significant evidence, summarized above, that indicates,
when released into the environment, these substances may present
substantial danger to the public health, welfare or the environment.
Collectively, this information demonstrates that PFOA and PFOS should
be designated as hazardous substances under CERCLA.

VI. Effect of Designation

    The designation of PFOA and PFOS would have three direct effects--
triggering reporting obligations when there is a release of PFOA or
PFOS above the reportable quantity, obligations on the U.S. Government
when it transfers certain properties, and an obligation on DOT to list
and regulate CERCLA designated hazardous substances as hazardous
materials.

A. Default Reportable Quantity

    Section 102(b) of CERCLA provides that, until superseded by
regulation, the reportable quantity for any hazardous substance is one
pound. This proposed rule does not include an RQ adjustment for PFOA or
PFOS. EPA is setting the RQ by operation of law at the statutory
default of one pound pursuant to Section 102(b) of CERCLA. If the
Agency chooses to propose adjusting the RQ in the future, it would do
so through notice-and-comment rulemaking.

B. Direct Effects of a Hazardous Substance Designation

1. Reporting and Notification Requirements for CERCLA Hazardous
Substances
    Section 103 of 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, as defined under CERCLA section 101(14), in an
amount equal to or greater than the RQ for that substance. The
reporting requirements are further codified in 40 CFR 302.6. If this
action is finalized, any person in charge of a vessel or facility as
soon as he or she has knowledge of a release from such vessel or
facility of one pound or more of PFOA or PFOS in a 24-hour period is
required to immediately notify the NRC in accordance with 40 CFR part
302. EPA solicits comment on the number of small entities affected by
and the estimated cost impacts on small entities from these reporting
requirements.
    In addition to these CERCLA reporting requirements, EPCRA section
304 also requires owners or operators of facilities to immediately
notify their SERC (or TERC) and LEPC (or TEPC) when there is a release
of a CERCLA hazardous substance in an amount equal to or greater than
the RQ for that substance within a 24-hour period. EPCRA section 304
requires these facilities to submit a follow-up written report to the
SERC (or TERC) and LEPC (or TEPC) within 30 days of the release. (Note:
Some states provide less than 30 days to submit the follow-up written
report. Facilities are encouraged to contact the appropriate state or
tribal agency for additional reporting requirements.) See 40 CFR part
355, subpart C, for information on the contents for the initial
telephone notification and the follow-up written report.
    EPCRA and CERCLA are separate, but interrelated, environmental laws
that work together to provide emergency release notifications to
Federal, state, Tribal, and local officials. 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 in
accordance with the National Oil and Hazardous Substances Contingency
Plan, the Federal government's framework for responding to both oil and
hazardous substance releases. The NRC maintains all reports of
hazardous substance and oil releases made to the Federal government.
    Relatedly, release notifications under EPCRA given to the SERC (or
TERC) and to the LEPC (or TEPC) are crucial so that these state,
Tribal, and local authorities have information to help protect the
community.
2. Requirements Upon Transfer of Government Property
    Under CERCLA section 120(h), when Federal agencies sell or transfer
federally-owned, real property, they must provide notice of when any
hazardous substances ``was stored for one year or more, known to have
been released, or disposed of'' and covenants concerning the
remediation of such hazardous substances in certain circumstances.
3. Requirement of DOT To List and Regulate CERCLA Hazardous Substances
    Section 306(a) of CERCLA requires substances designated as
hazardous under CERCLA be listed and regulated as hazardous materials
by DOT under the Hazardous Materials Transportation Act (HMTA). DOT
typically does not undertake a public notice and comment period when
adding a CERCLA-designated hazardous substance to the list of regulated
hazardous materials under HMTA.

VII. Regulatory and Advisory Status at EPA, Other Federal, State and
International Agencies

    Designating PFOA and PFOS as hazardous substances would be one
additional piece of an extensive, widespread response to address the
dangers these chemicals pose. Regulatory requirements, enforcement
actions, and other activities of many Federal, state, and international
entities together indicate the widespread and serious concern with PFOA
and PFOS.

A. EPA Actions

    The EPA has taken several actions in the past to address risks from
PFOA and PFOS. In 2006, the EPA launched the 2010/2015 PFOA Stewardship
Program, under which eight major chemical manufacturers and processors
agreed to phase out the use of PFOA and PFOA-related chemicals in their
products and emissions from their facilities. All companies met the
PFOA Stewardship Program goals by 2015.
    The TSCA program has taken a range of regulatory actions to address
PFAS in manufacturing and consumer products. Since 2002, EPA has
finalized a number of TSCA Section 5(a) Significant New Use Rules
(SNURs) covering hundreds of existing PFAS no longer in use. These
regulatory actions require notice to EPA, as well as Agency review and
regulation, as necessary, before manufacture (including import) or
processing for significant new uses of these chemicals can begin or
resume. The SNURs also apply to imported articles containing certain
PFAS, including consumer products such as carpets, furniture,
electronics, and household appliances. EPA also has issued SNURs for
dozens of PFAS that have undergone EPA's new chemicals review prior to
commercialization; these actions ensure that any new uses which may
present risk concerns but were not part of the EPA new chemicals
review, do not commence unless EPA is notified, conducts a risk review,
and regulates as appropriate under TSCA section 5.
    In 2009, EPA published provisional drinking water health advisories
of 400 ppt for PFOA and 200 ppt for PFOS based on health effects
information available at that time. The provisional health advisories
were developed for application to short-term (weeks to months) risk
assessment exposure scenarios. The provisional health advisories were
intended as guidelines for public water systems while allowing time for
EPA to develop final lifetime health advisories for PFOA and PFOS. EPA
published final lifetime drinking water health advisories for PFOA and
PFOS (70 ppt individually, and in combination) in 2016.
    New health information has become available since 2016, and in June
2022, EPA replaced the 2016 advisories with interim updated lifetime
health advisories for PFOA and PFOS based on human epidemiology studies
in populations exposed to these chemicals. Based on the new data and
EPA's draft analyses, the levels at which negative health effects could
occur are much lower than previously understood when EPA issued the
2016 health advisories for PFOA and PFOS. The interim updated health
advisory levels are 0.004 ppt for PFOA and 0.02 ppt for PFOS, which are
below the levels at which analytical methods can measure these PFAS in
drinking water. The EPA Science Advisory Board is reviewing EPA's
analyses, and therefore, the interim health advisories are subject to
change. However, EPA does not anticipate changes that will result in
health advisory levels that are greater than the minimum reporting
levels. The interim health advisories are intended to provide
information to states and public water systems until the PFAS National
Primary Drinking Water Regulation takes effect. Health advisories
provide drinking water system operators, and state, Tribal, and local
officials who have the primary responsibility for overseeing these
systems, with information on the health risks of these chemicals, so
they can take the appropriate actions to protect their residents.
    In 2019, EPA issued the Interim Recommendations to Address
Groundwater Contaminated with PFOA and PFOS to facilitate cleaning up
contaminated groundwater that is a current or potential source of
drinking water. The recommendations provide a starting point for making
site-specific cleanup decisions. The guidance recommends: \109\
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    \109\ U.S. EPA. (2019). USEPA draft interim recommendations to
address groundwater contaminated with perfluorooctanoic acid and
perfluorooctane sulfonate. (EPA-HQ-OLEM-2019-0229-0002). U.S.
Environmental Protection Agency. https://downloads.regulations.gov/EPA-HQ-OLEM-2019-0229-0002/content.pdf.
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     Use the following tapwater screening levels for PFOA and
PFOS to determine if PFOA and/or PFOS is present at a site and may
warrant further attention.
    [cir] If both are detected in tapwater--PFOS regional screening
level (RSL) = 6 parts per trillion (ppt) and PFOS regional removal
management levels (RMLs) = 4 ppt.
    [cir] If they are the only contaminant detected in tapwater--PFOA
RSL = 60 ppt and PFOS RSL = 40 ppt.
    [cir] Screening levels are risk-based values that are used to
determine if levels of contamination may warrant further investigation
at a site.
     Using EPA's 2016 PFOA and PFOS LHA level of 70 ppt as the
preliminary remediation goal (PRG) for contaminated groundwater that is
a current or potential source of drinking water, where no state or