[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Proposed Rules]
[Pages 54415-54442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 703-346-9536; 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
[[Page 54416]]
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.
[[Page 54417]]
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
[[Page 54418]]
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
[[Page 54419]]
(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
[[Page 54420]]
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''
[[Page 54421]]
(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.''
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\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,
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\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
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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
[[Page 54422]]
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.
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\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.
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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\
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\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).
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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
[[Page 54423]]
``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.
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\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).
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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.
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\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.
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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
[[Page 54424]]
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.
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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.
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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
[[Page 54425]]
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.
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\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\
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\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.
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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.
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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.
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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.
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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.
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[[Page 54426]]
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.
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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.
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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.
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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\
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\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.
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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
[[Page 54427]]
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.
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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.
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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\
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\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.
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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.
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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.
[[Page 54428]]
producers phased out these two substances.\80\
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\78\ Ibid.
\79\ Ibid.
\80\ Ibid.
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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\
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\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.
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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.
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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.
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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.
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[[Page 54429]]
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.
[[Page 54430]]
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
tribal maximum contaminant level (MCL) or other applicable or relevant
and appropriate requirements are available or sufficiently protective.
[cir] PRGs are generally initial targets for cleanup that may be
adjusted on a site-specific basis as more information becomes
available.
In 2020, the EPA issued a final rule strengthening the regulation
of PFAS (i.e., PFOA and its salts, long-chain perfluoroalkyl
carboxylate chemical substances) by requiring notice and EPA review
before the use of long-chain PFAS that have been phased out in the
United States could begin again. Additionally, products containing
certain long-chain PFAS as a surface coating and carpet containing
perfluoroalkyl sulfonate chemical substances can no longer be imported
into the United States without EPA review. This action means that
articles like textiles, carpet, furniture, electronics, and household
appliances that could contain certain PFAS cannot be imported into the
United States unless EPA reviews and approves the use or puts in place
the necessary restrictions to address any unreasonable risks.
In 2020, the EPA also added 172 PFAS (including PFOA and PFOS) to
the TRI, and 3 additional compounds were added in 2021. Additional PFAS
will continue to be added to TRI, consistent with the National Defense
Authorization Act for Fiscal Year 2020.
In October 2021, the EPA released the PFAS Strategic Roadmap that
presents EPA's whole-of-agency approach to addressing PFAS and sets
timelines by which the Agency plans to take concrete actions.\110\
Several actions described in the roadmap, including this proposed rule,
address PFOA and PFOS. Other ongoing EPA actions on PFOA and PFOS
include:
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\110\ U.S. EPA. (2021). PFAS strategic roadmap: EPA's
commitments to action 2021-2024. U.S. Environmental Protection
Agency. https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf.
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Finalizing a proposed rule that would impose certain
reporting and recordkeeping requirements under TSCA for PFAS, including
PFOA and PFOS, manufactured at any time since January 1, 2011 (86 FR
33926).
Finalizing the proposed Unregulated Contaminant Monitoring
Rule 5 (UCMR5). As proposed, UCMR5 would collect data on 29 PFAS,
including PFOA and PFOS, in public water systems (86 FR 13846).
Establishing a national primary drinking water regulation
for PFOA and PFOS under the Safe Drinking Water Act.
Publishing recommended aquatic life water quality criteria
for PFOA and
[[Page 54431]]
PFOS (draft criteria were released for public comment in May 2022) and
developing human health water quality criteria for PFOA and PFOS.
Finalizing a risk assessment for PFOA and PFOS in
biosolids, which will serve as the basis for determining whether
regulation of PFOA and PFOS in biosolids is appropriate.
Further, based on public health and environmental protection
concerns, and in response to a petition from the Governor of New
Mexico, which requested EPA to take regulatory action on PFAS under
RCRA, EPA announced on October 26, 2021, the initiation of two
rulemakings. First, EPA will initiate the rulemaking process to propose
adding four PFAS as RCRA hazardous constituents under 40 CFR part 261
Appendix VIII, by evaluating the existing data for these chemicals and
establishing a record to support such a proposed rule. The four PFAS
EPA will evaluate are: PFOA, PFOS, perfluorobutane sulfonic acid (PFBS)
and GenX chemicals (hexafluoropropylene oxide (HFPO) dimer acid and its
ammonium salt). Second, EPA will initiate a rulemaking to clarify in
the Agency's regulations that the RCRA Corrective Action Program has
the authority to require investigation and cleanup for wastes that meet
the statutory definition of hazardous waste, as defined under RCRA
section 1004(5). This modification would clarify that emerging
contaminants such as PFAS can be addressed through RCRA corrective
action.
Recent scientific data and the Agency's new analyses 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 Agency's new analyses were released in
November 2021 111 112 for independent scientific review by
the EPA Science Advisory Board. The draft documents present EPA's
initial analysis and findings with respect to this new information.
EPA's 2021 draft non-cancer reference doses based on human epidemiology
studies for various effects (e.g., developmental/growth, cardiovascular
health outcomes, immune health) range from ~10-7 to
10-9 milligram per kilogram per day (mg/kg/day). These draft
reference doses are two to four orders of magnitude lower than EPA's
2016 reference doses for PFOA and PFOS of 2 x 10-5 mg/kg/
day. Following peer review, this information will be used to inform
updated EPA drinking water health advisories and the development of
Maximum Contaminant Level Goals and a National Primary Drinking Water
Regulation for PFOA and PFOS.
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\111\ U.S. EPA (U.S. Environmental Protection Agency). 2021a.
External Peer Review Draft: Proposed Approaches to the Derivation of
a Draft Maximum Contaminant Level Goal for Perfluorooctanoic Acid
(PFOA) (CASRN 335-67-1) in Drinking Water. EPA-822-D-21-001. EPA,
Office of Water, Washington, DC. Accessed April 2022. https://sab.epa.gov/ords/sab/f?p=100:18:16490947993:::RP,18:P18_ID:2601.
\112\ U.S. EPA (U.S. Environmental Protection Agency). 2021b.
External Peer Review Draft: Proposed Approaches to the Derivation of
a Draft Maximum Contaminant Level Goal for Perfluorooctane Sulfonic
Acid (PFOS) CASRN 1763-23-1 in Drinking Water. EPA-822-D-21-002.
EPA, Office of Water, Washington, DC. Accessed April 2022. https://sab.epa.gov/ords/sab/f?p=100:18:16490947993:::RP,18:P18_ID:2601.
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The EPA routinely updates RSLs and RMLs two times per year. EPA's
next regularly scheduled update to the RSL and RML tables will be in
November 2022. Since the science of PFAS toxicity is evolving we expect
to update the numbers as appropriate during future updates.
B. Actions by Other Federal Agencies
ATSDR: The Agency for Toxic Substances and Disease
Registry (ATSDR), in response to a congressional mandate under CERCLA,
develops comparison values to help identify chemicals that may be of
concern to the public's health at hazardous waste sites. The ATSDR's
guideline values are minimal risk levels (MRLs). An MRL is an estimate
of the amount of a chemical a person can eat, drink, or breathe each
day over a specified duration without a detectable risk to health. MRLs
are developed for health effects other than cancer. If someone is
exposed to an amount above the MRLs, it does not mean that health
problems will happen. MRLs are a screening tool that help identify
exposures that could be potentially hazardous to human health. Exposure
above the MRLs does not mean that health problems will occur. Instead,
it may act as a signal to health assessors to look more closely at a
particular site where exposures may be identified.
The ATSDR works closely with EPA at both a national and regional
level to determine areas and populations potentially at risk for health
effects from exposure to PFAS.\113\ The ATSDR has final intermediate
duration (15-364 days) MRLs (2021) for PFOA and PFOS which are 3 x
10-6 mg/kg/day and 2 x 10-6 mg/kg/day,
respectively.\114\ ATSDR also has a PFAS strategy, exposure
assessments, and a multi-site study--PFAS Cooperative Agreement.
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\113\ ATSDR. (2018). Minimal risk levels (MRLs). Atlanta, GA:
Agency for Toxic Substances and Disease Registry. https://www.atsdr.cdc.gov/minimalrisklevels/.
\114\ 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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DoD: The Department of Defense (DoD) included PFOA and
PFOS on its list of emerging chemicals of concern.\115\ The DoD defines
emerging chemicals as chemicals or materials that the department
currently uses or plans to use that present a potentially unacceptable
human health or environmental risk; have a reasonably possible pathway
to enter the environment; and either do not have regulatory standards
based on peer-reviewed science, or their regulatory standards are
evolving due to new science, detection capabilities or exposure
pathways.\116\
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\115\ DoD. (2019). DoD instruction 4715.18: Emerging chemicals
(ECs) of environmental concern. U.S. Department of Defense. https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/471518p.pdf?ver=2017-12-13-110558-727.
\116\ Ibid.
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In 2017, the DoD updated their military specification for AFFF to
include no more than 800 parts per billion, the quantitation limit by
DoD Quality Systems Manual 5.1, of PFOA and PFOS in the
concentrate.\117\ The DoD is working to remove AFFF containing PFOA and
PFOS from the supply chain.\118\ ``In January 2016, the Office of the
Assistant Secretary of Defense for Energy, Installations and
Environment issued a policy requiring the DoD components to: (1) issue
Military Service-specific risk management procedures to prevent
uncontrolled land-based releases of AFFF during maintenance, testing
and training activities, and (2) remove and properly dispose of AFFF
containing PFOS from the local stored supplies for non-shipboard use to
prevent future environmental response action costs, where
practical''.\119\ Under this policy,
[[Page 54432]]
for example, the Air Force funded the removal of AFFF from all fire
trucks and crash response vehicles and replaced it with PFOS-free AFFF,
which contains only trace quantities of PFOA. All Air Force bases
except Thule Air Force Base, Greenland, have received replacement AFFF,
and 97 percent of the bases have completed the transition. In addition,
the Navy is updating the military specification requirements for AFFF
and DoD continues its research efforts to find a PFAS-free alternative
to AFFF.\120\ DoD has also set up a taskforce to address PFAS on and
near military bases from DoD activities.
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\117\ U.S. Navy. (2017). Performance specification fire
extinguishing agent, aqueous film-forming foam (AFFF) liquid
concentrate, for fresh and sea water. (MIL-PRF-24385F(SH) w/
Amendment 2). U.S. Navy, Naval Sea Systems Command (Ship Systems).
https://quicksearch.dla.mil/Transient/E3EA5BB276A741A292E87C18DE644702.pdf https://quicksearch.dla.mil/Transient/C26F946AAE39463BBFCB321B047611E4.pdf.
\118\ WH.gov. (2021). Fact sheet: President Biden signs
executive order catalyzing America's clean energy economy through
federal sustainability. Washington, DC: The White House. https://www.whitehouse.gov/briefing-room/statements-releases/2021/12/08/fact-sheet-president-biden-signs-executive-order-catalyzing-americas-clean-energy-economy-through-federal-sustainability/.
\119\ DoD. (2017). Aqueous film forming foam: Report to
Congress. U.S. Department of Defense, Office of the Under Secretary
of Defense for Acquisition, Technology and Logistics. https://www.denix.osd.mil/derp/home/documents/aqueous-film-forming-foam-report-to-congress/Aqueous%20Film%20Forming%20Foam%20(AFFF)%20Report%20to%20Congress_DEN
IX.PDF.
\120\ DoD. (2020). Per- and polyfluoroalkyl substances (PFAS)
Task Force progress report. U.S. Department of Defense. https://media.defense.gov/2020/Mar/13/2002264440/-1/-1/1/PFAS_Task_Force_Progress_Report_March_2020.pdf.
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DoD is investing over $49 million through fiscal year 2025 in
research, development, testing, and evaluation in collaboration with
academia and industry to identify alternative firefighting material and
practices. In the meantime, DoD only uses AFFF to respond to emergency
events and no longer uses it for uncontained land-based testing and
training.\121\
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\121\ Ibid.
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In addition, DoD has initiated other actions to test for,
investigate, and mitigate elevated levels of PFOA and PFOS at or near
installations across the military departments. Following the release of
EPA's LHAs for PFOA and PFOS in May 2016, each of the military
departments issued guidance directing installations to test for PFOA
and PFOS in their drinking water and take steps to address drinking
water that contained amounts of PFOA and PFOS above EPA's health
advisory level. The military departments also directed their
installations to identify locations with a known or suspected prior
release of PFOA and PFOS and to address any releases that pose a risk
to human health.\122\ As of December 31, 2021, the DoD was performing
the PA/SI for PFAS at 700 DoD installations and National Guard
Facilities.
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\122\ Ibid.
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DOE: On September 16, 2021, the Department of Energy (DOE)
issued a memo that focused on four main points; discontinue use of AFFF
except in emergencies, suspend disposal of AFFF pending further
guidance, establish reporting requirements for any release or spill of
PFAS and establish a DOE PFAS Coordinating Committee. DOE has completed
an assessment of its PFAS usage and inventory across the department and
is in the process of developing a department wide report of the results
of that assessment. At the request of Council on Environmental Quality,
DOE, as well as other agencies and departments, is developing a PFAS
Roadmap similar to EPA's that will guide future PFAS related actions
for 2022-2025.FAA: On January 17, 2019, the Federal Aviation
Administration (FAA) released guidance in the form of a CertAlert to
all certificated Part 139 Aircraft Rescue and Firefighting departments
regarding safer methods for the required bi-annual testing of AFFF for
firefighting. In the guidance, the FAA suggests alternative AFFF
testing systems that minimize environmental impact while still
satisfying the regulatory requirement for safety testing. The
recommendations include addressing environmental concerns such as
establishing safe and environmentally effective handling and disposal
procedures.\123\
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\123\ FAA. (2019). National part 139 CertAlert: Aqueous film
forming foam (AFFF) testing at certificated part 139 airports. (No.
19-01). Federal Aviation Administration. https://www.faa.gov/airports/airport_safety/certalerts/media/part-139-cert-alert-19-01-AFFF.pdf.
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On October 4, 2021, the FAA published a CertAlert which informs
Part 139 airport operators about changes to the military specification
(MIL-PRF-24385F(SH)) for firefighting foam referenced in Chapter 6 of
AC No.: 150/5210-6D. While the performance standard remains the same,
the military specification no longer requires the use of fluorinated
chemicals. One acceptable means of satisfying 14 CFR part 139
requirements is to continue to use the existing approved foam which
does contain fluorinated chemicals. However, FAA encourages certificate
holders that have identified a different foam that meets the
performance standard to seek approval for such foam from the FAA.\124\
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\124\ FAA. (2021). National part 139 CertAlert: Part 139
extinguishing agent requirements. (No. 21-05). Federal Aviation
Administration. https://www.faa.gov/airports/airport_safety/certalerts/media/part-139-cert-alert-21-05-Extinguishing-Agent-Requirements.pdf.
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FDA: In 2011, FDA reached voluntary agreements with
manufacturers and suppliers of long chain PFAS subject to Food Contact
Notification to no longer sell those substances for use in food contact
applications. In 2016, the FDA revoked the regulations authorizing the
remaining uses of these long-chain PFAS in food packaging (see 81 FR 5,
January 4, 2016, and 81 FR 83672, November 22, 2016). As of November
2016, long-chain PFAS are no longer used in food contact applications
sold in the United States.\125\
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\125\ https://www.fda.gov/food/chemical-contaminants-food/authorized-uses-pfas-food-contact-applications.
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In addition to EPA, a number of agencies including ATSDR, DoD, DOI,
DOT, FDA, and USDA Have or are developing PFAS plans outlining how
their agencies will address PFAS contamination.
C. State Actions
As concerns have arisen regarding PFOA and PFOS many states have
taken regulatory action.
In addition to some of the states discussed in more detail below,
Alabama, Arizona, Idaho, Kentucky, Nebraska, and West Virginia have
opted to use EPA's 2016 LHAs of 70 ppt for PFOA and
PFOS.126 127 128 129
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\126\ Pontius, F. (2019). Regulation of perfluorooctanoic acid
(PFOA) and perfluorooctane sulfonic acid (PFOS) in drinking water: A
comprehensive review. Water 11: 2003.
\127\ Idaho DEQ. (2021). PFAS and Idaho drinking water. Idaho
Department of Environmental Quality. https://www.deq.idaho.gov/water-quality/drinking-water/pfas-and-idaho-drinking-water/.
\128\ Kentucky EEC. (2019). Evaluation of Kentucky community
drinking water for per- & poly-fluoroalkyl substances. Kentucky
Energy and Environment Cabinet, Department for Environmental
Protection. https://eec.ky.gov/Documents%20for%20URLs/PFAS%20Drinking%20Water%20Report%20Final.pdf.
\129\ AWWA. (2020). Per- and polyfluoroalkyl substances (PFAS):
summary of state policies to protect drinking water. American Water
Works Association. https://www.awwa.org/LinkClick.aspx?fileticket=nCRhtmGcA3k%3D&portalid=0.
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Alaska: The Alaska Department of Environmental
Conservation (ADEC) promulgated groundwater cleanup levels of 400 ppt
and soil cleanup levels of 1.3 to 2.2 milligram per kilogram (mg/kg)
(range depending on precipitation zone) for PFOA and PFOS,
respectively, in Oil and Other Hazardous Substances Pollution Control
Regulations as amended through June 2021.\130\ Health-based action
levels for drinking water of 70 ppt for PFOA and PFOS, individually or
combined, were established by ADEC in 2018 (updated in 2019) based on
EPA's 2016 LHAs.\131\
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\130\ Alaska DEC. (2021). Oil and other hazardous substances
pollution control. (Alaska Admin Code 18 AAC 75). Alaska Department
of Environmental Conservation. https://dec.alaska.gov/commish/regulations/.
\131\ Alaska DEC. (2019). Technical memorandum: Action levels
for PFAS in water and guidance on sampling groundwater and drinking
water. Alaska Department of Environmental Conservation. https://dec.alaska.gov/media/15773/pfas-drinking-water-action-levels-technical-memorandum-10-2-19.pdf.
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California: In August 2019, the California Office of
Environmental Health Hazard Assessment developed PFOA and PFOS toxicity
values
[[Page 54433]]
(acceptable daily doses) of 4.5 x 10-7 mg/kg-day and 1.8 x
10-6 mg/kg-day, respectively, and reference levels based on
cancer effects of 0.1 ppt and 0.4 ppt, respectively. They noted that
the levels are lower than the levels of PFOA and PFOS that can be
reliably detected in drinking water using currently available
technologies. Thus, they recommended that the State Water Resources
Control Board set notification limits at the lowest levels at which
PFOA and PFOS can be reliably detected in drinking water using
available and appropriate technologies.\132\ The California State Water
Resources Control Board issued new drinking water notification limits
for local water agencies to follow for finding and reporting PFOA and
PFOS of 5.1 ppt for PFOA and 6.5 ppt for PFOS. As part of these
guidelines, California also established a response level of 10 ppt for
PFOA and 40 ppt for PFOS.133 134 If this level is exceeded
in drinking water provided to consumers, California recommends that the
water agency remove the water source from service.\135\
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\132\ OEHHA. (2019). Notification level recommendations:
Perfluorooctanoic acid and perfluorooctane sulfonate in drinking
water. California Office of Environmental Health Hazard Assessment.
https://oehha.ca.gov/media/downloads/water/chemicals/nl/final-pfoa-pfosnl082119.pdf.
\133\ California Water Boards. (2020). Notification level
issuance: Contaminant(s): perfluorooctanoic acid (PFOA). State Water
Resources Control Board. California Water Boards. https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/documents/pfos_and_pfoa/pfoa_nl_issuance_jan2020.pdf.
\134\ California Water Boards. (2020). Notification level
issuance: Contaminant(s): perfluorooctanesulfonic acid (PFOS). State
Water Resources Control Board. California Water Boards. https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/documents/pfos_and_pfoa/pfos_nl_issuance_jan2020.pdf.
\135\ California Water Boards. (2020). Perfluorooctanoic acid
(PFOA) and perfluorooctanesulfonic acid (PFOS). State Water
Resources Control Board. California Water Boards. https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/PFOA_PFOS.html.
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In July 2021, the California Office of Environmental Health Hazard
Assessment released draft Public Health Goals (PHGs) for PFOA of 0.007
ppt based on human kidney cancer data and PFOS of 1 ppt based on liver
and pancreatic tumor animal data. PHGs are not regulatory requirements
and are based solely on protection of public health without regard to
cost impacts or other factors.\136\
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\136\ OEHHA. (2021). Public health goals: First public review
draft: Perfluorooctanoic acid and perfluorooctane sulfonic acid in
drinking water Office of Environmental Health Hazard Assessment.
California Environmental Protection Agency. https://oehha.ca.gov/sites/default/files/media/downloads/crnr/pfoapfosphgdraft061021.pdf.
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California is also conducting sampling efforts targeting airports,
chrome plating facilities, landfills, WWTPs and nearby water supply
wells.\137\
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\137\ California Water Boards. (2021). GeoTracker PFAS map.
State Water Resources Control Board. California Water Boards.
https://geotracker.waterboards.ca.gov/map/pfas_map.
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Colorado: To address known contamination in El Paso
County, the Colorado Water Quality Control Commission (WQCC) adopted a
site-specific groundwater quality standard of 70 ppt for PFOA and PFOS
combined in 2018 based on the EPA 2016 LHAs.138 139 By 2019,
the Colorado Department of Public Health and Environment adopted a PFAS
Action Plan outlining methods by which the state planned to protect
residents from PFAS. As part of this initiative, a survey was conducted
regarding the use of firefighting foams that resulted in rules with
respect to the registration and use of PFAS-containing foams.\140\ The
Colorado WQCC approved a policy interpreting the existing narrative
standards for PFAS in 2020. This policy outlines the use of translation
levels of 70 ppt for PFOA, PFOS, PFOA and PFOS parent constituents, and
perfluorononanoic acid (PFNA), individually or combined, based on the
EPA's 2016 LHAs.\141\
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\138\ CDPHE. (2017). Site-specific groundwater standard: PFOA/
PFOS. Colorado Department of Public Health & Environment. https://www.colorado.gov/pacific/sites/default/files/WQ_GWStandard_PFOA_100417%20FINAL.pdf.
\139\ CDPHE. (2020). Policy 20-1. Policy for interpreting the
narrative water quality: Standards for per- and polyfluoroalkyl
substances (PFAS). Colorado Department of Public Health &
Environment, Water Quality Control Commission. https://drive.google.com/file/d/119FjO4GZVaJtw7YFvFqs9pmlwDhDO_eG/view.
\140\ Coleman, C. (2020). Colorado enacts arsenal of laws to
stop ``forever chemicals''. Water Education Colorado. https://www.watereducationcolorado.org/fresh-water-news/colorado-enacts-arsenal-of-laws-to-stop-forever-chemicals/.
\141\ CDPHE. (2020). Policy 20-1. Policy for interpreting the
narrative water quality: Standards for per- and polyfluoroalkyl
substances (PFAS). Colorado Department of Public Health &
Environment, Water Quality Control Commission. https://drive.google.com/file/d/119FjO4GZVaJtw7YFvFqs9pmlwDhDO_eG/view.
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Connecticut has issued a drinking water action level of 70
ppt for PFOA, PFOS, PFNA, perfluorohexanesulfonic acid (PFHxS) and
perfluoroheptanoic acid (PFHpA) individually or combined. The action
level is based on risk and similar health effects of the five PFAS. An
interagency task force was formed that has recommended actions
including take-back and safe disposal of AFFF containing PFAS from
state and municipal fire departments.\142\
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\142\ CT Interagency PFAS Task Force. (2019). PFAS action plan.
Connecticut Interagency PFAS Task Force. Department of Public Health
& Department of Energy and Environmental Protection. https://portal.ct.gov/-/media/Office-of-the-Governor/News/20191101-CT-Interagency-PFAS-Task-Force-Action-Plan.pdf.
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Delaware: Based on Delaware's Department of Natural
Resources and Environmental Control Hazardous Substance Cleaning Act
Screening Level Table Guidance (last updated in November 2021), a
screening/reporting level for PFOA and PFOS, individually or combined,
of 70 ppt in groundwater is based on EPA's 2016 LHAs; and a reporting/
screening level for PFOA and PFOS in the soil (of 0.13 mg/kg based on
screening document and 1.3 mg/kg based on the reporting level table) is
based on EPA's Regional Screening Level Calculator.143 144
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\143\ DNREC. (2021). Hazardous Substance Cleanup Act: Screening
level table guidance. Delaware Department of Natural Resources and
Environmental Control. https://documents.dnrec.delaware.gov/dwhs/remediation/HSCA-Screening-Level-Table-Guidance.pdf.
\144\ DNREC. (2021). Sortable HSCA reporting level table
(Excel). Delaware Department of Natural Resources and Environmental
Control. https://dnrec.alpha.delaware.gov/waste-hazardous/remediation/laws-regs-guidance/.
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Florida issued guidance identifying provisional
groundwater target cleanup levels of 70 ppt for PFOA and PFOS combined,
provisional soil cleanup target levels of 1.3 mg/kg for PFOA and PFOS,
and surface water screening levels of 500 ppt for PFOA and 10 ppt for
PFOS; these values were last updated in 2020.\145\
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\145\ Florida DEP. (2020). Provisional PFOA and PFOS cleanup
target levels & screening levels. Florida Department of
Environmental Protection. https://floridadep.gov/waste/district-business-support/documents/provisional-pfoa-and-pfos-cleanup-target-levels-screening.
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Hawaii: In 2020, Hawaii published a memorandum identifying
interim soil and water and soil environmental action levels (EALs) for
PFAS. For groundwater that is a current potential source of drinking
water, groundwater EALs are 40 ppt for PFOA and PFOS. Soil EALs are
0.0012 mg/kg for PFOA and 0.0075 mg/kg for PFOS.\146\
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\146\ Hawai'i DOH. (2020). Interim soil and water environmental
action levels (EALs) for perfluoroalkyl and polyfluoroalkyl
substances (PFASs). Hawaii State Department of Health. https://health.hawaii.gov/heer/files/2020/12/PFASs-Techncal-Memo-HDOH-Dec-2020.pdf.
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Illinois: By July 2021, Illinois EPA issued statewide
health advisories for six PFAS: PFOA, PFOS, PFNA, perfluorohexanoic
acid (PFHxA), PFHxS and PFBS. A health advisory is a regulatory action
that provides guidance to local officials and community water supply
operators in protecting the health of their customers. Illinois EPA is
authorized to issue a health advisory when there is a confirmed
detection in a community water supply well of a chemical substance for
which no
[[Page 54434]]
numeric groundwater standard exists. The health-based guidance level
for PFOA is 2 ppt and PFOS is 14 ppt.\147\ Illinois EPA is conducting a
statewide investigation into the prevalence and occurrence of PFAS in
finished water at entry points to the distribution system representing
1,749 community water supplies across Illinois.\148\
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\147\ Illinois EPA. (2021). PFAS statewide health advisory.
Illinois Environmental Protection Agency, Office of Toxicity
Assessment. https://www2.illinois.gov/epa/topics/water-quality/pfas/Pages/pfas-healthadvisory.aspx.
\148\ Illinois EPA. (2021). PFAS statewide investigation
network: Community water supply sampling. Illinois Environmental
Protection Agency, Office of Toxicity Assessment. https://www2.illinois.gov/epa/topics/water-quality/pfas/Pages/pfas-statewide-investigation-network.aspx.
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Iowa: The Iowa Department of Natural Resources issued
Statewide Standards for PFOA and PFOS in 2016. The standards were set
at 70 ppt for PFOA and PFOS for a protected groundwater source, and
50,000 ppt for PFOA and 1,000 ppt for PFOS for a non-protected
groundwater source. Statewide standards for soil are 35 mg/kg for PFOA
and 1.8 mg/kg for PFOS.\149\
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\149\ Iowa DNR. (2021). Cumulative risk calculator: Statewide
standards. Iowa Department of Natural Resources. https://programs.iowadnr.gov/riskcalc/Home/statewidestandards.
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Kansas: The Kansas Department of Health and Environment,
the Bureau of Environmental Remediation, and the Bureau of Water are
working together to address PFAS in drinking water. The process
involves the development of a statewide inventory and prioritization of
potential PFAS sources. This information will be used to develop a
public water supply monitoring program.\150\
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\150\ KDHE. (2021). Per- and polyfluoroalkyl substances (PFAS).
Kansas Department of Health and Environment. https://www.kdheks.gov/pws/PFAS.htm.
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Maine's Department of Environmental Protection requires
the testing of all sludge material licensed for land application in the
state for PFAS (including PFOA and PFOS). The governor created a task
force to mobilize state agencies and other stakeholders to review the
prevalence of PFAS in Maine.\151\ Maine Remedial Action Guidelines
(RAGs) for Sites Contaminated with Hazardous Substances (2018)
identified a water RAG of 400 ppt for PFOA and PFOS and a soils
(residential) RAG of 1.7 mg/kg for PFOA and PFOS.\152\ In June 2021,
the Governor also signed an emergency resolution establishing an
interim drinking water standard of 20 ppt for 6 PFAS. The resolution
also requires that the Maine Department of Health and Human Services
promulgate an MCL for PFAS by June 1, 2024.
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\151\ Maine EPA. (2021). Per- and polyfluoroalkyl substances
(PFAS). Maine Department of Environmental Protection Agency. https://www.maine.gov/dep/spills/topics/pfas/index.html.
\152\ Maine DEP. (2018). Maine remedial action guidelines (RAGs)
for sites contaminated with hazardous substances. Maine Department
of Environmental Protection. https://www.maine.gov/dep/spills/publications/guidance/rags/ME-Remedial-Action-Guidelines-10-19-18cc.pdf.
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Massachusetts: In December 2019, the Massachusetts
Department of Environmental Protection Office of Research and Standards
reassessed the toxicity information for a subgroup of longer chain
PFAS. They applied a revised reference dose (RfD) of 5 x
10-6 mg/kg-day to PFOA, PFOS, PFNA, PFHxS, PFHpA and
perfluorodecanoic acid (PFDA). This reassessment resulted in an MCL of
20 ppt, promulgated in October 2020.\153\ \154\ Also, PFAS are
considered to be hazardous material subject to the notification,
assessment and cleanup requirements of the Massachusetts Waste Site
Cleanup Program.\155\
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\153\ MassDEP. (2019). Technical support document: Per- and
polyfluoroalkyl substances (PFAS): An updated subgroup approach to
groundwater and drinking water values. Massachusetts Department of
Environmental Protection. https://www.mass.gov/files/documents/2019/12/27/PFAS%20TSD%202019-12-26%20FINAL.pdf.
\154\ MassDEP. (2020). 310 CMR 22: The Massachusetts drinking
water regulations. Massachusetts Department of Environmental
Protection, Drinking Water Program. https://www.mass.gov/doc/310-cmr-2200-the-massachusetts-drinking-water-regulations/download.
\155\ MassDEP. (2019). Final PFAS-related revisions to the MCP.
Massachusetts Department of Environmental Protection, Drinking Water
Program. https://www.mass.gov/lists/final-pfas-related-revisions-to-the-mcp-2019.
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Michigan derived a toxicity value of 3.9 x 10-6
mg/kg-day for PFOA and 2.89 x 10-6 mg/kg-day for PFOS.\156\
Michigan's public health drinking water MCLs are 8 ppt for PFOA and 16
ppt for PFOS, effective in August 2020. The Michigan PFAS Action
Response Team has coordinated many actions across the state. Michigan
Department of Health and Human Services has recommended people avoid
contaminant-induced foam occurring on certain PFAS-contaminated surface
water bodies and has initiated a PFAS Exposure and Health Study. The
Michigan Department of Environment, Great Lakes, and Energy began a
statewide initiative to test drinking water from all community water
supplies for PFAS and has been testing watersheds. Do not eat
advisories have also been issued for deer, fish, and other wildlife in
certain parts of the state.\157\ \158\ \159\ \160\ \161\ \162\
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\156\ Michigan.gov. (2022). Health-based drinking water value
recommendations for PFAS in Michigan. Michigan Department of
Environment, Great Lakes, and Energy. Science Advisory Workgroup.
https://www.michigan.gov/documents/pfasresponse/Health-Based_Drinking_Water_Value_Recommendations_for_PFAS_in_Michigan_Report_659258_7.pdf.
\157\ Michigan.gov. (2021). Michigan PFAS Action Response Team:
Investigations. Michigan Department of Environment, Great Lakes, and
Energy. https://www.michigan.gov/pfasresponse/0,9038,7-365-86511_-
,00.html.
\158\ Michigan.gov. (2021). Michigan PFAS Action Response Team:
Investigations: Watershed investigations. Michigan Department of
Environment, Great Lakes, and Energy. https://www.michigan.gov/
pfasresponse/0,9038,7-365-86511_95792_-,00.html.
\159\ Michigan.gov. (2018). Michigan PFAS Action Response Team:
Drinking water: Public drinking water: Statewide sampling
initiative: Statewide testing initiative. Michigan Department of
Environment, Great Lakes, and Energy. https://www.michigan.gov/
pfasresponse/0,9038,7-365-95571_95577_95587_-,00.html.
\160\ Michigan.gov. (2021). Michigan PFAS Action Response Team:
Fish and wildlife. Michigan Department of Environment, Great Lakes,
and Energy. https://www.michigan.gov/pfasresponse/0,9038,7-365-
86512_-,00.html.
\161\ Michigan.gov. (2021). Michigan PFAS Action Response Team:
MPART: Press releases: MDHHS recommends Michiganders avoid foam on
lakes and rivers. Michigan Department of Environment, Great Lakes,
and Energy. https://www.michigan.gov/pfasresponse/0,9038,7-365-
86513_96296-563821_y_2018,00.html.
\162\ Michigan.gov. (2020). Michigan PFAS Action Response Team:
MPART: Press releases: MDHHS announces launch of new PFAS health
study in impacted West Michigan communities. Michigan Department of
Environment, Great Lakes, and Energy. https://www.michigan.gov/
pfasresponse/0,9038,7-365-86513_96296-544808_y_2018,00.html.
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Minnesota's Department of Health (MDH) identified RfDs of
1.8 x 10-5 milligram/kilogram-day (mg/kg-day) for PFOA,
adopted as Rule in August 2018 \163\ and 3.1 x 10-6 mg/kg-
day for PFOS, adopted as Rule in August 2020.\164\ MDH developed
guidance values in drinking water of 35 ppt for PFOA and 15 ppt for
PFOS. The MDH is helping with drinking water well testing in certain
areas of the state. Due to PFAS contamination in surface water bodies
and levels of PFOS found in fish, the MDH has issued fish advisories
for certain surface water bodies. Minnesota's Pollution Control Agency
Toxics Reduction and Pollution Prevention program is working to reduce
PFAS in firefighting foam, chrome plating, and food packaging, with
related efforts in state and local government purchasing.\165\
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\163\ MDH. (2020). Toxicological summary for:
Perfluorooctanoate. Minnesota Department of Health. https://www.health.state.mn.us/communities/environment/risk/docs/guidance/gw/pfoa.pdf.
\164\ MDH. (2020). Toxicological summary for: Perfluorooctane
sulfonate. Minnesota Department of Health. https://www.health.state.mn.us/communities/environment/risk/docs/guidance/gw/pfos.pdf.
\165\ Minnesota PCA. (2022U.S.Navy). What is Minnesota doing
about PFAS? Minnesota Pollution Control Agency. https://www.pca.state.mn.us/waste/what-minnesota-doing-about-pfas.
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[[Page 54435]]
Montana Department of Environmental Quality set a
Groundwater Quality Standard for PFOA and PFOS, individually or
combined, of 70 ppt in 2019.\166\
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\166\ Montana DEQ. (2019). Circular DEQ-7. Montana numeric water
quality standards. Montana Department of Environmental Quality.
https://deq.mt.gov/files/Water/WQPB/Standards/PDF/DEQ7/DEQ-7.pdf.
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Nevada Division of Environmental Protection identified
basic comparison level values of 667 ppt for PFOA and PFOS in
residential water and 1.56 mg/kg in residential soil.\167\ Exceedance
of a basic comparison level does not automatically trigger a response
action but warrants further evaluation of health risks.\168\
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\167\ NDEP. (2017). Nevada Division of Environmental Protection
basic comparison levels. Nevada Division of Environmental
Protection. https://ndep.nv.gov/uploads/documents/july-2017-ndep-bcls.pdf.
\168\ Pontius, F. (2019). Regulation of perfluorooctanoic acid
(PFOA) and perfluorooctane sulfonic acid (PFOS) in drinking water: A
comprehensive review. Water 11: 2003.
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New Hampshire's Department of Environmental Services
recommended RfDs of 6.1 x 10-6 mg/kg/day and 3.0 x
10-6 mg/kg/day for PFOA and PFOS, respectively, in June
2019.\169\ New Hampshire has undertaken sampling for PFAS at water
supplies (including drinking water sources), wastewater treatment
plants, fire stations, landfills and contaminated waste sites to better
understand the scope of contamination in the state. The New Hampshire
Department of Environmental Services filed and finalized its rulemaking
to establish MCLs for PFOA of 12 ppt and PFOS of 15 ppt, as well as 11
ppt for PFNA and 18 ppt for PFHxS.\170\ The MCLs initially became
effective on September 30, 2019. However, on December 31, 2019, the
Merrimack County Superior Court issued a preliminary injunction barring
enforcement of the MCLs. The New Hampshire legislature subsequently
amended the New Hampshire Safe Drinking Water Act in July 2020
establishing the 4 PFAS MCLs.
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\169\ NHDES. (2019). Technical background report for the June
2019 proposed maximum contaminant levels (MCLs) and ambient
groundwater quality standards (AGQSs) for perfluorooctane sulfonic
acid (PFOS), perfluorooctanoic acid (PFOA), perfluorononanoic acid
(PFNA), and perfluorohexane sulfonic acid (PFHxS) and letter from
Dr. Stephen M. Roberts, Ph.D. dated 6/25/2019--findings of peer
review conducted on technical background report. New Hampshire
Department of Environmental Services. https://www4.des.state.nh.us/nh-pfas-investigation/wp-content/uploads/June-PFAS-MCL-Technical-Support-Document-FINAL.pdf.
\170\ NHDES. (2019). New Hampshire Code of Administrative Rules:
Section Env-Dw 701.03--Units of measure for maximum contaminant
levels (MCLs) and maximum contaminant level goals (MCLGs). New
Hampshire Department of Environmental Services. https://services.statescape.com/ssu/Regs/ss_8586370873779209008.pdf.
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New Jersey Department of Environmental Protection (NJDEP)
identified RfDs of 2 x 10-6 mg/kg-day for PFOA and 1.8 x
10-6 mg/kg-day for PFOS.171 172 On
June 1, 2020, the NJDEP published a health based MCL for PFOA of 14 ppt
and an MCL for PFOS of 13 ppt in the New Jersey Register. New Jersey
previously adopted an MCL for PFNA of 13 ppt on September 4, 2018. New
Jersey uses a risk assessment approach to protect for chronic drinking
water exposure when setting MCLs. The NJDEP also adopted these same
levels as formal groundwater quality standards for the purposes of site
remediation activities and discharges to groundwater.\173\ New Jersey
has added PFNA, PFOA and PFOS to its hazardous substances list.
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\171\ NJDWQI. (2017). Maximum contaminant level recommendation
for perfluorooctanoic acid in drinking water basis and background.
New Jersey Drinking Water Quality Institute. https://www.nj.gov/dep/watersupply/pdf/pfoa-recommend.pdf.
\172\ NJDWQI. (2017). Appendix A. Health-based maximum
contaminant level support document: perfluorooctanoic acid (PFOA).
New Jersey Drinking Water Quality Institute. https://www.nj.gov/dep/watersupply/pdf/pfoa-appendixa.pdf.
\173\ NJDEP. (2020). Ground water quality standards and maximum
contaminant levels (MCLs) for perfluorooctanoic acid (PFOA) and
perfluorooctanesulfonic acid (PFOS). New Jersey Department of
Environmental Protection. https://www.nj.gov/dep/rules/adoptions/adopt_20200601a.pdf.
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New Mexico Environment Department issued Risk Assessment
Guidance for Site Investigations and Remediation that identified
preliminary screening levels of 70 ppt for PFOA, PFOS, and PFHxS,
individually or combined, in drinking water and 1.56 mg/kg for PFOA,
PFOS, and PFHxS in residential soil in 2019.\174\
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\174\ NMED. (2019). Risk assessment guidance for site
investigations and remediation. Volume I. Soil screening guidance
for human health risk assessments. New Mexico Environment
Department. https://www.env.nm.gov/wp-content/uploads/sites/12/2016/11/Final-NMED-SSG-VOL-I_-Rev.2-6_19_19.pdf.
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New York regulates PFOA and PFOS as hazardous substances.
New York finalized regulations in 2017 that specify storage and
registration requirements for Class B firefighting foams containing at
least one percent by volume of one or more of four PFAS (including PFOA
and PFOS) and prohibits the release of one pound or more of each into
the environment during use. If a release meets or exceeds the one-pound
threshold, it is considered a hazardous waste spill and must be
reported, and cleanup may be required under the state's Superfund or
Brownfields programs. In August 2020, New York adopted MCLs of 10 ppt
for both PFOA and PFOS.175 176
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\175\ NYSDOH. (2020). Amendment of subpart 5-1 of title 10 NYCRR
(maximum contaminant levels (MCLs)) notice of revised rulemaking.
New York State Department of Health. https://regs.health.ny.gov/sites/default/files/proposed-regulations/Maximum%20Contaminant%20Levels%20%28MCLs%29_0.pdf.
\176\ DEC. (2017). Fact sheet: Storage and use of Class B
firefighting foams under new hazardous substance regulations. New
York State Department of Environmental Conservation. https://www.dec.ny.gov/docs/remediation_hudson_pdf/affffactsheet.pdf.
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North Carolina's Department of Environmental Quality
determined an Interim Maximum Allowable Concentration for groundwater
of 2,000 ppt for PFOA (table last updated in June 2021).\177\
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\177\ NCDEQ. (2021). Appendix #1: Interim maximum allowable
concentrations (IMACs). North Carolina Department of Environmental
Quality. https://files.nc.gov/ncdeq/Water%20Quality/Planning/CSU/Ground%20Water/APPENDIX_I_IMAC_2-01-21.pdf.
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Ohio Environmental Protection Agency and Ohio Department
of Health released a Polyfluoroalkyl Substances Action Plan for
Drinking Water in 2019. Objectives included gathering sampling data,
providing private water system owners with guidelines and resources to
identify and respond to PFAS contamination, identifying resources to
assist public water systems in the implementation of preventative and
long-term measures to reduce PFAS-related risks, increasing awareness
of PFAS and associated risks, ongoing engagement, and establishing
Action Levels for drinking water systems in Ohio that are protective
for human health. As part of this initiative, Ohio indicated that
Action Levels of 70 ppt for PFOA and PFOS, singly or combined, would be
established.\178\
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\178\ Ohio.gov. (2019). Ohio per- and polyfluoroalkyl substances
(PFAS) action plan for drinking water. Ohio Environmental Protection
Agency. Ohio Department of Health. https://content.govdelivery.com/attachments/OHOOD/2019/12/02/file_attachments/1335154/PFAS%20Action%20Plan%2012.02.19.pdf.
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Oregon Department of Environmental Quality set initiation
levels (ILs) for PFOA and PFOS of 24,000 ppt and 300,000 ppt,
respectively (last amended in 2019). The rule indicated that ILs
referred to concentrations in effluent, that, if exceeded, requires
preparation of a pollutant reduction plan.179 180
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\179\ OAR. (2019). Division 45. Regulations pertaining to NPDES
and WPCF permits 340-045-0100 Effect of a permit: Initiation level
rule. Oregon Administrative Rule. https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=256058.
\180\ OAR. ([2010]). OAR 340-045-0100: Table A--Persistent
pollutants. Oregon Administrative Rule. https://secure.sos.state.or.us/oard/viewAttachment.action;JSESSIONID_OARD=kx0KPdcNidFhJyQctRxEOn3fLasJ_U1
SHXoqfYc80w8WtuLnSAlk!-888754201?ruleVrsnRsn=256058.
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[[Page 54436]]
Pennsylvania Department of Environmental Protection
(PADEP) adopted a medium-specific concentration of 70 ppt in
groundwater for PFOA and PFOS, individually or combined, based on EPA's
2016 LHAs. MSCs are 4.4 mg/kg for PFOA and PFOS in residential soil.
PADEP has proposed rulemaking to incorporate groundwater and soil
cleanup standards for PFOA, PFOS, and PFBS, and has initiated the
process to set drinking water MCLs for PFOA and PFOS.\181\
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\181\ Schena, R. (2021). New Pennsylvania PFOS and PFOA cleanup
standards reach final major regulatory hurdle. JD Supra. https://www.jdsupra.com/legalnews/new-pennsylvania-pfos-and-pfoa-cleanup-3985880/.
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Rhode Island Department of Environmental Management
(RIDEM) set Groundwater Quality Standards for PFOA and PFOS,
individually or combined, of 70 ppt. RIDEM indicated that EPA's 2016
LHAs are used to determine the response to protect human health when
these substances are detected in groundwater known or presumed to be
suitable for drinking water use without treatment.\182\
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\182\ RIDEM. (2017). Rhode Island Department of Environmental
Management determination of a groundwater quality standard for:
Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS).
Rhode Island Department of Environmental Management. https://www.dem.ri.gov/programs/benviron/water/quality/pdf/pfoa.pdf.
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Texas has developed toxicity factors for PFOA and PFOS
(using appropriate adjustments and uncertainty factors) for use at
remediation sites. When combined with reasonable maximum long-term
exposure assumptions for standard receptors (e.g., residents,
commercial/industrial workers) and multiple simultaneous routes of
exposure (e.g., incidental soil ingestion, dermal exposure), the Texas
Commission on Environmental Quality believes these toxicity factors
(e.g., RfDs) will result in sufficiently protective environmental media
(e.g., soil) cleanup concentrations based on available data. Texas's
RfDs for PFOA and PFOS are 1.2 x 10-05 and 2.3 x
10-05 mg/kg/day, respectively.\183\ Tier 1 Protective
Concentration Level (PCL) tables, released in January 2021, identified
PCLs of 290 ppt for PFOA and 560 ppt for PFOS. PCLs are the default
cleanup standards in the Texas Reduction Program.\184\
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\183\ TCEQ. (2016). Perfluoro compounds (PFCs): Various CASRN
numbers. Texas Commission on Environmental Quality. https://www.tceq.texas.gov/assets/public/implementation/tox/evaluations/pfcs.pdf.
\184\ TCEQ. (2021). TRRP Protective concentration levels. Texas
Commission on Environmental Quality. https://www.tceq.texas.gov/remediation/trrp/trrppcls.html.
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Vermont's drinking water health advisory is 20 ppt for a
combination of five (PFOA, PFOS, PFHxS, PFHpA and PFNA) compounds based
on a combined risk assessment. Vermont has issued final rules amending
a number of regulations pertaining to groundwater to set cleanup levels
of 20 ppt for PFOA, PFOS, PFHxS, PFHpA and PFNA. These rules became
effective on July 6, 2019. Vermont passed a law in 2019 requiring
public water systems to monitor for PFAS.185 186 It also
directed the Agency of Natural Resources to potentially regulate PFAS
and report on various monitoring activities.\187\
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\185\ HealthVermont. (2018). Memorandum: Drinking water health
advisory for five PFAS (per- and polyfluorinated alkyl substances).
Vermont Department of Health. https://www.healthvermont.gov/sites/default/files/documents/pdf/ENV_DW_PFAS_HealthAdvisory.pdf.
\186\ Vermont ANR. (2019). Chapter 12 of the environmental
protection rules: Groundwater protection rule and strategy. Vermont
Agency of Natural Resources. https://dec.vermont.gov/sites/dec/files/dwgwp/DW/2019.07.06%20-%20GWPRS.pdf.
\187\ Vermont ANR. (2019). ACT 21 (S. 49): Vermont 2019 PFAS law
factsheet. Vermont Agency of Natural Resources. https://dec.vermont.gov/sites/dec/files/PFAS/Docs/Act21-2019-VT-PFAS-Law-Factsheet.pdf.
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Washington is developing rule language to establish
proposed state action levels (SALs) of 10 ppt for PFOA and 15 ppt for
PFOS (also levels for 3 other PFAS). SALs are levels set for long-term
daily drinking water to protect human health; systems that exceed SALs
would be required to notify their customers.\188\
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\188\ WA DOH. (2021). PFAS and drinking water: What is a state
action level? Washington State Department of Health. https://www.doh.wa.gov/CommunityandEnvironment/Contaminants/PFAS#StateActionLevels.
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Wisconsin identified a toxicity value (acceptable daily
intake) of 2 x 10-6 mg/kg-day for PFOA and recommended the
ATSDR value of 2 x 10-6 mg/kg-day for PFOS.\189\ The
Wisconsin Department of Health Services has sent to Wisconsin
Department of Natural Resources recommended groundwater standards of 20
ppt for PFOA and PFOS individually and combined.\190\ The Wisconsin
PFAS Action Council has developed statewide initiatives to address PFAS
in Wisconsin. The council led the development of a comprehensive
Wisconsin PFAS Action Plan that will serve as a roadmap for how state
agencies will address these emerging chemicals.\191\
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\189\ Wisconsin DHS. (2019). Recommended public health
groundwater quality standards: Scientific support documents for
cycle 10 substances. Wisconsin Department of Health Services.
https://www.dhs.wisconsin.gov/publications/p02434v.pdf.
\190\ Wisconsin DHS. (2021). Per- and polyfluoroalkyl substances
(PFAS). Wisconsin Department of Health Services. https://www.dhs.wisconsin.gov/chemical/pfas.htm.
\191\ WisPAC. (2020). Wisconsin PFAS Action Plan. Wisconsin PFAS
Action Council. Department of Natural Resources. https://dnr.wisconsin.gov/topic/Contaminants/ActionPlan.html.
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D. Enforcement
Enforcement actions, both by states and EPA, have been taken to
mitigate risks from PFOA and PFOS. To date, EPA has addressed PFAS in
16 cases using a variety of enforcement tools under the Safe Drinking
Water Act (SDWA), TSCA, RCRA, and CERCLA,\192\ as well as overseeing
PFAS response actions by Federal agencies at National Priorities List
sites.
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\192\ Where PFAS are commingled with CERCLA hazardous
substances, EPA can require PRPs to address the PFAS. Additionally,
CERCLA Section 120 federal facility agreements for federal
facilities listed on the NPL require federal agencies to investigate
and clean up hazardous substances, pollutants and contaminants which
includes PFAS.
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For example, in 2002 the EPA entered into an emergency
administrative order on consent under SDWA with E. I. du Pont de
Nemours and Company. DuPont agreed to provide alternative drinking
water or treatment for public or private water users living near the
Washington Works facility in Washington, West Virginia, if the level of
PFOA detected in their drinking water was greater than the PFOA
screening level established by a C-8 Assessment of Toxicity team. The
C-8 Assessment team was formed pursuant to a state order and
established the screening level for PFOA at 150,000 ppt. In 2006, after
the science on health effects of PFOA evolved, the EPA entered into a
second emergency administrative order under SDWA with DuPont that
replaced the 2002 order and established a site-specific action level
equal to or greater than 500 ppt.\193\
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\193\ U.S. EPA. (2021). E.I. DuPont de Nemours and Company PFOA
settlements. U.S. Environmental Protection Agency. https://www.epa.gov/enforcement/ei-dupont-de-nemours-and-company-pfoa-settlements.
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In 2009, after EPA scientists established a provisional health
advisory for PFOA of 400 ppt to address short-term exposure to PFOA,
EPA entered into a third emergency administrative order under the SDWA
with DuPont that replaced the 2006 order and lowered the allowable
concentration of PFOA in drinking water from 500 ppt to 400 ppt in
communities near the facility. The provisional health advisory for PFOA
[[Page 54437]]
was based on available science at that time.\194\
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\194\ Ibid.
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In 2017, EPA issued an amendment to the 2009 emergency
administrative order with DuPont by adding The Chemours Company as a
respondent and lowering the allowable concentration of PFOA in drinking
water from 400 ppt to 70 ppt in communities near the facility. The
amendment, issued on May 19, 2016, was based upon current science,
changed circumstances, site-specific information, and EPA's health
advisories for PFOA and PFOS.\195\
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\195\ U.S. EPA. (2017). News releases from Region 03 EPA amends
drinking water order to DuPont. U.S. Environmental Protection
Agency. https://archive.epa.gov/epa/newsreleases/epa-amends-drinking-water-order-dupont.html.
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Designating PFOA and PFOS as CERCLA hazardous substances will allow
EPA to use its CERCLA enforcement authorities, in appropriate
circumstances and where relevant statutory elements are met, which
could allow a transfer of the cost-burden of response activities at
privately owned sites from the taxpayers/fund to potentially
responsible parties.
E. International Actions
PFAS, including PFOA and PFOS, are subject to international
treaties and individual country regulations on their production, use,
and release to the environment.
PFOA is identified by the United Nations Environment Programme
(UNEP) as ``a substance of very high concern with a persistent,
bioaccumulative and toxic structure for the environment and living
organisms'' and is listed under Annex A of the Stockholm
convention.\196\ (Parties must take measures to eliminate production
and use of the chemicals listed in Annex A.)
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\196\ UNEP. (2019). POPs chemicals Mandeeps. Stockholm
Convention on Persistent Organic Pollutants. United Nations
Environment Programme. https://chm.pops.int/DNNADMIN/DataEntry/MandeepsHiddenModules/POPsChemicalsMandeeps/tabid/754/Default.aspx.
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In November 2017, the Persistent Organic Pollutants Review
Committee adopted a risk management evaluation for PFOA, its salts and
PFOA-related compounds, defined as ``any substances that degrade to
PFOA, including any substances (including salts and polymers) having a
linear or branched perfluoroheptyl group with the moiety
(C7F15)C as one of the structural elements, for
example: (i) Polymers with >=C8 based perfluoroalkyl side chains; 8:2
fluorotelomer compounds; and (iii) 10:2 fluorotelomer compounds''.\197\
\198\ In 2019, at the 9th Conference of Parties (COP-9) meeting, the
Stockholm Convention agreed to a global ban on PFOA and some related
compounds for criteria including health effects such as kidney cancer,
testicular cancer, thyroid disease, ulcerative colitis and pregnancy-
induced hypertension. This action also included five-year exemptions
for use in semiconductor manufacturing, firefighting foams, worker-
safety textiles, photographic coatings for films and medical devices.
While a signatory to the Stockholm Convention, the U.S. has not
ratified and is therefore not a Party to the convention however;
additional exemptions were requested by China, Iran and the European
Union.\199\
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\197\ UNEP. (2017). Report of the Persistent Organic Pollutants
Review Committee on the work of its thirteenth meeting: Addendum:
Risk management evaluation on pentadecafluorooctanoic acid (CAS No:
335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related
compounds. Stockholm Convention on Persistent Organic Pollutants.
(UNEP/POPS/POPRC.13/7/Add.2). United Nations Environment Programme.
https://chm.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC13/MeetingDocuments/tabid/6024/Default.aspx/.
\198\ UNEP. (2018). Report of the Persistent Organic Pollutants
Review Committee on the work of its fourteenth meeting--Addendum to
the risk management evaluation on perfluorooctanoic acid (PFOA), its
salts and PFOA-related compounds. Stockholm Convention on Persistent
Organic Pollutants. (UNEP/POPS/POPRC.14/6/Add.2). United Nations
Environment Programme. https://chm.pops.int/theconvention/popsreviewcommittee/meetings/poprc14/overview/tabid/7398/default.aspx.
\199\ UNEP. (2019). Recommendation by the Persistent Organic
Pollutants Review Committee to list perfluorooctanoic acid (PFOA),
its salts and PFOA-related compounds in Annex A to the Convention
and draft text of the proposed amendment. Stockholm Convention on
Persistent Organic Pollutants. (UNEP/POPS/COP.9/14). United Nations
Environment Programme. https://chm.pops.int/TheConvention/ConferenceoftheParties/Meetings/COP9/tabid/7521/Default.aspx.
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PFOS, along with its salts and precursor POSF have been classified
as a persistent, highly bioaccumulative organic pollutant and listed
under Annex B of the Stockholm Convention.\200\ At the 2009 Stockholm
Convention COP-4 meeting, parties to the convention restricted PFOS
production and use, but also included exemptions. The 2019 COP-9
meeting tightened PFOA and PFOS restrictions, but left an exemption for
the pesticide sulfluramid, which is known to degrade into PFOS and
PFOA.\201\ \202\ This pesticide is no longer registered for use in the
United States.
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\200\ UNEP. (2019). POPs chemicals Mandeeps. Stockholm
Convention on Persistent Organic Pollutants. United Nations
Environment Programme. https://chm.pops.int/DNNADMIN/DataEntry/MandeepsHiddenModules/POPsChemicalsMandeeps/tabid/754/Default.aspx.
\201\ UNEP. (2009). Listing of perfluorooctane sulfonic acid,
its salts and perfluorooctane sulfonyl fluoride. Stockholm
Convention on Persistent Organic Pollutants. (UNEP-POPS-COP.4-SC-4-
17). United Nations Environment Programme. https://chm.pops.int/TheConvention/ConferenceoftheParties/Meetings/COP4/COP4Documents/tabid/531/Agg3187_SelectTab/4/Default.aspx.
\202\ UNEP. (2019). Evaluation of perfluorooctane sulfonic acid,
its salts and perfluorooctane sulfonyl fluoride pursuant to
paragraphs 5 and 6 of part III of Annex B to the Convention.
Stockholm Convention on Persistent Organic Pollutants. (UNEP/POPS/
COP.9/7). United Nations Environment Programme. https://chm.pops.int/TheConvention/ConferenceoftheParties/Meetings/COP9/tabid/7521/Default.aspx.
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The European Union (EU) has taken steps to regulate PFOA, its salts
and related substances in a wide range of products.\203\ PFOA and APFO
are also required to be classified, labelled, and packaged under
regulation EC No 1272/2008 \204\ and there is a ban on placing these
chemicals on the market as substances, constituents of other
substances, or in mixtures for supply to the general public. PFNA and
PFDA have been proposed for similar classification and labelling by
Sweden.
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\203\ EU. (2017). Commission regulation (EU) 2017/1000 of 13
June 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the
European Parliament and of the Council concerning the registration,
evaluation, authorisation and restriction of chemicals (REACH) as
regards perfluorooctanoic acid (PFOA), its salts and PFOA-related
substances. (Official J Eur Union L150/14). European Union. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32017R1000.
\204\ EU. (2008). Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on classification,
labelling and packaging of substances and mixtures, amending and
repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. (Official J Eur Union L353/1).
European Union. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1272.
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In July 2020, the European Food Safety Authority \205\ modified its
2018 decision to set safety levels for PFOA and PFOS to include PFNA
and PFHxS, based on their observed human bioaccumulation and toxicity.
A combined safety threshold or group tolerable weekly limit in food and
water of 4.4 nanograms/kilogram of body weight was set for these four
PFAS.
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\205\ EFSA. (2020). Risk to human health related to the presence
of perfluoroalkyl substances in food. EFSA Journal 18: e06223.
https://www.ncbi.nlm.nih.gov/pubmed/32994824.
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Because there are thousands of PFAS widespread in the environment
and substance-by-substance risk assessments, environmental monitoring
and regulation would be extremely lengthy and resource-intensive, an
alternative approach has been proposed to regulate PFAS as a class, or
as subgroups, based on toxicity or chemical similarities. The agreement
by the European Parliament and the
[[Page 54438]]
Council in December 2019 on the recast of the Drinking Water Directive
includes a limit of 0.5 micrograms per liter for all PFAS.\206\ In
December 2020, the European Parliament formally adopted the revised
Drinking Water Directive.\207\ Based on the widespread occurrence of
PFAS in the environment and their risk properties, in June 2019 the
European Council of Ministers called for an action plan to eliminate
all non-essential uses of PFAS.\208\
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\206\ EEA. (2019). Emerging chemical risks in Europe--`PFAS'.
European Environment Agency. European Union. https://www.eea.europa.eu/ds_resolveuid/a8da291194084d2eaa5bb0a9147e793a.
\207\ EC. (2020). Review of the drinking water directive.
European Commission. https://ec.europa.eu/environment/water/water-drink/review_en.html.
\208\ EU. (2019). Outcome of proceedings: Subject: Towards a
sustainable chemicals policy strategy of the Union--Council
conclusions. Council of the European Union. https://www.consilium.europa.eu/media/40042/st10713-en19.pdf.
---------------------------------------------------------------------------
A number of countries have issued standards and guidance values for
PFOA, PFOS, and other PFAS individually or cumulatively. These are
summarized below.
Australia and New Zealand \209\--The Food Standards Australia New
Zealand (FSANZ), a statutory authority in the Australian Government
health portfolio, and the National Medical Research Council have
developed health-based guidance values for PFOA, PFOS, and PFHxS for
exposure from food, drinking water and surface water used for
recreation. The guidance values give tolerable daily intake (TDI) for
lifetime exposure levels from food or drinking water that will not
result in significant risk to human health. Based on the TDI, FSANZ
recommended tolerable daily intake and issued drinking water and
recreational water guideline values for use in site investigations in
Australia. TDI were derived from animal studies and pharmacokinetic
modeling used to extrapolate to humans. For PFHxS, FSANZ concluded that
the available data were insufficient to develop a TDI and that the PFOS
TDI should be applied to PFHxS and a combined concentration of PFOS
plus PFHxS should be used to evaluate exposure.
---------------------------------------------------------------------------
\209\ Australian Government. (2019). Health based guidance
values for PFAS. Australian Government, Department of Health.
https://www1.health.gov.au/internet/main/publishing.nsf/Content/
2200FE086D480353CA2580C900817CDC/$File/HBGV-Factsheet-20190911.pdf.
------------------------------------------------------------------------
Total
Health based guidance value PFOS+PFHxS PFOA
------------------------------------------------------------------------
Tolerable daily intake (nanograms/ 20 160
kilogram of body weight per day).......
Drinking water quality guideline value 70 560
(nanograms per liter)..................
Recreational water quality guideline 2,000 10,000
value (nanograms per liter)............
------------------------------------------------------------------------
Canada--PFOA, its salts and precursors, as well as long-chain
perfluorocarboxylic acids, their salts and precursors were assessed in
2012. These substances are prohibited for import and use with a limited
number of exemptions under the Prohibition of Certain Toxic Substances
Regulations, 2012. In 2018 additional proposed amendments to the
Canadian Environmental Protection Act, 1999, to regulate additional
PFAS were postponed to late 2021. The proposed amendments include PFOS,
its salts and precursors that contain one of the following groups:
C8F17SO2,
C8F17SO3 or
C8F17SO2N (PFOS), PFOA and its salts
and precursors. It also includes all longer chain perfluorocarboxylic
acids having the molecular formula
CnF2n+1CO2H in which 8 <= n <= 20,
their salts and precursors.\210\ \211\
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\210\ Environment and Climate Change Canada. (2021). Toxic
substances list: long-chain perfluorocarboxylic acids. Environment
and Climate Change Canada, Government of Canada. https://www.canada.ca/en/environment-climate-change/services/management-toxic-substances/list-canadian-environmental-protection-act/long-chain-perfluorocarboxylic-acids.html.
\211\ Environment and Climate Change Canada. (2021). Toxic
substances list: PFOS. Environment and Climate Change Canada,
Government of Canada. https://www.canada.ca/en/environment-climate-change/services/management-toxic-substances/list-canadian-environmental-protection-act/perfluorooctane-sulfonate.html.
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Guidelines for Canadian Drinking Water Quality set the maximum
acceptable concentration (MAC) for PFOA in drinking water at 200 ppt
\212\ and PFOS in drinking water at 600 ppt.\213\ These MACs are based
on exposure to individual chemicals. Because the toxicological effects
of PFOA and PFOS are additive they should be evaluated together, and
the ratio of the observed concentration for PFOS to its MAC plus the
ratio of the observed concentration for PFOA to its MAC should be below
1 for drinking water to considered safe.214 215 For other
PFAS with a more limited database, drinking water screening values were
developed.
---------------------------------------------------------------------------
\212\ Health Canada. (2018). Guidelines for Canadian drinking
water quality: Guideline technical document--perfluorooctanoic acid
(PFOA). Health Canada. Minister of Health. https://www.canada.ca/en/health-canada/services/publications/healthy-living/guidelines-canadian-drinking-water-quality-technical-document-perfluorooctanoic-acid/document.html.
\213\ Health Canada. (2018). Guidelines for Canadian drinking
water quality: Guideline technical document--perfluorooctane
sulfonate (PFOS). Health Canada. Minister of Health. https://www.canada.ca/en/health-canada/services/publications/healthy-living/guidelines-canadian-drinking-water-quality-guideline-technical-document-perfluorooctane-sulfonate/document.html.
\214\ Health Canada. (2018). Guidelines for Canadian drinking
water quality: Guideline technical document--perfluorooctanoic acid
(PFOA). Health Canada. Minister of Health. https://www.canada.ca/en/health-canada/services/publications/healthy-living/guidelines-canadian-drinking-water-quality-technical-document-perfluorooctanoic-acid/document.html.
\215\ Health Canada. (2018). Guidelines for Canadian drinking
water quality: Guideline technical document--perfluorooctane
sulfonate (PFOS). Health Canada. Minister of Health. https://www.canada.ca/en/health-canada/services/publications/healthy-living/guidelines-canadian-drinking-water-quality-guideline-technical-document-perfluorooctane-sulfonate/document.html.
---------------------------------------------------------------------------
Peoples Republic of China--The ``Industrial Recon-structuring Guide
Directory'' \216\ restricted the production of PFOS and PFOA. In 2014,
the Ministry of Environmental Protection announcement No. [2014]21,
banned ``production, transportation, application, imports and exports
of PFOS, its salts, and POSF, except for specific exemptions and
acceptable use.''
---------------------------------------------------------------------------
\216\ OECD. (2021). Portal on per and poly fluorinated
chemicals: Country information: People's Republic of China.
Organisation for Economic Co-operation and Development. https://www.oecd.org/chemicalsafety/portal-perfluorinated-chemicals/countryinformation/china.htm.
---------------------------------------------------------------------------
Denmark--Based on toxicity the Danish Environmental Protection
Agency \217\ has identified health-based criteria or limit values for
drinking water, groundwater used for drinking water and soil. Criteria
or limit values for drinking water and groundwater used for drinking
water are 100 nanograms per liter for PFOS and/or PFOSA (a PFOS
precursor) and 300
[[Page 54439]]
nanograms per liter for PFOA. For cumulative exposure the ratio of the
sum of concentration/limit value ratios for PFOA, PFOS and PFOSA should
be below 1.
---------------------------------------------------------------------------
\217\ Danish Ministry of the Environment. (2015).
Perfluoroalkylated substances: PFOA, PFOS and PFOSA: Evaluation of
health hazards and proposal of a health based quality criterion for
drinking water, soil and ground water. (Environmental project No.
1665). Copenhagen, Denmark: The Danish Environmental Protection
Agency. https://www2.mst.dk/Udgiv/publications/2015/04/978-87-93283-01-5.pdf.
---------------------------------------------------------------------------
The health-based criteria or limit value for soil is 390 micrograms
per kilogram for PFOS and PFOSA and 1,300 micrograms per kilogram for
PFOA and its salts. Cumulatively the sum of concentration/limit value
ratios for PFOA, PFOS and PFOSA should be below 1.\218\
---------------------------------------------------------------------------
\218\ Ibid.
---------------------------------------------------------------------------
The Danish Ministry of the Environment and Food \219\ banned food
contact paper and cardboard in which per and polyfluoro chemicals,
including PFOA and PFOS and their salts and precursors, have been used
unless they incorporate a barrier to prevent migration into food.
---------------------------------------------------------------------------
\219\ PackingLaw.com. (2020). Denmark's PFAS ban in paper and
cardboard effective in July 2020. Keller and Heckman LLP. https://www.packaginglaw.com/news/denmarks-pfas-ban-paper-and-cardboard-effective-july-2020.
---------------------------------------------------------------------------
Japan--In 2010, Japan designated PFOS, its salts, and POSF as Class
I Specified Chemical Substances following their addition to the
Stockholm Convention on Persistent to Organic Pollutants Annex B
regulating manufacture, use, export, and import of PFOA and its
salts.\220\
---------------------------------------------------------------------------
\220\ Ministry of the Environment of Japan. (2013). Summary of
the guideline on the treatment of wastes containing perfluorooctane
sulfonic acid (PFOS), and its salts in Japan. Ministry of the
Environment of Japan. https://www.env.go.jp/en/focus/docs/files/201304-89.pdf.
---------------------------------------------------------------------------
Norway--Norway listed PFOA and PFOS on its national list of
priority substances \221\ based on monitoring data that showed high
levels of these substances in the environment as well as their
toxicological profiles. In 2014, Norway banned manufacturing,
production, import and retail of consumer products containing
PFOA.\222\
---------------------------------------------------------------------------
\221\ OECD. (2021). Portal on per and poly fluorinated
chemicals: Country information: Norway. Organisation for Economic
Co-operation and Development. https://www.oecd.org/chemicalsafety/portal-perfluorinated-chemicals/countryinformation/norway.htm.
\222\ UL. (2013). Norway introduces restrictions on PFOA. UL,
LLC. https://www.ul.com/news/norway-introduces-restrictions-pfoa.
---------------------------------------------------------------------------
VIII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is a significant regulatory action that was submitted
to the OMB for review. While EPA is not considering costs in its
hazardous substance designation decisions in this proposed rule, and
despite that there is still significant uncertainty and lack of data as
discussed in the economic analysis (EA), OMB designated this proposed
rulemaking as an economically significant action. Any changes made in
response to the OMB recommendations have been documented in the docket.
Although CERCLA section 102(a) precludes EPA from taking cost into
account in the designation of a hazardous substance, to inform the
public, EPA prepared an EA of the potential costs, benefits, and
impacts associated with this action. This analysis, Economic Assessment
of the Potential Costs and Other Impacts of the Proposed Rulemaking to
Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as
Hazardous Substances is available in the docket for this action. The EA
includes request for comments on several topics that EPA does not
currently have robust information about. Please see Section ES-5 of the
EA for specific details.
If finalized, this proposed CERCLA designation is estimated to have
a quantifiable direct annual social cost of approximately $370,000 from
reporting releases at or above the RQ. Additional, unquantifiable
future costs may occur when Federal agencies sell or transfer real
property where PFOA or PFOS was stored, released or disposed of as
specified by CERCLA section 120(h). There is also the direct effect
resulting in an obligation of DOT to list and regulate CERCLA-
designated hazardous substances as hazardous materials under the
Hazardous Materials Transportation Act (see CERCLA Section 306(a)). EPA
estimates these incremental costs associated with the DOT rulemaking as
zero or negligible. This action's direct benefits from release
reporting include improved quality of information providing a more
comprehensive understanding of the number and location of PFOA and PFOS
releases meeting or exceeding the RQ. An important benefit of this
information is that it may lead to more efficient property and capital
markets. Another potential direct benefit from the proposed reporting
requirement is better waste management and/or treatment by facilities
handling PFOA or PFOS. Greater transparency provided by release
reporting can lead to fewer releases to the environment and thus to
health benefits associated with avoided exposure.
Designating PFOA and PFOS as hazardous substances may also have
indirect, indeterminate impacts associated with potential increases in
the speed of response activity and in the total number of response
actions taken to address PFOA and PFOS releases. Both potential
increases may lead to health benefits associated with avoided risks.
Other indirect effects may be experienced as a result of the movement
forward in time of assessment and cleanup costs. The proposed
designation would also improve the Agency's ability to transfer
response costs from the public to polluters contingent upon specific
statutory requirements being met and discretionary actions by EPA.
These indirect costs, benefits, and transfers cannot be quantified due
to significant uncertainties about each. The full discussion of these
impacts can be found in the EA.
B. Paperwork Reduction Act
The information collection activities in this proposed rule have
been submitted for approval to the OMB under the Paperwork Reduction
Act. The Information Collection Request (ICR) document that the EPA
prepared has been assigned EPA ICR number 2708.01. You can find a copy
of the ICR in the docket for this rule, and it is briefly summarized
here.
If finalized, the designation of PFOA and PFOS, and their salts and
structural isomers, as hazardous substances would require any person in
charge of a vessel or facility that identifies a release of one pound
or more within a 24-hour period of these substances to report the
release to the NRC under section 103 of CERCLA and to the SERC (or
TERC) and LEPC (or TEPC) under section 304 of EPCRA. The implementing
regulations of CERCLA section 103 and EPCRA section 304 are codified at
40 CFR parts 302 and 355, respectively.
Respondents/affected entities: Any person in charge of a vessel or
facility from which there is a release of PFOA or PFOS and their salts
and structural isomers, equal to or greater than the RQ of one pound
within 24 hours.
Respondent's obligation to respond: Mandatory under section 103 of
CERCLA and section 304 of EPCRA.
Estimated number of respondents: From 0 to 660 releases per year.
Frequency of response: Varies.
[[Page 54440]]
Total estimated burden: 6,415 hours (per year) maximum. Burden is
defined at 5 CFR 1320.3(b).
Total estimated cost: $370,000 (per year) maximum, includes $3,503
annualized operation and maintenance costs (and no capital costs).
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR 9.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates and any suggested methods for
minimizing respondent burden to the EPA using the docket identified at
the beginning of this rule. You may also send your ICR-related comments
to OMB's Office of Information and Regulatory Affairs using the
interface at www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function. Since OMB is
required to make a decision concerning the ICR between 30 and 60 days
after receipt, OMB must receive comments no later than October 6, 2022.
The EPA will respond to any ICR-related comments in the final rule.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. The
small entities subject to the requirements of this action are: (1)
producers and importers of PFOA and PFOS, (2) producers and users of
PFOA or PFOS-containing articles, and (3) waste management and
wastewater facilities. The Agency has estimated that there may be up to
660 reported releases of PFOA or PFOS in any one year and that an
indeterminate number, but small percentage, of the annual reports will
be submitted by small entities. The estimated cost of $561 to report a
release of PFOA or PFOS is not greater than 1% of the annual revenues
per small entity in any impacted industry. Details of this analysis are
presented 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. We have
therefore concluded that this action will not have a significant
regulatory burden for all directly regulated small entities.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. This action is
expected to result in reporting costs of $561 per release that meets or
exceeds the RQ, and the estimated annual cost of the proposed rule is
not expected to exceed $370,000 per year.
E. Executive Order 13132: Federalism
This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 because it does not have substantial direct
effects on one or more Tribal Nations, on the relationship between the
Federal Government and Tribal Nations, or on the distribution of power
and responsibilities between the Federal Government and Tribal Nations.
EPA does not expect that it would result in any adverse impacts on
tribal entities. Thus, Executive Order 13175 does not apply to this
action.
Consistent with the EPA Policy on Consultation with Tribal Nations,
the EPA intends to consult with and request comments from tribal
officials.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action, which proposes to designate PFOA and PFOS as hazardous
substances, does not itself address environmental health or safety
risks. Beyond the requirements of E.O. 13045, EPA's 2021 Policy on
Children's Health (October 5, 2021) \223\ requires EPA to consider
early life exposures and lifelong health consistently and explicitly in
all human health decisions. The EPA believes that the environmental
health or safety risk posed by exposure to PFOA and/or PFOS may have a
disproportionate effect on children. A discussion of health and risk
assessments related to PFOA and PFOS, including developmental and
reproductive health effects, are contained in EPA's Health Effects
Support Documents for PFOA and PFOS (2016).
---------------------------------------------------------------------------
\223\ U.S. EPA. (2021). The administrator: 2021 policy on
children's health. Washington, DC: U.S. Environmental Protection
Agency. https://www.epa.gov/system/files/documents/2021-10/2021-policy-on-childrens-health.pdf.
---------------------------------------------------------------------------
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution or use of energy. This action proposes to designate PFOA
and PFOS as hazardous substances, and thus, does not involve the
supply, distribution or use of energy.
I. National Technology Transfer and Advancement Act
This action does not involve technical standards.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
The EPA is unable to determine if this action does or does not have
disproportionately high and adverse human health or environmental
effects on minority populations, low-income populations and/or
indigenous peoples, as specified in Executive Order 12898 (59 FR 7629,
February 16, 1994).
Several key demographic categories were analyzed relative to
facilities with known historical use and/or releases of PFOA and
PFOS.\224\ Because the location of future releases of PFAS is
uncertain, this analysis considers populations around facilities in
sectors associated with widespread historical uses and releases of PFAS
as proxies for facilities that may have future releases of the PFAS
considered in the proposed rule. This analysis examines the following
site types as proxies for facilities that are known to have commonly
used PFAS:
---------------------------------------------------------------------------
\224\ U.S. EPA. ([2021]). Assessment of the potential costs and
other impacts of the proposed rulemaking to designate
perfluorooctanoic acid and perfluorooctanesulfonic acid as hazardous
substances. U.S. Environmental Protection Agency.
Operating Department of Defense (DOD) facilities
Operating U.S. airports and airfields
[[Page 54441]]
Plastics material and resin manufacturing firms identified as
having produced PFOS and/or PFOA,
2020 PFOS and PFOA releases reported to EPA's Toxic Release
Inventory (TRI)
On average, airports across the U.S. are surrounded by populations
that reflect national averages in relevant demographic categories.
Large airports, however, are more likely to be surrounded by minority
and low-income populations than medium or small airports. Some DOD
sites are surrounded by populations with higher
concentrations of minority and low-income residents, but the majority
of these sites are below the national averages for these metrics. In
contrast, areas around plastics material and resin manufacturer sites
and/or sites reporting releases to TRI, on average, are in areas with
higher concentrations of minority residents and households experiencing
poverty than the U.S. averages for these demographics, suggesting that
releases related to manufacturing facilities could have environmental
justice implications. A complete discussion of the analysis behind
these findings is available in Section 4.3 of the EA accompanying this
rulemaking. These findings, combined with the uncertainty surrounding
the location of future releases, are indicative of potential impacts
but do not provide a clear indication of the type of disparities
related to potential exposure to PFAS. Consistent with the priorities
outlined in Executive Orders 12898 \225\ and 14008,\226\ it is unclear
whether this proposed regulation will have a significant impact on
disadvantaged populations or communities with environmental justice
(EJ) concerns relative to other communities. While the locations that
may report releases are unknown, to the extent that these proxy
locations are representative of likely reporting locations, this
screening analysis suggests that the reporting required under the rule
may provide better information to nearby populations potentially at
risk of exposure, including communities with EJ concerns. To the extent
that PFAS releases are consistent with the broader releases reported to
TRI and typically involve disposal or manufacturing sites, demographic
data around plastics material and resin manufacturer sites and
historical releases may be a more reliable predictor of the type of
community potentially affected by this proposed rulemaking. Specific
site conditions and demographic patterns may become clear as reporting
occurs following completion of a final rule. Once available, this
information would improve EPA's ability to examine disparate impacts on
EJ communities. This improved information would not increase risk for
communities with EJ concerns and may improve the speed and design of
remediation. EPA is committed to minimizing and/or eliminating existing
barriers and burdens that communities with EJ concerns may encounter
related to accessing data and information collected as a result of this
rulemaking, if finalized. EPA seeks comment on strategies to improve
access to the reporting data expected to be collected, if designation
of PFOA and PFOS as hazardous substances is finalized, for communities
with environmental justice concerns.
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\225\ The White House. (1994). Presidential documents: Executive
order 12898 of February 11, 1994: Federal actions to address
environmental justice in minority populations and low-income
populations. Federal Register 59: 7629. https://www.archives.gov/files/federal-register/executive-orders/pdf/12898.pdf.
\226\ WH.gov. (2021). Executive order on tackling the climate
crisis at home and abroad. Washington, DC: The White House. https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/executive-order-on-tackling-the-climate-crisis-at-home-and-abroad/.
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Further, the documentation for this decision is contained in the
following sections in the preamble to this action: II.C., VI.A. and B.
These sections explain that the designation of PFOA and PFOS as
hazardous substances, if finalized, and the required reporting and
notification requirements, will result in more information about the
location and extent of releases. This improved information does not
increase risk or result in any adverse environmental justice impacts.
List of Subjects in 40 CFR Part 302
Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Natural resources, Reporting and recordkeeping requirements, Superfund,
Water pollution control, Water supply.
Michael S. Regan,
Administrator.
For the reasons set forth in the preamble, EPA proposes to amend 40
CFR part 302 as follows:
PART 302--DESIGNATION, REPORTABLE QUANTITIES, AND NOTIFICATION
0
1. The authority citation for part 302 continues to read as follows:
Authority: 33 U.S.C. 1251 et. seq., 42 U.S.C. 9601, et seq., 42
U.S.C. 9602, 42 U.S.C. 9603.
0
2. Amend Sec. 302.4 by:
0
a. Revising in paragraph (b) the Note II to Table;
0
b. Adding in the Table--List of Hazardous Substances and Reportable
Quantities in alphabetical order the following new entries for
''Perfluorooctanesulfonic acid, salts, & structural isomers'' and
``Perfluorooctanoic acid, & salts, & structural isomers'';
0
c. Adding in Appendix A--Sequential CAS Registry Number List of CERCLA
Hazardous Substances in numerical order the new entries for ``335-67-
1'' and ``1763-23-1''.
The revisions read as follows:
Sec. 302.4 [Amended]
* * * * *
(b) * * *
Note II to Table 302.4
Hazardous substances are given a Statutory Code based on their
statutory source. The ``Statutory Code'' column indicates the statutory
source for designating each substance as a CERCLA hazardous substance.
Statutory Code ``1'' indicates a Clean Water Act (CWA) Hazardous
Substance. Statutory Code ``2'' indicates a CWA Toxic Pollutant.
Statutory Code ``3'' indicates a CAA HAP. Statutory Code ``4''
indicates Resource Conservation and Recovery Act (RCRA) Hazardous
Wastes. Statutory Code ``5'' indicates a hazardous substance designated
under section 102(a) of CERCLA. The ``RCRA waste No.'' column provides
the waste identification numbers assigned by RCRA regulations. The
``Final RQ [pounds (kg)]'' column provides the reportable quantity for
each hazardous substance in pounds and kilograms.
* * * * *
[[Page 54442]]
Table 302.4--List of Hazardous Substances and Reportable Quantities
[All comments/notes are located at the end of this table]
----------------------------------------------------------------------------------------------------------------
Statutory
Hazardous substance CASRN code RCRA waste No. Final RQ
[dagger] [pounds (kg)]
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Perfluorooctanesulfonic acid, & salts, & 1763-23-1 5 ........................ ## (0.454)
structural isomers.
Perfluorooctanoic acid, & salts, & 335-67-1 5 ........................ ## (0.454)
structural isomers.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Appendix A to Sec. 302.4--Sequential CAS Registry Number List of
CERCLA Hazardous Substances
------------------------------------------------------------------------
CASRN Hazardous substance
------------------------------------------------------------------------
335-67-1................. Perfluorooctanoic acid, & salts, & structural
isomers.
1763-23-1................ Perfluorooctanesulfonic acid, & salts, &
structural isomers.
------------------------------------------------------------------------
[FR Doc. 2022-18657 Filed 9-2-22; 8:45 am]
BILLING CODE 6560-50-P