Addressing PFAS in the Environment, 22399-22403 [2023-07535]
Download as PDF
Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Proposed Rules
*
*
*
*
(34) 2′,5′-Dimethoxyfentanyl (N-(1(2,5dimethoxyphenethyl)piperidin-4yl)-N-phenylpropionamide) .........
*
*
*
*
(45) 3-Furanyl fentanyl (N-(1phenethylpiperidin-4-yl)-Nphenylfuran-3-carboxamide) .......
*
*
*
*
(50) Isovaleryl fentanyl (3-methylN-(1-phenethylpiperidin-4-yl)-Nphenylbutanamide) ......................
*
*
*
*
(54) meta-Fluorofentanyl (N-(3fluorophenyl)-N-(1phenethylpiperidin-4yl)propionamide) .........................
(55) meta-Fluoroisobutyryl fentanyl
(N-(3-fluorophenyl)-N-(1phenethylpiperidin-4yl)isobutyramide). ........................
*
*
*
*
(71) ortho-Fluorofuranyl fentanyl
(N-(2-fluorophenyl)-N-(1phenethylpiperidin-4-yl)furan-2carboxamide) ................................
*
*
*
*
(80) para-Methoxyfuranyl fentanyl
(N-(4-methoxyphenyl)-N-(1phenethylpiperidin-4-yl)furan-2carboxamide .................................
(81)
para-Methylcyclopropyl
fentanyl (N-(4-methylphenyl)-N(1-phenethylpiperidin-4yl)cyclopropanecarboxamide) .....
*
*
*
*
*
40 CFR Part 302
9861
*
9860
*
9862
*
9857
9858
*
9863
*
9859
9865
Signing Authority
lotter on DSK11XQN23PROD with PROPOSALS1
This document of the Drug
Enforcement Administration was signed
on April 3, 2023, by Administrator
Anne Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
[FR Doc. 2023–07576 Filed 4–12–23; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
17:22 Apr 12, 2023
Jkt 259001
[EPA–HQ–OLEM–2022–0922; FRL–9064–
01–OLEM]
RIN 2050–AH25
*
Scott Brinks,
Federal Register Liaison Officer, Drug
Enforcement Administration.
ENVIRONMENTAL PROTECTION
AGENCY
Addressing PFAS in the Environment
Environmental Protection
Agency (EPA).
ACTION: Advance notice of proposed
rulemaking (ANPRM).
AGENCY:
The Environmental Protection
Agency (EPA or the Agency) is seeking
public input and data to assist in the
consideration of potential development
of future regulations pertaining to perand polyfluoroalkyl substances (PFAS)
under the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA or Superfund). The Agency is
seeking input and data regarding
potential future hazardous substance
designation under CERCLA of: Seven
PFAS, besides perfluorooctanoic acid
(PFOA) and perfluorooctanesulfonic
acid (PFOS), and their salts and
structural isomers, or some subset
thereof; precursors (a precursor is a
chemical that is transformed into
another compound through the course
of a degradation process) to PFOA,
PFOS, and seven other PFAS; and/or
categories of PFAS.
DATES: Comments must be received on
or before June 12, 2023. 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 May 15, 2023.
ADDRESSES: You may send comments,
identified by Docket ID No. EPA–HQ–
OLEM–2022–0922, 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
SUMMARY:
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
22399
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 (5201T), Environmental
Protection Agency, 1200 Pennsylvania
Avenue NW, Washington, DC 20460;
telephone number 703–346–9536; email
address: schutz.michelle@epa.gov or
Linda Strauss, Office of Superfund
Remediation and Technology
Innovation (5201T), Environmental
Protection Agency, 1200 Pennsylvania
Avenue NW, Washington, DC 20460;
telephone number 202–564–0797; email
address: strauss.linda@epa.gov.
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 this
ANPRM and for reference purposes, the
EPA defines the following terms and
acronyms here:
AFFF Aqueous film forming foam
ANPRM Advance Notice of Proposed
Rulemaking
ATSDR Agency for Toxic Substances and
Disease Registry
CASRN Chemical Abstracts Service
Registry Numbers
CDC Centers for Disease Control and
Prevention
CERCLA Comprehensive Environmental
Response, Compensation, and Liability Act
DSSTox Distributed Structure-Searchable
Toxicity
EPA Environmental Protection Agency
GenX Trade name for technology platform
that uses HFPO–DA and its ammonium salt
as a polymerization aid in the production
of fluoropolymers
HFPO Hexafluoropropylene oxide
HFPO–DA Hexafluoropropylene oxide
dimer acid
IRIS Integrated Risk Information System
LCPFAC Long-chain perfluoroalkyl
carboxylate
NPL National Priorities List
NPRM Notice of Proposed Rulemaking
OMB Office of Management and Budget
PBI Proprietary Business Information
PFAS Per- and polyfluoroalkyl substances
PFBA Perfluorobutanoic acid
PFBS Perfluorobutanesulfonic acid
PFDA Perfluorodecanoic acid
PFHxA Perfluorohexanoic acid
PFHxS Perfluorohexanesulfonic acid
PFNA Perfluorononanoic acid
E:\FR\FM\13APP1.SGM
13APP1
22400
Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Proposed Rules
PFOA Perfluorooctanoic acid
PFOS Perfluorooctanesulfonic acid
SNUR Significant New Use Rule
TSCA Toxic Substances Control Act
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.
Table of Contents
I. Public Participation
A. Written Comments
II. What action is the Agency taking?
III. General Information
A. Executive Summary
B. What are PFAS?
C. What is the purpose of this notice?
IV. Statutory Background
V. What information is EPA seeking?
A. Request for Public Input Regarding
Potential Future Hazardous Substance
Designation of Seven Other PFAS
B. Request for Public Input Regarding
Potential Future Hazardous Substance
Designation of Precursors to PFOA and
PFOS and Other PFAS
C. Request for Public Input Regarding
Potential Future Designation, or
Designations, of Categories of PFAS as
Hazardous Substances
VI. Request for Comment and Additional
Information
VII. What are the next steps EPA will take?
VIII. Statutory and Executive Orders
lotter on DSK11XQN23PROD with PROPOSALS1
I. Public Participation
A. Written Comments
Submit your comments, identified by
Docket ID No. EPA–HQ–OLEM 2022–
0922, at https://www.regulations.gov
(our preferred method), or the other
methods identified in the ADDRESSES
section of this document. 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 Proprietary 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
VerDate Sep<11>2014
17:22 Apr 12, 2023
Jkt 259001
II. What action is the Agency taking?
The Agency is seeking input and data
to assist in its consideration of the
development of potential future
regulations pertaining to designation as
hazardous substances under CERCLA of:
(1) Seven PFAS, besides PFOA and
PFOS, and their salts and structural
isomers, or some subset thereof, which
include:
• Perfluorobutanesulfonic acid (PFBS),
CASRN 375–73–5
• Perfluorohexanesulfonic acid
(PFHxS), CASRN 355–46–4
• Perfluorononanoic acid (PFNA),
CASRN 375–95–1
• Hexafluoropropylene oxide dimer
acid (HFPO–DA), CASRN 13252–13–
6 (sometimes called GenX)
• Perfluorobutanoic acid (PFBA)
CASRN 375–22–4
• Perfluorohexanoic acid (PFHxA)
CASRN 307–24–4
• Perfluorodecanoic acid (PFDA)
CASRN 335–76–2;
(2) Precursors to PFOA, PFOS, and
other PFAS listed above; and
(3) Categories of PFAS.
III. General Information
A. Executive Summary
In October 2021, the EPA released the
PFAS Strategic Roadmap that presents
the EPA’s whole-of-agency approach to
addressing PFAS and sets timelines by
which the Agency plans to take concrete
actions to develop new policies to
safeguard public health, protect the
environment, and hold polluters
accountable.1 The actions described in
the PFAS Roadmap, including the
National PFAS Testing Strategy,2
represent important steps to safeguard
communities from PFAS contamination.
Cumulatively, these actions will build
upon one another and lead to more
enduring and protective solutions.
The EPA’s Office of Land and
Emergency Management is responsible
for three PFAS Roadmap actions,
including:
• Designating PFOA and PFOS as
CERCLA hazardous substances. EPA
recently published a notice of proposed
1 U.S. EPA. (2021). PFAS Strategic Roadmap:
EPA’s Commitments to Section 2021–2024. U.S.
Environmental Protection Agency. https://
www.epa.gov/system/files/documents/2021-10/
pfas-roadmap_final-508.pdf.
2 U.S. EPA. National PFAS Testing Strategy. U.S.
Environmental Protection Agency. https://
www.epa.gov/assessing-and-managing-chemicalsunder-tsca/national-pfas-testing-strategy.
PO 00000
Frm 00018
Fmt 4702
Sfmt 4702
rulemaking (NPRM), 87 FR 54420, that,
if finalized, is expected to increase
transparency around PFOA/PFOS
releases, offer additional tools that EPA
and other government agencies could
use to conduct faster cleanups at
contaminated sites, and support other
actions taken by EPA, other Federal
agencies, states, Tribal Nations and
international bodies that have set PFOA
and PFOS benchmarks and standards
and have undertaken PFOA- and PFOSbased regulatory activities and
enforcement actions.
• Issuing updated guidance on
destroying and disposing of certain
PFAS and PFAS-containing materials.
The 2020 National Defense
Authorization Act required EPA to
publish interim guidance on destroying
and disposing of PFAS and certain
identified non-consumer PFAScontaining materials. It also required
EPA to revise that guidance at least
every three years, as appropriate. EPA
published the first interim guidance in
December 2020. Since the publication of
the interim guidance, EPA and other
agencies have been conducting relevant
research on destruction and disposal
technologies. EPA anticipates that it
will update the guidance no later than
the statutory deadline of December
2023.
• Issuing this ANPRM regarding
various PFAS under CERCLA. EPA has
developed this ANPRM to seek public
input regarding potential hazardous
substance designation for: (1) Seven
PFAS besides PFOA and PFOS; (2)
precursors to PFOA, PFOS, and seven
other PFAS; and (3) categories of PFAS.
B. What are PFAS?
PFAS are a class of manufactured
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. Several
chemical definitions are used to
describe PFAS in the scientific
community, but it is generally
recognized that there are potentially
thousands of different PFAS, some of
which have been more widely used and/
or studied than others. Some PFAS,
such as PFOA and PFOS, have been
shown to be environmentally persistent,
bioaccumulative, and harmful to human
health and the environment at certain
exposure levels.
PFAS can be present in water, soil,
air, and food as well as materials found
in homes and workplaces, including:
Drinking water—in public drinking
water systems and private drinking
water wells;
E:\FR\FM\13APP1.SGM
13APP1
Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS1
Soil and water—at landfills, disposal
sites, and sites and potential or existing
CERCLA or RCRA facilities;
Fire extinguishing foam—aqueous
film forming foam (AFFF) is used for
fighting certain types of fires, including
burning petroleum. Some of these foams
contain multiple PFAS. PFAS can be
found in groundwater and surface water
at airports, military bases and other
facilities where PFAS containing
firefighting extinguishing foam was or is
used for training and incident response;
Manufacturing and chemical
production facilities that produce or use
PFAS—for example at fluoropolymer
production facilities, chrome plating,
electronics, and certain textile and
paper manufacturers;
Food—for example in fish caught
from water contaminated with PFAS
and dairy products derived from
livestock exposed to PFAS;
Food packaging—for example in
grease resistant papers, fast food
containers and wrappers, microwave
popcorn bags, pizza boxes, and candy
wrappers;
Household products and dust—for
example in stain and water-repellant
treatments for carpets, upholstery,
clothing, and other fabrics, cleaning
products, non-stick cookware, paints,
varnishes, and sealants; and
Personal care products—for example
in some shampoos, dental floss, and
cosmetics.
C. What is the purpose of this notice?
In this ANPRM, EPA is seeking input
and data to assist in the potential
development of future regulations
pertaining to the designation of
hazardous substances under section
102(a) of CERCLA, which authorizes the
EPA 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. Specifically, this
ANPRM seeks public input regarding
the possible designation of: (1) Seven
PFAS besides PFOA and PFOS; (2)
precursors to PFOA, PFOS, and certain
other PFAS; and/or (3) categories of
PFAS.
In EPA’s NPRM designating PFOA
and PFOS as hazardous substances, the
Agency noted that evidence indicates
that these chemicals may present
substantial danger to public health or
welfare or the environment when
released into the environment, thereby
warranting designation under section
102(a) of CERCLA. In reaching this
determination, the EPA considered a
VerDate Sep<11>2014
17:22 Apr 12, 2023
Jkt 259001
number of criteria, including adverse
human health effects and mobility,
persistence, and prevalence, in addition
to other factors. As mentioned in the
NPRM, it is not necessary to have
information on all of these criteria for
EPA to designate a PFAS compound as
a hazardous substance under CERCLA.
EPA is requesting information on these
factors in this ANPRM since it may be
relevant and to guide public input.
In evaluating whether to designate
additional PFAS as hazardous
substances, different levels of
information may exist for individual
compounds or categories of PFAS with
regards to adverse human health effects,
mobility, persistence, prevalence, and
other factors. Some of this information
is presented on EPA’s Comptox
Dashboard.3 EPA is seeking public input
and additional information pertaining to
these factors that the Agency could
consider in evaluating whether these
PFAS may present substantial danger to
the public health or welfare or the
environment.
EPA is not reopening for public
comment or otherwise proposing to
modify any proposed or existing
regulatory actions through this ANPRM.
IV. Statutory Background
On September 6, 2022, the EPA
published an NPRM designating PFOA
and PFOS as hazardous substances
pursuant to section 102(a) of CERCLA.
In the ‘‘Background’’ section of the
NPRM, 87 FR 54420, the Agency
described the role and function of
CERCLA and its authority to address the
release or potential threat of a release of
hazardous substances, pollutants, and/
or contaminants. This ANPRM is
soliciting public input to inform the
EPA’s consideration of the potential
development of future regulations
pertaining to additional PFAS, PFAS
precursors, and/or categories of PFAS.
Given the similarity of the issues of
concern in this ANPRM and the NPRM
the EPA encourages interested readers
to refer to the NPRM’s ‘‘Background’’
section for a detailed understanding of
the statutory context for today’s action.
Regarding CERCLA liability and
enforcement, EPA is already separately
developing a CERCLA PFAS
enforcement discretion and settlement
policy and seeking individual public
input on CERCLA PFAS enforcement/
liability concerns through two public
listening sessions. The public input will
be reviewed and considered by EPA in
drafting the policy.
3 U.S. EPA, Comptox Chemicals Dashboard, U.S.
Environmental Protection Agency https://
comptox.epa.gov/dashboard/.
PO 00000
Frm 00019
Fmt 4702
Sfmt 4702
22401
V. What information is EPA seeking?
A. Request for Public Input Regarding
Potential Future Hazardous Substance
Designation of Seven Other PFAS
As previously discussed, EPA
recently issued an NPRM, that, if
finalized, would designate PFOA and
PFOS and their salts and structural
isomers as CERCLA hazardous
substances. EPA is considering whether
to initiate a future action that would
potentially designate the following
additional, seven PFAS and their salts
and structural isomers or some subset
thereof, as hazardous substances under
CERCLA:
• Perfluorobutanesulfonic acid
(PFBS), CASRN 375–73–5;
• Perfluorohexanesulfonic acid
(PFHxS), CASRN 355–46–4;
• Perfluorononanoic acid (PFNA),
CASRN 375–95–1;
• Hexafluoropropylene oxide dimer
acid (HFPO–DA), CASRN 13252–13–6
(sometimes called GenX);
• Perfluorobutanoic acid (PFBA)
CASRN 375–22–4;
• Perfluorohexanoic acid (PFHxA)
CASRN 307–24–4; and
• Perfluorodecanoic acid (PFDA)
CASRN 335–76–2.
EPA is soliciting information relevant
to whether these compounds may
present substantial danger to public
health or welfare or the environment.
For example, the Agency requests
information concerning the
characteristics of these compounds,
such as mobility, persistence,
prevalence, and other characteristics,
that would supplement the existing
toxicity data for these compounds.
Although PFAS is a large class of
chemical substances, these seven
compounds were identified based on
the availability of toxicity information
previously reviewed by EPA and other
Federal agencies. In April 2021 and
2022, EPA issued the final human
health toxicity assessment for PFBS
[Human Health Toxicity Values for
Perfluorobutane Sulfonic Acid (CASRN
375–73–5) and Related Compound
Potassium Perfluorobutane Sulfonate
(CASRN 29420–49–3)], 4 Gen X
chemicals [Final Human Health
Toxicity Values for Hexafluoropropylene Oxide (HFPO) Dimer Acid
and its Ammonium Salt, CASRN 13252–
4 U.S.EPA (2021). Human Health Toxicity Values
for Perfluorobutane Sulfonic Acid (CASRN 375–73–
5) and Related Compound Potassium
Perfluorobutane Sulfonate (CASRN 29420–49–3).
U.S. Environmental Protection Agency,
Washington, DC. https://cfpub.epa.gov/ncea/risk/
recordisplay.cfm?deid=350888.
E:\FR\FM\13APP1.SGM
13APP1
22402
Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS1
12–6 and CSRN 62037–80–3],5 and
PFBA [IRIS Toxicological Review of
Perfluorobutanoic Acid (PFBA) and
Related Salts].6 In May 2021, the
Agency for Toxic Substances and
Disease Registry (ATSDR) released the
final Toxicological Profile for
Perfluoroalkyls, which includes
minimal risk levels for PFOA, PFOS,
PFHxS and PFNA.7 EPA’s Integrated
Risk Information System (IRIS) program
is currently developing human health
toxicity assessments of PFHxA, PFNA,
PFDA, and PFHxS.8
To inform EPA’s decision whether to
potentially designate PFBS, PFHxS,
PFNA, HFPO–DA, PFBA, PFHxA, and
PFDA, or some subset thereof, as
hazardous substances in a possible
future action, EPA is soliciting
responses to the following questions
and requests for the PFAS listed above,
and requests that commentors provide
supporting information and specific
scientific literature citations regarding
applicable information where
appropriate:
1. Please identify additional relevant
information in published scientific
literature or data regarding the
environmental fate and transport
(mobility, persistence, or other relevant
chemical and physical properties) and
environmental prevalence that would
assist EPA in making determinations
regarding potential designation as a
hazardous substance.
2. Are there other PFAS EPA could
consider designating as hazardous
substances in a possible future
rulemaking? If so, please provide
references to any published, scientific
information on the toxicity of these
other PFAS in addition to the
information requested in question one
for those substances.
3. Please provide available
information that EPA could consider in
preparing an economic analysis of the
5 U.S. EPA (2021). Human Health Toxicity Values
for GenX Chemicals, Hexafluoropropylene Oxide
(HFPO) Dimer Acid and its Ammonium Salt,
(CASRN 13252–12–6 and CSRN 62037–80–3). U.S.
Environmental Protection Agency, Washington, DC.
https://www.epa.gov/chemical-research/humanhealth-toxicity-assessments-genx-chemicals.
6 EPA (2022). IRIS Toxicological Review of
Perfluorobutanoic Acid (PFBA) and Related Salts
(Final Report). U.S. Environmental Protection
Agency, Washington, DC. https://www.epa.gov/
chemical-research/iris-toxicological-reviewperfluorobutanoic-acid-pfba-and-related-salts-final.
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. 13See Office of Regulatory
Enforcement.
8 U.S. EPA. IRIS Program Outlook. https://
www.epa.gov/iris/iris-program-outlook.
VerDate Sep<11>2014
17:22 Apr 12, 2023
Jkt 259001
potential direct and indirect costs and
benefits, including impacts on small
entities, associated with a potential
rulemaking designating any of the
above-mentioned compounds as
hazardous substances. Although
CERCLA section 102(a) precludes EPA
from taking cost into account in the
designation of a hazardous substance,
the Agency is requesting this
information to inform its understanding
of the potential costs and benefits
associated with any potential future
regulatory action.
B. Request for Public Input Regarding
Potential Future Hazardous Substance
Designation of Precursors to PFOA,
PFOS, and PFAS Listed in V.A.
EPA is also considering whether to
initiate a future action that would
potentially designate precursors to
PFOA, PFOS, and possibly the seven
PFAS and their salts and isomers, or
some subset thereof, listed in Section
V.A, of this SUPPLEMENTARY INFORMATION
section. as hazardous substances. Thus,
EPA is soliciting input regarding
information that will assist the Agency
in identifying compounds that degrade
to these PFAS through environmental
processes such as biodegradation,
photolysis, and hydrolysis.
An example of how EPA has
addressed precursors previously is the
2020 Significant New Use Rule (SNUR)
for long-chain perfluoroalkyl
carboxylate (LCPFAC) PFAS which
included salts and precursors of these
perfluorinated carboxylates. EPA
explained, ‘‘LCPFAC precursors may be
simple derivatives of perfluorooctanoic
acid (PFOA) and higher homologues or
certain polymers that may degrade to
PFOA or higher homologues,’’ 85 FR
45109 (July 27, 2020).
To inform EPA’s decision-making
regarding the potential designation of
precursors to PFOA, PFOS, and possibly
the seven PFAS, or some subset thereof,
listed in Section V.A as hazardous
substances, EPA is soliciting responses
to the following questions and requests
on the topics described below and
requests that commentors provide
supporting information and specific
scientific literature citations regarding
applicable information where
appropriate:
4. Please identify information in
published scientific literature or data
regarding the environmental
degradation of substances to PFOA,
PFOS, PFBS, PFHxS, PFNA, HFPO–DA,
PFBA, PFHxA, and/or PFDA.
5. What factors, if any, regarding
degradation time and environmental
conditions (e.g., aqueous vs. arid,
anaerobic vs. aerobic, available
PO 00000
Frm 00020
Fmt 4702
Sfmt 4702
nutrients) should be considered in
identifying the appropriate precursor
compounds?
6. Please provide relevant information
or data in published scientific literature
that characterizes the environmental
prevalence of PFOA, PFOS, PFBS,
PFHxS, PFNA, HFPO–DA, PFBA,
PFHxA, and/or PFDA from the
degradation of associated precursors
7. With respect to the preceding
questions, please identify names and
Chemical Abstracts Service Registry
Numbers (CASRNs) or Distributed
Structure-Searchable Toxicity (DSSTox)
substance identifier for substances that
EPA should consider as precursor
compounds.
8. Available standard analytical
methods, such as SW–846 Method 8327
or Method 533, may not include all
precursors to PFOA, PFOS, PFBS,
PFHxS, PFNA, HFPO–DA, PFBA,
PFHxA, and/or PFDA. Furthermore, the
development of additional methods may
be limited by the availability of
chemicals standards. Given these
limitations, please provide information
regarding how precursors could be
measured in environmental samples.
Additionally, please comment on
whether and how EPA should consider
the availability of analytical methods
when determining whether to designate
precursors as CERCLA hazardous
substances.
9. Please provide available
information that EPA could consider in
preparing an economic analysis of the
potential direct and indirect costs and
benefits, including impacts on small
entities, associated with a potential
rulemaking designating these precursors
as CERCLA hazardous substances.
Although CERCLA section 102(a)
precludes EPA from taking cost into
account in the designation of a
hazardous substance, the Agency is
requesting this information to inform its
understanding of the potential costs and
benefits associated with any potential
future regulatory action.
C. Request for Public Input Regarding
Potential Future Designation, or
Designations, of Categories of PFAS as
Hazardous Substances
EPA is considering whether to initiate
a future action that would potentially
designate groups or categories of PFAS
as hazardous substances. A group or
category refers to a set of PFAS that
share one or more similar
characteristics. Characteristics of
interest could include, but are not
limited to, chemical structure (e.g.,
carbon chain length, functional group),
physical and chemical properties, mode
E:\FR\FM\13APP1.SGM
13APP1
lotter on DSK11XQN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Proposed Rules
of toxicological action, precursors or
degradants, or co-occurrence.
EPA’s 2020 SNUR for LCPFAC
provides an example of a category based
on chemical structure. In the SNUR, the
LCPFAC category is defined as follows,
where 5 < n < 21 or 6 < m < 21:
a. CF3(CF2)n-COO–M where M = H+ or
any other group where a formal
dissociation can be made;
b. CF3(CF2)n-CH=CH2;
c. CF3(CF2)n-C(=O)-X where X is any
chemical moiety;
d. CF3(CF2)m-CH2-X where X is any
chemical moiety, and
e. CF3(CF2)m-Y–X where Y = non-S,
non-N heteroatom and where X is any
chemical moiety.
In addition to the structures identified
above, ‘‘the category also includes the
salts and precursors of these chemical
substances. The precursors may be
simple derivatives of PFOA and higher
homologues or polymers that contain or
may degrade to PFOA or higher
homologues. These precursors include
long-chain fluorotelomers.’’ [80 FR
2885] [FRL–9915–63]. Thus, EPA’s 2020
SNUR for LCPFAC included certain
PFAS based on their chemical structure
as well as other PFAS based on whether
they degrade to the targeted LCPFACs.
To inform EPA’s decision whether to
designate certain groups or categories of
PFAS as hazardous substances, EPA is
soliciting responses to the following
questions and requests, and requests
that commentors provide supporting
information and specific scientific
literature citations regarding applicable
information where appropriate:
10. Please identify published
scientific literature that can inform
whether categories of PFAS could or
could not be designated as hazardous
substances. This could include, for
example, scientific data or information
on the similarities or differences of a
specific characteristic among PFAS.
This could also include scientific data
and information on the relationship
between different characteristics, such
as the relationship between chemical
structure and specific chemical,
physical, or toxicological properties.
11. Is there other information that
EPA should consider when determining
whether to designate one or more
categories of PFAS as hazardous
substances? Please provide comment on
the extent to which EPA could include
related PFAS in a given category (e.g.,
structural isomers and/or salts).
VerDate Sep<11>2014
17:22 Apr 12, 2023
Jkt 259001
12. Please provide available
information that EPA could consider in
preparing an economic analysis of the
potential costs and benefits, including
impacts on small entities, associated
with a potential rulemaking designating
categories of PFAS as hazardous
substances. Although CERCLA section
102(a) precludes EPA from taking cost
into account in the designation of a
hazardous substance, the Agency is
requesting this information to inform its
understanding of the potential costs and
benefits associated with any potential
future regulatory action.
VI. Request for Comment and
Additional Information
EPA is seeking comment on all
questions and topics described in this
ANPRM and requests that you submit
any other information, which may not
be specifically mentioned in this notice,
that you believe is important for EPA to
consider in connection with these
questions and topics. At the same time,
EPA does not plan to consider
comments that are beyond the scope of
the questions and topics described in
this ANPRM. EPA requests that
commenters making specific
recommendations include supporting
documentation where appropriate.
Instructions for providing written
comments are provided under
ADDRESSES, including how to submit
any comments that contain PBI.
VII. What are the next steps EPA will
take?
EPA intends to carefully review all
comments and information received in
response to this ANPRM. Once that
review is completed, EPA would
supplement the collected information,
as appropriate, with information that
the Agency has obtained independently,
to determine whether a future
rulemaking should address the
designation of additional PFAS or
precursors as CERCLA hazardous
substances or whether one or more
categories of PFAS can be designated as
CERCLA hazardous substances.
VIII. Statutory and Executive Order
Reviews
Under Executive Order 12866 (58 FR
51735; October 4, 1993) and Executive
Order 13563 (76 FR 3821; January 21,
2011), this action was submitted to the
OMB for review. Any changes made in
response to OMB recommendations
have been documented in the docket for
PO 00000
Frm 00021
Fmt 4702
Sfmt 9990
22403
this action. Because this action does not
impose or propose any requirements,
and instead seeks comments and
suggestions for the Agency to consider
in possibly developing a subsequent
proposed rule, other statutory and
Executive Order reviews that apply to
rulemaking do not apply to this action.
Should EPA subsequently determine to
pursue a rulemaking, EPA will address
the statutes and Executive Orders
applicable to the rulemaking.
Nevertheless, the Agency welcomes
comments and/or information that
would help the Agency to assess any of
the following: the potential impact of a
possible future rule on small entities
pursuant to the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.); potential
impacts on Federal, state, or local
governments pursuant to the Unfunded
Mandates Reform Act (2 U.S.C. 1531–
1538); federalism implications pursuant
to Executive Order 13132, entitled
Federalism (64 FR 43255; November 2,
1999); availability of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995,
Public Law 104–113; tribal implications
pursuant to Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249; November 6, 2000);
environmental health or safety effects
on children pursuant to Executive Order
13045, entitled Protection of Children
from Environmental Health Risks and
Safety Risks (62 FR 19885; April 23,
1997) and EPA’s 2021 Policy on
Children’s Health; energy effects
pursuant to Executive Order 13211,
entitled Actions Concerning Regulations
that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355; May
22, 2001); Paperwork burdens pursuant
to the Paperwork Reduction Act (44
U.S.C. 3501); or human health or
environmental effects on minority or
low-income populations pursuant to
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629;
February 16, 1994). The Agency will
consider such comments during the
development of any subsequent
proposed rulemaking.
Michael S. Regan,
Administrator.
[FR Doc. 2023–07535 Filed 4–12–23; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\13APP1.SGM
13APP1
Agencies
[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Proposed Rules]
[Pages 22399-22403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07535]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 302
[EPA-HQ-OLEM-2022-0922; FRL-9064-01-OLEM]
RIN 2050-AH25
Addressing PFAS in the Environment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Advance notice of proposed rulemaking (ANPRM).
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
seeking public input and data to assist in the consideration of
potential development of future regulations pertaining to per- and
polyfluoroalkyl substances (PFAS) under the Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA or Superfund). The
Agency is seeking input and data regarding potential future hazardous
substance designation under CERCLA of: Seven PFAS, besides
perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS),
and their salts and structural isomers, or some subset thereof;
precursors (a precursor is a chemical that is transformed into another
compound through the course of a degradation process) to PFOA, PFOS,
and seven other PFAS; and/or categories of PFAS.
DATES: Comments must be received on or before June 12, 2023. 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 May 15, 2023.
ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OLEM-2022-0922, 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 (5201T), Environmental Protection
Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone
number 703-346-9536; email address: [email protected] or Linda
Strauss, Office of Superfund Remediation and Technology Innovation
(5201T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW,
Washington, DC 20460; telephone number 202-564-0797; 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 this ANPRM and for reference purposes, the EPA defines the
following terms and acronyms here:
AFFF Aqueous film forming foam
ANPRM Advance Notice of Proposed Rulemaking
ATSDR Agency for Toxic Substances and Disease Registry
CASRN Chemical Abstracts Service Registry Numbers
CDC Centers for Disease Control and Prevention
CERCLA Comprehensive Environmental Response, Compensation, and
Liability Act
DSSTox Distributed Structure-Searchable Toxicity
EPA Environmental Protection Agency
GenX Trade name for technology platform that uses HFPO-DA and its
ammonium salt as a polymerization aid in the production of
fluoropolymers
HFPO Hexafluoropropylene oxide
HFPO-DA Hexafluoropropylene oxide dimer acid
IRIS Integrated Risk Information System
LCPFAC Long-chain perfluoroalkyl carboxylate
NPL National Priorities List
NPRM Notice of Proposed Rulemaking
OMB Office of Management and Budget
PBI Proprietary Business Information
PFAS Per- and polyfluoroalkyl substances
PFBA Perfluorobutanoic acid
PFBS Perfluorobutanesulfonic acid
PFDA Perfluorodecanoic acid
PFHxA Perfluorohexanoic acid
PFHxS Perfluorohexanesulfonic acid
PFNA Perfluorononanoic acid
[[Page 22400]]
PFOA Perfluorooctanoic acid
PFOS Perfluorooctanesulfonic acid
SNUR Significant New Use Rule
TSCA Toxic Substances Control Act
Table of Contents
I. Public Participation
A. Written Comments
II. What action is the Agency taking?
III. General Information
A. Executive Summary
B. What are PFAS?
C. What is the purpose of this notice?
IV. Statutory Background
V. What information is EPA seeking?
A. Request for Public Input Regarding Potential Future Hazardous
Substance Designation of Seven Other PFAS
B. Request for Public Input Regarding Potential Future Hazardous
Substance Designation of Precursors to PFOA and PFOS and Other PFAS
C. Request for Public Input Regarding Potential Future
Designation, or Designations, of Categories of PFAS as Hazardous
Substances
VI. Request for Comment and Additional Information
VII. What are the next steps EPA will take?
VIII. Statutory and Executive Orders
I. Public Participation
A. Written Comments
Submit your comments, identified by Docket ID No. EPA-HQ-OLEM 2022-
0922, at https://www.regulations.gov (our preferred method), or the
other methods identified in the ADDRESSES section of this document.
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 Proprietary 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. What action is the Agency taking?
The Agency is seeking input and data to assist in its consideration
of the development of potential future regulations pertaining to
designation as hazardous substances under CERCLA of:
(1) Seven PFAS, besides PFOA and PFOS, and their salts and
structural isomers, or some subset thereof, which include:
Perfluorobutanesulfonic acid (PFBS), CASRN 375-73-5
Perfluorohexanesulfonic acid (PFHxS), CASRN 355-46-4
Perfluorononanoic acid (PFNA), CASRN 375-95-1
Hexafluoropropylene oxide dimer acid (HFPO-DA), CASRN 13252-
13-6 (sometimes called GenX)
Perfluorobutanoic acid (PFBA) CASRN 375-22-4
Perfluorohexanoic acid (PFHxA) CASRN 307-24-4
Perfluorodecanoic acid (PFDA) CASRN 335-76-2;
(2) Precursors to PFOA, PFOS, and other PFAS listed above; and
(3) Categories of PFAS.
III. General Information
A. Executive Summary
In October 2021, the EPA released the PFAS Strategic Roadmap that
presents the EPA's whole-of-agency approach to addressing PFAS and sets
timelines by which the Agency plans to take concrete actions to develop
new policies to safeguard public health, protect the environment, and
hold polluters accountable.\1\ The actions described in the PFAS
Roadmap, including the National PFAS Testing Strategy,\2\ represent
important steps to safeguard communities from PFAS contamination.
Cumulatively, these actions will build upon one another and lead to
more enduring and protective solutions.
---------------------------------------------------------------------------
\1\ U.S. EPA. (2021). PFAS Strategic Roadmap: EPA's Commitments
to Section 2021-2024. U.S. Environmental Protection Agency. https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf.
\2\ U.S. EPA. National PFAS Testing Strategy. U.S. Environmental
Protection Agency. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/national-pfas-testing-strategy.
---------------------------------------------------------------------------
The EPA's Office of Land and Emergency Management is responsible
for three PFAS Roadmap actions, including:
Designating PFOA and PFOS as CERCLA hazardous substances.
EPA recently published a notice of proposed rulemaking (NPRM), 87 FR
54420, that, if finalized, is expected to increase transparency around
PFOA/PFOS releases, offer additional tools that EPA and other
government agencies could use to conduct faster cleanups at
contaminated sites, and support other actions taken by EPA, other
Federal agencies, states, Tribal Nations and international bodies that
have set PFOA and PFOS benchmarks and standards and have undertaken
PFOA- and PFOS-based regulatory activities and enforcement actions.
Issuing updated guidance on destroying and disposing of
certain PFAS and PFAS-containing materials. The 2020 National Defense
Authorization Act required EPA to publish interim guidance on
destroying and disposing of PFAS and certain identified non-consumer
PFAS-containing materials. It also required EPA to revise that guidance
at least every three years, as appropriate. EPA published the first
interim guidance in December 2020. Since the publication of the interim
guidance, EPA and other agencies have been conducting relevant research
on destruction and disposal technologies. EPA anticipates that it will
update the guidance no later than the statutory deadline of December
2023.
Issuing this ANPRM regarding various PFAS under CERCLA.
EPA has developed this ANPRM to seek public input regarding potential
hazardous substance designation for: (1) Seven PFAS besides PFOA and
PFOS; (2) precursors to PFOA, PFOS, and seven other PFAS; and (3)
categories of PFAS.
B. What are PFAS?
PFAS are a class of manufactured 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.
Several chemical definitions are used to describe PFAS in the
scientific community, but it is generally recognized that there are
potentially thousands of different PFAS, some of which have been more
widely used and/or studied than others. Some PFAS, such as PFOA and
PFOS, have been shown to be environmentally persistent,
bioaccumulative, and harmful to human health and the environment at
certain exposure levels.
PFAS can be present in water, soil, air, and food as well as
materials found in homes and workplaces, including:
Drinking water--in public drinking water systems and private
drinking water wells;
[[Page 22401]]
Soil and water--at landfills, disposal sites, and sites and
potential or existing CERCLA or RCRA facilities;
Fire extinguishing foam--aqueous film forming foam (AFFF) is used
for fighting certain types of fires, including burning petroleum. Some
of these foams contain multiple PFAS. PFAS can be found in groundwater
and surface water at airports, military bases and other facilities
where PFAS containing firefighting extinguishing foam was or is used
for training and incident response;
Manufacturing and chemical production facilities that produce or
use PFAS--for example at fluoropolymer production facilities, chrome
plating, electronics, and certain textile and paper manufacturers;
Food--for example in fish caught from water contaminated with PFAS
and dairy products derived from livestock exposed to PFAS;
Food packaging--for example in grease resistant papers, fast food
containers and wrappers, microwave popcorn bags, pizza boxes, and candy
wrappers;
Household products and dust--for example in stain and water-
repellant treatments for carpets, upholstery, clothing, and other
fabrics, cleaning products, non-stick cookware, paints, varnishes, and
sealants; and
Personal care products--for example in some shampoos, dental floss,
and cosmetics.
C. What is the purpose of this notice?
In this ANPRM, EPA is seeking input and data to assist in the
potential development of future regulations pertaining to the
designation of hazardous substances under section 102(a) of CERCLA,
which authorizes the EPA 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. Specifically, this ANPRM seeks public input regarding the
possible designation of: (1) Seven PFAS besides PFOA and PFOS; (2)
precursors to PFOA, PFOS, and certain other PFAS; and/or (3) categories
of PFAS.
In EPA's NPRM designating PFOA and PFOS as hazardous substances,
the Agency noted that evidence indicates that these chemicals may
present substantial danger to public health or welfare or the
environment when released into the environment, thereby warranting
designation under section 102(a) of CERCLA. In reaching this
determination, the EPA considered a number of criteria, including
adverse human health effects and mobility, persistence, and prevalence,
in addition to other factors. As mentioned in the NPRM, it is not
necessary to have information on all of these criteria for EPA to
designate a PFAS compound as a hazardous substance under CERCLA. EPA is
requesting information on these factors in this ANPRM since it may be
relevant and to guide public input.
In evaluating whether to designate additional PFAS as hazardous
substances, different levels of information may exist for individual
compounds or categories of PFAS with regards to adverse human health
effects, mobility, persistence, prevalence, and other factors. Some of
this information is presented on EPA's Comptox Dashboard.\3\ EPA is
seeking public input and additional information pertaining to these
factors that the Agency could consider in evaluating whether these PFAS
may present substantial danger to the public health or welfare or the
environment.
---------------------------------------------------------------------------
\3\ U.S. EPA, Comptox Chemicals Dashboard, U.S. Environmental
Protection Agency https://comptox.epa.gov/dashboard/.
---------------------------------------------------------------------------
EPA is not reopening for public comment or otherwise proposing to
modify any proposed or existing regulatory actions through this ANPRM.
IV. Statutory Background
On September 6, 2022, the EPA published an NPRM designating PFOA
and PFOS as hazardous substances pursuant to section 102(a) of CERCLA.
In the ``Background'' section of the NPRM, 87 FR 54420, the Agency
described the role and function of CERCLA and its authority to address
the release or potential threat of a release of hazardous substances,
pollutants, and/or contaminants. This ANPRM is soliciting public input
to inform the EPA's consideration of the potential development of
future regulations pertaining to additional PFAS, PFAS precursors, and/
or categories of PFAS. Given the similarity of the issues of concern in
this ANPRM and the NPRM the EPA encourages interested readers to refer
to the NPRM's ``Background'' section for a detailed understanding of
the statutory context for today's action.
Regarding CERCLA liability and enforcement, EPA is already
separately developing a CERCLA PFAS enforcement discretion and
settlement policy and seeking individual public input on CERCLA PFAS
enforcement/liability concerns through two public listening sessions.
The public input will be reviewed and considered by EPA in drafting the
policy.
V. What information is EPA seeking?
A. Request for Public Input Regarding Potential Future Hazardous
Substance Designation of Seven Other PFAS
As previously discussed, EPA recently issued an NPRM, that, if
finalized, would designate PFOA and PFOS and their salts and structural
isomers as CERCLA hazardous substances. EPA is considering whether to
initiate a future action that would potentially designate the following
additional, seven PFAS and their salts and structural isomers or some
subset thereof, as hazardous substances under CERCLA:
Perfluorobutanesulfonic acid (PFBS), CASRN 375-73-5;
Perfluorohexanesulfonic acid (PFHxS), CASRN 355-46-4;
Perfluorononanoic acid (PFNA), CASRN 375-95-1;
Hexafluoropropylene oxide dimer acid (HFPO-DA), CASRN
13252-13-6 (sometimes called GenX);
Perfluorobutanoic acid (PFBA) CASRN 375-22-4;
Perfluorohexanoic acid (PFHxA) CASRN 307-24-4; and
Perfluorodecanoic acid (PFDA) CASRN 335-76-2.
EPA is soliciting information relevant to whether these compounds
may present substantial danger to public health or welfare or the
environment. For example, the Agency requests information concerning
the characteristics of these compounds, such as mobility, persistence,
prevalence, and other characteristics, that would supplement the
existing toxicity data for these compounds. Although PFAS is a large
class of chemical substances, these seven compounds were identified
based on the availability of toxicity information previously reviewed
by EPA and other Federal agencies. In April 2021 and 2022, EPA issued
the final human health toxicity assessment for PFBS [Human Health
Toxicity Values for Perfluorobutane Sulfonic Acid (CASRN 375-73-5) and
Related Compound Potassium Perfluorobutane Sulfonate (CASRN 29420-49-
3)],\4\ Gen X chemicals [Final Human Health Toxicity Values for
Hexafluoro-propylene Oxide (HFPO) Dimer Acid and its Ammonium Salt,
CASRN 13252-
[[Page 22402]]
12-6 and CSRN 62037-80-3],\5\ and PFBA [IRIS Toxicological Review of
Perfluorobutanoic Acid (PFBA) and Related Salts].\6\ In May 2021, the
Agency for Toxic Substances and Disease Registry (ATSDR) released the
final Toxicological Profile for Perfluoroalkyls, which includes minimal
risk levels for PFOA, PFOS, PFHxS and PFNA.\7\ EPA's Integrated Risk
Information System (IRIS) program is currently developing human health
toxicity assessments of PFHxA, PFNA, PFDA, and PFHxS.\8\
---------------------------------------------------------------------------
\4\ U.S.EPA (2021). Human Health Toxicity Values for
Perfluorobutane Sulfonic Acid (CASRN 375-73-5) and Related Compound
Potassium Perfluorobutane Sulfonate (CASRN 29420-49-3). U.S.
Environmental Protection Agency, Washington, DC. https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=350888.
\5\ U.S. EPA (2021). Human Health Toxicity Values for GenX
Chemicals, Hexafluoropropylene Oxide (HFPO) Dimer Acid and its
Ammonium Salt, (CASRN 13252-12-6 and CSRN 62037-80-3). U.S.
Environmental Protection Agency, Washington, DC. https://www.epa.gov/chemical-research/human-health-toxicity-assessments-genx-chemicals.
\6\ EPA (2022). IRIS Toxicological Review of Perfluorobutanoic
Acid (PFBA) and Related Salts (Final Report). U.S. Environmental
Protection Agency, Washington, DC. https://www.epa.gov/chemical-research/iris-toxicological-review-perfluorobutanoic-acid-pfba-and-related-salts-final.
\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. 13See Office of
Regulatory Enforcement.
\8\ U.S. EPA. IRIS Program Outlook. https://www.epa.gov/iris/iris-program-outlook.
---------------------------------------------------------------------------
To inform EPA's decision whether to potentially designate PFBS,
PFHxS, PFNA, HFPO-DA, PFBA, PFHxA, and PFDA, or some subset thereof, as
hazardous substances in a possible future action, EPA is soliciting
responses to the following questions and requests for the PFAS listed
above, and requests that commentors provide supporting information and
specific scientific literature citations regarding applicable
information where appropriate:
1. Please identify additional relevant information in published
scientific literature or data regarding the environmental fate and
transport (mobility, persistence, or other relevant chemical and
physical properties) and environmental prevalence that would assist EPA
in making determinations regarding potential designation as a hazardous
substance.
2. Are there other PFAS EPA could consider designating as hazardous
substances in a possible future rulemaking? If so, please provide
references to any published, scientific information on the toxicity of
these other PFAS in addition to the information requested in question
one for those substances.
3. Please provide available information that EPA could consider in
preparing an economic analysis of the potential direct and indirect
costs and benefits, including impacts on small entities, associated
with a potential rulemaking designating any of the above-mentioned
compounds as hazardous substances. Although CERCLA section 102(a)
precludes EPA from taking cost into account in the designation of a
hazardous substance, the Agency is requesting this information to
inform its understanding of the potential costs and benefits associated
with any potential future regulatory action.
B. Request for Public Input Regarding Potential Future Hazardous
Substance Designation of Precursors to PFOA, PFOS, and PFAS Listed in
V.A.
EPA is also considering whether to initiate a future action that
would potentially designate precursors to PFOA, PFOS, and possibly the
seven PFAS and their salts and isomers, or some subset thereof, listed
in Section V.A, of this SUPPLEMENTARY INFORMATION section. as hazardous
substances. Thus, EPA is soliciting input regarding information that
will assist the Agency in identifying compounds that degrade to these
PFAS through environmental processes such as biodegradation,
photolysis, and hydrolysis.
An example of how EPA has addressed precursors previously is the
2020 Significant New Use Rule (SNUR) for long-chain perfluoroalkyl
carboxylate (LCPFAC) PFAS which included salts and precursors of these
perfluorinated carboxylates. EPA explained, ``LCPFAC precursors may be
simple derivatives of perfluorooctanoic acid (PFOA) and higher
homologues or certain polymers that may degrade to PFOA or higher
homologues,'' 85 FR 45109 (July 27, 2020).
To inform EPA's decision-making regarding the potential designation
of precursors to PFOA, PFOS, and possibly the seven PFAS, or some
subset thereof, listed in Section V.A as hazardous substances, EPA is
soliciting responses to the following questions and requests on the
topics described below and requests that commentors provide supporting
information and specific scientific literature citations regarding
applicable information where appropriate:
4. Please identify information in published scientific literature
or data regarding the environmental degradation of substances to PFOA,
PFOS, PFBS, PFHxS, PFNA, HFPO-DA, PFBA, PFHxA, and/or PFDA.
5. What factors, if any, regarding degradation time and
environmental conditions (e.g., aqueous vs. arid, anaerobic vs.
aerobic, available nutrients) should be considered in identifying the
appropriate precursor compounds?
6. Please provide relevant information or data in published
scientific literature that characterizes the environmental prevalence
of PFOA, PFOS, PFBS, PFHxS, PFNA, HFPO-DA, PFBA, PFHxA, and/or PFDA
from the degradation of associated precursors
7. With respect to the preceding questions, please identify names
and Chemical Abstracts Service Registry Numbers (CASRNs) or Distributed
Structure-Searchable Toxicity (DSSTox) substance identifier for
substances that EPA should consider as precursor compounds.
8. Available standard analytical methods, such as SW-846 Method
8327 or Method 533, may not include all precursors to PFOA, PFOS, PFBS,
PFHxS, PFNA, HFPO-DA, PFBA, PFHxA, and/or PFDA. Furthermore, the
development of additional methods may be limited by the availability of
chemicals standards. Given these limitations, please provide
information regarding how precursors could be measured in environmental
samples. Additionally, please comment on whether and how EPA should
consider the availability of analytical methods when determining
whether to designate precursors as CERCLA hazardous substances.
9. Please provide available information that EPA could consider in
preparing an economic analysis of the potential direct and indirect
costs and benefits, including impacts on small entities, associated
with a potential rulemaking designating these precursors as CERCLA
hazardous substances. Although CERCLA section 102(a) precludes EPA from
taking cost into account in the designation of a hazardous substance,
the Agency is requesting this information to inform its understanding
of the potential costs and benefits associated with any potential
future regulatory action.
C. Request for Public Input Regarding Potential Future Designation, or
Designations, of Categories of PFAS as Hazardous Substances
EPA is considering whether to initiate a future action that would
potentially designate groups or categories of PFAS as hazardous
substances. A group or category refers to a set of PFAS that share one
or more similar characteristics. Characteristics of interest could
include, but are not limited to, chemical structure (e.g., carbon chain
length, functional group), physical and chemical properties, mode
[[Page 22403]]
of toxicological action, precursors or degradants, or co-occurrence.
EPA's 2020 SNUR for LCPFAC provides an example of a category based
on chemical structure. In the SNUR, the LCPFAC category is defined as
follows, where 5 < n < 21 or 6 < m < 21:
a. CF3(CF2)n-COO-M where M = H\+\
or any other group where a formal dissociation can be made;
b. CF3(CF2)n-CH=CH2;
c. CF3(CF2)n-C(=O)-X where X is
any chemical moiety;
d. CF3(CF2)m-CH2-X
where X is any chemical moiety, and
e. CF3(CF2)m-Y-X where Y = non-S,
non-N heteroatom and where X is any chemical moiety.
In addition to the structures identified above, ``the category also
includes the salts and precursors of these chemical substances. The
precursors may be simple derivatives of PFOA and higher homologues or
polymers that contain or may degrade to PFOA or higher homologues.
These precursors include long-chain fluorotelomers.'' [80 FR 2885]
[FRL-9915-63]. Thus, EPA's 2020 SNUR for LCPFAC included certain PFAS
based on their chemical structure as well as other PFAS based on
whether they degrade to the targeted LCPFACs.
To inform EPA's decision whether to designate certain groups or
categories of PFAS as hazardous substances, EPA is soliciting responses
to the following questions and requests, and requests that commentors
provide supporting information and specific scientific literature
citations regarding applicable information where appropriate:
10. Please identify published scientific literature that can inform
whether categories of PFAS could or could not be designated as
hazardous substances. This could include, for example, scientific data
or information on the similarities or differences of a specific
characteristic among PFAS. This could also include scientific data and
information on the relationship between different characteristics, such
as the relationship between chemical structure and specific chemical,
physical, or toxicological properties.
11. Is there other information that EPA should consider when
determining whether to designate one or more categories of PFAS as
hazardous substances? Please provide comment on the extent to which EPA
could include related PFAS in a given category (e.g., structural
isomers and/or salts).
12. Please provide available information that EPA could consider in
preparing an economic analysis of the potential costs and benefits,
including impacts on small entities, associated with a potential
rulemaking designating categories of PFAS as hazardous substances.
Although CERCLA section 102(a) precludes EPA from taking cost into
account in the designation of a hazardous substance, the Agency is
requesting this information to inform its understanding of the
potential costs and benefits associated with any potential future
regulatory action.
VI. Request for Comment and Additional Information
EPA is seeking comment on all questions and topics described in
this ANPRM and requests that you submit any other information, which
may not be specifically mentioned in this notice, that you believe is
important for EPA to consider in connection with these questions and
topics. At the same time, EPA does not plan to consider comments that
are beyond the scope of the questions and topics described in this
ANPRM. EPA requests that commenters making specific recommendations
include supporting documentation where appropriate.
Instructions for providing written comments are provided under
ADDRESSES, including how to submit any comments that contain PBI.
VII. What are the next steps EPA will take?
EPA intends to carefully review all comments and information
received in response to this ANPRM. Once that review is completed, EPA
would supplement the collected information, as appropriate, with
information that the Agency has obtained independently, to determine
whether a future rulemaking should address the designation of
additional PFAS or precursors as CERCLA hazardous substances or whether
one or more categories of PFAS can be designated as CERCLA hazardous
substances.
VIII. Statutory and Executive Order Reviews
Under Executive Order 12866 (58 FR 51735; October 4, 1993) and
Executive Order 13563 (76 FR 3821; January 21, 2011), this action was
submitted to the OMB for review. Any changes made in response to OMB
recommendations have been documented in the docket for this action.
Because this action does not impose or propose any requirements, and
instead seeks comments and suggestions for the Agency to consider in
possibly developing a subsequent proposed rule, other statutory and
Executive Order reviews that apply to rulemaking do not apply to this
action. Should EPA subsequently determine to pursue a rulemaking, EPA
will address the statutes and Executive Orders applicable to the
rulemaking.
Nevertheless, the Agency welcomes comments and/or information that
would help the Agency to assess any of the following: the potential
impact of a possible future rule on small entities pursuant to the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.); potential impacts on
Federal, state, or local governments pursuant to the Unfunded Mandates
Reform Act (2 U.S.C. 1531-1538); federalism implications pursuant to
Executive Order 13132, entitled Federalism (64 FR 43255; November 2,
1999); availability of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
of 1995, Public Law 104-113; tribal implications pursuant to Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249; November 6, 2000); environmental health or
safety effects on children pursuant to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885; April 23, 1997) and EPA's 2021 Policy on Children's
Health; energy effects pursuant to Executive Order 13211, entitled
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355; May 22, 2001); Paperwork burdens
pursuant to the Paperwork Reduction Act (44 U.S.C. 3501); or human
health or environmental effects on minority or low-income populations
pursuant to Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629; February 16, 1994). The Agency will consider
such comments during the development of any subsequent proposed
rulemaking.
Michael S. Regan,
Administrator.
[FR Doc. 2023-07535 Filed 4-12-23; 8:45 am]
BILLING CODE 6560-50-P