[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]
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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).
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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.
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\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.
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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.
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\3\ U.S. EPA, Comptox Chemicals Dashboard, U.S. Environmental
Protection Agency https://comptox.epa.gov/dashboard/.
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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\
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\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.
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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