[Federal Register Volume 89, Number 27 (Thursday, February 8, 2024)]
[Proposed Rules]
[Pages 8606-8621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02324]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 261 and 271
[EPA-HQ-OLEM-2023-0278; FRL-9248-01-OLEM]
RIN 2050-AH26
Listing of Specific PFAS as Hazardous Constituents
AGENCY: Environmental Protection Agency (EPA)
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
proposing to amend its regulation under the Resource Conservation and
Recovery Act (RCRA) by adding nine specific per-and polyfluoroalkyl
substances (PFAS), their salts, and their structural isomers, to its
list of hazardous constituents. These nine PFAS are perfluorooctanoic
acid (PFOA), perfluorooctanesulfonic acid (PFOS),
perfluorobutanesulfonic acid (PFBS), hexafluoropropylene oxide-dimer
acid (HFPO-DA or GenX), perfluorononanoic acid (PFNA),
perfluorohexanesulfonic acid (PFHxS), perfluorodecanoic acid (PFDA),
perfluorohexanoic acid (PFHxA), and perfluorobutanoic acid (PFBA).
EPA's criteria for listing substances as hazardous constituents under
RCRA require that they have been shown in scientific studies to have
toxic, carcinogenic, mutagenic, or teratogenic effects on humans or
other life forms. EPA reviewed and evaluated key toxicity and
epidemiological studies and assessments for the nine PFAS to determine
whether the available data for these PFAS meet the Agency's criteria
for listing substances as hazardous constituents under RCRA. Based on
EPA's evaluation, the above nine PFAS, their salts, and their
structural isomers meet the criteria for being listed as RCRA hazardous
constituents. As a result of this proposed rule, if finalized, when
corrective action requirements are imposed at a facility, these PFAS
would be among the hazardous constituents expressly identified for
consideration in RCRA facility assessments and, where necessary,
further investigation and cleanup through the RCRA corrective action
process at RCRA treatment, storage, and disposal facilities.
DATES: Comments must be received on or before April 8, 2024.
ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OLEM-2023-0278, 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: Narendra Chaudhari, Office of Resource
Conservation and Recovery (5304T), Environmental Protection Agency,
1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number
202-566-0495; email address: [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Public Participation
A. Written Comments
II. General Information
A. Does this action apply to me?
B. What action is the Agency taking?
C. Why is the Agency taking this action?
D. Impacts of the Proposed Rule
E. What are the incremental costs and benefits of this action?
III. Legal Authority
A. What is the Agency's authority for taking this action?
B. RCRA Sections 3001 and 3004(u) Preclude Consideration of Cost
in Identifying Hazardous Constituents
IV. Background
A. What are PFAS?
B. What has been learned from PFAS toxicity studies?
[[Page 8607]]
V. Review of the Available Toxicity and Health Effects Information
for PFAS
A. PFAS Identified To Have Sufficient Information To Be
Evaluated for Appendix VIII Listing Criteria
B. Summary of Toxicity and Health Effects Information for the
Nine PFAS
C. EPA's Proposed Conclusions on Whether the Nine PFAS, Their
Salts, and Their Structural Isomers Meet the Criteria for Listing on
Appendix VIII
VI. State Authorization
A. Applicability of the Rule in Authorized States
B. Effect on State Authorization
VII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 14094: Modernizing Regulatory Review
B. Paperwork Reduction Act (PRA)
C. Regulatory Flexibility Act (RFA)
D. Unfunded Mandates Reform Act (UMRA)
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act (NTTAA)
J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations; Executive Order 14096: Revitalizing Our Nation's
Commitment to Environmental Justice for All
VIII. References
List of Abbreviations and Acronyms
The following list is for reference only and is not exhaustive:
AFFF Aqueous film-forming foam
ATSDR Agency for Toxic Substances and Disease Registry
CDC Centers for Disease Control and Prevention
CERCLA Comprehensive Environmental Response, Compensation, and
Liability Act
CFR Code of Federal Regulations
ECF Electrochemical fluorination
EJ Environmental justice
EPA Environmental Protection Agency
FR Federal Register
GenX Processing aid technology that includes Hexafluoropropylene
Oxide-Dimer acid and its ammonium salt
HFPO-DA Hexafluoropropylene Oxide-Dimer acid
HSWA Hazardous and Solid Waste Amendments of 1984
mg/kg milligram per kilogram
mg/kg/day milligram per kilogram per day
NAICS North American Industrial Classification System
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
PFOA Perfluorooctanoic acid
PFOS Perfluorooctanesulfonic acid
RCRA Resource Conservation and Recovery Act
RFA Regulatory Flexibility Act
RfD Reference dose
SWMU Solid Waste Management Unit
TSDFs Treatment, storage, and disposal facilities
UMRA Unfunded Mandates Reform Act
U.S. United States
U.S.C. United States Code
I. Public Participation
A. Written Comments
Submit your comments, identified by Docket ID No. EPA-HQ-OLEM-2023-
0278, at https://www.regulations.gov (our preferred method), or the
other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. 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. 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.
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. General Information
A. Does this action apply to me?
The purpose of this proposed rulemaking is to add nine PFAS, their
salts, and their structural isomers, to the list of hazardous
constituents in 40 CFR part 261 Appendix VIII (Appendix VIII). Entities
potentially affected by this action include hazardous waste treatment,
storage, and disposal facilities (TSDFs) with solid waste management
units (SWMUs) that have released or could release any of the PFAS
proposed to be listed as RCRA hazardous constituents. EPA has
identified 1,740 such facilities, which could be subject to additional
corrective action requirements (pursuant to RCRA section 3004(u) and
(v)) to address releases not already subject to corrective action
pursuant to EPA's corrective action regulations.
The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide for readers to determine whether this action may
affect them. For further details about the potentially affected
universe of facilities, refer to Section 3.2 of the draft Economic
Assessment of the Potential Costs, Benefits, and Other Impacts of the
Proposed Rulemaking to List Specific PFAS as RCRA Hazardous
Constituents (Ref. 41), which can be found in the public docket for
this action. Potentially affected entities may include:
Table II-1--Potentially Affected Entities
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Facilities
Universe of with higher
NAICS (3-digits) NAICS description facilities likelihood of
handling PFAS
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111.............. Crop Production...... 2 ..............
115.............. Support Activities 1 ..............
for Agriculture and
Forestry.
211.............. Oil and Gas 2 1
Extraction.
213.............. Support Activities 2 ..............
for Mining.
[[Page 8608]]
221.............. Utilities............ 25 1
233.............. Building, Developing, 1 ..............
and General
Contracting.
238.............. Specialty Trade 2 ..............
Contractors.
311.............. Food Manufacturing... 3 ..............
312.............. Beverage and Tobacco 1 ..............
Product
Manufacturing.
313.............. Textile Mills........ 4 4
321.............. Wood Product 52 ..............
Manufacturing.
322.............. Paper Manufacturing.. 3 1
323.............. Printing and Related 1 ..............
Support Activities.
324.............. Petroleum and Coal 79 76
Products
Manufacturing.
325.............. Chemical 335 278
Manufacturing.
326.............. Plastics and Rubber 14 9
Products
Manufacturing.
327.............. Nonmetallic Mineral 23 9
Product
Manufacturing.
331.............. Primary Metal 68 1
Manufacturing.
332.............. Fabricated Metal 68 28
Product
Manufacturing.
333.............. Machinery 20 ..............
Manufacturing.
334.............. Computer and 46 19
Electronic Product
Manufacturing.
335.............. Electrical Equipment, 12 3
Appliance, and
Component
Manufacturing.
336.............. Transportation 64 ..............
Equipment
Manufacturing.
337.............. Furniture and Related 1 ..............
Product
Manufacturing.
339.............. Miscellaneous 14 2
Manufacturing.
422.............. Wholesale Trade, 6 ..............
Nondurable Goods.
423.............. Merchant Wholesalers, 14 ..............
Durable Goods.
424.............. Merchant Wholesalers, 38 38
Nondurable Goods.
447.............. Gasoline Stations.... 1 ..............
454.............. Non-store Retailers.. 1 ..............
481.............. Air Transportation... 3 ..............
482.............. Rail Transportation.. 4 ..............
484.............. Truck Transportation. 2 ..............
486.............. Pipeline 4 ..............
Transportation.
488.............. Support Activities 11 1
for Transportation.
493.............. Warehousing and 22 ..............
Storage.
519.............. Other Information 1 ..............
Services.
525.............. Funds, Trusts, and 3 ..............
Other Financial
Vehicles.
531.............. Real Estate.......... 12 ..............
532.............. Rental and Leasing 4 ..............
Services.
541.............. Professional, 39 ..............
Scientific, and
Technical Services.
551.............. Management of 2 ..............
Companies and
Enterprises.
561.............. Administrative and 22 ..............
Support Services.
562.............. Waste Management and 461 359
Remediation Services.
611.............. Educational Services. 31 ..............
621.............. Ambulatory Health 2 ..............
Care Services.
622.............. Hospitals............ 3 ..............
811.............. Repair and 7 ..............
Maintenance.
813.............. Religious, 2 ..............
Grantmaking, Civic,
Professional, and
Similar
Organizations.
921.............. Executive, 13 ..............
Legislative, and
Other General
Government Support.
922.............. Justice, Public 2 ..............
Order, and Safety
Activities.
924.............. Administration of 9 ..............
Environmental
Quality Programs.
925.............. Administration of 1 ..............
Housing Programs,
Urban Planning, and
Community
Development.
926.............. Administration of 3 ..............
Economic Programs.
927.............. Space Research and 5 ..............
Technology.
928.............. National Security and 142 1
International
Affairs.
Missing.......... ..................... 27 ..............
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Total........ ..................... 1,740 831
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Notes: 1. This proposed rule only lists specific PFAS as hazardous
constituents in 40 CFR part 261, Appendix VIII. EPA notes that listing
these PFAS as RCRA hazardous constituents does not make them, or the
wastes containing them, RCRA hazardous wastes.
[[Page 8609]]
B. What action is the Agency taking?
This action is proposing to amend EPA's regulations under RCRA by
listing the following nine PFAS (names given for acid forms below),
their salts, and their structural isomers \1\ as hazardous constituents
in 40 CFR part 261 Appendix VIII:
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\1\ All references to PFOA, PFOS, PFBS, HFPO-DA (or GenX), PFNA,
PFHxS, PFDA, PFHxA, and PFBA or to all nine PFAS in this notice are
meant to include their salts and their linear and branched
structural isomers, except where the notice expressly distinguishes
the different forms. The CASRN for the linear acid version is given
for reference. Linear and branched structural isomers maintain the
carboxylic acid and sulfonic acid functional groups, respectively,
but have different arrangements of the carbon atoms in the
fluorinated carbon chain. The reference to HFPO-DA only applies to
the specific structural isomer noted, including both enantiomers.
1. Perfluorooctanoic acid (PFOA; CASRN 335-67-1). PFOA is an
eight-carbon molecule with seven fully fluorinated carbon atoms and
one carboxylic acid functional group. It has been used as a
processing aid to produce fluoropolymers and has been found in
cleaning agents, waxes, aqueous film-forming foam (AFFF), and other
products.
2. Perfluorooctanesulfonic acid (PFOS; CASRN 1763-23-1). PFOS is
a fully fluorinated eight-carbon molecule with one sulfonic acid
functional group. It has been used in AFFF, in surface treatments of
textiles to provide oil and water resistance, in metal plating, and
other uses and industries.
3. Perfluorobutanesulfonic acid (PFBS; CASRN 375-73-5). PFBS is
a fully fluorinated four-carbon molecule with one sulfonic acid
group. It has been used as a replacement for PFOS and has been used
in the manufacture of paints and cleaning agents, metal plating,
AFFF, to provide oil and water resistance, and other uses and
industries.
4. Hexafluoropropylene oxide-dimer acid (HFPO-DA or GenX; CASRN
13252-13-6). HFPO-DA is a six-carbon molecule consisting of five
fully fluorinated carbon atoms, one ether functional group, and one
carboxylic acid functional group. HFPO-DA is a chemical associated
with GenX processing aid technology used to make fluoropolymers
without the use of PFOA.
5. Perfluorononanoic acid (PFNA; CASRN 375-95-1). PFNA is a
nine-carbon molecule with eight fully fluorinated carbon atoms and
one carboxylic acid functional group. It has been used as a
processing aid to produce fluoropolymers and has been used or found
in metal plating, cleaning agents, waxes, AFFF, energetic materials,
and other products.
6. Perfluorohexanesulfonic acid (PFHxS; CASRN 355-46-4). PFHxS
is a fully fluorinated six-carbon molecule with one sulfonic acid
functional group. It has been used in AFFF, in surface treatments of
textiles to provide oil and water resistance, in metal plating, and
other uses and industries.
7. Perfluorodecanoic acid (PFDA; CASRN 335-76-2). PFDA is a ten-
carbon molecule with nine fully fluorinated carbon atoms and a
carboxylic acid functional group. It has been used as a processing
aid to produce fluoropolymers and has been used or found in metal
plating solutions, cleaning agents, waxes, AFFF, and other products.
8. Perfluorohexanoic acid (PFHxA; CASRN 307-24-4). PFHxA is a
six-carbon molecule with five fully fluorinated carbon atoms and a
carboxylic acid functional group. It has been used or found in metal
plating solutions, cleaning agents, waxes, AFFF, and other products.
9. Perfluorobutanoic acid (PFBA; CASRN 375-22-4). PFBA is a
four-carbon molecule with three fully fluorinated carbon atoms and
one carboxylic acid functional group. It has been used or found in
metal plating, cleaning agents, waxes, AFFF, energetic materials,
and other products.
In addition, if finalized, this action would add this listing
action, as it would apply for corrective action purposes, to Table 1 in
40 CFR 271.1. Table 1 in 40 CFR 271.1 identifies the Federal program
requirements that are promulgated pursuant to HSWA and take effect in
all States, regardless of their authorization status.
C. Why is the Agency taking this action?
EPA is proposing to list the nine PFAS, their salts, and their
structural isomers as RCRA hazardous constituents because animal and
epidemiological studies and assessments have shown that exposure to
these PFAS have toxic and adverse effects in animals, humans, or both.
The toxic and adverse effects include reproductive effects,
developmental effects, increased risk of some cancers, reduced immune
system response, and increased cholesterol levels (Refs. 1 and 2).
In addition, EPA has received three petitions requesting that the
Agency take regulatory actions on PFAS under RCRA. The petitions were
submitted by Public Employees for Environmental Responsibility (PEER),
Environmental Law Clinic of University of California, Berkeley (UC
Berkeley), and the Governor of New Mexico. PEER's petition, submitted
on September 19, 2019, requested that EPA develop regulations for
listing wastes containing PFAS (long-chain and short chain) as
hazardous wastes under Subtitle C of RCRA to ensure the safe management
and disposal of these wastes (Ref. 3). UC Berkeley's petition,
submitted on January 15, 2020, on behalf of six community and
environmental advocacy groups from six different states (California,
Alaska, North Carolina, Pennsylvania, Michigan, and Colorado),
requested that EPA promulgate regulations listing wastes containing
PFOA, PFOS, GenX chemicals (including HFPO-DA and its ammonium salt),
or any combination of these, as hazardous wastes and that the RCRA
hazardous waste listings for PFOA and PFOS wastes extend to cover the
full chemical subclass of each (long-chain perfluoroalkyl carboxylates
and sulfonates) (Ref. 4). The Governor of New Mexico's petition,
submitted on June 23, 2021, incorporated the above two petitions by
reference and requested a timely listing of PFAS, as a class of
chemicals, as hazardous wastes under the RCRA Subtitle C regulations,
or in the alternative, a listing of individual PFAS chemicals as
hazardous wastes under the regulations (Ref. 5). EPA acted upon the
Governor of New Mexico's petition with its October 26, 2021 letter
(Ref. 6). EPA indicated in that letter that it would be initiating the
rulemaking process for two rulemakings. This proposal, along with EPA's
proposal titled Definition of Hazardous Waste Applicable to Corrective
Action for Releases from Solid Waste Management Units, constitute
initiation of those rulemakings.
EPA evaluated the information in the above three petitions in
addition to the toxicity and health effects data available for PFAS and
determined that the existing data for PFAS supports listing the nine
PFAS, their salts, and their structural isomers at issue in this action
as RCRA hazardous constituents in 40 CFR part 261 Appendix VIII (see
section V for additional information).
A hazardous constituent listing is a step toward a potential
hazardous waste listing. To list a waste as a RCRA hazardous waste
under 40 CFR 261.11(a)(3), the Agency must show that the waste contains
a hazardous constituent listed on Appendix VIII and determine that it
is capable of posing a substantial hazard. This determination requires
EPA to collect and carefully consider information on the eleven
regulatory factors specified in 40 CFR 261.11(a)(3).\2\ If finalized,
this hazardous constituent listing would form part of the basis for any
future action the Agency may take to list these substances as a
hazardous waste. EPA will continue to evaluate available data to
determine whether a future regulatory action to list certain PFAS, or
waste containing such PFAS, as regulatory hazardous waste is
appropriate. In the meantime, based on the toxicity and human health
effects data available and
[[Page 8610]]
evaluated by EPA for each of the nine PFAS, EPA is moving forward with
this regulatory action under RCRA to add the nine PFAS, their salts,
and their structural isomers, as hazardous constituents in 40 CFR part
261 Appendix VIII.
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\2\ The eleven factors to be considered are: constituent
toxicity, concentration, migration potential, persistence,
degradation product potential, bioaccumulation potential, plausible
management scenarios, waste quantity, damage cases, coverage by
other regulatory programs, and other factors as may be appropriate.
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Finally, EPA is proposing to designate these PFAS as hazardous
constituents so that when corrective action requirements are imposed by
program implementers these PFAS would be among the constituents
expressly identified for consideration in RCRA facility assessments,
and where necessary, further investigation and cleanup through the RCRA
corrective action process at RCRA TSDFs.
D. Impacts of the Proposed Rule
EPA is proposing to list nine PFAS, their salts, and their
structural isomers, as RCRA hazardous constituents in 40 CFR part 261
Appendix VIII. The Appendix VIII list of hazardous constituents does
not by itself impose regulatory requirements. Rather, references to
hazardous constituents are found in various sections of the Federal
hazardous waste regulations in Parts 261, 264, 265, 268, and 270.
The principal impacts of this rule will be on the RCRA Corrective
Action Program. EPA expects that the proposed rule, combined with the
Agency's increased attention to addressing risks associated with
PFAS,\3\ would facilitate and likely result in additional corrective
action to address releases of specific PFAS listed as RCRA hazardous
constituents. RCRA section 3004(u) requires that any permit issued to a
TSDF after November 8, 1984 require corrective action for all releases
of hazardous waste or hazardous constituents from solid waste
management units at the facility. In the 1990 Subpart S proposed
corrective action rule (see 55 FR 30798; July 27, 1990), EPA stated its
view that the use of the phrase ``hazardous waste or constituents'' in
section 3004(u) indicates that Congress was particularly concerned that
the Agency use its corrective action authority to address hazardous
constituents and stated that the term ``hazardous constituents'' in
section 3004(u) means those constituents found in Appendix VIII.\4\
Thus, hazardous constituents listed on Appendix VIII are assessed for
and addressed as part of the corrective action process as necessary to
protect human health and the environment. As a result of this proposed
rule, nine PFAS, their salts, and their structural isomers would be
among the hazardous constituents expressly identified for consideration
in RCRA facility assessments and, where necessary, further
investigation and cleanup through the corrective action process.\5\
Additional discussion of this topic can be found in the draft Economic
Assessment (Ref. 41). Applicability of the rule in authorized states
and effect on state authorization are discussed in Section VI of this
preamble.
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\3\ For example, see, PFAS Strategic Roadmap, EPA's Commitment
to Action 2021-2024, https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf.
\4\ EPA, in addition, proposed to include constituents appearing
in 40 CFR part 264 Appendix IX as hazardous constituents subject to
corrective action. 55 FR at 30809.
\5\ A facility-specific administrative record would still be
needed to support corrective action measures imposed on the basis of
protection of human health or the environment.
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While various RCRA regulatory provisions, unrelated to corrective
action, reference hazardous constituents, EPA expects that any impacts
from those references would be negligible, as EPA expects that the
processes and procedures currently in place to meet the requirements of
these regulations would likely address PFAS as well as other
constituents already on Appendix VIII. Furthermore, there are also a
few references to hazardous constituents or Appendix VIII in other,
non-RCRA, EPA regulations; EPA also believes the impacts from these
regulations would be negligible.
The scope of this proposal is limited. Listing these PFAS as RCRA
hazardous constituents does not make them, or the wastes containing
them, RCRA hazardous wastes. Additionally, only facilities that are
hazardous waste TSDFs are subject to RCRA corrective action. 42 U.S.C.
3004(u), (v). Therefore, EPA anticipates that, for example, a facility
such as a publicly owned treatment works (POTW), would not be
potentially affected by the RCRA corrective action requirements unless
the facility is a hazardous waste TSDF. Finally, the domestic sewage
exclusion in 40 CFR 261.4(a)(1), which excludes domestic sewage and any
mixture of domestic sewage and other wastes that passes through a sewer
system from being considered solid wastes (with some exceptions),
applies to the POTW influent.
Similarly, solid waste disposal facilities, such as municipal
waste, or construction and demolition landfills would not be
potentially affected by the RCRA corrective action requirements unless
such facilities also operate as hazardous waste TSDFs.
EPA solicits comment on the impacts of this rule on the RCRA
Corrective Action Program and the interaction with other existing RCRA
regulatory provisions including those non-corrective action provisions
that reference hazardous constituents.
E. What are the incremental costs and benefits of this action?
EPA has evaluated the potential impacts and associated costs and
benefits of this proposed rule. The draft Economic Assessment (EA) for
this action, Economic Assessment of the Potential Costs, Benefits, and
Other Impacts of the Proposed Rulemaking to List Specific PFAS as RCRA
Hazardous Constituents (Ref. 41), is available in the docket for this
action. If finalized, the quantifiable direct annual social cost of
this proposed rule is estimated to be negligible, as EPA anticipates no
significant direct impacts (see Sections II.A. and II.D. of this
preamble).
However, listing the specific PFAS as RCRA hazardous constituents
may have indirect, indeterminate impacts associated with potential
increases in the speed, extent, and total number of corrective action
activities at certain TSDFs to address PFAS releases. Such potential
increases are dependent upon subsequent actions and numerous factors,
including decisions made and implemented by the permitting authority
regarding associated corrective actions at certain TSDFs.
RCRA Corrective Action Program implementers already have authority
to require investigation and cleanup at RCRA TSDFs for substances not
identified as hazardous constituents either through state cleanup
regulations, or through the authority provided by section 270.32(b)(2),
EPA's omnibus authority, and authorized state analogues. In addition,
cleanup at TSDFs can also be required or conducted pursuant to CERCLA,
such as ongoing DOD PFAS investigations and responses under CERCLA. EPA
has also proposed to designate certain PFAS as CERCLA hazardous
substances (see 87 FR 54415; September 6, 2022). It is uncertain how
many investigative and response actions for releases of these nine
PFAS, and their salts, and structural isomers, would occur under the
authority of this rule that would not have occurred absent this rule
under one of these other authorities.
While there are significant uncertainties about potential indirect
impacts and the precise costs and benefits associated with corrective
action are nonquantifiable due to these significant uncertainties, EPA
provides hypothetical scenarios for how corrective action activity
costs may increase for certain TSDFs as a result of
[[Page 8611]]
addressing PFAS contamination. EPA also considers potential indirect
benefits associated with corrective action, including avoided risk
exposures, improved waste management practices, and improved quality of
information about PFAS cleanup efforts. Other indirect effects may be
experienced as a result of hastened investigative and cleanup
activities that would otherwise be implemented pursuant to RCRA or
other authorities which are not predicated upon a hazardous constituent
determination. The full discussion of direct and indirect impacts is
presented in the EA, which can be found in the public docket. EPA
requests comment on specific aspects of the EA; see EA sections
4.3.3.1, 4.3.3.2, and 5.3.4.5. EPA also solicits comment on whether the
potential impacts of this rulemaking may be affected by the
availability of other authorities that program implementers might rely
on to satisfy corrective action requirements to address PFAS at RCRA
facilities including other RCRA authorities such as omnibus permitting
authority and RCRA section 7003, and CERCLA.
III. Legal Authority
A. What is the Agency's authority for taking this action?
EPA is proposing these regulations under the authority of sections
2002(a), 3001, and 3004 of the Solid Waste Disposal Act of 1965, as
amended by the Resource Conservation and Recovery Act of 1976 (RCRA),
as amended, by the Hazardous and Solid Waste Amendments of 1984 (HSWA),
among other amendments, 42 U.S.C. 6912(a), 6921, and 6924. These public
laws combined are commonly referred to as the ``Resource Conservation
and Recovery Act'' (RCRA) and will be referred to as such for the
remainder of this notice.
RCRA was enacted to effectively manage hazardous and solid wastes
and thereby protect human health and the environment. RCRA 2002(a)
provides EPA the general authority to prescribe regulations to carry
out the functions of RCRA. RCRA section 3001 provides EPA with the
authority to promulgate criteria for identifying and listing hazardous
waste, and to identify and list hazardous wastes based on those
criteria.\6\ On May 19, 1980, EPA promulgated the initial list of
hazardous constituents under this authority, which serve as part of the
criteria for listing hazardous wastes,\7\ 40 CFR part 261, Appendix
VIII. EPA has amended Appendix VIII several times to list or delete
hazardous constituents. The criteria for listing substances as RCRA
hazardous constituents on Appendix VIII are specified under 40 CFR
261.11(a)(3). The criteria state that substances will be listed on
Appendix VIII ``only if they have been shown in scientific studies to
have toxic, carcinogenic, mutagenic or teratogenic effects on humans or
other life forms.''
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\6\ RCRA section 3001(a) and (b), 42 U.S.C. 6921(a), (b).
\7\ Hazardous Waste Management System: Identification and
Listing of Hazardous Waste, 45 FR 33084, May 19, 1980.
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The 1984 Hazardous and Solid Waste Amendments (HSWA) to RCRA
expanded EPA's authority to address releases of hazardous waste and
constituents at RCRA treatment, storage, and disposal facilities. This
includes section 3004(u) and (v) of RCRA, which provides for corrective
action requirements at permitted facilities. Section 3004(u) authorizes
EPA to promulgate standards requiring corrective action for all
releases of hazardous waste and hazardous constituents from solid waste
management units at permitted hazardous waste treatment, storage, or
disposal facilities regardless of the time at which waste was placed in
the units.\8\ Section 3004(u) further mandates that permits require
financial assurance for completion of corrective action.
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\8\ Section 3004(u) provides that ``standards promulgated under
this section shall require, and a permit issued . . . by the
Administrator or a State shall require, corrective action for all
releases of hazardous waste or constituents from any solid waste
management unit . . . regardless of the time at which waste was
placed in such unit.''
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Section 3004(v) directed EPA to require that corrective action be
taken beyond facility boundaries where necessary to protect human
health and the environment unless facility owners/operators demonstrate
to the Agency's satisfaction that, despite their best efforts, they
were unable to obtain the necessary permission to undertake off-site
corrective action. 40 CFR 264.101 essentially codifies these RCRA
section 3004(u) and (v) requirements. EPA has interpreted the hazardous
constituents subject to corrective action as including those
constituents identified in 40 CFR part 261 Appendix VIII and 40 CFR
part 264 Appendix IX, 55 FR 30798, 30809 (July 27, 1990).
A significant part of EPA's objective in proposing to add the new
constituents to Appendix VIII is to ensure that releases of those
substances can be effectively and efficiently considered and addressed
through corrective action. In addition, the principal regulatory impact
of this action would be to expand the scope of constituents subject to
routine consideration in the corrective action process. Therefore, EPA
is relying on its authority under RCRA section 3004(u) to propose
listing these PFAS as hazardous constituents for the purposes of
corrective action.
B. RCRA Sections 3001 and 3004(u) Preclude Consideration of Cost in
Identifying Hazardous Constituents
In RCRA section 3001, Congress directed EPA to promulgate criteria
for identifying the characteristics of hazardous waste and listing
hazardous waste. Cost has no bearing on whether a material is
hazardous, under the ordinary meaning of the word. Consistent with this
ordinary meaning, Congress directed EPA to take into account
``toxicity, persistence, and degradability in nature, potential for
accumulation in tissue, and other related factors such as flammability,
corrosiveness, and other hazardous characteristics.'' RCRA section
3001(a); see also, RCRA section 3001(b) (``such as identified
carcinogens, mutagens, or teratogens''). These statutory factors focus
on various hazardous characteristics. Congress did not list cost as a
required or permissible factor, and none of the Congressionally-listed
statutory factors encompass a consideration of costs. This reflects the
Agency's longstanding position. See, Hazardous Waste Management System:
Identification and Listing of Hazardous Waste, 45 FR 33084, 33089, May
19, 1980. Additionally, determining whether something is ``toxic'' or
has any of the other identified characteristics described in section
3001 does not naturally lend itself to considerations of cost--that is,
whether a substance is or is not toxic is determined by examining the
properties of the substance at issue.
In carrying out this statutory obligation, EPA has promulgated
regulatory criteria for adding constituents to Appendix VIII.
Consistent with the health- and hazard- related factors identified in
section 3001(a) and (b), these criteria (``toxic, carcinogenic,
mutagenic or teratogenic effects on humans or other life forms.''), 40
CFR 261.11(a)(3), do not include cost nor does cost have any bearing or
relevance on them.
EPA interprets the RCRA section 3004(u) corrective action standard-
setting authority as authorizing the identification of hazardous
constituents subject to corrective action. Moreover, Congress
identified Appendix VIII as the source for the hazardous constituents
referenced in 3004(u). See
[[Page 8612]]
H.R. REP. 98-198, 98th Cong., 1st Sess., pt. 1 at 60-61 (1983),
reprinted in 1984 U.S.C.C.A.N. 5576, 5619-20. (``The term `hazardous
constituent' as used in this provision is intended to mean those
constituents listed in Appendix VIII of the RCRA regulations.''). As
discussed above, cost is not a relevant consideration under the
ordinary meaning of ``hazardous.'' Thus, as under section 3001, cost
may not be considered in identifying hazardous constituents under
section 3004(u).
If finalized, this rule may have indirect, indeterminate costs and
benefits associated with the speed, extent, and total number of
corrective action activities at certain TSDFs to address these nine
PFAS, their salts, and their structural isomers. EPA has presented cost
and benefit information consistent with Executive Order 12866 in the EA
for this rule, but these costs and benefits do not form any part of
EPA's decision to designate these PFAS substances as hazardous
constituents.
IV. Background
A. What are PFAS?
Per- and polyfluoroalkyl substances, also known as PFAS, are a
class of manufactured chemicals that have been widely used in many
industrial and consumer products since the 1940s, and they are still
being used today. PFAS have been or are currently being manufactured
for a variety of different uses, ranging from adhesives, coatings for
clothes and furniture, fire-fighting foam, and other uses. PFAS have
been released into the environment during the manufacturing process and
from various uses in industrial, commercial, and consumer settings.
PFAS have carbon chains with fluorine atoms attached to the carbons
potentially linked to functional groups. Because the carbon-fluorine
bond is the strongest known single carbon bond, these chemicals do not
degrade readily in the environment (Ref. 7). However, some bigger
molecules where a portion of the molecule has fluorinated carbons,
known as precursors, can degrade or transform into other PFAS that are
known to be toxic and are potentially mobile in the subsurface
environment. For example, each of the nine PFAS that are the subject of
this proposed rulemaking could be present as a result of degradation of
a precursor. This proposed rulemaking applies to the PFAS identified in
this action regardless of whether they exist as chemical substances on
their own or result from degradation of precursors. There are thousands
of different PFAS (https://comptox.epa.gov/dashboard/chemical-lists/PFASMASTER), some of which have been more widely used and studied than
others. A growing body of scientific evidence shows that exposure to
certain PFAS can adversely impact human health and other living things.
B. What has been learned from PFAS toxicity studies?
Certain PFAS, such as perfluorinated alkyl acids (e.g., PFOA,
PFOS), are manufactured in both acid and salt forms. In aqueous
environments, such as groundwater or the digestive system of humans and
other animals, the acids and salts will dissociate into the ion form.
Exposure to the salts or acid form of certain PFAS have been shown to
lead to similar toxicity, as it has often been the salt form used in
experimental animal toxicity studies.
PFAS may also be present in products and in the environment as
mixtures of linear and branched isomers, depending on the methods by
which they are manufactured. Most studies do not clearly state what
isomers were used, but of those that do, a mixture of linear and
branched isomers was generally used. Studies generally only state the
material purity, but purity does not refer to isomeric mixture. As a
result, it's not currently practicable to differentiate the toxicity of
the individual isomers, including the linear isomer. Therefore, any
reference in this proposal to toxicity and health effects or listing of
the nine PFAS as hazardous constituents on Appendix VIII includes the
acids, salts, and structural isomers of the nine PFAS.
V. Review of the Available Toxicity and Health Effects Information for
PFAS
A. PFAS Identified To Have Sufficient Information To Be Evaluated for
Appendix VIII Listing Criteria
EPA's evaluation of the available toxicity and health effects
information for PFAS focused on PFAS that have final peer reviewed
assessments and those with toxicity studies supporting ongoing
assessments. The toxicity and health effects assessments that EPA is
relying on for this proposal are those published by EPA and the Agency
for Toxic Substances and Disease Registry (ATSDR).
The EPA published a final peer reviewed toxicity and health effects
assessment for PFOA and PFOS in 2016 (Ref. 9 and 14). Updated, draft
toxicity and health effects assessments for PFOA and PFOS were
published in 2023 as part of EPA's proposed National Primary Drinking
Water Regulation for specific PFAS (Ref. 10 and 11). In 2021, EPA
published a final peer reviewed toxicity and health effects assessment
for PFBS (Ref. 15) and for HFPO-DA (Ref. 16). EPA published final peer
reviewed toxicity and health effects assessments for PFBA in 2022 (Ref.
17) and PFHxA in 2023 (Ref. 32). EPA published a draft toxicity and
health effects assessment for PFDA in 2023 and sought public comment
and external peer review (Ref. 31), the final peer review report has
been published (Ref. 45). EPA's ongoing toxicity and health effects
assessment process for PFDA is expected to be finalized in the near
future. EPA also released a draft toxicity and health effects
assessment for PFHxS in 2023 and sought public comment and external
peer review (Ref. 44). EPA's ongoing toxicity and health effects
assessment for PFNA is in progress. ATSDR, in their 2021 Toxicological
Profile for Perfluoroalkyls, reviewed toxicity information for twelve
PFAS including PFOA, PFOS, PFBS, PFBA, PFHxA, PFNA, PFDA, and PFHxS
(Ref. 18). In this Profile ATSDR derived toxicity values for PFOA,
PFOS, PFNA, and PFHxS.
Assessments conducted by EPA, ATSDR, and information published in
scientific studies support the conclusion that PFOA, PFOS, PFBS, HFPO-
DA, PFBA, PFNA, PFHxS, PFDA, and PFHxA warrant a hazardous constituent
designation.
It should be noted that EPA's criteria for listing a substance as a
hazardous constituent on Appendix VIII under 40 CFR 261.11(a)(3) do not
require a finalized toxicity assessment, or exhaustive search and
evaluation of all published scientific studies for the substance, or a
final toxicity value. Rather, the criteria for listing substances on
Appendix VIII only require that scientific studies have shown one or
more of the criteria effects for the substances (i.e., toxic,
carcinogenic, mutagenic or teratogenic effects).
The Agency's evaluation has determined that more than the required
scientific information showing toxic, carcinogenic, mutagenic or
teratogenic effects already exists to list the selected PFAS as RCRA
hazardous constituents.
B. Summary of Toxicity and Health Effects Information for the Nine PFAS
Below are brief summaries of the toxicity and adverse health
effects information for the nine PFAS from the final peer reviewed
assessments or toxicity studies supporting ongoing assessments. Please
see the list of references and docket for this proposed rule to
completely examine these assessments and studies which form the basis
of EPA's proposed conclusions that these PFAS, their salts, and their
[[Page 8613]]
structural isomers meet the criteria for listing as RCRA hazardous
constituents.
Interpreting epidemiology data for PFAS and determining the
individual toxicological responses of each PFAS individually (or their
interaction effects) is an ongoing challenge because multiple PFAS have
been shown to induce similar adverse health effects (e.g., immune,
developmental, hepatic, cardiovascular effects, cancer). This is a
subject where the science is rapidly evolving.
1. PFOA
Human epidemiology data report associations between PFOA exposure
and high cholesterol, increased liver enzymes and serum lipid levels,
decreased vaccination response, thyroid disorders, pregnancy-induced
hypertension and preeclampsia, cancer (testicular and kidney), and
decreases in birth weight (Refs. 9 and 18).
Oral animal studies of short-term subchronic and chronic duration
are available in multiple species including monkeys, rats, and mice.
These studies report developmental effects, liver toxicity including
degenerative and necrotic effects, kidney toxicity, immune effects
including impaired response to antigens, and cancer (liver, testicular,
and pancreatic). Developmental effects observed in animals include
decreased survival, delayed eye opening and reduced ossification,
skeletal defects, altered puberty (delayed vaginal opening in females
and accelerated puberty in males), and altered mammary gland
development (Refs. 9 and 18).
There has been consistent evidence of associations between PFOA
exposure and immunosuppression including reduced response to vaccines.
Epidemiology studies have looked at the effects of exposure to several
PFAS. In one study (Ref. 22), large datasets have been used to mutually
adjust for concomitant PFAS exposures. Epidemiological studies have
associated decreased vaccine response in children with elevated levels
of PFOA in sera (Refs. 19, 20, 21, 22 and 40). Epidemiological studies
have also indicated an increased risk of renal cell carcinoma with PFOA
exposure (Refs. 42 and 43). An association with increased risk of
ulcerative colitis has also been observed. The results of several mouse
studies reported findings consistent with the epidemiological data
suggesting that exposure to PFOA can result in immunosuppression (Ref.
18).\9\
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\9\ It is important to note that in March 2023, EPA proposed a
National Primary Drinking Water Regulation for certain PFAS,
including PFOA and PFOS (88 FR 18638; March 29, 2023). To support
this rule, EPA developed and released updated draft toxicity
assessments for PFOA and PFOS for public comment, to which EPA is
currently responding (Refs. 10 and 11). The draft toxicity
assessments underwent external peer review through EPA's Science
Advisory Board PFAS Review Panel (Ref. 12), and EPA responded to the
SAB's recommendations in the updated draft toxicity assessments
(Ref. 13).
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2. PFOS
Epidemiology data report associations between PFOS exposure and
high cholesterol, decreased vaccination response, and altered
reproductive and developmental parameters including low birth weight.
The strongest associations are related to serum lipids with increased
total cholesterol and high-density lipoproteins (HDLs), and there are
also associations with increases in serum enzymes and decreases in
serum bilirubin (Refs. 14 and 18). There is suggestive epidemiological
evidence for an association between serum PFOS and pregnancy-induced
hypertension and/or pre-eclampsia (Ref. 18). Data also suggest a
correlation between higher PFOS levels and decreases in female
fecundity and fertility, in addition to decreased body weights in
offspring, and other measures of postnatal growth (Ref. 14).
There is consistent evidence of immunotoxicity after PFOS exposure.
There is evidence of an association between serum PFOS levels and
decreased antibody responses to vaccines in children (Ref. 18).
Epidemiology studies have looked at the effects of exposure to several
PFAS. In one study (Ref. 22), large datasets have been used to mutually
adjust for concomitant PFAS exposures. Epidemiological studies have
indicated decreased vaccine response in children associated with
elevated levels of PFOS in sera (Refs. 19, 20, 21, 22 and 40). Rodent
studies have also shown immunotoxicity after PFOS exposure (Ref. 18).
Short-term and chronic exposure studies in animals consistently
demonstrate increases in liver weight with co-occurring effects that
include decreased cholesterol, hepatic steatosis, lower body weight,
and liver histopathology (Ref. 14). Some degenerative and necrotic
effects that are likely relevant to humans have been observed (Ref.
18). One and two generation toxicity studies also show decreased pup
survival and body weights. Additionally, developmental neurotoxicity
studies show increased motor activity and decreased habituation and
increased escape latency in the water maze test following in utero and
lactational exposure to PFOS. Gestational and lactational exposures
were also associated with higher serum glucose levels and evidence of
insulin resistance in adult offspring (Ref. 14).
3. PFBS
Asthma and serum cholesterol levels in humans were found to exhibit
a statistically significant positive association with PFBS exposure. No
studies have been identified that evaluate the association between PFBS
exposure and potential cancer outcomes (Ref. 15).
The limited number of human studies examining oral PFBS exposure
does not inform the potential for effects in thyroid, developing
offspring, or the renal system (Ref. 15). Animal studies of repeated-
dose PFBS exposure have been exclusively via the oral route, used the
potassium salt of PFBS as the source exposure material, and have
examined noncancer effects only. The available rat and mouse studies
support identification of thyroid, developmental, and kidney endpoints
as potential health effects following repeated exposures in utero and/
or during adulthood. Thyroid effects in exposed adult rats and mice and
in developing mice were primarily expressed through significant
decreases in circulating levels of hormones such as thyroxine and
triiodothyronine. In early developmental life stages in mice (e.g.,
newborn), decreases in thyroid hormones were accompanied by other
effects indicative of delayed maturation or reproductive development
(e.g., vaginal patency and eyes opening). Kidney weight and/or
histopathological alterations (e.g., renal tubular and ductal
epithelial hyperplasia) were observed in rats following short-term and
subchronic oral exposures. Many of the kidney effects, however,
occurred at higher doses than did the thyroid and developmental
effects.
Animal studies have also evaluated other health outcomes, such as
liver effects, reproductive parameters, lipid/lipoprotein homeostasis,
and effects on the spleen and blood; however, the evidence currently
available does not support a clear association with PFBS exposure and
these outcomes (Ref. 15).
4. HFPO-DA (GenX)
Most of the available data for HFPO-DA and its ammonium salt (also
known as GenX chemicals) were submitted to EPA by the manufacturer
(DuPont/Chemours) under the Toxic Substances Control Act (TSCA), as
required by TSCA reporting requirements (15 U.S.C.
[[Page 8614]]
2607.8(e)) or pursuant to a consent order (Ref. 23).
Oral toxicity studies for HFPO-DA and its ammonium salt were
available for acute, short-term, subchronic, and chronic durations of
exposure in rats and mice. These studies reported liver effects
(increased relative liver weight, hepatocellular hypertrophy, single
cell necrosis and apoptosis), kidney effects (increased relative kidney
weight), immune effects (antibody suppression), developmental effects
(increased early deliveries and delays in genital development), and
tumorigenesis (liver and pancreatic tumors) (Ref. 16). Overall, the
weight of the scientific evidence indicates the liver as a sensitive
target for toxicity (meaning the liver is most susceptible to the toxic
effects); however, the available data are inadequate to determine the
mode of action for these effects.
EPA's Office of Water followed current EPA risk assessment guidance
and recommendations to select points of departure from the available
animal studies for RfD derivation to support risk characterization. EPA
also conducted literature searches to identify publicly available peer-
reviewed hazard studies on HFPO-DA and its ammonium salt. All
laboratory animal studies containing dose-response information were
evaluated for study quality using an approach consistent with the
Office of Research and Development's Handbook for developing IRIS
assessments (Ref. 25).
EPA selected an oral reproductive/developmental toxicity study in
mice (Ref. 26) showing hepatotoxicity (i.e., cytoplasmic alterations,
apoptosis, single-cell necrosis, and focal necrosis) as the critical
study and effect, respectively. Selection of this effect (liver
toxicity) is supported by the National Toxicology Program Pathology
Working Group's conclusion that the dose response for the constellation
of liver lesions observed following oral exposure to HFPO-DA and its
ammonium salt represents an adverse (rather than adaptive) response.
The National Toxicology Program Pathology Working Group's Final Report
on the Pathology Peer Review of Liver Findings is Appendix D of EPA's
Human Health Toxicity Values for Hexafluoropropylene Oxide (HFPO) Dimer
Acid and Its Ammonium Salt (CASRN 13252-13-6 and CASRN 62037-80-3, Ref.
16). Further support for the selection of liver toxicity as a critical
effect was obtained from additional animal studies showing similar
hazard outcomes (i.e., increased liver enzyme levels, histopathological
lesions, and tumors) in both male and female mice and rats following
various durations and levels of exposure (Ref. 16).
5. PFNA
The available epidemiological studies suggest associations between
PFNA and several health outcomes including increases in serum hepatic
enzymes, particularly alanine aminotransferase (Ref. 18). Numerous
studies have evaluated the hepatic toxicity of PFNA. The observed
effects are consistent with effects observed for other perfluoroalkyl
acids such as PFOA including alterations in serum lipid levels (Ref.
18). An epidemiological study has also indicated increased risk of
renal cell carcinoma with exposure to PFNA, especially within African-
Americans (Ref. 43).
Some studies have found associations between serum PFNA and
diphtheria and tetanus antibody levels. Grandjean and associates found
a significant inverse association between diphtheria antibodies levels
at age 5 and serum PFNA levels at age 5, but not for antibody levels at
age 13 and PFNA levels at age 7 or 13. Some others also reported an
inverse association between serum PFNA and diphtheria antibody levels
in a small study of adults. An inverse association between maternal
serum PFNA and rubella antibody levels was observed in children (Refs.
19, 20, 21, 22, and 24). Timmermann et al. found each 1 ng/mL increase
in serum concentrations of PFNA was associated with decreases of 39%
(95% CI: -4-64%) in diphtheria antibody concentrations (Ref. 40).
Animal studies have also shown detrimental health effects. Two
weeks after a single administration of PFNA in mice, Kielsen et al.
also observed a number of immunological alterations (Ref. 24). Two
acute-duration studies have evaluated the reproductive toxicity of PFNA
in male rats. PFNA exposure resulted in decreases in serum testosterone
and increases in serum estradiol levels and morphological changes.
These changes as well as others were suggestive of damage to the
secretory function of the Sertoli cells. In mice administered PFNA for
90 days, decreases in sperm motility, viability, and count and
degenerative changes in the seminiferous tubules were observed. When
the mice were mated with unexposed females, significant decreases in
litter size were observed (Ref. 18).
Three studies were identified that examined the developmental
toxicity of PFNA in laboratory animals. Full litter resorptions were
observed in mice administered PFNA, and maternal weight loss was also
observed. Decreases in postnatal survival were observed. Decreases in
birth weight were observed in female offspring of rats. Postnatal
growth was decreased in the offspring of mice, and the decreases in
body weight persisted in the pups. Reductions in nephron endowment
(number of functioning nephrons at birth) were observed in male rat
pups. Delays in eye opening and decrease in pup body weight gain were
observed in offspring of mice administered PFNA (Ref. 18).
6. PFHxS
The available epidemiological studies suggest associations between
PFHxS and several health outcomes including decreased antibody response
to vaccines in humans and increases in serum lipids, particularly total
cholesterol and low-density lipoprotein (LDL) cholesterol, in animals
(Ref. 18). EPA has released a draft assessment for PFHxS for public
comment (Ref. 44).
Epidemiology studies have looked at the effects of exposure to
several PFAS. In one study (Ref. 22), large datasets have been used to
mutually adjust for concomitant PFAS exposures. Epidemiological studies
have indicated decreased vaccine response in children associated with
elevated levels of PFHxS in sera (Refs. 19, 20, 21, 22, and 40).
Inverse associations were observed between tetanus antibody levels in
5- and 7-year-old children and PFHxS levels in maternal serum and in
children at age 5. A study in 3-year-old children found an inverse
association between maternal PFHxS levels and rubella antibody levels,
but no association with influenza type B or tetanus antibody levels. In
adolescents, serum PFHxS levels were also inversely associated with
rubella antibody titers in a seropositive subcohort (Ref. 18).
Timmermann et al. found each 1 ng/mL increase in serum concentrations
of PFHxS was associated with decreases of 78% (95% CI: 25-94%) in
diphtheria antibody concentrations.
Centrilobular hepatocellular hypertrophy was observed in rodents.
Microvascular fatty changes were also observed. In male mice, dietary
exposure to PFHxS in a western-type diet resulted in decreases in
plasma triglyceride, total cholesterol, non-HDL cholesterol, and HDL
cholesterol levels and decreases in the hepatic production of VLDL.
Increases in liver weight and hepatic triglyceride levels were also
observed (Ref. 18).
7. PFDA
PFDA has been associated with cardiovascular disease, immunological
[[Page 8615]]
affects, and developmental affects. In this subsection, limited human
and then animal evidence for potentially related health end points are
discussed together for each end point. EPA has released a draft
assessment for PFDA for public comment (Ref. 31).
In a study of NHANES participants, Huang et al. (Ref. 27) found an
increased risk of any type of cardiovascular disease among participants
with the highest serum PFDA levels when the statistical analyses
adjusted for serum total protein levels and estimated glomerular
filtration rate; however, no associations were found for specific types
of cardiovascular disease. Death in female mice following
administration of a single lethal dose of PFDA by gavage was associated
with mural thrombosis of the left ventricle of the heart. Non-lethal
doses did not cause gross or microscopic alterations in the heart,
assessed 30 days after dosing, but significantly decreased relative
heart weight. Significant decrease in mean corpuscular hemoglobin and
mean corpuscular hemoglobin concentration were observed in rats
administered PFDA for 28 days (Ref. 18).
Epidemiology studies have looked at the effects of exposure to
several PFAS. In one study, large datasets have been used to mutually
adjust for concomitant PFAS exposures. Epidemiological studies have
indicated decreased vaccine response in children associated with
elevated levels of PFDA in sera (Refs. 19, 20, 21, 22, and 40). Inverse
associations were observed between serum PFDA levels at age 5 and
tetanus antibody levels at ages 5 and 7 (Ref. 19) and serum PFDA levels
at age 7 and antibody levels at age 13 (Ref. 20). Similarly, diphtheria
antibody levels at age 13 were inversely associated with serum PFDA
levels at age 7 years (Ref. 20). In adults, diphtheria antibody levels
were inversely associated with serum PFDA levels, but there was no
association for tetanus antibody levels.
In case-control studies, associations between asthma diagnosis and
asthma severity were observed in children; associations with serum
immunoglobulin E levels, absolute eosinophil counts, and eosinophil
cationic protein levels were also observed. A case-control study in
adolescents found significantly higher serum PFDA levels among the
asthmatic cases (Ref. 18).
Lind et al. found an inverse association between maternal PFDA
levels and anogenital distance in human girls, but not in boys (Ref.
28). An increase in fetal mortality was observed in mice exposed to
PFDA, and PFDA was also associated with a marked decrease in fetal
weight/litter, 100% incidence of variations in ossification of the
braincase, decreases in maternal body weight, and maternal mortality
(Ref. 18). Decreases in fetal body weight/litter in mice also were
observed (Ref. 18).
8. PFHxA
Although some human epidemiological studies have examined possible
associations between PFHxA exposure and several adverse health
outcomes, they are sparse and overall insufficient on their own to draw
conclusions regarding adverse health effects. Based primarily on animal
studies, certain PFHxA exposure levels have led to hepatic,
developmental, hematopoietic, and endocrine effects (Refs. 18 and 32).
In humans, an increased risk of cardiovascular disease (any type)
was found in NHANES participants with higher serum PFHxA levels. A
study of 70-year-old adults reported increases in the intima media
thickness in the common carotid artery that was associated with serum
PFHxA levels (Ref. 18). Several studies in rats have identified the
hematological system as a target of PFHxA toxicity. Decreases in red
blood cell counts, hemoglobin levels, and/or hematocrit levels and
increases in reticulocyte levels have been observed in rats
administered PFHxA (Refs. 18 and 32).
Increases in liver weight, decreases in serum cholesterol levels,
and centrilobular hepatocellular hypertrophy have been observed in rats
administered PFHxA. In a chronic-duration study, gavage administration
of PFHxA for 2 years resulted in increases in the incidence of
hepatocellular necrosis in female rats. Decreases in triglyceride
levels were observed in male rats (Ref. 18). Thus, the hepatic findings
correlated with changes in clinical chemistry and necrosis (Ref. 32).
Administration of PFHxA resulted in decreases in fetal weight in
rats (Ref. 30). Similarly, decreases in pup body weight were observed
in the offspring of rats administered PFHxA for 70 days prior to
mating, during mating, and throughout gestation and lactation (Refs. 18
and 30).
9. PFBA
Although several human epidemiological studies have examined
possible associations between PFBA exposure and several adverse health
outcomes, they are sparse and overall insufficient on their own to draw
conclusions regarding toxic effects. Based primarily on animal studies,
developmental, thyroid, and liver effects in humans are likely caused
by PFBA exposure, given sufficient exposure conditions. In human
studies, increases in the risk of hypertension in men and women, which
was associated with serum PFBA levels, have been found. Systolic blood
pressure levels were also associated with serum PFBA levels in men and
women combined or in men only; no associations were found for diastolic
blood pressure (Ref. 17).
Oral doses of PFBA for 90 days resulted in significant reductions
in red blood cell counts, hemoglobin, and hematocrit, and an increase
in red blood cell distribution width in male rats. This dose level also
caused a reduction in mean corpuscular hemoglobin and reduced mean
corpuscular hemoglobin concentration in male rats. The lower hemoglobin
and hematocrit observed in males were still detected at the end of a 3-
week recovery period (Ref. 18).
PFBA intermediate-duration studies have consistently found
increases in liver weight and histological alterations. Dosing rats
with PFBA resulted in significant increases in absolute and relative
liver weight and decreases in serum cholesterol and hepatocellular
hypertrophy (Ref. 17 and 18).
Thyroid effects in adult exposed rats were expressed through
decreases in free and total thyroxine (T4) and increased incidence of
thyroid follicular hypertrophy and hyperplasia. Developmental effects
in exposed animals were expressed as the loss of viable offspring
(total litter resorption), and postnatal delays in postnatal
developmental milestones: eye opening, vaginal opening, and preputial
separation (Ref. 17).
C. EPA's Proposed Conclusions on Whether the Nine PFAS, Their Salts,
and Their Structural Isomers Meet the Criteria for Listing on Appendix
VIII
The Agency's proposed conclusions are that the nine PFAS, their
salts, and their structural isomers meet the criteria for listing as
RCRA hazardous constituents on Appendix VIII because it has been shown
through scientific studies referenced above that they have toxic
effects on humans or other life forms.
The nine PFAS discussed in this proposed rule can occur in acid
forms (e.g., perfluorooctanoic acid) and salt forms (e.g., ammonium
perfluorooctanoate). Salts are deemed to have the same toxicity as the
commonly referenced acid versions because, once put in water (and
likewise when in human blood), the acid and salt forms will dissociate
to the ionic form. Further, toxicity studies on PFAS were
[[Page 8616]]
often performed using the salt form. Thus, EPA is proposing to list
both acid and salt forms of the nine PFAS on Appendix VIII.
Additionally, PFAS exist as linear and branched isomers, depending
on the process used to manufacture them. For example, PFAS when
manufactured through electrochemical fluorination consist of an
isomeric mixture that is approximately 70% linear isomers and 30%
branched isomers. The linear and branched isomers have been found in
environmental media and in human sera. Most animal toxicity studies
using isomeric mixtures do not state the ratio of linear and branched
isomers in the test material, and, therefore, it is not feasible to
distinguish the toxicity of the individual isomers. However, in a few
studies, including Lieder et al. (2009) for PFBS, George and Andersen
(1986) for PFDA, Bijland et al. (2011) for PFHxS, Butenhoff et al.
(2004), Lau et al. (2006), and Lou et al. (2009) for PFOA, and Ankley
et al. (2004) for PFOS (Refs. 33-39), the authors stated that the PFAS
test substance was not 100% linear, and thus any effects indicated in
these studies can only be associated with the isomeric mixture of
linear and branched and not specifically with linear isomers or
branched isomers. Further, Loveless et al. (2006) compared the toxicity
of linear ammonium PFOA, branched ammonium PFOA, and a mixture of
linear and branched ammonium PFOA in rodents, and demonstrated that
both linear and branched isomers exhibit similar types of toxicity
(Ref. 29). While toxicity studies such as these are not available for
all PFAS included in this proposal, EPA believes it is both reasonable
and public health protective, based on the available toxicity data for
isomeric mixtures, to list the structural isomers. Thus, EPA is
proposing to also list the structural isomers for the nine PFAS on
Appendix VIII.
VI. State Authorization
A. Applicability of the Rule in Authorized States
Under section 3006 of RCRA, 42 U.S.C. 6926, EPA may authorize a
qualified State to administer and enforce a hazardous waste program
within the State in lieu of the Federal program, and to issue and
enforce permits in the State. Following authorization, EPA retains
enforcement authority under sections 3008, 3013, and 7003 of RCRA,
although authorized States have primary enforcement responsibility. The
standards and requirements for State authorization are found at 40 CFR
part 271.
Prior to enactment of the Hazardous and Solid Waste Amendments of
1984 (HSWA), a State with final RCRA authorization administered its
hazardous waste program entirely in lieu of EPA administering the
Federal program in that State. The Federal requirements no longer
applied in the authorized State, and EPA could not issue permits for
any facilities in that State, since only the State was authorized to
issue RCRA permits. When new, more stringent Federal requirements were
promulgated, the State was obligated to enact equivalent authorities
within specified timeframes. However, the new Federal requirements did
not take effect in an authorized State until the State adopted the
Federal requirements.
In contrast, under RCRA section 3006(g), (42 U.S.C. 6926(g)) (which
was added by HSWA), new Federal requirements and prohibitions imposed,
pursuant to HSWA authority, take effect in authorized States at the
same time that they take effect in unauthorized States. Although
authorized States are still required to update their hazardous waste
programs to remain equivalent to the Federal program, EPA is directed
by the statute to implement the requirements and prohibitions in
authorized States, including the issuance of new permits implementing
those new requirements, until EPA authorizes the State to do so.
Authorized States are required to modify their programs only when
EPA promulgates Federal requirements that are more stringent or broader
in scope than existing Federal requirements. RCRA section 3009 allows
the States to impose standards more stringent than those in the Federal
program. See also 40 CFR 271.1(i). If EPA promulgates a Federal
requirement that is less stringent than an existing requirement,
authorized States may, but are not required to, adopt the requirement
regardless of whether it is a HSWA or non-HSWA requirement.
B. Effect on State Authorization
This rule is promulgated pursuant to both non-HSWA authority (RCRA
section 3001) and HSWA authority (RCRA section 3004(u)). The changes to
Appendix VIII proposed in this rule are more stringent than the current
Federal requirements because adding new substances to Appendix VIII
expands the list of hazardous constituents that are subject to RCRA
regulatory requirements. Therefore, States will be required to adopt
and seek authorization for these changes. The Appendix VIII list of
hazardous constituents does not by itself impose regulatory
requirements. Rather, requirements to address hazardous constituents
are found in various sections throughout the Federal hazardous waste
regulations.
Today's proposal, if finalized, would add nine PFAS, their salts,
and their structural isomers to Appendix VIII for all purposes except
corrective action, pursuant to RCRA section 3001. Today's action would
also add these substances to Appendix VIII for corrective action
purposes and add this listing action, as it would apply to corrective
action purposes, to Table 1 in 40 CFR 271.1, pursuant to RCRA section
3004(u). Given the dual nature of today's proposal, EPA would consider
the final rule to be a non-HSWA rule promulgated under RCRA 3001 for
all purposes except corrective action under RCRA 3004(u) and (v), and
would consider the final rule to be a HSWA rule as applied to such
corrective action (for example, as applied to the scope of hazardous
constituents subject to corrective action under 40 CFR 264.101, the
principal regulation implementing these provisions). Thus, the addition
of the nine PFAS, their salts, and their structural isomers, as applied
to RCRA section 3004(u) and (v) corrective action would become
immediately effective in all States on the effective date (which would
be provided in any final notice for the action); and EPA would
implement the new rule as applied to corrective action in all States
until those States become authorized for the new rule.
States with authorized RCRA programs may already include one or
more of these PFAS on their lists of hazardous constituents, since RCRA
contemplates that States may promulgate regulations which are more
stringent than the Federal RCRA requirements. These State regulations
have not been assessed against the Federal regulations proposed today
to determine whether they meet the authorization requirements. Thus,
such a State would not be authorized to implement these regulations as
RCRA requirements until the State program provisions are submitted to
EPA and approved, pursuant to 40 CFR 271.21. Of course, States with
existing regulations that are more stringent than or broader in scope
than current Federal regulations may continue to administer and enforce
their regulations as a matter of State law. In implementing the HSWA
corrective action requirements, EPA will work with the States under
agreements to avoid duplication of effort.
[[Page 8617]]
VII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review
This action is a ``significant regulatory action'' as defined in
Executive Order 12866, as amended by Executive Order 14094.
Accordingly, EPA submitted this action to the Office of Management and
Budget (OMB) for Executive Order 12866 review. Documentation of any
changes made in response to Executive Order 12866 review is available
in the docket. The EPA prepared an analysis of the potential impacts
associated with this action. This analysis, the draft Economic
Assessment of the Potential Costs, Benefits, and Other Impacts of the
Proposed Rulemaking to List Specific PFAS as RCRA Hazardous
Constituents (Ref. 41), is available in the docket for this action.
B. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.,
because it does not contain any information collection activities.
Burden is defined at 5 CFR 1320.3(b).
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601, et seq. EPA projects negligible direct impacts to regulated
entities associated with the proposed rule (see Sections II.A. and
II.D.). To the extent the proposed rule may result in indirect costs
associated with corrective action, the small entity analysis in the
draft Economic Assessment identifies 75 small entities that could be
impacted.
Because the proposed rule estimates negligible costs associated
with direct impacts, EPA concludes the proposed rule will not result in
a significant economic impact for a substantial number of small
entities. Additional details of the small entity analysis, including
information about the broader universe of TSDFs, are presented in the
draft Economic Assessment of the Potential Costs, Benefits, And Other
Impacts of the Proposed Rulemaking to List Specific PFAS as RCRA
Hazardous Constituents (Ref. 41), available in the public docket for
this action.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments because direct costs
are projected to be negligible.
E. Executive Order 13132: Federalism
This action does not have federalism implications based on EPA's
policy for implementing E.O. 13132, entitled ``Federalism.'' It will
not have substantial direct effects on the States or localities based
on EPA's intergovernmental cost threshold for the E.O. 13132 analysis;
it will not preempt State or local law or substantially affect the
distribution of power and responsibilities among the various levels of
government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 because it does not have substantial direct
effects on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes.
There is only one facility on Tribal lands that EPA has identified that
could be potentially affected by this rulemaking, and because the rule
is not expected to result in substantial direct impacts (i.e., EPA
anticipates negligible direct impacts) it is also not expected to
result in adverse impacts on this tribal entity. Thus, Executive Order
13175 does not apply to this action.
However, consistent with the EPA Policy on Consultation and
Coordination with Indian Tribes, the EPA intends to consult with and
request comments from the affected tribe and other tribal officials
that wish to consult with the Agency on this rulemaking.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) directs Federal
agencies to include an evaluation of the health and safety effects of
the planned regulation on children in Federal health and safety
standards and explain why the regulation is preferable to potentially
effective and reasonably feasible alternatives. This action is not
subject to Executive Order 13045 because it is not ``economically
significant'' as defined in Executive Order 12866, and because it does
not concern an environmental health risk or safety risk. This action,
which proposes to add nine PFAS, their salts, and their structural
isomers as RCRA hazardous constituents, does not itself address
environmental health or safety risks. Therefore, EPA does not believe
there are disproportionate risks to children.
However, EPA's 2021 Policy on Children's Health applies to this
action, which requires EPA to consider early life exposures and
lifelong health consistently and explicitly in all human health
decisions.\10\ To the extent that the proposed rulemaking leads to the
remediation of select PFAS, potential exposure to these PFAS is
expected to be reduced for the population living in close proximity to
these sites, including susceptible subpopulations such as workers and
children. Additionally, to the extent that the proposed rule reduces
exposure, a reduction in the risks of adverse health effects in
children might be expected, as well as associated health care cost
savings. The information that EPA used to evaluate the toxicity and
health effects of these PFAS, which includes many studies that looked
at effects during development and on children, is described above in
the Section Summary of toxicity and health effects information for the
nine PFAS and the supporting documents in the public docket for this
action.
---------------------------------------------------------------------------
\10\ https://www.epa.gov/system/files/documents/2021-10/2021-policy-on-childrens-health.pdf.
---------------------------------------------------------------------------
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' because it is
not related to, or likely to have a significant adverse effect on, the
supply, distribution, or use of energy. This action proposes to add
nine PFAS, their salts, and structural isomers as RCRA hazardous
constituents, and thus, does not involve the supply, distribution, or
use of energy.
I. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve technical standards.
[[Page 8618]]
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations; Executive
Order 14096: Revitalizing Our Nation's Commitment to Environmental
Justice for All
Executive Order 14096 (88 FR 25251, Apr. 26, 2023) directs Federal
agencies to advance the goal of environmental justice for all. This
action builds upon and supplements the efforts of Executive Order 12898
(59 FR 7629, February 16, 1994) to address environmental justice.
The EPA believes that the human health or environmental conditions
that exist prior to this action may result in or have the potential to
result in disproportionate and adverse human health or environmental
effects on communities with environmental justice concerns.
Several key demographic categories were analyzed relative to the
universe of facilities potentially affected by the proposed rule. This
proposed regulation identifies groundwater and surface water as
potential sources of exposure for the identified PFAS. Due to
uncertainty surrounding the location of PFAS releases, this analysis
additionally considers a subset of the total universe of facilities
which are associated with a potentially higher likelihood of handling
PFAS, and where corrective action for PFAS may occur. These facilities
are identified based on:
A list of NAICS codes (at the 6-digit level) used by
Salvatore et al. (2022) for identifying presumptive PFAS
contamination across the U.S.\11\
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\11\ See Salvatore et al., ``Presumptive Contamination: A New
Approach to PFAS Contamination Based on Likely Sources'', Environ
Sci Technol Lett. Vol. 9, Issue 11. November 8, 2022. Accessed at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9648201/.
---------------------------------------------------------------------------
EPA's proposed rule, `Designation of Perfluorooctanoic
Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA
Hazardous Substances', identified industries (at the 6-digit NAICS
level) historically associated with PFAS; therefore, TSDFs in these
industries are also assumed to have higher likelihood of handling
PFAS.
The PFAS Analytical Tools page in EPA's Enforcement and
Compliance History Online (ECHO) includes a list of industry sectors
potentially associated with PFAS, defined by 6-digit NAICS.\12\ Any
permitted TSDFs within these industries are also assumed to have a
higher likelihood of handling PFAS.
---------------------------------------------------------------------------
\12\ See United States Environmental Protection Agency, PFAS
Analytical Tools, available at https://echo.epa.gov/trends/pfas-tools.
---------------------------------------------------------------------------
If a TSDF in the regulatory universe reported any of
the specific PFAS proposed for addition to 40 CFR part 261, Appendix
VIII in the EPA's Toxic Release Inventory (TRI),\13\ that facility
is also assumed to have a higher likelihood of handling PFAS.
---------------------------------------------------------------------------
\13\ PFAS chemicals included in search: PFOS, PFOA, PFBS, HFPO-
DA (GenX), PFNA, PFHxS, PFDA, PFHxA, and PFBA. Environmental
Protection Agency, ``Envirofacts: TRI Search'', December 2022.
Accessed at: https://www.epa.gov/enviro/tri-search.
The sites identified as having potential association with PFAS make
them a reasonable proxy for identifying where corrective action for
these substances may be required and offer an associated surrounding
demographic context. However, the spatial distribution and predicted
risk factor of a PFAS release cannot be certain without further site-
specific investigation into a facility's waste handling capacity,
proximity to population centers, and interconnectivity of local
environmental resources.
The EPA believes that this action may indirectly reduce existing
disproportionate and adverse effects on communities with environmental
justice concerns. To the extent that the proposed rule leads to the
remediation of releases for any of the nine PFAS, their salts, and
their structural isomers that EPA proposes to list as RCRA hazardous
constituents, health risks for populations living in close proximity to
these sites (particularly populations that rely on private well water
near these sites) may decline. As groundwater and surface water have
been identified as potential exposure pathways of PFAS, the inclusion
of private well usage rates in areas surrounding facilities known to
use, produce, or release PFAS provides additional information about
populations that may have a potentially higher likelihood of negative
health outcomes from a PFAS release. In some cases, focusing the
analysis solely on those potentially more vulnerable populations served
by private wells reveals further demographic disparities compared to
the total U.S. population served by private wells.
Details of the full analysis and findings are presented in the
draft Economic Assessment of the Potential Costs, Benefits, and Other
Impacts of the Proposed Rulemaking to List Specific PFAS as RCRA
Hazardous Constituents (Ref. 41), which can be found in the public
docket for this action.
Better understanding the impacts of a PFAS release and the factors
that determine the magnitude of effects on the surrounding human and
natural environment will potentially become more apparent over time,
allowing for improved information and a more robust analysis on any
disproportionate and adverse outcomes experienced by populations with
EJ concerns. This improved information would not increase risk for
communities with EJ concerns and may improve the speed and design of
remediation. The EPA is committed to minimizing and/or eliminating
existing barriers and burdens that communities with EJ concerns may
encounter related to accessing data and information associated with
this rulemaking, if finalized. EPA seeks comment on strategies to
improve access to associated data, which may become available in RCRA
Info, for communities with environmental justice concerns.
VIII. References
1. U.S. EPA. (2023). PFOA, PFOS and other PFAS: Basic information on
PFAS. U.S. Environmental Protection Agency. https://www.epa.gov/pfas/basic-information-pfas.
2. ATSDR. (2023). PFAS and Your Health. https://www.atsdr.cdc.gov/pfas/index.html.
3. Public Employees for Environmental Responsibility (PEER) to the
Administrator of EPA concerning RCRA Regulation of a Class of Wastes
Containing PFAS. September 19, 2019. https://www.epa.gov/system/files/documents/2021-09/peer_pfas_rulemaking_petition_metadata_added.pdf.
4. Petition for Rulemaking from Environmental Law Clinic of
University of California, Berkeley to the Administrator of EPA
concerning RCRA Regulation of Wastes Containing Long-Chain PFASs and
GenX Chemicals. January 15, 2020. https://www.epa.gov/system/files/documents/2021-09/pfas_petition_for_haz_waste_jan_2020_metadata_added.pdf.
5. Petition from the Governor of New Mexico to the Administrator of
EPA concerning action on PFAS under RCRA. June 23, 2021. https://www.epa.gov/system/files/documents/2021-10/508compliant_ezd5442262_2021-06-23-governor-letter-to-epa-for-pfas-petition.pdf-incoming-document.pdf.
6. EPA Administrator's letter to the Governor of New Mexico in
response to the petition on PFAS. October 26, 2021. https://www.epa.gov/system/files/documents/2021-10/oct_2021_response_to_nm_governor_pfas_petition_corrected.pdf.
7. NIEHS. (2023). Perfluoroalkyl and Polyfluoroalkyl Substances
(PFAS). https://www.niehs.nih.gov/health/topics/agents/pfc/index.cfm.
8. Press release on EPA's response to New Mexico Governor's petition
on PFAS. October 26, 2021. https://www.epa.gov/newsreleases/epa-responds-new-mexico-governor-and-acts-address-pfas-under-hazardous-waste-law.
9. U.S. EPA. (2016). Health effects support document for
perfluorooctanoic acid (PFOA). U.S. Environmental Protection
[[Page 8619]]
Agency Office of Water. EPA-822-R-16-003. https://www.epa.gov/sites/default/files/2016-05/documents/pfoa_hesd_final-plain.pd.f
10. U.S. EPA. (2023). Public Comment Draft--Toxicity Assessment and
Proposed Maximum Contaminant Level Goal (MCLG) for Perfluorooctanoic
Acid (PFOA) (CASRN 335-67-1) in Drinking Water. EPA-822-P-23-005.
11. U.S. EPA. (2023). Public Comment Draft--Toxicity Assessment and
Proposed Maximum Contaminant Level Goal (MCLG) for Perfluorooctane
Sulfonic Acid (PFOS) (CASRN 1763-23-1) in Drinking Water. EPA-822-P-
23-007.
12. U.S. EPA. (2022). Transmittal of the Science Advisory Board
Report titled, ``Review of EPA's Analyses to Support EPA's National
Primary Drinking Water Rulemaking for PFAS.'' EPA-22-008. https://sab.epa.gov/ords/sab/f?p=114:12:15255596377846.
13. U.S. EPA. (2023). EPA Response to Final Science Advisory Board
Recommendations (August 2022) on Four Draft Support Documents for
the EPA's Proposed PFAS National Primary Drinking Water Regulation.
EPA-822-D-23-001.
14. U.S. EPA. (2016). Health effects support document for
perfluorooctane sulfonate (PFOS). U.S. Environmental Protection
Agency Office of Water. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf.
15. 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 Office of Research and Development.
https://www.epa.gov/chemical-research/learn-about-human-health-toxicity-assessment-pfbs.
16. U.S. EPA. (2021). Human Health Toxicity Values for
Hexafluoropropylene Oxide (HFPO) Dimer Acid and Its Ammonium Salt
(CASRN 13252-13-6 and CASRN 62037- 80-3) Also Known as ``GenX
Chemicals.'' U.S. Environmental Protection Agency Office of Water.
https://www.epa.gov/system/files/documents/2021-10/genx-chemicals-toxicity-assessment_tech-edited_oct-21-508.pdf.
17. U.S. EPA. (2022). IRIS Toxicological Review of Perfluorobutanoic
Acid (PFBA) and Related Salts (Final Report). U.S. Environmental
Protection Agency Office of Research and Development. https://iris.epa.gov/static/pdfs/0701tr.pdf.
18. 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://stacks.cdc.gov/view/cdc/59198.
19. Grandjean et al. (2012). ``Serum Vaccine Antibody Concentrations
in Children Exposed to Perfluorinated Compounds'' JAMA 307 (4): 391-
397. DOI:10.1001/jama.2011.2034.
20. Grandjean et al. (2017). ``Serum Vaccine Antibody Concentrations
in Adolescents Exposed to Perfluorinated Compounds'' Environ Health
Perspect 125 (7): 077018 DOI: 10.1289/EHP275.
21. Grandjean et al. (2017). ``Estimated exposures to perfluorinated
compounds in infancy predict attenuated vaccine antibody
concentrations at age 5-years'' J Immunotoxicol 14 (1): 188-195.
DOI: 10.1080/1547691X.2017.1360968.
22. Budtz-Jorgensen and Grandjean. (2018). ``Application of
benchmark analysis for mixed contaminant exposures: Mutual
adjustment of perfluoroalkylate substances associated with
immunotoxicity'' PLoS One 13 (10): e0205388. DOI: 10.1371/
journal.pone.0205388.
23. U.S. EPA. (2009). Consent Order and Determinations Supporting
Consent Order for Premanufacture Notice Numbers: P-08-508 and P-08-
509. EPA, Office of Pollution Prevention and Toxics, Washington, DC.
https://chemview.epa.gov/chemview/proxy?filename=sanitized_consent_order_p_08_0508c.pdf.
24. Kielsen et al. (2016). Antibody response to booster vaccination
with tetanus and diphtheria in adults exposed to perfluorinated
alkylates. J Immunotoxicol 13(2):270-273.
25. U.S. EPA. (2020). ORD Staff Handbook for Developing IRIS
Assessments (Public Comment Draft, Nov 2020). EPA/600/R-20/137. EPA,
Office of Research and Development, Washington, DC.
26. DuPont-18405-1037: E.I. du Pont de Nemours and Company. 2010. An
Oral (Gavage) Reproduction/Developmental Toxicity Screening Study of
H-28548 in Mice. U.S. EPA OPPTS 870.3550; OECD Test Guideline 421.
Study conducted by WIL Research Laboratories, LLC (Study Completion
Date: December 29, 2010), Ashland, OH.
27. Huang et al. (2018). Serum polyfluoroalkyl chemicals are
associated with risk of cardiovascular diseases in national US
population. Environ Int 119:37-46. http://doi.org/10.1016/j.envint.2018.05.051.
28. Lind et al. (2017). Prenatal exposure to perfluoroalkyl
substances and anogenital distance at 3 months of age in a Danish
mother-child cohort. Reprod Toxicol 68:200-206. http://doi.org/10.1016/j.reprotox.2016.08.019.
29. Loveless et al. (2006). ``Comparative responses of rats and mice
exposed to linear/branched, linear, or branched ammonium
perfluorooctanoate (APFO)'' Toxicology 220(2-3): 203-17. DOI:
10.1016/j.tox.2006.01.003.
30. Loveless et al. (2009). ``Toxicological evaluation of sodium
perfluorohexanoate'' Toxicology 264 (1-2): 32-44. DOI: 10.1016/
j.tox.2009.07.011.
31. U.S. EPA. (2023). IRIS Toxicological Review of Perfluorodecanoic
Acid (PFDA) and Related Salts (Draft Report). U.S. Environmental
Protection Agency Office of Research and Development. https://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=354408.
32. U.S. EPA. (2023). IRIS Toxicological Review of Perfluorohexanoic
Acid (PFHxA) and Related Salts (Final Report). U.S. Environmental
Protection Agency Office of Research and Development. https://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=357314.
33. Lieder et al. (2009). ``A two-generation oral gavage
reproduction study with potassium perfluorobutanesulfonate (K+PFBS)
in Sprague Dawley rats.'' Toxicology 259 (1-2): 33-45. DOI: 10.1016/
j.tox.2009.01.027.
34. George and Andersen (1986). ``Toxic effects of nonadecafluoro-n-
decanoic acid in rats.'' Toxicology and Applied Pharmacology 85(2):
169-180. DOI: 10.1016/0041-008X(86)90110-9.
35. Bijland et al. (2011). ``Perfluoroalkyl sulfonates cause alkyl
chain length-dependent hepatic steatosis and hypolipidemia mainly by
impairing lipoprotein production in APOE*3-Leiden CETP mice.''
Toxicol Sci 123(1): 290-303. DOI: 10.1093/toxsci/kfr142.
36. Butenhoff et al. (2004). ``The reproductive toxicology of
ammonium perfluorooctanoate (APFO) in the rat.'' Toxicology 196 (1-
2): 95-116. DOI: 10.1016/j.tox.2003.11.005.
37. Lau et al. (2006). ``Effects of perfluorooctanoic acid exposure
during pregnancy in the mouse.'' Toxicol Sci 90(2): 510-518. DOI:
10.1093/toxsci/kfj105.
38. Lou et al. (2009). ``Modeling single and repeated dose
pharmacokinetics of PFOA in mice.'' Toxicol Sci 107(2): 331-41. DOI:
10.1093/toxsci/kfn234.
39. Ankley et al. (2004). ``Partial life-cycle toxicity and
bioconcentration modeling of perfluorooctanesulfonate in the
northern leopard frog (Rana pipiens).'' Environmental Toxicology and
Chemistry 23(11): 2745-2755. DOI: 10.1897/03-667.
40. Timmermann et al. (2022). ``Concentrations of tetanus and
diphtheria antibodies in vaccinated Greenlandic children aged 7-12
years exposed to marine pollutants, a cross sectional study.''
Environmental Research 203. DOI: 10.1016/j.envres.2021.111712.
41. U.S. EPA. (2023). Draft Economic Assessment of the Potential
Costs, Benefits, and Other Impacts of the Proposed Rulemaking to
List Specific PFAS as RCRA Hazardous Constituents. U.S.
Environmental Protection Agency Office of Land and Emergency
Management.
42. Shearer et al. (2021). ``Serum Concentrations of Per- and
Polyfluoroalkyl Substances and Risk of Renal Cell Carcinoma.'' J
Natl Cancer Inst. 113(5): 580-587. DOI: 10.1093/jnci/djaa143.
43. Rhee et al. (2023). ``Serum Concentrations of Per- and
Polyfluoroalkyl Substances and Risk of Renal Cell Carcinoma in the
Multiethnic Cohort Study.'' Environmental International Volume 180,
108197. https://doi.org/10.1016/J.envint.2023.108197.
[[Page 8620]]
44. U.S. EPA. (2023). IRIS Toxicological Review of
Perfluorohexanesulfonic Acid (PFHxS) and Related Salts (Draft
Report). U.S. Environmental Protection Agency Office of Research and
Development. https://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=355410.
45. U. S. EPA (2023). External Panel Peer Review of EPA's Draft
``IRIS Toxicological Review of Perfluorodecanoic Acid (PFDA) and
Related Salts'' (Final Peer Review Report). U.S. Environmental
Protection Agency Office of Research and Development. https://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=354408.
List of Subjects
40 CFR Part 261
Environmental protection, Hazardous waste, Recycling, Reporting and
recordkeeping requirements.
40 CFR Part 271
Administrative practice and procedure, Confidential business
information, Environmental protection, Hazardous materials
transportation, Hazardous waste, Indians--lands, Intergovernmental
relations, penalties, and Reporting and recordkeeping requirements.
Michael S. Regan,
Administrator.
For the reasons set out in the preamble, EPA proposes to amend
title 40, chapter I of the Code of Federal Regulations as follows:
PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE
0
1. The authority citation for part 261 continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and
6938.
0
2. Appendix VIII to Part 261 is amended by adding in alphabetical order
the following entries:
Appendix VIII to Part 261--Hazardous Constituents
* * * * *
------------------------------------------------------------------------
Chemical
Common name Chemical abstracts Hazardous
abstracts name No. waste No.
------------------------------------------------------------------------
HFPO-DA...................... Hexafluoropropyl 13252-13-6 ..........
ene oxide-dimer
acid.
HFPO-DA salts and enantiomers
PFBA......................... Perfluorobutanoi 375-22-4 ..........
c acid.
PFBA salts and structural
isomers.
PFBS......................... Perfluorobutanes 375-73-5 ..........
ulfonic acid.
PFBS salts and structural
isomers.
PFDA......................... Perfluorodecanoi 335-76-2 ..........
c acid.
PFDA salts and structural
isomers.
PFHxA........................ Perfluorohexanoi 307-24-4 ..........
c acid.
PFHxA salts and structural
isomers.
PFHxS........................ Perfluorohexanes 355-46-4 ..........
ulfonic acid.
PFHxS salts and structural
isomers.
PFNA......................... Perfluorononanoi 375-95-1 ..........
c acid.
PFNA salts and structural
isomers.
PFOA......................... Perfluorooctanoi 335-67-1 ..........
c acid.
PFOA salts and structural
isomers.
PFOS......................... Perfluorooctanes 1763-23-1 ..........
ulfonic acid.
PFOS salts and structural
isomers.
------------------------------------------------------------------------
PART 271--REQUIREMENTS FOR AUTHORIZATION OF STATE HAZARDOUS WASTE
PROGRAMS
0
3. The authority citation for Part 271 continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), 6926, and 6939g.
0
4. Section 271.1(j) is amended by adding the following entry to Table 1
in chronological order by date of publication to read as follows.
---------------------------------------------------------------------------
\6\ This listing implements HSWA only to the extent it applies
to 40 CFR 264.101 and 270.14(d) and to 40 CFR Subpart S.
---------------------------------------------------------------------------
Sec. 271.1 Purpose and scope.
(j) * * *
Table 1--Regulations Implementing the Hazardous and Solid Waste Amendments of 1984
----------------------------------------------------------------------------------------------------------------
Federal Register
Promulgation date Title of regulation reference Effective date
----------------------------------------------------------------------------------------------------------------
* * * * * * *
[DATE OF PUBLICATION OF FINAL RULE].. Listing of certain [FEDERAL REGISTER PAGE [EFFECTIVE DATE OF
PFAS.\6\ NUMBERS FOR FINAL FINAL RULE]
RULE].
* * * * * * *
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[[Page 8621]]
[FR Doc. 2024-02324 Filed 2-7-24; 8:45 am]
BILLING CODE 6560-50-P