Clean Water Act Effluent Limitations Guidelines and Standards for the Organic Chemicals, Plastics and Synthetic Fibers Point Source Category, 14560-14567 [2021-05402]
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14560
Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 414
[EPA–HQ–OW–2020–0582; FRL 10019–06–
OW]
RIN 2040–AG10
Clean Water Act Effluent Limitations
Guidelines and Standards for the
Organic Chemicals, Plastics and
Synthetic Fibers Point Source
Category
Environmental Protection
Agency (EPA).
ACTION: Advance notice of proposed
rulemaking.
AGENCY:
The U.S. Environmental
Protection Agency (EPA or Agency) is
initiating further data collection and
analysis to support potential future
rulemaking, under the Clean Water Act
(CWA), relating to the effluent
limitations guidelines, pretreatment
standards and new source performance
standards applicable to the Organic
Chemicals, Plastics and Synthetic Fibers
(OCPSF) point source category to
address discharges from manufacturers
of per- and polyfluoroalkyl substances
(PFAS) and is considering revising the
same for formulators of PFAS. PFAS are
a group of man-made organic chemicals.
Some PFAS compounds are persistent
in the environment and in the human
body. Analysis of animal studies and
human epidemiological research suggest
that exposure above certain levels to
some PFAS may be associated with
adverse human health effects. The
Agency has identified several industries
with facilities that are likely to be
discharging PFAS in their wastewater,
including OCPSF manufacturers and
formulators. This advance notice of
proposed rulemaking (ANPRM)
provides for public review and
comment on the information and data
regarding PFAS manufacturers and
formulators that EPA has collected to
date. EPA is requesting public comment
on the information and data presented
in this ANPRM. EPA is also soliciting
additional information and data
regarding discharges of PFAS from these
facilities to inform future revisions to
the wastewater discharge requirements
that apply to the OCPSF point source
category.
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SUMMARY:
Comments must be received on
or before May 17, 2021.
ADDRESSES: You may send comments,
identified by Docket ID No. EPA–HQ–
OW–2020–0582, by any of the following
methods:
DATES:
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• 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,
Office of Water, Office of Science and
Technology Docket, Mail Code 28221T,
1200 Pennsylvania Avenue NW,
Washington, DC 20460.
• Hand Delivery or Courier (by
scheduled appointment only): 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. Out of an abundance of
caution for members of the public and
our staff, the EPA Docket Center and
Reading Room are closed to the public,
with limited exceptions, to reduce the
risk of transmitting COVID–19. Our
Docket Center staff will continue to
provide remote customer service via
email, phone, and webform. We
encourage the public to submit
comments via https://
www.regulations.gov/ or email, as there
may be a delay in processing mail and
faxes. Hand deliveries and couriers may
be received by scheduled appointment
only. 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: Ms.
Samantha Lewis, Engineering and
Analysis Division, Office of Science and
Technology, Office of Water; telephone
number: 202–566–1058; email address:
lewis.samantha@epa.gov.
I. Public Participation
A. Written Comments
Submit your comments, identified by
Docket ID No. EPA–HQ–OW–2020–
0582, 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
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you consider to be Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. If you wish to
submit such information, consult the
person listed for additional information
in the preceding FOR FURTHER
INFORMATION CONTACT section.
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 CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www.epa.gov/dockets/
commenting-epa-dockets.
EPA is temporarily suspending its
Docket Center and Reading Room for
public visitors, with limited exceptions,
to reduce the risk of transmitting
COVID–19. Our Docket Center staff will
continue to provide remote customer
service via email, phone, and webform.
We encourage the public to submit
comments via https://
www.regulations.gov/ as there may be a
delay in processing mail and faxes.
Hand deliveries or couriers will be
received by scheduled appointment
only. For further information and
updates on EPA Docket Center services,
please visit us online at https://
www.epa.gov/dockets.
EPA continues to carefully and
continuously monitor information 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.
B. Supporting Information
This notice is supported by
documents that are contained in the
public docket. EPA has prepared an
index of these materials to aid in the
public’s review and comment. The
index can be identified by searching the
docket for DCN OCPSF00116.
II. General Information
A. Does this action apply to me?
Entities potentially affected by any
rulemaking following this notice
include:
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Category
Example of
regulated entity
Industry .....................
PFAS Manufacturers.
PFAS Formulators.
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This section is not intended to be
exhaustive, but rather provides a guide
regarding entities likely to be regulated
by any future rulemaking activities
following this notice. Other types of
entities that are not included in the
examples above could also be regulated.
PFAS manufacturers are facilities that
produce PFAS compounds or precursors
through processes including, but not
limited to, electrochemical fluorination
(ECF) and telomerization. Facilities that
manufacture PFAS are currently
regulated under EPA’s national Effluent
Limitations Guidelines and Standards
(ELGs) for the OCPSF category (40 CFR
part 414). EPA has also gathered more
limited information about PFAS
formulators. PFAS formulators are
facilities that are the primary customers
of the PFAS manufacturers, and that use
raw PFAS feedstock to (a) produce
commercial or consumer goods (e.g.,
weather-proof caulking), or (b) as
intermediary products for use in the
manufacture of commercial goods (e.g.,
a grease-proof coating for a pizza box).
If you still have questions regarding
the applicability of any future
rulemaking activities following this
notice to a particular entity, please
consult the person listed for additional
information in the preceding FOR
FURTHER INFORMATION CONTACT section.
B. What is the purpose of this notice?
As part of EPA’s statutorily required
Effluent Guidelines planning process,
EPA has reviewed readily available
information about PFAS surface water
discharges to identify industrial sources
that may warrant further study for
potential regulation through national
ELGs. Based on the limited data
available at the time, in February of
2019, EPA published the PFAS Action
Plan, in which it identified several
industries with facilities that are likely
to be discharging PFAS compounds in
their wastewater and EPA began a more
detailed study to evaluate the potential
for PFAS presence in their wastewater
discharges. Through the PFAS MultiIndustry Study, described in EPA’s
Preliminary Effluent Guidelines
Program Plan 14, EPA gathered a range
of information about PFAS
manufacturers and formulators, as well
as the potential discharges of PFAS from
these facilities (further details on these
efforts are provided in Section V below).
PFAS manufacturers are facilities that
produce PFAS compounds or precursors
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through processes including, but not
limited to, ECF and telomerization.
Facilities that manufacture PFAS are
currently regulated under EPA’s
national ELGs for the OCPSF category
(40 CFR part 414). EPA has also
gathered some information about PFAS
formulators. PFAS formulators are
facilities that are the primary customers
of PFAS manufacturers, and that use
raw PFAS feedstock to (a) produce
commercial or consumer goods (e.g.,
weather-proof caulking), or (b) as
intermediary products for use in the
manufacture of commercial goods (e.g.,
a grease-proof coating for a pizza box).
EPA’s data set for formulators is more
limited than for manufacturers, as the
Agency has identified little publicly
available information on these facilities
and their potential discharges.
This notice provides for public review
and comment on the information that
EPA has collected to date on PFAS
discharges from both PFAS
manufacturers and formulators. In
addition, as detailed in Section V below,
EPA is soliciting additional information
and data regarding PFAS manufacturers
and formulators, including wastewater
characteristics and treatability. EPA will
use any information and data received
to inform potential next steps, which
could include developing new or
revised ELGs for these categories of
dischargers. Because formulators may be
subject to national ELGs outside of the
OCPSF category, future EPA actions to
address PFAS discharges from these
facilities may include revisions to ELGs
other than the ELGs that apply to the
OCPSF category or proposal of a new
ELG.
III. Background
A. Clean Water Act
Among its core provisions, the Clean
Water Act (CWA) prohibits the
discharge of pollutants from a point
source to waters of the United States,
except as authorized under the CWA.
Under CWA Section 402, 33 U.S.C.
1342, discharges may be authorized
through a National Pollutant Discharge
Elimination System (NPDES) permit.
The CWA outlines a dual approach for
establishing discharge limits for these
permits: (1) Technology-based effluent
limitations that establish a floor of
performance for categories of
dischargers, and (2) water quality-based
effluent limitations that are established
where technology-based effluent
limitations are insufficient to meet
applicable state water quality standards
(WQS) or site specific water quality
goals. The CWA authorizes EPA to
establish national technology-based
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ELGs and new source performance
standards for discharges to waters of the
United States from categories of point
sources (such as industrial, commercial,
and public sources). These national
ELGs are used by state permitting
authorities to establish technologybased effluent limitations for NPDES
permits.
The CWA also authorizes EPA to
promulgate nationally applicable
pretreatment standards that control
pollutant discharges from sources that
discharge wastewater indirectly to
waters of the United States through
Publicly Owned Treatment Works
(POTWs), as outlined in Sections 307(b)
and (c) of the CWA, 33 U.S.C. 1317(b)
and (c). EPA establishes national
pretreatment standards for pollutants in
wastewater from such indirect
dischargers shown to pass through, to
interfere with, or to be otherwise
incompatible with POTW operations.
Pretreatment standards are designed to
ensure that wastewaters from indirect
industrial dischargers are subject to
similar levels of treatment as direct
dischargers in the same industrial
category. See CWA Section 301(b), 33
U.S.C. 1311(b).
Technology-based effluent limitations
in NPDES permits are derived from
effluent limitations guidelines (CWA
Sections 301 and 304, 33 U.S.C. 1311
and 1314) and new source performance
standards (CWA Section 306, 33 U.S.C.
1316) promulgated by EPA. Where EPA
has not promulgated an applicable ELG
or new source performance standard,
technology-based effluent limitations
are based on the best professional
judgment (BPJ) of the permitting
authority. Additional limitations are
also required in a permit where
necessary to meet WQS. CWA Section
301(b)(1)(C), 33 U.S.C. 1311(b)(1)(C).
The ELGs are established by EPA
regulation for categories of industrial
dischargers and are based on the degree
of control that can be achieved using
various levels of pollution control
technology, as specified in the CWA
(e.g., Best Practicable Control
Technology Currently Available (BPT),
Best Conventional Pollutant Control
Technology (BCT), Best Available
Technology Economically Achievable
(BAT); see below).
The EPA promulgates national ELGs
for industrial categories for three classes
of pollutants: (1) Conventional
pollutants (total suspended solids (TSS),
oil and grease, biochemical oxygen
demand (BOD5), fecal coliform, and pH),
as outlined in CWA Section 304(a)(4),
33 U.S.C. 1314(a)(4), and 40 CFR 401.16;
(2) toxic pollutants (e.g., toxic metals
such as arsenic, mercury, selenium, and
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chromium; toxic organic pollutants such
as benzene, benzo-a-pyrene, phenol, and
naphthalene), as outlined in CWA
Section 307(a), 33 U.S.C. 1317(a); 40
CFR 401.15 and 40 CFR part 423,
appendix A; and (3) nonconventional
pollutants, which are those pollutants
that are not categorized as conventional
or toxic (e.g., ammonia-N, phosphorus,
and total dissolved solids (TDS)). PFAS
compounds fall into the category of
nonconventional pollutant, as they are
not defined as a toxic or conventional
pollutant in the CWA or the Code of
Federal Regulations (CFR).
B. Effluent Guidelines Program
EPA establishes ELGs based on the
performance of well-designed and welloperated control and treatment
technologies. EPA is not to base
technology-based requirements on their
effects on the receiving water. See
Weyerhaeuser Co. v. Costle, 599 F.2d
1011, 1028, 1042 (D.C. Cir. 1978).
There are four levels of technologybased controls applicable to direct
dischargers and two levels of controls
applicable to indirect dischargers. These
are described in detail below as general
background information:
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1. Best Practicable Control Technology
Currently Available (BPT)
Consistent with the CWA, EPA
establishes effluent limitations based on
BPT by reference to the average of the
best performances of facilities within
the industry, grouped to reflect various
ages, sizes, processes, or other common
characteristics. EPA promulgates BPT
effluent limitations for conventional,
toxic, and nonconventional pollutants.
In specifying BPT, EPA looks at a
number of factors. EPA first considers
the cost of achieving effluent reductions
in relation to the effluent reduction
benefits. The Agency also considers the
age of equipment and facilities, the
processes employed, engineering
aspects of the control technologies, any
required process changes, non-water
quality environmental impacts
(including energy requirements), and
such other factors as the Administrator
deems appropriate. See CWA Section
304(b)(1)(B), 33 U.S.C. 1314(b)(1)(B).
2. Best Conventional Pollutant Control
Technology (BCT)
The 1977 amendments to the CWA
require EPA to identify additional levels
of effluent reduction for conventional
pollutants associated with Best
Conventional Pollutant Control
Technology (BCT) for discharges from
existing industrial point sources. In
addition to other factors specified in
Section 304(b)(4)(B), 33 U.S.C.
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1314(b)(4)(B), the CWA requires that
EPA establish BCT limitations after
consideration of a two-part ‘‘cost
reasonableness’’ test. EPA explained its
methodology for the development of
BCT limitations on July 9, 1986 (51 FR
24974). Section 304(a)(4) designates the
following as conventional pollutants:
BOD5, TSS, fecal coliform, pH, and any
additional pollutants defined by the
Administrator as conventional. The
Administrator designated oil and grease
as a conventional pollutant on July 30,
1979 (44 FR 44501; 40 CFR 401.16).
3. Best Available Technology
Economically Achievable (BAT)
BAT represents the second level of
control for direct discharges of toxic and
nonconventional pollutants. As the
statutory phrase intends, EPA considers
technological availability and the
economic achievability in determining
what level of control represents BAT.
CWA Section 301(b)(2)(A), 33 U.S.C.
1311(b)(2)(A). Other statutory factors
that EPA must consider in assessing
BAT are the cost of achieving BAT
effluent reductions, the age of
equipment and facilities involved, the
process employed, potential process
changes, non-water quality
environmental impacts (including
energy requirements), and such other
factors as the Administrator deems
appropriate. CWA Section 304(b)(2)(B),
33 U.S.C. 1314(b)(2)(B); Texas Oil & Gas
Ass’n v. EPA, 161 F.3d 923, 928 (5th Cir.
1998). The Agency retains considerable
discretion in assigning the weight to be
accorded each of these factors.
Weyerhaeuser Co., 590 F.2d at 1045.
Generally, EPA determines economic
achievability based on the effect of the
cost of compliance with BAT limitations
on overall industry and subcategory (if
applicable) financial conditions. BAT is
intended to reflect the highest
performance in the industry, and it may
reflect a higher level of performance
than is currently being achieved based
on technology transferred from a
different subcategory or category, bench
scale or pilot studies, or foreign
facilities. Am. Paper Inst. v. Train, 543
F.2d 328, 353 (D.C. Cir. 1976); Am.
Frozen Food Inst. v. Train, 539 F.2d
107, 132 (D.C. Cir. 1976). BAT may be
based upon process changes or internal
controls, even when these technologies
are not common industry practice. See
Am. Frozen Food Inst., 539 F.2d at 132,
140; Reynolds Metals Co. v. EPA, 760
F.2d 549, 562 (4th Cir. 1985); Cal. &
Hawaiian Sugar Co. v. EPA, 553 F.2d
280, 285–88 (2nd Cir. 1977).
One way that EPA may consider
differences within an industry when
establishing BAT limitations is through
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subcategorization. The Supreme Court
has recognized that the substantive test
for subcategorizing an industry is the
same as that which applies to
establishing fundamentally different
factor variances—i.e., whether the
plants are different with respect to
relevant statutory factors. See Chem.
Mfrs. Ass’n v. EPA, 870 F.2d 177, 214
n.134 (5th Cir. 1989) (citing Chem. Mfrs.
Ass’n v. NRDC, 470 U.S. 116, 119–22,
129–34 (1985)). Courts have stated that
there need only be a rough basis for
subcategorization. See Chem. Mfrs.
Ass’n, 870 F.2d at 215 n.137
(summarizing cases).
4. Best Available Demonstrated Control
Technology/New Source Performance
Standards (NSPS)
NSPS reflect ‘‘the greatest degree of
effluent reduction’’ that is achievable
based on the ‘‘best available
demonstrated control technology’’
(BADCT), ‘‘including, where
practicable, a standard permitting no
discharge of pollutants.’’ CWA Section
306(a)(1), 33 U.S.C. 1316(a)(1). Owners
of new facilities have the opportunity to
install the best and most efficient
production processes and wastewater
treatment technologies. As a result,
NSPS generally represent the most
stringent controls attainable through the
application of BADCT for all pollutants
(that is, conventional, nonconventional,
and toxic pollutants). In establishing
NSPS, EPA is directed to take into
consideration the cost of achieving the
effluent reduction and any non-water
quality environmental impacts and
energy requirements. CWA Section
306(b)(1)(B), 33 U.S.C. 1316(b)(1)(B).
5. Pretreatment Standards for Existing
Sources (PSES)
Section 307(b) of the CWA, 33 U.S.C.
1317(b), authorizes EPA to promulgate
pretreatment standards for discharges of
pollutants to POTWs. PSES are designed
to prevent the discharge of pollutants
that pass through, interfere with, or
otherwise are incompatible with the
operation of POTWs. Categorical
pretreatment standards are technologybased and are analogous to BPT and
BAT effluent limitations guidelines, and
thus the Agency typically considers the
same factors in promulgating PSES as it
considers in promulgating BPT and
BAT. The General Pretreatment
Regulations, which set forth the
framework for the implementation of
categorical pretreatment standards, are
found at 40 CFR part 403. These
regulations establish pretreatment
standards that apply to all non-domestic
dischargers. See 52 FR 1586 (January 14,
1987).
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6. Pretreatment Standards for New
Sources (PSNS)
Section 307(c) of the CWA, 33 U.S.C.
1317(c), authorizes EPA to promulgate
PSNS at the same time it promulgates
NSPS. As is the case for PSES, PSNS are
designed to prevent the discharge of any
pollutant into a POTW that interferes
with, passes through, or otherwise is
incompatible with the POTW. In
selecting the PSNS technology basis, the
Agency generally considers the same
factors it considers in establishing
NSPS, along with the results of a passthrough analysis. Like new sources of
direct discharges, new sources of
indirect discharges have the opportunity
to incorporate into their operations the
best available demonstrated
technologies. As a result, EPA
promulgates pretreatment standards for
new sources based on best available
demonstrated control technology for
new sources. See Nat’l Ass’n of Metal
Finishers v. EPA, 719 F.2d 624, 634 (3rd
Cir. 1983).
C. Summary of the Existing OCPSF ELGs
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The OCPSF ELGs (40 CFR part 414)
were originally promulgated in 1987,
and then amended in 1989, 1990, 1992,
and 1993. The OCPSF category includes
more than 1,000 chemical facilities
producing over 25,000 end products.
These include such products as
benzene, toluene, polypropylene,
polyvinyl chloride, chlorinated
solvents, rubber precursors, rayon,
nylon, and polyester. The OCPSF
industry is large and diverse with
complex operations and processes.
Some plants produce chemicals in large
volumes through continuous chemical
processes, while others produce only
small volumes of ‘‘specialty’’ chemicals
through batch chemical processes.
Only a small subset of the facilities
that are currently regulated under the
OCPSF ELGs manufacture or formulate
PFAS. Although the OCPSF ELGs may
apply to PFAS manufacturers and
formulators, the OCPSF ELGs do not
establish effluent limitations or
pretreatment standards for any PFAS
compounds. Rather, the revision to the
OCPSF ELGs would address PFAS
discharges from PFAS manufacturers
and formulators.
IV. The EPA’s PFAS Multi-Industry
Study and Identification of PFAS
Manufacturers and Formulators for
Potential Regulation
As described in the Preliminary
Effluent Guidelines Program Plan 14
(Preliminary Plan 14), published in
October 2019, EPA conducted an initial
examination of readily available public
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information about PFAS surface water
discharges to identify industrial sources
that may warrant further study. The
Preliminary Plan 14 docket (EPA–HQ–
OW–2018–0618) includes a summary of
the information EPA reviewed and a
report with a more thorough description
of our review activities. Based on this
initial review, EPA decided to conduct
further studies to better understand and
document facilities discharging PFAS
compounds to surface waters and to
POTWs. This was introduced in the
Preliminary Plan 14 as the PFAS MultiIndustry Study.
The goals of the PFAS Multi-Industry
Study are to identify industries and
specific facilities producing or using
PFAS compounds; quantify—to the best
of EPA’s ability—the amounts of PFAS
being discharged; identify PFAS control
practices and treatment technologies;
document PFAS removal efficiency in
wastewater; and estimate costs
associated with PFAS treatment
systems. EPA identified the following
industrial point source categories as the
primary focus of this study: OCPSF
manufacturers; pulp and paper
manufacturers; textiles and carpet
manufacturers; and commercial
airports.1
For the OCPSF manufacturers, EPA
reviewed numerous data sources and
identified six PFAS manufacturers and
ten likely PFAS formulators. EPA is not
sure that the ten facilities that it
identified as ‘‘likely’’ PFAS formulators
are actually PFAS formulators due to
limited data available at this time. We
discuss each of these data sources in
greater detail below.
EPA reviewed 2019 Discharge
Monitoring Reports (DMRs) and
obtained PFAS data for six PFAS
manufacturers and three likely PFAS
formulators (the other seven facilities do
not report PFAS compounds in their
DMRs or they do not have DMRs
because they are indirect dischargers).
These nine facilities combined reported
a total of 17 PFAS compounds in their
discharges. Based on the DMRs, effluent
data detected a total of 15 PFAS
compounds, and concentrations ranged
from non-detect to 777 parts per billion
(ppb). The ‘‘2019 Monitoring Period
Level DMR PFAS Data’’ (DCN
OCPSF00030) includes additional
information on the compounds that
were monitored, and the concentration
ranges reported in DMRs.
EPA reviewed NPDES permits for
these PFAS manufacturers and
formulators to evaluate whether their
permits contain effluent limitations or
1 Military bases and airports are not included in
the scope of this study.
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monitoring requirements for PFAS
compounds. One current NPDES permit
in West Virginia contains effluent
limitations for two PFAS compounds
(Perfluorooctanoic acid (PFOA) and
Hexafluoropropylene oxide dimer acid
(HFPODA) that go into effect on
September 1, 2021. Another facility in
North Carolina is under a consent
decree with requirements for no
discharge of PFAS process wastewater.
See DCN OCPSF00079 for consent
decree. The North Carolina facility is
currently hauling all PFAS process
wastewater off-site for disposal. The
consent decree went into effect on
February 25, 2019 and ends on January
31, 2023. This North Carolina facility
reported detections of PFOA for 9 of 12
reporting periods in 2019 DMRs,
including periods after February 2019.
Four of the other PFAS manufacturers
and formulators have PFAS monitoring
requirements, and no effluent
limitations, in their NPDES permits.
Two Alabama facilities and one Illinois
facility are operating under expired,
administratively continued NPDES
permits. The NPDES permit materials
collected and reviewed are available as
DCNs OCPSF000008 to OCPSF00025.
EPA also reviewed the Toxics Release
Inventory (TRI), which is managed by
EPA’s Office of Chemical Safety and
Pollution Prevention (OCSPP) and
tracks annual environmental waste
management, including releases, of 767
individually listed chemicals and 33
chemical categories from industrial
facilities that manufacture, process, or
otherwise use these chemicals in
amounts above their applicable
reporting thresholds. Release of a TRI
chemical refers to an emission to air,
discharge to water, or placement in
some type of land disposal. EPA has not
yet received any information or data
pertaining to the release of PFAS
compounds through TRI reporting.
However, the National Defense
Authorization Act for Fiscal Year 2020
added 172 PFAS compounds to the TRI.
TRI reporting for these PFAS will be
due to EPA by July 1, 2021, for calendar
year 2020 data. For additional
information on the addition of 172
PFAS to TRI, see https://www.epa.gov/
toxics-release-inventory-tri-program/listpfas-added-tri-ndaa.
EPA reviewed data from the Toxic
Substances Control Act (TSCA)
Inventory, which lists chemicals
manufactured (including imported) or
processed in the United States. The
TSCA Inventory, managed by the Office
of Pollution Prevention and Toxics
(OPPT) within OCSPP, currently lists
more than 86,000 chemicals, of which
approximately half are currently in
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commerce or ‘‘active.’’ For PFAS
specifically, the TSCA Inventory lists
over one thousand compounds, of
which approximately half are known to
be commercially active within the last
decade. The TSCA Inventory by itself
cannot be used to identify dischargers.
EPA also reviewed the Chemical Data
Reporting (CDR) database, which
compiles information collected under a
TSCA Section 8(a) rule that requires
chemical manufacturers (including
importers) to provide EPA with
production, import, and customer use
information about chemicals in
commerce. Manufacturers and importers
must report to the CDR database if they
meet certain annual volume thresholds,
typically 25,000 pounds, but 2,500
pounds for chemicals subject to certain
TSCA actions. EPA matched the
chemicals in the 2016 CDR data (the
most recent year available) 2 against
EPA’s Cross-Agency Research List 3 and
identified 118 PFAS compounds in the
CDR database. See DCN OCPSF00032
for ‘‘2016 nonCBI CDR Data for PFAS
Compounds’’ and DCN OCPSF00003 for
‘‘EPA’s CompTox Cross Agency PFAS
List.’’ Using this list of CDR PFAS
compounds, EPA summed the reported
production volumes to calculate a total
PFAS production and importation
volume of approximately 608 million
pounds for 2015. See DCN OCPSF00033
for ‘‘Review of 2015 non-CBI CDR Data
for PFAS Compounds.’’ The CDR
database contains data identifying
which facilities produced PFAS
compounds, but does not have any
information on PFAS discharges. The
six PFAS manufacturing facilities that
reported 2019 DMR data also appear in
the CDR data as domestic manufacturers
of 76 separate PFAS compounds. An
additional 55 facilities appear in the
CDR dataset; however, EPA has no
corresponding data on their potential
PFAS discharges. The deadline for the
CDR data for the 2020 reporting cycle is
in January 2021. Additional PFASrelated data submitted by CDR sites can
be assessed shortly thereafter.
EPA collected and reviewed 15
treatment technology technical articles
from a range of sources including EPA
2 The information for the CDR is collected every
four years from manufacturers (including
importers). The 2016 CDR data contains
information reported in 2016 and covering 2012 to
2015. https://www.epa.gov/chemical-datareporting/basic-information-about-chemical-datareporting#what.
3 EPA’s Cross-Agency Research PFAS list, from
the CompTox Chemicals Dashboard, is a manually
curated listing of mainly straight-chain and
branched PFAS compiled from various internal,
literature and public sources by EPA researchers
and program office representative (https://
comptox.epa.gov/dashboard).
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publications, federal, state, and local
government publications, PFAS
manufacturers, and non-governmental
organizations (NGOs). Through these
articles, EPA identified eight potential
technologies that can remove PFAS
from wastewater. These include
granular activated carbon, reverse
osmosis filtration, and ion exchange. A
full list of available technologies that
EPA has identified to date is included
in DCN OCPSF00096.
EPA began stakeholder outreach in
July 2019 by meeting with stakeholders
to collect, on a voluntary basis,
additional information such as
supplementary effluent data,
information on PFAS compounds being
produced/used and discharged, and any
information about treatment
technologies being used, along with
their effectiveness and costs, to augment
the available information EPA reviewed.
This information gathering effort was
performed under the Multi-Industry
Study noted above. The information
provided by stakeholders is included in
DCN OCPSF00042–OCPSF00078.
EPA met with the FluoroCouncil of
the American Chemistry Council,4 the
primary trade association that
represents PFAS manufacturers and
formulators, and its members. See DCN
OCPSF00054 for meeting notes. They
provided EPA with technical literature
concerning PFAS terminology and
classification, a list of short chain
fluorotelomers studies, an economic
assessment of the U.S. fluoropolymer
industry, and the names of contacts at
entities that they identified as the sole
three PFAS manufacturing companies in
the United States. These three
manufacturers (with a total of six
facilities) mirrored the six facilities for
which EPA found DMR data and an
additional facility for which EPA
received internal monitoring data.
EPA met with representatives of one
company that operates multiple
facilities that manufacture PFAS in
West Virginia, New Jersey and North
Carolina. They provided EPA with a
copy of the presentation they gave
during their meeting with the Agency, a
copy of a New Jersey facility’s NPDES
permit, data for an internal outfall at
that facility, a document addressing
PFAS concerns at a North Carolina
facility, and technical literature on
fluoropolymers of low concern. See
DCN OCPSF00061 for meeting notes
and DCNs OCPSF00062 to OCPSF00064
for materials provided.
4 The FluoroCouncil of the American Chemistry
Council has disbanded since EPA last spoke to
them.
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EPA met with representatives of one
company that operates multiple
facilities that manufacture PFAS in
Alabama, Illinois and Minnesota.
Representatives of this company
provided EPA with a PFAS production
history in addition to current PFAS
product categories, wastewater process
flow diagrams, copies of their NPDES
permits, documentation for a direct
injection analytical method, sampling
data for both PFAS manufacturing
facilities and a formulating facility, and
related published literature. See DCN
OCPSF00042 for meeting notes and
DCNs OCPSF00043 to OCPSF00052 for
materials provided.
EPA met with representatives of
another PFAS manufacturing facility in
Alabama. See DCN OCPSF00065 for
meeting notes.
EPA spoke to a representative of
another company who stated that the
company does not produce PFAS
compounds in the United States. EPA
learned that this company imports
products from international
manufacturing facilities and other
manufacturers both inside and outside
of the United States. Those materials are
further processed at a domestic facility
in Pennsylvania. See DCN OCPSF00060
for meeting notes. EPA is not aware of
any PFAS discharge data from this
facility, but EPA is requesting additional
information regarding these and similar
operations through this notice.
EPA made attempts to contact the
other PFOA/PFOS Stewardship Program
https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/factsheet-20102015-pfoa-stewardshipprogram) companies but did not receive
any additional information. EPA
continues to coordinate with
manufacturers to obtain additional
information, including a list of PFAS
compounds they manufacture,
documentation for the analytical
methods they use to analyze PFAS in
waste streams, and PFAS analytical data
collected from source water, process
water, and effluent at their facilities.
EPA spoke with representatives of the
Michigan Department of Environment,
Great Lakes, & Energy (MI EGLE).
Michigan EGLE provided EPA with
sampling data for 30 direct discharging
facilities and 633 indirect discharging
facilities across 44 industrial categories,
mostly for PFOA and PFOS. See DCN
OCPSF00067 for direct discharging data
and DCN OCPSF00068 for indirect
discharging data provided by MI EGLE.
Four of these facilities were likely
PFAS formulators based on the
concentrations of PFAS in discharges
and the operations of the facilities. EPA
also reviewed an investigation report
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from EPA’s Region 3, looking for
potential PFAS sources in Goose Creek,
Pennsylvania. From this report, EPA
was able to identify another likely PFAS
formulator. See DCN OCPSF00038 for
report and communications.
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V. Request for Further Information on
PFAS Manufacturers and Formulators
A. PFAS Manufacturers
EPA has identified six facilities
(Alabama, North Carolina, West
Virginia, New Jersey, Illinois) in the
United States that currently
manufacture PFAS compounds and
have an associated wastewater
discharge.
Throughout the course of EPA’s PFAS
Multi-Industry Study, the Agency
worked collaboratively with
stakeholders to obtain information
regarding facilities that manufacture and
formulate fluorochemicals in the United
States. EPA appreciates the information
that these entities have provided to the
Agency to date.5 This information has
greatly increased the Agency’s
understanding of current manufacturing
facilities, their operations, their
production of fluorochemicals, their
wastewater generation activities, and
their wastewater treatment activities.
After reviewing the information
received to date, EPA is inviting
stakeholders to review this information
and provide comment and is seeking
additional information and data to
inform EPA’s next steps.
Specifically, EPA is requesting the
following information and data
regarding PFAS manufacturers:
1. The identity of or suggestions for
how to identify any other facilities in
the United States currently
manufacturing PFAS.
2. Descriptions of the manufacturing
processes being employed at PFAS
manufacturing facilities, including
process flow diagrams.
3. Information and data on the
specific PFAS compounds that are
currently being produced (including as
byproducts) at these facilities (including
the product name, CAS number and
class of each compound), the quantities
that are being produced, the customers
or industries that are purchasing these
materials, and the quantities of
materials sold to various customers. For
sales, EPA is also interested in knowing
the quantities of PFAS compounds that
are exported outside of the United
States.
4. Identification of the wastewater
streams at manufacturing facilities that
contain PFAS (e.g., process wastewater,
5 These data and information are contained in the
docket supporting this notice.
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cooling water, contaminated
stormwater, wastewater from aqueous
scrubbers or air pollution control
equipment, off-specification products,
equipment cleaning wastewater, spills
and leaks), their volumes,
characteristics, the identity (including
CAS Number), and concentrations of
PFAS compounds in those individual
waste streams.
5. Information and data on the current
wastewater treatment and management
practices (including pollution
prevention and product recovery
practices) being utilized at existing
PFAS manufacturers. Specific
information requested includes
descriptions of the treatment
technologies, their size and flow rate,
process flow diagrams, capital and
operation and maintenance costs,
treatment chemical utilization, and
residuals generation and management. If
wastewater storage ponds are used to
hold PFAS wastewater, EPA also
requests a description of the ponds,
including purpose, age, capacity,
design, wastewater characteristics,
whether they are lined or unlined, and
whether they have discharge outfalls.
6. If manufacturers are not treating
PFAS containing wastewater onsite,
EPA is requesting information on the
management or disposal practices being
utilized (e.g., zero liquid discharge,
disposal wells, transfer to off-site
centralized waste treatment facilities or
transfer to POTWs), the volumes of
wastewaters being managed via different
practices, the name and location of the
facilities receiving wastewaters, and
their associated costs.
7. Information and data on future
planned process changes at existing
PFAS manufacturing facilities, any
plans to change or phase-out
manufacture of specific fluorinated
compounds or to increase or decrease
production of specific compounds, and
any planned major upgrades to existing
manufacturing facilities or construction
of new PFAS manufacturing facilities in
the United States. EPA is also requesting
information regarding any potential
changes in PFAS manufacturing
processes, pollution prevention
practices or chemicals used as PFAS
substitution, or use and cost of specific
technologies that can reduce the
quantity of PFAS in wastewater from
PFAS manufacturing operations.
8. EPA has collected existing publicly
available DMR data and monitoring data
from known manufacturers, as well as
data from TRI and CDR databases, as
indicated in the docket. These DMRs
contain data on only a subset of the total
PFAS that are potentially present in
discharges from these facilities. EPA
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14565
requests additional monitoring data (see
DCN OCPSF00115 for suggested data
format and fields) on PFAS compounds
in wastewater discharges from PFAS
manufacturing facilities. Since there is
currently no CWA-approved analytical
method promulgated for analysis of
PFAS compounds in wastewater, EPA
requests that monitoring data that is
submitted include information on the
analytical methods used as well as
associated information and data that can
be used by EPA to determine the quality
of the data. EPA also requests comment
on whether additional PFAS
compounds or precursors that are not
reported in DMRs are found in
wastewater discharges from these
facilities, and the quantities of such
PFAS compounds, precursors, and other
organofluoride compounds found in
untreated and treated wastewaters from
these facilities. In addition to data on
individual compounds, EPA is also
particularly interested in data that
would provide the total quantity of
organofluorides present, such as would
be provided by a Total Organic Fluorine
(TOF) analysis or other assays.
9. In addition to treatment
technologies being used at the six
known PFAS manufacturing facilities,
EPA is requesting additional
information and data regarding
treatment and destruction technologies
for PFAS in industrial wastewater,
including data on their performance,
costs (both capital and operation and
maintenance), and the types, quantities
and management practices for any
treatment residuals that are generated.
Data from laboratory, bench, pilot, and
full-scale facilities are requested. EPA
also requests comment on the 15
treatment technology articles included
in the docket.
10. Analytical methodologies used to
monitor wastewater at PFAS
manufacturing facilities, including in
house SOPs and method performance
data, including lists of specific PFAS
compounds being monitored, and any
aggregate procedures (e.g., adsorbable or
extractable organic fluorine by
combustion ion chromatography).
11. Any studies that have been
conducted concerning environmental or
human health impacts (e.g., toxicity,
risk, fate and transfer, cross media) of
PFAS discharges from PFAS
manufacturers.
B. PFAS Formulators
EPA has identified limited publicly
available information regarding the
universe of PFAS formulators. To date,
EPA has identified ten facilities (in
Ohio, Virginia, Michigan, Minnesota,
Pennsylvania and New Jersey) that are
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potential formulators, but requests
additional details regarding formulator
facilities.
As with manufacturers, EPA is
interested in obtaining additional
information and data regarding
discharges of PFAS from formulators in
order to inform the Agency’s decisionmaking regarding the need for new or
revised ELGs for these types of facilities.
EPA is requesting the following
information and data from PFAS
formulators:
1. Identification of all known PFAS
formulators in the United States.
2. Descriptions of the manufacturing
processes occurring at formulating
facilities, including descriptions of how
PFAS compounds are utilized at these
facilities.
3. The SIC or NAICS codes of
formulating facilities.
4. Information and data on the PFAS
compounds that are currently being
used at these facilities (including the
product name, CAS number and class of
each compound), the quantities that are
being used, the quantities that are being
sold or transferred for further processing
or as materials for incorporation into
finished products, and the customers or
industries that are purchasing these
materials and products.
5. Information on whether PFAS is
being imported by formulators from
outside the United States, and if any
formulators are exclusively utilizing
imported PFAS.
6. The locations and number of
formulating facilities, as well as whether
process wastewater associated with
PFAS formulating is being discharged at
these facilities.
7. Whether facilities have current
monitoring requirements for PFAS or
other fluorocarbons.
8. Information and data on the current
wastewater treatment and management
practices (including pollution
prevention and product recovery
practices) being utilized at existing
PFAS formulators. Specific information
requested includes descriptions of the
treatment technologies, their size and
flow rate, process flow diagrams, capital
and operation and maintenance costs,
treatment chemical utilization, and
residuals generation and management. If
wastewater storage ponds are used to
hold PFAS wastewater, provide a
description of the ponds including
purpose, age, capacity, design,
wastewater characteristics, whether they
are lined or unlined, and whether they
have discharge outfalls.
9. For facilities that discharge process
wastewater, whether facilities are
subject to national ELGs, and if so,
identification of the applicable part(s)
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and subpart(s) (e.g., 40 CFR 414 Subpart
H) and the wastewater discharge permit
identification numbers. EPA is also
requesting copies of NPDES permits and
fact sheets (or statement of basis) for
direct discharging facilities, and copies
of control agreements for indirect
discharging facilities.
10. Process flow diagrams showing
where wastewater is generated.
11. Identification of the wastewater
streams at formulating facilities that
contain PFAS (e.g., process wastewater,
cooling water, contaminated
stormwater, wastewater from aqueous
scrubbers or air pollution control
equipment, off-specification products,
equipment cleaning wastewater, spills
and leaks), their volumes,
characteristics, and concentrations of
PFAS compounds in those individual
waste streams.
12. If formulators are not treating
PFAS containing wastewater onsite,
EPA is requesting information on the
management or disposal practices being
utilized (e.g., zero liquid discharge,
disposal wells, transfer to off-site
centralized waste treatment facilities or
transfer to POTWs), the volumes of
wastes being managed via different
practices, and their associated costs.
13. Information and data on future
planned process changes at formulators,
any plans to change or phase-out use of
specific fluorinated compounds or to
increase or decrease production of
specific compounds, and any planned
major upgrades to existing formulating
facilities or construction of new
formulating facilities in the United
States.
14. EPA has collected existing
publicly available DMR data and
monitoring data from potential PFAS
formulators, as well as data from TRI
and CDR databases, as indicated in the
docket. These DMRs contain data on
only a subset of the total PFAS that are
potentially present in discharges from
these facilities. EPA requests additional
monitoring data (see DCN OCPSF00115
for suggested data format and fields) on
PFAS compounds in wastewater
discharges from PFAS formulating
facilities. Since there is currently no
CWA-approved analytical method
promulgated for analysis of PFAS
compounds in wastewater, EPA requests
that monitoring data that is submitted
include information on the analytical
methods used as well as associated
information and data that can be used
by EPA to determine the quality of the
data. EPA also requests comment on
whether additional PFAS compounds or
precursors that are not reported in
DMRs are found in wastewater
discharges from these facilities, and the
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quantities of such PFAS compounds,
precursors and other organofluoride
compounds found in untreated and
treated wastewaters from these facilities.
In addition to data on individual
compounds, EPA is also particularly
interested in data that would provide
the total quantity of organofluorides
present, such as would be provided by
a Total Organic Fluorine (TOF) analysis
or other assays.
15. EPA is interested in information
regarding any potential changes in
PFAS formulating processes, pollution
prevention practices or product
substitution, or use and cost of specific
technologies that can reduce the
quantity of PFAS in wastewater from
PFAS formulating operations.
16. Analytical methodologies used to
monitor wastewater at PFAS
formulating facilities, including in
house SOPs and method performance
data, including lists of specific PFAS
compounds being monitored, and any
aggregate procedures (e.g., adsorbable or
extractable organic fluorine by
combustion ion chromatography).
17. Any studies that have been
conducted concerning environmental or
human health impacts (e.g., toxicity,
risk, fate and transfer, cross media) of
PFAS discharges from formulators.
VI. Statutory and Executive Order
Reviews
Under Executive Order 12866, titled
Regulatory Planning and Review (58 FR
51735, October 4, 1993), this is a
‘‘significant regulatory action’’ ‘‘because
the action raises novel legal or policy
issues.’’ Accordingly, EPA submitted
this action to the Office of Management
and Budget (OMB) for review under
Executive Order 12866, and any changes
made in response to OMB
recommendations have been
documented in the docket for this
action. Because this action does not
propose or impose any requirements,
other statutory and Executive Order
reviews that apply to rulemaking do not
apply. Should EPA subsequently
determine to pursue a rulemaking, EPA
will address the statutes and Executive
Orders that apply to that rulemaking.
EPA welcomes comments and/or
information that would help the Agency
to assess any of the following: The
potential impact of a rule on small
entities pursuant to the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.); potential impacts on federal, state,
or local governments pursuant to the
Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1531–1538);
federalism implications pursuant to
Executive Order 13132, entitled
Federalism (64 FR 43255, November 2,
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1999); availability of voluntary
consensus standards pursuant to
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104–
113; tribal implications pursuant to
Executive Order 13175, entitled
Consultation and Coordination with
Indian Tribal Governments (65 FR
67249, November 6, 2000);
environmental health or safety effects
on children pursuant to Executive Order
13045, entitled Protection of Children
from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23,
1997); energy effects pursuant to
Executive Order 13211, entitled Actions
Concerning Regulations that
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001); Paperwork burdens pursuant
to the Paperwork Reduction Act (PRA)
(44 U.S.C. 3501); or human health or
environmental effects on minority or
low-income populations pursuant to
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994). The Agency will
consider such comments during the
development of any subsequent
rulemaking.
List of Subjects in 40 CFR Part 414
Environmental protection, Chemicals,
Plastics materials and synthetics, Waste
treatment and disposal, Water pollution
control.
Jane Nishida,
Acting Administrator.
[FR Doc. 2021–05402 Filed 3–16–21; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 100
RIN 0906–AB24
National Vaccine Injury Compensation
Program: Revisions to the Vaccine
Injury Table
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of proposed withdrawal;
request for comments.
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AGENCY:
HHS proposes rescinding the
final rule entitled ‘‘National Vaccine
Injury Compensation Program:
Revisions to the Vaccine Injury Table,’’
published in the Federal Register on
January 21, 2021. That final rule, if it
were to go into effect, would amend our
SUMMARY:
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regulations by removing Shoulder Injury
Related to Vaccine Administration
(SIRVA), vasovagal syncope, and the
new vaccines category (Item XVII) from
the Vaccine Injury Table (Table). HHS
seeks comments on this proposed
rescission.
The final rule published January
21, 2021, at 86 FR 6249, delayed
February 23, 2021, at 86 FR 10835, is
proposed to be withdrawn. Written
comments and related material to this
proposed withdrawal must be received
on or before April 16, 2021.
ADDRESSES: You may submit written
comments electronically by the
following method: Federal eRulemaking
Portal: https://www.regulations.gov.
Follow the instructions on the website
for submitting comments.
Instructions. Include the HHS Docket
No. HRSA–2021–0001 in your
comments. All comments received will
be posted without change to https://
www.regulations.gov. Please do not
include any personally identifiable or
confidential business information you
do not want publicly disclosed.
FOR FURTHER INFORMATION CONTACT:
Please visit the National Vaccine Injury
Compensation Program’s website,
https://www.hrsa.gov/
vaccinecompensation/, or contact
Tamara Overby, Acting Director,
Division of Injury Compensation
Programs, Healthcare Systems Bureau,
HRSA, Room 08N146B, 5600 Fishers
Lane, Rockville, MD 20857; by email at
vaccinecompensation@hrsa.gov; or by
telephone at (855) 266–2427.
SUPPLEMENTARY INFORMATION: This is a
notice of proposed rulemaking by which
HHS proposes to rescind the final rule
titled ‘‘National Vaccine Injury
Compensation Program: Revisions to the
Vaccine Injury Table,’’ (final rule),
January 21, 2021, 86 FR 6249, delayed
February 23, 2021, 86 FR 10835, which,
if it were to go into effect, would amend
the provisions of 42 CFR 100.3 by
removing Shoulder Injury Related to
Vaccine Administration (SIRVA),
vasovagal syncope, and the new
vaccines category (Item XVII) from the
Table.
DATES:
I. Background and Purpose
The National Childhood Vaccine
Injury Act of 1986, title III of Public Law
99–660 (42 U.S.C. 300aa–10 et seq.)
(Vaccine Act), established the National
Vaccine Injury Compensation Program
(VICP) to ensure an adequate supply of
vaccines, stabilize vaccine costs, and
establish and maintain an accessible
and efficient forum for individuals
found to be injured by certain vaccines
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14567
to be compensated. The Vaccine Act has
been amended several times since 1986.
Petitions for compensation under this
Program are filed in the United States
Court of Federal Claims (Court), with a
copy served on the Secretary, who is the
‘‘Respondent.’’ The Court, acting
through judicial officers called Special
Masters, makes findings as to eligibility
for, and the amount of, compensation.
To be found entitled to an award under
the VICP, a petitioner must establish a
vaccine-related injury or death, either
by proving that a vaccine actually
caused or significantly aggravated an
injury (causation-in-fact) or by
demonstrating the occurrence of what
has been referred to as a Table injury.
That is, a petitioner may show that the
vaccine recipient suffered an injury of
the type enumerated in the regulations
at 42 CFR 100.3—the Vaccine Injury
Table—corresponding to the vaccination
in question, and that the onset of such
injury took place within a time period
also specified in the Table. The Table is
accompanied by, among other
provisions, the Qualifications and Aids
to Interpretation (QAI), which defines
the injuries and conditions listed on the
Table. If these criteria are met, the
injury is presumed to have been caused
by the vaccination, and the petitioner is
entitled to compensation (assuming that
other requirements are satisfied), unless
the respondent affirmatively shows that
the injury was caused by some factor
other than the vaccination (see 42 U.S.C.
300aa–11(c)(1)(C)(i), 300aa–13(a)(1)(B)),
and 300aa–14(a)). Currently, cases are
often resolved by negotiated settlements
between the parties and approved by the
Court. In such situations, HHS and the
Court have not concluded, based upon
review of the evidence, that the vaccine
caused the alleged injury.
Revisions to the Table are authorized
under the Vaccine Act (42 U.S.C. 300aa–
14(c)–(e)). The Vaccine Act prohibits the
Secretary of HHS from proposing a
revision to the Table ‘‘unless the
Secretary has first provided to the
[Advisory] Commission [on Childhood
Vaccines] a copy of the proposed
regulation or revision, requested
recommendations and comments by the
Commission, and afforded the
Commission at least 90 days to make
such recommendations’’ (42 U.S.C.
300aa–14(d)). Further, once the
proposed revision is published, the
Secretary must afford the public at least
180 days of public comment (42 U.S.C.
300aa–14(c)(1)).
HHS added SIRVA and vasovagal
syncope to the Table in March 2017,
following an extensive, multi-year
process that involved nine HHS
workgroups, including HRSA and the
E:\FR\FM\17MRP1.SGM
17MRP1
Agencies
[Federal Register Volume 86, Number 50 (Wednesday, March 17, 2021)]
[Proposed Rules]
[Pages 14560-14567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05402]
[[Page 14560]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 414
[EPA-HQ-OW-2020-0582; FRL 10019-06-OW]
RIN 2040-AG10
Clean Water Act Effluent Limitations Guidelines and Standards for
the Organic Chemicals, Plastics and Synthetic Fibers Point Source
Category
AGENCY: Environmental Protection Agency (EPA).
ACTION: Advance notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency) is
initiating further data collection and analysis to support potential
future rulemaking, under the Clean Water Act (CWA), relating to the
effluent limitations guidelines, pretreatment standards and new source
performance standards applicable to the Organic Chemicals, Plastics and
Synthetic Fibers (OCPSF) point source category to address discharges
from manufacturers of per- and polyfluoroalkyl substances (PFAS) and is
considering revising the same for formulators of PFAS. PFAS are a group
of man-made organic chemicals. Some PFAS compounds are persistent in
the environment and in the human body. Analysis of animal studies and
human epidemiological research suggest that exposure above certain
levels to some PFAS may be associated with adverse human health
effects. The Agency has identified several industries with facilities
that are likely to be discharging PFAS in their wastewater, including
OCPSF manufacturers and formulators. This advance notice of proposed
rulemaking (ANPRM) provides for public review and comment on the
information and data regarding PFAS manufacturers and formulators that
EPA has collected to date. EPA is requesting public comment on the
information and data presented in this ANPRM. EPA is also soliciting
additional information and data regarding discharges of PFAS from these
facilities to inform future revisions to the wastewater discharge
requirements that apply to the OCPSF point source category.
DATES: Comments must be received on or before May 17, 2021.
ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OW-2020-0582, 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, Office of Water, Office of Science and Technology Docket, Mail
Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
Hand Delivery or Courier (by scheduled appointment only):
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. Out
of an abundance of caution for members of the public and our staff, the
EPA Docket Center and Reading Room are closed to the public, with
limited exceptions, to reduce the risk of transmitting COVID-19. Our
Docket Center staff will continue to provide remote customer service
via email, phone, and webform. We encourage the public to submit
comments via https://www.regulations.gov/ or email, as there may be a
delay in processing mail and faxes. Hand deliveries and couriers may be
received by scheduled appointment only. 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: Ms. Samantha Lewis, Engineering and
Analysis Division, Office of Science and Technology, Office of Water;
telephone number: 202-566-1058; email address: [email protected].
I. Public Participation
A. Written Comments
Submit your comments, identified by Docket ID No. EPA-HQ-OW-2020-
0582, 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 Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. If you wish to submit such
information, consult the person listed for additional information in
the preceding FOR FURTHER INFORMATION CONTACT section. 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 CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
EPA is temporarily suspending its Docket Center and Reading Room
for public visitors, with limited exceptions, to reduce the risk of
transmitting COVID-19. Our Docket Center staff will continue to provide
remote customer service via email, phone, and webform. We encourage the
public to submit comments via https://www.regulations.gov/ as there may
be a delay in processing mail and faxes. Hand deliveries or couriers
will be received by scheduled appointment only. For further information
and updates on EPA Docket Center services, please visit us online at
https://www.epa.gov/dockets.
EPA continues to carefully and continuously monitor information
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.
B. Supporting Information
This notice is supported by documents that are contained in the
public docket. EPA has prepared an index of these materials to aid in
the public's review and comment. The index can be identified by
searching the docket for DCN OCPSF00116.
II. General Information
A. Does this action apply to me?
Entities potentially affected by any rulemaking following this
notice include:
[[Page 14561]]
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Category Example of regulated entity
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Industry.................................. PFAS Manufacturers.
PFAS Formulators.
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This section is not intended to be exhaustive, but rather provides
a guide regarding entities likely to be regulated by any future
rulemaking activities following this notice. Other types of entities
that are not included in the examples above could also be regulated.
PFAS manufacturers are facilities that produce PFAS compounds or
precursors through processes including, but not limited to,
electrochemical fluorination (ECF) and telomerization. Facilities that
manufacture PFAS are currently regulated under EPA's national Effluent
Limitations Guidelines and Standards (ELGs) for the OCPSF category (40
CFR part 414). EPA has also gathered more limited information about
PFAS formulators. PFAS formulators are facilities that are the primary
customers of the PFAS manufacturers, and that use raw PFAS feedstock to
(a) produce commercial or consumer goods (e.g., weather-proof
caulking), or (b) as intermediary products for use in the manufacture
of commercial goods (e.g., a grease-proof coating for a pizza box).
If you still have questions regarding the applicability of any
future rulemaking activities following this notice to a particular
entity, please consult the person listed for additional information in
the preceding FOR FURTHER INFORMATION CONTACT section.
B. What is the purpose of this notice?
As part of EPA's statutorily required Effluent Guidelines planning
process, EPA has reviewed readily available information about PFAS
surface water discharges to identify industrial sources that may
warrant further study for potential regulation through national ELGs.
Based on the limited data available at the time, in February of 2019,
EPA published the PFAS Action Plan, in which it identified several
industries with facilities that are likely to be discharging PFAS
compounds in their wastewater and EPA began a more detailed study to
evaluate the potential for PFAS presence in their wastewater
discharges. Through the PFAS Multi-Industry Study, described in EPA's
Preliminary Effluent Guidelines Program Plan 14, EPA gathered a range
of information about PFAS manufacturers and formulators, as well as the
potential discharges of PFAS from these facilities (further details on
these efforts are provided in Section V below). PFAS manufacturers are
facilities that produce PFAS compounds or precursors through processes
including, but not limited to, ECF and telomerization. Facilities that
manufacture PFAS are currently regulated under EPA's national ELGs for
the OCPSF category (40 CFR part 414). EPA has also gathered some
information about PFAS formulators. PFAS formulators are facilities
that are the primary customers of PFAS manufacturers, and that use raw
PFAS feedstock to (a) produce commercial or consumer goods (e.g.,
weather-proof caulking), or (b) as intermediary products for use in the
manufacture of commercial goods (e.g., a grease-proof coating for a
pizza box). EPA's data set for formulators is more limited than for
manufacturers, as the Agency has identified little publicly available
information on these facilities and their potential discharges.
This notice provides for public review and comment on the
information that EPA has collected to date on PFAS discharges from both
PFAS manufacturers and formulators. In addition, as detailed in Section
V below, EPA is soliciting additional information and data regarding
PFAS manufacturers and formulators, including wastewater
characteristics and treatability. EPA will use any information and data
received to inform potential next steps, which could include developing
new or revised ELGs for these categories of dischargers. Because
formulators may be subject to national ELGs outside of the OCPSF
category, future EPA actions to address PFAS discharges from these
facilities may include revisions to ELGs other than the ELGs that apply
to the OCPSF category or proposal of a new ELG.
III. Background
A. Clean Water Act
Among its core provisions, the Clean Water Act (CWA) prohibits the
discharge of pollutants from a point source to waters of the United
States, except as authorized under the CWA. Under CWA Section 402, 33
U.S.C. 1342, discharges may be authorized through a National Pollutant
Discharge Elimination System (NPDES) permit. The CWA outlines a dual
approach for establishing discharge limits for these permits: (1)
Technology-based effluent limitations that establish a floor of
performance for categories of dischargers, and (2) water quality-based
effluent limitations that are established where technology-based
effluent limitations are insufficient to meet applicable state water
quality standards (WQS) or site specific water quality goals. The CWA
authorizes EPA to establish national technology-based ELGs and new
source performance standards for discharges to waters of the United
States from categories of point sources (such as industrial,
commercial, and public sources). These national ELGs are used by state
permitting authorities to establish technology-based effluent
limitations for NPDES permits.
The CWA also authorizes EPA to promulgate nationally applicable
pretreatment standards that control pollutant discharges from sources
that discharge wastewater indirectly to waters of the United States
through Publicly Owned Treatment Works (POTWs), as outlined in Sections
307(b) and (c) of the CWA, 33 U.S.C. 1317(b) and (c). EPA establishes
national pretreatment standards for pollutants in wastewater from such
indirect dischargers shown to pass through, to interfere with, or to be
otherwise incompatible with POTW operations. Pretreatment standards are
designed to ensure that wastewaters from indirect industrial
dischargers are subject to similar levels of treatment as direct
dischargers in the same industrial category. See CWA Section 301(b), 33
U.S.C. 1311(b).
Technology-based effluent limitations in NPDES permits are derived
from effluent limitations guidelines (CWA Sections 301 and 304, 33
U.S.C. 1311 and 1314) and new source performance standards (CWA Section
306, 33 U.S.C. 1316) promulgated by EPA. Where EPA has not promulgated
an applicable ELG or new source performance standard, technology-based
effluent limitations are based on the best professional judgment (BPJ)
of the permitting authority. Additional limitations are also required
in a permit where necessary to meet WQS. CWA Section 301(b)(1)(C), 33
U.S.C. 1311(b)(1)(C). The ELGs are established by EPA regulation for
categories of industrial dischargers and are based on the degree of
control that can be achieved using various levels of pollution control
technology, as specified in the CWA (e.g., Best Practicable Control
Technology Currently Available (BPT), Best Conventional Pollutant
Control Technology (BCT), Best Available Technology Economically
Achievable (BAT); see below).
The EPA promulgates national ELGs for industrial categories for
three classes of pollutants: (1) Conventional pollutants (total
suspended solids (TSS), oil and grease, biochemical oxygen demand
(BOD5), fecal coliform, and pH), as outlined in CWA Section
304(a)(4), 33 U.S.C. 1314(a)(4), and 40 CFR 401.16; (2) toxic
pollutants (e.g., toxic metals such as arsenic, mercury, selenium, and
[[Page 14562]]
chromium; toxic organic pollutants such as benzene, benzo-a-pyrene,
phenol, and naphthalene), as outlined in CWA Section 307(a), 33 U.S.C.
1317(a); 40 CFR 401.15 and 40 CFR part 423, appendix A; and (3)
nonconventional pollutants, which are those pollutants that are not
categorized as conventional or toxic (e.g., ammonia-N, phosphorus, and
total dissolved solids (TDS)). PFAS compounds fall into the category of
nonconventional pollutant, as they are not defined as a toxic or
conventional pollutant in the CWA or the Code of Federal Regulations
(CFR).
B. Effluent Guidelines Program
EPA establishes ELGs based on the performance of well-designed and
well-operated control and treatment technologies. EPA is not to base
technology-based requirements on their effects on the receiving water.
See Weyerhaeuser Co. v. Costle, 599 F.2d 1011, 1028, 1042 (D.C. Cir.
1978).
There are four levels of technology-based controls applicable to
direct dischargers and two levels of controls applicable to indirect
dischargers. These are described in detail below as general background
information:
1. Best Practicable Control Technology Currently Available (BPT)
Consistent with the CWA, EPA establishes effluent limitations based
on BPT by reference to the average of the best performances of
facilities within the industry, grouped to reflect various ages, sizes,
processes, or other common characteristics. EPA promulgates BPT
effluent limitations for conventional, toxic, and nonconventional
pollutants. In specifying BPT, EPA looks at a number of factors. EPA
first considers the cost of achieving effluent reductions in relation
to the effluent reduction benefits. The Agency also considers the age
of equipment and facilities, the processes employed, engineering
aspects of the control technologies, any required process changes, non-
water quality environmental impacts (including energy requirements),
and such other factors as the Administrator deems appropriate. See CWA
Section 304(b)(1)(B), 33 U.S.C. 1314(b)(1)(B).
2. Best Conventional Pollutant Control Technology (BCT)
The 1977 amendments to the CWA require EPA to identify additional
levels of effluent reduction for conventional pollutants associated
with Best Conventional Pollutant Control Technology (BCT) for
discharges from existing industrial point sources. In addition to other
factors specified in Section 304(b)(4)(B), 33 U.S.C. 1314(b)(4)(B), the
CWA requires that EPA establish BCT limitations after consideration of
a two-part ``cost reasonableness'' test. EPA explained its methodology
for the development of BCT limitations on July 9, 1986 (51 FR 24974).
Section 304(a)(4) designates the following as conventional pollutants:
BOD5, TSS, fecal coliform, pH, and any additional pollutants
defined by the Administrator as conventional. The Administrator
designated oil and grease as a conventional pollutant on July 30, 1979
(44 FR 44501; 40 CFR 401.16).
3. Best Available Technology Economically Achievable (BAT)
BAT represents the second level of control for direct discharges of
toxic and nonconventional pollutants. As the statutory phrase intends,
EPA considers technological availability and the economic achievability
in determining what level of control represents BAT. CWA Section
301(b)(2)(A), 33 U.S.C. 1311(b)(2)(A). Other statutory factors that EPA
must consider in assessing BAT are the cost of achieving BAT effluent
reductions, the age of equipment and facilities involved, the process
employed, potential process changes, non-water quality environmental
impacts (including energy requirements), and such other factors as the
Administrator deems appropriate. CWA Section 304(b)(2)(B), 33 U.S.C.
1314(b)(2)(B); Texas Oil & Gas Ass'n v. EPA, 161 F.3d 923, 928 (5th
Cir. 1998). The Agency retains considerable discretion in assigning the
weight to be accorded each of these factors. Weyerhaeuser Co., 590 F.2d
at 1045. Generally, EPA determines economic achievability based on the
effect of the cost of compliance with BAT limitations on overall
industry and subcategory (if applicable) financial conditions. BAT is
intended to reflect the highest performance in the industry, and it may
reflect a higher level of performance than is currently being achieved
based on technology transferred from a different subcategory or
category, bench scale or pilot studies, or foreign facilities. Am.
Paper Inst. v. Train, 543 F.2d 328, 353 (D.C. Cir. 1976); Am. Frozen
Food Inst. v. Train, 539 F.2d 107, 132 (D.C. Cir. 1976). BAT may be
based upon process changes or internal controls, even when these
technologies are not common industry practice. See Am. Frozen Food
Inst., 539 F.2d at 132, 140; Reynolds Metals Co. v. EPA, 760 F.2d 549,
562 (4th Cir. 1985); Cal. & Hawaiian Sugar Co. v. EPA, 553 F.2d 280,
285-88 (2nd Cir. 1977).
One way that EPA may consider differences within an industry when
establishing BAT limitations is through subcategorization. The Supreme
Court has recognized that the substantive test for subcategorizing an
industry is the same as that which applies to establishing
fundamentally different factor variances--i.e., whether the plants are
different with respect to relevant statutory factors. See Chem. Mfrs.
Ass'n v. EPA, 870 F.2d 177, 214 n.134 (5th Cir. 1989) (citing Chem.
Mfrs. Ass'n v. NRDC, 470 U.S. 116, 119-22, 129-34 (1985)). Courts have
stated that there need only be a rough basis for subcategorization. See
Chem. Mfrs. Ass'n, 870 F.2d at 215 n.137 (summarizing cases).
4. Best Available Demonstrated Control Technology/New Source
Performance Standards (NSPS)
NSPS reflect ``the greatest degree of effluent reduction'' that is
achievable based on the ``best available demonstrated control
technology'' (BADCT), ``including, where practicable, a standard
permitting no discharge of pollutants.'' CWA Section 306(a)(1), 33
U.S.C. 1316(a)(1). Owners of new facilities have the opportunity to
install the best and most efficient production processes and wastewater
treatment technologies. As a result, NSPS generally represent the most
stringent controls attainable through the application of BADCT for all
pollutants (that is, conventional, nonconventional, and toxic
pollutants). In establishing NSPS, EPA is directed to take into
consideration the cost of achieving the effluent reduction and any non-
water quality environmental impacts and energy requirements. CWA
Section 306(b)(1)(B), 33 U.S.C. 1316(b)(1)(B).
5. Pretreatment Standards for Existing Sources (PSES)
Section 307(b) of the CWA, 33 U.S.C. 1317(b), authorizes EPA to
promulgate pretreatment standards for discharges of pollutants to
POTWs. PSES are designed to prevent the discharge of pollutants that
pass through, interfere with, or otherwise are incompatible with the
operation of POTWs. Categorical pretreatment standards are technology-
based and are analogous to BPT and BAT effluent limitations guidelines,
and thus the Agency typically considers the same factors in
promulgating PSES as it considers in promulgating BPT and BAT. The
General Pretreatment Regulations, which set forth the framework for the
implementation of categorical pretreatment standards, are found at 40
CFR part 403. These regulations establish pretreatment standards that
apply to all non-domestic dischargers. See 52 FR 1586 (January 14,
1987).
[[Page 14563]]
6. Pretreatment Standards for New Sources (PSNS)
Section 307(c) of the CWA, 33 U.S.C. 1317(c), authorizes EPA to
promulgate PSNS at the same time it promulgates NSPS. As is the case
for PSES, PSNS are designed to prevent the discharge of any pollutant
into a POTW that interferes with, passes through, or otherwise is
incompatible with the POTW. In selecting the PSNS technology basis, the
Agency generally considers the same factors it considers in
establishing NSPS, along with the results of a pass-through analysis.
Like new sources of direct discharges, new sources of indirect
discharges have the opportunity to incorporate into their operations
the best available demonstrated technologies. As a result, EPA
promulgates pretreatment standards for new sources based on best
available demonstrated control technology for new sources. See Nat'l
Ass'n of Metal Finishers v. EPA, 719 F.2d 624, 634 (3rd Cir. 1983).
C. Summary of the Existing OCPSF ELGs
The OCPSF ELGs (40 CFR part 414) were originally promulgated in
1987, and then amended in 1989, 1990, 1992, and 1993. The OCPSF
category includes more than 1,000 chemical facilities producing over
25,000 end products. These include such products as benzene, toluene,
polypropylene, polyvinyl chloride, chlorinated solvents, rubber
precursors, rayon, nylon, and polyester. The OCPSF industry is large
and diverse with complex operations and processes. Some plants produce
chemicals in large volumes through continuous chemical processes, while
others produce only small volumes of ``specialty'' chemicals through
batch chemical processes.
Only a small subset of the facilities that are currently regulated
under the OCPSF ELGs manufacture or formulate PFAS. Although the OCPSF
ELGs may apply to PFAS manufacturers and formulators, the OCPSF ELGs do
not establish effluent limitations or pretreatment standards for any
PFAS compounds. Rather, the revision to the OCPSF ELGs would address
PFAS discharges from PFAS manufacturers and formulators.
IV. The EPA's PFAS Multi-Industry Study and Identification of PFAS
Manufacturers and Formulators for Potential Regulation
As described in the Preliminary Effluent Guidelines Program Plan 14
(Preliminary Plan 14), published in October 2019, EPA conducted an
initial examination of readily available public information about PFAS
surface water discharges to identify industrial sources that may
warrant further study. The Preliminary Plan 14 docket (EPA-HQ-OW-2018-
0618) includes a summary of the information EPA reviewed and a report
with a more thorough description of our review activities. Based on
this initial review, EPA decided to conduct further studies to better
understand and document facilities discharging PFAS compounds to
surface waters and to POTWs. This was introduced in the Preliminary
Plan 14 as the PFAS Multi-Industry Study.
The goals of the PFAS Multi-Industry Study are to identify
industries and specific facilities producing or using PFAS compounds;
quantify--to the best of EPA's ability--the amounts of PFAS being
discharged; identify PFAS control practices and treatment technologies;
document PFAS removal efficiency in wastewater; and estimate costs
associated with PFAS treatment systems. EPA identified the following
industrial point source categories as the primary focus of this study:
OCPSF manufacturers; pulp and paper manufacturers; textiles and carpet
manufacturers; and commercial airports.\1\
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\1\ Military bases and airports are not included in the scope of
this study.
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For the OCPSF manufacturers, EPA reviewed numerous data sources and
identified six PFAS manufacturers and ten likely PFAS formulators. EPA
is not sure that the ten facilities that it identified as ``likely''
PFAS formulators are actually PFAS formulators due to limited data
available at this time. We discuss each of these data sources in
greater detail below.
EPA reviewed 2019 Discharge Monitoring Reports (DMRs) and obtained
PFAS data for six PFAS manufacturers and three likely PFAS formulators
(the other seven facilities do not report PFAS compounds in their DMRs
or they do not have DMRs because they are indirect dischargers). These
nine facilities combined reported a total of 17 PFAS compounds in their
discharges. Based on the DMRs, effluent data detected a total of 15
PFAS compounds, and concentrations ranged from non-detect to 777 parts
per billion (ppb). The ``2019 Monitoring Period Level DMR PFAS Data''
(DCN OCPSF00030) includes additional information on the compounds that
were monitored, and the concentration ranges reported in DMRs.
EPA reviewed NPDES permits for these PFAS manufacturers and
formulators to evaluate whether their permits contain effluent
limitations or monitoring requirements for PFAS compounds. One current
NPDES permit in West Virginia contains effluent limitations for two
PFAS compounds (Perfluorooctanoic acid (PFOA) and Hexafluoropropylene
oxide dimer acid (HFPODA) that go into effect on September 1, 2021.
Another facility in North Carolina is under a consent decree with
requirements for no discharge of PFAS process wastewater. See DCN
OCPSF00079 for consent decree. The North Carolina facility is currently
hauling all PFAS process wastewater off-site for disposal. The consent
decree went into effect on February 25, 2019 and ends on January 31,
2023. This North Carolina facility reported detections of PFOA for 9 of
12 reporting periods in 2019 DMRs, including periods after February
2019. Four of the other PFAS manufacturers and formulators have PFAS
monitoring requirements, and no effluent limitations, in their NPDES
permits. Two Alabama facilities and one Illinois facility are operating
under expired, administratively continued NPDES permits. The NPDES
permit materials collected and reviewed are available as DCNs
OCPSF000008 to OCPSF00025.
EPA also reviewed the Toxics Release Inventory (TRI), which is
managed by EPA's Office of Chemical Safety and Pollution Prevention
(OCSPP) and tracks annual environmental waste management, including
releases, of 767 individually listed chemicals and 33 chemical
categories from industrial facilities that manufacture, process, or
otherwise use these chemicals in amounts above their applicable
reporting thresholds. Release of a TRI chemical refers to an emission
to air, discharge to water, or placement in some type of land disposal.
EPA has not yet received any information or data pertaining to the
release of PFAS compounds through TRI reporting. However, the National
Defense Authorization Act for Fiscal Year 2020 added 172 PFAS compounds
to the TRI. TRI reporting for these PFAS will be due to EPA by July 1,
2021, for calendar year 2020 data. For additional information on the
addition of 172 PFAS to TRI, see https://www.epa.gov/toxics-release-inventory-tri-program/list-pfas-added-tri-ndaa.
EPA reviewed data from the Toxic Substances Control Act (TSCA)
Inventory, which lists chemicals manufactured (including imported) or
processed in the United States. The TSCA Inventory, managed by the
Office of Pollution Prevention and Toxics (OPPT) within OCSPP,
currently lists more than 86,000 chemicals, of which approximately half
are currently in
[[Page 14564]]
commerce or ``active.'' For PFAS specifically, the TSCA Inventory lists
over one thousand compounds, of which approximately half are known to
be commercially active within the last decade. The TSCA Inventory by
itself cannot be used to identify dischargers.
EPA also reviewed the Chemical Data Reporting (CDR) database, which
compiles information collected under a TSCA Section 8(a) rule that
requires chemical manufacturers (including importers) to provide EPA
with production, import, and customer use information about chemicals
in commerce. Manufacturers and importers must report to the CDR
database if they meet certain annual volume thresholds, typically
25,000 pounds, but 2,500 pounds for chemicals subject to certain TSCA
actions. EPA matched the chemicals in the 2016 CDR data (the most
recent year available) \2\ against EPA's Cross-Agency Research List \3\
and identified 118 PFAS compounds in the CDR database. See DCN
OCPSF00032 for ``2016 nonCBI CDR Data for PFAS Compounds'' and DCN
OCPSF00003 for ``EPA's CompTox Cross Agency PFAS List.'' Using this
list of CDR PFAS compounds, EPA summed the reported production volumes
to calculate a total PFAS production and importation volume of
approximately 608 million pounds for 2015. See DCN OCPSF00033 for
``Review of 2015 non-CBI CDR Data for PFAS Compounds.'' The CDR
database contains data identifying which facilities produced PFAS
compounds, but does not have any information on PFAS discharges. The
six PFAS manufacturing facilities that reported 2019 DMR data also
appear in the CDR data as domestic manufacturers of 76 separate PFAS
compounds. An additional 55 facilities appear in the CDR dataset;
however, EPA has no corresponding data on their potential PFAS
discharges. The deadline for the CDR data for the 2020 reporting cycle
is in January 2021. Additional PFAS-related data submitted by CDR sites
can be assessed shortly thereafter.
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\2\ The information for the CDR is collected every four years
from manufacturers (including importers). The 2016 CDR data contains
information reported in 2016 and covering 2012 to 2015. https://www.epa.gov/chemical-data-reporting/basic-information-about-chemical-data-reporting#what.
\3\ EPA's Cross-Agency Research PFAS list, from the CompTox
Chemicals Dashboard, is a manually curated listing of mainly
straight-chain and branched PFAS compiled from various internal,
literature and public sources by EPA researchers and program office
representative (https://comptox.epa.gov/dashboard).
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EPA collected and reviewed 15 treatment technology technical
articles from a range of sources including EPA publications, federal,
state, and local government publications, PFAS manufacturers, and non-
governmental organizations (NGOs). Through these articles, EPA
identified eight potential technologies that can remove PFAS from
wastewater. These include granular activated carbon, reverse osmosis
filtration, and ion exchange. A full list of available technologies
that EPA has identified to date is included in DCN OCPSF00096.
EPA began stakeholder outreach in July 2019 by meeting with
stakeholders to collect, on a voluntary basis, additional information
such as supplementary effluent data, information on PFAS compounds
being produced/used and discharged, and any information about treatment
technologies being used, along with their effectiveness and costs, to
augment the available information EPA reviewed. This information
gathering effort was performed under the Multi-Industry Study noted
above. The information provided by stakeholders is included in DCN
OCPSF00042-OCPSF00078.
EPA met with the FluoroCouncil of the American Chemistry
Council,\4\ the primary trade association that represents PFAS
manufacturers and formulators, and its members. See DCN OCPSF00054 for
meeting notes. They provided EPA with technical literature concerning
PFAS terminology and classification, a list of short chain
fluorotelomers studies, an economic assessment of the U.S.
fluoropolymer industry, and the names of contacts at entities that they
identified as the sole three PFAS manufacturing companies in the United
States. These three manufacturers (with a total of six facilities)
mirrored the six facilities for which EPA found DMR data and an
additional facility for which EPA received internal monitoring data.
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\4\ The FluoroCouncil of the American Chemistry Council has
disbanded since EPA last spoke to them.
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EPA met with representatives of one company that operates multiple
facilities that manufacture PFAS in West Virginia, New Jersey and North
Carolina. They provided EPA with a copy of the presentation they gave
during their meeting with the Agency, a copy of a New Jersey facility's
NPDES permit, data for an internal outfall at that facility, a document
addressing PFAS concerns at a North Carolina facility, and technical
literature on fluoropolymers of low concern. See DCN OCPSF00061 for
meeting notes and DCNs OCPSF00062 to OCPSF00064 for materials provided.
EPA met with representatives of one company that operates multiple
facilities that manufacture PFAS in Alabama, Illinois and Minnesota.
Representatives of this company provided EPA with a PFAS production
history in addition to current PFAS product categories, wastewater
process flow diagrams, copies of their NPDES permits, documentation for
a direct injection analytical method, sampling data for both PFAS
manufacturing facilities and a formulating facility, and related
published literature. See DCN OCPSF00042 for meeting notes and DCNs
OCPSF00043 to OCPSF00052 for materials provided.
EPA met with representatives of another PFAS manufacturing facility
in Alabama. See DCN OCPSF00065 for meeting notes.
EPA spoke to a representative of another company who stated that
the company does not produce PFAS compounds in the United States. EPA
learned that this company imports products from international
manufacturing facilities and other manufacturers both inside and
outside of the United States. Those materials are further processed at
a domestic facility in Pennsylvania. See DCN OCPSF00060 for meeting
notes. EPA is not aware of any PFAS discharge data from this facility,
but EPA is requesting additional information regarding these and
similar operations through this notice.
EPA made attempts to contact the other PFOA/PFOS Stewardship
Program https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/fact-sheet-20102015-pfoa-stewardship-program) companies but did
not receive any additional information. EPA continues to coordinate
with manufacturers to obtain additional information, including a list
of PFAS compounds they manufacture, documentation for the analytical
methods they use to analyze PFAS in waste streams, and PFAS analytical
data collected from source water, process water, and effluent at their
facilities.
EPA spoke with representatives of the Michigan Department of
Environment, Great Lakes, & Energy (MI EGLE). Michigan EGLE provided
EPA with sampling data for 30 direct discharging facilities and 633
indirect discharging facilities across 44 industrial categories, mostly
for PFOA and PFOS. See DCN OCPSF00067 for direct discharging data and
DCN OCPSF00068 for indirect discharging data provided by MI EGLE.
Four of these facilities were likely PFAS formulators based on the
concentrations of PFAS in discharges and the operations of the
facilities. EPA also reviewed an investigation report
[[Page 14565]]
from EPA's Region 3, looking for potential PFAS sources in Goose Creek,
Pennsylvania. From this report, EPA was able to identify another likely
PFAS formulator. See DCN OCPSF00038 for report and communications.
V. Request for Further Information on PFAS Manufacturers and
Formulators
A. PFAS Manufacturers
EPA has identified six facilities (Alabama, North Carolina, West
Virginia, New Jersey, Illinois) in the United States that currently
manufacture PFAS compounds and have an associated wastewater discharge.
Throughout the course of EPA's PFAS Multi-Industry Study, the
Agency worked collaboratively with stakeholders to obtain information
regarding facilities that manufacture and formulate fluorochemicals in
the United States. EPA appreciates the information that these entities
have provided to the Agency to date.\5\ This information has greatly
increased the Agency's understanding of current manufacturing
facilities, their operations, their production of fluorochemicals,
their wastewater generation activities, and their wastewater treatment
activities. After reviewing the information received to date, EPA is
inviting stakeholders to review this information and provide comment
and is seeking additional information and data to inform EPA's next
steps.
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\5\ These data and information are contained in the docket
supporting this notice.
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Specifically, EPA is requesting the following information and data
regarding PFAS manufacturers:
1. The identity of or suggestions for how to identify any other
facilities in the United States currently manufacturing PFAS.
2. Descriptions of the manufacturing processes being employed at
PFAS manufacturing facilities, including process flow diagrams.
3. Information and data on the specific PFAS compounds that are
currently being produced (including as byproducts) at these facilities
(including the product name, CAS number and class of each compound),
the quantities that are being produced, the customers or industries
that are purchasing these materials, and the quantities of materials
sold to various customers. For sales, EPA is also interested in knowing
the quantities of PFAS compounds that are exported outside of the
United States.
4. Identification of the wastewater streams at manufacturing
facilities that contain PFAS (e.g., process wastewater, cooling water,
contaminated stormwater, wastewater from aqueous scrubbers or air
pollution control equipment, off-specification products, equipment
cleaning wastewater, spills and leaks), their volumes, characteristics,
the identity (including CAS Number), and concentrations of PFAS
compounds in those individual waste streams.
5. Information and data on the current wastewater treatment and
management practices (including pollution prevention and product
recovery practices) being utilized at existing PFAS manufacturers.
Specific information requested includes descriptions of the treatment
technologies, their size and flow rate, process flow diagrams, capital
and operation and maintenance costs, treatment chemical utilization,
and residuals generation and management. If wastewater storage ponds
are used to hold PFAS wastewater, EPA also requests a description of
the ponds, including purpose, age, capacity, design, wastewater
characteristics, whether they are lined or unlined, and whether they
have discharge outfalls.
6. If manufacturers are not treating PFAS containing wastewater
onsite, EPA is requesting information on the management or disposal
practices being utilized (e.g., zero liquid discharge, disposal wells,
transfer to off-site centralized waste treatment facilities or transfer
to POTWs), the volumes of wastewaters being managed via different
practices, the name and location of the facilities receiving
wastewaters, and their associated costs.
7. Information and data on future planned process changes at
existing PFAS manufacturing facilities, any plans to change or phase-
out manufacture of specific fluorinated compounds or to increase or
decrease production of specific compounds, and any planned major
upgrades to existing manufacturing facilities or construction of new
PFAS manufacturing facilities in the United States. EPA is also
requesting information regarding any potential changes in PFAS
manufacturing processes, pollution prevention practices or chemicals
used as PFAS substitution, or use and cost of specific technologies
that can reduce the quantity of PFAS in wastewater from PFAS
manufacturing operations.
8. EPA has collected existing publicly available DMR data and
monitoring data from known manufacturers, as well as data from TRI and
CDR databases, as indicated in the docket. These DMRs contain data on
only a subset of the total PFAS that are potentially present in
discharges from these facilities. EPA requests additional monitoring
data (see DCN OCPSF00115 for suggested data format and fields) on PFAS
compounds in wastewater discharges from PFAS manufacturing facilities.
Since there is currently no CWA-approved analytical method promulgated
for analysis of PFAS compounds in wastewater, EPA requests that
monitoring data that is submitted include information on the analytical
methods used as well as associated information and data that can be
used by EPA to determine the quality of the data. EPA also requests
comment on whether additional PFAS compounds or precursors that are not
reported in DMRs are found in wastewater discharges from these
facilities, and the quantities of such PFAS compounds, precursors, and
other organofluoride compounds found in untreated and treated
wastewaters from these facilities. In addition to data on individual
compounds, EPA is also particularly interested in data that would
provide the total quantity of organofluorides present, such as would be
provided by a Total Organic Fluorine (TOF) analysis or other assays.
9. In addition to treatment technologies being used at the six
known PFAS manufacturing facilities, EPA is requesting additional
information and data regarding treatment and destruction technologies
for PFAS in industrial wastewater, including data on their performance,
costs (both capital and operation and maintenance), and the types,
quantities and management practices for any treatment residuals that
are generated. Data from laboratory, bench, pilot, and full-scale
facilities are requested. EPA also requests comment on the 15 treatment
technology articles included in the docket.
10. Analytical methodologies used to monitor wastewater at PFAS
manufacturing facilities, including in house SOPs and method
performance data, including lists of specific PFAS compounds being
monitored, and any aggregate procedures (e.g., adsorbable or
extractable organic fluorine by combustion ion chromatography).
11. Any studies that have been conducted concerning environmental
or human health impacts (e.g., toxicity, risk, fate and transfer, cross
media) of PFAS discharges from PFAS manufacturers.
B. PFAS Formulators
EPA has identified limited publicly available information regarding
the universe of PFAS formulators. To date, EPA has identified ten
facilities (in Ohio, Virginia, Michigan, Minnesota, Pennsylvania and
New Jersey) that are
[[Page 14566]]
potential formulators, but requests additional details regarding
formulator facilities.
As with manufacturers, EPA is interested in obtaining additional
information and data regarding discharges of PFAS from formulators in
order to inform the Agency's decision-making regarding the need for new
or revised ELGs for these types of facilities. EPA is requesting the
following information and data from PFAS formulators:
1. Identification of all known PFAS formulators in the United
States.
2. Descriptions of the manufacturing processes occurring at
formulating facilities, including descriptions of how PFAS compounds
are utilized at these facilities.
3. The SIC or NAICS codes of formulating facilities.
4. Information and data on the PFAS compounds that are currently
being used at these facilities (including the product name, CAS number
and class of each compound), the quantities that are being used, the
quantities that are being sold or transferred for further processing or
as materials for incorporation into finished products, and the
customers or industries that are purchasing these materials and
products.
5. Information on whether PFAS is being imported by formulators
from outside the United States, and if any formulators are exclusively
utilizing imported PFAS.
6. The locations and number of formulating facilities, as well as
whether process wastewater associated with PFAS formulating is being
discharged at these facilities.
7. Whether facilities have current monitoring requirements for PFAS
or other fluorocarbons.
8. Information and data on the current wastewater treatment and
management practices (including pollution prevention and product
recovery practices) being utilized at existing PFAS formulators.
Specific information requested includes descriptions of the treatment
technologies, their size and flow rate, process flow diagrams, capital
and operation and maintenance costs, treatment chemical utilization,
and residuals generation and management. If wastewater storage ponds
are used to hold PFAS wastewater, provide a description of the ponds
including purpose, age, capacity, design, wastewater characteristics,
whether they are lined or unlined, and whether they have discharge
outfalls.
9. For facilities that discharge process wastewater, whether
facilities are subject to national ELGs, and if so, identification of
the applicable part(s) and subpart(s) (e.g., 40 CFR 414 Subpart H) and
the wastewater discharge permit identification numbers. EPA is also
requesting copies of NPDES permits and fact sheets (or statement of
basis) for direct discharging facilities, and copies of control
agreements for indirect discharging facilities.
10. Process flow diagrams showing where wastewater is generated.
11. Identification of the wastewater streams at formulating
facilities that contain PFAS (e.g., process wastewater, cooling water,
contaminated stormwater, wastewater from aqueous scrubbers or air
pollution control equipment, off-specification products, equipment
cleaning wastewater, spills and leaks), their volumes, characteristics,
and concentrations of PFAS compounds in those individual waste streams.
12. If formulators are not treating PFAS containing wastewater
onsite, EPA is requesting information on the management or disposal
practices being utilized (e.g., zero liquid discharge, disposal wells,
transfer to off-site centralized waste treatment facilities or transfer
to POTWs), the volumes of wastes being managed via different practices,
and their associated costs.
13. Information and data on future planned process changes at
formulators, any plans to change or phase-out use of specific
fluorinated compounds or to increase or decrease production of specific
compounds, and any planned major upgrades to existing formulating
facilities or construction of new formulating facilities in the United
States.
14. EPA has collected existing publicly available DMR data and
monitoring data from potential PFAS formulators, as well as data from
TRI and CDR databases, as indicated in the docket. These DMRs contain
data on only a subset of the total PFAS that are potentially present in
discharges from these facilities. EPA requests additional monitoring
data (see DCN OCPSF00115 for suggested data format and fields) on PFAS
compounds in wastewater discharges from PFAS formulating facilities.
Since there is currently no CWA-approved analytical method promulgated
for analysis of PFAS compounds in wastewater, EPA requests that
monitoring data that is submitted include information on the analytical
methods used as well as associated information and data that can be
used by EPA to determine the quality of the data. EPA also requests
comment on whether additional PFAS compounds or precursors that are not
reported in DMRs are found in wastewater discharges from these
facilities, and the quantities of such PFAS compounds, precursors and
other organofluoride compounds found in untreated and treated
wastewaters from these facilities. In addition to data on individual
compounds, EPA is also particularly interested in data that would
provide the total quantity of organofluorides present, such as would be
provided by a Total Organic Fluorine (TOF) analysis or other assays.
15. EPA is interested in information regarding any potential
changes in PFAS formulating processes, pollution prevention practices
or product substitution, or use and cost of specific technologies that
can reduce the quantity of PFAS in wastewater from PFAS formulating
operations.
16. Analytical methodologies used to monitor wastewater at PFAS
formulating facilities, including in house SOPs and method performance
data, including lists of specific PFAS compounds being monitored, and
any aggregate procedures (e.g., adsorbable or extractable organic
fluorine by combustion ion chromatography).
17. Any studies that have been conducted concerning environmental
or human health impacts (e.g., toxicity, risk, fate and transfer, cross
media) of PFAS discharges from formulators.
VI. Statutory and Executive Order Reviews
Under Executive Order 12866, titled Regulatory Planning and Review
(58 FR 51735, October 4, 1993), this is a ``significant regulatory
action'' ``because the action raises novel legal or policy issues.''
Accordingly, EPA submitted this action to the Office of Management and
Budget (OMB) for review under Executive Order 12866, and any changes
made in response to OMB recommendations have been documented in the
docket for this action. Because this action does not propose or impose
any requirements, other statutory and Executive Order reviews that
apply to rulemaking do not apply. Should EPA subsequently determine to
pursue a rulemaking, EPA will address the statutes and Executive Orders
that apply to that rulemaking.
EPA welcomes comments and/or information that would help the Agency
to assess any of the following: The potential impact of a rule on small
entities pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.); potential impacts on federal, state, or local governments
pursuant to the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-
1538); federalism implications pursuant to Executive Order 13132,
entitled Federalism (64 FR 43255, November 2,
[[Page 14567]]
1999); availability of voluntary consensus standards pursuant to
Section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113; tribal implications pursuant to
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 6, 2000);
environmental health or safety effects on children pursuant to
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997); energy effects pursuant to Executive Order 13211, entitled
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001); Paperwork burdens
pursuant to the Paperwork Reduction Act (PRA) (44 U.S.C. 3501); or
human health or environmental effects on minority or low-income
populations pursuant to Executive Order 12898, entitled Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994). The Agency will consider
such comments during the development of any subsequent rulemaking.
List of Subjects in 40 CFR Part 414
Environmental protection, Chemicals, Plastics materials and
synthetics, Waste treatment and disposal, Water pollution control.
Jane Nishida,
Acting Administrator.
[FR Doc. 2021-05402 Filed 3-16-21; 8:45 am]
BILLING CODE 6560-50-P