Changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting, 74360-74368 [2023-23413]
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Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 372
[EPA–HQ–TRI–2022–0270; FRL–8741–04–
OCSPP]
RIN 2070–AK97
Changes to Reporting Requirements
for Per- and Polyfluoroalkyl
Substances and to Supplier
Notifications for Chemicals of Special
Concern; Community Right-to-Know
Toxic Chemical Release Reporting
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is adding per- and
polyfluoroalkyl substances (PFAS)
subject to reporting under the
Emergency Planning and Community
Right-to-Know Act (EPCRA) and the
Pollution Prevention Act (PPA)
pursuant to the National Defense
Authorization Act for Fiscal Year 2020
(NDAA) to the list of Lower Thresholds
for Chemicals of Special Concern
(chemicals of special concern). These
PFAS already have a lower reporting
activity threshold of 100 pounds. The
addition of these PFAS to the list of
chemicals of special concern means
such PFAS are subject to the same
reporting requirements as other
chemicals of special concern (i.e., it
eliminates the use of the de minimis
exemption and the option to use Form
A and would limit the use of range
reporting for PFAS). Removing the
availability of these burden-reduction
reporting options will result in a more
complete picture of the releases and
waste management quantities for these
PFAS. EPA is removing the availability
of the de minimis exemption for
purposes of the Supplier Notification
Requirements for all chemicals on the
list of chemicals of special concern.
This will help ensure that purchasers of
mixtures and trade name products
containing such chemicals are informed
of their presence in mixtures and
products they purchase to better inform
any TRI reporting obligations.
DATES: This final rule is effective
November 30, 2023 and shall apply for
the reporting year beginning January 1,
2024 (reports due July 1, 2025).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–TRI–2022–0270, is
available online at https://
www.regulations.gov or in person at the
Office of Pollution Prevention and
Toxics Docket (OPPT Docket) in the
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SUMMARY:
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Environmental Protection Agency
Docket Center (EPA/DC). All documents
in the docket are listed on https://
www.regulations.gov. Although listed in
the index, some information is not
publicly available, e.g., Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the internet and will be
publicly available only in hard copy
form. Additional instructions on visiting
the docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Daniel R. Ruedy, Data Gathering and
Analysis Division (7406M), Office of
Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–7974; email: ruedy.daniel@epa.gov.
For general information contact: The
Emergency Planning and Community
Right-to-Know Hotline; telephone
numbers: toll free at (800) 424–9346
(select menu option 3) or (703) 348–
5070 in the Washington, DC Area and
International; or go to https://
www.epa.gov/home/epa-hotlines.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or otherwise use listed PFAS or any
chemicals listed under 40 CFR 372.28.
The following list of North American
Industry Classification System (NAICS)
codes is not intended to be exhaustive,
but rather provides a guide to help
readers determine whether this action
applies to them. Potentially affected
entities may include:
• Facilities included in the following
NAICS manufacturing codes
(corresponding to Standard Industrial
Classification (SIC) codes 20 through
39): 311 *, 312 *, 313 *, 314 *, 315 *, 316,
321, 322, 323 *, 324, 325 *, 326 *, 327 *,
331, 332, 333, 334 *, 335 *, 336, 337 *,
339 *, 111998 *, 113310, 211130 *,
212323 *, 212390 *, 488390 *, 512230 *,
512250 *, 5131 *, 516210 *, 519290 *,
541713 *, 541715 * or 811490 *.
* Exceptions and/or limitations exist for
these NAICS codes.
• Facilities included in the following
NAICS codes (corresponding to SIC
codes other than SIC codes 20 through
39): 211130 * (corresponds to SIC code
1321, Natural Gas Liquids, and SIC
2819, Industrial Inorganic Chemicals,
Not Elsewhere Classified); or 212114,
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212115, 212220, 212230, 212290 *; or
2211 *, 221210 *, 221330 (limited to
facilities that combust coal and/or oil
for the purpose of generating power for
distribution in commerce) (corresponds
to SIC codes 4911, 4931, and 4939,
Electric Utilities); or 424690, 424710
(corresponds to SIC code 5171,
Petroleum Bulk Terminals and Plants);
425120 (limited to facilities previously
classified in SIC code 5169, Chemicals
and Allied Products, Not Elsewhere
Classified); or 562112 (limited to
facilities primarily engaged in solvent
recovery services on a contract or fee
basis (previously classified under SIC
code 7389, Business Services, NEC)); or
562211 *, 562212 *, 562213 *, 562219 *,
562920 * (limited to facilities regulated
under the Resource Conservation and
Recovery Act, subtitle C, 42 U.S.C. 6921
et seq.) (corresponds to SIC code 4953,
Refuse Systems). * Exceptions and/or
limitations exist for these NAICS codes.
• Federal facilities.
• Facilities that the EPA
Administrator has specifically required
to report to TRI pursuant to a
determination under EPCRA section
313(b)(2).
A more detailed description of the
types of facilities covered by the NAICS
codes subject to reporting under EPCRA
section 313 can be found at: https://
www.epa.gov/toxics-release-inventorytri-program/tri-covered-industry-sectors.
To determine whether your facility is
affected by this action, you should
carefully examine the applicability
criteria in part 372, subpart B of title 40
of the Code of Federal Regulations.
Federal facilities are required to report
under Section 6(a)–(b) of Executive
Order 14096 (88 FR 25251 April 21,
2023), Revitalizing Our Nation’s
Commitment to Environmental Justice
for All. If you have questions regarding
the applicability of this action to a
particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. What action is the Agency taking?
EPA is adding all PFAS included on
the Toxics Release Inventory (TRI)
pursuant to sections 7321(b) and 7321(c)
of the 2020 NDAA to the list of
chemicals of special concern (40 CFR
372.28). EPA maintains a list of PFAS
added to the TRI list pursuant to the
NDAA at: https://www.epa.gov/toxicsrelease-inventory-tri-program/list-pfasadded-tri-ndaa. The addition of PFAS
added to TRI pursuant to sections
7321(b) and (c) of the NDAA to the list
of chemicals of special concern aligns
reporting requirements for these PFAS
with other chemicals of special concern.
EPA anticipates this will result in
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additional Form R reports being filed for
these PFAS due to the removal of the de
minimis exemption and the option to
use Form A. It also limits the use of
range reporting, which will capture
more specific information for PFAS
added pursuant to sections 7321(b) and
7321(c) of the NDAA.
In addition, EPA is removing the
availability of the de minimis exemption
under the Supplier Notification
Requirements (40 CFR 372.45) for
facilities that manufacture or process
any chemicals included on the list of
chemicals of special concern.
This action does not make any
changes to the article exemption.
C. What is the Agency’s authority for
this action?
This action is issued under EPCRA
sections 313, 42 U.S.C. 11023 and 328,
42 U.S.C. 11048. EPCRA is also referred
to as Title III of the Superfund
Amendments and Reauthorization Act
of 1986.
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D. Why is the Agency taking this action?
EPA is taking this action to increase
the data collected for PFAS. Removing
the availability of certain burdenreduction reporting options will result
in a more complete picture of the
releases and waste management
quantities for PFAS. This will increase
the number of TRI reports on listed
PFAS and the amount of information
provided on such reports, resulting in
more information on the waste
management of these chemicals
available to the Agency, as well as to the
public. EPA expects this information
will be a benefit to the public, including
communities with environmental justice
concerns and public water utilities, as
well as inform future Agency actions,
including under the Clean Water Act,
the Resource Conservation and
Recovery Action, the Comprehensive
Environmental Response,
Compensation, and Liability Act, and
the Toxic Substances Control Act. In
addition, this action will increase data
collected for all chemicals of special
concern by eliminating the de minimis
exemption for purposes of the Supplier
Notification Requirements for all
chemicals on the list of chemicals of
special concern. The elimination of this
exemption from Supplier Notification
Requirements ensures that purchasers of
mixtures and trade name products
containing such chemicals are informed
of their presence in mixtures and
products they purchase.
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E. What are the estimated incremental
impacts of this action?
EPA prepared an updated economic
analysis for this action entitled,
‘‘Economic Analysis for the Changes to
Reporting Requirements for Per- and
Polyfluoroalkyl Substances and to
Supplier Notification Requirements for
Chemicals of Special Concern;
Community Right-to-Know Toxic
Chemical Release Reporting,’’ which
presents an analysis of the costs of the
reporting changes for PFAS and other
chemicals of special concern based on
updated 2022 wage rates and an
increase in supplier notification burden
estimates (Ref. 1). EPA estimates that
this action will result in an additional
623 to 2,015 Form R reports being filed
annually. EPA estimates that the costs of
this action will be approximately
$3,318,492 and $10,733,149 in the first
year of reporting and approximately
$1,580,214 and $5,111,044 in the
subsequent years. In addition, EPA has
determined that, of the 486 to 1,333
small businesses affected by this action,
none are estimated to incur annualized
cost impacts of more than 1% of
revenues. Thus, this action is not
expected to have a significant adverse
economic impact on a substantial
number of small entities.
Removing the availability of certain
burden-reduction reporting options will
result in a more complete picture of the
releases and waste management
quantities for PFAS. This will increase
the number of TRI reports on listed
PFAS and the amount of information
provided on such reports, resulting in
more information on the waste
management of these chemicals
available to the Agency, as well as to the
public.
II. Background Information
A. What is EPCRA section 313?
EPCRA section 313, 42 U.S.C. 11023
(also known as the Toxics Release
Inventory (TRI)), requires certain
facilities that manufacture, process, or
otherwise use listed toxic chemicals in
amounts above reporting activity
threshold levels to report their
environmental releases and other waste
management quantities of such
chemicals annually. These facilities
must also report pollution prevention
and recycling data for such chemicals,
pursuant to PPA section 6607, 42 U.S.C.
13106.
TRI provides information about
releases of toxic chemicals from covered
facilities throughout the United States;
however, TRI data do not reveal
whether or to what degree the public is
exposed to listed chemicals. TRI data
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can, in conjunction with other
information, be used as a starting point
in evaluating such exposures and the
risks posed by such exposures. The
determination of potential risk to
human health and/or the environment
depends upon many factors, including
the toxicity of the chemical, the fate of
the chemical in the environment, and
the amount and duration of human or
other exposure to the chemical.
For more information on TRI, visit the
TRI website at https://www.epa.gov/tri.
Note that TRI does not cover all
chemicals, facilities, or types of
pollution (see https://www.epa.gov/
toxics-release-inventory-tri-program/
what-toxics-release-inventory for
information on which chemicals and
facilities are regulated under TRI).
Additionally, via this website, EPA
provides a guidance document entitled
‘‘Factors to Consider When Using
Toxics Release Inventory Data’’
available at: https://www.epa.gov/
system/files/documents/2022-02/
factorstoconsider_approved-by-opa_
1.25.22-copy.pdf, which helps explain
some of the uses, as well as limitations,
of data TRI collects.
B. What are PFAS?
PFAS are synthetic organic
compounds that do not occur naturally
in the environment. PFAS contain an
alkyl carbon chain on which the
hydrogen atoms have been partially or
completely replaced by fluorine atoms.
Definitions of what constitutes ‘‘PFAS’’
differ amongst scientific and regulatory
bodies. However, in general, the strong
carbon-fluorine bonds of PFAS make
them resistant to degradation and thus
highly persistent in the environment
(Refs. 2 and 3). Some of these chemicals
have been used for decades in a wide
variety of consumer and industrial
products (Refs. 2 and 3). Some PFAS
have been detected in wildlife
indicating that at least some PFAS have
the ability to bioaccumulate (Ref. 3).
Because of the widespread use of PFAS
in commerce and their tendency to
persist in the environment, most people
in the United States have been exposed
to PFAS (Refs. 2, 4 and 5). Some PFAS
can accumulate in humans and remain
in the human body for long periods of
time (e.g., months to years) (Refs. 2 and
3), as a result, several PFAS have been
detected in human blood serum (Refs. 2,
3, 4, and 5).
C. What PFAS have been added to the
TRI list?
On December 20, 2019, the NDAA
was signed into law (Pub. L. 116–92,
https://www.congress.gov/public-laws/
116th-congress). The NDAA included
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two provisions that automatically add
PFAS to the TRI list. First, section
7321(b) of the NDAA added to the TRI
list, effective January 1, 2020, 14
chemicals by name and/or Chemical
Abstracts Service Registry Number
(CASRN) and additional PFAS that meet
specific criteria. On June 22, 2020 (85
FR 37354 (FRL–10008–09)), EPA
updated the TRI list in the CFR to reflect
the 172 non-CBI PFAS added to TRI by
section 7321(b) of the NDAA.
Additional PFAS are added to the TRI
list on an annual basis by the NDAA.
Specifically, PFAS that meet the criteria
in section 7321(c) of the NDAA are
deemed added to the TRI list on January
1 of the year after specific criteria are
met. Through this provision, the NDAA
will continue to add PFAS to the TRI
list over time as additional PFAS meet
the criteria outlined in 7321(c). The
criteria of section 7321(c) require the
addition to the TRI list of certain PFAS
after any one of the following dates:
• Final Toxicity Value. The date on
which the Administrator finalizes a
toxicity value for the PFAS or class of
PFAS;
• Significant New Use Rule. The date
on which the Administrator makes a
covered determination for the PFAS or
class of PFAS;
• Addition to Existing Significant
New Use Rule. The date on which the
PFAS or class of PFAS is added to a list
of substances covered by a covered
determination.
• Addition as an Active Chemical
Substance. The date on which the PFAS
or class of PFAS to which a covered
determination applies is:
• Added to the list published under
section 8(b)(1) of the Toxic Substances
Control Act (TSCA) (15 U.S.C. 2601 et
seq.) and designated as an active
chemical substance under TSCA section
8(b)(5)(A); or
• Designated as an active chemical
substance under TSCA section 8(b)(5)(B)
on the list published under TSCA
section 8(b)(1).
EPA updates the TRI list in the CFR
to reflect the PFAS added to TRI by
section 7321(c) of the NDAA. The first
update rule identifying PFAS that met
the 7321(c) criteria during 2020 was
published on June 3, 2021 (86 FR 29698
(FRL–10022–25)).
To date, section 7321 of the NDAA
has added a total of 189 PFAS to the TRI
list at: https://www.epa.gov/tri/PFAS. A
complete list of the PFAS added to the
TRI list can be found at: https://
www.epa.gov/toxics-release-inventorytri-program/list-pfas-added-tri-ndaa. In
addition, the NDAA established a
manufacture, processing, or otherwise
use reporting threshold of 100 pounds
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for each of the PFAS added to the TRI
list by sections 7321(b) and 7321(c) of
the NDAA. In the first year of reporting
for the initial 172 listed PFAS, EPA only
received 89 reports from 38 facilities
covering 43 different PFAS. Similar
levels of PFAS reporting were observed
in the subsequent year: with 176 PFAS
on the TRI list in RY2021, only 42
facilities reported submitted a total of 87
reports covering 43 different PFAS.
III. Summary of Public Comments on
Proposed Rule
Upon publication of the proposed rule
on December 5, 2022, EPA provided a
60-day comment period (87 FR 74379
(FRL–8714–03–OCSPP)). EPA received
36 comments on the proposed rule. EPA
received comments from citizens,
industry groups, non-governmental
organizations, and state governments.
The majority of comments on the
proposed rule addressed EPA’s burden
estimates, with the majority stating EPA
underestimated the burden of listing
PFAS as chemicals of special concern
and removing the supplier notification
de minimis exemption would impose.
Several commenters requested EPA
lower the activity thresholds for PFAS.
Many of the commenters stated that
EPA has not demonstrated PFAS meet
the criteria to be classified as chemicals
of special concern. Many of the
commenters stated that eliminating the
regulatory exemptions for PFAS will
create a more complete picture of PFAS
in communities and the environment.
After considering the public comments,
EPA updated the economic analysis to
incorporate 2022 wage rates, include a
summary of small entity analysis, and
increase the supplier notification
burden estimates. Further edits to the
analysis were not required because EPA
has made no substantive changes as
compared with what had been
proposed. Summaries of the comments
and EPA’s responses to the comments
appear in the Response to Comment
document (Ref. 6) which is in the docket
for this rulemaking.
IV. What changes is EPA making to the
TRI reporting requirements?
A. Designating PFAS Automatically
Added to the TRI List by the 2020
NDAA as Chemicals of Special Concern
EPA is adding all PFAS included on
the TRI list pursuant to sections 7321(b)
and 7321(c) of the NDAA (see 40 CFR
372.65(d) and (e)) to the list of
chemicals of special concern at 40 CFR
372.28. EPA first created the list of
chemicals of special concern to increase
the utility of TRI data by ensuring that
the data collected and shared through
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TRI are relevant and topical (Ref. 7).
EPA lowered the reporting thresholds
for chemicals of special concern because
even small quantities of releases of these
chemicals can be of concern. The first
chemicals that were added to the list of
chemicals of special concern were those
identified as persistent, bioaccumulative
and toxic (PBT) chemicals which,
except for the dioxin and dioxin-like
compounds category, have reporting
thresholds of either 10 or 100 pounds
depending on their persistent and
bioaccumulative properties (Ref. 7).
Chemicals of special concern are also
excluded from the de minimis
exemption, may not be reported on
Form A (Alternate Threshold
Certification Statement), and have limits
on the use of range reporting.
The de minimis exemption allows
facilities to not consider small
concentrations of TRI chemicals not
classified as chemicals of special
concern in mixtures or other trade name
products when making threshold
determinations and release and other
waste management calculations. The de
minimis exemption does not apply to
the manufacture of a TRI chemical
except if that chemical is manufactured
as an impurity and remains in the
product distributed in commerce, or if
the chemical is imported below the
appropriate de minimis level. The de
minimis exemption does not apply to a
byproduct manufactured coincidentally
as a result of manufacturing, processing,
otherwise use, or any waste
management activities.
The Form A provides facilities that
otherwise meet TRI-reporting thresholds
the option of certifying on a simplified
reporting form provided that they do not
exceed 500 pounds for the total annual
reportable amount (described
subsequently in this document) for that
chemical and that their amounts
manufactured, processed, or otherwise
used do not exceed 1 million pounds.
All chemicals of special concern (except
certain instances of reporting lead in
stainless steel, brass, or bronze alloys)
are excluded from Form A eligibility.
Form A does not include any
information on releases or other waste
management. Nor does it include source
reduction information or any other
chemical-specific information other
than the identity of the chemical.
For certain data elements (Part II,
Sections 5, 6.1, and 6.2 of Form R), for
chemicals not classified as chemicals of
special concern, the reportable quantity
may be reported either as an estimate or
by using the range codes that have been
developed. Currently, TRI reporting
provides three reporting ranges: 1–10
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pounds, 11–499 pounds, and 500–999
pounds.
The availability of these burden
reduction tools is inconsistent with a
concern for small quantities of the
chemicals and the expanded reporting
that was sought for chemicals with
lower reporting thresholds. In the
preamble to the 1999 final rule (Ref 7),
EPA outlined the reasons for
promulgating the de minimis exemption
(e.g., that facilities had limited access to
information and that low concentrations
would not contribute to the activity
threshold) and determined that those
rationales did not apply to chemicals of
special concern. Id. at 58670. Among
the reasons provided, EPA explained
that even minimal releases of persistent
bioaccumulative toxic chemicals may
result in significant adverse effects and
can reasonably be expected to
significantly contribute to exceeding the
proposed lower threshold. Id. EPA also
determined that facilities reporting on
chemicals of special concern could not
avail themselves of Form A reporting
because the information provided on
Form A is ‘‘insufficient for conducting
analyses’’ on chemicals of special
concern and would be ‘‘virtually useless
for communities interested in assessing
risk from releases and other waste
management’’ of such chemicals (i.e.,
the Form A does not include estimated
release and other waste management
quantities). Id. Lastly, EPA eliminated
range reporting for chemicals of special
concern because the use of ranges could
misrepresent data accuracy for PBT
chemicals because the low or the highend range numbers may not really be
that close to the estimated value. Id. For
the full discussion, see Persistent
Bioaccumulative Toxic (PBT)
Chemicals; Lowering of Reporting
Thresholds for Certain PBT Chemicals;
Addition of Certain PBT Chemicals;
Community Right-to-Know Toxic
Chemical Reporting (Refs. 7 and 8)
EPA has determined that PFAS added
to EPCRA section 313 by sections
7321(b) and 7321(c) of the 2020 NDAA
should be categorized as chemicals of
special concern and added to the list in
40 CFR 372.28. The NDAA set a 100pound annual reporting threshold for
PFAS added by sections 7321(b) and
7321(c), which indicates a concern for
small quantities of such PFAS. EPA has
therefore determined that the
availability of certain burden reduction
tools (i.e., de minimis levels, Form A,
and range reporting) is not justified for
these chemicals as the availability of
these tools is inconsistent with a
concern for small quantities.
Further, due to the strength of the
carbon-fluorine bonds, many PFAS can
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be very persistent in the environment
(Refs. 2, 3, and 9). Persistence in the
environment allows PFAS
concentrations to build up over time;
thus, even small releases can be of
concern. As with PBT chemicals,
permitting reporting facilities to
continue to rely on the burden
reduction tools (de minimis levels, Form
A, and range reporting) would eliminate
reporting on potentially significant
quantities of the listed PFAS. As
explained in more detail in Unit IV.,
EPA’s rationale for eliminating these
burden reduction tools for PBT
chemicals (Refs. 7 and 8) applies
equally well to PFAS.
The de minimis exemption allows
facilities to not consider concentrations
of TRI listed chemicals in Unit IV., 1%
(0.1% for carcinogens) in mixtures or
other trade name products they import,
process, or otherwise use in making
threshold calculations and release and
other waste management (including
disposal to land and other types of
waste management (i.e., energy
recovery, recyling, treatment))
determinations. Since the de minimis
level is based on relative concentration
rather than a specific amount, the
application of this exemption to PFAS
listed under sections 7321(b) and
7321(c) could allow significant
quantities of such PFAS to be excluded
from TRI reporting by facilities. For
example, if a facility imports, processes,
or otherwise uses 100,000 pounds of a
mixture or trade name product that
contains 0.5% of a listed PFAS, then
500 pounds (or five times the reporting
threshold) would be disregarded. This
exclusion is inconsistent with a concern
for small quantities of PFAS. Many
PFAS are used in products below the
established de minimis levels (Refs. 4
and 10), and the continued availability
of the exemption for PFAS would
permit facilities to discount those uses
when determining whether an
applicable threshold has been met to
trigger reporting.
The Form A provides certain covered
facilities the option of submitting a
substantially shorter form with a
reduced reporting burden (Ref. 11). For
example, the Form A does not require
facilities to report any information on
releases (e.g., releases through fugitive
or non-point air emissions, discharges to
streams or water bodies) or waste
management quantities. Facilities can
qualify to file a Form A if the total
annual reportable amount for the listed
chemical does not exceed 500 pounds,
and the amounts manufactured,
processed, or otherwise used do not
exceed 1 million pounds. The annual
reportable amount is equal to the
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combined total quantities released at the
facility (including disposed of within
the facility), treated at the facility (as
represented by amounts destroyed or
converted by treatment processes),
recovered at the facility as a result of
recycling operations, combusted for the
purpose of energy recovery at the
facility, and amounts transferred from
the facility to off-site locations for the
purpose of recycling, energy recovery,
treatment, and/or disposal. This means
that facilities that are required to report
data on PFAS and also qualify to file a
Form A will not be providing specific
quantity data on up to 500 pounds of a
listed PFAS (five times the reporting
threshold). For reporting year 2020,
approximately 10% of the reporting
forms submitted for the listed PFAS
were Forms A (i.e., reporting for TRI
reflects 93 active reporting forms of
which 84 were Forms R and 9 were
Forms A). This trend continued with
reporting year 2021, in which 9 of the
total 87 reporting forms for PFAS were
Form A.
While the Form A does provide some
general information on the quantities of
the chemical that the facility manages as
waste, this information may be
insufficient for conducting analyses on
PFAS and may be less meaningful for
communities interested in assessing risk
from releases of PFAS. The threshold
category for amounts managed as waste
does not include quantities released to
the environment as a result of remedial
actions or catastrophic events not
associated with production processes
(section 8.8 of Form R). Thus, the waste
threshold category in Form A does not
include all releases. Given that even
small quantities of PFAS may result in
elevated concentrations in the
environment, EPA believes it would be
inappropriate to allow a reporting
option that would exclude information
on some releases. Thus, removing the
availability of the use of Form A for
PFAS is consistent with a concern for
understanding small quantities of PFAS.
For TRI-listed chemicals, other than
chemicals of special concern, releases
and off-site transfers for further waste
management of less than 1,000 pounds
can be reported using ranges or as a
whole number. The reporting ranges are:
1–10 pounds; 11–499 pounds; and 500–
999 pounds. For larger releases and offsite transfers for further waste
management of the toxic chemical, the
facility must report the whole number.
Use of ranges could reduce data
accuracy because the low or the highend range numbers may not be that
close to the estimated value, even taking
into account inherent data errors (i.e.,
errors in measurements and developing
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estimates). For PFAS, it is important to
have accurate data regarding the amount
released even when the quantities are
relatively small, since concern may be
tied to even small quantities of a
substance. This issue was apparent for
PFAS for reporting years 2020 and 2021
since much of the data reported was for
less than 1,000 pounds.
EPA anticipates that the elimination
of these burden reduction tools will
increase the amount and quality of data
collected for PFAS and is consistent
with the concern for small quantities of
PFAS (Ref. 1).
B. Elimination of the Supplier
Notification Requirement De Minimis
Exemption for Chemicals of Special
Concern
EPA is also eliminating the use of the
de minimis exemption under the
Supplier Notification Requirements at
40 CFR 372.45(d)(1) for all substances
on the list of chemicals of special
concern. EPA extended the de minimis
exemption to the supplier notification
requirement in its initial TRI reporting
rule (53 FR 4500, February 16, 1988
(FRL–3298–2)). The revised text reads as
follows:
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If a mixture or trade name product contains
no toxic chemical in excess of the applicable
de minimis concentration as specified in 40
CFR 372.38(a) except for chemicals listed
under 40 CFR 372.28 which are excluded
from the de minimis exemption.
The de minimis exemption to the
Supplier Notification Requirements
allows suppliers to not provide
notifications for mixtures or trade name
products containing the listed toxic
chemicals if the chemicals are present at
concentrations below 1% of the mixture
(0.1% for carcinogens). The de minimis
exemption is not a small quantity
exemption; it is a small concentration
exemption. Therefore, it is possible that
significant quantities of chemicals of
special concern can be overlooked by
reporting facilities if suppliers can use
the de minimis exemption. For example,
if a mixture or trade name product
contains 0.9% of a listed PFAS and
100,000 pounds of the product is
purchased, the supplier need not
provide notification and the purchaser
could be unaware of and not account for
900 pounds of PFAS. The impact of this
exemption for the PBT chemicals with
10-pound reporting thresholds is even
greater. Using the same 100,000-pound
example, if mercury were present at
0.9% then that same 900 pounds would
be 90 times the mercury reporting
threshold.
It is also possible that quantities of
chemicals of special concern would be
included in supplier notifications by
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reporting facilities if suppliers cannot
use the de minimis exemption. For
example, if a mixture or trade name
product contains 0.9% of a listed PFAS
and 1,000 pounds of the product is
purchased, the supplier would need to
provide notification for 9 pounds of
PFAS. This would also impact PBT
chemicals with 10-pound reporting
thresholds. Using the same 1,000-pound
example, if mercury was present at
0.9% then that same 9 pounds would be
below the mercury reporting threshold.
However, such quantities may become
reportable, in aggregate, if a reporting
entity receives multiple shipments
(including from multiple suppliers) of a
given product in a year and performs a
threshold activity in excess of the TRI
reporting threshold. Further, TRI
supplier notification regulations do not
require a person to consider the total
quantity of the chemical being supplied
but rather require the person to consider
the concentration of the chemical in the
product or mixture. Including a
consideration of quantity rather than
concentration shipped would
complicate as well as reduce the ability
of supplier notifications to inform
downstream recipients of products and
mixtures containing a TRI-listed
chemical.
EPA considered whether to include a
small quantity exemption in lieu of a de
minimis exemption for supplier
notification. However, EPA is concerned
that such an exemption would not
provide adequate information to
facilities receiving multiple shipments
over the course of a year to address TRI
reporting requirements that may apply
to them, based on the total aggregated
quantity received. Without such
information on the TRI-listed chemical,
the receiving facility may not have
sufficient data to inform potential TRI
reporting obligations.
Many PFAS are used in products
below the established de minimis levels
(Refs. 4 and 10) which results in users
of those products not knowing they are
receiving a product that contains a TRIreportable PFAS. PFAS reports received
for the TRI 2020 and 2021 reporting
years were mostly from manufacturers
and waste disposal facilities which
suggests that the de minimis exemption
may have been used by most users and
processors see https://www.epa.gov/
toxics-release-inventory-tri-program/
find-understand-and-use-tri. EPA has
concluded that it is important and
necessary to eliminate the supplier
notification de minimis exemption for
PFAS added to the TRI list pursuant to
sections 7321(b) and 7321(c) of the
NDAA because if that exemption were
to remain in place the Agency may fail
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to collect information on amounts of
PFAS that significantly exceed the
reporting threshold.
In addition, eliminating the use of the
de minimis exemption for supplier
notification purposes for all other
chemicals of special concern ensures
that potentially significant quantities of
such chemicals are not overlooked by
reporting facilities. The PBT chemicals
and chemical categories that are
classified as chemicals of special
concern, and are thus also impacted by
this change, are as follows:
• Aldrin (CASRN: 309–00–2);
• Benzo[g,h,i]perylene (CASRN: 191–
24–2);
• Chlordane (CASRN: 57–74–9);
• Dioxin and dioxin-like compounds
category (manufacturing; and the
processing or otherwise use of dioxin
and dioxin-like compounds category if
the dioxin and dioxin-like compounds
are present as contaminants in a
chemical and if they were created
during the manufacturing of that
chemical) (TRI Category Code: N150);
• Heptachlor (CASRN: 76–44–8);
• Hexabromocyclododecane category
(TRI Category Code: N270);
• Hexachlorobenzene (CASRN: 118–
74–1);
• Isodrin (CASRN: 465–73–6);
• Lead (this lower threshold does not
apply to lead when it is contained in
stainless steel, brass or bronze alloy;
(CASRN: 7439–92–1);
• Lead compounds category (TRI
Category Code: N420);
• Mercury (CASRN: 7439–97–6);
• Mercury compounds category (TRI
Category Code: N458);
• Methoxychlor (CASRN: 72–43–5);
• Octachlorostyrene (CASRN: 29082–
74–4);
• Pendimethalin (CASRN: 40487–42–
1);
• Pentachlorobenzene (CASRN: 608–
93–5);
• Polychlorinated biphenyls (CASRN:
1336–36–3);
• Polycyclic aromatic compounds
category (PACs) (TRI Category Code:
N590);
• Tetrabromobisphenol A (CASRN:
79–94–7);
• Toxaphene (CASRN: 8001–35–2);
and
• Trifluralin (CASRN: 1582–09–8).
When EPA established the chemicals
of special concern list, it decided to not
remove the de minimis exemption
eligibility from supplier notification
requirements, indicating that the
Agency believed that there was
sufficient information available on PBT
chemicals by suppliers. (Refs. 7 and 8).
However, EPA has determined that
there are situations where this
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information is not available. For
example, the Agency has found that
there is significant variability in the
concentration of PACs in fuels, yet the
presence and concentration of PACs in
fuel oil is often not provided in supplier
notifications or SDSs. Additionally, EPA
is aware of metal mixtures and products
containing low concentrations of lead
(not contained in stainless steel, brass or
bronze alloys) whose supplier
notifications and SDSs do not state there
is lead present in the mixture or
product. Further, it is unclear whether
downstream purchasers would be made
aware of PBT chemicals contained in
many products without notification of
the presence of such chemicals.
In situations where such information
is already available, supplier
notifications may already be addressed
(e.g., if such information in already
included on an SDS) or the burden of
a supplier to provide such information
is minimal (i.e., if the information is
redundant then the burden to provide
such known information should be
trivial). However, as noted in Unit IV.,
the quantity information EPA is
requiring for de minimis concentrations
below the concentration threshold may
not be provided in SDSs. OSHA
maintains a 1% concentration threshold
for reporting the presence and
concentration of most hazardous
chemicals on SDSs (29 CFR part 1910,
subpart Z). For chronic hazards (with
Carcinogenicity, Germ Cell
Mutagenicity, and Reproductive
Toxicity), OSHA has established a 0.1%
concentration threshold for reporting
the presence and concentration of
chemicals on SDSs (29 CFR part 1910,
subpart Z). EPA notes that there may be
other reasons for a chemical’s exclusion
from an SDS (e.g., a chemical may be in
an article that is not covered by SDS
requirements but is subject to TRI
supplier notification requirements). As
described in section 4.3 of the EA (Ref.
1) for this final rule, EPA believes that
any potential increase in new supplier
reporting is minimal, particularly
regarding non-PFAS chemicals of
special concern.
In the 1999 proposal to establish a
chemical of special concern list, EPA
also reasoned that entities subject to TRI
supplier notification requirements could
retain use of the de minimis exemption
for PBTs because ‘‘[m]any of the
chemicals identified as persistent and
bioaccumulative in today’s action are
not imported, processed, or otherwise
used but are manufactured as
byproducts’’ (Ref. 8). However, the
Agency has since learned that several
PBT chemicals are not manufactured as
byproducts, and those chemicals are
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known to be processed for distribution
to customers. For example, in Reporting
Year 2021, the Agency received 55
Forms R for tetrabromobisphenol A
(TBBPA). None of those forms indicated
that TBBPA had been manufactured as
a byproduct. However, some forms
indicated the TBBPA is processed,
including as an article component.
Similarly, for Reporting Year 2021, the
Agency received 76 Forms R on
polychlorinated biphenyls (PCBs); 64 of
those forms did not indicate those PCBs
had been manufactured as byproducts,
though some forms indicated the PCBs
had been processed, including as an
article component. Because many PBT
chemicals are not manufactured as
byproducts and may exist in relatively
lower concentrations within products or
mixtures, the Agency’s initial rationale
to allow suppliers to exempt
concentrations of PBT chemicals below
de minimis from supplier notification
requirements warrants reconsideration.
Therefore, EPA has reassessed this
exemption and modified it
appropriately to provide TRI facilities
that receive products or mixtures
containing chemicals of special concern
with additional information related to
quantities of chemicals of special
concern that may contribute to their
reporting thresholds. EPA created the de
minimis exemption pursuant to the
authority provided in EPCRA section
328 (42 U.S.C. 11048) and is adjusting
the scope of the exemption under that
same authority. EPCRA section 328
provides that EPA has authority to
promulgate regulations as may be
necessary to carry out this chapter. EPA
has concluded that it is important and
necessary to eliminate the supplier
notification de minimis exemption for
all chemicals of special concern because
if that exemption were to remain in
place the Agency may fail to collect
information on amounts of such
chemicals that significantly exceed the
reporting threshold.
This action reflects EPA’s current
understanding of chemical activities
involving all chemicals of special
concern (i.e., both PBTs and PFAS).
C. Impact of Listing Certain PFAS on the
Chemicals of Special Concern List
This action revises the regulatory text
to add PFAS currently on TRI pursuant
to 7321(b) and 7321(c) of the NDAA to
the list of chemicals of special concern.
Additionally, the regulatory text, as
revised by this action, provides that all
PFAS added to TRI pursuant to sections
7321(b) and 7321(c), regardless of the
date of their addition, are included on
the chemicals of special concern list.
Thus, as PFAS continue to be added to
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74365
TRI pursuant to sections 7321(b) and
7321(c), they will also be added to the
list of chemicals of special concern as of
the date they are added to the TRI. It is
likely that some of the substances
meeting the criteria in 7321(b) and
7321(c) will be subject to confidential
business information claims. For
substances subject to such claims, the
Agency must follow the process
outlined in section 7321(e) of the
NDAA.
As with PFAS currently on the TRI
list, future PFAS added to the TRI list
under 7321(b) and 7321(c) will have a
100-pound reporting threshold, per
sections 7321(b)(2)(A) and 7321(c)(2)(B).
Congress’ use of this low reporting
threshold demonstrates a concern for
even relatively small quantities of these
PFAS. Therefore, EPA has concluded
that it is appropriate for all PFAS added
to the TRI list under these provisions to
be added to the chemicals of special
concern list upon listing. If these PFAS
were not added to the chemicals of
special concern list at the time of their
addition to the TRI list, there would be
a delay in the reporting requirements
while EPA conducts a rulemaking
simply to add them to the chemicals of
special concern list. This would result
in differences in how previously listed
PFAS and newly listed PFAS are treated
even though they were automatically
listed with the same reporting
thresholds. The chemicals of special
concern designation is a regulatory
construct and here, EPA has determined
it is appropriate to designate all PFAS
added to TRI pursuant to 7321(b) and
7321(c) as chemicals of special concern
due to Congress’ use of the 100-pound
reporting threshold, indicating a
concern for even relatively small
quantities of PFAS, and PFAS’
persistence in the environment and
growing evidence showing potential
adverse human health effects (Refs. 2, 3,
and 9). Further, this regulatory change
will provide additional data that will
help the Agency to better understand
the extent of potential impacts caused
by these PFAS. Given that the NDAA set
a 100-pound reporting threshold for all
PFAS added pursuant to sections
7321(b) and 7321(c), EPA has
determined that additional rulemakings
to designate these chemicals as
chemicals of special concern are
unnecessary because the rationale for
any future rulemakings would remain
the same and would result in a delay of
reporting requirements. EPA has
finalized regulatory text that adds those
PFAS added pursuant to 7321(b) and
7321(c) to the chemicals of special
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concern list upon their addition to the
TRI list.
EPA has decided not to provide a
structural definition (e.g., OECD) of
PFAS as part of this action, because
doing so is outside the scope of this
rulemaking. This rulemaking only
concerns chemical substances added to
the TRI by sections 7321(b) and 7321(c)
of the NDAA, neither of which require
EPA to provide a definition of PFAS.
Section 7321(b) added by name and/or
CASRN specific PFAS to the TRI list
and sections 7321(b) and (c) identify
EPA activities involving PFAS that
would cause a PFAS to be added to the
TRI list. The activities described by
sections 7321(b) and (c) indicate
whether they pertain to a PFAS, and
thus a separate determination of
whether or not the covered activity
involves a PFAS is not necessary. EPA
is therefore not providing a definition of
PFAS for purposes of this rulemaking,
and issues relating to the definition of
PFAS are outside the scope of this
rulemaking. EPA will consider the need
for a PFAS definition for a purpose
other than the NDAA section 7321(b)
and (c) listings, should the need for
such a definition arise. As indicated in
the proposal for this rulemaking, EPA
acknowledges there is another
rulemaking underway to list PFAS
additions for NDAA 7321(d), and the
Agency expects that rulemaking to
clarify the status of those listed PFAS as
chemicals of special concern.
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V. References
The following is a listing of the
documents that are specifically
referenced in this document. The docket
includes these documents and other
information considered by EPA,
including documents that are referenced
within the documents that are included
in the docket, even if the referenced
document is not itself physically located
in the docket. For assistance in locating
these other documents, please consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
1. USEPA. Economic Analysis for the
Changes to TRI Reporting for PFAS.
October 2023.
2. USEPA. Our Current Understanding of the
Human Health and Environmental Risks
of PFAS. U.S. Environmental Protection
Agency, Washington, DC. https://
www.epa.gov/pfas/our-currentunderstanding-human-health-andenvironmental-risks-pfas.
3. ATSDR. Agency for Toxic Substances and
Disease Registry. Toxicological Profile
for Perfluoroalkyls. May 2021. https://
www.atsdr.cdc.gov/toxprofiles/
tp200.pdf.
4. ATSDR. Agency for Toxic Substances and
Disease Registry. Per- and
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Polyfluoroalkyl Substances (PFAS) and
Your Health. PFAS in the U.S.
Population. https://www.atsdr.cdc.gov/
pfas/health-effects/us-population.html.
5. Centers for Disease Control and
Prevention, U.S. Department of Health
and Human Services. National Report on
Human Exposure to Environmental
Chemicals. Updated March 2022.
Accessed [insert date]. https://
www.cdc.gov/exposurereport/.
6. USEPA. Response to Comment document.
October 2023.
7. USEPA. Final Rule: Persistent
Bioaccumulative Toxic (PBT) Chemicals;
Lowering of Reporting Thresholds for
Certain PBT Chemicals; Addition of
Certain PBT Chemicals; Community
Right-to-Know Toxic Chemical
Reporting. Federal Register. 64 FR
58666, October 29, 1999 (FRL–6389–11).
8. USEPA. Proposed Rule: Persistent
Bioaccumulative Toxic (PBT) Chemicals;
Lowering of Reporting Thresholds for
Certain PBT Chemicals; Addition of
Certain PBT Chemicals; Community
Right-to-Know Toxic Chemical
Reporting. Federal Register. 64 FR 688,
January 5, 1999 (FRL–6389–11).
9. National Institute of Environmental Health
Sciences. Perfluoroalkyl and
Polyfluoroalkyl Substances (PFAS).
https://www.niehs.nih.gov/health/topics/
agents/pfc/index.cfm.
10. Kotthoff, et al. 2015. Perfluoroalkyl and
polyfluoroalkyl substances in consumer
products. Environmental Science and
Pollution Research 22:14546–14559.
11. USEPA. Toxics Release Inventory Form
A. https://ordspub.epa.gov/ords/
guideme_ext/guideme_ext/guideme/file/
ry_2021_form_a.pdf.
12. USEPA. Supporting Statement for an
Information Collection Request (ICR)
‘‘Rule-Related Amendment; Changes to
Reporting Requirements for Per- and
Polyfluoroalkyl Substances; Community
Right-to-Know Toxic Chemical Release
Reporting; Final Rule (RIN 2070–
AK97).’’ EPA ICR No.2724.02; OMB
Control No. 2070–0225. July 2023.
VI. Statutory and Executive Orders
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 14094: Modernizing Regulatory
Review
This action is a ‘‘significant regulatory
action’’ as defined in Executive Order
12866 (58 FR 51735, October 4, 1993),
as amended by Executive Order 14094
(88 FR 21879, April 11, 2023).
Accordingly, EPA submitted this action
to the Office of Management and Budget
(OMB) for Executive Order 12866
review. Documentation of any changes
made in response to the Executive Order
12866 review is available in the docket.
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EPA prepared an economic analysis of
the potential impacts associated with
this action. This analysis, ‘‘Economic
Analysis for the Changes to TRI
Reporting for PFAS’’ (Ref. 1) is also
available in the docket and summarized
in Unit E.1.
B. Paperwork Reduction Act (PRA)
The information collection activities
in this rule will be submitted to OMB
for approval under the PRA, 44 U.S.C.
3501 et seq. The Information Collection
Request (ICR) document that EPA
prepared has been assigned EPA ICR
No. 2724.02 and the OMB Control No.
2070–0225. You can find a copy of the
ICR in the docket for this rule, and it is
briefly summarized here (Ref. 12). The
information collection requirements are
not enforceable until OMB approves
them.
Currently, the facilities subject to the
reporting requirements under EPCRA
section 313 and PPA section 6607 may
use either EPA Toxic Chemicals Release
Inventory Form R (EPA Form 1B9350–
1), or EPA Toxic Chemicals Release
Inventory Form A (EPA Form 1B9350–
2). The Form R must be completed if a
facility manufactures, processes, or
otherwise uses any listed chemical
above threshold quantities and meets
certain other criteria. For the Form A,
EPA established an alternative threshold
for facilities with low annual reportable
amounts of a listed toxic chemical. A
facility that meets the appropriate
reporting thresholds, but estimates that
the total annual reportable amount of
the chemical does not exceed 500
pounds per year, can take advantage of
an alternative manufacture, process, or
otherwise use threshold of 1 million
pounds per year of the chemical,
provided that certain conditions are
met, and submit the Form A instead of
the Form R. In addition, respondents
may designate the specific chemical
identity of a substance as a trade secret
pursuant to EPCRA section 322 (42
U.S.C. 11042) and 40 CFR part 350.
OMB has approved the reporting and
recordkeeping requirements related to
Forms A and R, supplier notification,
and petitions under OMB Control
number 2070–0212 (EPA ICR No.
2613.04) and those related to trade
secret designations under OMB Control
2050–0078 (EPA ICR No. 1428.12). As
such, this ICR is intended to amend the
existing ICR to include the following
additional details:
• Respondents/affected entities:
Facilities covered under EPCRA section
313 that manufacture, process or
otherwise use listed PFAS (See Unit
I.A.).
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• Respondent’s obligation to respond:
Mandatory (EPCRA section 313).
• Frequency of response: Annual.
• Total estimated number of
respondents: 623 to 2,015.
• Total estimated burden: 43,843 and
111,768 burden hours in the first year
and approximately 22,244 and 71,946
burden hours in the steady state. Burden
is defined at 5 CFR 1320.3(b).
• Total estimated cost:
Approximately $3,318,492 and
$10,733,149 in the first year of reporting
and approximately $1,580,214 and
$5,111,044 in the steady state (per year)
includes $0 annualized capital or
operation & maintenance costs.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for the EPA’s regulations in 40
CFR are listed in 40 CFR part 9. When
OMB approves this ICR, the Agency will
announce that approval in the Federal
Register and publish a technical
amendment to 40 CFR part 9 to display
the OMB control number for the
approved information collection
activities contained in this final rule.
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C. Regulatory Flexibility Act (RFA)
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA, 5 U.S.C. 601 et seq. The
small entities subject to the
requirements of this action are primarily
classified within the manufacturing and
waste management industry sectors. The
Agency has determined that of the 623
to 2,015 entities estimated to be
impacted by this action, 486 to 1,333 are
small businesses; no small governments
or small organizations are expected to
be affected by this action. The average
cost per small firm is $7,413 (at a 3%
discount rate) or $7,520 (at a 7%
discount rate). All small businesses
affected by this action are estimated to
incur annualized cost impacts of less
than 1%. Even under a worst-case
scenario comparing compliance costs to
average revenue of firms with between
10 (smallest number required to report)
and 14 employees instead of comparing
compliance costs to the weighted
average revenue of small firms, there are
still no costs that exceed the 1% impact
threshold. Thus, this action is not
expected to have a significant adverse
economic impact on a substantial
number of small entities. A more
detailed analysis of the impacts on
small entities is provided in EPA’s
economic analysis (Ref. 1).
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D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain an
unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C.
1531–1538, and does not significantly or
uniquely affect small governments. The
action imposes no enforceable duty on
any state, local or tribal governments or
the private sector. EPA did not identify
any small governments that would be
impacted by this action. EPA’s
economic analysis indicates that the
total cost of this action is estimated to
be from $3,318,492 and $10,733,149 in
the first year of reporting and from
$1,580,214 and $5,111,044 in
subsequent reporting years (Ref. 1).
E. Executive Order 13132: Federalism
This action does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999), because it will not have
substantial direct effects on states, on
the relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000) because it will not have
substantial direct effects on tribal
governments, on the relationship
between the Federal government and
the Indian tribes, or on the distribution
of power and responsibilities between
the Federal government and Indian
tribes. It does not have substantial direct
effects on tribal government because
this action relates to toxic chemical
reporting under EPCRA section 313,
which primarily affects private sector
facilities. Thus, Executive Order 13175
does not apply to this action.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
EPA interprets Executive Order 13045
(62 FR 19885, April 23, 1997) as
applying only to regulatory actions
considered significant under section
3(f)(1) of Executive Order 12866 and
that concern environmental health or
safety risks that EPA has reason to
believe may disproportionately affect
children, per the definition of ‘‘covered
regulatory action’’ in section 2–202 of
Executive Order 13045.
Although this action does not concern
an environmental health or safety risk,
the data collected as a result of this
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action will provide information about
releases to the environment that could
be used to inform the public on
potential exposures to toxic chemical
releases, pursuant to the right-to-know
principles. EPA also believes that the
information obtained as a result of this
action could be used by government
agencies, researchers, and others to
identify potential problems, set
priorities, and take appropriate steps to
reduce any potential exposures and
related human health or environmental
risks identified as a result of increased
knowledge of exposures to PFAS.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not a ‘‘significant
energy action’’ as defined in Executive
Order 13211 (66 FR 28355, May 22,
2001), because it is not likely to have a
significant adverse effect on the supply,
distribution or use of energy and has not
otherwise been designated by the
Administrator of the Office of
Information and Regulatory Affairs as a
significant energy action.
I. National Technology Transfer and
Advancement Act (NTTAA)
This action does not involve technical
standards under the NTTAA section
12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations and; Executive
Order 14096: Revitalizing Our Nation’s
Commitment to Environmental Justice
for All
EPA finds that it is not practicable to
perform an environmental justice
analysis because it lacks data on the
exact locations of every exposure
source. EPA was unable to perform an
environmental justice analysis because
it lacks data on the exact location of
every exposure source based on
reporting activity. The purpose of this
action is to require reporting activity.
However, this regulatory action makes
changes to the reporting requirements
for PFAS that will result in more
information being collected and
provided to better evaluate exposures
and the risks posed by such exposures.
The determination of potential risk to
human health and/or the environment
depends upon many factors, including
the toxicity of the chemical, the fate of
the chemical in the environment, and
the amount and duration of human or
other exposure to the chemical. This
action does not directly address human
health or environmental risks. However,
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Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Rules and Regulations
the action will increase the level of
information available to assess
environmental protection for all affected
populations without having any
disproportionate and adverse human
health or environmental effects on any
population, including any community
with environmental justice concerns.
Specifically, changes to the reporting
requirements for PFAS will provide
more information on releases and waste
management of PFAS. By requiring
reporting of this additional information,
EPA will be providing communities
across the U.S. (including communities
with environmental justice concerns)
with access to data which they may use
to seek lower exposures and
consequently reductions in chemical
risks for themselves and their children.
This information can also be used by
government agencies and others to
identify potential problems, set
priorities, and take appropriate steps to
reduce any potential risks to human
health and the environment. Therefore,
informational benefits, of the action,
including behavioral changes such as
consumers avoiding specific products,
may have positive impact on the human
health and environmental impacts on all
Authority: 42 U.S.C. 11023 and 11048.
communities, including communities
with environmental justice concerns.
§ 372.22
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5
U.S.C. 801 et seq., and EPA will submit
a rule report to each House of the
Congress and to the Comptroller General
of the United States. This action is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
[Amended]
2. Amend § 372.22(c) by removing
‘‘§ 372.25, § 372.27, § 372.28, or
§ 372.29’’ and adding in its place
‘‘§§ 372.25, 372.27, or 372.28’’.
■
§ 372.25
[Amended]
3. Amend § 372.25 by:
a. In the introductory text, remove
‘‘Except as provided in § 372.27,
§ 372.28, and § 372.29’’ and add in its
place ‘‘Except as provided in §§ 372.27
and 372.28’’; and
■ b. In paragraphs (f), (g), and (h),
remove ‘‘§ 372.27, § 372.28, or § 372.29’’
and add in its place ‘‘§§ 372.27 or
372.28’’.
■
■
List of Subjects in 40 CFR Part 372
Environmental protection,
Community right-to-know, Reporting
and recordkeeping requirements, and
Toxic chemicals.
Dated: October 18, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 372—TOXIC CHEMICAL
RELEASE REPORTING: COMMUNITY
RIGHT-TO-KNOW
1. The authority citation for part 372
continues to read as follows:
■
4. In § 372.28, amend table 1 to
paragraph (a)(1) by adding the entry
‘‘Per- and polyfluoroalkyl substances’’
alphabetically to read as follows:
■
§ 372.28 Lower thresholds for chemicals
of special concern.
*
*
*
(a) * * *
(1) * * *
*
*
TABLE 1 TO PARAGRAPH (a)(1)
Chemical name
CAS No.
*
*
*
*
*
Per- and polyfluoroalkyl substances (Individually listed per- and polyfluoroalkyl substances
added by 15 U.S.C. 8921(b)(1) and (c)(1)). (EPA periodically updates the lists of covered
chemicals at § 372.65(d) and (e) to reflect chemicals that have been added by 15 U.S.C.
8921).
*
see § 372.65(d) and (e) ...........
*
§ 372.29
■
*
*
[Removed]
§ 372.38
5. Remove § 372.29.
§ 372.30
6. Amend § 372.30 by:
a. In paragraph (a), remove ‘‘in
§ 372.25, § 372.27, § 372.28, or § 372.29
at’’ and add in its place ‘‘in §§ 372.25,
372.27, or 372.28 at’’; and
■ b. In paragraphs (b)(1), (b)(3)
introductory text, (b)(3)(i), and (b)(3)(iv),
remove ‘‘§ 372.25, § 372.27, § 372.28, or
§ 372.29’’ and add in its place
‘‘§§ 372.25, 372.27, or 372.28’’.
lotter on DSK11XQN23PROD with RULES1
■
■
16:38 Oct 30, 2023
*
[Amended]
7. Amend § 372.38 by:
a. In paragraph (a)(2), remove ‘‘except
for purposes of § 372.45(d)(1)’’; and
■ b. In paragraphs (b), (c), (d), (f), (g) and
(h), remove ‘‘§ 372.25, § 372.27,
§ 372.28, or § 372.29’’ and add in its
place ‘‘§§ 372.25, 372.27, or 372.28’’.
■ 8. Amend § 372.45, by revising
paragraph (d)(1) to read as follows:
■
■
[Amended]
VerDate Sep<11>2014
*
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§ 372.45 Notification about toxic
chemicals.
*
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*
(d) * * *
(1) If a mixture or trade name product
contains no toxic chemical in excess of
the applicable de minimis concentration
as specified in § 372.38(a), except for
chemicals listed in § 372.28(a), which
are excluded from the de minimis
exemption.
*
*
*
*
*
[FR Doc. 2023–23413 Filed 10–30–23; 8:45 am]
BILLING CODE 6560–50–P
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threshold
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Agencies
[Federal Register Volume 88, Number 209 (Tuesday, October 31, 2023)]
[Rules and Regulations]
[Pages 74360-74368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23413]
[[Page 74360]]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[EPA-HQ-TRI-2022-0270; FRL-8741-04-OCSPP]
RIN 2070-AK97
Changes to Reporting Requirements for Per- and Polyfluoroalkyl
Substances and to Supplier Notifications for Chemicals of Special
Concern; Community Right-to-Know Toxic Chemical Release Reporting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is adding per- and
polyfluoroalkyl substances (PFAS) subject to reporting under the
Emergency Planning and Community Right-to-Know Act (EPCRA) and the
Pollution Prevention Act (PPA) pursuant to the National Defense
Authorization Act for Fiscal Year 2020 (NDAA) to the list of Lower
Thresholds for Chemicals of Special Concern (chemicals of special
concern). These PFAS already have a lower reporting activity threshold
of 100 pounds. The addition of these PFAS to the list of chemicals of
special concern means such PFAS are subject to the same reporting
requirements as other chemicals of special concern (i.e., it eliminates
the use of the de minimis exemption and the option to use Form A and
would limit the use of range reporting for PFAS). Removing the
availability of these burden-reduction reporting options will result in
a more complete picture of the releases and waste management quantities
for these PFAS. EPA is removing the availability of the de minimis
exemption for purposes of the Supplier Notification Requirements for
all chemicals on the list of chemicals of special concern. This will
help ensure that purchasers of mixtures and trade name products
containing such chemicals are informed of their presence in mixtures
and products they purchase to better inform any TRI reporting
obligations.
DATES: This final rule is effective November 30, 2023 and shall apply
for the reporting year beginning January 1, 2024 (reports due July 1,
2025).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-TRI-2022-0270, is available online at
https://www.regulations.gov or in person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket) in the Environmental
Protection Agency Docket Center (EPA/DC). All documents in the docket
are listed on https://www.regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Additional instructions on visiting the docket,
along with more information about dockets generally, is available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Daniel R. Ruedy, Data Gathering
and Analysis Division (7406M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 564-7974; email:
[email protected].
For general information contact: The Emergency Planning and
Community Right-to-Know Hotline; telephone numbers: toll free at (800)
424-9346 (select menu option 3) or (703) 348-5070 in the Washington, DC
Area and International; or go to https://www.epa.gov/home/epa-hotlines.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or otherwise use listed PFAS or any chemicals listed under 40
CFR 372.28. The following list of North American Industry
Classification System (NAICS) codes is not intended to be exhaustive,
but rather provides a guide to help readers determine whether this
action applies to them. Potentially affected entities may include:
Facilities included in the following NAICS manufacturing
codes (corresponding to Standard Industrial Classification (SIC) codes
20 through 39): 311 *, 312 *, 313 *, 314 *, 315 *, 316, 321, 322, 323
*, 324, 325 *, 326 *, 327 *, 331, 332, 333, 334 *, 335 *, 336, 337 *,
339 *, 111998 *, 113310, 211130 *, 212323 *, 212390 *, 488390 *, 512230
*, 512250 *, 5131 *, 516210 *, 519290 *, 541713 *, 541715 * or 811490
*. * Exceptions and/or limitations exist for these NAICS codes.
Facilities included in the following NAICS codes
(corresponding to SIC codes other than SIC codes 20 through 39): 211130
* (corresponds to SIC code 1321, Natural Gas Liquids, and SIC 2819,
Industrial Inorganic Chemicals, Not Elsewhere Classified); or 212114,
212115, 212220, 212230, 212290 *; or 2211 *, 221210 *, 221330 (limited
to facilities that combust coal and/or oil for the purpose of
generating power for distribution in commerce) (corresponds to SIC
codes 4911, 4931, and 4939, Electric Utilities); or 424690, 424710
(corresponds to SIC code 5171, Petroleum Bulk Terminals and Plants);
425120 (limited to facilities previously classified in SIC code 5169,
Chemicals and Allied Products, Not Elsewhere Classified); or 562112
(limited to facilities primarily engaged in solvent recovery services
on a contract or fee basis (previously classified under SIC code 7389,
Business Services, NEC)); or 562211 *, 562212 *, 562213 *, 562219 *,
562920 * (limited to facilities regulated under the Resource
Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et seq.)
(corresponds to SIC code 4953, Refuse Systems). * Exceptions and/or
limitations exist for these NAICS codes.
Federal facilities.
Facilities that the EPA Administrator has specifically
required to report to TRI pursuant to a determination under EPCRA
section 313(b)(2).
A more detailed description of the types of facilities covered by
the NAICS codes subject to reporting under EPCRA section 313 can be
found at: https://www.epa.gov/toxics-release-inventory-tri-program/tri-covered-industry-sectors. To determine whether your facility is
affected by this action, you should carefully examine the applicability
criteria in part 372, subpart B of title 40 of the Code of Federal
Regulations. Federal facilities are required to report under Section
6(a)-(b) of Executive Order 14096 (88 FR 25251 April 21, 2023),
Revitalizing Our Nation's Commitment to Environmental Justice for All.
If you have questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. What action is the Agency taking?
EPA is adding all PFAS included on the Toxics Release Inventory
(TRI) pursuant to sections 7321(b) and 7321(c) of the 2020 NDAA to the
list of chemicals of special concern (40 CFR 372.28). EPA maintains a
list of PFAS added to the TRI list pursuant to the NDAA at: https://www.epa.gov/toxics-release-inventory-tri-program/list-pfas-added-tri-ndaa. The addition of PFAS added to TRI pursuant to sections 7321(b)
and (c) of the NDAA to the list of chemicals of special concern aligns
reporting requirements for these PFAS with other chemicals of special
concern. EPA anticipates this will result in
[[Page 74361]]
additional Form R reports being filed for these PFAS due to the removal
of the de minimis exemption and the option to use Form A. It also
limits the use of range reporting, which will capture more specific
information for PFAS added pursuant to sections 7321(b) and 7321(c) of
the NDAA.
In addition, EPA is removing the availability of the de minimis
exemption under the Supplier Notification Requirements (40 CFR 372.45)
for facilities that manufacture or process any chemicals included on
the list of chemicals of special concern.
This action does not make any changes to the article exemption.
C. What is the Agency's authority for this action?
This action is issued under EPCRA sections 313, 42 U.S.C. 11023 and
328, 42 U.S.C. 11048. EPCRA is also referred to as Title III of the
Superfund Amendments and Reauthorization Act of 1986.
D. Why is the Agency taking this action?
EPA is taking this action to increase the data collected for PFAS.
Removing the availability of certain burden-reduction reporting options
will result in a more complete picture of the releases and waste
management quantities for PFAS. This will increase the number of TRI
reports on listed PFAS and the amount of information provided on such
reports, resulting in more information on the waste management of these
chemicals available to the Agency, as well as to the public. EPA
expects this information will be a benefit to the public, including
communities with environmental justice concerns and public water
utilities, as well as inform future Agency actions, including under the
Clean Water Act, the Resource Conservation and Recovery Action, the
Comprehensive Environmental Response, Compensation, and Liability Act,
and the Toxic Substances Control Act. In addition, this action will
increase data collected for all chemicals of special concern by
eliminating the de minimis exemption for purposes of the Supplier
Notification Requirements for all chemicals on the list of chemicals of
special concern. The elimination of this exemption from Supplier
Notification Requirements ensures that purchasers of mixtures and trade
name products containing such chemicals are informed of their presence
in mixtures and products they purchase.
E. What are the estimated incremental impacts of this action?
EPA prepared an updated economic analysis for this action entitled,
``Economic Analysis for the Changes to Reporting Requirements for Per-
and Polyfluoroalkyl Substances and to Supplier Notification
Requirements for Chemicals of Special Concern; Community Right-to-Know
Toxic Chemical Release Reporting,'' which presents an analysis of the
costs of the reporting changes for PFAS and other chemicals of special
concern based on updated 2022 wage rates and an increase in supplier
notification burden estimates (Ref. 1). EPA estimates that this action
will result in an additional 623 to 2,015 Form R reports being filed
annually. EPA estimates that the costs of this action will be
approximately $3,318,492 and $10,733,149 in the first year of reporting
and approximately $1,580,214 and $5,111,044 in the subsequent years. In
addition, EPA has determined that, of the 486 to 1,333 small businesses
affected by this action, none are estimated to incur annualized cost
impacts of more than 1% of revenues. Thus, this action is not expected
to have a significant adverse economic impact on a substantial number
of small entities.
Removing the availability of certain burden-reduction reporting
options will result in a more complete picture of the releases and
waste management quantities for PFAS. This will increase the number of
TRI reports on listed PFAS and the amount of information provided on
such reports, resulting in more information on the waste management of
these chemicals available to the Agency, as well as to the public.
II. Background Information
A. What is EPCRA section 313?
EPCRA section 313, 42 U.S.C. 11023 (also known as the Toxics
Release Inventory (TRI)), requires certain facilities that manufacture,
process, or otherwise use listed toxic chemicals in amounts above
reporting activity threshold levels to report their environmental
releases and other waste management quantities of such chemicals
annually. These facilities must also report pollution prevention and
recycling data for such chemicals, pursuant to PPA section 6607, 42
U.S.C. 13106.
TRI provides information about releases of toxic chemicals from
covered facilities throughout the United States; however, TRI data do
not reveal whether or to what degree the public is exposed to listed
chemicals. TRI data can, in conjunction with other information, be used
as a starting point in evaluating such exposures and the risks posed by
such exposures. The determination of potential risk to human health
and/or the environment depends upon many factors, including the
toxicity of the chemical, the fate of the chemical in the environment,
and the amount and duration of human or other exposure to the chemical.
For more information on TRI, visit the TRI website at https://www.epa.gov/tri. Note that TRI does not cover all chemicals,
facilities, or types of pollution (see https://www.epa.gov/toxics-release-inventory-tri-program/what-toxics-release-inventory for
information on which chemicals and facilities are regulated under TRI).
Additionally, via this website, EPA provides a guidance document
entitled ``Factors to Consider When Using Toxics Release Inventory
Data'' available at: https://www.epa.gov/system/files/documents/2022-02/factorstoconsider_approved-by-opa_1.25.22-copy.pdf, which helps
explain some of the uses, as well as limitations, of data TRI collects.
B. What are PFAS?
PFAS are synthetic organic compounds that do not occur naturally in
the environment. PFAS contain an alkyl carbon chain on which the
hydrogen atoms have been partially or completely replaced by fluorine
atoms. Definitions of what constitutes ``PFAS'' differ amongst
scientific and regulatory bodies. However, in general, the strong
carbon-fluorine bonds of PFAS make them resistant to degradation and
thus highly persistent in the environment (Refs. 2 and 3). Some of
these chemicals have been used for decades in a wide variety of
consumer and industrial products (Refs. 2 and 3). Some PFAS have been
detected in wildlife indicating that at least some PFAS have the
ability to bioaccumulate (Ref. 3). Because of the widespread use of
PFAS in commerce and their tendency to persist in the environment, most
people in the United States have been exposed to PFAS (Refs. 2, 4 and
5). Some PFAS can accumulate in humans and remain in the human body for
long periods of time (e.g., months to years) (Refs. 2 and 3), as a
result, several PFAS have been detected in human blood serum (Refs. 2,
3, 4, and 5).
C. What PFAS have been added to the TRI list?
On December 20, 2019, the NDAA was signed into law (Pub. L. 116-92,
https://www.congress.gov/public-laws/116th-congress). The NDAA included
[[Page 74362]]
two provisions that automatically add PFAS to the TRI list. First,
section 7321(b) of the NDAA added to the TRI list, effective January 1,
2020, 14 chemicals by name and/or Chemical Abstracts Service Registry
Number (CASRN) and additional PFAS that meet specific criteria. On June
22, 2020 (85 FR 37354 (FRL-10008-09)), EPA updated the TRI list in the
CFR to reflect the 172 non-CBI PFAS added to TRI by section 7321(b) of
the NDAA.
Additional PFAS are added to the TRI list on an annual basis by the
NDAA. Specifically, PFAS that meet the criteria in section 7321(c) of
the NDAA are deemed added to the TRI list on January 1 of the year
after specific criteria are met. Through this provision, the NDAA will
continue to add PFAS to the TRI list over time as additional PFAS meet
the criteria outlined in 7321(c). The criteria of section 7321(c)
require the addition to the TRI list of certain PFAS after any one of
the following dates:
Final Toxicity Value. The date on which the Administrator
finalizes a toxicity value for the PFAS or class of PFAS;
Significant New Use Rule. The date on which the
Administrator makes a covered determination for the PFAS or class of
PFAS;
Addition to Existing Significant New Use Rule. The date on
which the PFAS or class of PFAS is added to a list of substances
covered by a covered determination.
Addition as an Active Chemical Substance. The date on
which the PFAS or class of PFAS to which a covered determination
applies is:
Added to the list published under section 8(b)(1) of the
Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.) and
designated as an active chemical substance under TSCA section
8(b)(5)(A); or
Designated as an active chemical substance under TSCA
section 8(b)(5)(B) on the list published under TSCA section 8(b)(1).
EPA updates the TRI list in the CFR to reflect the PFAS added to
TRI by section 7321(c) of the NDAA. The first update rule identifying
PFAS that met the 7321(c) criteria during 2020 was published on June 3,
2021 (86 FR 29698 (FRL-10022-25)).
To date, section 7321 of the NDAA has added a total of 189 PFAS to
the TRI list at: https://www.epa.gov/tri/PFAS. A complete list of the
PFAS added to the TRI list can be found at: https://www.epa.gov/toxics-release-inventory-tri-program/list-pfas-added-tri-ndaa. In addition,
the NDAA established a manufacture, processing, or otherwise use
reporting threshold of 100 pounds for each of the PFAS added to the TRI
list by sections 7321(b) and 7321(c) of the NDAA. In the first year of
reporting for the initial 172 listed PFAS, EPA only received 89 reports
from 38 facilities covering 43 different PFAS. Similar levels of PFAS
reporting were observed in the subsequent year: with 176 PFAS on the
TRI list in RY2021, only 42 facilities reported submitted a total of 87
reports covering 43 different PFAS.
III. Summary of Public Comments on Proposed Rule
Upon publication of the proposed rule on December 5, 2022, EPA
provided a 60-day comment period (87 FR 74379 (FRL-8714-03-OCSPP)). EPA
received 36 comments on the proposed rule. EPA received comments from
citizens, industry groups, non-governmental organizations, and state
governments. The majority of comments on the proposed rule addressed
EPA's burden estimates, with the majority stating EPA underestimated
the burden of listing PFAS as chemicals of special concern and removing
the supplier notification de minimis exemption would impose. Several
commenters requested EPA lower the activity thresholds for PFAS. Many
of the commenters stated that EPA has not demonstrated PFAS meet the
criteria to be classified as chemicals of special concern. Many of the
commenters stated that eliminating the regulatory exemptions for PFAS
will create a more complete picture of PFAS in communities and the
environment. After considering the public comments, EPA updated the
economic analysis to incorporate 2022 wage rates, include a summary of
small entity analysis, and increase the supplier notification burden
estimates. Further edits to the analysis were not required because EPA
has made no substantive changes as compared with what had been
proposed. Summaries of the comments and EPA's responses to the comments
appear in the Response to Comment document (Ref. 6) which is in the
docket for this rulemaking.
IV. What changes is EPA making to the TRI reporting requirements?
A. Designating PFAS Automatically Added to the TRI List by the 2020
NDAA as Chemicals of Special Concern
EPA is adding all PFAS included on the TRI list pursuant to
sections 7321(b) and 7321(c) of the NDAA (see 40 CFR 372.65(d) and (e))
to the list of chemicals of special concern at 40 CFR 372.28. EPA first
created the list of chemicals of special concern to increase the
utility of TRI data by ensuring that the data collected and shared
through TRI are relevant and topical (Ref. 7). EPA lowered the
reporting thresholds for chemicals of special concern because even
small quantities of releases of these chemicals can be of concern. The
first chemicals that were added to the list of chemicals of special
concern were those identified as persistent, bioaccumulative and toxic
(PBT) chemicals which, except for the dioxin and dioxin-like compounds
category, have reporting thresholds of either 10 or 100 pounds
depending on their persistent and bioaccumulative properties (Ref. 7).
Chemicals of special concern are also excluded from the de minimis
exemption, may not be reported on Form A (Alternate Threshold
Certification Statement), and have limits on the use of range
reporting.
The de minimis exemption allows facilities to not consider small
concentrations of TRI chemicals not classified as chemicals of special
concern in mixtures or other trade name products when making threshold
determinations and release and other waste management calculations. The
de minimis exemption does not apply to the manufacture of a TRI
chemical except if that chemical is manufactured as an impurity and
remains in the product distributed in commerce, or if the chemical is
imported below the appropriate de minimis level. The de minimis
exemption does not apply to a byproduct manufactured coincidentally as
a result of manufacturing, processing, otherwise use, or any waste
management activities.
The Form A provides facilities that otherwise meet TRI-reporting
thresholds the option of certifying on a simplified reporting form
provided that they do not exceed 500 pounds for the total annual
reportable amount (described subsequently in this document) for that
chemical and that their amounts manufactured, processed, or otherwise
used do not exceed 1 million pounds. All chemicals of special concern
(except certain instances of reporting lead in stainless steel, brass,
or bronze alloys) are excluded from Form A eligibility. Form A does not
include any information on releases or other waste management. Nor does
it include source reduction information or any other chemical-specific
information other than the identity of the chemical.
For certain data elements (Part II, Sections 5, 6.1, and 6.2 of
Form R), for chemicals not classified as chemicals of special concern,
the reportable quantity may be reported either as an estimate or by
using the range codes that have been developed. Currently, TRI
reporting provides three reporting ranges: 1-10
[[Page 74363]]
pounds, 11-499 pounds, and 500-999 pounds.
The availability of these burden reduction tools is inconsistent
with a concern for small quantities of the chemicals and the expanded
reporting that was sought for chemicals with lower reporting
thresholds. In the preamble to the 1999 final rule (Ref 7), EPA
outlined the reasons for promulgating the de minimis exemption (e.g.,
that facilities had limited access to information and that low
concentrations would not contribute to the activity threshold) and
determined that those rationales did not apply to chemicals of special
concern. Id. at 58670. Among the reasons provided, EPA explained that
even minimal releases of persistent bioaccumulative toxic chemicals may
result in significant adverse effects and can reasonably be expected to
significantly contribute to exceeding the proposed lower threshold. Id.
EPA also determined that facilities reporting on chemicals of special
concern could not avail themselves of Form A reporting because the
information provided on Form A is ``insufficient for conducting
analyses'' on chemicals of special concern and would be ``virtually
useless for communities interested in assessing risk from releases and
other waste management'' of such chemicals (i.e., the Form A does not
include estimated release and other waste management quantities). Id.
Lastly, EPA eliminated range reporting for chemicals of special concern
because the use of ranges could misrepresent data accuracy for PBT
chemicals because the low or the high-end range numbers may not really
be that close to the estimated value. Id. For the full discussion, see
Persistent Bioaccumulative Toxic (PBT) Chemicals; Lowering of Reporting
Thresholds for Certain PBT Chemicals; Addition of Certain PBT
Chemicals; Community Right-to-Know Toxic Chemical Reporting (Refs. 7
and 8)
EPA has determined that PFAS added to EPCRA section 313 by sections
7321(b) and 7321(c) of the 2020 NDAA should be categorized as chemicals
of special concern and added to the list in 40 CFR 372.28. The NDAA set
a 100-pound annual reporting threshold for PFAS added by sections
7321(b) and 7321(c), which indicates a concern for small quantities of
such PFAS. EPA has therefore determined that the availability of
certain burden reduction tools (i.e., de minimis levels, Form A, and
range reporting) is not justified for these chemicals as the
availability of these tools is inconsistent with a concern for small
quantities.
Further, due to the strength of the carbon-fluorine bonds, many
PFAS can be very persistent in the environment (Refs. 2, 3, and 9).
Persistence in the environment allows PFAS concentrations to build up
over time; thus, even small releases can be of concern. As with PBT
chemicals, permitting reporting facilities to continue to rely on the
burden reduction tools (de minimis levels, Form A, and range reporting)
would eliminate reporting on potentially significant quantities of the
listed PFAS. As explained in more detail in Unit IV., EPA's rationale
for eliminating these burden reduction tools for PBT chemicals (Refs. 7
and 8) applies equally well to PFAS.
The de minimis exemption allows facilities to not consider
concentrations of TRI listed chemicals in Unit IV., 1% (0.1% for
carcinogens) in mixtures or other trade name products they import,
process, or otherwise use in making threshold calculations and release
and other waste management (including disposal to land and other types
of waste management (i.e., energy recovery, recyling, treatment))
determinations. Since the de minimis level is based on relative
concentration rather than a specific amount, the application of this
exemption to PFAS listed under sections 7321(b) and 7321(c) could allow
significant quantities of such PFAS to be excluded from TRI reporting
by facilities. For example, if a facility imports, processes, or
otherwise uses 100,000 pounds of a mixture or trade name product that
contains 0.5% of a listed PFAS, then 500 pounds (or five times the
reporting threshold) would be disregarded. This exclusion is
inconsistent with a concern for small quantities of PFAS. Many PFAS are
used in products below the established de minimis levels (Refs. 4 and
10), and the continued availability of the exemption for PFAS would
permit facilities to discount those uses when determining whether an
applicable threshold has been met to trigger reporting.
The Form A provides certain covered facilities the option of
submitting a substantially shorter form with a reduced reporting burden
(Ref. 11). For example, the Form A does not require facilities to
report any information on releases (e.g., releases through fugitive or
non-point air emissions, discharges to streams or water bodies) or
waste management quantities. Facilities can qualify to file a Form A if
the total annual reportable amount for the listed chemical does not
exceed 500 pounds, and the amounts manufactured, processed, or
otherwise used do not exceed 1 million pounds. The annual reportable
amount is equal to the combined total quantities released at the
facility (including disposed of within the facility), treated at the
facility (as represented by amounts destroyed or converted by treatment
processes), recovered at the facility as a result of recycling
operations, combusted for the purpose of energy recovery at the
facility, and amounts transferred from the facility to off-site
locations for the purpose of recycling, energy recovery, treatment,
and/or disposal. This means that facilities that are required to report
data on PFAS and also qualify to file a Form A will not be providing
specific quantity data on up to 500 pounds of a listed PFAS (five times
the reporting threshold). For reporting year 2020, approximately 10% of
the reporting forms submitted for the listed PFAS were Forms A (i.e.,
reporting for TRI reflects 93 active reporting forms of which 84 were
Forms R and 9 were Forms A). This trend continued with reporting year
2021, in which 9 of the total 87 reporting forms for PFAS were Form A.
While the Form A does provide some general information on the
quantities of the chemical that the facility manages as waste, this
information may be insufficient for conducting analyses on PFAS and may
be less meaningful for communities interested in assessing risk from
releases of PFAS. The threshold category for amounts managed as waste
does not include quantities released to the environment as a result of
remedial actions or catastrophic events not associated with production
processes (section 8.8 of Form R). Thus, the waste threshold category
in Form A does not include all releases. Given that even small
quantities of PFAS may result in elevated concentrations in the
environment, EPA believes it would be inappropriate to allow a
reporting option that would exclude information on some releases. Thus,
removing the availability of the use of Form A for PFAS is consistent
with a concern for understanding small quantities of PFAS.
For TRI-listed chemicals, other than chemicals of special concern,
releases and off-site transfers for further waste management of less
than 1,000 pounds can be reported using ranges or as a whole number.
The reporting ranges are: 1-10 pounds; 11-499 pounds; and 500-999
pounds. For larger releases and off-site transfers for further waste
management of the toxic chemical, the facility must report the whole
number. Use of ranges could reduce data accuracy because the low or the
high-end range numbers may not be that close to the estimated value,
even taking into account inherent data errors (i.e., errors in
measurements and developing
[[Page 74364]]
estimates). For PFAS, it is important to have accurate data regarding
the amount released even when the quantities are relatively small,
since concern may be tied to even small quantities of a substance. This
issue was apparent for PFAS for reporting years 2020 and 2021 since
much of the data reported was for less than 1,000 pounds.
EPA anticipates that the elimination of these burden reduction
tools will increase the amount and quality of data collected for PFAS
and is consistent with the concern for small quantities of PFAS (Ref.
1).
B. Elimination of the Supplier Notification Requirement De Minimis
Exemption for Chemicals of Special Concern
EPA is also eliminating the use of the de minimis exemption under
the Supplier Notification Requirements at 40 CFR 372.45(d)(1) for all
substances on the list of chemicals of special concern. EPA extended
the de minimis exemption to the supplier notification requirement in
its initial TRI reporting rule (53 FR 4500, February 16, 1988 (FRL-
3298-2)). The revised text reads as follows:
If a mixture or trade name product contains no toxic chemical in
excess of the applicable de minimis concentration as specified in 40
CFR 372.38(a) except for chemicals listed under 40 CFR 372.28 which
are excluded from the de minimis exemption.
The de minimis exemption to the Supplier Notification Requirements
allows suppliers to not provide notifications for mixtures or trade
name products containing the listed toxic chemicals if the chemicals
are present at concentrations below 1% of the mixture (0.1% for
carcinogens). The de minimis exemption is not a small quantity
exemption; it is a small concentration exemption. Therefore, it is
possible that significant quantities of chemicals of special concern
can be overlooked by reporting facilities if suppliers can use the de
minimis exemption. For example, if a mixture or trade name product
contains 0.9% of a listed PFAS and 100,000 pounds of the product is
purchased, the supplier need not provide notification and the purchaser
could be unaware of and not account for 900 pounds of PFAS. The impact
of this exemption for the PBT chemicals with 10-pound reporting
thresholds is even greater. Using the same 100,000-pound example, if
mercury were present at 0.9% then that same 900 pounds would be 90
times the mercury reporting threshold.
It is also possible that quantities of chemicals of special concern
would be included in supplier notifications by reporting facilities if
suppliers cannot use the de minimis exemption. For example, if a
mixture or trade name product contains 0.9% of a listed PFAS and 1,000
pounds of the product is purchased, the supplier would need to provide
notification for 9 pounds of PFAS. This would also impact PBT chemicals
with 10-pound reporting thresholds. Using the same 1,000-pound example,
if mercury was present at 0.9% then that same 9 pounds would be below
the mercury reporting threshold. However, such quantities may become
reportable, in aggregate, if a reporting entity receives multiple
shipments (including from multiple suppliers) of a given product in a
year and performs a threshold activity in excess of the TRI reporting
threshold. Further, TRI supplier notification regulations do not
require a person to consider the total quantity of the chemical being
supplied but rather require the person to consider the concentration of
the chemical in the product or mixture. Including a consideration of
quantity rather than concentration shipped would complicate as well as
reduce the ability of supplier notifications to inform downstream
recipients of products and mixtures containing a TRI-listed chemical.
EPA considered whether to include a small quantity exemption in
lieu of a de minimis exemption for supplier notification. However, EPA
is concerned that such an exemption would not provide adequate
information to facilities receiving multiple shipments over the course
of a year to address TRI reporting requirements that may apply to them,
based on the total aggregated quantity received. Without such
information on the TRI-listed chemical, the receiving facility may not
have sufficient data to inform potential TRI reporting obligations.
Many PFAS are used in products below the established de minimis
levels (Refs. 4 and 10) which results in users of those products not
knowing they are receiving a product that contains a TRI-reportable
PFAS. PFAS reports received for the TRI 2020 and 2021 reporting years
were mostly from manufacturers and waste disposal facilities which
suggests that the de minimis exemption may have been used by most users
and processors see https://www.epa.gov/toxics-release-inventory-tri-program/find-understand-and-use-tri. EPA has concluded that it is
important and necessary to eliminate the supplier notification de
minimis exemption for PFAS added to the TRI list pursuant to sections
7321(b) and 7321(c) of the NDAA because if that exemption were to
remain in place the Agency may fail to collect information on amounts
of PFAS that significantly exceed the reporting threshold.
In addition, eliminating the use of the de minimis exemption for
supplier notification purposes for all other chemicals of special
concern ensures that potentially significant quantities of such
chemicals are not overlooked by reporting facilities. The PBT chemicals
and chemical categories that are classified as chemicals of special
concern, and are thus also impacted by this change, are as follows:
Aldrin (CASRN: 309-00-2);
Benzo[g,h,i]perylene (CASRN: 191-24-2);
Chlordane (CASRN: 57-74-9);
Dioxin and dioxin-like compounds category (manufacturing;
and the processing or otherwise use of dioxin and dioxin-like compounds
category if the dioxin and dioxin-like compounds are present as
contaminants in a chemical and if they were created during the
manufacturing of that chemical) (TRI Category Code: N150);
Heptachlor (CASRN: 76-44-8);
Hexabromocyclododecane category (TRI Category Code: N270);
Hexachlorobenzene (CASRN: 118-74-1);
Isodrin (CASRN: 465-73-6);
Lead (this lower threshold does not apply to lead when it
is contained in stainless steel, brass or bronze alloy; (CASRN: 7439-
92-1);
Lead compounds category (TRI Category Code: N420);
Mercury (CASRN: 7439-97-6);
Mercury compounds category (TRI Category Code: N458);
Methoxychlor (CASRN: 72-43-5);
Octachlorostyrene (CASRN: 29082-74-4);
Pendimethalin (CASRN: 40487-42-1);
Pentachlorobenzene (CASRN: 608-93-5);
Polychlorinated biphenyls (CASRN: 1336-36-3);
Polycyclic aromatic compounds category (PACs) (TRI
Category Code: N590);
Tetrabromobisphenol A (CASRN: 79-94-7);
Toxaphene (CASRN: 8001-35-2); and
Trifluralin (CASRN: 1582-09-8).
When EPA established the chemicals of special concern list, it
decided to not remove the de minimis exemption eligibility from
supplier notification requirements, indicating that the Agency believed
that there was sufficient information available on PBT chemicals by
suppliers. (Refs. 7 and 8). However, EPA has determined that there are
situations where this
[[Page 74365]]
information is not available. For example, the Agency has found that
there is significant variability in the concentration of PACs in fuels,
yet the presence and concentration of PACs in fuel oil is often not
provided in supplier notifications or SDSs. Additionally, EPA is aware
of metal mixtures and products containing low concentrations of lead
(not contained in stainless steel, brass or bronze alloys) whose
supplier notifications and SDSs do not state there is lead present in
the mixture or product. Further, it is unclear whether downstream
purchasers would be made aware of PBT chemicals contained in many
products without notification of the presence of such chemicals.
In situations where such information is already available, supplier
notifications may already be addressed (e.g., if such information in
already included on an SDS) or the burden of a supplier to provide such
information is minimal (i.e., if the information is redundant then the
burden to provide such known information should be trivial). However,
as noted in Unit IV., the quantity information EPA is requiring for de
minimis concentrations below the concentration threshold may not be
provided in SDSs. OSHA maintains a 1% concentration threshold for
reporting the presence and concentration of most hazardous chemicals on
SDSs (29 CFR part 1910, subpart Z). For chronic hazards (with
Carcinogenicity, Germ Cell Mutagenicity, and Reproductive Toxicity),
OSHA has established a 0.1% concentration threshold for reporting the
presence and concentration of chemicals on SDSs (29 CFR part 1910,
subpart Z). EPA notes that there may be other reasons for a chemical's
exclusion from an SDS (e.g., a chemical may be in an article that is
not covered by SDS requirements but is subject to TRI supplier
notification requirements). As described in section 4.3 of the EA (Ref.
1) for this final rule, EPA believes that any potential increase in new
supplier reporting is minimal, particularly regarding non-PFAS
chemicals of special concern.
In the 1999 proposal to establish a chemical of special concern
list, EPA also reasoned that entities subject to TRI supplier
notification requirements could retain use of the de minimis exemption
for PBTs because ``[m]any of the chemicals identified as persistent and
bioaccumulative in today's action are not imported, processed, or
otherwise used but are manufactured as byproducts'' (Ref. 8). However,
the Agency has since learned that several PBT chemicals are not
manufactured as byproducts, and those chemicals are known to be
processed for distribution to customers. For example, in Reporting Year
2021, the Agency received 55 Forms R for tetrabromobisphenol A (TBBPA).
None of those forms indicated that TBBPA had been manufactured as a
byproduct. However, some forms indicated the TBBPA is processed,
including as an article component. Similarly, for Reporting Year 2021,
the Agency received 76 Forms R on polychlorinated biphenyls (PCBs); 64
of those forms did not indicate those PCBs had been manufactured as
byproducts, though some forms indicated the PCBs had been processed,
including as an article component. Because many PBT chemicals are not
manufactured as byproducts and may exist in relatively lower
concentrations within products or mixtures, the Agency's initial
rationale to allow suppliers to exempt concentrations of PBT chemicals
below de minimis from supplier notification requirements warrants
reconsideration. Therefore, EPA has reassessed this exemption and
modified it appropriately to provide TRI facilities that receive
products or mixtures containing chemicals of special concern with
additional information related to quantities of chemicals of special
concern that may contribute to their reporting thresholds. EPA created
the de minimis exemption pursuant to the authority provided in EPCRA
section 328 (42 U.S.C. 11048) and is adjusting the scope of the
exemption under that same authority. EPCRA section 328 provides that
EPA has authority to promulgate regulations as may be necessary to
carry out this chapter. EPA has concluded that it is important and
necessary to eliminate the supplier notification de minimis exemption
for all chemicals of special concern because if that exemption were to
remain in place the Agency may fail to collect information on amounts
of such chemicals that significantly exceed the reporting threshold.
This action reflects EPA's current understanding of chemical
activities involving all chemicals of special concern (i.e., both PBTs
and PFAS).
C. Impact of Listing Certain PFAS on the Chemicals of Special Concern
List
This action revises the regulatory text to add PFAS currently on
TRI pursuant to 7321(b) and 7321(c) of the NDAA to the list of
chemicals of special concern. Additionally, the regulatory text, as
revised by this action, provides that all PFAS added to TRI pursuant to
sections 7321(b) and 7321(c), regardless of the date of their addition,
are included on the chemicals of special concern list. Thus, as PFAS
continue to be added to TRI pursuant to sections 7321(b) and 7321(c),
they will also be added to the list of chemicals of special concern as
of the date they are added to the TRI. It is likely that some of the
substances meeting the criteria in 7321(b) and 7321(c) will be subject
to confidential business information claims. For substances subject to
such claims, the Agency must follow the process outlined in section
7321(e) of the NDAA.
As with PFAS currently on the TRI list, future PFAS added to the
TRI list under 7321(b) and 7321(c) will have a 100-pound reporting
threshold, per sections 7321(b)(2)(A) and 7321(c)(2)(B). Congress' use
of this low reporting threshold demonstrates a concern for even
relatively small quantities of these PFAS. Therefore, EPA has concluded
that it is appropriate for all PFAS added to the TRI list under these
provisions to be added to the chemicals of special concern list upon
listing. If these PFAS were not added to the chemicals of special
concern list at the time of their addition to the TRI list, there would
be a delay in the reporting requirements while EPA conducts a
rulemaking simply to add them to the chemicals of special concern list.
This would result in differences in how previously listed PFAS and
newly listed PFAS are treated even though they were automatically
listed with the same reporting thresholds. The chemicals of special
concern designation is a regulatory construct and here, EPA has
determined it is appropriate to designate all PFAS added to TRI
pursuant to 7321(b) and 7321(c) as chemicals of special concern due to
Congress' use of the 100-pound reporting threshold, indicating a
concern for even relatively small quantities of PFAS, and PFAS'
persistence in the environment and growing evidence showing potential
adverse human health effects (Refs. 2, 3, and 9). Further, this
regulatory change will provide additional data that will help the
Agency to better understand the extent of potential impacts caused by
these PFAS. Given that the NDAA set a 100-pound reporting threshold for
all PFAS added pursuant to sections 7321(b) and 7321(c), EPA has
determined that additional rulemakings to designate these chemicals as
chemicals of special concern are unnecessary because the rationale for
any future rulemakings would remain the same and would result in a
delay of reporting requirements. EPA has finalized regulatory text that
adds those PFAS added pursuant to 7321(b) and 7321(c) to the chemicals
of special
[[Page 74366]]
concern list upon their addition to the TRI list.
EPA has decided not to provide a structural definition (e.g., OECD)
of PFAS as part of this action, because doing so is outside the scope
of this rulemaking. This rulemaking only concerns chemical substances
added to the TRI by sections 7321(b) and 7321(c) of the NDAA, neither
of which require EPA to provide a definition of PFAS. Section 7321(b)
added by name and/or CASRN specific PFAS to the TRI list and sections
7321(b) and (c) identify EPA activities involving PFAS that would cause
a PFAS to be added to the TRI list. The activities described by
sections 7321(b) and (c) indicate whether they pertain to a PFAS, and
thus a separate determination of whether or not the covered activity
involves a PFAS is not necessary. EPA is therefore not providing a
definition of PFAS for purposes of this rulemaking, and issues relating
to the definition of PFAS are outside the scope of this rulemaking. EPA
will consider the need for a PFAS definition for a purpose other than
the NDAA section 7321(b) and (c) listings, should the need for such a
definition arise. As indicated in the proposal for this rulemaking, EPA
acknowledges there is another rulemaking underway to list PFAS
additions for NDAA 7321(d), and the Agency expects that rulemaking to
clarify the status of those listed PFAS as chemicals of special
concern.
V. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not itself physically located in the
docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
1. USEPA. Economic Analysis for the Changes to TRI Reporting for
PFAS. October 2023.
2. USEPA. Our Current Understanding of the Human Health and
Environmental Risks of PFAS. U.S. Environmental Protection Agency,
Washington, DC. https://www.epa.gov/pfas/our-current-understanding-human-health-and-environmental-risks-pfas.
3. ATSDR. Agency for Toxic Substances and Disease Registry.
Toxicological Profile for Perfluoroalkyls. May 2021. https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf.
4. ATSDR. Agency for Toxic Substances and Disease Registry. Per- and
Polyfluoroalkyl Substances (PFAS) and Your Health. PFAS in the U.S.
Population. https://www.atsdr.cdc.gov/pfas/health-effects/us-population.html.
5. Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services. National Report on Human Exposure to
Environmental Chemicals. Updated March 2022. Accessed [insert date].
https://www.cdc.gov/exposurereport/.
6. USEPA. Response to Comment document. October 2023.
7. USEPA. Final Rule: Persistent Bioaccumulative Toxic (PBT)
Chemicals; Lowering of Reporting Thresholds for Certain PBT
Chemicals; Addition of Certain PBT Chemicals; Community Right-to-
Know Toxic Chemical Reporting. Federal Register. 64 FR 58666,
October 29, 1999 (FRL-6389-11).
8. USEPA. Proposed Rule: Persistent Bioaccumulative Toxic (PBT)
Chemicals; Lowering of Reporting Thresholds for Certain PBT
Chemicals; Addition of Certain PBT Chemicals; Community Right-to-
Know Toxic Chemical Reporting. Federal Register. 64 FR 688, January
5, 1999 (FRL-6389-11).
9. National Institute of Environmental Health Sciences.
Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS). https://www.niehs.nih.gov/health/topics/agents/pfc/index.cfm.
10. Kotthoff, et al. 2015. Perfluoroalkyl and polyfluoroalkyl
substances in consumer products. Environmental Science and Pollution
Research 22:14546-14559.
11. USEPA. Toxics Release Inventory Form A. https://ordspub.epa.gov/ords/guideme_ext/guideme_ext/guideme/file/ry_2021_form_a.pdf.
12. USEPA. Supporting Statement for an Information Collection
Request (ICR) ``Rule-Related Amendment; Changes to Reporting
Requirements for Per- and Polyfluoroalkyl Substances; Community
Right-to-Know Toxic Chemical Release Reporting; Final Rule (RIN
2070-AK97).'' EPA ICR No.2724.02; OMB Control No. 2070-0225. July
2023.
VI. Statutory and Executive Orders Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review
This action is a ``significant regulatory action'' as defined in
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA
submitted this action to the Office of Management and Budget (OMB) for
Executive Order 12866 review. Documentation of any changes made in
response to the Executive Order 12866 review is available in the
docket. EPA prepared an economic analysis of the potential impacts
associated with this action. This analysis, ``Economic Analysis for the
Changes to TRI Reporting for PFAS'' (Ref. 1) is also available in the
docket and summarized in Unit E.1.
B. Paperwork Reduction Act (PRA)
The information collection activities in this rule will be
submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared has
been assigned EPA ICR No. 2724.02 and the OMB Control No. 2070-0225.
You can find a copy of the ICR in the docket for this rule, and it is
briefly summarized here (Ref. 12). The information collection
requirements are not enforceable until OMB approves them.
Currently, the facilities subject to the reporting requirements
under EPCRA section 313 and PPA section 6607 may use either EPA Toxic
Chemicals Release Inventory Form R (EPA Form 1B9350-1), or EPA Toxic
Chemicals Release Inventory Form A (EPA Form 1B9350-2). The Form R must
be completed if a facility manufactures, processes, or otherwise uses
any listed chemical above threshold quantities and meets certain other
criteria. For the Form A, EPA established an alternative threshold for
facilities with low annual reportable amounts of a listed toxic
chemical. A facility that meets the appropriate reporting thresholds,
but estimates that the total annual reportable amount of the chemical
does not exceed 500 pounds per year, can take advantage of an
alternative manufacture, process, or otherwise use threshold of 1
million pounds per year of the chemical, provided that certain
conditions are met, and submit the Form A instead of the Form R. In
addition, respondents may designate the specific chemical identity of a
substance as a trade secret pursuant to EPCRA section 322 (42 U.S.C.
11042) and 40 CFR part 350. OMB has approved the reporting and
recordkeeping requirements related to Forms A and R, supplier
notification, and petitions under OMB Control number 2070-0212 (EPA ICR
No. 2613.04) and those related to trade secret designations under OMB
Control 2050-0078 (EPA ICR No. 1428.12). As such, this ICR is intended
to amend the existing ICR to include the following additional details:
Respondents/affected entities: Facilities covered under
EPCRA section 313 that manufacture, process or otherwise use listed
PFAS (See Unit I.A.).
[[Page 74367]]
Respondent's obligation to respond: Mandatory (EPCRA
section 313).
Frequency of response: Annual.
Total estimated number of respondents: 623 to 2,015.
Total estimated burden: 43,843 and 111,768 burden hours in
the first year and approximately 22,244 and 71,946 burden hours in the
steady state. Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: Approximately $3,318,492 and
$10,733,149 in the first year of reporting and approximately $1,580,214
and $5,111,044 in the steady state (per year) includes $0 annualized
capital or operation & maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The small entities subject to the requirements of
this action are primarily classified within the manufacturing and waste
management industry sectors. The Agency has determined that of the 623
to 2,015 entities estimated to be impacted by this action, 486 to 1,333
are small businesses; no small governments or small organizations are
expected to be affected by this action. The average cost per small firm
is $7,413 (at a 3% discount rate) or $7,520 (at a 7% discount rate).
All small businesses affected by this action are estimated to incur
annualized cost impacts of less than 1%. Even under a worst-case
scenario comparing compliance costs to average revenue of firms with
between 10 (smallest number required to report) and 14 employees
instead of comparing compliance costs to the weighted average revenue
of small firms, there are still no costs that exceed the 1% impact
threshold. Thus, this action is not expected to have a significant
adverse economic impact on a substantial number of small entities. A
more detailed analysis of the impacts on small entities is provided in
EPA's economic analysis (Ref. 1).
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local or tribal governments or the
private sector. EPA did not identify any small governments that would
be impacted by this action. EPA's economic analysis indicates that the
total cost of this action is estimated to be from $3,318,492 and
$10,733,149 in the first year of reporting and from $1,580,214 and
$5,111,044 in subsequent reporting years (Ref. 1).
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000) because it will
not have substantial direct effects on tribal governments, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes. It does not have substantial direct
effects on tribal government because this action relates to toxic
chemical reporting under EPCRA section 313, which primarily affects
private sector facilities. Thus, Executive Order 13175 does not apply
to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to regulatory actions considered significant under
section 3(f)(1) of Executive Order 12866 and that concern environmental
health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of Executive Order 13045.
Although this action does not concern an environmental health or
safety risk, the data collected as a result of this action will provide
information about releases to the environment that could be used to
inform the public on potential exposures to toxic chemical releases,
pursuant to the right-to-know principles. EPA also believes that the
information obtained as a result of this action could be used by
government agencies, researchers, and others to identify potential
problems, set priorities, and take appropriate steps to reduce any
potential exposures and related human health or environmental risks
identified as a result of increased knowledge of exposures to PFAS.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy and has not otherwise been designated by the
Administrator of the Office of Information and Regulatory Affairs as a
significant energy action.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve technical standards under the NTTAA
section 12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and;
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
EPA finds that it is not practicable to perform an environmental
justice analysis because it lacks data on the exact locations of every
exposure source. EPA was unable to perform an environmental justice
analysis because it lacks data on the exact location of every exposure
source based on reporting activity. The purpose of this action is to
require reporting activity.
However, this regulatory action makes changes to the reporting
requirements for PFAS that will result in more information being
collected and provided to better evaluate exposures and the risks posed
by such exposures. The determination of potential risk to human health
and/or the environment depends upon many factors, including the
toxicity of the chemical, the fate of the chemical in the environment,
and the amount and duration of human or other exposure to the chemical.
This action does not directly address human health or environmental
risks. However,
[[Page 74368]]
the action will increase the level of information available to assess
environmental protection for all affected populations without having
any disproportionate and adverse human health or environmental effects
on any population, including any community with environmental justice
concerns. Specifically, changes to the reporting requirements for PFAS
will provide more information on releases and waste management of PFAS.
By requiring reporting of this additional information, EPA will be
providing communities across the U.S. (including communities with
environmental justice concerns) with access to data which they may use
to seek lower exposures and consequently reductions in chemical risks
for themselves and their children. This information can also be used by
government agencies and others to identify potential problems, set
priorities, and take appropriate steps to reduce any potential risks to
human health and the environment. Therefore, informational benefits, of
the action, including behavioral changes such as consumers avoiding
specific products, may have positive impact on the human health and
environmental impacts on all communities, including communities with
environmental justice concerns.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 372
Environmental protection, Community right-to-know, Reporting and
recordkeeping requirements, and Toxic chemicals.
Dated: October 18, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 372--TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW
0
1. The authority citation for part 372 continues to read as follows:
Authority: 42 U.S.C. 11023 and 11048.
Sec. 372.22 [Amended]
0
2. Amend Sec. 372.22(c) by removing ``Sec. 372.25, Sec. 372.27,
Sec. 372.28, or Sec. 372.29'' and adding in its place ``Sec. Sec.
372.25, 372.27, or 372.28''.
Sec. 372.25 [Amended]
0
3. Amend Sec. 372.25 by:
0
a. In the introductory text, remove ``Except as provided in Sec.
372.27, Sec. 372.28, and Sec. 372.29'' and add in its place ``Except
as provided in Sec. Sec. 372.27 and 372.28''; and
0
b. In paragraphs (f), (g), and (h), remove ``Sec. 372.27, Sec.
372.28, or Sec. 372.29'' and add in its place ``Sec. Sec. 372.27 or
372.28''.
0
4. In Sec. 372.28, amend table 1 to paragraph (a)(1) by adding the
entry ``Per- and polyfluoroalkyl substances'' alphabetically to read as
follows:
Sec. 372.28 Lower thresholds for chemicals of special concern.
* * * * *
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Reporting
Chemical name CAS No. threshold (in
pounds)
------------------------------------------------------------------------
* * * * * * *
Per- and polyfluoroalkyl substances see Sec. 100
(Individually listed per- and 372.65(d) and (e).
polyfluoroalkyl substances added
by 15 U.S.C. 8921(b)(1) and
(c)(1)). (EPA periodically updates
the lists of covered chemicals at
Sec. 372.65(d) and (e) to
reflect chemicals that have been
added by 15 U.S.C. 8921).
* * * * * * *
------------------------------------------------------------------------
Sec. 372.29 [Removed]
0
5. Remove Sec. 372.29.
Sec. 372.30 [Amended]
0
6. Amend Sec. 372.30 by:
0
a. In paragraph (a), remove ``in Sec. 372.25, Sec. 372.27, Sec.
372.28, or Sec. 372.29 at'' and add in its place ``in Sec. Sec.
372.25, 372.27, or 372.28 at''; and
0
b. In paragraphs (b)(1), (b)(3) introductory text, (b)(3)(i), and
(b)(3)(iv), remove ``Sec. 372.25, Sec. 372.27, Sec. 372.28, or Sec.
372.29'' and add in its place ``Sec. Sec. 372.25, 372.27, or 372.28''.
Sec. 372.38 [Amended]
0
7. Amend Sec. 372.38 by:
0
a. In paragraph (a)(2), remove ``except for purposes of Sec.
372.45(d)(1)''; and
0
b. In paragraphs (b), (c), (d), (f), (g) and (h), remove ``Sec.
372.25, Sec. 372.27, Sec. 372.28, or Sec. 372.29'' and add in its
place ``Sec. Sec. 372.25, 372.27, or 372.28''.
0
8. Amend Sec. 372.45, by revising paragraph (d)(1) to read as follows:
Sec. 372.45 Notification about toxic chemicals.
* * * * *
(d) * * *
(1) If a mixture or trade name product contains no toxic chemical
in excess of the applicable de minimis concentration as specified in
Sec. 372.38(a), except for chemicals listed in Sec. 372.28(a), which
are excluded from the de minimis exemption.
* * * * *
[FR Doc. 2023-23413 Filed 10-30-23; 8:45 am]
BILLING CODE 6560-50-P