Rule2023-22094
Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 11, 2023
Effective
November 13, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is finalizing reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). In accordance with obligations under TSCA, as amended by the National Defense Authorization Act for Fiscal Year 2020, EPA is requiring persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, to submit information to EPA regarding PFAS uses, production volumes, byproducts, disposal, exposures, and existing information on environmental or health effects. In addition to fulfilling statutory obligations under TSCA, this rule will enable EPA to better characterize the sources and quantities of manufactured PFAS in the United States.
Full Text
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[Federal Register Volume 88, Number 195 (Wednesday, October 11, 2023)]
[Rules and Regulations]
[Pages 70516-70559]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22094]
[[Page 70515]]
Vol. 88
Wednesday,
No. 195
October 11, 2023
Part III
Environmental Protection Agency
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40 CFR Part 705
Toxic Substances Control Act Reporting and Recordkeeping Requirements
for Perfluoroalkyl and Polyfluoroalkyl Substances; Final Rule
Federal Register / Vol. 88, No. 195 / Wednesday, October 11, 2023 /
Rules and Regulations
[[Page 70516]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 705
[EPA-HQ-OPPT-2020-0549; FRL-7902-02-OCSPP]
RIN 2070-AK67
Toxic Substances Control Act Reporting and Recordkeeping
Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA) is finalizing
reporting and recordkeeping requirements for per- and polyfluoroalkyl
substances (PFAS) under the Toxic Substances Control Act (TSCA). In
accordance with obligations under TSCA, as amended by the National
Defense Authorization Act for Fiscal Year 2020, EPA is requiring
persons that manufacture (including import) or have manufactured these
chemical substances in any year since January 1, 2011, to submit
information to EPA regarding PFAS uses, production volumes, byproducts,
disposal, exposures, and existing information on environmental or
health effects. In addition to fulfilling statutory obligations under
TSCA, this rule will enable EPA to better characterize the sources and
quantities of manufactured PFAS in the United States.
DATES: This final rule is effective on November 13, 2023.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2020-0549, is available online
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional instructions for visiting
the docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Alie Muneer, 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) 564-6369; email address: <a href="/cdn-cgi/l/email-protection#18756d767d7d6a367974717d587d6879367f776e"><span class="__cf_email__" data-cfemail="0c61796269697e226d6065694c697c6d226b637a">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#c99d9a8a88e481a6bda5a0a7ac89acb9a8e7aea6bf"><span class="__cf_email__" data-cfemail="c397908082ee8bacb7afaaada683a6b3a2eda4acb5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action may apply to you if you have manufactured (defined by
statute at 15 U.S.C. 2602(9) to include import) PFAS for a commercial
purpose at any time since January 1, 2011. The following list of North
American Industrial Classification System (NAICS) codes is not intended
to be exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include:
<bullet> Construction (NAICS code 23);
<bullet> Manufacturing (NAICS code 31 through 33);
<bullet> Wholesale trade (NAICS code 42);
<bullet> Retail trade (NAICS code 44 through 45); and
<bullet> Waste management and remediation services (NAICS code
562).
This list details the types of entities that EPA is aware could
potentially be regulated by this action. Other types of entities not
listed could also be regulated. To determine whether your entity is
regulated by this action, you should carefully examine the
applicability criteria found in 40 CFR 705.10 and 705.12. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the FOR FURTHER INFORMATION
CONTACT section.
B. What is the Agency's authority for taking this action?
EPA is promulgating this rule pursuant to its authority in TSCA
section 8(a)(7) (15 U.S.C. 2607(a)(7)). The National Defense
Authorization Act for Fiscal Year 2020 (FY 2020 NDAA) (Pub. L. 116-92,
section 7351) amended TSCA section 8(a) in December 2019, adding
section 8(a)(7), titled ``PFAS Data.'' TSCA section 8(a)(7) requires
EPA to promulgate a rule ``requiring each person who has manufactured a
chemical substance that is a [PFAS] in any year since January 1, 2011''
to report information described in TSCA section 8(a)(2)(A) through (G).
This includes a broad range of information, such as information related
to chemical identity and structure, production, use, byproducts,
exposure, disposal, and health and environmental effects.
TSCA section 14 imposes requirements for the assertion,
substantiation, and review of information that is claimed as
confidential business information (CBI).
C. What action is the Agency taking?
In this action, EPA is promulgating reporting and recordkeeping
requirements for entities who have manufactured (including imported) a
PFAS for commercial purposes at any point since January 1, 2011. This
rule takes into consideration comments received on the proposed rule
(86 FR 33926, June 28, 2021 (FRL-10017-78)) input from the Small
Business Advocacy Review (SBAR) Panel that was convened following
publication of the proposed rule, and comments received on the SBAR
Panel Report and Initial Regulatory Flexibility Analysis (IRFA), which
EPA published with a Notice of Data Availability (NODA) (Ref. 1).
Details on the final rule requirements, including modifications from
the proposal, are explained in Unit III.
EPA is finalizing this rule both to fulfill its obligations under
TSCA section 8(a)(7), as amended by the FY 2020 NDAA, and to create a
more comprehensive database of previously manufactured PFAS to improve
the Agency's understanding of PFAS in commerce and to support actions
to address PFAS exposure and contamination.
D. Why is the Agency taking this action?
TSCA section 8(a)(7) requires EPA to promulgate a rule requiring
each person who has manufactured a PFAS in any year since January 1,
2011, to report certain information for each year since January 1,
2011.
E. What are the incremental economic impacts?
EPA has evaluated the costs and benefits of this rulemaking and
provided an Economic Analysis of the potential impacts associated with
this rule (Ref. 2). The primary benefit of this rule is providing EPA
with data on PFAS which have been manufactured, including imported, for
commercial purposes since 2011; the Agency is not currently aware of
any similar source of information for these substances of interest.
Subsequently, EPA will use these data to support activities addressing
PFAS under TSCA, as well as activities and programs under other
environmental statutes. The additional data on the production, use,
exposure, and environmental and health effects of PFAS in the United
States may allow EPA to more effectively determine whether additional
risk assessment and management measures are needed. This information
may lead to reduced costs of risk-based decision making and improved
decisions concerning PFAS.
EPA has evaluated the potential costs of this reporting and
recordkeeping requirement for manufacturers and article importers.
Since the notice of proposed rulemaking for this action
[[Page 70517]]
published on June 28, 2021 (86 FR 33926 (FRL-10017-78)), EPA found
additional data and received feedback via public comments to update its
economic analysis, including estimating the number of PFAS article
importers. EPA revised cost estimates from $10.8 million in industry
costs detailed in the draft Economic Analysis for the proposed rule to
$876 million detailed in the IRFA and NODA (Ref. 1), to $843 million
using a 3 percent discount rate and $800 million using a 7 percent
discount rate at the final rule stage. The final Economic Analysis
(Ref. 2), which is available in the docket, is briefly summarized here.
The regulated community is expected to incur one-time burdens and costs
associated with rule familiarization, compliance determination, form
completion, CBI claim substantiation, recordkeeping, and electronic
reporting activities. Industry is estimated to incur a burden of
approximately 11.6 million hours, with a cost of approximately $843
million and $800 million under a 3 percent and 7 percent discount rate,
respectively. The Agency is expected to incur a cost of $1.6 million.
The total social cost is therefore estimated to be approximately $844.8
million and $801.7 million under a 3 percent and 7 percent discount
rate, respectively.
II. Background
A. What are PFAS?
PFAS are a group of synthetic chemicals that have been in use since
the 1940s and can be found in a wide array of industrial and consumer
products (Refs. 2 and 3). PFAS are synthesized for many different uses,
ranging from firefighting foams to coatings for clothes and furniture,
to food contact substances, to the manufacture of other chemicals and
products. They are used in a wide variety of products, including
textiles, electronics, wires and cables, pipes, cooking and bakeware,
sport articles, automotive products, toys, transportation equipment,
and musical instruments, which may be imported into the United States
as finished articles (Ref. 2). PFAS can be released to the environment
throughout the lifecycle of manufacturing, processing, distribution,
use, and disposal (Refs. 3 and 4). There is evidence that exposure to
some PFAS in the environment may be linked to harmful health effects in
humans and animals, and that continued exposure above specific levels
to certain PFAS may lead to adverse health effects (Refs. 2, 3, and 4).
B. What is TSCA section 8(a)(7)?
On December 20, 2019, the National Defense Authorization Act for
Fiscal Year 2020 (NDAA) was signed into law (Pub. L. 116-92). Among
other provisions, section 7321 of NDAA added TSCA section 8(a)(7) which
states that the Administrator shall promulgate a rule in accordance
with this subsection requiring each person who has manufactured a
chemical substance that is a perfluoroalkyl or polyfluoroalkyl
substance (PFAS) in any year since January 1, 2011, to submit to the
Administrator a report that includes, for each year since January 1,
2011, the information described in subparagraphs (A) through (G) of
paragraph (2). The categories of information described in sections
8(a)(2)(A) through (G) are:
<bullet> The common or trade name, chemical identity and molecular
structure of each chemical substance or mixture for which a report is
required;
<bullet> Categories or proposed categories of use for each
substance or mixture;
<bullet> Total amount of each substance or mixture manufactured or
processed, the amounts manufactured or processed for each category of
use, and reasonable estimates of the respective proposed amounts;
<bullet> Descriptions of byproducts resulting from the manufacture,
processing, use, or disposal of each substance or mixture;
<bullet> All existing information concerning the environmental and
health effects of each substance or mixture;
<bullet> The number of individuals exposed, and reasonable
estimates on the number of individuals who will be exposed, to each
substance or mixture in their places of work and the duration of their
exposure; and
<bullet> The manner or method of disposal of each substance or
mixture, and any change in such manner or method.
Finally, in carrying out TSCA section 8, section 8(a)(5) requires
EPA, to the extent feasible, to (A) not require unnecessary or
duplicative reporting, (B) minimize compliance costs on small
manufacturers and processors, and (C) apply any reporting obligations
to those persons likely to have information relevant to effective
implementation of TSCA.
C. What did EPA propose?
In the proposed rule, EPA published for the reporting and
recordkeeping requirements for PFAS manufacturers under TSCA section
8(a)(7). EPA proposed to require any entity who had commercially
manufactured a PFAS that is a TSCA chemical substance at any time since
January 1, 2011, to electronically report certain information to EPA
regarding PFAS identity, production volumes, industrial uses,
commercial and consumer uses, byproducts, worker exposure, disposal,
and any existing information related to environmental and health
effects. Such information would be reported for each year since 2011 in
which a covered PFAS was manufactured, to the extent such information
were known to or reasonably ascertainable by the reporter. EPA also
proposed a five-year recordkeeping period following the submission
date.
EPA also proposed the following structural definition of PFAS: per-
and polyfluorinated substances that structurally contain the unit R-
(CF<INF>2</INF>)-C(F)(R')R''. Both the CF<INF>2</INF> and CF moieties
are saturated carbons and none of the R groups (R, R', or R'') can be
hydrogen. Under the proposal, reporting would have been required for
any TSCA chemical substance (including any mixture with a chemical
substance) which met the proposed structural definition and had been
manufactured for a commercial purpose at any time since January 1,
2011.
EPA did not propose any reporting exemptions or production volume
thresholds. The scope of covered chemical substances under the proposed
rule included any amounts of PFAS which were known to or reasonably
ascertainable by the manufacturer, including PFAS-containing articles,
byproducts, and impurities. EPA also did not propose any exemptions or
flexibilities for small manufacturers.
EPA proposed a six-month information collection period following
the effective date of the final rule, after which the reporting tool
would open for a six-month reporting period. Thus, the proposed rule
stipulated a reporting deadline one year from the effective date of the
final rule.
III. Final PFAS Reporting and Recordkeeping Requirements
In this unit, EPA discusses in detail the final reporting and
recordkeeping requirements, including changes from the proposed rule in
response to public input.
A. What substances are covered by this rule?
1. The Scope of PFAS for the Purpose of This Rule
Under TSCA section 8(a)(7), EPA must collect information on
chemical substances manufactured (including imported) for commercial
purposes, including chemical substances present in a mixture, that are
``perfluoroalkyl or
[[Page 70518]]
polyfluoroalkyl substances,'' or PFAS. TSCA section 8(a)(7) does not
define or characterize ``PFAS.'' EPA has determined that any TSCA
chemical substance (as that term is defined by TSCA section 3(2); see
Unit IV.A.2.) that falls within the structural definition at 40 CFR
705.3 is subject to reporting under TSCA section 8(a)(7), if it has
been manufactured for commercial purposes in any year since January 1,
2011. The proposed definition defined PFAS as a substance that includes
the following structure: R-(CF<INF>2</INF>)-C(F)(R')R'', in which both
the CF<INF>2</INF> and CF moieties are saturated carbons and none of
the R groups (R, R' or R'') can be hydrogen. EPA found that at least
1,364 substances from both the TSCA Inventory (Inventory) and Low-
Volume Exemption (LVE) claims would meet the proposed structural
definition. Separately, a count of chemicals meeting the proposed
definition on EPA's CompTox Chemicals Dashboard (Ref. 6) found
approximately 9,400 structures, though many of those structures are not
known TSCA chemical substances and would be out of scope of reporting
for this rule, as explained in section III.A.2 of this rule.
EPA determined that a structural definition was more appropriate
for this rule than a discrete list of specifically identified
substances. Other TSCA requirements have relied on a structural
definition when appropriate (e.g., the long-chain perfluoroalkyl
carboxylate (LCPFAC) significant new use rule (SNUR) defines covered
substances using a structural definition (40 CFR 721.10536) (Ref. 7),
and the polymer exemption rule for new chemical pre-manufacture notices
(PMNs) defines covered PFAS polymers using structural definitions (40
CFR 723.250)). Additionally, other scientific and regulatory bodies,
such as the Organization of Economic Cooperation and Development (OECD)
(Refs. 8 and 9), have defined PFAS using various structural
definitions. Thus, there is clear precedent for using a structural
definition both for TSCA rules and for actions addressing PFAS, and a
structural definition is consistent with the text of TSCA section
8(a)(7). EPA also determined that limiting the scope of reporting to a
discrete list of chemicals would eliminate reporting on substances of
interest to the Agency. Given various reporting exemptions for both
existing chemicals (e.g., certain byproducts and research and
development (R&D) substances are exempt from reporting in the Chemical
Data Reporting (CDR) rule) and new chemicals (e.g., byproducts and
impurities that are not listed on the Inventory), and with minimum
reporting thresholds under other rules, EPA may be unaware of some TSCA
chemical substances which meet this structural definition of PFAS.
Providing a discrete list based on substances currently on the
Inventory and in LVEs likely limits EPA's ability to capture all
substances that meet the structural definition, and which may present
properties similar to perfluorooctanoic acid (PFOA), perfluorooctane
sulfonic acid (PFOS), and hexafluoropropylene oxide dimer acid (HFPO-
DA) and its ammonium salt (popularly known as ``GenX''). Therefore, EPA
is defining PFAS for this TSCA section 8(a)(7) rule using a structural
definition to avoid inadvertently limiting the scope of reporting to
substances on a discrete list.
After reviewing public comments, EPA determined that the proposed
definition may not include all substances for which EPA believes
reporting of information is necessary (see additional discussion of
relevant public comment in Unit IV.A). Therefore, EPA is modifying the
definition of PFAS from the proposal. For the purpose of this TSCA
section 8(a)(7) reporting rule, EPA is defining ``PFAS'' using a
structural definition. PFAS is defined as including at least one of
these three structures:
<bullet> R-(CF<INF>2</INF>)-CF(R')R'', where both the
CF<INF>2</INF> and CF moieties are saturated carbons;
<bullet> R-CF<INF>2</INF>OCF<INF>2</INF>-R', where R and R' can
either be F, O, or saturated carbons; and
<bullet> CF<INF>3</INF>C(CF<INF>3</INF>)R'R'', where R' and R'' can
either be F or saturated carbons.
Manufacturers of substances that do not meet this structural
definition are not required to report under this rule. EPA is providing
a list of substances that meet this definition, gathered from the
Inventory, LVEs, and the CompTox Chemicals Dashboard; this list will be
available in the CompTox Chemicals Dashboard at <a href="https://comptox.epa.gov/dashboard">https://comptox.epa.gov/dashboard</a>. A substance that is not on this list but
still falls under the definition of a ``chemical substance'' under TSCA
(see Unit III.A.2) is subject to this rule if the substance has been
manufactured for a commercial purpose since 2011.
EPA is modifying the proposed definition first to remove the R
group requirements, resulting in the first sub-structure of this rule's
definition of PFAS (i.e., R-(CF<INF>2</INF>)-CF(R')R'', where both the
CF<INF>2</INF> and CF moieties are saturated carbons). The removal of
the R group requirements from the proposed definition will expand the
universe of PFAS to include additional substances of potential concern
because they are likely to be persistent. While the proposed definition
was developed to focus on substances most likely to be persistent in
the environment while excluding those substances that are ``lightly''
fluorinated (i.e., the molecule only contains unconnected
CF<INF>2</INF> or CF<INF>3</INF> moieties), EPA acknowledges that
substances that are not fully fluorinated may still be persistent in
the environment. This is because the persistence of organofluoro
compounds is more related to the density of C-F bonds within the
molecule than simply the existence of fully fluorinated carbons (Ref.
10). The final definition, which does not include the proposed
definition's R group requirements focuses the definition on those
substances most likely to persist in the environment. The final
definition does not include substances that only have a single
fluorinated carbon, or unsaturated fluorinated moieties (e.g.,
fluorinated aromatic rings and olefins). The latter set of substances
are more susceptible to chemical transformation than their saturated
counterparts, and therefore, are less likely to persist in the
environment (Ref. 10). EPA has determined that, for the purpose of this
rule, it is unnecessary to extend reporting requirements to substances
that only have a single fluorinated carbon or unsaturated fluorinated
moieties and are therefore less likely to persist in the environment,
unlike substances like PFOA, PFOS, and GenX.
In addition to modifying the proposed definition by removing the R
group requirements, EPA determined that the definition should be
further expanded by adding two sub-structures that will include certain
substances of interest to the Agency and to public commenters.
Furthermore, the additional two sub-structures will encompass other
chemical substances that are persistent in the environment but were not
covered by the proposed definition. The second sub-structure (R-
CF<INF>2</INF>OCF<INF>2</INF>-R', where R and R' can either be F, O, or
saturated carbons) aims to capture certain fluorinated ethers. EPA
believes that these ethers are likely to be found in water; for
example, perfluoro-2-methoxyacetic acid (PFMOAA) (Chemical Abstracts
Service Registry Number (CASRN) 674-13-5) and other chemicals with
structures similar to GenX found in the Cape Fear River. However, they
may not have been reported to the Inventory or as an LVE, and therefore
would not have been considered when developing the proposed definition,
which focused on substances in the known TSCA universe
[[Page 70519]]
(i.e., the Inventory and LVEs). Additionally, it is possible that such
substances are not on the Inventory due to TSCA reporting exemptions
(e.g., byproducts, or certain R&D substances). Based on these ethers'
properties and the lack of prior TSCA reporting, EPA believes that data
related to the manufacturing of these PFAS is necessary to carry out
TSCA section 8(a)(7) and would not be duplicative of other reporting.
Thus, EPA is interested in known or reasonably ascertainable
information on substances meeting this sub-structure definition, as it
meets EPA's threshold of focusing on chemicals more likely to exhibit
properties similar to GenX (along with PFOA and PFOS), including their
likely presence in the environment.
Finally, the third sub-structure
(CF<INF>3</INF>C(CF<INF>3</INF>)R'R'', where R' and R'' can either be F
or saturated carbons) aims to capture a different type of branching for
highly fluorinated substances that would not meet the proposed
definition due to their non-adjacent fluorinated carbons. These
substances are likely to be persistent, and EPA believes that reporting
for these more branched substances is necessary to collect the
information described in TSCA section 8(a)(2)(A)-(G) for substances
with similar persistence properties as PFOA, PFOS, or GenX. For
instance, 4,4,4-Trifluoro-2,2,3,3-tetra)kis(trifluoromethyl)butanoic
acid (CASRN 1882109-62-7) would not have met the proposed definition
due to its non-adjacent fluorinated carbons, but it has the same number
of carbon, fluorine, and oxygen atoms as PFOA, and has been identified
as an isomer of PFOA under the Stockholm Convention (Ref. 11). Further,
this substance, like other substances meeting this sub-structure, has
many highly fluorinated moieties such that EPA believes it is likely to
be persistent in the environment. EPA is interested in known or
reasonably ascertainable information on substances meeting this sub-
structure definition, as these chemicals are likely to persist in
environments to which they are released.
Under this rule's definition of PFAS, EPA identified additional
substances that may be subject to the rule from the Inventory and LVEs,
i.e., ``known TSCA chemical substances.'' Specifically, EPA identified
an additional 22 chemical substances on the Inventory and 19 LVEs, all
of which are now covered under the first sub-structure of this rule's
definition. To date, EPA has not identified any additional substances
on the Inventory or as an LVE under the second and third sub-
structures. This relatively modest increase of 41 known TSCA chemical
substances would bring the known universe of TSCA chemical substances
meeting this rule's definition of PFAS to 1,462, from 1,364 known TSCA
PFAS identified by the proposed definition. However, as discussed
previously, a substance's absence on the Inventory or LVEs may be due,
at least in part, to several exemptions for Inventory and new chemicals
reporting (e.g., byproducts, impurities, certain R&D substances). In
the absence of those exemptions, a PFAS meeting the definition under
TSCA section 3(2) may be subject to reporting under this rule.
EPA is also affirming that fluoropolymers which meet this rule's
definition of PFAS are reportable under this rule; this includes higher
molecular weight fluoropolymers. EPA does not believe the requested
data on fluoropolymers would be considered duplicative or unnecessary:
this information is not reported to EPA otherwise, and any
manufacturers' existing information on such fluoropolymers will inform
EPA's understanding of such types of PFAS within U.S. commerce,
including their downstream uses and their disposal methods.
EPA notes that this definition may not be identical to other
definitions of PFAS used within EPA and/or by other organizations. The
term ``PFAS'' has been used broadly by many organizations for their
individual research and/or regulatory needs. Various programs or
organizations have distinct needs or purposes apart from this TSCA
section 8(a)(7) reporting rule, and therefore, different definitions of
the term ``PFAS'' may be appropriate for other purposes. The Agency
notes that this perspective, that different users may have very
different needs and no single PFAS characterization or definition meets
all needs, is shared by many other organizations, including OECD (see
page 29, Ref. 8). EPA has determined the final definition of ``PFAS''
is the most appropriate definition for this TSCA section 8(a)(7) rule
and acknowledges that there may be other rules or programs who apply
different definitions to meet their own needs.
2. Definition of ``Chemical Substance'' Under TSCA and PFAS in Mixtures
This rule is limited to manufacturers (including importers) of PFAS
that are considered a ``chemical substance.'' Under TSCA section 3(2),
``chemical substance'' means any organic or inorganic substance of a
particular molecular identity, including: (1) Any combination of such
substances occurring in whole or in part as a result of a chemical
reaction or occurring in nature, and (2) Any element or uncombined
radical. This rule does not require reporting on activities that are
excluded from the definition of ``chemical substance'' in TSCA section
3(2)(B).
Even though the definition of chemical substance excludes mixtures,
PFAS as a chemical substance may be present in a mixture. Therefore,
this rule requires reporting on each chemical substance that is a PFAS,
including as a component of a mixture. This rule does not require
reporting on components of a mixture that do not fall under the
structural definition of PFAS, as explained in Unit III.A.1.
B. Which entities are covered by this rule?
1. Scope of Covered Entities
Anyone who has manufactured (including imported) a PFAS for a
commercial purpose in any year since January 1, 2011, is covered by
this rule. As noted in Unit III.B.2, ``manufacture for a commercial
purpose'' includes the coincidental manufacture of PFAS as byproducts
or impurities. EPA believes at least portions of the NAICS codes listed
in Unit I.A. may be covered by this rule. This rule extends to
manufacturers (including importers) only. Importers of PFAS in articles
are considered PFAS manufacturers.
Persons who have only processed, distributed in commerce, used,
and/or disposed of PFAS are not required to report under this rule,
unless they also have manufactured PFAS for a commercial purpose. If an
entity (such as a wastewater treatment plant) is simply processing PFAS
they received domestically, and not also manufacturing PFAS, including
as a byproduct, then the entity is not covered by this rule. Although
EPA received several public comments about extending the rule to cover
processors (see Unit IV.), TSCA section 8(a)(7) only refers to
manufacturers and expanding the rule to processors would be pursuant to
EPA's separate rulemaking authority at TSCA section 8(a)(1), which the
Agency is not pursuing at this time.
2. Scope of ``Manufacture for Commercial Purposes''
Pursuant to TSCA section 8(f), the scope of ``manufacturing'' for
the purposes of this rule is limited to entities manufacturing for a
commercial purpose. EPA is defining ``manufacture for commercial
purposes'' to align with definitions used in other rules. Specifically,
``manufacture for
[[Page 70520]]
commercial purposes'' includes the import, production, or manufacturing
of a chemical substance or mixture containing a chemical substance with
the purpose of obtaining an immediate or eventual commercial advantage
for the manufacturer. This includes, but is not limited to, the
manufacture of chemical substances or mixtures for commercial
distribution, including test marketing, or for use by the manufacturer
itself as an intermediate or for product research and development.
``Manufacture for commercial purposes'' also includes the coincidental
manufacture of byproducts and impurities that are produced during the
manufacture, processing, use, or disposal of another chemical substance
or mixture. As described in Unit III.B.1, simply receiving PFAS from
domestic suppliers or other domestic sources is not, in itself,
considered manufacturing PFAS for commercial purposes. Entities that
process and/or use PFAS only need to report on PFAS they have
manufactured (including imported), if any.
However, certain activities are not considered ``manufacture for
commercial purposes'' under TSCA section 8(f) (e.g., non-commercial R&D
activities such as scientific experimentation, research, or analysis
conducted by academic, government, or independent not-for-profit
research organizations, unless the activity is for eventual commercial
purposes) and are not subject to the reporting requirements in this
rule. For example, reporting would not be required for a Federal agency
which manufactures or imports PFAS when it is not for any immediate or
eventual commercial advantage.
3. Non-Reportable Activities
As discussed in Unit III.B.2, entities who have manufactured PFAS
for a commercial purpose include those who have imported PFAS
(including in wastes), or those who have coincidentally produced PFAS
during the manufacture, processing, use, or disposal of another
chemical substance or mixture. EPA noted in the proposed rule that this
may include certain waste management companies, if they have imported
PFAS in a waste or produced PFAS at their site during the disposal of
another chemical substance or mixture. Through public comments and
input during the SBAR Panel, EPA understands that entities engaged in
certain waste management activities are in the unique position of not
having knowledge of PFAS they may have manufactured for commercial
purposes. Entities that import municipal solid wastes (MSW) for the
purpose of disposal or destruction cannot know or reasonably ascertain
that they imported PFAS in the MSW streams. MSW streams are
heterogeneous and generally difficult to characterize, in the absence
of notification or labeling requirements related to the content of the
waste. There were no Federal labeling or notification requirements for
PFAS in wastes concurrent with this reporting period, nor are there
general labeling practices for PFAS in MSW streams that are sent for
disposal or destruction. Additionally, standard analytical methods for
PFAS in MSW streams were not available during this reporting period.
Because no PFAS was listed as a hazardous waste and subject to
notification requirements under the Resource Conservation and Recovery
Act (RCRA) or other Federal laws during this rule's lookback period
(i.e., since January 1, 2011), and due to general industry practices,
EPA understands that importers of MSW streams for disposal or
destruction would not have any records or data that they had imported
PFAS or any other information relevant to TSCA section 8(a)(7).
Therefore, EPA has determined that waste management activities
involving importing municipal solid waste streams for the purpose of
disposal or destruction are not within scope of this rule's reporting
requirements, per EPA's obligations under TSCA section 8(a)(5)(C).
However, EPA is not broadly exempting all waste management
facilities from this rule. Facilities that have imported waste
containing PFAS, other than in MSW streams for destruction or disposal,
are likely to have information relevant to this rule. Other waste
management sites may have relevant information regarding PFAS contents
in waste they have imported outside of MSW, or for the purpose of
recycle or reuse; thus, EPA is required to apply reporting requirements
to such entities who may have relevant information, pursuant to TSCA
section 8(a)(5)(C). This would include waste management sites who
import PFAS-containing waste (including in MSW) for the purpose of
recycling or reuse for PFAS-containing products, as well as waste
management sites who import PFAS in wastes that are not municipal solid
waste streams. In the former activity, entities who import wastes that
may contain PFAS, such as some carpets and rugs, for the purpose of
recycling or reusing the PFAS-containing material, may be aware of the
general nature of those materials and the downstream processing and use
information that is responsive to this rule (see Table 14, Ref. 12). In
the latter activity, importers of PFAS-containing wastes that are not
MSW (such as industrial wastes) may also have knowledge of the contents
of the waste they have imported due to labeling or notification
practices, including under international agreements affecting
transboundary movement of wastes (Ref. 13). Because certain importers
of waste (besides MSW that is imported for the purpose of disposal or
destruction) are anticipated to know or reasonably ascertain that they
have manufactured PFAS, EPA is extending reporting requirements to
manufacturers (including importers) of PFAS in wastes, unless they have
imported PFAS in municipal solid waste streams for the purpose of
disposal or destruction.
C. What is the reporting standard of this rule?
For the purpose of this rule, the reporting standard is information
known to or reasonably ascertainable by the manufacturer, which is the
standard used in other TSCA section 8 rules, including CDR since 2011
(see TSCA section 8(a)(2)). ``Known to or reasonably ascertainable by''
is defined to include ``all information in a person's possession or
control, plus all information that a reasonable person similarly
situated might be expected to possess, control, or know'' (40 CFR
704.3). This reporting standard requires reporting entities to evaluate
their current level of knowledge of their manufactured products
(including imports), as well as evaluate whether there is additional
information that a reasonable person, similarly situated, would be
expected to know, possess, or control. This standard carries with it an
exercise of due diligence, and the information-gathering activities
that may be necessary for manufacturers to achieve this reporting
standard may vary from case-to-case.
This standard would require that submitters conduct a reasonable
inquiry within the full scope of their organization (not just the
information known to managerial or supervisory employees). This
standard may also entail inquiries outside the organization to fill
gaps in the submitter's knowledge. Such activities may, though not
necessarily, include phone calls or email inquiries to upstream
suppliers or downstream users or employees or other agents of the
manufacturer, including persons involved in the research and
development, import or production, or marketing of the PFAS. Examples
of types of information that are considered to be in a manufacturer's
possession or
[[Page 70521]]
control, or that a reasonable person similarly situated might be
expected to possess, control, or know include: files maintained by the
manufacturer such as marketing studies, sales reports, or customer
surveys; information contained in standard references showing use
information or concentrations of chemical substances in mixtures, such
as a Safety Data Sheet (SDS) or a supplier notification; and
information from the CAS or from Dun & Bradstreet (D-U-N-S). However,
if particular information cannot be derived or reasonably estimated
without conducting further customer surveys (i.e., without sending a
comprehensive set of identical questions to multiple customers), it
would not be ``reasonably ascertainable'' to the submitter. Thus, there
is not a need to conduct new surveys for purposes of this rule. As
described previously, however, existing survey data may nevertheless be
``known to'' the organization. This information may also include
documented knowledge gained through discussions, conferences, and
technical publications. In addition, this is the same reporting
standard employed in the TSCA section 8(a) CDR rule (40 CFR 711.15). In
response to public comments and input received through the SBAR Panel,
EPA has also created additional compliance guidance related to this
reporting standard, including for small entities and for article
importers (Ref. 14). Therefore, EPA anticipates many reporters under
this rule are familiar with this reporting standard, and resources are
available to support those reporters who may not be familiar with the
standard.
In the event that a manufacturer (including importer) does not have
actual data (e.g., measurements or monitoring data) to report to EPA,
the manufacturer (including importer) should consider whether
``reasonable estimates'' of such information are ascertainable.
``Reasonable estimates'' may rely, for example, on approaches such as
mass balance calculations, emissions factors, or best engineering
judgment. EPA notes that many of the data elements requested under this
rule, including production volumes or environmental release volumes,
incorporate a level of estimation by requiring only two significant
figures. Other data elements, including worker exposure, are reported
as ranges, as with CDR. For instance, a manufacturer may be able to
estimate the range of number of workers reasonably likely to be exposed
for each commercial use based on the manufacturer's knowledge of the
commercial sites' sizes, without specific workplace monitoring data;
the manufacturer, would report the estimated range, rather than
reporting that the information is not known. In general, EPA believes
that industry possesses a greater knowledge than EPA about its own
supply chain and operations related to the chemical substances it
manufactures and the downstream uses, even if they do not control their
customers' sites. However, if manufacturers do not know nor can
reasonably make estimates for certain data elements, except for
production volumes, they may indicate such information is ``Not Known
or Reasonably Ascertainable'' (NKRA) to them in lieu of the requested
estimate or range. For instance, if a manufacturer does not know and
cannot reasonably ascertain (including, having no basis for a
reasonable estimate or assumption based on past experiences for the
same or similar substances) how a PFAS is disposed of as a waste in a
given year, the manufacturer may submit ``NKRA'' for that information.
Reporters are also advised that ``NKRA'' designations cannot be claimed
as CBI under TSCA section 14. Reporting NKRA should only happen when
data are truly not reasonably ascertainable or are unattainable (e.g.,
when the appropriate recordkeeping period has lapsed and a past record
is no longer available).
EPA has published reporting instructions and a Small Entity
Compliance Guide, which include information related to this reporting
standard and the activities that small entities, including article
importers, may take to meet the due diligence requirement (Ref. 14).
If, after conducting due diligence and reviewing known or
reasonably ascertainable existing information, a manufacturer,
particularly an importer of articles containing PFAS, may not have
knowledge that they have manufactured or imported PFAS and thus need
not report under this rule. EPA encourages such an entity to document
its activities to provide evidence of due diligence. Additionally,
consistent with their own business practices, companies may elect to
retain documentation of their conclusion that they were not subject to
reporting requirements.
D. What information must be reported under this rule?
1. General Reporting Form
EPA is requiring that PFAS manufacturers submit the following
information for each PFAS, for each year in which that substance was
manufactured since January 1, 2011, to the extent the information is
known or reasonably ascertainable. For the purposes of this rule, EPA
is requiring this information to be submitted for each chemical
substance that is a PFAS. For mixtures that contain at least one
chemical substance that is a PFAS, manufacturers must submit
information for each chemical substance in the mixture that is a PFAS.
For example, a mixture comprised of PFAS A and PFAS B would result in
the submission of two forms containing the information described later
in this unit for each PFAS. For chemical substances of unknown or
variable compositions, complex reaction products, and biological
materials (UVCBs), including polymers, a single form may be submitted
for that UVCB. EPA encourages submitters of mixtures and UVCBs that
contain PFAS to provide additional information in the optional free
text box related to the composition of that mixture or UVCB at the time
of manufacture, if known.
EPA is largely finalizing the proposed reporting requirements, with
a few modifications based on public comments. Changes to the proposed
requirements include: removing the requirements for reporting maximum
production volume in the first 12 months and maximum yearly production
volume in any 3 years; removing the requirement for reporting the
maximum quantity on-site at any time (including storage); modifying the
requirement to submit the molecular structure for each substance by
making the submission optional for any Class 1 chemical substance on
the Inventory (but required for all others); requiring submitters to
provide a generic name or description (which indicates, at least, that
the substance is fluorinated) in lieu of the specific chemical identity
or trade name when neither are known; reporting analytical methods, if
any; adding optional comment boxes to provide any additional
information or clarification to EPA.
A spreadsheet containing the reporting requirements is also
available in the docket (Ref. 15).
2. Streamlined Reporting Form Option for Article Importers
Article importers are not exempt from this rule. Given the
reporting exemptions in other TSCA reporting rules, exempting imported
articles from the scope of this TSCA section 8(a)(7) reporting rule
would perpetuate data gaps in EPA's level of knowledge related to PFAS
manufactured for a commercial purpose since 2011. EPA cannot know what
requested information is ``reasonably ascertainable'' to all article
[[Page 70522]]
importers without knowing the full range of potentially available
information to be reported. Thus, EPA does not otherwise have the
information outlined in TSCA section 8(a)(7) on PFAS within imported
articles, and the Agency cannot justify a broad exemption of imported
articles under TSCA section 8(a)(5)(A), which requires EPA, to the
extent feasible, to not require unnecessary or duplicative reporting.
However, after considering public input on the information that may be
known to or reasonably ascertainable by some PFAS article importers,
EPA is finalizing a reporting option for article importers to provide
data to EPA on a streamlined form, if they do not know or cannot
reasonably ascertain information requested on the longer standard form
described in Unit III.D.1.
If an article importer determines they have imported a covered
substance in an article, they would have the option to provide
information to EPA through the streamlined form. The information
requested through this streamlined form would still include chemical
identity, processing and use information, and production volume, as
well as the option to provide any additional information to EPA that
the entity may have (e.g., SDS, disposal information).
The production volume requested is the volume of the imported
article, rather than the PFAS. EPA believes it is more likely that an
article importer is able to determine the total imported production
volume of articles rather than the volume related to just the PFAS
contained within the article. For instance, an article importer may
submit as the production volume the total weight of the PFAS-containing
imported articles (e.g., in tons or pounds). Alternatively, the article
importer could report the production volume in terms of quantity of the
article imported (e.g., number of vehicles). The reporter would also be
required to specify the unit of measurement reflected in the imported
production volume. Based on information provided from article importers
during the public comment period and the SBAR Panel, EPA believes that
many article importers would have more difficulty providing precise
production volumes of just the PFAS within an article. Industry input
indicated that the historical documentation provided to article
importers would not always or reliably include the weight or
concentration of a PFAS contained in the article, making it more
difficult for article importers to precisely calculate the production
volume of just the PFAS contained within the article. Based on public
input on the historical reporting practices and knowledge of PFAS in
imported articles, and the fact that this rule is not a product testing
requirement, EPA believes that article importers are more easily able
to determine the imported production volume of the article itself. EPA
acknowledges that it would be preferable to have the production volume
of the chemical itself, though having the production volume of the
imported article would still confer meaningful information to EPA for
the purpose of chemical assessments under TSCA and other programs.
Because EPA would rather have data on the production volume of the
imported article, rather than many ``NKRA'' responses related to the
production volume of the PFAS itself, EPA is requiring article
importers to submit the production volume information on the whole
article rather than the PFAS contained within the article.
The streamlined article importer form would require the following
information to the extent it is known or reasonably ascertainable:
1. Chemical identity:
a. Specific chemical name, or
b. Generic name(s) or description(s) if the specific chemical
name(s) is claimed as CBI and/or when a manufacturer knows they have a
PFAS but is unaware of its specific chemical identity. A generic name
must meet the naming requirements for this rule and indicate the
substance is a fluorinated substance (i.e., contain ``fluor'').
2. Chemical identification number:
a. CASRN, or
b. Accession or LVE case number, if applicable, and if the specific
CASRN is unknown. EPA notes that this rule does not require
manufacturers to obtain a CASRN or other identifier for a substance
without such a number for the purpose of complying with this rule.
3. Trade name or common name, if applicable.
4. Representative molecular structure, for any PFAS that is not a
Class 1 substance on the Inventory. And optional free text for further
clarification on the chemical identity or molecular structure (such as
for Class 2 substances, or where the molecular structure is of unknown
or variable composition).
5. Import production volume of the imported article and the unit of
measurement for that production volume (e.g., quantity of the imported
article, pounds, tons).
6. Industrial processing and use:
a. Type of process or use;
b. Sector(s);
c. Functional use category(ies); and
d. Percent of production volume for each use.
7. Consumer and commercial use:
a. indicator for whether this is a consumer and/or commercial
product;
b. Product category;
c. Functional use category(ies);
d. Percent production volume for each use;
e. Maximum concentration in any product;
f. Indicator for use in products intended for children;
g. Indicator for imported but never physically at site; and
h. Any optional information the article importer wishes to provide.
Under TSCA section 8(a)(5)(C), EPA must, to the extent feasible,
``apply any reporting obligations to those persons likely to have
information relevant to the effective implementation of [TSCA].'' EPA
believes that this streamlined reporting form option for any article
importer would still provide necessary information to EPA under TSCA
section 8(a)(7), while reducing the reporting burden for the data
elements that EPA understands may not be known to or reasonably
ascertainable by article importers. However, to the extent any
additional information requested on the longer forms is known to or
reasonably ascertainable by the article importer (e.g., information on
disposal of that PFAS, or an SDS or other existing information
regarding environmental or health effects), the reporter would have the
option and ability to submit that information to EPA through the
``optional'' field. EPA also notes that it is possible that a
manufacturer both imports a PFAS within an article, and otherwise
manufactures (including imports) the same PFAS beyond an article. In
such scenarios, the reporter would still have to provide information on
the longer standard form for the non-imported article and would have
the option to report on the PFAS within the imported article either on
the streamlined form or within the longer standard form. The reporting
tool for this rule will enable multiple form options for the same PFAS
if appropriate.
3. Streamlined Reporting Form Option for R&D Substances Manufactured
Below 10 Kilograms
EPA is also including R&D substances that were manufactured,
including imported, for a commercial purpose within the scope of this
rule. EPA notes that the scope of ``manufacture for commercial
purposes'' encompasses any importing, production, or other
manufacturing activities with the purpose of obtaining an immediate or
eventual commercial advantage and includes chemicals ``for use by the
[[Page 70523]]
manufacturer, including use for product research and development'' (40
CFR 704.3). R&D substances which meet the scope of ``manufacture for
commercial purposes'' must be reported under this rule, even if the
PFAS itself was not later commercialized. However, R&D substances which
have not been manufactured for commercial purposes (such as for
scientific experimentation, research, or analysis conducted by
academic, government, or independent not-for-profit research
institutions, unless the activity is for eventual commercial purposes)
would not be within scope of this rule (40 CFR 720.30(i)).
EPA believes that the submission of information related to the
commercial manufacture of PFAS as R&D substances is necessary to
understand the scope of PFAS manufactured in the United States. With
existing R&D reporting exemptions under other TSCA rules (including CDR
and PMN submissions), EPA does not have a dataset of PFAS manufactured
as R&D substances. Therefore, reporting on such substances is necessary
to the effective implementation of TSCA. Further, EPA understands that
manufacturers of R&D substances that have been exempt under other
reporting rules should have certain documentation available to support
those exemption claims, in accordance with their recordkeeping
requirements.
However, EPA understands through input from public commenters and
the SBAR Panel that much of the information requested for this rule is
unknown and not reasonably ascertainable to manufacturers of R&D
substances, particularly small entities who may manufacture R&D
substances in small quantities. EPA believes that manufacturers of R&D
substances in such low quantities are likely to have manufactured those
substances purely for laboratory analytical purposes, which may be at
their own site or their customers' sites. As such, these manufacturers
are aware of the R&D chemical identity and production volume but are
unlikely to have any other information requested. However, EPA believes
that manufacturers of R&D chemicals manufactured in larger quantities
(i.e., greater than 10 kilograms per year) are more likely to have the
other information requested, including worker exposure information,
disposal information, and health or environmental effects information
(such as monitoring or toxicity data). Given EPA's understanding of
typical recordkeeping practices of R&D activities, it is likely that a
manufacturer with greater quantities of R&D substances would know the
requested information on those substances beyond their identities and
production volumes. Under TSCA section 8(a)(5)(C), EPA shall, to the
extent feasible, apply reporting requirements to those persons likely
to have relevant information. Therefore, EPA is providing another
streamlined reporting option to manufacturers of R&D substances that
were manufactured in volumes under 10 kilograms per year, if they do
not know or cannot reasonably ascertain information requested on the
longer standard form described in Unit III.D.1.
Information requested on this form, for each R&D PFAS manufactured
below 10 kilograms per year, will include the following to the extent
it is known or reasonably ascertainable:
1. Chemical identity:
a. Specific chemical name, or
b. Generic name(s) or description(s) if the chemical name(s) is
claimed as CBI and/or when a manufacturer knows they have a PFAS but is
unaware of its specific chemical identity. A generic name must meet the
naming requirements for this rule and indicate the substance is a
fluorinated substance (i.e., contain ``fluor'').
2. Chemical identification number:
a. CASRN, or
b. TSCA Accession Number or LVE case number, if applicable, and if
the specific CASRN is unknown. EPA notes that this rule does not
require manufacturers to obtain a CASRN or other identifier for a
substance without such a number for the purpose of complying with this
rule.
3. Trade name or common name, if applicable.
4. Representative molecular structure, for any PFAS that is not a
Class 1 substance on the Inventory. With optional free text for further
clarification on the chemical identity or molecular structure (such as
for Class 2 substances, or where the molecular structure is of unknown
or variable composition).
5. Production volume:
a. Domestically manufactured.
b. Imported.
6. Indicator for imported but never physically at site.
7. Any optional information the manufacturer wishes to provide.
EPA believes that this streamlined reporting form option for any
manufacturer of R&D substances in low volumes (i.e., below 10 kilograms
per year) would still provide necessary information to EPA under TSCA
section 8(a)(7), while minimizing the cost of compliance for certain
small manufacturers, consistent with TSCA section 8(a)(5), for the data
elements that EPA understands may not be known to or reasonably
ascertainable by such manufacturers. However, to the extent any
additional information requested on the longer forms is known to or
reasonably ascertainable by the manufacturer (e.g., information on
disposal of that PFAS, or existing information regarding environmental
or health effects), the manufacturer would be required to submit that
information to EPA through the ``optional'' field on the streamlined
reporting form.
E. What must be submitted as ``all existing information concerning the
environmental and health effects'' of a chemical substance?
Pursuant to TSCA section 8(a)(2)(E), EPA is requiring the
submission of ``all existing information concerning the environmental
and health effects'' of the chemical substances covered by this rule.
``All existing information concerning environmental and health
effects'' is defined as ``any information of any effect of a chemical
substance or mixture on health or the environment or both'' (to be
codified at 40 CFR 705.3) and is intended to be interpreted broadly.
The scope of ``all existing information concerning environmental and
health effects'' includes all health and safety studies but is not
limited to formal studies. Chemical identity is always part of a health
and safety study, and TSCA section 14(b) limits the extent to which
health and safety studies and information from studies may be withheld
from the public as confidential business information (CBI). Any
information that bears on the effects of a PFAS on human health or the
environment would be included, including information on the chemical
substance developed or generated prior to the year 2011. The codified
definition of ``all existing information concerning environmental and
health effects'' at 40 CFR 705.3 provides non-exhaustive examples, such
as:
<bullet> Toxicity information (e.g., long- and short-term tests of
mutagenicity, carcinogenicity, teratogenicity; pharmacological effects;
acute, subchronic, and chronic effects);
<bullet> Ecological or other environmental effects on fish,
invertebrates, or other animals and plants, such as bioconcentration or
bioaccumulation tests;
<bullet> Human and environmental exposure assessments, including
workplace exposure, and the impacts of a chemical substance or mixture
on the environment; and
<bullet> Other data relevant to environmental and health effects
including monitoring data to measure the exposure of humans or the
[[Page 70524]]
environment or a chemical substance, range-finding studies, preliminary
studies, adverse effects reports, and any information, including
medical screening or surveillance, such as under the American
Conference of Government Industrial Hygienists (ACGIH).
Following public comments, EPA is also clarifying that the scope of
``all existing information concerning environmental and health
effects'' is information in the submitter's possession or control. For
the purpose of requiring existing information related to health or
environmental effects, EPA is adopting the same definition of
``possession or control'' as in the TSCA Pre-Manufacture Notice (PMN)
regulations (40 CFR 720.3(y)). Thus, a PFAS manufacturer would not
necessarily be searching all information in the public realm but would
be submitting information in their possession or control, or other
information for which they are responsible. This includes any data or
other information in files maintained by the submitter's employees, or
the employees of a submitter's subsidiary or partnership which is
associated with research and development, test marketing or commercial
marketing of the PFAS, regardless of the publication status. EPA is not
requiring manufacturers to search open scientific literature to find
relevant information on a PFAS that was previously not in their
possession or control for the purpose of this rule. EPA believes that
implementing such a requirement may result in duplicative information,
if multiple PFAS manufacturers are submitting the same studies or other
information that are available publicly (including in EPA's scientific
literature databases).
EPA considered ways to avoid requiring the submission of
potentially duplicative information concerning health and environmental
effects (see TSCA section 8(a)(5)(A)), while still fulfilling EPA's
obligation under TSCA section 8(a)(7) to require reporting of such
information. Such information concerning environmental or health
effects may have been submitted to EPA previously under either TSCA
section 8(d) rules (as unpublished health and safety information) or
TSCA section 8(e) (as a substantial risk notice). If a reporter has
already submitted information concerning environmental or health
effects to EPA under specific TSCA submissions, they need not re-submit
that information if they provide the details of to which program (or
under which rule) that information was submitted and in which year
(e.g., TSCA section 8(e), in 2010). In the event of a reporter having
previously submitted relevant environmental and health effects
information, the reporter must ensure that the previous submission
included all existing underlying information, including test data. Note
that a previous submission of information concerning environmental or
health effects does not relieve a manufacturer of providing all
existing information concerning environmental or health effects that
has not previously been submitted to EPA. See Unit III.F for more
discussion on how EPA is mitigating potentially duplicative reporting
for this rule.
For environmental and health effects information that was
previously submitted to EPA as CBI, the reporter would need to resubmit
if that information predated the 2016 Lautenberg Act amending TSCA and
its CBI submission requirements and reassert the CBI claim (see
Sec. Sec. 705.22(f) and 705.30). If a reporter has submitted
environmental and health effects information as CBI since the 2016
Lautenberg Amendments to TSCA were implemented, then the manufacturer
must provide EPA with details regarding when, how, and under which
title and/or statutory authority the CBI claim was submitted, and the
TSCA section 14 certification. In order for a reporter to earn an
exemption from resubmitting that environmental and health effects
information and re-asserting a CBI claim, the reporter must be able to
point to a previous claim that adequately covers the current claim. In
any event of a reporter having previously submitted environmental or
health effects information as CBI, whether pre- or post-Lautenberg
Amendments, they must adequately substantiate their CBI claim. EPA
encourages all reporters who have previously submitted environmental or
health effects information as CBI to carefully review their previous
submissions and determine whether the previous claims satisfy current
CBI substantiation requirements, and to assert a new claim and
substantiate if appropriate. More discussion on submitting CBI under
this rule is in Unit III.G.
Additionally, EPA is finalizing the requirement to submit all
existing information concerning health and environmental effects in the
format of OECD-harmonized templates, where such templates exist for the
type of data (to be codified at 40 CFR 705.15(f)). OECD templates are
accessible to the public online at <a href="https://oecd.org/ehs/templates/harmonised-templates.htm">https://oecd.org/ehs/templates/harmonised-templates.htm</a> (Ref. 16). This can be accomplished by using
the freely available IUCLID6 software by exporting the dossier in the
OECD Harmonized Template working context. At the time of this rule
publication, EPA can accept any dossiers generated using any version of
IUCLID6. Users should refer to EPA web pages (to be identified) for
updates on which version of IUCLID files will be accepted.
A standardized format such as the OECD templates will improve the
efficiency of review and organization of the submitted data. EPA
believes that some of the data will already be available as an OECD
template if the company had already submitted the studies under the
European Union's Registration, Evaluation, Authorization and
Restriction of Chemicals (REACH) regulation (Ref. 16). In addition to
the required template format, those subject to this rulemaking must
submit any associated full study reports or underlying data as support
documents. The full study reports and support documents are necessary
for EPA to understand the full context and evaluate the quality of the
data, which is necessary for the Agency to review to determine whether
such data may be used for any future Agency actions.
If an OECD-harmonized template is not available for a particular
endpoint for which the manufacturer has relevant information, then the
manufacturer must still submit the data. Such information may include,
but is not limited to, raw monitoring data (regardless of having been
aggregated or analyzed) of human or environmental exposure assessments
and toxicity tests for either human health effects or ecological other
environmental effects.
F. What steps is the Agency taking to reduce potentially
``duplicative'' reporting? Does information need to be reported on the
basis that it has already been reported to the Agency?
TSCA section 8(a)(5)(A) requires EPA, to the extent feasible when
carrying out TSCA section 8, to avoid requiring unnecessary or
duplicative reporting. The Agency seeks to avoid collecting data on
PFAS that would duplicate information already reported to the Agency,
while ensuring EPA obtains all data required to be collected under TSCA
section 8(a)(7) and that such data are submitted in a format that is
conducive to the collection and review of a manufactured PFAS dataset.
While developing this rule, EPA reviewed the data elements submitted
under the CDR Rule to evaluate whether there may be some overlap with
the information requested under this rule. Through internal review, and
from input received
[[Page 70525]]
during the public comment periods and the SBAR Panel, the Agency has
identified the following data elements that may have some overlap with
CDR requirements:
<bullet> Physical state of the chemical or mixture;
<bullet> Production volume (domestically manufactured);
<bullet> Production volume (imported);
<bullet> Volume directly exported;
<bullet> Indicator for imported but never physically at site;
<bullet> Industrial processing and use type, sector(s), functional
category(ies), and percent of production volume for each use;
<bullet> Consumer and/or commercial indicator, product
category(ies), functional category(ies), percent of production volume
for each use, indicator for use in products intended for children, and
maximum concentration in the product; and
<bullet> Number of workers reasonably likely to be exposed for each
combination of industrial processing or use operation, sector, and
function, and the number of commercial workers reasonably likely to be
exposed if the PFAS is contained in a commercial product.
However, EPA notes that even though there are some potentially
overlapping data elements between this rule and CDR, any duplication of
reporting requirements is likely to be narrower in scope. For instance,
CDR is limited to chemical substances on the Inventory. In contrast,
the reporting requirements in this rule extend beyond chemicals on the
Inventory and may cover chemicals subject to LVEs, byproducts, and
other chemicals that may not have been reported on or added to the
Inventory. In addition, CDR has a reporting threshold of 25,000 pounds
(or 2,500 pounds for chemicals subject to certain TSCA actions), along
with several reporting exemptions, including for imported articles,
certain byproducts, non-isolated intermediates, and small quantities of
R&D substances, while this reporting rule does not incorporate any such
thresholds or exemptions. Finally, while this rule requests the same
data to be submitted for each year in which a PFAS has been
manufactured since 2011, CDR requires different information to be
submitted in different years: for instance, reporters submit the total
annual domestically manufactured production volume and the total annual
imported volume separately only for the principal reporting year (e.g.,
2019 for the 2020 reporting cycle), but only the combined total annual
production volume is required reporting for the intervening years.
Additionally, the CDR rule has been amended over the course of this
reporting period, meaning certain data elements were not requested or
submitted for all CDR cycles overlapping this rule's lookback period.
Specifically, the CDR industrial processing and use codes and consumer/
commercial processing and use codes did not align with the OECD-
harmonized use codes until the 2020 reporting cycle. While CDR
submitters may have provided certain processing and use information
related to PFAS they manufactured during previous CDR cycles, any CDR
responses that do not sufficiently respond to this data call by
providing the required OECD codes would not be duplicative of the
information being reported under this rule. Therefore, while some data
elements of this rule may be considered duplicative of CDR
requirements, differences between CDR and this rule's requirements
(including reporting thresholds and reporting exemptions) may limit the
scope of what is duplicative and duplicative information does not need
to be re-reported for this rule. If the previous submission for the
same data element under a different reporting rule was not accurate for
purposes of this rule (e.g., by not reporting volumes related to an
activity exemption that does not apply to this rule, or by reporting
industrial processing and use information that does not align with the
OECD-harmonized use codes required under this rule), then the submitter
must report the accurate information and cannot rely on their prior
submission to satisfy this rule's requirements.
Beyond the CDR rule, some commenters and participants in the SBAR
Panel suggested that other information requested under this rule may
have been reported to EPA through a TSCA section 8(d) rule. Under TSCA
section 8(d), EPA has the authority to request unpublished health and
safety data studies, or lists of such studies, known to or reasonably
ascertainable by manufacturers, processors, and distributors of certain
chemical substances or mixtures. Commenters suggested that some
``existing environmental and health effects information'' on PFAS may
have already been submitted to EPA through a TSCA section 8(d) rule and
would be duplicative of information requested under this rule.
While EPA agrees that any previous submissions of unpublished
studies under TSCA section 8(d) need not be resubmitted under this TSCA
section 8(a)(7) rule, EPA does not anticipate that there will be much
overlap between information requested under this rule and information
that may have already been submitted through the reporting requirements
related to the TSCA section 8(d) rule codified in 40 CFR part 716.
First, only a few substances already listed in a section 8(d) rule
would meet this rule's definition of PFAS; out of the many examples of
PFAS, only oxirane, 2-(2,2,3,3,4,4,5,5,6,6,7,7,7-tridecafluoroheptyl)-
(CASRN 38565-52-5), hexane, 1,1,1,2,2,3,3,4,4,5,5,6,6,6-
tetradecafluoro- (CASRN 355-42-0), and 1-butanamine, 1,1,2,2,3,3,4,4,4-
nonafluoro-N,N-bis(1,1,2,2,3,3,4,4,4-nonafluorobutyl)- (CASRN 311-89-7)
are listed as PFAS, which can be found in 40 CFR 716. Secondly, the
substances which are listed in 40 CFR part 716 have sunset dates, or
reporting deadlines. The PFAS that have previously been listed in a
section 8(d) rule have sunset dates between 1988 and 1995; therefore,
potentially duplicative section 8(d) reporting stops decades short of
the scope of reporting for this rule (40 CFR 716) (53 FR 38645,
September 30, 1988 (FRL-3439-9)). Finally, the scope of ``unpublished
health and safety studies'' requested under a TSCA section 8(d) rule
may not be as inclusive as the scope of ``all existing information
concerning the environmental and health effects'' requested for the
substances under this TSCA section 8(a)(7) rule. This rule's scope of
all existing information concerning environmental and health effects is
intended to be broadly interpreted and is inclusive of any health and
safety study, regardless of the date the information was collected or
generated; see the discussion in Unit III.E.
Similarly, ``all existing information concerning the environmental
and health effects'' of a PFAS may include previous submissions to EPA
pursuant to TSCA section 8(e). TSCA section 8(e) requires
manufacturers, processors, and distributors of chemicals to notify EPA
immediately of information that reasonably supports the conclusion that
their substances or mixtures present a substantial risk of injury to
health or the environment. To the extent that a substantial risk
notification under TSCA section 8(e) may be duplicative with this
rule's requirements, the reporter need not resubmit such information,
but will be required to indicate when they had previously provided that
notification under TSCA section 8(e) so that EPA is able to locate that
previous submission and satisfy the requirements of TSCA section
8(a)(7). Manufacturers who have previously submitted information to EPA
under TSCA section 8(d) or TSCA section 8(e) that may be
[[Page 70526]]
considered ``existing information concerning the environmental and
health effects'' of a PFAS for which they are reporting under this TSCA
section 8(a)(7) rule need not resubmit the duplicative information.
However, the manufacturer must indicate in the reporting form the year
in which they had previously provided that information and under which
rule (e.g., TSCA section 8(d), section 8(e)). If EPA has previously
collected information relevant to the implementation of TSCA section
8(a)(7) and is able to locate that information based on the reporter's
submission, then EPA would be able to meet the information collection
obligations under TSCA section 8(a)(7) without requiring potentially
duplicative reporting.
EPA also considered other, non-TSCA reporting rules' potential
overlap with this rule. These include the Toxics Release Inventory
(TRI) and the Greenhouse Gas Reporting Program (GHGRP). Under the TRI,
certain industrial and Federal facilities are required to report their
annual releases and other waste management quantities and activities
for TRI-listed toxic chemicals that are manufactured, processed, or
otherwise used above the respective threshold. Information reported to
TRI that is also requested under this rule includes:
<bullet> Total volume recycled on-site;
<bullet> Description of disposal process(es);
<bullet> Total volume released to land;
<bullet> Total volume released to water;
<bullet> Total volume released to air; and
<bullet> Total volume incinerated on-site.
However, in the same vein as the limitations on potentially
duplicative reporting with CDR and TSCA section 8(d) rules, EPA does
not anticipate much, if any, overlap in reporting between this rule and
TRI. First, PFAS were not on the TRI chemical list until the FY 2020
NDAA automatically added 172 PFAS effective calendar year 2020, with
additional PFAS added annually since 2020 (Ref. 17). Therefore, the
only potentially overlapping reporting of PFAS releases and other waste
management quantities would be since 2020, instead of the entire
lookback period of this rule. Additional limitations in the potential
overlap between this rule and TRI include the PFAS reporting threshold
for TRI of 100 pounds manufactured, processed, or otherwise used and
certain TRI reporting exemptions for quantities below de minimis
concentrations and in articles. Without a reporting threshold or
similar reporting exemptions applicable for this rule, there may be
more PFAS releases and other waste management activities reportable for
this rule than for TRI.
EPA also considered potential overlaps with GHGRP. The GHGRP
requires annual reporting of greenhouse gas (GHG) data and other
information from large GHG emissions sources (i.e., those that emit at
least 25,000 tons of CO<INF>2</INF>-equivalent, any electricity
generation site, aluminum, ammonia or cement production facility, and
some municipal solid waste landfills), fuel and industrial gas
suppliers, and carbon dioxide injection sites (Ref. 18) (40 CFR part
98). 111 compounds covered as GHGs and heat transfer fluids (HTF) would
also be considered PFAS under this rule. Between this rule and the
GHGRP, the following data elements may be duplicative for at least some
GHGRP reporters:
<bullet> Production volume (imported);
<bullet> Volume directly exported; and
<bullet> Total volume incinerated on-site.
Besides the limited number of PFAS covered by GHGRP, other
limitations on the potential overlap between this rule and GHGRP
include the exemption of GHGRP reporting for quantities imported or
exported below 25 kilograms. Additionally, not all coincidentally
manufactured chemicals (such as byproducts) are covered by GHGRP,
though they fall under the definition of ``manufacture for a commercial
purpose'' under this rule (40 CFR 705.3). Overall, there is a
significant difference between the reporting requirements in the GHGRP
and this rule, though EPA is allowing reporters to abstain from re-
reporting any of the information listed previously in this unit for a
PFAS that was previously reported to GHGRP, unless the GHGRP submission
did not account for all quantities that are covered by this rule.
EPA also notes the potential for duplicative reporting of
environmental releases of certain byproducts within this rule. Pursuant
to TSCA section 8(a)(2)(D), EPA is requiring PFAS manufacturers to
provide a ``description of the byproducts resulting from the
manufacture, processing, use, or disposal of each [PFAS].'' However,
EPA notes there may be occasions where a byproduct that resulted from
the manufacture, processing, use, or disposal of a reported PFAS also
meets this rule's definition of PFAS. Because ``manufacture for
commercial purposes'' includes the coincidental manufacture of
byproducts, that byproduct would also need to be reported under this
rule to the extent data are known or reasonably ascertainable. As a
reportable PFAS, information on that byproduct's environmental releases
would be requested twice, both as a byproduct of the originally
manufactured PFAS and as a commercially manufactured PFAS itself. To
mitigate potentially duplicative reporting concerns in such situations,
manufacturers of byproducts that are also reportable PFAS under this
rule need not re-report the environmental release information of that
byproduct on the original PFAS's form.
To address potentially duplicative reporting, EPA is identifying
specific types of information that need not be reported if the
reporting entity indicates in the reporting tool that they have
previously provided such information to EPA and provides information
sufficient to allow the agency to locate that information. Pursuant to
TSCA section 8(a)(5)(A), EPA is limiting the requirement for reporting
``duplicative'' information if a PFAS manufacturer has previously
submitted the requested information to EPA for that same PFAS in that
same year through CDR, TRI, GHGRP, or TSCA sections 8(d) and 8(e), or
is also reporting a PFAS byproduct on its own reporting form. Only the
aforementioned data elements from CDR, TRI, and GHGRP; studies
submitted under TSCA section 8(d) or 8(e); and certain byproduct
release information may be exempt from re-reporting under this rule as
potentially duplicative information. In these cases, the manufacturer
would be required to indicate to which program (and in which year) that
information was submitted (e.g., CDR, in 2016). Additionally, EPA notes
that a manufacturer's previous submission for the same data element
under a different reporting rule (e.g., a manufacturer previously
reported the production volume to CDR for a particular year) does not
necessarily mean that the same quantity or information would be
accurate for this rule's purposes. Because this rule does not provide
for the same exemptions as the rules discussed in Unit III.F., the
manufacturer must ensure that all quantities and other requested
information for that PFAS are reported under this rule to the extent
such information is known or reasonably ascertainable. In the previous
example of a CDR reporter who had previously reported a PFAS's
production volume, the reporter must ensure that all manufactured
quantities covered under this rule (including those that are exempt
from CDR, such as impurities or imported articles) are accounted for.
If a previous submission for a data element does not account for all
covered volumes or activities, then the submitter
[[Page 70527]]
may not rely on that prior submission to satisfy the reporting
requirements of this rule.
EPA considered other previous information collection requests
related to PFAS but did not determine those to be ``duplicative'' such
that reporting may be exempt under TSCA section 8(a)(5)(A). For
instance, EPA received many public comments asserting that information
submitted through a PMN is duplicative of the information that would be
collected through this rule. EPA disagrees. Information collected
through a PMN (or an LVE) reflects information before manufacture of a
substance commences.
EPA notes that the Agency has also required the submission of
information on PFAS using a variety of enforcement authorities under
different environmental statutes. However, most, if not all, of the
information collected in the course of investigating potential non-
compliance with, or liability under, TSCA or other statutes is
different in numerous respects from information requested pursuant to
this rule. EPA does not anticipate there to be duplicative reporting as
the enforcement requests are generally narrower in scope. The
enforcement requests generally focus on fewer years than this rule's
reporting period, and those requests tend to focus on far fewer
substances. Additionally, the requested data for enforcement
authorities is both aggregated and reported in formats differently than
this rule's requirements. While this rule requires data to be reported
for each year over the reporting period in which the PFAS was
manufactured, some enforcement requests have focused on just single
years, or have requested quantities to be reported to reflect
cumulative totals over multiple years. In that latter example, such a
submission would not satisfy EPA's obligations under TSCA section
8(a)(7) requesting certain information ``for each year since January 1,
2011.'' In terms of information reporting formats, EPA notes that
enforcement requests may often ask for responses in a narrative format,
distinct from this rule's requests for information in quantities or
within specific ranges. For these discrepancies, EPA does not believe
that most information requested through previous enforcement request
letters is duplicative of information requested under this rule.
The only information that may have been submitted in response to
past enforcement letters that may be potentially duplicative of this
rule relates to ``all existing information concerning environmental and
health effects.'' Such information includes but is not limited to
environmental monitoring, sampling, or worker exposure data. Thus, if a
manufacturer has previously submitted certain information concerning
environmental or health effects of a PFAS to EPA under an enforcement
authority, that manufacturer does not need to resubmit that
environmental or health effects information to EPA under this rule,
provided that the manufacturer indicates to which program or office and
in which year such information was submitted to EPA.
While the use of those enforcement authorities may be duplicative
in some cases, the information is needed to ensure protection of public
health and the environment in instances where the Agency feels it needs
information from an entity to make that judgment call and determine if
action is needed. Therefore, information duplication between previous
enforcement requests and this rule is unlikely for many reasons,
including various limitations on information gathered under the
enforcement authorities and the fundamental differences in the type of
information sought under this rule as compared with the information
gathered under the other authorities. While information from PFAS
manufacturers requested by EPA is, in all cases, needed to ensure the
protection of public health and the environment, the information
requested under the different authorities serves different purposes.
EPA has determined that the information submitted in response to an
enforcement letter is not duplicative of the information requested
under this rule, except for certain information concerning
environmental and health effects.
Finally, some reporters may also have submitted certain information
concerning environmental or health effects of a PFAS pursuant to either
a TSCA section 4 action or voluntarily, in conjunction with EPA's
National PFAS Testing Strategy. To the extent a reporting entity has
already provided information concerning environmental or health effects
(such as chemical and physical properties, hazard testing, or exposure
testing), that entity need not resubmit the information to this
reporting rule. Instead, the reporter should indicate that they have
already submitted such information to EPA and provide the program, the
specific chemical identity, the date, and an associated case number, if
available, of that submission.
G. What are the requirements for submitting CBI claims?
The 2016 amendments to TSCA included new procedural requirements
for the submission and Agency management of CBI claims, including new
substantiation requirements, generic name requirements, a certification
requirement, and a requirement for Agency review of specified CBI
claims within 90 days after receipt of the claim (15 U.S.C. 2613). In
accordance with the 2016 TSCA amendments, the Agency recently proposed
a rule addressing the procedures for submitting CBI claims to EPA under
TSCA and the procedures for EPA's review of such claims (87 FR 29078,
May 6, 2022 (FRL-8223-01-OCSPP)). PFAS manufacturers reporting under
this rule may claim certain portions of the reporting form are CBI
confidential business information, consistent with TSCA section 14,
such as specific chemical identities that are not on the public
Inventory, company identifier, and production volumes. Only
confidentiality claims made through this rule's PFAS reporting tool
will be considered properly asserted; any additional TSCA CBI claims
made elsewhere will be considered improperly presented and will not be
treated as having asserted a CBI claim under TSCA, and the information
may be disclosed to the public without further notice. In addition to
the requirement that CBI claims be submitted through the PFAS reporting
tool, TSCA requires the reporter to certify that it has: (1) Taken
reasonable measures to protect the confidentiality of the information;
(2) Determined the information is not required to be disclosed or made
public under Federal law; (3) A reasonable basis to believe that
disclosure of the information is likely to cause substantial
competitive harm; and (4) A reasonable basis to believe that the
information is not readily discoverable through reverse engineering;
and, (5) To certify that these statements and any information provided
are true and correct. Consistent with the format of other TSCA
reporting forms, the statements and certification would be combined
into a single certification statement.
Information under this rule that may not be asserted as CBI
includes:
<bullet> Specific chemical identity if the chemical is on the
public (non-confidential) Inventory or reported as non-confidential in
an LVE;
<bullet> All generic chemical names;
<bullet> For any PFAS that are on the public (non-confidential)
Inventory, the chemical's CASRN;
[[Page 70528]]
<bullet> For PFAS that are on the confidential Inventory, the
Inventory Accession Number cannot be claimed as CBI (but the underlying
chemical identity can be claimed as CBI);
<bullet> LVE numbers;
<bullet> The following categories of use information: industrial
processing and use type, sector, and functional categories, whether a
chemical is in a consumer and/or commercial product, the consumer/
commercial product categories and functional categories, and its
presence in products for children; or
<bullet> Any blank or NKRA designation or response.
Any entity that claims a specific chemical identity as CBI must
also submit a generic name pursuant to TSCA section 14(c)(1)(C). This
includes reporting a PFAS by either an Accession number or LVE number
(assuming that the specific chemical identity is not on the public
Inventory), or reporting by a CAS name on a PFAS for which the CASRN,
Accession number, and LVE number are not known to be assigned (i.e.,
the CASRN and specific identifiers have not been created or generated).
Entities must ensure that that any such generic name is consistent with
EPA's Generic Name Guidance (Ref. 19). The generic name must also
``describe the chemical structure of the chemical substance as
specifically as practicable while protecting those features of the
chemical structure that are claimed as confidential; and the disclosure
of which would be likely to cause substantial harm to the competitive
position of the person.'' 15 U.S.C. 2613(c)(1)(C)(ii). Generic names
must be sufficiently detailed to identify the reported chemical as a
PFAS. Specifically, any generic name reported for a PFAS that does not
contain ``fluor'' in the name would be rejected by EPA as insufficient
under TSCA section 14(c)(1)(C). As the Agency described in the NODA
published for this rule (Ref. 1), any generic name for a PFAS
(including previously existing generic names from earlier TSCA section
5 submissions) that does not contain ``fluor'' in the name is
inconsistent with this provision and will be rejected. Ultimately, if a
generic name reported under the TSCA section 8(a)(7) rule lacks the
structural unit ``fluor,'' the Agency will publicly identify the
chemical substance as a PFAS.
TSCA section 14 further requires that substantiation be provided
for each data element claimed as CBI. The substantiation must be
provided at the time of submission. However, TSCA section 14(c)(2)
exempts certain information from the substantiation requirements (e.g.,
specific production volume). Under this rule, CBI claims for specific
production or import volumes of the manufacturer need not be
substantiated. Additionally, the specific chemical identity and
molecular structure need not be substantiated when the substance has
not been introduced into commerce (e.g., an R&D substance manufactured
in small quantities meeting the new chemical reporting exemption under
section 5(h)(3)). No other TSCA section 14(c)(2) exemptions apply to
information requested under this rule, so CBI claims must be
substantiated for all other such information. Any information which is
claimed as CBI will be disclosed by EPA only in accordance with the
procedures and requirements of TSCA section 14 and 40 CFR parts 2 and
703. TSCA limits CBI protections for information in health and safety
studies.
Generally, information from health and safety studies is not
protected from disclosure, except to the extent such studies or
information reveal information ``that discloses processes used in the
manufacturing or processing of a chemical substance or mixture or, in
the case of a mixture, the portion of the mixture comprised by any of
the chemical substances in the mixture,'' 15 U.S.C. 2613(2)(B).
Additional information, listed in the rule's definition of health and
safety study, are not part of a health and safety study (e.g., names of
laboratory personnel). Submitters asserting a CBI claim for information
under Sec. 705.15(f) are required to submit a sanitized copy, removing
only the information that is claimed as CBI.
EPA expects that article importers generally do not know the
Accession number or other specific identifiers (e.g., PMN or LVE
number) for a confidential Inventory chemical that may be included in
the article they are importing. As a result, article importers must
report chemical identities to the extent that they are known to or
reasonably ascertainable (generic name, trade name, or CASRN if it is a
publicly known chemical substance) and use the article importer
streamlined form. Public identifiers like generic names and public
Inventory CASRNs may not be claimed as CBI and it is unnecessary for
article importers to assert CBI claims for the specific identities of
substances that are not reported by a specific identifier (i.e.,
Accession number or LVE number). EPA would not be able to determine an
underlying confidential chemical identity from this generic identifying
information, so could not disclose that specific chemical identity,
regardless of whether the submitter asserted a CBI claim. It would be
purposeless for the submitter to assert a CBI claim for this
information or for EPA to review such claims. In this TSCA section
8(a)(7) rule, and for these reasons, EPA believes that it is
appropriate to differentiate article importers from other reporters
with respect to chemical identity CBI claims.
However, all other entities (i.e., other than article importers)
who report a CAS name, CASRN, or specific identifier (i.e., Accession
number, LVE number) must assert and substantiate a CBI claim for the
specific chemical identity if the reporter wants the chemical identity
to receive confidential treatment. A person or entity (other than an
article importer) who does not have knowledge of such an identifier
(CAS name, CASRN, Accession number, or LVE number) must initiate a
joint submission with its supplier or other entity who can provide this
identifying information, if such an entity is known to or reasonably
ascertainable by the manufacturer. In these cases, the secondary
submitter would be responsible for providing the CAS name, CASRN,
Accession number, or LVE number and for asserting and substantiating
any CBI claims concerning the chemical identity (see e.g., 40 CFR
711.15(b)(3); 711.30(c)). In light of the extended timeframe (11 years)
covered by this reporting rule, it is possible that the submitter's
supplier is unknown or no longer exists (e.g., supplier has gone out of
business without a successor entity). As applied to this reporting rule
only, a submitter who lacks knowledge of the CAS name, CASRN or a
specific identifier (i.e., Accession number or LVE number) and who--
after conducting due diligence and reviewing known or reasonably
ascertainable existing information--cannot identify a supplier or any
other entity who could provide this information in a joint submission,
the submitter would indicate that secondary submitter information is
not known or reasonably ascertainable and therefore does not need to
initiate a joint submission.
Generally, reporting entities will not have an opportunity to add
or modify substantiations once the reporting period concludes.
Therefore, reporting entities should communicate with suppliers, or any
other entities with CBI concerns (e.g., non-disclosure agreements) and
carefully consider the CBI implications of this rule. However,
reporting entities may amend their submission to withdraw CBI claims at
any time during the reporting period.
In response to comments received on CBI claims concerning the
specific chemical identity, following the
[[Page 70529]]
conclusion of the reporting period for this rule, EPA will compile a
list of reported substances it plans to move to the public Inventory
because either no chemical identity CBI claim was asserted, or the
claim was denied. Similar to past compilations, EPA will publish a list
of Accession numbers associated with these substances on the EPA
website for several months in advance of any update to the Inventory.
Interested parties will have an opportunity to review the list for
possible errors and contact EPA with any questions or concerns about
specific candidates. In some cases, there may be assertions by a
company that a mistake has been made (e.g., the wrong chemical identity
was reported by a third party) or that a waiver of a CBI claim was made
by a company that may not know the specific chemical identity, in which
case EPA will undertake appropriate factual investigations as necessary
to confirm whether EPA should reconsider whether the chemical is no
longer entitled to confidential Inventory protection. Where EPA
determines that a chemical identity was identified as a candidate for
disclosure because there was an error or because the sole basis for the
proposed move to the public portion of the Inventory was a waiver of a
CBI claim by an entity that did not know the specific chemical
identity, it will not move the chemical identity to the public portion
of the Inventory. This investigation would take place prior to the
point that the specific chemical identity would be disclosed on the
public Inventory.
H. What are the electronic reporting requirements?
EPA is requiring all information to be submitted electronically,
similar to the requirements established in 2013 for submitting other
information under TSCA (see 40 CFR 704.20(e)). Reporters must use EPA's
Central Data Exchange (CDX), the Agency's electronic reporting portal,
to submit all information under this rule. EPA developed the Chemical
Information Submission System (CISS) for use in submitting data
electronically to the Agency for TSCA sections 4, 5, 6, 8(a), 8(b),
8(d), and 8(e) and Title VI. CISS, a web-based reporting tool housed
within the CDX environment, provides submitters with user-friendly
applications to build and submit data packages to EPA within a secure,
encrypted environment. CISS applications provide for the capture of
both fielded data as well as the attachment of additional information
using a wide variety of file types. Within CDX, CISS is available under
the ``Submission for Chemical Safety and Pesticide Program (CSPP)'' CDX
flow. Users who have previously submitted under TSCA through CDX,
including submitting information under sections 4 and 5, or CDR, will
already have the CSPP flow linked to their account. Users reporting to
EPA using other CDX housed applications, including the Toxics Release
Inventory TRI-MEweb, would be able to add the CSPP flow to their
existing CDX accounts.
EPA is developing a rule-specific reporting tool within CISS, which
reporters must use to submit the required information. This tool will
be available in CISS prior to the start of the reporting period (see
the discussion in Unit III.I on reporting deadlines). EPA believes that
electronic reporting reduces the reporting burden for submitters by
reducing the cost and time required to review, edit, and transmit data
to the Agency. It also allows submitters to share a draft submission
within their organization and more easily save a copy for their records
or future use. Additionally, EPA believes that many of the anticipated
reporters under this rule have experience with reporting electronically
to EPA through CDX. For those reporters who do not have experience
submitting information to EPA via CDX, EPA has provided guidance
documents and support via a help desk to assist users with technical
questions related to CDX. The resource and time requirements to review
and process data by the Agency will also be reduced, and document
storage and retrieval will require fewer resources.
I. What if an entity who knows the specific chemical identity will not
disclose it to the PFAS manufacturer (including importer)?
In response to public comment, EPA is also enabling joint
submissions for PFAS manufacturers (including importers) other than
article importers who do not know the CASRN, Accession Number, and/or
LVE number and whose suppliers will not disclose the identity to the
PFAS reporter. Similar to the 2020 CDR cycle, this joint submission
tool would allow manufacturers (including importers) to submit all
importing, processing, use, and other information to the extent it is
known or reasonably ascertainable and to send a request to the
appropriate supplier or other entity to create a submission to supply
the PFAS identity to EPA through the reporting tool. The joint
submission process does not require the supplier or other entity to
disclose the specific chemical identity to their customer, thus
maintaining confidentiality between the two entities.
The joint submission tool would be relevant when a manufacturer
(including importer) cannot provide the CAS name, CASRN, Accession
number, or LVE number of a chemical substance it manufactures,
generally because it is unknown to the manufacturer (including
importer) and claimed in part or in its entirety as CBI by the supplier
of the chemical substance or mixture.
In a joint submission, the primary submitter (i.e., the PFAS
manufacturer) may assert CBI claims over some of their supplier
information, including the supplier identity and the chemical substance
or mixture trade name (or other designation). Substantiation of the CBI
claims for this information will not be required at the time of the
primary submitter's submission. The secondary submitter of the joint
submission must register with CDX if they have not previously and
provide its company name and location, a technical contact, trade name,
chemical identity, function, and, for PFAS in mixtures, the percentage
of each PFAS in the mixture represented by the trade name. The
secondary submitter is responsible for asserting all confidentiality
claims for the data elements that it submits directly to EPA and for
substantiating those claims not exempt under 40 CFR 705.30(a)(2). The
specific chemical identity may be claimed as CBI by the secondary
submitter following the provisions in 40 CFR 705.30. If the secondary
submitter does not assert and substantiate a CBI claim for the identity
of the chemical substance in its response to the Agency, then the
chemical is not entitled to confidential treatment. Except for the
percentage composition information, which is generally exempt from
substantiation pursuant to TSCA section 14(c)(2)(D), all other reported
data elements are subject to substantiation at the time the information
is submitted.
Similar to the CDR joint submissions, any secondary submitter in
this rule will be able to request the chemical information from their
own suppliers as needed, should the importer's direct supplier not have
the information. There may be instances where a foreign supplier
purchases a mixture, under a trade name, from another company (tertiary
company) and does not know the chemical components of the mixture. The
foreign supplier can ask the tertiary company manufacturing the trade
secret mixture or PFAS within the mixture to directly provide EPA with
the correct chemical identity in the reporting tool. In this case, the
tertiary company would register with CDX and use the Unique Identifier
for Joint Submissions, sent to the tertiary
[[Page 70530]]
company by the secondary company (i.e., the foreign supplier), to
complete the reporting form.
Under this scenario, the foreign supplier does not have access to
any of the information submitted to EPA by the tertiary company.
Likewise, the tertiary company cannot see the information the foreign
supplier or the primary company (i.e., the U.S. manufacturer (including
importer)) reports to EPA. This way, the confidentiality of information
for all parties is protected. EPA believes this functionality addresses
some concerns that have been voiced from stakeholders, including an
importer's direct (or immediate) supplier may not have knowledge of the
PFAS identity. By allowing a foreign supplier (secondary submitter) to
request the required information from their own supplier (a tertiary
submitter) as needed, EPA believes this will capture more information
related to specific PFAS identities that may not be known to the
importer due to confidentiality or trade secret claims, while not
requiring suppliers to share any information they wish to protect from
their customers.
Joint submissions are to be used only in cases when the PFAS
reporter does not know the CAS name, CASRN, Accession number, or LVE
number for the PFAS, but another entity (e.g., a supplier or other
manufacturer) does and will not disclose it to the reporter. If a
reporter (including importer) or joint reporter (secondary or tertiary
submitter) actually knows or can reasonably ascertain the CAS name,
CASRN, Accession number, or LVE number of a PFAS, the reporter
(including importer) must provide that information irrespective of
others' confidentiality claims. If the reporter wishes to claim the
specific chemical identity as confidential, the chemical substance must
not be listed on the public portion of the Inventory, the submitter
must check the CBI box in the reporting tool and provide the
appropriate substantiation. Such a CBI claim only relates to the
specific chemical identity as listed on the confidential portion of the
Inventory (i.e., CAS name and/or CASRN) and does not apply to the
Accession number and generic name listed on the public portion of the
Inventory.
Because article importers are not required to assert or
substantiate CBI claims for the chemical identity for this rule, EPA is
not requiring or enabling joint submissions for article importers when
they do not know the CAS name, CASRN, Accession number, or LVE number
of the PFAS. Additionally, in scenarios where a secondary submitter is
not known or existent (e.g., a supplier has gone out of business and
does not have a successor entity), the primary submitter would indicate
in the reporting tool that the secondary submitter is ``not known or
reasonably ascertainable.'' In this case, however, the PFAS
manufacturer would be required to provide as much identifying detail as
they have regarding the PFAS identity (e.g., trade name), but would be
able to report to EPA without initiating a joint submission.
J. When are reports due?
EPA proposed a six-month information collection period following
the effective date of the final rule, then a six-month reporting
period. Thus, the proposed rule stipulated a reporting deadline one
year following the effective date of the final rule. EPA received many
public comments on the reporting timeframe, which are detailed in Unit
IV.K.
In response to public comment, EPA has decided to finalize a one-
year information collection period following the effective date of this
rule, which will then be followed by a six-month reporting period.
Further, EPA is granting an additional six months for reporting to
small manufacturers (as defined at 40 CFR 704.3) whose reporting
obligations under this rule are exclusively from article import.
``Small manufacturers'' as defined at 40 CFR 704.3 include
manufacturers who meet one of two standards: (1) a manufacturer
(including importer) whose total annual sales, when combined with those
of its parent company, are less than $120 million, and the annual
production volume of a chemical substance is less than 100,000 lbs; or
(2) a manufacturer (including importer) whose total annual sales, when
combined with those of its parent company, are less than $12 million.
EPA acknowledges that the scope of reporting for this rule is broader
than for CDR, and that there may be some reporting entities who have
not submitted information to EPA under a TSCA section 8(a) reporting
rule before (e.g., some small manufacturers). Therefore, EPA agrees
that additional time is warranted for PFAS manufacturers to familiarize
themselves with the scope of the reporting rule and reporting standard,
as well as begin to collect the required information and create a CDX
account if necessary. The extended time period for information
collection also benefits both EPA and the reporting community by
providing the Agency with additional time to develop and test the CDX
reporting application for this rule. Thus, reporting forms will be due
18 months following the effective date of this rule, except for small
article importers (as defined at 40 CFR 704.3), whose reporting forms
are due 24 months following the effective date of this rule.
K. What are the recordkeeping requirements?
EPA is finalizing the proposed recordkeeping requirements. Each
person who is subject to the reporting requirements must retain records
that document any information reported to EPA for five years, beginning
on the last date of the information submission period. The five-year
retention requirement is consistent with the CDR rule and corresponds
with the statute of limitations for violations and is necessary to
preserve records to support future regulatory activities that will be
informed by this information collection. Further, EPA believes the
burden of retaining these records, which are likely electronic, is
minimal.
L. Which proposed requirements are not being finalized as proposed?
EPA is modifying the following items from the proposed rule: the
definition of ``PFAS''; the reporting deadline; some of the data
elements requested; enabling streamlined reporting options for article
importers and manufacturers of R&D substances below 10 kilograms;
enabling joint submissions; and [certain waste management/disposal
facility exemptions].
As noted in Unit III.A.1, this rule defines ``PFAS'' as including
at least one of these three structures:
<bullet> R-(CF<INF>2</INF>)-CF(R')R'', where both the
CF<INF>2</INF> and CF moieties are saturated carbons;
<bullet> R-CF<INF>2</INF>OCF<INF>2</INF>-R', where R and R' can
either be F, O, or saturated carbons; and
<bullet> CF<INF>3</INF>C(CF<INF>3</INF>)R'R'', where R' and R'' can
either be F or saturated carbons.
This definition is an expansion of the proposed definition of
``PFAS'', which was defined as R-(CF<INF>2</INF>)-CF(R')R'', where both
the CF<INF>2</INF> and CF moieties are saturated carbons, and none of
the R groups can be hydrogen. The proposed definition defined PFAS as a
substance that includes the following structure: R-(CF<INF>2</INF>)-
C(F)(R')R'', in which both the CF<INF>2</INF> and CF moieties are
saturated carbons and none of the R groups (R, R' or R'') can be
hydrogen. The proposed definition, which existed previously in EPA's
Office of Pollution Prevention and Toxics (OPPT), was developed to
focus on chemical substances in the Inventory with properties similar
to PFOA, PFOS, and GenX. EPA notes that the proposed definition of
``PFAS'' had previously been used by OPPT, although this definition has
changed
[[Page 70531]]
over time. For instance, the polymer exemption for PMNs provided a
different definition of ``perfluoroalkyl'' in its PFAS exception rule
in 2010 (40 CFR 723.250) (Ref. 20). Over many years of research and
data collection, EPA continues to learn more about these substances and
may consider whether modifications to the definition are appropriate.
See Unit IV.A.1 for a more detailed discussion of EPA's reasons for
modifying this definition for this rule.
EPA is also modifying the reporting deadline from the proposed
rule. As noted in Unit III. J, EPA believes additional time for rule
familiarization and data collection is warranted given the lookback
period of this rule and that there are entities that are potentially
covered by this rule which have not been previously required to respond
to other TSCA section 8 reporting rules, such as CDR. Given public
comments and input during the SBAR Panel, EPA is providing a one-year
period following the effective date of this rule for data collection,
followed by a six-month reporting period during which the reporting
application will be open. EPA is further granting an additional six
months for reporting to small manufacturers (as defined at 40 CFR
704.3) who would report exclusively as article importers for the
purpose of this rule. Thus, reporting forms are due 18 months following
the effective date of this rule, except for small article importers,
which are due 24 months from the effective date of this rule.
EPA is slightly modifying the data elements requested by PFAS
manufacturers. Based on public comments, EPA is not including the
following proposed data elements within this rule: the maximum quantity
on-site at any time, including storage; the maximum first 12 months
production volume, and the maximum yearly production volume in any 3
years. EPA received public comment that it is unlikely that
manufacturers have information related to the storage quantities, and
other comments stated that requesting the maximum production quantities
in either the first 12 months or in any three years may be duplicative
of other production volume data requested. Therefore, EPA is removing
these three items from the scope of the final rule. For more discussion
on the comments received on the scope of data elements, see the
Response to Comments document (Ref. 21).
Pursuant to public comments, EPA is also modifying the request for
the molecular structure of the PFAS in all reports: submitting
molecular structure of the reported PFAS is optional for any Class 1
PFAS on the Inventory. Class 1 chemical substances are those chemical
substances composed of molecules with particular atoms arranged in a
definite, known structure. If a Class 1 substance is also on the
Inventory, EPA knows its particular molecular structure. However, many
commercially-manufactured chemicals are not Class 1 substances (i.e.,
they are Class 2 substances comprised of specific molecular formula
representations in variable structures, or they have unknown or
indefinite molecular formulas and/or incomplete structural diagrams).
Additionally, not all commercially-manufactured substances that are
subject to TSCA may be on the Inventory due to various reporting
exemptions. While EPA has the authority and obligation to request the
molecular structure of any reported PFAS pursuant to TSCA section
8(a)(2)(A), EPA does already know the structure of Class 1 substances
on the Inventory; thus, pursuant to TSCA section 8(a)(5)(A), EPA is
limiting the scope of this reporting requirement in cases where the
information would be duplicative of information EPA has obtained
through TSCA reporting. Therefore, EPA is modifying the proposed rule
by limiting the reporting requirement of molecular structures to those
PFAS that are not Class 1 substances on the Inventory.
Finally, EPA is also modifying the proposed data elements for
worker exposure duration. EPA proposed to request information on worker
exposure for the manufacturing site, each industrial process and use,
and each commercial use. For all three categories, EPA proposed to
request ``maximum duration of exposure for any worker'' in both hours
per day and days per year. However, following the publication of the
proposed rule, EPA understands that the worker exposure duration
information, as proposed, could lead to a manufacturer reporting
unassociated variables; that is, the worker with the maximum duration
of exposure in hours per day is not the same as the worker with the
maximum duration of exposure in days per year. Without additional
clarifying information on which worker(s) the reported durations
reflect, such a request may not yield data useful for EPA's
assessments. EPA is therefore modifying the proposed request for the
worker exposure duration data by clarifying the workers for whom the
maximum exposure durations or frequency must be reported. EPA is
requesting worker exposure duration information (in hours per day and
days per year) both for the worker with the greatest daily exposure
duration (i.e., the worker with the greatest exposure in hours per day)
and for the worker with the greatest annual exposure frequency (i.e.,
the worker exposed during the most days per year).
Additionally, EPA is modifying the scope of data elements requested
for some article importers and manufacturers of R&D substances in
quantities below 10 kilograms annually. Based on feedback through
public comments and the SBAR Panel, EPA understands that some article
importers and some manufacturers of R&D substances may not know or be
able to ascertain all information being requested. Therefore, EPA is
offering two streamlined reporting options for those manufacturers.
(For more information on these reporting options, see additional
discussions in Units III.D.2 and III.D.3.)
EPA is also modifying the proposed rule by enabling joint
submissions. In the proposed rule, EPA did not propose joint
submissions, but did specifically request comment on whether to enable
them for this rule in cases where a supplier may not disclose the
chemical identity to an importer who is covered by this reporting rule.
Following public comments, EPA is finalizing this rule to include joint
submissions for situations in which an importer does not know the CASRN
or specific identifier (i.e., Accession number or LVE number) (see Unit
III.I.). EPA further discussed requiring submitters who lack knowledge
of a chemical's specific chemical identity to initiate a joint
submission in the NODA.
Finally, EPA is modifying the scope of reportable activities under
this rule to clarify that importing municipal solid waste streams for
the purpose of disposal or destruction is not a reportable activity
under this rule. As explained in Unit III.B.3., EPA learned through
public comments and the SBAR Panel that entities engaged in certain
municipal solid waste management activities are in the unique position
of not having any knowledge of the contents of the municipal solid
waste they have imported. Therefore, extending reporting requirements
to such sites would not result in any responsive information under TSCA
section 8(a)(7), and EPA does not consider the import of municipal
solid waste for the purpose of disposal or destruction to be a
reportable activity.
IV. Summary of Comments and Other Public Input and EPA's Response
EPA received 109 unique public comments during the proposed rule's
public comment period. Following
[[Page 70532]]
publication of the proposed rule, EPA received more data related to the
proposed rule's burden and cost estimates. At the time of the proposed
rule's publication, EPA did not have sufficient and reliable data to
inform an estimate of the scope of article importers that may be
affected by the proposed rule's requirements. However, after receiving
comments through the docket related to the scope of article importers
(including estimates provided by companies and industry trade
associations), and through the discovery of additional information and
data sources related to the scope of potentially affected article
importers, EPA determined the proposed rule could no longer support a
certification under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601
et seq., that there would be no significant economic impact on a
substantial number of small entities. Specifically, the number of small
businesses who may be considered importers of PFAS-containing articles
and therefore potentially affected by the proposed rule was estimated
to be approximately 130,000. Thus, EPA convened an SBAR Panel under the
RFA to hear directly from small entities on the anticipated impact of
the proposed rule on their organizations, and to hear feedback
regarding recommended paths forward to finalize a rulemaking that would
minimize the burden of compliance on small entities while still
achieving the objectives of TSCA section 8(a)(7). This Panel convened
in April 2022, with a Panel Outreach meeting conducted on April 20,
2022. The Panel (which included EPA, Office of Management and Budget
(OMB), and Small Business Administration (SBA) representatives) used
feedback from the small entity representatives submitted during and
after the Outreach meeting to develop its Panel Report (Ref. 22), which
included recommendations for EPA to consider in its final rule.
Along with public comments on the overall cost estimates of the
2021 proposed rule, EPA received many public comments both in support
of and against EPA's position to not exempt entities or activities that
are often exempt under CDR, including small manufacturers and article
importers, and the use of a structural definition for PFAS rather than
a discrete list of substances.
Following this Panel, EPA published a NODA (Ref. 1) to solicit
public comment on the rule's IRFA and other aspects of the proposed
rule that may have been impacted by EPA actions or proposed actions
since the public comment period had closed for the proposed rule in
September 2021. EPA also published the SBAR Panel Report (Ref. 22) for
public comment. The notice was published on November 25, 2022 (Ref.1),
for a 33-day public comment period ending on December 27, 2022. EPA
received 44 unique public comments during the public comment period
following the publication of the NODA (Ref. 1). Comments largely
focused on different regulatory alternatives presented in the Panel
Report (including certain exemptions, or using a discrete list of
covered PFAS) and on EPA's discussion of its approach to CBI claims of
the chemical identity.
EPA considered all comments and other stakeholder input, including
from the SBAR Panel, in the development of this final rule. This unit
discusses many of the comments on the proposed rule received through
both avenues and the Agency's responses; however, the more
comprehensive response to comments related to this rule can be found in
the Response to Comments document, which is available in the docket for
this rulemaking (Ref. 21).
A. What is the proposed definition of covered substances?
1. Summary of Public Input
Many commenters provided feedback on the specific definition of
PFAS in the proposed rule. These commenters either were unsupportive of
EPA's definition and requested that the Agency narrow the proposed
definition of PFAS or requested that EPA broaden their definition of
PFAS, while generally supporting EPA's proposed structural definition.
Commenters who were generally unsupportive of EPA's proposed
definition of PFAS noted that ``the proposed rule contains a definition
of `PFAS' not recognized by any other federal agency or international
organization, and which EPA itself does not use consistently.'' One
commenter mentioned that treating PFAS as a single group or class of
chemicals is ``not scientifically sound or appropriate'' due to it
being ``over- and under-inclusive.'' Another commenter stated that
EPA's proposed definition of PFAS is overly expansive ``because it
includes molecules that are not obviously PFAS'' such as ``highly
fluorinated molecules that are not PFAS by any common understanding of
PFAS.'' This commenter suggested that the definition of PFAS in the
final rule ``hew much more closely to the types of PFAS molecules that
motivated Section 7351 of the NDAA 2020.'' Commenters who suggested
that EPA's proposed PFAS definition is overly broad, also suggested
that an overly broad PFAS definition will ``almost certainly'' result
in unnecessary reporting of ``PFAS molecules' that are ``likely
unrelated to the underlying problems.''
Some commenters suggested that EPA use the OECD definition of PFAS,
with a few commenters recommending that EPA define PFAS ``at least as
broadly as the recent OECD definition.'' Supporters of adopting the
OECD definition claimed that the OECD definition incorporates sound
science based on input from the ``world's leading developed countries,
including scientists from EPA'' and mentioned that it might make
reporting compliance easier for PFAS manufacturers who have a global
presence. Another commenter who supported use of the OECD definition
mentioned that EPA's proposed definition excludes ``many PFAS of known
concern, undercutting the benefits of the Agency's actions.''
A few commenters who claimed that EPA's proposed PFAS definition is
overly narrow, mentioned that other regulatory agencies in some states
have taken a ``class-based approach'' to PFAS by regulating them as a
chemical class. Commenters specifically cited Vermont, Massachusetts,
and California as examples of States that are regulating PFAS in this
way, ``given that all PFAS, or their degradation, reaction, or
metabolism products, display commonly hazardous traits.'' Some
commenters pointed to additional States (Colorado, Maine, Washington)
that have adopted or are considering adopting a broader definition of
PFAS similar to the OECD definition.
2. EPA's Response
EPA appreciates that there are differences between the definition
of PFAS used for this rule, for other actions in the Agency, and by
non-EPA entities. While EPA's rule is not dictated by the definitions
used by other regulatory bodies or international organizations, the
Agency did consider adopting the different definitions suggested by the
commenters, but ultimately determined those definitions would not
satisfy EPA's obligations under TSCA section 8(a)(7). In the
development of this proposed definition, EPA intended to include
substances with a strong electron withdrawing nature as this greatly
effects the chemistry of the substituted, adjacent and nearby atoms,
meaning they would have a minimum of two fluorine atoms on at least one
carbon (e.g., -CF<INF>2</INF>-). Additionally, EPA wanted the covered
substances to be unlikely to degrade or metabolize, so an adjacent CF
group was added to the requirement/
[[Page 70533]]
definition, with the stipulations that the substitutions could not be H
and both carbons must be saturated (e.g., -CF<INF>2</INF>-CFR-). EPA
also thought that branching might make a chemical less susceptible to
degradation and metabolism, so EPA also removed the option for -
CF<INF>2</INF>-CF<INF>2</INF>- when developing the proposed definition.
After reviewing public comments, EPA is modifying the proposed
definition of PFAS. For the purposes of this section 8(a)(7) reporting
rule, EPA is defining ``PFAS'' using a structural definition. PFAS is
defined as including at least one of these three structures:
<bullet> R-(CF<INF>2</INF>)-CF(R')R'', where both the
CF<INF>2</INF> and CF moieties are saturated carbons;
<bullet> R-CF<INF>2</INF>OCF<INF>2</INF>-R', where R and R' can
either be F, O, or saturated carbons; and
<bullet> CF<INF>3</INF>C(CF<INF>3</INF>)R'R'', where R' and R'' can
either be F or saturated carbons.
For the purposes of this rule, EPA has defined PFAS to include
chemical substances whose structures or sub-structures resemble, at
least in part, chemicals widely known to be of concern to human health
and/or the environment, i.e., PFOA, PFOS, and GenX. The definition also
captures substances that may metabolize or degrade to PFAS which may
present similar properties to PFOA, PFOS, or GenX. This definition is
focused on substances likely to be present in the environment, thereby
focusing on substances with greater potential for exposures to people
and/or the environment and by extension more potential to present
risks.
EPA considered adopting OECD's definition for the purpose of this
rule, but for the reasons provided in this unit, determined it is not
appropriate to do so. First, EPA notes that ``alkyl'' means an alkane
missing one hydrogen, and acyclic alkyl has the general formula of
C<INF>n</INF>H<INF>2(n+1)</INF>, while a cycloalkyl has the general
formula C<INF>n</INF>H<INF>2(n-1)</INF>. Rather than limiting the
definition of PFAS to alkyl chains, the OECD definition covers, with
certain exceptions, any chemical with one or more fluorinated alkyl
groups (i.e., -CF<INF>2</INF>-, -CF<INF>3</INF>). Many chemical
substances covered by the OECD definition are unlike the structures of
the PFAS of concern (i.e., PFOA, PFOS, GenX), which have more
fluorinated carbons and are more likely to be present in the
environment. The substances with only single fluorinated alkyl groups
and no additional fluorinated moieties do not share the same
environmental and/or human health impacts (including bioaccumulation,
persistence, or toxicity) as substances such as PFOA, PFOS, or GenX.
Further, many substances with one terminal -CF<INF>3</INF> (e.g.,
trifluoroacetic acid (TFA)) are well-studied. Using structures in the
CompTox Chemicals Dashboard, EPA estimates that approximately 23,000
additional substances would be captured by the OECD definition, though
approximately 17,000 of those would be covered only due to having one
terminal -CF<INF>3</INF> and no additional fluorine. Thus, adopting the
OECD definition of PFAS in this rule would mainly serve to
significantly add reporting burden on many substances whose only
fluorine atom is in a terminal -CF<INF>3</INF> and that do not share a
fluorinated substructure that is likely to result in their persistence
in the environment, nor to degrade to a substance that shares
toxicological or physiochemical properties with PFOA, PFOS, or GenX.
Therefore, EPA is using its authority under TSCA section 8(a)(5)(A) to
focus reporting on structures that contain at least one fluorinated
alkyl chain rather than isolated fluorinated alkyl groups. Information
on structures that would meet the OECD definition due to an isolated
fluorinated alkyl group is considered ``unnecessary'' for the purpose
of this rule and is out of scope of reporting requirements under EPA's
authority under TSCA section 8(a)(5)(A).
Further, OECD's general definition is ``based on molecular
structure alone'' (Ref. 8). In its 2021 terminology document, OECD
notes that the current definition ``serves as a starting and reference
point to guide individual users to have a comprehensive understanding
of the PFAS universe and to keep the big picture of the PFAS universe
in mind. At the same time, individual users may define their own
working scope of PFASs for specific activities according to their
specific needs by combining the general definition of PFASs with
additional considerations (e.g., specific properties, use areas)''
(Ref. 8). Accordingly, EPA determined it is appropriate to define
``PFAS'' differently for this rule and to establish a definition which
characterizes PFAS based on pre-defined traits. Substances which meet
the OECD's definition of PFAS but that would not be considered PFAS
under this rule do not share properties with substances of concern to
EPA (i.e., PFOA, PFOS, and GenX). As noted previously, EPA is defining
PFAS for this rule to focus on reporting that is necessary under TSCA
section 8(a)(7), while reducing unnecessary or duplicative reporting
pursuant to EPA's obligations under TSCA section 8(a)(5)(A).
Additionally, while the OECD definition of PFAS is broader than
other entities' definitions of PFAS, EPA is aware of some TSCA chemical
substances which would meet this rule's definition of PFAS but not
OECD's. In comparing the universe of PFAS that would be subject to
EPA's proposed definition and those substances captured by OECD's
definition, EPA determined that some substances with halogens (e.g.,
iodine, chlorine, bromine) on the same carbon as the CF or
CF<INF>2</INF> moiety would be in scope of EPA's proposed definition
but not OECD's. Examples of substances which are considered PFAS under
this rule's definition but not OECD's definition include 1-chloro-
1,1,2,2-tetrafluoroethane (CASRN 354-25-6) or 1,2-dichloro-1,1,2,2-
tetrafluoroethane (CASRN 76-14-2). Because all substances which were
captured by the proposed definition are still captured in this final
rule, EPA points out that adopting the OECD definition would still have
excluded some substances that are captured by this rule's definition.
Many commenters also suggested that trifluoroacetyl fluoride (TFA;
CASRN 354-34-7) should be included within the scope of this rule. Under
this rule's definition of PFAS, TFA is not within scope. EPA believes
TFA does not meet the threshold for reporting under TSCA section
8(a)(7), as it is a short-chain molecule (C<INF>2</INF>) with only one
terminal -CF<INF>3</INF>, and no other fluorine atom, unlike substances
such as PFOA, PFOS, and GenX. TFA is naturally occurring in some
instances or is produced as an environmental degradant of many other
substances, especially those with only one terminal carbon (-
CF<INF>3</INF>) (Refs. 23, 24, and 25). EPA understands that the
manufacture of TFA would not always be considered ``manufactured for
commercial purposes'' under TSCA, such as its production as an
environmental degradant or its presence as a naturally-occurring
substance, and therefore EPA would not receive any TSCA section 8(a)(7)
reporting on those quantities. Additionally, as EPA has noted in
responding to a request for testing on PFAS, TFA is ``a well-studied
substance'' with ``relatively robust toxicity information available''
(Ref. 25). Therefore, EPA believes that reporting on TFA under a TSCA
section 8(a) rule (i.e., one in which the scope is limited to those
substances manufactured for commercial purposes and does not include
environmental degradants) is not warranted as such requirements would
be ``unnecessary'' and
[[Page 70534]]
``duplicative'' under TSCA section 8(a)(5)(A).
EPA also disagrees with commenters who expressed that the scope of
substances reportable under this rule should be a discrete list and not
a structural definition. EPA points out that other TSCA requirements
have relied on a structural definition when appropriate (e.g., the
LCPFAC SNUR defines covered substances using a structural definition
(40 CFR 721.10536) (Ref. 7), and the polymer exemption rule for new
chemical pre-manufacture notices (PMNs) defines covered PFAS polymers
using structural definitions (40 CFR 723.250). As some commenters
pointed out, reporting exemptions for both existing chemicals (e.g.,
certain byproduct exemptions in the CDR rule) and new chemicals (e.g.,
byproducts and impurities not listed on the Inventory) mean that EPA
may be unaware of some substances which meet this definition of PFAS,
and which would also meet the TSCA definition of ``chemical
substance.'' Therefore, EPA has chosen to define the scope of covered
substances for the purpose of this rule using a structural definition
and not inadvertently limit the scope of reporting to a discrete list.
B. What is the inclusion for articles?
1. Summary of Public Input
Several commenters provided feedback on the inclusion of articles
(whether imported or domestically produced) in the proposed reporting
requirements.
Commenters who expressed support for the inclusion of articles in
the proposed reporting requirements provided the following rationales:
<bullet> It is necessary that EPA include articles in the scope of
reporting requirements to better understand where PFAS are used in
products and the extent of human exposure. Additionally, EPA has
recognized that PFAS in articles can be released during use and
disposal, and therefore it is necessary for EPA to gather this
information.
<bullet> Information on PFAS-containing articles is critical to
states that are beginning to regulate PFAS-containing items.
<bullet> Even if there are data gaps related to the presence of
PFAS in articles, EPA would benefit from knowing the existence of these
gaps, and therefore, EPA should move forward with requiring reporting
on articles.
<bullet> Congress has authorized inclusion of articles in the
reporting requirements; reporting of ``known or reasonably
ascertainable information'' is not an excessive burden. Commenters
argued that excluding articles from the scope of the final rule would
be inconsistent with Congressional intent.
<bullet> The definition of ``chemical substance'' under TSCA is not
incompatible with the inclusion of articles. Further, in other sections
of TSCA, Congress specified distinct requirements for chemical
substances depending on their presence in articles, though it did not
do so in TSCA section 8(a)(7).
Commenters who suggested that EPA exempt articles from the proposed
reporting requirements provided the following rationales:
<bullet> The proposed requirements are at odds with regulatory
practices; historically, EPA has not included articles in reporting
requirements. Additionally, CDR does not include reporting on imported
articles, and some commenters stated that EPA should be consistent with
those requirements. Some commenters suggested that the reasons EPA has
provided in the past for certain CDR exemptions, including imported
articles, are relevant here (i.e., the potential for exposure to
chemicals contained in articles is ``limited'') and encouraged EPA to
incorporate an imported article exemption under this rule. Several of
these comments also mentioned previous EPA actions, such as the TSCA
Fees Rule and the phenol, isopropylated phosphate (3:1) (PIP (3:1))
rule, in which EPA initially aimed to include articles but eventually
changed course due to ``workability'' issues of including articles
(Refs. 26 and 27).
<bullet> EPA did not provide sufficient justification in the
proposed rule for requiring article reporting, and there is no mandate
in the FY 2020 NDAA for inclusion of articles. Commenters claimed that
EPA underestimated or failed to account for the burden this reporting
will have on article importers, and EPA is unable to accurately
estimate how many importers this proposed rule would affect.
<bullet> Under TSCA, the definition of ``chemical substance'' has
not been interpreted to include articles which contain the chemical
substance. Commenters argue that TSCA section 8 implementing
regulations also distinguish ``articles'' from ``chemical substances.''
<bullet> Requiring reporting on articles would place undue burden
on industry and for manufacturers or importers to obtain the
information EPA seeks is very difficult given the absence of historical
PFAS reporting requirements. Commenters claimed that there will be
significant data gaps if EPA requires article information, and that EPA
will not be able to obtain the information it seeks. Additionally,
reporting on articles going back ten years is impractical.
<bullet> EPA has acknowledged that article manufacturers and
importers likely will not have the information EPA seeks, and
therefore, manufacturers and importers should be exempt. These
commenters also cite their foreign suppliers' confidentiality or trade
secret claims over their products and indicate that it is unlikely
their suppliers will divulge the information necessary to comply with
this rule.
<bullet> Supply chains are too broad and requiring articles
reporting will result in duplicative information, especially for more
complex articles or finished products.
Neutral comments suggested that if EPA is going to require
reporting on articles, they should require reporting for domestic
article manufacturers only and not article importers, and that even
beyond this rule, EPA should fully consider the complexities associated
with collecting data on articles under TSCA. One commenter stated that
EPA should consider focusing its reporting requirements on articles
with the greatest potential for human exposure. The commenter offered
as an example the differences between articles containing PFAS on its
surface due to the properties that PFAS would impart on the product
(such as carpets or cookware) and articles containing PFAS within
resins of multi-component parts. The commenter suggested that EPA
exclude articles containing PFAS unless the PFAS was intentionally
added to the article due to properties imparted on the article.
2. EPA's Response
EPA appreciates the broad interest in the general topic of
requiring reporting on PFAS within articles (either imported articles
or articles that are domestically produced). This topic was also
discussed at length during the SBAR Panel, and EPA considered all
public input on the proposed inclusion of PFAS-containing articles in
this rule. EPA is finalizing the requirement to include PFAS-containing
articles within the scope of this rule, to the extent that the
manufacturer (including importer) of PFAS within articles knows or can
reasonably ascertain the requested information. EPA disagrees with
commenters who stated that the Agency does not have the authority to
collect information on PFAS-containing articles given the language in
the FY 2020 NDAA. While the FY 2020 NDAA did not explicitly direct EPA
to collect data
[[Page 70535]]
on articles containing PFAS, the FY 2020 NDAA also did not explicitly
prevent EPA from collecting information on PFAS-containing articles.
Further, EPA notes that it is within the Agency's authority to collect
information on chemical substances which are manufactured or imported
through articles. Thus, the FY 2020 NDAA's direction to EPA to require
data from PFAS manufacturers necessarily includes those PFAS
manufactured (including imported) within articles. Although EPA has not
typically included articles in some other TSCA section 8 reporting
rules, the Agency both has the authority and has previously done so.
Other TSCA rules, including other TSCA section 8 reporting rules (such
as the Preliminary Assessment Information Reporting rule under TSCA
section 8(a) (40 CFR part 712) and the TSCA section 8(d) Health and
Safety Data Reporting rule (40 CFR part 716) include reporting on
articles as needed for EPA to fulfill its responsibilities under TSCA.
Additionally, EPA points out that the TSCA Fees and PIP 3:1 rules
(Refs. 26 and 27) are authorized under separate sections of TSCA. This
PFAS reporting rule was proposed and required under TSCA section 8(a),
which authorizes EPA to require reporting and recordkeeping
requirements of manufacturers and/or processors, to the extent such
information is known to or reasonably ascertainable by the reporter.
The requirements and compliance standards of the PIP 3:1 (use in
article prohibition) (Ref. 27) and Fees (self-identification of
manufacture) rules were different (Ref. 26).
EPA disagrees with the commenters that under TSCA, the definition
of `chemical substance' ``cannot be and has never been interpreted to
include articles that contain the regulated chemical substance.'' TSCA
section 3(2) does not define ``chemical substance'' to exclude
articles. Generally speaking, articles are manufactured goods or
finished products--and the chemicals in them are subject to TSCA. The
law is clear that when a chemical substance is manufactured (including
imported into the United States) or is distributed or processed in the
United States--whether in bulk form or in an article--it can be subject
to regulation under TSCA. As such, EPA can and has imposed regulatory
requirements on chemical substances in articles under TSCA. Further, no
TSCA section 8 regulations exclude articles from the definition of
``chemical substances.'' While implementing regulations for other TSCA
section 8 rules may exempt reporting for activities related to a
covered chemical substance in an article (e.g., general reporting and
recordkeeping provisions for TSCA section 8(a) information-gathering
rules (40 CFR part 704) or the Chemical Data Reporting rule (40 CFR
part 711)), there is no definitional distinction for a chemical
substance depending on whether it is incorporated into an article;
nothing says that an ``article'' is exclusive or distinct from a
``chemical substance.'' While the CDR rule has exempted the import of
articles from reporting, the domestic manufacture of a chemical
substance within an article is still subject to CDR. Further, EPA
points out that the introductory paragraph of 40 CFR 704.5 for
exemptions states this section is superseded by any TSCA section 8(a)
rule that adds to, removes, or revises the exemptions described in this
section. Thus, the commenters' reliance on precedent under 40 CFR part
704 fails to acknowledge that EPA has long allowed for different
exemptions (or lack thereof) to apply under different TSCA section 8(a)
rules as appropriate.
EPA also disagrees with commenters' statements that reporting on
articles would place undue burden on industry. EPA points out that the
reporting standard of TSCA section 8(a) rules is limited to information
which is known to or reasonably ascertainable by the manufacturer.
Thus, if requested information is beyond that scope of known or
reasonably ascertainable, the reporting entity would not be required to
submit anything beyond indicating that such information is not known or
reasonably ascertainable to them. In other words, this reporting
standard is not a testing requirement; rather it asks reporters to
share with EPA the information they already have (or can reasonably
determine) on their manufactured and imported PFAS.
Regarding comments on the lookback period for article importers,
EPA points out that the lookback period proposed is consistent with
Congress's direction to EPA in TSCA section 8(a)(7). EPA is not
changing the proposed requirement to provide any known or reasonably
ascertainable information for the period beginning in 2011.
Regarding comments stating that requiring reporting on articles may
result in duplicative information for complex articles or products that
are re-imported, EPA disagrees that the information reported will
result in duplicative information, especially given the reporting
standard applicable to this rule. EPA acknowledges that some supply
chains of manufacturers reporting under this rule are complex. However,
EPA believes that information known to or reasonably ascertainable by
an article manufacturer at the first instance the PFAS is imported into
the United States is likely different than the scope of information
known to an article importer farther down the supply chain who may re-
import that PFAS later, as the article is incorporated into more
complex articles or products. For instance, the person who imports a
PFAS within an article in the first instance may have different worker
exposure information to report than a person who may later re-import
that PFAS-containing article as part of a more complex product. In
another example, information related to the known industrial or
consumer uses of a PFAS within an article may be clearer to the person
who re-imports a PFAS within a larger complex product than it is to the
person who first manufactured the PFAS within the article. Thus, EPA
does not believe that the information requested of PFAS article
manufacturers would be duplicative, given the different steps of a
supply chain and manufacturing processes, and is requiring all PFAS-
containing article manufacturers to report the requested data to EPA to
the extent it is known or reasonably ascertainable. EPA also believes
that applying the reporting requirements each time a PFAS is imported
into the United States is consistent with TSCA's definition of
manufacturing under TSCA section 3(9) (which means ``to import into the
customs territory of the United States (as defined in general note 2 of
the Harmonized Tariff Schedules of the United States), produce, or
manufacture'') and the directive under TSCA section 8(a)(7). EPA also
believes that if a PFAS is imported, exported, then re-imported,
limiting the scope of reporting to just one instance of importation
into the United States may result in certain burden on manufacturers
within the supply chain who need to further communicate with each other
to determine whether a PFAS within an article has already been reported
and who is responsible for reporting. Further, with respect to comments
claiming that the inclusion of articles will necessarily result in
significant data gaps, EPA respectfully points out that there is no
current database with comparable information on PFAS in commerce,
including within articles, over the reporting timeframe. EPA cannot
make an assessment of potential PFAS data gaps without considering all
reasonably available information. Additionally, as noted by other
commenters, EPA would benefit
[[Page 70536]]
from better characterizing any data gaps after receipt of all
reasonably known information.
EPA disagrees with commenters' suggestions to limit the scope of
reporting on PFAS in articles by extending reporting requirements to
only those articles ``with the greatest exposure potential.'' For the
purpose of a TSCA section 8 information reporting rule, there is no
requirement for EPA to determine which substances or types of articles
may pose greater exposure potential, unlike some other sections of TSCA
(e.g., TSCA section 6 Significant New Use Rules). This TSCA section
8(a)(7) rule in particular aims to provide EPA with a greater
understanding of the scope of existing information of PFAS within the
supply chain and the quantities and uses of commercially manufactured
PFAS, which may include PFAS manufactured or imported within a variety
of articles or products.
Finally, EPA took appropriate and necessary steps to consult with
the public and consider stakeholder input on the proposed rule,
including reporting on PFAS-containing articles. These steps included
convening an SBAR Panel and meeting with stakeholders to discuss the
proposed rule and potential reporting obligations. EPA has considered
all input for this rule, including the complexity of different supply
chains with respect to collecting data on articles. While EPA was not
able to estimate the burden on article importers given the data
limitations at the time of the proposed rule's publication, the Agency
has since been able to provide such estimates, including input from
public commenters, peer-reviewed journals, other government datasets,
and input from the SBAR Panel. EPA has now remedied this omission in
the Economic Analysis.
C. What are the exclusion of processors from rule?
1. Summary of Public Input
EPA received comments both in support of and in opposition to the
addition of processors to the proposed rule. Ten commenters stated that
EPA should expand the rule beyond manufacturers (including importers)
to cover all facilities processing PFAS. Two of these commenters
expressed that processors are often in the best position to provide the
information required under TSCA section 8(a). Several commenters
emphasized the importance of collecting information on the full life
cycle of PFAS, including from processing operations. Some commenters
were concerned with a potential data gap of PFAS exposures if
processors are omitted from the final rule. Another commenter
highlighted the importance of tracking the PFAS solid waste stream to
enhance understanding of health risks associated with PFAS and to
inform other actions under environmental regulations such as the Safe
Drinking Water Act (SDWA) and Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA). Many commenters in support of
adding processors also stated that EPA has the authority to require
reporting from processors, citing both the FY 2020 NDAA and TSCA
section 8(a)(1).
Four commenters indicated that the Congress did not intend for the
proposed rule to include processors and that EPA should not require
them to report. Two of these commenters referred to the FY 2020 NDAA
section 7351 language stating that the Act does not identify
manufacturers that process PFAS substances as entities that would be
subject to the rule. Commenters in opposition to adding processors also
claimed that EPA would be creating confusion and the potential for
duplicative reporting. One commenter urged EPA to clarify in the final
rule that reporting is limited to only the initial importers of PFAS-
containing products and not any downstream processors or users.
Commenters also said that such reporting would create unnecessary
burden for both EPA and processors.
2. EPA's Response
EPA appreciates commenters' perspectives on extending reporting
requirements to processors for this rule under TSCA section 8(a)(7).
However, the Agency's reading of the text in TSCA section 8(a)(7) and
the FY 2020 NDAA's legislative history conclude that the intended scope
of this rule is to only require reporting from manufacturers (including
importers), distinct from processors. EPA is clarifying that entities
who solely process, distribute, and/or use PFAS, and do not manufacture
(including import) PFAS for a commercial purpose, are not required to
report under this rule.
As some commenters noted, the Agency would have the authority to
promulgate such a rule for processors under TSCA section 8(a)(1).
However, this rule is being promulgated under TSCA section 8(a)(7). EPA
also notes that the exclusion of processors from the scope of this rule
does not preclude any potential future rulemaking under TSCA section
8(a)(1), should the Agency determine such data are needed. EPA will
review the data submitted by manufacturers under this rule and reserves
the right to promulgate a rule under TSCA section 8(a)(1) to capture
information from PFAS processors if appropriate. EPA disagrees with
commenters who noted that including processors in the scope of this
rule would lead to confusion and duplicative reporting. EPA points out
that other TSCA section 8(a) rules have included processors, such as
the nanoscale materials reporting rule (40 CFR 740.20).
D. What were the small business considerations?
1. Summary of Public Input
Many commenters opined on the inclusion of small businesses,
including small manufacturers, under the proposed rule. Several
commenters stated that EPA should exempt small businesses from
reporting under the proposed rule. Some of these commenters said that
small businesses are not likely to provide useful information and will
be disproportionately affected by the rule (including potentially being
forced out of business) because fewer resources are available to them.
Others expressed that they thought EPA had not evaluated whether small
businesses would actually contribute meaningful data to EPA as a result
of the rule.
Four commenters disagreed with EPA's position that the FY 2020 NDAA
authorizes data collection from all manufacturers, including small
manufacturers. Two of these commenters felt that, by not providing
relief for small manufacturers, EPA did not appropriately apply TSCA
section 8(a)(5) requirements. Some commenters referred to TSCA section
8(a)(1), which they state excludes small manufacturers from reporting
rules. Another commenter stated that EPA needs to consider the
historical lack of TSCA section 8 reporting requirements on small
manufacturers or article importers, including from CDR.
Other commenters said that EPA should collect the information
required under the proposed rule from all businesses regardless of
size. While one commenter acknowledged that the rule could be
burdensome for small entities, they also said that the health risks
associated with PFAS are significant and warrant the data collection
from small businesses. Another commenter described EPA's definition of
small manufacturer under TSCA section 8 as ``expansive'' and noted that
the existing ``small manufacturer'' definition would
[[Page 70537]]
result in omitting reporting from significant PFAS manufacturing and
importing activities such that it would undermine this data collection
effort.
One commenter stated that EPA could help small businesses comply
with the proposed rule in lieu of a small manufacturer exemption by
extending other reporting exemptions to them, including R&D substances,
non-isolated intermediates, impurities, byproducts, and articles, as
well as a minimum reporting threshold.
2. EPA's Response
EPA disagrees with commenters' positions that a broad small
business or a small manufacturer exemption is appropriate for this
rule. EPA appreciates that small businesses, especially those which
have not previously reported under CDR or other TSCA section 8(a)
rules, may not have the same resources that are available to large
companies. This feedback was also voiced through the rule's SBAR Panel,
and EPA is greatly appreciative of the input related to small
businesses' resources and ability to respond to the rule. To that end,
EPA has modified the proposed rule to include options that provide some
relief to all manufacturers, including small entities. Specifically,
article importers and manufacturers of R&D substances in quantities
below 10 kilograms per year will have the option to submit more
streamlined reporting forms than the longer, standard form for all
other PFAS manufacturers. Additionally, EPA is extending the deadline
for reporting forms by at least six months from what was proposed, so
that all entities, including small entities, have 18 months from the
effective date of this rule to submit the requested information. For
small manufacturers (as defined at 40 CFR 704.3) whose reporting
obligations under this rule are exclusively from article imports, EPA
is further extending the deadline for reporting forms by an additional
six months. Thus, small article importers have 24 months from the
effective date of this rule to submit the requested information.
In response to commenters who refer to TSCA section 8(a)(1) in
their support of an exemption for small manufacturers, EPA respectfully
points out that this is a rule authorized under TSCA section 8(a)(7),
not under TSCA section 8(a)(1). While Congress explicitly carved out
potential exemptions for small manufacturers and small processors for
rules implemented under TSCA section 8(a)(1) for chemicals not subject
to certain TSCA actions, Congress chose not to do so in the text of
TSCA section 8(a)(7). EPA considered the provisions at TSCA section
8(a)(5) to limit reporting requirements for small manufacturers and
determined that reporting from small manufacturers would be appropriate
under TSCA section 8(a)(5)(A) through (C). The information requested
under this rule is not unnecessary nor duplicative due, in part, to
exemptions in other TSCA reporting rules. Additionally, a broad
exemption for all entities deemed a ``small manufacturer'' would not
enable EPA to fulfill the express requirements of the NDAA to require
``each person'' to report their PFAS manufacturing activities to the
extent they know or can reasonably ascertain. Regarding the provision
to minimize the cost of compliance on small manufacturers, EPA has
identified regulatory alternatives to the proposed rule that reduce
compliance costs without a complete exemption. Finally, based on public
comments and input from the SBAR Panel, EPA believes that small
manufacturers are likely to have information regarding commercially
manufactured PFAS, which is relevant to the effective implementation of
TSCA.
E. What is the concern regarding a lack of common TSCA reporting
exemptions or reporting threshold?
1. Summary of Public Input
Many commenters opined on the proposed rule's lack of common TSCA
reporting exemptions and a reporting threshold. Several commenters
added that incorporating exemptions and/or a reporting threshold would
make the proposed rule consistent with other TSCA rules such as CDR,
Fees, PAIR, and PMN reporting (Refs. 20, 26, and 27). Commenters cited
potential compliance challenges and reporting burden as the rationale
for such exemptions, as they stated that the work involved in
identifying, tracing, and reporting under the proposed rule is
significantly increased without exemptions. Other commenters said that
the lack of exemptions would significantly increase the number of
substances for which reporting must occur as opposed to the 1,364 PFAS
estimated in the proposed rule, as those only reflected those PFAS on
the Inventory or subject to an LVE, yet those sources exempt several
types of substances (e.g., impurities, byproducts, R&D substances).
Another commenter said that these types of substances are not likely to
result in exposure to humans or the environment, and that EPA has not
articulated what the benefit of the additional data would be.
On the other hand, several commenters supported implementation of
the proposed rule without any exemptions. They said that Congress
intended for each person who manufactures a PFAS to be subject to the
rule, without exemptions, and that incorporating exemptions would not
be consistent with EPA's past approach for PFAS. Some commenters also
pointed out the differences between the objectives of CDR and this PFAS
reporting rule, stating that CDR's intent is to obtain initial
screening information on a broad universe of chemicals, while this
rule's aim is to collect information specifically on PFAS.
2. EPA's Response
EPA appreciates the input from commenters on the impacts of not
incorporating certain reporting exemptions or thresholds. EPA
appreciates the support from commenters who supported promulgating the
final rule without exemption and, after reviewing public input, has
decided to finalize that aspect of the proposed rule.
EPA disagrees with commenters' requests to include many of the
reporting exemptions found in other TSCA rules such as in PMN reporting
and the Fees Rule (Refs. 20 and 26). EPA points out that, unlike the
Fees Rule, the scope of this rule is information which is known to or
reasonably ascertainable by the manufacturer (Ref. 26).
While this rule uses the same reporting standard as CDR and other
TSCA section 8(a) rules, this rule is focused on improving EPA's
knowledge of commercially manufactured PFAS and their uses, which
includes chemicals of concern to human health and the environment.
Therefore, EPA does not believe many of the same reporting exemptions
used in other TSCA rules are warranted. As directed by the statute, EPA
is requesting information on PFAS manufactured for a commercial purpose
to the extent such information is known or reasonably ascertainable to
the manufacturer. EPA also points out that, whether types of substances
(such as non-isolated intermediates, impurities, or articles) are
likely to result in human or environmental exposures is not a threshold
that EPA needs to satisfy for requiring reporting on those substances
under TSCA section 8(a)(7). EPA aims to better understand the scope of
existing knowledge of the universe of historically manufactured PFAS
and implementing certain exemptions may inadvertently lead to the
omission of information known to or reasonably ascertainable to some
manufacturers.
[[Page 70538]]
The information EPA receives through this rule will refine the Agency's
understanding of certain exposure-related data of PFAS manufactured. If
certain substances have not resulted in significant human and
environmental exposures, then that would be reflected in the submitted
information.
EPA appreciates the public input on the proposed rule's burden
analysis, including additional information received during the proposed
rule's comment period, the SBAR Panel, and the IRFA comment period. EPA
has refined its economic analysis, including the estimated scope of
covered substances and associated burden of determining whether
reporting is required. Regarding commenters' claims that the estimated
scope of covered substances may be significantly greater than estimated
without certain exemptions, EPA points out that the exact challenge
articulated by commenters justifies the lack of exemptions in this
rule: the fact that stakeholders have questions surrounding the number
of covered substances under this rule, including as impurities,
intermediates, or R&D substances, reveals the lack of existing
information of the universe of PFAS in commerce. EPA aims to better
understand what manufacturers know or may reasonably ascertain
regarding manufactured PFAS, and exempting substances that were not
previously reported under other TSCA rules would hinder that effort.
F. What is the application of the reporting standard?
1. Summary of Public Input
EPA received many comments on the reporting standard proposed for
this rule: information known to or reasonably ascertainable by the
manufacturer. The majority of these commenters suggested that EPA
revise their definition of ``reasonably ascertainable'' to assist
businesses with compliance. Specifically, these commenters voiced
concerns over the time spent to conduct compliance determination
activities to satisfy the ``due diligence'' requirement of the
reporting standard for many substances and products, and for which they
do not anticipate information being readily available even after an
extensive search. Commenters claimed that, for substances which have
been historically exempt from other TSCA reporting requirements
(especially imported articles), there is likely little if any
information available, yet entities would still be required to perform
due diligence and demonstrated they have examined each imported
article.
However, other commenters largely supported EPA's proposed
requirements. One commenter suggested that ``known and reasonably
ascertainable'' should be broadly interpreted and that the proposed
definition of ``known and reasonably ascertainable'' is consistent with
definitions in TSCA recordkeeping regulations and should therefore be
included, as is, in the final rule. Other commenters stated that the
requirement for manufacturers to assess whether they know or can
reasonably ascertain PFAS' presence in their articles is a modest cost
that is outweighed by the benefits of the data to EPA and the public.
In addition, there were several comments requesting that EPA
clarify or provide additional guidance on the reporting standard for
this rule, including guidance tailored to article importers and what
constitutes due diligence under this standard. Some suggestions
included stipulating that the scope of a manufacturer's inquiry within
their supply chain is limited to just immediate suppliers (i.e., no
need to inquire multiple levels of their supply chain), and that if a
supplier refuses to share information with a manufacturer, then the
manufacturer need not inquire further and would not face EPA
enforcement action. Some commenters also requested further
clarification of the proposed requirement to submit ``reasonable
estimates'' for certain data elements where actual data are not
available.
2. EPA's Response
EPA appreciates the input from commenters and the SBAR Panel
related to the scope of information that may be known to or reasonably
ascertainable by (KRA) PFAS manufacturers, including small article
importers. EPA has incorporated the feedback into both the rule (e.g.,
providing an option of streamlined reporting forms for article
importers and manufacturers of small quantities of R&D substances who
would not know the downstream processing, use, and disposal
information) and this rule's accompanying guidance and instructions on
applying the KRA standard.
Regarding manufacturers who have concerns over the due diligence
expected under this rule, including those who believe they ultimately
will not obtain any reportable information, EPA clarifies that there is
no reporting or recordkeeping requirement if an entity has no relevant
information. This rule does not itself require any company to maintain
information upon which a decision not to report is based. Consistent
with their own business practices, companies may elect to retain
documentation of their conclusion that they were not subject to
reporting requirements. While manufacturers and importers are expected
to exercise ``due diligence'' in looking for reportable PFAS and
information, that effort will look different for different entities.
EPA also acknowledges that it may not be within the scope of
``reasonably ascertainable'' to survey all articles and products,
especially for article importers. In addition to the existing guidance
on this reporting standard, EPA is providing guidance on this reporting
standard with respect to article importers and other entities who may
be exempt under other TSCA regulations (e.g., manufacturers of small
quantities of R&D substances).
Regarding the suggestions that the rule should limit the scope of a
manufacturer's inquiry of its supplier(s) to only information which the
supplier does not claim as CBI or trade secret, EPA is enabling a joint
submission option within the future reporting tool. Similar to one of
the joint submission options in the CDR tool, a PFAS manufacturer whose
supplier does not volunteer requested information, including the
specific chemical identity of a PFAS imported from the supplier, would
have the option to complete the PFAS reporting form to the extent
information is known or reasonably ascertainable. The manufacturer
would then initiate an email to its supplier via the CDX-based tool and
request the supplier provide the necessary information to EPA, using a
secondary reporting form, without needing to divulge to the reporting
entity the specific chemical identity of the PFAS or the composition of
the product. The tool will create an electronic record of the U.S.-
based importer's attempts to contact the supplier and request
information. Further, if the immediate supplier does not know the
information, they may continue to send an email via the reporting tool
to their own suppliers, in an effort to secure the requested
information.
G. What are the concerns regarding potential duplicative reporting?
1. Summary of Public Input
EPA received comments on potential duplicative reporting under the
proposed rule and NODA public comment periods. The majority of
commenters shared the sentiment that the proposed reporting
requirements
[[Page 70539]]
would result in duplicative reporting that is contrary to TSCA section
8(a)(5)(A), which requires EPA to avoid, to the extent feasible,
reporting which is unnecessary or duplicative. Most of these commenters
shared the opinion that some information required to be reported under
the proposed rule is extremely similar to, if not the same as,
information required under the CDR rule. One commenter, however, shared
a contrasting opinion that EPA should not exclude information
previously reported under CDR requirements on the grounds that omitting
that information would compromise EPA's ability to collect and
aggregate PFAS data pursuant to TSCA section 8(a)(7).
The commenters who stated that the requirements in the proposed
rule consist of duplicative reporting primarily cited reporting
requirements under the CDR rule as justification for their position.
Multiple commenters also cited studies submitted as unpublished health
and safety studies under TSCA section 8(d) and the substantial risk
notification requirements under TSCA section 8(e). One commenter
claimed that EPA is likely already in possession of a considerable
amount of PFAS information from studies submitted to EPA under new
chemicals reporting (i.e., PMN and LVE applications) and TSCA section
8(e) reporting. A few commenters also suggested that companies should
not be required to collect and repeat data for past non-principal
reporting years. Other commenters specified that EPA should limit
reporting of information concerning environmental or health effects by
excluding information that is publicly available, such as information
published in scientific journals, as requiring reporting of this
information would be unnecessary and duplicative.
Multiple commenters claimed that including articles in the required
reporting would substantially increase duplicative reporting due to the
number of entities an article may pass through, who would then all be
required to report information on that chemical. Two commenters raised
the issue of articles which are exported from and then reimported into
the U.S. and asserted that the reporting of reimported articles would
be considered duplicative reporting. To remedy this situation, a
commenter suggested that EPA require reporting at the level of
manufacturing the PFAS itself, and possibly the first supplier that
incorporates a PFAS, but no further.
2. EPA's Response
EPA acknowledges that some of the data elements may overlap with
the data required under the 2020 CDR cycle but disagrees that the scope
of such overlap is significant. There are several differences between
the CDR rule and this rule which limit the scope of any potential
overlaps between the datasets. First, CDR includes several reporting
exemptions and a reporting threshold based on production volume, which
are not included in this rule: imported articles, certain byproducts,
non-isolated intermediates, small quantities of R&D chemicals, small
manufacturers, and a minimum production volume reporting threshold of
25,000 lbs/year (or 2,500 lbs/year for substances subject to certain
TSCA actions). Therefore, PFAS reporters with activities that are
exempt in CDR or who manufacture PFAS below the CDR threshold will not
have reported such information to CDR before and would not be
considered ``duplicative'' here. Further, CDR reporters may have
excluded quantities that would be reportable under this rule, based on
certain CDR exemptions, and therefore the information they previously
submitted to CDR would not be considered duplicative and would not be
responsive to this rule. Secondly, the PFAS that have been reported to
CDR are a subset of the scope of PFAS for this rule. The scope of CDR
chemical substances is limited to those on the Inventory and excludes
polymers. The scope of this reporting rule includes any chemical
substance meeting the rule's structural definition, which is not
limited to those on the Inventory (e.g., LVEs), and includes any
fluoropolymers that meet the structural definition. Finally, the years
for which certain required data elements may have been reported to CDR
differ. Some of the information described earlier in this unit is
reported differently for the principal reporting year compared to the
other three years within the four-year CDR period. For instance, the
production volumes for domestic manufacture and import are combined for
any non-principal reporting year. Further, prior CDR cycles had
different required information. Therefore, the extent of potentially
``duplicative'' reporting between CDR and this rule is limited,
especially when considering each year for which reporting is required
under this rule.
EPA is finalizing the proposal to not require resubmission of
information that has been reported to CDR, unless that information did
not reflect all activities or quantities for which reporting is
required under this rule. EPA disagrees with the commenter who
suggested that EPA should not exclude information previously reported
under CDR. Such information could be duplicative and therefore EPA is
limiting that reporting under TSCA section 8(a)(5)(A).
EPA also appreciates the commenters' input regarding information
previously submitted via TSCA section 8(e) reporting. EPA agrees that
substantial risk notification requirements submitted to EPA under TSCA
section 8(e) could be considered ``information concerning the
environmental or health effects'' of a PFAS. To that end, EPA is
finalizing the rule to acknowledge that manufacturers who have
previously submitted substantial risk notifications, other unpublished
health and safety studies under TSCA section 8(d), or other relevant
information concerning environmental or health effects need not
resubmit the information. However, to enable EPA to easily collect
those prior submissions, the manufacturers must indicate the rule or
program to which they submitted that prior information concerning the
environmental or health effects of that PFAS and the year in which it
was submitted to EPA. EPA also reiterates that manufacturers need not
submit health and environmental effects information that is not in
their possession or control, but could be found from a publicly
available source.
Finally, regarding the comments related to whether reporting
certain imported articles in complex products may lead to duplicative
reporting: EPA disagrees that the information reported will result in
duplicative information, especially given the reporting standard
applicable to this rule. EPA believes that information known to or
reasonably ascertainable by an article manufacturer at the first
instance the PFAS is imported into the United States is likely
different than the scope of information known to an article importer
farther down the supply chain who may re-import that PFAS later, as the
article is incorporated into more complex articles or products. EPA
also believes that applying the reporting requirements each time a PFAS
is imported into the United States is consistent with TSCA's definition
of manufacturing and directive under TSCA section 8(a)(7). If a PFAS is
imported, exported, then re-imported, then limiting the scope of
reporting to just one instance of importation into the United States
may result in certain burdens on manufacturers within the supply chain
who need to further communicate with each other to determine whether a
PFAS within an article has already been reported and who is responsible
for reporting.
[[Page 70540]]
H. What are the concerns regarding the lookback period?
1. Summary of Public Input
Several commenters stated that attempting to obtain or develop the
required information over a ten-year lookback period is not feasible
and would constitute a significant burden to reporters, and they felt
that EPA should eliminate or shorten the lookback period. These
commenters suggested either setting the lookback period to either 3
years, or 5 years to be consistent with the CDR recordkeeping
requirement. Commenters stated that it would be difficult or impossible
to collect the information required due to the complexities of their
supply chains, the turnover rate of foreign suppliers especially for
fad markets, the lack of historical reporting requirements for PFAS in
products, and the concurrent supply chain disruptions rendered by the
COVID-19 pandemic. Commenters also suggested that creating or
recreating data from the lookback period will result in imprecise data.
In addition to the suggestions to reduce the lookback period, some
commenters suggested that EPA consider implementing a ``principal
reporting year'' approach as used in CDR, in which only production
volumes are reported for each year, while the more detailed data
elements are reported for only the principal reporting year. Other
suggestions included exempting articles or exempting companies that
have since phased out PFAS by the reporting deadline.
2. EPA's Response
EPA disagrees with the commenters who have suggested altering the
lookback period from 2011 to a more recent year. The language in TSCA
section 8(a)(7) directs EPA to promulgate a reporting rule for ``each
person who has manufactured a chemical substance that is a [PFAS] in
any year since January 1, 2011, to submit to the Administrator a report
that includes, for each year since January 1, 2011, the information
described in subparagraphs (A) through (G) of paragraph (2).''
Congress's direction to EPA is clear: the lookback period for this
reporting rule must begin on January 1, 2011. EPA understands the
extent of information known to or reasonably ascertainable by a
manufacturer may vary for several reasons. However, EPA's obligation
under TSCA section 8(a)(7) and interest in identifying the scope of
available and existing data on historically manufactured PFAS demand
that PFAS manufacturers conduct their due diligence and submit
requested information to the extent it is known or reasonably
ascertainable.
I. What is the submission period duration and reporting deadline?
1. Summary of Public Input
EPA received significant input on the duration of the proposed
submission period. Many commenters and input during the SBAR Panel
claimed that the proposed rule's reporting deadline is unrealistic, and
EPA should allow more time for reporting to accomplish the required
data collection. Commenters provided a range of alternatives to
consider for the reporting deadline, from 1.5 years from rule
promulgation to 5 years from rule promulgation for article importers.
Several commenters provided detailed descriptions of the types of
activities that would need to occur during the submission period as
evidence of why they felt the proposed submission period to be
inadequate. Some commenters raised EPA's experiences with the PIP (3:1)
rule as justification for a longer time frame for extensive PFAS data
reporting (Ref. 27). Other reasons provided by commenters regarding why
additional time is needed include: time to familiarize themselves with
the rule; unclear scope of requirements in the proposed rule; lack of
systems in place with which to track the data leading to manual
collection; and lack of ability to outsource the task to contractors
due to the confidentiality concerns. In addition, one commenter noted
that other jurisdictions have delayed the implementation of new rules
in light of overwhelming burden, COVID, and supply chain disruptions.
EPA also received some comments urging the Agency to finalize this
aspect of the proposed rule and not delay the deadline by which PFAS
data are submitted. Commenters cited the pressing need for such data
and the awareness within the regulated community of this rule.
2. EPA's Response
EPA appreciates the significant feedback the Agency received from
the public, including through the SBAR Panel, on the duration of the
reporting submission period. After considering input from the
commenters and other stakeholders, EPA agrees that the proposed
reporting time frame may not be sufficient for identifying, collecting,
and reporting the scope of information requested by this rule. While
EPA disagrees that the extent of activities necessarily requires
investigations of the supply chain that would take up to five years to
complete, it is modifying the proposal by adding six more months to the
information collection period ahead of the reporting tool opening (for
a total of one year from the effective date of this rule). This one-
year information collection period will then be followed by a six-month
reporting submission period. Thus, information will be due 18 months
following the effective date of this rule for all PFAS manufacturers
except certain small article importers. EPA has provided an additional
six months for small manufacturers (as defined at 40 CFR 704.3) who
would report exclusively article importers for the purposes of this
rule. Therefore, small article importers have two years from the
effective date of this final rule to report. Thus, information will be
due 24 months following the effective date of this rule for small
manufacturers (per 40 CFR 704.3) who are reporting exclusively as
article importers. EPA believes this timeframe will be sufficient to
allow reporters to familiarize themselves with the rule, identify PFAS
they have produced or imported, identify any suppliers or other
contacts, collect information, and submit the information to EPA. The
additional time will enable reporters to thoroughly review their known
or reasonably ascertainable information and provide EPA with the extent
of the requested information under this reporting standard.
Additionally, as this is a TSCA section 8(a) reporting rule, EPA
disagrees with commenters who request additional reporting time by
comparing this rule to the PIP (3:1) rule or other non-section 8
reporting rules (Ref. 27). The reporting standard under TSCA section
8(a) does not apply to those rules, which may require additional
compliance activities. However, EPA agrees with commenters who pointed
out the distinctions between this rule and CDR as a basis for extending
the reporting period: the CDR rule requires only a four-year lookback
period, includes certain exemptions and reporting thresholds, different
data elements, and is regularly occurring so that companies can
anticipate reporting. Due, in part, to these differences with CDR, EPA
is extending the information collection period ahead of the submission
period, thereby providing reporters with 18 months to submit
information for this rule (or 24 months for small article importers).
EPA disagrees with commenters who have suggested the reporting
deadline should be sooner than what was proposed. EPA appreciates the
commenters' interest in reviewing the submitted PFAS data as soon as
[[Page 70541]]
possible, but notes the scope of this rule and differences between this
rule and CDR as factors in allowing the reporting community extra time
to sufficiently review their known or reasonably ascertainable
information and to submit the required data to EPA.
J. Can joint submissions be allowed?
1. Summary of Public Input
Some commenters requested that EPA allow joint submissions. They
suggested it might ease the reporting burden and simplify the reporting
process while still protecting CBI. However, other commenters stated
that joint submissions can still be a substantial burden for companies
already trying to complete their own reporting within a prescribed
timeframe. Commenters urged EPA to carefully consider a workable
solution to protecting CBI and reducing industry burden for compliance.
In response to the NODA, one commenter asked EPA to eliminate the
requirement for joint submissions in response to chemical identity CBI
concerns.
2. EPA's Response
EPA agrees with the commenters' requests for joint submissions and
is finalizing this requirement for reporters (other than article
importers) whose suppliers do not wish to disclose chemical identity.
EPA agrees that such an approach would help protect suppliers' CBI
while not withholding necessary information from EPA related to PFAS
identity. While this may increase burden on upstream companies, EPA
believes this approach will both help downstream manufacturing and
reporting entities, as well as protect CBI if the suppliers do not wish
to disclose it to their customers, including reporting entities.
K. What are the economic analysis considerations?
1. Summary of Public Input
Many commenters addressed the impact of the proposed rule in
general: on industry, EPA, and the general public. Several commenters
provided input on the industry burden estimates provided in EPA's draft
Economic Analysis for the proposed rule, with many stating that EPA
underestimated the cost industry would incur to comply with the
proposed rule and failed to include article importer costs. Commenters
provided specific feedback on EPA's burden and cost estimates for
certain activities including rule familiarization, CBI substantiation,
article identification, determination of chemical identity,
identification of byproducts, outreach to suppliers, data collection,
CDX access and training, form completion and recordkeeping. Some of
these commenters provided additional data or factors to consider when
estimating burden or costs for these compliance activities, including
providing results of their own industry surveys. Commenters also
provided specific feedback on the proposed rule's burden on article
importers and stated that EPA's draft burden assessment is
significantly underestimated. Some commenters stated that article
importers may face substantially more costs than domestic producers
because they lack the knowledge needed for compliance yet would still
incur costs under the reporting standard. Additionally, because article
importers do not have experience with CDR, commenters believed their
cost would be higher than EPA's draft estimates which used CDR to
extrapolate burden estimates for this rule.
Some commenters also claimed that EPA's use of CDR burden to derive
burden estimates under this rule was inappropriate due to the
differences between the two rules. Commenters also provided feedback on
the estimated number of substances subject to reporting in the draft
Economic Analysis and claimed that the draft estimates were too low.
Some commenters pointed out that, because the proposed rule does not
have the same exemptions as CDR nor is limited to a discrete list of
substances, the number of substances subject to reporting would be
substantially higher than the estimates provided in the draft Economic
Analysis.
EPA also received comments that the proposed rule significantly
underestimated the universe of small entities that would be subject to
the rule, both due to the lack of estimates related to article
importers and to the extrapolation from CDR data. Some commenters
described the unique difficulties or burdens small businesses face when
complying with the proposed rule compared to larger businesses.
Commenters stated that EPA cannot justify an RFA certification without
further analysis of the small business impacts and requested that EPA
convene an SBAR Panel under the RFA to obtain feedback from small
businesses potentially affected by the rule.
Some commenters also stated that EPA's draft Economic Analysis
underestimated burden on the Agency itself. Namely, the need to
increase CDX capacity to handle the number of reporting forms and other
administrative costs of reviewing the submitted data are not reflected
in the draft Economic Analysis.
Finally, other commenters claimed that EPA had not accounted for
the social and health costs associated with PFAS exposure in the burden
analysis. Commenters added that the public and various government
entities have incurred significant health, social, and financial costs
due to inadequate information related to PFAS, and that even an
underestimation of industry compliance costs for this rule are minimal
compared to the externalized costs that the public and governments bear
related to PFAS exposure and remediation.
2. EPA's Response
EPA appreciates the feedback on the draft Economic Analysis and
agrees with commenters that an SBAR Panel was appropriate given the
limitations of data related to the small entity universe at the time of
the proposed rule's publication. Accordingly, EPA convened an SBAR
Panel for this rule in April 2022 and completed it in August 2022.
Using feedback from commenters, input during the SBAR Panel, and
additional data made available to EPA since the proposed rule's
publication, EPA has since accounted for the burden that the rule would
impose on article importers and small entities. The burden estimates
include the number of article importers who will be required to report
as well as the number of entities that will have to assess their
product lines to determine whether they must submit reports. EPA
disagrees that the article importer compliance determination activities
are too low. EPA recognizes that a range of activities may be involved
depending on the level of experience of the importer. Actual costs may
vary based on the number of articles imported, the complexity of the
articles, the number of suppliers, and the frequency of supplier
changes. EPA has increased the rule familiarization costs as well as
included the burden of understanding the structural definition of PFAS.
Readers are referred to EPA's updated Economic Analysis for details
regarding the assumptions of calculating burden and costs for article
importers and small entities.
With regards to the use of CDR data, EPA acknowledges that CDR data
are subject to reporting thresholds and that the CDR universe does not
reflect a perfect representation of the likely reporting universe of
this rule. EPA recognizes the limitations of using CDR data in
estimating the burden, including the number of PFAS for which companies
may ultimately report. However, there is no comprehensive
[[Page 70542]]
database of PFAS manufactured in the U.S. that EPA could use to develop
more precise estimates. The reporting requirements of this rule will
serve to fill this knowledge gap. After considering input from the
proposed rule's public comments, stakeholders in the SBAR Panel, and
comments received on the IRFA, EPA is continuing to rely on the CDR
data to extrapolate the estimated number of PFAS to be reported per
firm. EPA acknowledges that the number may vary for some manufacturers
but believes that using CDR for such estimates will help provide an
industry average.
EPA has updated the Agency costs to account for the volume of
reports that will be submitted. EPA will incur costs in administering
the final rule associated with processing submitted reports, analyzing
data from the reports, maintaining the information technology systems
that support these activities, reviewing CBI claim substantiations, and
information technology infrastructure.
Finally, with regard to the comments that EPA has not accounted for
social and health costs associated with PFAS, EPA points out that this
rule is a TSCA section 8(a) reporting and recordkeeping rule and does
not impose any restrictions or other chemical management requirements.
While the benefits of this rule include additional information related
to potential PFAS exposure, which will help inform future regulatory
and research activities, EPA cannot quantify those benefits at this
time, though the Agency discusses them qualitatively in the Economic
Analysis.
L. What are the CBI claim submission requirements?
1. Summary of Public Input
Several commenters submitted comments regarding reporting
requirements in the proposed rule and EPA's intended approach to
reviewing CBI claims as stated in the NODA. Their comments generally
fell into two categories: (1) Urging EPA to protect CBI and simplify
electronic reporting to allow joint submissions when needed, in
addition to making substantiation procedures for CBI claims more
simplified, and not allowing reporters without knowledge of a specific
chemical identity to waive a CBI claim for that chemical identity; and
(2) Urging EPA to require valid and well-explained rationale for any
CBI exemptions, and generally asking EPA to disclose as much
information to the public as possible. Some commenters also cited
concerns with the proposed rule's CBI protections as being inadequate
for R&D activities, including those in the defense or national security
industries. Some commenters requested that the Agency allow a ``blanket
substantiation'' for all CBI claims so that reporters would not be
required to substantiate each individual CBI claim.
On the other hand, commenters who are supportive of limiting the
amount of information claimed as CBI (especially regarding health and
safety studies) cited the urgent need for states to address their own
PFAS exposure and contamination issues and the benefit that this rule
will confer on state agencies struggling with inadequate PFAS
information. These commenters encouraged EPA to review claims and
disclose as much information submitted under this rule as possible.
Commenters during the NODA comment period also addressed EPA's
proposal to require that any PFAS generic name include ``fluor,'' at
minimum, and EPA's proposal to determine that failure to stipulate that
a chemical for which the identity is being claimed as CBI is
fluorinated would be an insufficient claim. Some commenters were
supportive of such requirements; other commenters discouraged EPA from
implementing this requirement as it may create confusion. Finally,
commenters diverged on EPA's intent to move any PFAS identity to the
public TSCA Inventory without prior
[…truncated; see source link]Indexed from Federal Register on October 11, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.