[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 [www.gpo.gov]
[FR Doc No: 2023-22094]



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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 https://www.regulations.gov. Additional instructions for visiting 
the docket, along with more information about dockets generally, is 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
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 https://comptox.epa.gov/dashboard. 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

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(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 https://oecd.org/ehs/templates/harmonised-templates.htm (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 notice if it is not claimed as CBI. 
While some commenters supported this approach, others described 
potential complications of confidential chemical identity protection 
when multiple entities submit reports for the same substance, some of 
whom may not assert CBI for the identity, and requested that EPA notify 
all claimants of a potential change in CBI status for a chemical 
identity and allow appeal opportunities.
2. EPA's Response
    EPA does not believe that an option for blanket CBI claims 
substantiation is appropriate for an information collection rule such 
as this one, in which several types of information are requested. TSCA 
section 14(c) requires substantiation specific to each claim. Because 
the type of information requested under this rule varies, a blanket 
substantiation is unlikely to address the specific reasons for each 
data element claimed as CBI. The more generic a substantiation gets, 
the less support it provides for any specific claim. In terms of 
information disclosure, EPA is committed to reviewing CBI claims and 
substantiations pursuant to TSCA section 14 and implementing 
regulations, and publicly disclosing data that are not approved as CBI 
to the extent possible.
    As noted in the preamble of the proposed rule, TSCA limits 
confidentiality protections for health and safety studies, and 
information from health and safety studies (except to the extent such 
studies or information reveals ``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''). 
Submitters asserting a confidentiality claim for such information in 
health and safety studies are also required to submit a sanitized copy 
of the study, removing only that information which is claimed as CBI 
and that discloses the process or portion of mixture information 
described in TSCA section 14(b). However, certain other information 
within study reports may be claimed as CBI, such as the names of lab 
personnel or the company, or other information that is not related to 
health or environmental effects.
    In response to requests for EPA to work directly with states on 
disclosing CBI submitted under this rule, EPA points out that TSCA 
section 14(d)(4) permits states, tribes, and political sub-divisions of 
states to request access to CBI in writing. Under this authority, the 
entity seeking CBI access must show that it can continue to protect the 
information as confidential. If a state or tribe requests access and 
that is granted per statutory conditions, EPA would have an agreement 
in place laying out how the requestor was going to protect the 
information.
    In response to comments on the CBI procedures described in the 
NODA, EPA is not requiring article importers to assert CBI for the 
chemical identity and will not make public any chemical identity based 
on article importer submissions alone (see discussion in Unit III.G). 
Further, EPA acknowledges some commenters' concerns that multiple 
manufacturers may report the same PFAS, but not all submitters may 
assert a CBI claim for the PFAS identity. EPA will publish a list of 
Accession numbers associated with chemical identities that it plans to 
move to the public portion of the Inventory because either no chemical 
identity CBI claim was asserted or the claim was denied. Publication of 
these Accession numbers will provide entities an opportunity to contact 
EPA with questions or concerns before specific chemical identities are 
moved to the public Inventory (see Unit III.G for more details on this 
process). Finally, EPA believes that requiring ``fluor'' in generic 
name submissions is

[[Page 70543]]

consistent with PMN reporting requirements which provide that a generic 
name ``should reveal the chemical identity of the substance to the 
maximum extent possible'' (40 CFR 720.85(a)(3)(i)(B)), and is 
finalizing this requirement as discussed in the NODA (Ref. 1).

V. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

    1. EPA (2022). TSCA Section 8(a)(7) Reporting and Recordkeeping 
Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances; 
Notice of Data Availability and Request for Comment (87 FR 72439, 
November 25, 2022 (FRL-7902-04-OCSPP)).
    2. EPA (2023). Economic Analysis for the Final TSCA Section 
8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl 
and Polyfluoroalkyl Substances. September 2023.
    3. EPA (2023). Research on Per- and Polyfluoroalkyl Substances 
(PFAS). Available at https://www.epa.gov/chemical-research/research-and-polyfluoroalkyl-substances-pfas.
    4. Agency for Toxic Substances and Disease Registry (ATSDR) 
(2021). Toxicological Profile for Perfluoroalkyls. Available at 
https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf [accessed February 
10, 2023].
    5. EPA (2021). PFAS Strategic Roadmap: EPA's Commitments to 
Action 2021-2024. October 2021. Available at https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf.
    6. EPA. CompTox Chemicals Dashboard. Available at https://comptox.epa.gov/dashboard/.
    7. EPA (2020) Long-Chain Perfluoroalkyl Carboxylate and 
Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use 
Rule (85 FR 45109, June 27, 2020 (FRL-10010-44)).
    8. OECD (2021). Reconciling Terminology of the Universe of Per- 
and Polyfluoroalkyl Substances: Recommendations and Practical 
Guidance. July 9, 2021. Series on Risk Management. No.61. 
Environment Directorate Chemicals and Biotechnology Committee. 
Available at https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/CBC/MONO(2021)25&docLanguage=En.
    9. Buck, Robert C., et al. (2021). Identification and 
Classification of Commercially Relevant Per- and Poly-Fluoroalkyl 
Substances (PFAS). May 14, 2021. Integrated Environmental Assessment 
and Management, vol. 17, no. 5. Available at https://setac.onlinelibrary.wiley.com/doi/full/10.1002/ieam.4450.
    10. Gaines, Linda, et al. (2023). A Proposed Approach to 
Defining Per- and Polyfluoroalkyl Substances (PFAS) Based on 
Molecular Structure and Formula. Integrated Environmental Assessment 
and Management. Accepted Author Manuscript. https://doi.org/10.1002/ieam.4735.
    11. United Nations Environment Programme (UNEP) (2022). Updated 
indicative list of substances covered by the listing of 
perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds. 
March 4, 2022. Stockholm Convention on Persistent Organic 
Pollutants. Available at https://chm.pops.int/Portals/0/download.aspx?d=UNEP-POPS-POPRC.17-INF-14-Rev.1.English.PDF.
    12. EPA (2020). Advancing Sustainable Materials Management: 2018 
Facts and Figures Report. December 2020. https://www.epa.gov/sites/default/files/2021-01/documents/2018_tables_and_figures_dec_2020_fnl_508.pdf.
    13. EPA (2023). International Agreements on Transboundary 
Shipments of Hazardous Waste. https://www.epa.gov/hwgenerators/international-agreements-transboundary-shipments-hazardous-waste.
    14. EPA (2023). Small Entity Compliance Guidance for the TSCA 
PFAS Data Call. September 2023.
    15. EPA (2023). Data Elements included in the TSCA Section 
8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl 
and Polyfluoroalkyl Substances, Final Rule. September 2023.
    16. OECD. OECD Harmonised Templates. Available at https://www.oecd.org/ehs/templates/harmonised-templates.htm.
    17. EPA (2023). Addition of Certain PFAS to the TRI by the 
National Defense Authorization Act. Available at https://www.epa.gov/toxics-release-inventory-tri-program/addition-certain-pfas-tri-national-defense-authorization-act.
    18. EPA (2023). Greenhouse Gas Reporting Program (GHGRP). 
Available at https://www.epa.gov/ghgreporting.
    19. EPA (2018). Guidance for Creating Generic Names for 
Confidential Chemical Substance Identity Reporting under Toxic 
Substances Control Act. EPA 743B18001. June 2018.
    20. EPA (2010) Premanufacture Notification Exemption for 
Polymers; Amendment of Polymer Exemption Rule to exclude Certain 
Perfluorinated Polymers (75 FR 4295, January 27, 2010 (FRL-8805-5)).
    21. EPA (2023). Response to Public Comments: TSCA Section 
8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl 
and Polyfluoroalkyl Substances. September 2023.
    22. EPA (2022). TSCA Section 8(a)(7) Small Business Advocacy 
Review (SBAR) Panel Report. August 2022.
    23. EPA (2022). Initial Regulatory Flexibility Analysis and 
Updated Economic Analysis for TSCA Section 8(a)(7) Reporting and 
Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl 
Substances. November 2022.
    24. EPA (2021). EPA Response to Petition on Testing for Certain 
PFAS. December 2021. Available at https://www.epa.gov/system/files/documents/2021-12/pfaspetitionresponse.pdf.
    25. Frank, Harmut, et al. (2002). Trifluoroacetate in ocean 
waters. 2002. Environmental Science & Technology, 36(1), 12-15. 
Available at https://doi.org/10.1021/es0101532.
    26. EPA (2018). Fees for the Administration of the Toxic 
Substances Control Act (TSCA) (83 FR 52694, October 17, 2018 (FRL-
9984-41)).
    27. EPA (2022). Regulation of Persistent, Bioaccumulative, and 
Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated 
Phosphate (3:1); Further Compliance Date Extension (87 FR 12875, 
March 8, 2022 (FRL-6015.6-02-OCSPP)).
    28. EPA (2023). Information Collection Request Supporting 
Statement entitled ``Final Rule ICR: Reporting and Recordkeeping 
Requirements for PFAS (RIN 2070-AK67).'' EPA Information Collection 
Request (ICR) No. 2682.02. September 2023.
    29. EPA (2023). Final Regulatory Flexibility Analysis and 
Updated Economic Analysis for TSCA Section 8(a)(7) Reporting and 
Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl 
Substances. September 2023.
    30. EPA. Unfunded Mandates Reform Act Statement. PFAS; Reporting 
and Recordkeeping Requirements under the Toxic Substances Control 
Act (TSCA); Final. May 2023.

VI. Statutory and Executive Orders Reviews

    Additional information about these statutes and Executive orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Orders 12866: Regulatory Planning and Review and 14094: 
Modernizing Regulatory Review

    This action is a ``significant regulatory action'' as defined under 
section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4, 
1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 
2023). Accordingly, EPA submitted this action to the Office of 
Management and Budget (OMB) for Executive Order 12866 review. 
Documentation of any changes made in response to the Executive Order 
12866 review is available in the docket. EPA prepared an analysis of 
the potential costs and benefits associated with this action. This 
analysis, entitled ``Economic Analysis for the Final TSCA Section 
8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and 
Polyfluoroalkyl Substances'' (Ref. 1), is also available in the docket 
and is briefly summarized in Unit 1.E.

B. Paperwork Reduction Act (PRA)

    The information collection requirements in this rule will be

[[Page 70544]]

submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The 
Information Collection Request (ICR) document that EPA prepared has 
been assigned the EPA ICR No. 2682.02 (Ref. 28) and the OMB Control 
number 2070-0217. You can find a copy of the ICR in the docket for this 
action, and it is briefly summarized here. The information collection 
requirements are not enforceable until OMB approves them.
    The reporting requirements identified in the rule will enable EPA 
to meet the statutory obligations required by TSCA section 8(a)(7) and 
collect data related to the identities, manufacture, use, exposure, and 
disposal of PFAS manufactured in the United States since 2011. These 
one-time reporting requirements will also help the Agency to collect 
existing information on the health and environmental effects of PFAS. 
EPA intends to use information collected under the rule to assist in 
chemical assessments under TSCA, and to inform any additional work 
necessary under environmental protection mandates beyond TSCA. 
Respondents may claim some of the information reported to EPA under the 
rule as CBI under TSCA section 14. TSCA section 14(c) requires a 
supporting statement and certification for confidentiality claims 
asserted after June 22, 2016.
    Respondents/affected entities: PFAS manufacturers (including 
importers). See Unit I.A.
    Respondent obligation to respond: Mandatory. TSCA section 8(a) and 
40 CFR part 705.
    Total estimated number of respondents: 131,410.
    Frequency of response: One time.
    Total estimated burden: 3,878,744 hours (per year). Burden is 
defined at 5 CFR 1320.3(b).
    Total estimated cost: $281 million (per year) and $266.7 million 
(per year) using a 3 percent and 7 percent discount rate, respectively, 
which includes no annualized capital or operation and maintenance 
costs.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for the 
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB 
approves this ICR, the Agency will announce that approval in the 
Federal Register and publish a technical amendment to 40 CFR part 9 to 
display the OMB control number for the approved information collection 
activities contained in this final rule.

C. Regulatory Flexibility Act (RFA)

    Pursuant to the RFA, 5 U.S.C. 601 et seq., EPA prepared an IRFA for 
the proposed rule and convened an SBAR Panel under RFA sections 603 and 
609(b) to obtain advice and recommendations from small entity 
representatives that potentially would be subject to the rule's 
requirements. Summaries of the IRFA and Panel recommendations are 
presented in the proposed rule's NODA (Ref. 1).
    As required by RFA section 604, EPA prepared a final regulatory 
flexibility analysis (FRFA) for this action. The FRFA addresses the 
issues raised by public comments on the IRFA for the proposed rule. The 
complete FRFA is available for review in the docket (Ref. 29) and is 
summarized here.
    <bullet> Statement of need and rule objectives. Section 7351 of the 
FY2020 NDAA amended TSCA by adding section 8(a)(7), which obligates EPA 
to promulgate a rule by January 1, 2023, that requires each person who 
has manufactured PFAS in any year since 2011 to report and maintain 
records, for each year, information described in TSCA section 
8(a)(2)(A)-(G). This includes a broad range of information, such as 
information related to chemical identity and structure, production, 
use, exposure, disposal, and health and environmental effects. In 
addition, EPA believes that the collected data may help provide more 
information about PFAS manufacture, and to the extent that new 
information indicates the presence of negative externalities or data 
gaps, inform future agency actions and/or legislation governing the 
manufacture, processing, use, and disposal of PFAS.
    EPA developed this final rule after considering findings from 
information provided in public comments on the proposed rule, findings 
from and comments on the SBAR Panel, and public comments on the IRFA. 
The final rule requires all manufacturers of PFAS in any year since 
2011 to report certain information to EPA related to chemical identity, 
categories of use, volume manufactured, byproducts, environmental and 
health effects, worker exposure, and disposal (i.e., the TSCA section 
8(a)(2)(A)-(G) requirements). This rule also requires a five-year 
retention period for all relevant records following the submission 
period.
    <bullet> Significant comments on the IRFA. In response to the IRFA 
and notice of data availability, EPA received 44 unique comments in the 
docket. EPA has provided a comprehensive summary of all comments 
received and EPA's responses in a supporting document that is included 
in the docket for this rulemaking (Ref. 21; see Part 2).
    <bullet> SBA Office of Advocacy comments and EPA response. EPA 
received comments from SBA's Office of Advocacy on the proposed rule 
and the IRFA. SBA's comments and EPA's responses are in the Responses 
to Comments document for this rule (Ref. 21) and in the FRFA (Ref. 29). 
SBA comments that led to changes to the proposed rule, and EPA's 
responses to those comments, are also summarized in this unit.
    Comments: EPA has improperly certified the rule under the RFA. EPA 
should convene a Small Business Regulatory Enforcement Fairness Act 
(SBREFA) Panel and consider burden-reducing compliance flexibilities 
for small businesses. Additionally, EPA underestimated the impact of 
compliance costs associated with the proposed reporting requirements.
    Response: EPA initially certified the proposed rule under the RFA 
based on all information available to it at the time of proposal. 
However, after receiving additional information related to the scope of 
small entities (including article importers) potentially impacted by 
the proposed rule, EPA updated its estimated scope of the universe of 
small entities potentially affected (including article importers) and 
the small entity compliance costs. Thus, EPA convened an SBAR Panel in 
April 2022. The Panel concluded in August 2022, and EPA subsequently 
published the Panel Report, updated Economic Analysis, and IRFA for 
public comment in November 2022. Input received through the Panel and 
during the subsequent comment period for the IRFA were considered in 
the development of this final rule, including comments related to EPA's 
small entity analysis. As a result of public input, EPA identified 
certain regulatory alternatives to the proposed rule, which EPA is 
implementing in the final rule: streamlined reporting forms for article 
importers and for manufacturers of low quantities of R&D substances; 
extending the reporting deadline; providing additional guidance on the 
TSCA section 8(a) reporting standard for article importers. These 
modifications to the proposed rule reduce compliance costs without a 
complete exemption of small entities. EPA has not made a determination 
that a complete exemption of small entities is not legally viable in 
this rulemaking. EPA believes such an exemption would result in 
diminished collection of reasonably known or ascertainable information 
about PFAS manufacturing and import

[[Page 70545]]

since 2011 and therefore is exercising its discretion to not implement 
this alternative. EPA estimates that each manufacturer would incur 
$2,240 in costs to complete the streamlined R&D form and $41,850 in 
costs to complete the general reporting form. Thus, incurring a total 
of $44,089 in costs per firm for form completion, compared to $52,739 
without the streamlined form. For the streamlined form for article 
importers, EPA estimates that each article importer will incur an 
average of approximately 91.7 burden hours and $7,531 in costs per 
firm. Without a streamlined reporting form, EPA estimates that each 
article importer would incur an average of approximately 168 burden 
hours and $13,818 in costs for form completion. Additionally, extending 
the reporting deadline may reduce the opportunity costs if firms are 
diverting resources from other business activities to report 
information under the rule. This may be particularly true for small 
entities. See Table 24 for more information on the costs associated 
with the finalized option and alternatives identified in the IRFA (Ref. 
23).
    <bullet> Estimate of the number of small entities to which the 
final rule applies. This final rule will impact PFAS manufacturers, 
including article importers, across a broad number of industries, 
including the following: utilities; construction; manufacturing; 
wholesale and retail trade; and some waste management. Entities who 
solely process, distribute, and/or use PFAS, and do not manufacture 
(including import) PFAS, are not covered. EPA estimates that 
approximately 97% of all firms potentially affected by this rule would 
meet the SBA standard of ``small business,'' for a total of 128,051 
affected small entities. It is expected that all 128,051 firms will 
undertake structural definition familiarization, some rule 
familiarization activity, and compliance determination, including 
article importers that do not report under this rule. However, EPA does 
not assume that all potentially affected firms will ultimately have 
known or reasonably ascertainable information to report, so 13,021 
small entities are estimated to report under this rule.
    <bullet> Reporting, recordkeeping, and other compliance 
requirements of the final rule.
    i. Compliance requirements. Pursuant to TSCA section 8(a)(7), EPA 
is finalizing this reporting and recordkeeping rule for entities who 
have manufactured a PFAS in any year since January 1, 2011. For each 
year since January 1, 2011, PFAS manufacturers (including importers) 
are required to report the following types of information for each PFAS 
to the extent it is known or reasonably ascertainable: chemical 
identity, production volume, categories of use, byproducts, worker 
exposure, disposal practices, and existing information concerning 
environmental or health effects. In instances where reporters have 
already submitted the requested information to EPA under certain 
reporting programs, they will not be required to re-report. The 
reporters will simply indicate they have already submitted such 
information to EPA. The reporting deadline is 18 months following the 
effective date of this rule, except for small manufacturers (defined at 
40 CFR 704.3) whose reporting obligations exclusively arise from 
article imports; the latter's reporting deadline is 24 months following 
the effective date of this rule. The reporting deadline is then 
followed by a five-year recordkeeping period.
    ii. Classes of small entities subject to the compliance 
requirements. The small entities that are potentially affected by this 
rule are manufacturers (including importers) who have manufactured 
(including imported) PFAS in any year since January 1, 2011. This 
includes entities who have imported articles containing PFAS in any 
year since January 1, 2011.
    iii. Professional skills needed to comply. Understanding some of 
the reporting requirements may involve special skills or expertise, 
though hiring or contracting such skills specifically for this rule are 
not required to comply, given the TSCA section 8(a) reporting standard 
of ``known or reasonably ascertainable.'' For example, understanding 
the rule's structural definition of PFAS and other reporting 
requirements may involve special expertise of chemistry. EPA assumes 
that chemical manufacturing and importing firms and large article 
importers will have staff with the technical knowledge to understand a 
structural definition more easily than small article importers. Based 
on input from the Small Entity Representatives, EPA estimated the cost 
of small article importer firms contracting outside help to understand 
the chemical structural definition, despite it not being a necessary 
step for compliance. Small article importers that contract outside help 
(which is not required for this rule's compliance) would incur $1,212 
in structural definition compliance costs, while small article 
importers that do not contract outside help would incur approximately 
$831. Additionally, environmental and health effects data may require 
some technical knowledge to report.
    <bullet> Steps taken to reduce economic impact to small entities.
    i. Small Business Advocacy Review Panel. As required by RFA section 
609(b), EPA convened an SBAR Panel to obtain advice and recommendations 
from small entity representatives that potentially would be subject to 
the rule's requirements. A copy of the full SBAR Panel Report (Ref. 22) 
is available in the docket. The comments received on the proposed rule, 
the IRFA and EPA's responses to those comments are summarized in Unit 
IV and in further detail in the Response to Comments document in the 
docket (Ref. 21).
    ii. Alternatives considered. EPA considered a wide variety of 
alternatives to the proposed rule. EPA considered the impact (both cost 
and in anticipated reporting) of providing exemptions for all small 
businesses, or a portion of small businesses (e.g., small article 
importers, small manufacturers using the TSCA section 8 definition, or 
entities below various sales thresholds). EPA also evaluated the impact 
of exemptions for certain substances, including imported articles, 
byproducts, impurities, non-isolated intermediates, and R&D substances. 
EPA also evaluated the impact of implementing a production volume-based 
reporting threshold in this rule. For each of these alternatives, EPA 
found that it would reduce the amount of PFAS reporting of reasonably 
known or ascertainable information from PFAS manufacturers (including 
importers) under TSCA section 8(a)(7). The amount of reporting that 
certain alternatives would reduce varied, ranging from exempting 
approximately 91% of all potentially covered firms from reporting under 
a small manufacturer exemption for any firm with under $12 million in 
sales (which would have resulted in a final rule costing small 
businesses approximately $48.8 million under a 7 percent discount 
rate), to exempting 69% of firms (all article importers) under an 
exemption for just article importers with sales below $2 million (which 
would have resulted in a final rule costing small businesses 
approximately $229.5 million under a 7 percent discount rate). EPA also 
considered applying a production volume reporting threshold of both 
2,500 lbs per year and 25,000 lbs per year, to align with CDR reporting 
thresholds. Because the amount of reporting and burden under a 
reporting threshold was difficult to estimate with existing data, EPA 
conducted sensitivity analyses for this alternative, based on the 
estimated number of PFAS article

[[Page 70546]]

importers who would be able to determine whether they are below the 
reporting threshold. On the low-end estimate for this alternative 
(i.e., 5% of affected article importers import PFAS-containing articles 
above threshold), EPA estimates that total number of PFAS reports 
submitted would decrease by 49 percent, and total small business costs 
would be approximately $736.6 million under a 7 percent discount rate. 
On the high-end (i.e., 9.5% of affected article importers import PFAS-
containing articles above threshold), EPA estimates the total number of 
PFAS reports submitted to decrease by 5%, with total small business 
costs of $785.2 million under a 7 percent discount rate. Given the 
reduced reporting expected under alternatives including various 
exemptions and reporting thresholds, EPA determined that implementing 
such alternatives contradicted EPA's mandate under section 8(a)(7) to 
collect information from ``each person'' who had manufactured a PFAS. 
Further, while EPA recognizes there is a tradeoff between rule 
compliance costs and information collection, PFAS exposure presents 
significant human health and environmental concerns that it is critical 
for EPA to collect as much existing information on PFAS presence in 
commerce (including through disposal) as possible.
    In addition to alternatives related to reporting exemptions and 
reporting thresholds, EPA considered limiting the scope of PFAS subject 
to this rule to a finite list, rather than a structural definition. 
This alternative simplifies rule familiarization for affected entities 
and removes the cost and burden of understanding the structural 
definition of PFAS. Additionally, it reduces compliance determination 
costs for affected firms. However, this also significantly limits the 
number of PFAS subject to the rule and excludes many PFAS that cannot 
be listed due to CBI claims but are active in U.S. commerce. If EPA 
limited the scope to a discrete list of PFAS on the TSCA Inventory and 
LVEs that could be specifically named under the final definition, 602 
PFAS would be subject to the rule. This alternative would result in an 
estimated 50% decrease in reporting forms submitted, along with an 
estimated small business cost of approximately $626.4 million under a 7 
percent discount rate.
    However, EPA also considered alternatives to the proposed rule that 
the Agency is finalizing to reduce burden on small entities. EPA 
considered providing streamlined reporting form options for both 
imported articles and R&D substances manufactured in low quantities 
(i.e., no more than 10 kg/year). Based on EPA's knowledge of 
manufacturers of those substances, and public input from commenters and 
small entity representatives, EPA believes such manufacturers have less 
information that is known or reasonably ascertainable to them. 
Therefore, the streamlined reporting form reduces the burden of 
reporting on the standard form while still enabling EPA to collect all 
known or reasonably ascertainable historical PFAS data. Additionally, 
EPA considered and is finalizing a longer compliance timeframe for all 
reporting entities. Providing an additional six months for a data 
collection period ahead of the reporting period will reduce the 
opportunity costs on affected firms, particularly small entities, 
without sacrificing any PFAS manufacturing data. In addition, EPA is 
granting small manufacturers (as defined at 40 CFR 704.3) who would 
report exclusively as article importers an additional six months to 
collect data. Therefore, those small entities would have 24 months from 
the effective date of this rule to submit information on their imported 
articles. EPA is finalizing such alternatives to meet the Agency's 
obligations under TSCA sections 8(a)(5)(A) through (C), as this rule is 
requesting information that is neither duplicative nor unnecessary and 
will not exclude manufacturers who are likely to have relevant 
information, while minimizing costs on small manufacturers to the 
extent feasible.
    <bullet> Small entity compliance guide. EPA prepared a Small Entity 
Compliance Guide to help small entities comply with the rule. This 
guide is available in the docket for this rulemaking and will be 
available on EPA's website prior to the effective date of this final 
rule (Ref. 14).

D. Unfunded Mandates Reform Act (UMRA)

    This action contains a Federal mandate under UMRA, 2 U.S.C. 1531-
1538, that may result in expenditures of $100 million or more for 
State, local, and Tribal governments, in the aggregate, or for private 
sector in any one year. Accordingly, the EPA has prepared a written 
statement (Ref. 30) as required under UMRA section 202 that is include 
in the docket for this action and is briefly summarized here.
    1. Authorizing legislation. This rule is issued under the authority 
of TSCA section 8(a)(7) (15 U.S.C. 2607(a)(7)).
    2. Benefit-cost analysis. EPA has prepared an Economic Analysis 
(Ref. 2) and a Final Regulatory Flexibility Analysis (Ref. 29) to 
evaluate, among other things, the benefits and costs of this rule as 
well as various regulatory options. The rule is calculated to result in 
a total one-time cost to the private sector of approximately $843 
million using a 3 percent discount rate and $800 million using a 7 
percent discount rate. When adjusted for inflation, the $100 million 
UMRA threshold is equivalent to approximately $184 million. Thus, the 
cost of the rule to the private sector in the aggregate exceeds the 
inflation-adjusted UMRA threshold.
    Because this is an information-collecting rule, EPA is not able to 
quantitatively measure the associated benefits. However, the rule may 
supply information on PFAS to which Federal agencies (and the public) 
do not currently have access. By enhancing the data supplied to risk-
screening and risk-management programs, EPA expects to more effectively 
and expeditiously evaluate and manage any potential unreasonable risk 
posed by PFAS. The more EPA can base its decisions on actual data 
rather than on assumptions, the better EPA is able to tailor its risk 
management decisions to the level of actual risk, whether higher or 
lower than it would be if based on assumptions alone. Ultimately, 
enhancing the risk evaluation process will have positive consequences 
for human health and the environment and may enable a more efficient 
allocation of EPA's and society's resources. Additionally, this rule 
fulfills EPA's obligations under TSCA section 8(a)(7).
    3. Impacts on State, local, and Tribal governments. This rule does 
not contain a significant Federal intergovernmental mandate because it 
neither imposes enforceable duties on State, local, or Tribal 
governments nor reduces an authorized amount of Federal financial 
assistance provided to State, local, or Tribal governments. This rule 
contains no regulatory requirements that might significantly or 
uniquely affect small governments. The rule would require reporting 
from certain persons who manufactured (including imported) PFAS for 
commercial purposes, including in articles. Governments do not 
typically engage in these activities, so State, local, and Tribal 
government entities are not expected to be subject to the rule's 
requirements. This action is not subject to the requirements of section 
203 of UMRA because it contains no regulatory requirements that might 
significantly or uniquely affect small governments. The requirements of 
this action would primarily affect manufacturers (including importers) 
of PFAS.

[[Page 70547]]

E. Executive Order 13132: Federalism

    This action does not have federalism implications, as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999) because it will 
not have substantial direct effects on States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have Tribal implications, as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000) because it will 
not have substantial direct effects on Tribal governments, on the 
relationship between the Federal Government and the Indian Tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. It does not have substantial direct 
effects on Tribal government because EPA does not anticipate that PFAS 
was manufactured (including imported) for commercial purposes by Tribes 
so this rulemaking is not expected to impose substantial direct 
compliance costs on Tribal governments.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) 
as applying only to those regulatory actions that concern environmental 
health or safety risks that EPA has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of Executive Order 13045. This 
action is not subject to Executive Order 13045, because it does not 
concern an environmental health or safety risk. Since this action does 
not concern human health, EPA's Policy on Children's Health also does 
not apply.
    Although this action does not concern an environmental health or 
safety risk, this one-time data collection will aid in collecting all 
existing and reasonably ascertainable information related to the 
manufacturing (including importing) of PFAS since 2011. This rule will 
be of use in identifying current data gaps surrounding the knowledge of 
commercially manufactured PFAS. Understanding the extent of existing 
data gaps related to manufactured PFAS will also help inform and tailor 
future EPA actions to address PFAS as needed. This regulatory action 
establishes one-time reporting requirements for PFAS that will result 
in information on the quantity of PFAS to which children may be 
exposed. EPA believes that the information obtained as a result of this 
one-time data collection could also be used by the public, government 
agencies and others to identify potential problems, set priorities, and 
take appropriate steps to reduce any potential human health or 
environmental risks.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution in Commerce, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have a significant adverse effect on the supply, distribution 
or use of energy. Further, we have concluded that this action is not 
likely to have any adverse effect on the supply, distribution or use of 
energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards. As such, 
NTTAA section 12(d), 15 U.S.C. 272.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations and 
Executive Order 14096: Revitalizing Our Nation's Commitment to 
Environmental Justice for All

    The EPA believes that it is not practicable to assess whether the 
human health or environmental conditions that exist prior to this 
action result in disproportionate and adverse effects on communities 
with environmental justice concerns. The purpose of this action is to 
require reporting activity. EPA was unable to perform an environmental 
justice analysis because it lacks data on every exposure source.
    However, this regulatory action makes changes to the reporting 
requirements for PFAS that will result in more information being 
collected and provided to better evaluate exposures and the risks posed 
by such exposures as explained in Unit II.A., certain PFAS exposure may 
be a hazard to human health. This action establishes one-time reporting 
requirements for companies to submit to EPA certain known or reasonably 
ascertainable information on manufactured PFAS by those entities as 
discussed in detailed in Unit III.D. The determination of potential 
risk to human health and/or the environment depends upon many factors, 
including the toxicity of the chemical, the fate of the chemical in the 
environment, and the amount and duration of human or other exposure to 
the chemical. This action does not directly address human health or 
environmental risks. However, the action will increase the level of 
information available to assess environmental protection for all 
affected populations without having any disproportionate and adverse 
human health or environmental effects on any population, including any 
community with environmental justice concerns. The information obtained 
as a result of this action may be used to collect all existing and 
reasonably ascertainable information related to PFAS-containing 
articles will be of use in identifying current data gaps surrounding 
the knowledge of commercially manufactured PFAS, and reporting of PFAS 
within imported articles will enable EPA to meet its obligations under 
the FY 2020 NDAA. Understanding the extent of existing data gaps 
related to manufactured PFAS will also help inform and tailor future 
EPA actions to address PFAS as needed. EPA also believes that the 
information obtained as a result of this action potentially could be 
used by the public (including communities with environmental justice 
concerns) with access to data which they may use to seek lower 
exposures and consequently reductions in chemical risks for themselves 
and their children. Technical assistance may be provided to communities 
with environmental justice concerns and efforts will be made to ensure 
meaningful access for individuals with limited English proficiency and 
individuals with disabilities. This information can also be used by 
government agencies and others to identify potential problems, set 
priorities, and take appropriate steps to reduce any potential risks to 
human health and the environment. Therefore, informational benefits, of 
the action, including behavioral changes such as consumers avoiding 
specific products, may have positive impact on the human health and 
environmental impacts on all communities, including communities with 
environmental justice concerns.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA 
will submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. This action is not a ``major 
rule'' as defined by 5 U.S.C. 804(2).

[[Page 70548]]

List of Subjects in 40 CFR Part 705

    Chemicals, Environmental protection, Hazardous materials, Reporting 
and recordkeeping requirements.

    Dated: September 28, 2023.
Michal Freedhoff,
Assistant Administrator Office of Chemical Safety and Pollution 
Prevention.
    Therefore, for the reasons set forth in the preamble, 40 CFR 
chapter I, subchapter R, is amended by adding part 705 to read as 
follows:

PART 705--REPORTING AND RECORDKEEPING REQUIREMENTS FOR CERTAIN PER- 
AND POLYFLUOROALKYL SUBSTANCES

Sec.
705.1 Scope, compliance, and enforcement.
705.3 Definitions.
705.5 Substances for which reports must be submitted.
705.10 Persons who must report.
705.12 Activities for which reporting is not required.
705.15 What information to report.
705.18 Article importer and R&D substance reporting options.
705.20 When to report.
705.22 Duplicative reporting.
705.25 Recordkeeping requirements.
705.30 Confidentiality claims.
705.35 Electronic reporting.

    Authority:  15 U.S.C. 2607(a)(7).


Sec.  705.1   Scope, compliance, and enforcement.

    (a) This part specifies reporting and recordkeeping procedures for 
manufacturers (including importers) of per- and polyfluoroalkyl 
substances (hereafter referred to as PFAS) under section 8(a)(7) of the 
Toxic Substances Control Act (TSCA).
    (b) TSCA section 15(3) makes it unlawful for any person to fail or 
refuse to submit information required under this part. In addition, 
TSCA section 15(3) makes it unlawful for any person to fail to keep, 
and permit access to, records required by this part. TSCA section 16 
provides that any person who violates a provision of TSCA section 15 is 
liable to the United States for a civil penalty and may be criminally 
prosecuted. Pursuant to TSCA section 17, the Federal Government may 
seek judicial relief to compel submission of TSCA section 8(a) 
information and to otherwise restrain any violation of TSCA section 15. 
TSCA section 11 allows for inspections to assure compliance, and the 
Environmental Protection Agency's (EPA) Administrator may by subpoena 
require the attendance and testimony of witnesses and the production of 
reports, papers, documents, answers to questions, and other information 
that the Administrator deems necessary.
    (c) Each person who reports under this part must maintain records 
that document information reported under this part and, in accordance 
with TSCA, permit access to, and the copying of, such records by EPA 
officials.


Sec.  705.3   Definitions.

    The definitions in this section and the definitions in TSCA section 
3 apply to this part. In addition, the definitions in 40 CFR 704.3 also 
apply to this part, except the definition for small quantities solely 
for research and development.
    Article means a manufactured item which:
    (1) Is formed to a specific shape or design during manufacture;
    (2) Has end use function(s) depending in whole or in part upon its 
shape or design during end use; and
    (3) Has either no change of chemical composition during its end use 
or only those changes of composition which have no commercial purpose 
separate from that of the article, and that result from a chemical 
reaction that occurs upon end use of other chemical substances, 
mixtures, or articles; except that fluids and particles are not 
considered articles regardless of shape or design.
    Central Data Exchange or CDX means EPA's centralized electronic 
submission receiving system.
    Chemical Information Submission System or CISS means EPA's 
electronic, web-based reporting tool for the completion and submission 
of data, reports, and other information, or its successors.
    Commercial use means the use of a chemical substance or a mixture 
containing a chemical substance (including as part of an article) in a 
commercial enterprise providing saleable goods or services.
    Consumer use means the use of a chemical substance or a mixture 
containing a chemical substance (including as part of an article) when 
sold to or made available to consumers for their use.
    Environmental or health effects information means any information 
of any effect of a chemical substance or mixture containing a chemical 
substance on health or the environment or on both. This includes all 
health and safety studies.
    (1) Not only is information that arises as a result of a formal, 
disciplined study included, but other information relating to the 
effects of a chemical substance or mixture containing a chemical 
substance on health or the environment is also included. Any 
information that bears on the effects of a chemical substance on health 
or the environment would be included.
    (2) Examples are:
    (i) Long- and short-term tests of mutagenicity, carcinogenicity, or 
teratogenicity; data on behavioral disorders; dermatoxicity; 
pharmacological effects; mammalian absorption, distribution, 
metabolism, and excretion; cumulative, additive, and synergistic 
effects; and acute, subchronic, and chronic effects.
    (ii) Tests for ecological or other environmental effects on 
invertebrates, fish, or other animals, and plants, including acute 
toxicity tests, chronic toxicity tests, critical life-stage tests, 
behavioral tests, algal growth tests, seed germination tests, plant 
growth or damage tests, microbial function tests, bioconcentration or 
bioaccumulation tests, and model ecosystem (microcosm) studies.
    (iii) Assessments of human and environmental exposure, including 
workplace exposure, and impacts of a particular chemical substance or 
mixture containing a chemical substance on the environment, including 
surveys, tests, and studies of: Biological, photochemical, and chemical 
degradation; structure/activity relationships; air, water, and soil 
transport; biomagnification and bioconcentration; and chemical and 
physical properties, e.g., boiling point, vapor pressure, evaporation 
rates from soil and water, octanol/water partition coefficient, and 
water solubility.
    (iv) Monitoring data, including but not limited to when they have 
been aggregated and analyzed to measure the exposure of humans or the 
environment to a chemical substance or mixture containing a chemical 
substance.
    Health and safety studies means any study of any effect of a 
chemical substance or mixture on health or the environment or on both, 
including underlying information and epidemiological studies, studies 
of occupational exposure to a chemical substance or mixture, 
toxicological, clinical, and ecological studies of a chemicals 
substance or mixture containing a chemical substance, and any test 
performed under TSCA. The following information is not part of a health 
and safety study:
    (1) The name, address, or other identifying information for the 
submitting company, including identification of the laboratory that 
conducted the study in cases where the laboratory is part of or closely 
affiliated with the submitting company;

[[Page 70549]]

    (2) Internal product codes (i.e., code names for the test substance 
used internally by the submitting company or to identify the test 
substance to the test laboratory);
    (3) Names and contact details for testing laboratory personnel and 
names and other private information for health and safety study 
participants or persons involved in chemical incidents such as would 
typically be withheld under 5 U.S.C. 552(b)(6) or under other privacy 
laws; and
    (4) Information pertaining to test substance product development, 
advertising, or marketing plans, or to cost and other financial data.
    Highest-level U.S. parent company means the highest-level company 
of the site's ownership hierarchy as of the start of the submission 
period during which data are being reported according to the following 
instructions. The highest-level U.S. parent company is located within 
the United States. The following rules govern how to identify the 
highest-level U.S. parent company:
    (1) If the site is entirely owned by a single U.S. company that is 
not owned by another company, that single company is the U.S. parent 
company.
    (2) If the site is entirely owned by a single U.S. company that is, 
itself, owned by another U.S.-based company (e.g., it is a division or 
subsidiary of a higher-level company), the highest-level domestic 
company in the ownership hierarchy is the U.S. parent company.
    (3) If the site is owned by more than one company (e.g., company A 
owns 40 percent, company B owns 35 percent, and company C owns 25 
percent), the company with the largest ownership interest in the site 
is the U.S. parent company. If a higher-level company in the ownership 
hierarchy owns more than one ownership company, then determine the 
entity with the largest ownership by considering the lower-level 
ownerships in combination (e.g., corporation X owns companies B and C, 
for a total ownership of 60 percent for the site).
    (4) If the site is owned by a 50:50 joint venture or a cooperative, 
the joint venture or cooperative is its own parent company. If the site 
is owned by a U.S. joint venture or cooperative, the highest level of 
the joint venture or cooperative is the U.S. parent company.
    (5) If the site is federally owned, the highest-level Federal 
agency or department is the U.S. parent company.
    (6) If the site is owned by a non-Federal public entity, that 
entity (such as a municipality, State, or tribe) is the U.S. parent 
company.
    Industrial function means the intended physical or chemical 
characteristic for which a chemical substance or mixture is consumed as 
a reactant; incorporated into a formulation, mixture, reaction product 
or article; repackaged; or used.
    Industrial use means use at a site at which one or more chemical 
substances or mixtures are manufactured (including imported) or 
processed.
    Intended for use by children means the chemical substance or 
mixture is used in or on a product that is specifically intended for 
use by children aged 14 or younger. A chemical substance or mixture 
containing a chemical substance is intended for use by children when 
the submitter answers ``yes'' to at least one of the following 
questions for the product into which the submitter's chemical substance 
or mixture containing a chemical substance is incorporated:
    (1) Is the product commonly recognized (i.e., by a reasonable 
person) as being intended for children aged 14 or younger?
    (2) Does the manufacturer of the product state through product 
labeling or other written materials that the product is intended for or 
will be used by children aged 14 or younger?
    (3) Is the advertising, promotion, or marketing of the product 
aimed at children aged 14 or younger?
    Known to or reasonably ascertainable by means 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.
    Manufacture means to import into the customs territory of the 
United States (as defined in general note 2 of the Harmonized Tariff 
Schedule of the United States (19 U.S.C. 1202)), produce, or 
manufacture for commercial purposes.
    Manufacture for commercial purposes means:
    (1) To import, produce, or manufacture with the purpose of 
obtaining an immediate or eventual commercial advantage for the 
manufacturer, and includes among other things, such ``manufacture'' of 
any amount of a chemical substance or mixture containing a chemical 
substance:
    (i) For commercial distribution, including for test marketing; and/
or
    (ii) For use by the manufacturer, including use for product 
research and development, or as an intermediate.
    (2) Manufacture for commercial purposes also applies to substances 
that are produced coincidentally during the manufacture, processing, 
use, or disposal of another substance or mixture containing a chemical 
substance, including both byproducts that are separated from that other 
substance or mixture containing a chemical substance and impurities 
that remain in that substance or mixture containing a chemical 
substance. Such byproducts and impurities may, or may not, in 
themselves have commercial value. They are nonetheless produced for the 
purpose of obtaining a commercial advantage since they are part of the 
manufacture of a chemical product for a commercial purpose.
    Per- and polyfluoroalkyl substances or PFAS means, for the purpose 
of this part, any chemical substance or mixture containing a chemical 
substance that structurally contains at least one of the following 
three sub-structures:
    (1) R-(CF<INF>2</INF>)-CF(R')R'', where both the CF<INF>2</INF> and 
CF moieties are saturated carbons.
    (2) R-CF<INF>2</INF>OCF<INF>2</INF>-R', where R and R' can either 
be F, O, or saturated carbons.
    (3) CF<INF>3</INF>C(CF<INF>3</INF>)R'R'', where R' and R'' can 
either be F or saturated carbons.
    Possession or control means in possession or control of the 
submitter, or of any subsidiary, partnership in which the submitter is 
a general partner, parent company, or any company or partnership which 
the parent company owns or controls, if the subsidiary, parent company, 
or other company or partnership is associated with the submitter in the 
research, development, test marketing, or commercial marketing of the 
chemical substance in question. (A parent company owns or controls 
another company if the parent owns or controls 50 percent or more of 
the other company's voting stock. A parent company owns or controls any 
partnership in which it is a general partner.) Information is included 
within this definition if it is:
    (1) In files maintained by submitter's employees who are:
    (i) Associated with research, development, test marketing, or 
commercial marketing of the chemical substance in question; and/or
    (ii) Reasonably likely to have such data.
    (2) Maintained in the files of other agents of the submitter who 
are associated with research, development, test marketing, or 
commercial marketing of the chemical substance in question in the 
course of their employment as such agents.
    Research and development (R&D) means activities intended solely as 
scientific experimentation, research, or analysis. R&D focuses on the 
analysis of the chemical or physical characteristics, the performance, 
or the production characteristics of a chemical substance, a mixture 
containing the substance, or

[[Page 70550]]

an article. R&D encompasses a wide range of activities which may occur 
in a laboratory, pilot plant, commercial plant outside the research 
facility, or at other sites appropriate for R&D. General distribution 
of chemical substances to consumers does not constitute R&D.
    Site-limited means a chemical substance is manufactured and 
processed only within a site and is not distributed as a chemical 
substance or as part of a mixture or article containing a chemical 
substance outside the site. Imported chemical substances are never 
site-limited.
    Worker means someone at a site of manufacture, import, or 
processing who performs work activities near sources of a chemical 
substance or mixture or directly handles the chemical substance or 
mixture during the performance of work activities.


Sec.  705.5   Substances for which reports must be submitted.

    The requirements of this part apply to all chemical substances and 
mixtures containing a chemical substance (including articles) that are 
a PFAS, consistent with the definition of PFAS at Sec.  705.3.


Sec.  705.10   Persons who must report.

    Persons who have manufactured for commercial purposes a chemical 
substance identified in Sec.  705.5 at any period from January 1, 2011, 
through the end of the last calendar year prior to November 13, 2023, 
except as described in Sec.  705.12, is subject to the requirements of 
this part.


Sec.  705.12   Activities for which reporting is not required.

    Reporting under this part is not required for the import of 
municipal solid waste streams for the purpose of disposal or 
destruction of the waste. Additionally, reporting is not required for a 
Federal agency which imports PFAS when it is not for any immediate or 
eventual commercial advantage.


Sec.  705.15   What information to report.

    For the one-time submission, persons identified in Sec.  705.10 
must report to EPA, for each site of each of the chemical substances 
identified in Sec.  705.5, the following information to the extent 
known to or reasonably ascertainable by them, except as allowed under 
Sec.  705.18. In the event that actual data is not known to or 
reasonably ascertainable by the submitter, then reasonable estimates 
may be submitted:
    (a) Company and plant site information. The following currently 
correct company and plant site information must be reported for each 
site at which a reportable chemical substance is manufactured (see 40 
CFR 711.3 for the ``site'' for importers):
    (1) The highest-level U.S. parent company name, address, and Dun 
and Bradstreet D-U-N-S[supreg] (D&B) number, if one exists.
    (2) The name of a person who will serve as Authorized Official for 
the submitter company, and who will be able to sign the certification 
statement as described in Sec.  705.30(d), the Authorized Official's 
full mailing address, telephone number, and email address.
    (3) The name of a person who will serve as technical contact for 
the submitter company, and who will be able to answer questions about 
the information submitted by the company to EPA, the contact person's 
full mailing address, telephone number, and email address.
    (4) The name, full street address, and six-digit North American 
Industry Classification System (NAICS) code(s) of the site. A submitter 
under this part must include the appropriate D&B number for each plant 
site reported, and the county or parish (or other jurisdictional 
indicator) in which the plant site is located. A submitter under this 
part must obtain a D&B number for the site reported if none exists. A 
submitter under this part must also provide other site identification 
numbers, including the Facility Registry Service (FRS) identification 
number, if they exist.
    (b) Chemical-specific information. The following chemical-specific 
information must be reported for each chemical substance that is a PFAS 
manufactured for each year since January 1, 2011, except as allowed 
under Sec.  705.18. This includes each chemical substance that is a 
PFAS and incorporated into mixtures:
    (1) The common or trade name, the chemical identity, and, except 
for chemical substances that are Class 1 substances on the TSCA 
Inventory, the representative molecular structure of each PFAS for 
which such a report is required.
    (i) The specific, currently correct Chemical Abstracts (CA) Index 
name as used to list the chemical substance on the TSCA Inventory and 
the correct corresponding Chemical Abstracts Service Registry Number 
(CASRN) for each reportable PFAS at each site. Submitters who wish to 
report chemical substances listed on the confidential portion of the 
TSCA Inventory will need to report the chemical substance using a TSCA 
Accession Number. If a submitter has a low-volume exemption (LVE) case 
number for the chemical substance, that number may also be used if a 
CASRN is not known to or reasonably ascertainable by the submitter.
    (ii) In addition to reporting the number itself, submitters must 
specify the type of number they are reporting by selecting from among 
the codes in table 1 to this paragraph (b)(1)(ii).

   Table 1 to Paragraph (b)(1)(ii)--Codes To Specify Type of Chemical
                           Identifying Number
------------------------------------------------------------------------
              Code                              Number type
------------------------------------------------------------------------
A...............................  TSCA Accession Number.
C...............................  Chemical Abstracts Service Registry
                                   Number (CASRN).
L...............................  Low-volume exemption (LVE) case
                                   number.
------------------------------------------------------------------------

    (iii) If the CASRN or specific identifier (i.e., Accession Number 
or LVE number) of the PFAS is not known to or reasonably ascertainable 
(NKRA) to the submitter (e.g., if the chemical identity is claimed as 
confidential business information by the submitter's supplier, or if 
the submitter knows they have a PFAS but are unable to ascertain its 
specific identifier and/or specific chemical identity), the submitter 
may provide a generic name or description of the PFAS and also initiate 
a joint submission if the secondary submitter is known. The submitter 
may only initiate a joint submission if the CASRN or the specific 
identifier (i.e., Accession Number or LVE number) is not known or 
reasonably ascertainable, and a secondary submitter (who would provide 
such information) is known. The manufacturer (including importer) must 
use the reporting tool described under Sec.  705.35 to ask the supplier 
or other entity to provide the chemical identity directly to EPA in a 
joint submission. Such request must include instructions for submitting 
chemical identity information electronically, using e-CDRweb and CDX 
(see 40 CFR 711.35), and for clearly referencing the manufacturer's 
(including importer) submission. Contact information for the supplier 
or other entity, a trade name or other designation for the chemical 
substance, and a copy of the request to the supplier or other entity 
must be included with the manufacturer's (including importer) 
submission. If, after conducting due diligence and reviewing known or 
reasonably ascertainable information, a secondary submitter to complete 
the joint submission is not known, the reporter may indicate that the 
secondary submitter is NKRA. However, the PFAS manufacturer would be 
required to

[[Page 70551]]

provide as much identifying detail as they have regarding the PFAS 
identity, and would be able to report to EPA without initiating a joint 
submission even if they do not know the underlying identity of the 
chemical substance.
    (2) The physical form(s) of the PFAS as it is sent off-site from 
each site. If the PFAS is site-limited, you must report the physical 
form(s) of the PFAS at the time it is reacted on-site to produce a 
different chemical substance. For each PFAS at each site, the submitter 
must report as many physical forms as applicable from among the 
physical forms listed in this unit:
    (i) Dry powder.
    (ii) Pellets or large crystals.
    (iii) Water- or solvent-wet solid.
    (iv) Other solid.
    (v) Gas or vapor.
    (vi) Liquid.
    (c) Categories of use. For each year since January 1, 2011, report 
the following information on categories of use of each chemical 
substance that is a PFAS manufactured for commercial purposes.
    (1) Industrial processing and use information. A designation 
indicating the type of industrial processing or use operation(s) at 
each site that receives a PFAS from the submitter site directly or 
indirectly (whether the recipient site(s) are controlled by the 
submitter site or not). For each PFAS, report the letters which 
correspond to the appropriate processing or use operation(s) listed in 
table 2 to this paragraph (c)(1). A particular designation may need to 
be reported more than once, to the extent that a submitter reports more 
than one sector that applies to a given designation under this 
paragraph (c)(1).

   Table 2 to Paragraph (c)(1)--Codes for Reporting Type of Industrial
                       Processing or Use Operation
------------------------------------------------------------------------
             Designation                           Operation
------------------------------------------------------------------------
PC..................................  Processing as a reactant.
PF..................................  Processing--incorporation into
                                       formulation, mixture, or reaction
                                       product.
PA..................................  Processing--incorporation into
                                       article.
PK..................................  Processing--repackaging.
U...................................  Use--non-incorporative activities.
------------------------------------------------------------------------

    (2) Corresponding sector code. A code indicating the sector(s) that 
best describes the industrial activities associated with each 
industrial processing or use operation reported under this section. For 
each chemical substance, report the code that corresponds to the 
appropriate sector(s) listed in table 3 to this paragraph (c)(2). A 
particular sector code may need to be reported more than once, to the 
extent that a submitter reports more than one function code that 
applies to a given sector code under this paragraph (c)(2).

   Table 3 to Paragraph (c)(2)--Codes for Reporting Industrial Sectors
------------------------------------------------------------------------
              Code                          Sector description
------------------------------------------------------------------------
IS1.............................  Agriculture, forestry, fishing, and
                                   hunting.
IS2.............................  Oil and gas drilling, extraction, and
                                   support activities.
IS3.............................  Mining (except oil and gas) and
                                   support activities.
IS4.............................  Utilities.
IS5.............................  Construction.
IS6.............................  Food, beverage, and tobacco product
                                   manufacturing.
IS7.............................  Textiles, apparel, and leather
                                   manufacturing.
IS8.............................  Wood product manufacturing.
IS9.............................  Paper manufacturing.
IS10............................  Printing and related support
                                   activities.
IS11............................  Petroleum refineries.
IS12............................  Asphalt paving, roofing, and coating
                                   materials manufacturing.
IS13............................  Petroleum lubricating oil and grease
                                   manufacturing.
IS14............................  All other petroleum and coal products
                                   manufacturing.
IS15............................  Petrochemical manufacturing.
IS16............................  Industrial gas manufacturing.
IS17............................  Synthetic dye and pigment
                                   manufacturing.
IS18............................  Carbon black manufacturing.
IS19............................  All other basic inorganic chemical
                                   manufacturing.
IS20............................  Cyclic crude and intermediate
                                   manufacturing.
IS21............................  All other basic organic chemical
                                   manufacturing.
IS22............................  Plastics material and resin
                                   manufacturing.
IS23............................  Synthetic rubber manufacturing.
IS24............................  Organic fiber manufacturing.
IS25............................  Pesticide, fertilizer, and other
                                   agricultural chemical manufacturing.
IS26............................  Pharmaceutical and medicine
                                   manufacturing.
IS27............................  Paint and coating manufacturing.
IS28............................  Adhesive manufacturing.
IS29............................  Soap, cleaning compound, and toilet
                                   preparation manufacturing.
IS30............................  Printing ink manufacturing.
IS31............................  Explosives manufacturing.
IS32............................  Custom compounding of purchased
                                   resins.
IS33............................  Photographic film, paper, plate, and
                                   chemical manufacturing.
IS34............................  All other chemical product and
                                   preparation manufacturing.
IS35............................  Plastics product manufacturing.
IS36............................  Rubber product manufacturing.
IS37............................  Non-metallic mineral product
                                   manufacturing (includes cement, clay,
                                   concrete, glass, gypsum, lime, and
                                   other non-metallic mineral product
                                   manufacturing).
IS38............................  Primary metal manufacturing.
IS39............................  Fabricated metal product
                                   manufacturing.
IS40............................  Machinery manufacturing.
IS41............................  Computer and electronic product
                                   manufacturing.
IS42............................  Electrical equipment, appliance, and
                                   component manufacturing.
IS43............................  Transportation equipment
                                   manufacturing.
IS44............................  Furniture and related product
                                   manufacturing.
IS45............................  Miscellaneous manufacturing.
IS46............................  Wholesale and retail trade.
IS47............................  Services.
IS48............................  Other (requires additional
                                   information).
------------------------------------------------------------------------

    (3) Corresponding function category. For each sector reported under 
paragraph (c)(2) of this section, the applicable code(s) from table 4 
to this paragraph (c)(3) must be selected to designate the function 
category(ies) that best represents the specific manner in which the 
PFAS is used.

  Table 4 to Paragraph (c)(3)--Codes for Reporting Function Categories
------------------------------------------------------------------------
              Code                               Category
------------------------------------------------------------------------
F001............................  Abrasives.
F002............................  Etching agent.
F003............................  Adhesion/cohesion promoter.
F004............................  Binder.
F005............................  Flux agent.
F006............................  Sealant (barrier).
F007............................  Absorbent.
F008............................  Adsorbent.
F009............................  Dehydrating agent (desiccant).
F010............................  Drier.
F011............................  Humectant.
F012............................  Soil amendments (fertilizers).
F013............................  Anti-adhesive/cohesive.
F014............................  Dusting agent.
F015............................  Bleaching agent.
F016............................  Brightener.
F017............................  Anti-scaling agent.
F018............................  Corrosion inhibitor.
F019............................  Dye.
F020............................  Fixing agent (mordant).
F021............................  Hardener.
F022............................  Filler.
F023............................  Anti-static agent.
F024............................  Softener and conditioner.
F025............................  Swelling agent.
F026............................  Tanning agents not otherwise
                                   specified.
F027............................  Waterproofing agent.
F028............................  Wrinkle resisting agent.
F029............................  Flame retardant.
F030............................  Fuel agents.
F031............................  Fuel.
F032............................  Heat transferring agent.
F033............................  Hydraulic fluids.
F034............................  Insulators.
F035............................  Refrigerants.

[[Page 70552]]

 
F036............................  Anti-freeze agent.
F037............................  Intermediate.
F038............................  Monomers.
F039............................  Ion exchange agent.
F040............................  Anti-slip agent.
F041............................  Lubricating agent.
F042............................  Deodorizer.
F043............................  Fragrance.
F044............................  Oxidizing agent.
F045............................  Reducing agent.
F046............................  Photosensitive agent.
F047............................  Photosensitizers.
F048............................  Semiconductor and photovoltaic agent.
F049............................  UV stabilizer.
F050............................  Opacifer.
F051............................  Pigment.
F052............................  Plasticizer.
F053............................  Plating agent.
F054............................  Catalyst.
F055............................  Chain transfer agent.
F056............................  Chemical reaction regulator.
F057............................  Crystal growth modifiers (nucleating
                                   agents).
F058............................  Polymerization promoter.
F059............................  Terminator/Blocker.
F060............................  Processing aids, specific to petroleum
                                   production.
F061............................  Antioxidant.
F062............................  Chelating agent.
F063............................  Defoamer.
F064............................  pH regulating agent.
F065............................  Processing aids not otherwise
                                   specified.
F066............................  Energy Releasers (explosives, motive
                                   propellant).
F067............................  Foamant.
F068............................  Propellants, non-motive (blowing
                                   agents).
F069............................  Cloud-point depressant.
F070............................  Flocculating agent.
F071............................  Flotation agent.
F072............................  Solids separation (precipitating)
                                   agent, not otherwise specified.
F073............................  Cleaning agent.
F074............................  Diluent.
F075............................  Solvent.
F076............................  Surfactant (surface active agent).
F077............................  Emulsifier.
F078............................  Thickening agent.
F079............................  Viscosity modifiers.
F080............................  Laboratory chemicals.
F081............................  Dispersing agent.
F082............................  Freeze-thaw additive.
F083............................  Surface modifier.
F084............................  Wetting agent (non-aqueous).
F085............................  Aerating and deaerating agents.
F086............................  Explosion inhibitor.
F087............................  Fire extinguishing agent.
F088............................  Flavoring and nutrient.
F089............................  Anti-redeposition agent.
F090............................  Anti-stain agent.
F091............................  Anti-streaking agent.
F092............................  Conductive agent.
F093............................  Incandescent agent.
F094............................  Magnetic element.
F095............................  Anti-condensation agent.
F096............................  Coalescing agent.
F097............................  Film former.
F098............................  Demulsifier.
F099............................  Stabilizing agent.
F100............................  Alloys.
F101............................  Density modifier.
F102............................  Elasticizer.
F103............................  Flow promoter.
F104............................  Sizing agent.
F105............................  Solubility enhancer.
F106............................  Vapor pressure modifiers.
F107............................  Embalming agent.
F108............................  Heat stabilizer.
F109............................  Preservative.
F110............................  Anti-caking agent.
F111............................  Deflocculant.
F112............................  Dust suppressant.
F113............................  Impregnation agent.
F114............................  Leaching agent.
F115............................  Tracer.
F116............................  X-ray absorber.
F999............................  Other.
------------------------------------------------------------------------

    (4) Consumer and commercial use information. Using the applicable 
codes listed in table 5 to this paragraph (c)(4), submitters must 
designate the consumer and commercial product category(ies) that best 
describe the consumer and commercial products in which each PFAS is 
used (whether the recipient site(s) are controlled by the submitter 
site or not). If more than 10 codes apply to a PFAS, submitters need 
only report the 10 codes for PFAS that cumulatively represent the 
largest percentage of the submitter's production volume for that 
chemical, measured by weight. If none of the listed consumer and 
commercial product categories accurately describes the consumer and 
commercial products in which each PFAS is used, the category ``Other'' 
may be used, and must include a description of the use.

Table 5 to Paragraph (c)(4)--Codes for Reporting Consumer and Commercial
                           Product Categories
------------------------------------------------------------------------
              Code                               Category
------------------------------------------------------------------------
  Chemical Substances in Furnishing, Cleaning, Treatment Care Products
------------------------------------------------------------------------
CC101...........................  Construction and building materials
                                   covering large surface areas
                                   including stone, plaster, cement,
                                   glass and ceramic articles; fabrics,
                                   textiles, and apparel.
CC102...........................  Furniture & furnishings including
                                   plastic articles (soft); leather
                                   articles.
CC103...........................  Furniture & furnishings including
                                   stone, plaster, cement, glass and
                                   ceramic articles; metal articles; or
                                   rubber articles.
CC104...........................  Leather conditioner.
CC105...........................  Leather tanning, dye, finishing,
                                   impregnation and care products.
CC106...........................  Textile (fabric) dyes.
CC107...........................  Textile finishing and impregnating/
                                   surface treatment products.
CC108...........................  All-purpose foam spray cleaner.
CC109...........................  All-purpose liquid cleaner/polish.
CC110...........................  All-purpose liquid spray cleaner.
CC111...........................  All-purpose waxes and polishes.
CC112...........................  Appliance cleaners.
CC113...........................  Drain and toilet cleaners (liquid).
CC114...........................  Powder cleaners (floors).
CC115...........................  Powder cleaners (porcelain).
CC116...........................  Dishwashing detergent (liquid/gel).
CC117...........................  Dishwashing detergent (unit dose/
                                   granule).
CC118...........................  Dishwashing detergent liquid (hand-
                                   wash).
CC119...........................  Dry cleaning and associated products.
CC120...........................  Fabric enhancers.
CC121...........................  Laundry detergent (unit-dose/granule).
CC122...........................  Laundry detergent (liquid).
CC123...........................  Stain removers.
CC124...........................  Ion exchangers.
CC125...........................  Liquid water treatment products.
CC126...........................  Solid/Powder water treatment products.
CC127...........................  Liquid body soap.
CC128...........................  Liquid hand soap.
CC129...........................  Solid bar soap.
CC130...........................  Air fresheners for motor vehicles.
CC131...........................  Continuous action air fresheners.
CC132...........................  Instant action air fresheners.
CC133...........................  Anti-static spray.
CC134...........................  Apparel finishing, and impregnating/
                                   surface treatment products.
CC135...........................  Insect repellent treatment.
CC136...........................  Pre-market waxes, stains, and polishes
                                   applied to footwear.
CC137...........................  Post-market waxes, and polishes
                                   applied to footwear (shoe polish).
CC138...........................  Waterproofing and water-resistant
                                   sprays.
------------------------------------------------------------------------
    Chemical Substances in Construction, Paint, Electrical, and Metal
                                Products
------------------------------------------------------------------------
CC201...........................  Fillers and putties.
CC202...........................  Hot-melt adhesives.
CC203...........................  One-component caulks.
CC204...........................  Solder.
CC205...........................  Single-component glues and adhesives.
CC206...........................  Two-component caulks.
CC207...........................  Two-component glues and adhesives.
CC208...........................  Adhesive/Caulk removers.
CC209...........................  Aerosol spray paints.
CC210...........................  Lacquers, stains, varnishes and floor
                                   finishes.
CC211...........................  Paint strippers/removers.
CC212...........................  Powder coatings.
CC213...........................  Radiation curable coatings.
CC214...........................  Solvent-based paint.
CC215...........................  Thinners.
CC216...........................  Water-based paint.

[[Page 70553]]

 
CC217...........................  Construction and building materials
                                   covering large surface areas,
                                   including wood articles.
CC218...........................  Construction and building materials
                                   covering large surface areas,
                                   including paper articles; metal
                                   articles; stone, plaster, cement,
                                   glass and ceramic articles.
CC219...........................  Machinery, mechanical appliances,
                                   electrical/electronic articles.
CC220...........................  Other machinery, mechanical
                                   appliances, electronic/electronic
                                   articles.
CC221...........................  Construction and building materials
                                   covering large surface areas,
                                   including metal articles.
CC222...........................  Electrical batteries and accumulators.
------------------------------------------------------------------------
 Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products
------------------------------------------------------------------------
CC990...........................  Non-TSCA use.
CC301...........................  Packaging (excluding food packaging),
                                   including paper articles.
CC302...........................  Other articles with routine direct
                                   contact during normal use, including
                                   paper articles.
CC303...........................  Packaging (excluding food packaging),
                                   including rubber articles; plastic
                                   articles (hard); plastic articles
                                   (soft).
CC304...........................  Other articles with routine direct
                                   contact during normal use including
                                   rubber articles; plastic articles
                                   (hard).
CC305...........................  Toys intended for children's use (and
                                   child dedicated articles), including
                                   fabrics, textiles, and apparel; or
                                   plastic articles (hard).
CC306...........................  Adhesives applied at elevated
                                   temperatures.
CC307...........................  Cement/concrete.
CC308...........................  Crafting glue.
CC309...........................  Crafting paint (applied to body).
CC310...........................  Crafting paint (applied to craft).
CC311...........................  Fixatives and finishing spray
                                   coatings.
CC312...........................  Modelling clay.
CC313...........................  Correction fluid/tape.
CC314...........................  Inks in writing equipment (liquid).
CC315...........................  Inks used for stamps.
CC316...........................  Toner/Printer cartridge.
CC317...........................  Liquid photographic processing
                                   solutions.
------------------------------------------------------------------------
    Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use
                                Products
------------------------------------------------------------------------
CC401...........................  Exterior car washes and soaps.
CC402...........................  Exterior car waxes, polishes, and
                                   coatings.
CC403...........................  Interior car care.
CC404...........................  Touch up auto paint.
CC405...........................  Degreasers.
CC406...........................  Liquid lubricants and greases.
CC407...........................  Paste lubricants and greases.
CC408...........................  Spray lubricants and greases.
CC409...........................  Anti-freeze liquids.
CC410...........................  De-icing liquids.
CC411...........................  De-icing solids.
CC412...........................  Lock de-icers/releasers.
CC413...........................  Cooking and heating fuels.
CC414...........................  Fuel additives.
CC415...........................  Vehicular or appliance fuels.
CC416...........................  Explosive materials.
CC417...........................  Agricultural non-pesticidal products.
CC418...........................  Lawn and garden care products.
------------------------------------------------------------------------
      Chemical Substances in Products Not Described by Other Codes
------------------------------------------------------------------------
CC980...........................  Other (specify).
CC990...........................  Non-TSCA use.
------------------------------------------------------------------------

    (5) Applicable codes for each commercial and consumer products. For 
each consumer and commercial product category reported under paragraph 
(c)(4) of this section, the applicable code(s) described in table 4 to 
paragraph (c)(3) of this section must be selected to designate the 
function category(ies) that best represents the specific manner in 
which the PFAS is used.
    (6) Commercial and consumer products. Submitters must indicate, for 
each consumer and commercial product category reported under paragraph 
(c)(4) of this section, whether the use is a consumer or a commercial 
use, or both.
    (7) Consumer product category. Submitters must determine, within 
each consumer and commercial product category reported under paragraph 
(c)(4) of this section, whether any amount of each reportable chemical 
substance manufactured (including imported) by the submitter is present 
in (for example, a plasticizer chemical substance used to make 
pacifiers) or on (for example, as a component in the paint on a toy) 
any consumer products intended for use by children age 14 or younger, 
regardless of the concentration of the chemical substance remaining in 
or on the product. Submitters must select from the following options: 
The chemical substance is used in or on any consumer products intended 
for use by children; the chemical substance is not used in or on any 
consumer products intended for use by children; or information as to 
whether the chemical substance is used in or on any consumer products 
intended for use by children is not known to or reasonably 
ascertainable by the submitter.
    (8) Concentrations of PFAS. For each year where the PFAS is used in 
consumer or commercial products, the estimated typical maximum 
concentration, measured by weight, of the chemical substance in each 
consumer and commercial product category reported under paragraph 
(c)(4) of this section. For each PFAS in each commercial and consumer 
product category reported under paragraph (c)(4) of this section, 
submitters must select from among the ranges of concentrations listed 
in table 6 to this paragraph (c)(8) and report the corresponding code 
(i.e., M1 through M5):

 Table 6 to Paragraph (c)(8)--Codes for Reporting Maximum Concentration
                          of Chemical Substance
------------------------------------------------------------------------
              Code                    Concentration range  (% weight)
------------------------------------------------------------------------
M1..............................  Less than 1% by weight.
M2..............................  At least 1 but less than 30% by
                                   weight.
M3..............................  At least 30 but less than 60% by
                                   weight.
M4..............................  At least 60 but less than 90% by
                                   weight.
M5..............................  At least 90% by weight.
------------------------------------------------------------------------

    (d) Manufactured amounts. For each year since January 1, 2011, the 
total amounts manufactured of each PFAS, including the amounts 
manufactured in each calendar year for each category of use as 
described in paragraph (c) of this section.
    (1) Total volume. For each year the PFAS was manufactured, the 
total annual volume (in pounds) of each PFAS domestically manufactured 
or imported at each site. The total annual domestically manufactured 
volume (not including imported volume) and the total annual imported 
volume must be separately reported. These amounts must be reported to 
two significant figures of accuracy.
    (2) Site designation. A designation indicating, for each PFAS at 
each site, whether the imported PFAS is physically present at the 
reporting site.
    (3) Volume imported. The volume directly exported of each PFAS 
domestically manufactured or imported at each site. These amounts must 
be reported to two significant figures of accuracy.
    (4) Production volume. The estimated percentage, rounded off to the 
closest 10 percent, of total production volume of the reportable 
chemical substance associated with each combination of industrial 
processing or use operation, sector, and function category as reported 
in paragraph (c) of this section. Where a particular combination of 
industrial processing or use operation, sector, and function category 
accounts for less than

[[Page 70554]]

5 percent of the submitter's site's total production volume of a 
reportable chemical substance, the percentage must not be rounded off 
to 0 percent. Instead, in such a case, submitters must report the 
percentage, rounded off to the closest 1 percent, of the submitter's 
site's total production volume of the reportable chemical substance 
associated with the particular combination of industrial processing or 
use operation, sector, and function category.
    (5) Site production volume. The estimated percentage, rounded off 
to the closest 10 percent, of the submitter's site's total production 
volume of the PFAS associated with each consumer and commercial product 
category as reported in paragraph (c)(4) of this section. Where a 
particular consumer and commercial product category accounts for less 
than 5 percent of the total production volume of a reportable chemical 
substance, the percentage must not be rounded off to 0 percent. 
Instead, in such a case, submitters must report the percentage, rounded 
off to the closest 1 percent, of the submitter's site's total 
production volume of the reportable chemical substance associated with 
the particular consumer and commercial product category.
    (6) Site-limited. An indication of whether the PFAS was site-
limited.
    (7) Volume recycled. The total volume (in pounds) of each PFAS 
recycled on-site.
    (e) Byproduct reporting. A description of the byproducts resulting 
from the manufacture, processing, use, or disposal of each PFAS.
    (1) Byproduct identification. For each byproduct produced from the 
manufacture, processing, use, or disposal of a PFAS, the submitter will 
identify the byproduct by its specific, currently correct CA Index name 
as used to list the chemical substance on the TSCA Inventory and the 
correct corresponding CASRN. A submitter under this part may use a 
known EPA-designated TSCA Accession Number for a chemical substance in 
lieu of a CASRN when a CASRN is not known to or reasonably 
ascertainable by the submitter. Submitters who wish to report chemical 
substances listed on the confidential portion of the TSCA Inventory 
will need to report the chemical substance using a TSCA Accession 
Number.
    (i) In addition to reporting the number itself, submitters must 
specify the type of number they are reporting by selecting from among 
the codes in table 1 to paragraph (b)(1)(ii) of this section.
    (ii) If the specific chemical identity of the byproduct is unknown 
to the submitter, the submitter may provide a description of the 
chemical substance.
    (iii) An indication of which specific PFAS activity(ies) (i.e., 
manufacture, process, use, or disposal) manufactured the byproduct.
    (2) Releases. An indication of whether the byproduct is released to 
the environment, and if so, the environmental medium to which it is 
released (i.e., air, water, land).
    (3) Volume. For each year, the byproduct volume (in pounds) 
released to the environment.
    (f) Environmental and health effects. All existing information 
concerning the environmental and health effects of such substance or 
mixture containing a chemical substance in the manufacturer's 
possession or control. The scope of this information shall not be 
limited to studies conducted or published since 2011.
    (1) Organization for Economic Cooperation and Development (OECD) 
Harmonized Templates. For each published study report, the submitter 
shall complete an OECD Harmonized Templates for Reporting Chemical Test 
Summaries and submit the accompanying study reports and supporting 
information. This can be accomplished by using the freely available 
IUCLID software.
    (2) Human health data--preliminary studies. Submitters shall also 
provide any additional human health data not in study reports, 
including but not limited to any preliminary studies, informal test 
results in workers, or inhalation studies.
    (3) Analytical tests. Submitters shall also provide the names of 
any analytical or test methods used to detect or otherwise test for the 
PFAS.
    (g) Worker exposure data. The number of individuals exposed to PFAS 
in their places of employment and the duration of such exposure.
    (1) Employment activities. A narrative description of worker 
activities involving the PFAS at the manufacturing site, such as bag 
dumping, sampling, cleaning, or unloading drums.
    (2) Number of workers. For each worker activity in this paragraph, 
indicate the number of workers reasonably likely to be exposed. The 
submitter must select from among the worker ranges listed in table 7 to 
this paragraph (g)(2) and report the corresponding code (i.e., W1 
though W8).

   Table 7 to Paragraph (g)(2)--Codes for Reporting Number of Workers
                     Reasonably Likely To Be Exposed
------------------------------------------------------------------------
              Code                                 Range
------------------------------------------------------------------------
W1..............................  Fewer than 10 workers.
W2..............................  At least 10 but fewer than 25 workers.
W3..............................  At least 25 but fewer than 50 workers.
W4..............................  At least 50 but fewer than 100
                                   workers.
W5..............................  At least 100 but fewer than 500
                                   workers.
W6..............................  At least 500 but fewer than 1,000
                                   workers.
W7..............................  At least 1,000 but fewer than 10,000
                                   workers.
W8..............................  At least 10,000 workers.
------------------------------------------------------------------------

    (3) Exposure scenarios. For each worker activity in this paragraph 
(g), the maximum duration of exposure for any worker at the 
manufacturing site, for each of the following scenarios:
    (i) The daily exposure duration (in hours per day) in the case of 
the worker with greatest annual exposure frequency (i.e., the worker 
exposed the most days per year); and
    (ii) The annual exposure frequency (in days per year) in the case 
of the worker with greatest daily exposure duration (i.e., the worker 
exposed for the most hours per day during the year).
    (4) Exposure by category. For each combination of industrial 
processing or use operation, sector, and function category identified 
in paragraph (c) of this section, the submitter must estimate the 
number of workers reasonably likely to be exposed to each PFAS. For 
each combination associated with each chemical substance, the submitter 
must select from among the worker ranges listed in table 7 to paragraph 
(g)(2) of this section and report the corresponding code (i.e., W1 
though W8).
    (5) Duration of exposure industrial use. For each PFAS, the maximum 
duration of exposure for any worker for each combination of industrial 
processing or use operation, sector, and function category, for each of 
the following scenarios:
    (i) The daily exposure duration (in hours per day) in the case of 
the worker with the greatest annual exposure frequency (i.e., the 
worker exposed the most days per year); and
    (ii) The annual exposure frequency (in days per year) in the case 
of the worker with the greatest daily exposure duration (i.e., the 
worker exposed for the most hours per day during the year).
    (6) Commercial workers. Where the PFAS is used in a commercial 
product,

[[Page 70555]]

the submitter must estimate the number of commercial workers reasonably 
likely to be exposed to each reportable chemical substance. For each 
commercial use associated with each substance, the submitter must 
select from among the worker ranges listed in table 7 to paragraph 
(g)(2) of this section and report the corresponding code (i.e., W1 
though W8).
    (7) Duration of exposure commercial use. For each PFAS, the maximum 
duration of exposure for any worker for each commercial use, for each 
of the following scenarios:
    (i) The daily exposure duration (in hours per day) in the case of 
the worker with greatest annual exposure frequency (i.e., the worker 
exposed the most days per year); and
    (ii) The annual exposure frequency (in days per year) in the case 
of the worker with greatest daily exposure duration (i.e., the worker 
exposed for the most hours per day during the year).
    (h) Disposal data. During the years in which the PFAS was 
manufactured, the manners or methods of its disposal, and any changes 
to the disposal methods or processes.
    (1) Categories of disposal methods. Description of disposal 
processes or methods, using the appropriate codes in table 8 to this 
paragraph (h)(1), and additional descriptions as needed.

    Table 8 to Paragraph (h)(1)--Codes for Reporting Disposal Methods
------------------------------------------------------------------------
              Code                            Disposal method
------------------------------------------------------------------------
D1..............................  On-site land disposal: Resource
                                   Conservation and Recovery Act (RCRA)
                                   Class C landfill (hazardous).
D2..............................  On-site land disposal: other landfill.
D3..............................  Other on-site land disposal.
D4..............................  On-site underground injection (UIC).
D5..............................  Off-site land disposal: RCRA Class C
                                   landfill (hazardous).
D6..............................  Off-site land disposal: other
                                   landfill.
D7..............................  On-site incineration.
D8..............................  Off-site incineration.
D9..............................  Publicly owned treatment works (POTW).
D10.............................  Other off-site waste transfer.
D11.............................  Release to surface water.
D12.............................  Release to air (stack emissions).
D13.............................  Release to air (fugitive emissions).
D99.............................  Other.
------------------------------------------------------------------------

    (2) Disposal processes. Describe any changes to the disposal 
process(es) or method(s) indicated in paragraph (h)(1) of this section 
for any PFAS manufactured since 2011.
    (3) Disposal volume. Indicate total volume of the PFAS that was 
released to each environmental medium in each year since 2011: land, 
water, and air.
    (4) Incineration volume. Indicate total volume of the PFAS that was 
incinerated on-site in each year since 2011. If incineration occurred, 
indicate the temperature (in degrees Celsius) at which the PFAS was 
incinerated. If incineration occurred at multiple temperatures, 
indicate the minimum temperature (in degrees Celsius) at which the PFAS 
was incinerated.


Sec.  705.18   Article importer and R&D substance reporting options.

    For the one-time submission, certain manufacturers have the option 
to use a streamlined reporting form if they do not know nor can 
reasonably ascertain information requested under Sec.  705.15, beyond 
what is listed in this part. Paragraph (a) of this section lists the 
information which a manufacturer who has imported a PFAS within an 
article must report to the extent they know or can reasonably 
ascertain. Paragraph (b) of this section lists the information that 
manufacturers of PFAS that are solely R&D substances manufactured in 
volumes no greater than 10 kilograms per year must report to the extent 
they know or can reasonably ascertain.
    (a) Article reporting. Any importer of an article which contains a 
chemical substance that is a PFAS and who meets the reporting 
requirements described in Sec.  705.10 has the option to submit 
information to EPA using a streamlined reporting form for that PFAS in 
the imported article, for each year since January 1, 2011, in which the 
PFAS was imported in an article. Information must be submitted to the 
extent the submitter knows or can reasonably ascertain. In the event 
that actual data is not known to or reasonably ascertainable by the 
submitter, then reasonable estimates may be submitted. The information 
requested on the streamlined reporting form for article importers 
includes:
    (1) Company and plant site information. All company and plant site 
information requested under Sec.  705.15(a) shall be reported.
    (2) Chemical-specific information. The following chemical-specific 
information must be reported for each chemical substance that is a PFAS 
imported in an article, for each year since January 1, 2011, in which 
that PFAS was imported within an article.
    (i) The common or trade name, the chemical identity, and, except 
for chemical substances that are Class 1 substances on the TSCA 
Inventory (Inventory), the representative molecular structure of each 
PFAS for which such a report is required. Submitters who wish to report 
chemical substances listed on the confidential portion of the Inventory 
will need to report the chemical substance using a TSCA Accession 
Number. If a submitter has a low-volume exemption (LVE) case number for 
the chemical substance, that number may also be used if a CASRN is not 
known to or reasonably ascertainable by the submitter. In addition to 
reporting the number itself, submitters must specify the type of number 
they are reporting by selecting from among the codes in table 1 to 
Sec.  705.15(b)(1)(ii).
    (ii) If the specific chemical identity of the PFAS imported in an 
article is not known to or reasonably ascertainable to the submitter 
(e.g., if the chemical identity is claimed as confidential business 
information by the submitter's supplier, or if the submitter knows they 
have a PFAS but is unable to ascertain its specific chemical identity), 
the submitter may provide a generic name or description of the PFAS.
    (3) Categories of use. For each year since January 1, 2011, report 
the following information on categories of use of each PFAS imported in 
an article.
    (i) Industrial processing and use information. A designation 
indicating the type of industrial processing or use operation(s) at 
each site that receives a PFAS from the submitter site directly or 
indirectly (whether the recipient site(s) are controlled by the 
submitter site or not). For each PFAS that was imported in an article, 
report the letters which correspond to the appropriate processing or 
use operation(s) listed in table 2 to Sec.  705.15(c)(1). A particular 
designation may need to be reported more than once, to the extent that 
a submitter reports more than one sector that applies to a given 
designation under this paragraph (a)(3)(i).
    (ii) Industrial activities sector. A code indicating the sector(s) 
that best describe the industrial activities associated with each 
industrial processing or use operation reported under this section. For 
each PFAS that was imported in an article, report the code that 
corresponds to the appropriate sector(s) listed in table 3 to Sec.  
705.15(c)(2). A particular sector code may need to be reported more 
than once, to the extent that a submitter reports more than one 
function code that applies to a given sector code under this paragraph 
(a)(3)(ii).
    (iii) Sector specific function categories. For each sector reported 
under paragraph (a)(3)(ii) of this section, the applicable code(s) from 
table 4 to Sec.  705.15(c)(3) must be selected to designate the 
function category(ies) that best represents the specific manner in 
which the PFAS in the imported article is used.

[[Page 70556]]

    (iv) Consumer and commercial use information. Using the applicable 
codes listed in table 5 to Sec.  705.15(c)(4), submitters must 
designate the consumer and commercial product category(ies) that best 
describe the consumer and commercial products in which each PFAS that 
is in an imported article is used (whether the recipient site(s) are 
controlled by the submitter site or not). If more than 10 codes apply 
to a PFAS in an imported article, submitters need only report the 10 
codes for PFAS that cumulatively represent the largest percentage of 
the submitter's production volume for that chemical, measured by 
weight. If none of the listed consumer and commercial product 
categories accurately describe the consumer and commercial products in 
which each PFAS is used, the category ``Other'' may be used, and must 
include a description of the use.
    (v) Product specific function categories. For each consumer and 
commercial product category reported under paragraph (a)(3)(iv) of this 
section, the applicable code(s) described in table 4 to Sec.  
705.15(c)(3) must be selected to designate the function category(ies) 
that best represents the specific manner in which the PFAS in an 
imported article is used.
    (vi) Consumer or commercial use designation. Submitters must 
indicate, for each consumer and commercial product category reported 
under paragraph (a)(3)(v) of this section, whether the use is a 
consumer or a commercial use, or both.
    (vii) In or on consumer products intended for children. Submitters 
must determine, within each consumer and commercial product category 
reported under paragraph (a)(3)(v) of this section, whether any amount 
of each reportable chemical substance manufactured (including imported) 
by the submitter is present in (for example, a plasticizer chemical 
substance used to make pacifiers) or on (for example, as a component in 
the paint on a toy) any consumer products intended for use by children 
age 14 or younger, regardless of the concentration of the chemical 
substance remaining in or on the product. Submitters must select from 
the following options: The chemical substance is used in or on any 
consumer products intended for use by children; the chemical substance 
is not used in or on any consumer products intended for use by 
children; or information as to whether the chemical substance is used 
in or on any consumer products intended for use by children is not 
known to or reasonably ascertainable by the submitter.
    (viii) Estimated maximum concentration. For each year where the 
PFAS in an imported article is used in consumer or commercial products, 
the submitter must report the estimated typical maximum concentration, 
measured by weight, of the chemical substance in each consumer and 
commercial product category reported under paragraph (a)(3)(v) of this 
section. For each PFAS in an imported article in each commercial and 
consumer product category reported under paragraph (a)(3)(v) of this 
section, submitters must select from among the ranges of concentrations 
listed in table 1 to this paragraph (a)(3)(viii) and report the 
corresponding code (i.e., AM1 through AM5):

     Table 1 to Paragraph (a)(3)(viii)--Codes for Reporting Maximum
              Concentration of PFAS in an Imported Article
------------------------------------------------------------------------
              Code                    Concentration range (% weight)
------------------------------------------------------------------------
AM1.............................  Less than 0.1% by weight.
AM2.............................  At least 0.1% but less than 1% by
                                   weight.
AM3.............................  At least 1% but less than 10% by
                                   weight.
AM4.............................  At least 10% but less than 30% by
                                   weight.
AM5.............................  At least 30% by weight.
------------------------------------------------------------------------

    (4) Imported article production volume. For each calendar year 
since January 1, 2011, in which the PFAS was imported in an article, 
the production volume of the imported article. The imported production 
volume must be reported to two significant figures of accuracy. The 
submitter must also provide the unit of measurement of the imported 
production volume by selecting among the table 2 to this paragraph 
(a)(4). The submitter must also designate, for each PFAS imported in an 
article, whether the imported PFAS was ever physically present at the 
reporting site.

  Table 2 to Paragraph (a)(4)--Codes To Specify Unit of Measurement for
                 the Imported Article Production Volume
------------------------------------------------------------------------
              Code                          Unit of measurement
------------------------------------------------------------------------
LB..............................  Pounds.
TN..............................  Tons.
QT..............................  Quantity of imported article.
O...............................  Other (must specify).
------------------------------------------------------------------------

    (5) Additional article data. The submitter has the option to 
provide any additional information to EPA that is requested under Sec.  
705.15 on the PFAS imported in an article, including supplemental 
attachments.
    (b) Research and development (R&D). Any manufacturer of a PFAS R&D 
substance that was manufactured in volumes no greater than 10 kilograms 
per year and who meets the reporting requirements described in Sec.  
705.10 has the option to submit information to EPA using a streamlined 
reporting form for each such PFAS, for each year since January 1, 2011, 
in which the PFAS was manufactured for R&D purposes in volumes no 
greater than 10 kilograms per year. Information must be submitted to 
the extent the submitter knows or can reasonably ascertain. In the 
event that actual data is not known to or reasonably ascertainable by 
the submitter, then reasonable estimates may be submitted. The 
information requested on the streamlined reporting form for R&D 
manufacturers includes:
    (1) Company and plant site information. All company and plant site 
information requested under Sec.  705.15(a) shall be reported.
    (2) Chemical-specific information. The following chemical-specific 
information must be reported for each R&D chemical substance that is a 
PFAS and each mixture containing a chemical substance that is a PFAS 
and meets the requirements for the reporting option under this 
paragraph (b)(2). The information must be reported for each year since 
January 1, 2011, in which that PFAS was manufactured for R&D purposes 
in quantities no greater than 10 kilograms per year.
    (i) The common or trade name, the chemical identity, and, except 
for chemical substances that are Class 1 substances on the TSCA 
Inventory, the representative molecular structure of each PFAS for 
which such a report is required. Submitters who wish to report chemical 
substances listed on the confidential portion of the TSCA Inventory 
will need to report the chemical substance using a TSCA Accession 
Number. If a submitter has a low-volume exemption (LVE) case number for 
the chemical substance, that number may also be used if a CASRN is not 
known to or reasonably ascertainable by the submitter. In addition to 
reporting the number itself, submitters must specify the type of number 
they are reporting by selecting from among the codes in table 1 to 
Sec.  705.15(b)(1)(ii).
    (ii) If the specific chemical identity of the PFAS is not known to 
or reasonably ascertainable to the submitter (e.g., if the chemical 
identity is claimed as confidential business information by the 
submitter's supplier, or if the submitter knows they have a PFAS but 
are unable

[[Page 70557]]

to ascertain its specific chemical identity), the submitter may provide 
a generic name or description of the PFAS.
    (3) Production volume. The submitter must report for each year 
since January 1, 2011, in which the PFAS was manufactured, the total 
annual volume (in pounds) of each PFAS domestically manufactured or 
imported at each site. The total annual domestically manufactured 
volume (not including imported volume) and the total annual imported 
volume must be separately reported. These amounts must be reported to 
two significant figures of accuracy.
    (i) A designation indicating, for each PFAS at each site, whether 
any imported PFAS is ever physically present at the reporting site.
    (ii) [Reserved]
    (4) Additional R&D data. The submitter has the option to provide 
any additional information to EPA that is requested under Sec.  705.15 
on the PFAS, including supplemental attachments.


Sec.  705.20   When to report.

    All information reported to EPA in response to the requirements of 
this part must be submitted during the applicable submission period. 
For all reporters submitting information pursuant to Sec. Sec.  705.15 
and 705.18(b) (research and development), the submission period shall 
begin one year following November 13, 2023, and last for six months: 
November 12, 2024, through May 8, 2025. For any reporter who is 
reporting under this part exclusively pursuant to Sec.  705.18(a) 
(article importers), and is also considered a small manufacturer under 
the definition at 40 CFR 704.3, the submission period shall begin one 
year following November 13, 2023, and last for 12 months: November 12, 
2024, through November 10, 2025.


Sec.  705.22   Duplicative reporting.

    Any person covered in this part may notify EPA through the 
electronic reporting system in Sec.  705.35 that certain information 
has already been submitted to EPA, and any such person does not need to 
re-submit the information. The notification must include the statutory 
and regulatory provision under which the information was submitted and 
in which year it was submitted. This ability is limited to the type of 
information listed in this section. If the previous submission did not 
account for all information required to be submitted pursuant to this 
part (e.g., due to exemptions inapplicable to this part), then the 
person may not rely on that prior submission to satisfy the reporting 
requirements of this part.
    (a) Chemical Data Reporting rule. If a person identified in Sec.  
705.10 has already reported certain information in Sec.  705.15 to EPA 
pursuant to the Chemical Data Reporting rule at 40 CFR part 711, then 
duplicative reporting of that information is not required of the years 
for which the information has already been reported. Such information 
that may potentially be duplicative under this part is limited to:
    (1) Chemical description. Physical state of the chemical or mixture 
containing a chemical substance, pursuant to 40 CFR 
711.15(b)(3)(C)(ix).
    (2) Sector description. Industrial processing and use type, 
sector(s), functional category(ies), and percent of production volume 
for each use, pursuant to 40 CFR 711.15(b)(4)(i)(A) through (D).
    (3) Product category. 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, pursuant to 40 CFR 
711.15(b)(4)(ii)(A) through (F).
    (4) Workers. Number of workers reasonably likely to be exposed for 
each combination of industrial processing or use operation, sector, and 
function, pursuant to 40 CFR 711.15(b)(4)(i)(F), and the number of 
commercial workers reasonably likely to be exposed when the substance 
is used in a commercial product, pursuant to 40 CFR 
711.15(b)(4)(ii)(G).
    (5) Volume. Production volume, both domestically manufactured and 
imported, an indicator for the imported chemical never physically at 
site, and the volume directly exported, pursuant to 40 CFR 
711.15(b)(3)(iii) through (v).
    (b) Greenhouse Gas Reporting rule. If a person identified in Sec.  
705.10 has already reported certain information in Sec.  705.15 to EPA 
pursuant to the Greenhouse Gas Reporting rule at 40 CFR part 98, then 
duplicative reporting of that information is not required of the years 
for which the information has already been reported. Such information 
that may potentially be duplicative under this part is limited to:
    (1) Imported. Production volume (imported), pursuant to 40 CFR 
98.416(c)(1) and (2).
    (2) Exported. Volume directly exported, pursuant to 40 CFR 
98.416(d)(1).
    (3) Incinerated. Total volume incinerated on-site, pursuant to 40 
CFR part 98.
    (c) Toxics Release Inventory reporting rule. If a person identified 
in Sec.  705.10 has already reported certain information in Sec.  
705.15 to EPA pursuant to the Toxics Release Inventory reporting rule 
at 40 CFR part 372, then duplicative reporting of that information is 
not required of the years for which the information has already been 
reported. Such information that may potentially be duplicative under 
this part is limited to:
    (1) Recycled. Total volume recycled on-site, pursuant to 40 CFR 
372.85(b)(16).
    (2) Disposal. Description of disposal process(es), pursuant to 40 
CFR 372.85(b)(14) and (15).
    (3) Release to land. Total volume released to land, pursuant to 40 
CFR 372.85(b)(14)(i)(D) and (E).
    (4) Release to water. Total volume released to water, pursuant to 
40 CFR 372.85(b)(14)(i)(C).
    (5) Release to air. Total volume released to air, pursuant to 40 
CFR 372.85(b)(14)(i)(A) and (B).
    (6) Incinerated. Total volume incinerated on-site, pursuant to 40 
CFR 372.85(b)(16).
    (d) TSCA sections 8(d) and 8(e) reporting. If a person identified 
in Sec.  705.10 has already reported certain information in Sec.  
705.15(f) to EPA, then duplicative reporting of that information is not 
required of the years for which the information has already been 
reported. Such information that may potentially be duplicative under 
this part is limited to health and safety studies submitted pursuant to 
TSCA section 8(d), notification of substantial risks pursuant to TSCA 
section 8(e), or other information concerning environmental and health 
effects of the PFAS.
    (e) Byproduct reporting. If a person identified in Sec.  705.10 
must report byproducts information pursuant to Sec.  705.15(e), and 
those byproducts are also PFAS that are reported independently pursuant 
to this part, then duplicative reporting of the environmental releases 
as byproducts is not required. Such information that may potentially be 
duplicative is limited to:
    (1) Incineration. An indication of whether the byproduct is 
released to the environment, and if so, the environmental medium to 
which it is released (i.e., air, water, land), pursuant to Sec.  
705.15(e)(2).
    (2) Byproduct volume. For each year, the byproduct volume (in 
pounds) released to the environment, pursuant to Sec.  705.15(e)(3).
    (f) Environmental and health effects information. If a person 
identified in Sec.  705.10 has already reported the

[[Page 70558]]

information in Sec.  705.15(f) to EPA, then duplicative reporting of 
that information is not required, except to the extent required by to 
Sec.  705.30. The notification required by this paragraph (f) must also 
include the EPA office (e.g., EPA region or Headquarters Office) and 
case number or other identifier for the prior submission.
    (g) Reporting timeframe. Any person covered in this part must 
report all information to EPA in Sec.  705.15 for each year since 
January 1, 2011, in which that person manufactured a chemical substance 
that is a PFAS or a mixture containing a PFAS. If a person has already 
reported any of the data elements identified in paragraph (a) of this 
section, but not for all years since 2011, then that person must submit 
the required information for the intervening years. If a person has 
already reported any of the data elements identified in paragraph (a), 
(b), or (c) of this section, and the previous submissions did not 
account for all activities that are reportable under this part due to 
exemptions or thresholds that do not apply to this part, then that 
information is not considered duplicative reporting, and the person 
must submit information for that data element responsive to this part.


Sec.  705.25   Recordkeeping requirements.

    Each person who is subject to the reporting requirements of this 
part must retain records that document any information reported to EPA. 
Relevant records must be retained for a period of 5 years beginning on 
the last day of the submission period.


Sec.  705.30   Confidentiality claims.

    (a) Making confidentiality claims--(1) Generally. Any person 
submitting information under this part may assert a confidentiality 
claim for that information, except for information described in 
paragraph (a)(2) of this section. All such confidentiality claims must 
be asserted at the time the information is submitted. Instructions for 
asserting confidentiality claims are provided in the document 
identified in Sec.  705.35. Information claimed as confidential 
business information in accordance with this section will be treated 
and disclosed in accordance with the procedures in 40 CFR part 703 and 
TSCA section 14.
    (2) Exceptions. Confidentiality claims cannot be asserted for the 
following:
    (i) Specific chemical identity if the chemical is on the public 
(non-confidential) TSCA Inventory or reported as non-confidential in an 
LVE;
    (ii) For processing and use data elements required by Sec. Sec.  
705.15(c)(1) through (7) and 705.18(a)(3)(i) through (vii);
    (iii) When a response is left blank or designated as ``not known or 
reasonably ascertainable;''
    (iv) For specific chemical identity by submitters of article 
importer forms described in Sec.  705.18(a);
    (v) For all generic chemical names;
    (vi) For any PFAS that are on the public (non-confidential) TSCA 
Inventory, the chemical's CASRN;
    (vii) For the Inventory Accession Numbers for PFAS that are on the 
confidential TSCA Inventory; or,
    (viii) For LVE numbers.
    (3) All existing information concerning environmental and health 
effects. (i) Any person submitting a health and safety study, or 
information from a healthy and safety study, under this part may only 
assert a confidentiality claim for information that discloses processes 
used in the manufacturing or processing of a chemical substance or 
mixture or, in the case of a mixture, the release of data disclosing 
the portion of the mixture comprised by any of the chemical substances 
in the mixture.
    (ii) If any information submitted under Sec.  705.15(f) is claimed 
as confidential business information, a person who submits the 
information must provide EPA, at the time of submission, a sanitized 
copy for public release, removing only that information that is claimed 
as confidential business information.
    (iii) Any person who has previously submitted information under 
Sec.  705.15(f) and claimed it as confidential business information is 
required to reassert and re-substantiate the confidential business 
information claim if they seek to maintain the claim of confidential 
business information. Such persons are required to submit s a revised 
sanitized copy.
    (b) Substantiation of confidentiality claims. (1) Unless exempted, 
all confidentiality claims require substantiation at the time of 
submission and must be signed and dated by an authorized official.
    (2) Confidentiality claims for the following data elements are 
exempt from the substantiation requirement in paragraph (b)(1) of this 
section:
    (i) Volume. Production volume information required pursuant to 
Sec. Sec.  705.15(d)(1), (5), and (6) and 705.18(a)(4) and (b)(3)(i).
    (ii) Primary submitter. Joint submission information from the 
primary submitter, consisting of trade name and supplier identification 
required pursuant to Sec.  705.15(b)(1)(i) and (ii).
    (iii) Secondary submitter. Joint submission information from the 
secondary submitter, consisting of the percentage of formulation 
required pursuant to Sec.  705.15(b)(1)(i) and (ii).
    (c) Marking information claimed as confidential business 
information in confidentiality substantiation documentation. If any of 
the information contained in the answers to the questions listed in 
paragraph (e) of this section is asserted to contain information that 
itself is considered to be confidential, you must clearly identify the 
information that is claimed confidential.
    (d) Certification statement for claims. An authorized official 
representing a person asserting a claim of confidentiality must certify 
that the submission complies with the requirements of this part by 
signing and dating the following certification statement:

    ``I certify that all claims for confidentiality asserted with 
this submission are true and correct, and all information submitted 
herein to substantiate such claims is true and correct. Any knowing 
and willful misrepresentation is subject to criminal penalty 
pursuant to 18 U.S.C. 1001. I further certify that: (1) I have taken 
reasonable measures to protect the confidentiality of the 
information; (2) I have determined that the information is not 
required to be disclosed or otherwise made available to the public 
under any other Federal law; (3) I have a reasonable basis to 
conclude that disclosure of the information is likely to cause 
substantial harm to the competitive position of my company; and (4) 
I have a reasonable basis to believe that the information is not 
readily discoverable through reverse engineering.''

    (e) Substantiation requirements for all types of confidentiality 
claims. For each data element that is claimed as confidential business 
information, you must submit with your report detailed written answers 
to the following questions:
    (1) Substantial harm due to release. Please specifically explain 
what harm to the competitive position of your business would be likely 
to result from the release of the information claimed as confidential 
business information. How would that harm be substantial? Why is the 
substantial harm to your competitive position likely (i.e., probable) 
to be caused by release of the information rather than just possible? 
If you claimed multiple types of information to be confidential (e.g., 
site information, exposure information, environmental release 
information, etc.), explain how disclosure of each type of information 
would be likely to cause substantial harm to the competitive position 
of your business. (40 CFR 703.5(b)(3))

[[Page 70559]]

    (2) Precautions to protect confidentiality. Has your business taken 
precautions to protect the confidentiality of the disclosed 
information? If yes, please explain and identify the specific measures, 
including but not limited to internal controls, that your business has 
taken to protect the information claimed as confidential business 
information. If the same or similar information was previously reported 
to EPA as non-confidential (such as in an earlier version of this 
submission), please explain the circumstances of that prior submission 
and reasons for believing the information is nonetheless still 
confidential.
    (3) Disclosure under Federal law or publicly available information. 
(i) Is any of the information claimed as confidential business 
information required to be publicly disclosed under any other Federal 
law? If yes, please explain.
    (ii) Does any of the information claimed as confidential business 
information otherwise appear in any public documents, including (but 
not limited to) safety data sheets; advertising or promotional 
material; professional or trade publications; state, local, or Federal 
agency files; or any other media or publications available to the 
general public? If yes, please explain why the information should be 
treated as confidential. If this chemical is patented and the patent 
reveals the information you are claiming to be confidential business 
information, please explain your reasons for believing the information 
is nonetheless still confidential.
    (4) Duration of claims. Is the claim of confidentiality intended to 
last less than 10 years (see TSCA section 14(e)(1)(B))? If yes, please 
indicate the number of years (between 1-10 years) or the specific date 
after which the claim is withdrawn.
    (5) Previously disclosed information. Has EPA, another Federal 
agency, or court made any confidentiality determination regarding 
information associated with this chemical substance? If yes, please 
provide the circumstances associated with the prior determination, 
whether the information was found to be entitled to confidential 
treatment, the entity that made the decision, and the date of the 
determination.
    (f) Additional requirements for specific chemical identity. A 
person may assert a claim of confidentiality for the specific chemical 
identity of a chemical substance as described in Sec. Sec.  
705.15(b)(1)(i) and 705.18(b)(2)(i) only if the identity of that 
chemical substance is treated as confidential in the Master Inventory 
File (or as a confidential LVE) as of the time the report is submitted 
for that chemical substance, if that substance is currently on the 
Inventory or is an LVE. Any person who asserts a claim of 
confidentiality for the specific chemical identity under this paragraph 
must provide a generic chemical name. To assert a claim of 
confidentiality for the identity of a reportable chemical substance, 
you must submit with the report detailed written answers to the 
questions from paragraph (b) of this section and to the following 
questions.
    (1) Chemical substance in U.S. commerce. Is this chemical substance 
publicly known (including by your competitors) to be in U.S. commerce? 
If yes, please explain why the specific chemical identity should still 
be afforded confidential status (e.g., the chemical substance is 
publicly known only as being distributed in commerce for research and 
development purposes, but no other information about the current 
commercial distribution of the chemical substance in the United States 
is publicly available) (40 CFR 703.5(b)(4)). If no, please complete the 
certification statement:

    ``I certify that on the date referenced, I searched the internet 
for the chemical substance identity (i.e., by both chemical 
substance name and CASRN). I did not find a reference to this 
chemical substance and have no knowledge of public information that 
would indicate that the chemical is being manufactured or imported 
by anyone for a commercial purpose in the United States. [provide 
date].''

    (2) Leave manufacturing site. Does this particular chemical 
substance leave the site of manufacture (including import) in any form, 
e.g., as a product, effluent, emission? If yes, please explain what 
measures have been taken to guard against the discovery of its 
identity.
    (3) Chemical identity. If the chemical substance leaves the site in 
a form that is available to the public or your competitors, can the 
chemical identity be readily discovered by analysis of the substance 
(e.g., product, effluent, emission), in light of existing technologies 
and any costs, difficulties, or limitations associated with such 
technologies? Please explain why or why not.
    (4) Chemical name. Would disclosure of the specific chemical name 
release confidential process information? If yes, please explain.
    (g) Joint submissions. If a primary submitter asks a secondary 
submitter to provide information directly to EPA in a joint submission 
under Sec. Sec.  705.15(b)(1)(i) and 705.18(b)(2)(i), only the primary 
submitter may assert a confidentiality claim for the data elements that 
it directly submits to EPA. The primary submitter must substantiate 
those claims that are not exempt under paragraph (b)(2) of this 
section. 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 that are not exempt under 
paragraph (b)(3) of this section.
    (h) No claim of confidentiality. Except for the chemical identity 
on article importer forms submitted under Sec.  705.18(a), information 
not claimed as confidential business information in accordance with the 
requirements of this section may be made public (e.g., by publication 
of specific chemical name and CASRN on the public portion of the TSCA 
Inventory). EPA will provide advance public notice of specific chemical 
identities to be added to the public portion of the TSCA Inventory.


Sec.  705.35   Electronic reporting.

    You must use CDX to complete and submit the reporting form required 
under this part. Submissions may only be made as set forth in this 
section. Submissions must be sent electronically to EPA via CDX. The 
information submitted and all attachments (unless the attachment 
appears in scientific literature) must be in English. All information 
must be true and correct. Access the PFAS 8(a)(7) reporting tool and 
instructions, as follows:
    (a) By website. Access the PFAS 8(a)(7) reporting tool via the CDX 
homepage at https://cdx.epa.gov/ and follow the appropriate links.
    (b) By phone or email. Contact the EPA TSCA Hotline at (202) 554-
1404 or <a href="/cdn-cgi/l/email-protection#9fcbccdcdeb2d7f0ebf3f6f1fadffaeffeb1f8f0e9"><span class="__cf_email__" data-cfemail="a3f7f0e0e28eebccd7cfcacdc6e3c6d3c28dc4ccd5">[email protected]</span></a>.

[FR Doc. 2023-22094 Filed 10-10-23; 8:45 am]
BILLING CODE 6560-50-P


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