[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Proposed Rules]
[Pages 68647-68667]
[FR Doc No: 2022-24137]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 700

[EPA-HQ-OPPT-2020-0493; FRL-7911-04-OCSPP]
RIN 2070-AK64

Fees for the Administration of the Toxic Substances Control Act
(TSCA)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Supplemental notice of proposed rulemaking.

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SUMMARY: The Environmental Protection Agency (EPA) is issuing this
document to modify and supplement its proposed rule issued on January
11, 2021, in which the Agency proposed updates and adjustments to the
2018 Fee Rule established under the Toxic Substances Control Act
(TSCA). With over five years of experience administering the TSCA
amendments of 2016, EPA is publishing this document to ensure that the
fees charged accurately reflect the level of effort and resources
needed to implement TSCA in the manner envisioned by Congress when it
reformed the law. Additionally, the purpose of this document is to
propose narrowing certain proposed exemptions for entities subject to
the EPA-initiated risk evaluation fees and propose exemptions for the
test rule fee activities; to propose modifications to the self-
identification and reporting requirements for EPA-initiated risk
evaluation and test rule fees; to propose a partial refund of fees for
premanufacture notices withdrawn at any time after the first 10
business days during the assessment period of the chemical; to propose
modifications to EPA's proposed methodology for the production volume-
based fee allocation for EPA-initiated risk evaluation fees in any
scenario where a consortium is not formed; to propose expanding the fee
requirements to companies required to submit information for test
orders; to propose modifying the fee payment obligations to require
payment by processors subject to test orders and enforceable consent
agreements (ECA); to propose extending the timeframe for test order and
test rule payments; as well as to propose changes to the fee amounts
and the estimate of EPA's total costs for administering TSCA.

DATES: Comments must be received on or before January 17, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0493, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and 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: Marc Edmonds, Existing Chemicals
Risk Management Division (7404M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be affected by this action if you manufacture (including
import), process, or distribute in commerce a chemical substance (or
any combination of such activities) and are required to submit
information to EPA under TSCA sections 4 or 5, or if you manufacture a
chemical substance that is the subject of a risk evaluation under TSCA
section 6(b).The following list of North American Industry
Classification System (NAICS) codes is not intended to be exhaustive,
but rather provides a guide to help readers determine whether this
document applies to them.
    Potentially affected entities may include companies found in major
NAICS groups:
     Chemical Manufacturers (NAICS code 325).
     Petroleum and Coal Products (NAICS code 324).
     Chemical, Petroleum and Merchant Wholesalers (NAICS code
424).
    If you have any questions regarding the applicability of this
action, please consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    TSCA, 15 U.S.C. 2601 et seq., as amended by the Frank R. Lautenberg
Chemical Safety for the 21st Century Act of 2016 (Pub. L. 114-182)
(Ref. 1), provides EPA with authority to establish fees to defray, or
provide payment for, a portion of the costs associated with
administering TSCA sections 4, 5, and 6, as amended, as well as the
costs of collecting, processing, reviewing, and providing access to and
protecting from disclosure as appropriate under TSCA section 14
information on chemical substances under TSCA. EPA is required in TSCA
section 26(b)(4)(F) to review and, if necessary, adjust the fees every
three years, after consultation with parties potentially subject to
fees, to ensure that funds are sufficient to defray part of the cost of
administering TSCA. EPA is issuing this supplemental notice of proposed
rulemaking under TSCA section 26(b), 15 U.S.C. 2625(b).

C. What action is the Agency taking?

    After establishing fees under TSCA section 26(b), TSCA requires EPA
to review and, if necessary, adjust the fees every three years, after
consultation with parties potentially subject to fees.

This document describes proposed changes to 40 CFR part 700, subpart C
as promulgated in the 2018 Fee Rule (Ref. 2) and explains the
methodology by which these proposed changes to TSCA fees were
determined. This supplemental notice of proposed rulemaking adds to and
modifies the proposed rulemaking issued on January 11, 2021 (``the 2021
Proposal'') (Ref. 3). EPA is proposing to narrow certain proposed
exemptions for entities subject to the EPA-initiated risk evaluation
fees and propose exemptions for test rule fee activities; to modify the
self-identification and reporting requirements for EPA-initiated risk
evaluation and test rule fees; to institute a partial refund of fees
for premanufacture notices withdrawn at any time after the first 10
business days during the assessment period of the chemical; to modify
EPA's proposed methodology for the production volume-based fee
allocation for EPA-initiated risk evaluation fees in any scenario where
a consortium is not formed; to expand the fee requirements to companies
required to submit information for test orders; to modify the fee
payment obligations to require payment by processors subject to test
orders and ECA; to extend the timeframe for test order and test rule
payments; and to change the fee amounts and the estimate of EPA's total
costs for administering TSCA sections 4, 5, 6, and 14.

D. Why is the Agency taking this action?

    The fees collected under TSCA are intended to achieve the goals
articulated by Congress by providing a sustainable source of funds for
EPA to fulfill its legal obligations under TSCA sections 4, 5, and 6
and with respect to information management under TSCA section 14.
Information management includes ``collecting, processing, reviewing,
and providing access to and protecting from disclosure as appropriate
under [section 14] information on chemical substances under [TSCA]. In
2021, EPA proposed changes to the TSCA fee requirements established in
the 2018 Fee Rule based upon TSCA fee implementation experience and
proposed to adjust the fee amounts based on changes to program costs
and inflation and to address certain issues related to implementation
of the fee requirements (Ref. 3). EPA consulted and met with
stakeholders that were potentially subject to fees, including several
meetings with individual stakeholders and a public webinar in February
2021. Additional information on stakeholder engagement can be found in
the 2021 Proposal Unit III.A.1 (Ref. 3). EPA is hosting another public
engagement after the publication of this proposed rule where EPA will
hear from stakeholders on the proposed TSCA fees. This engagement and
the previous stakeholder outreach will inform EPA's final rule.
    This supplemental proposal takes into consideration comments
received in response to the 2021 Proposal which EPA plans to respond
to, along with comments received on this notice, when EPA finalizes the
rule. Based on these comments, adjustments to EPA's cost estimates, and
experience implementing the 2018 Fee Rule, EPA is issuing this
supplemental notice and is requesting comments on the proposed
provisions and primary alternative provisions described herein that
would add to or modify the 2021 Proposal. TSCA allows the Agency to
collect approximately but not more than 25 percent of its costs for
eligible TSCA activities via fees; however, fee revenue has been
roughly half of the estimated costs for eligible activities than EPA
estimated in the 2018 Fees Rule. The reason for the shortfall was, in
part, that EPA used estimates of the costs based on what the Agency had
historically spent on implementing TSCA prior to the 2016 amendments,
not what it would cost the Agency to implement TSCA in the manner
envisioned and directed by Congress in the Lautenberg Amendments. In
the first four years following the 2016 law's enactment, EPA also did
not conduct a comprehensive budget analysis designed to estimate the
actual costs of implementing the amended law until the spring of 2021.
In this notice, EPA is proposing to revise its cost estimate to
adequately account for the anticipated costs of meeting its statutory
mandates, which are based on the comprehensive analysis conducted in
2021. These proposed revisions are designed to ensure fee amounts
capture approximately but not more than 25 percent of the costs of
administering certain TSCA activities, fees are distributed equitably
among fee payers when multiple fee payers are identified by revising
the fee allocation methodology for EPA-initiated risk evaluations, and
fee payers are identified via a transparent process.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential incremental economic impacts of the
2021 Proposal, as modified by this supplemental notice for FY 2023
through FY 2025. The ``Economic Analysis of the Supplemental Notice of
Proposed Rule for Fees for the Administration of the Toxic Substances
Control Act'' (Economic Analysis) (Ref. 4) is available in the docket
and is briefly summarized here.
    1. Benefits. The principal benefit of the 2021 Proposal, as
modified by this supplemental notice, is to provide EPA a sustainable
source of funding necessary to administer certain provisions of TSCA.
    2. Cost. The annualized fees collected from industry under the
proposed cost estimate described in this supplemental notice are
approximately $45.47 million (at both 3 percent and 7 percent discount
rates [Note: The annualized fee collection is independent of the
discount rate.]), excluding fees collected for manufacturer-requested
risk evaluations. Total annualized fee collection was calculated by
multiplying the estimated number of fee-triggering events anticipated
each year by the corresponding fees (Ref. 4). Total annual fee
collection for manufacturer-requested risk evaluations is estimated to
be $3.01 million for chemicals included in the 2014 TSCA Work Plan
(TSCA Work Plan) (based on the assumed potential for two requests over
the three-year period) and approximately $2.99 million for chemicals
not included in the TSCA Work Plan (based on the assumed potential for
one request over the three-year period) (Refs. 4 and 5). EPA analyzed a
three-year period because the statute requires EPA to reevaluate and
adjust, as necessary, the fees every three years.
    3. Small entity impact. EPA estimates that 29 percent of section 5
submissions will be from small businesses that are eligible to pay the
section 5 small business fee because they meet the definition of
``small business concern.'' Total annualized fee collection from small
businesses submitting notices under section 5 is estimated to be
$666,810 (Ref. 4). For sections 4 and 6, reduced fees paid by eligible
small businesses and fees paid by non-small businesses may differ
because the fee paid by each entity would be dependent on the number of
entities identified per fee-triggering event and production volume of
that chemical substance. EPA estimates that average annual fee
collection from small businesses for fee-triggering events under
section 4 and section 6 would be approximately $103,574 and $2,896,351,
respectively (Ref. 4). For each of the three years covered by this
proposed rule, EPA estimates that total fee revenue collected from
small businesses will account for about 6 percent of the approximately
$52 million total fee collection, for an

annual average total of approximately $3 million.
    4. Environmental justice. Although not directly impacting
environmental justice-related concerns, the fees will enable the Agency
to better protect human health and the environment, including in
helping minority, low-income, tribal, or indigenous populations in the
United States that potentially experience disproportionate
environmental harms and risks, and supporting the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation and enforcement of environmental laws, regulations and
policies involving TSCA. EPA identifies and addresses environmental
justice concerns by providing for fair treatment and meaningful
involvement in the implementation of the TSCA program and addressing
unreasonable risks from chemical substances.
    5. Effects on State, local, and Tribal governments. The proposed
rule would not have any significant or unique effects on small
governments, or federalism or tribal implications.

F. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through
https://www.regulations.gov or email. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
as CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets#tips.

II. Background

    TSCA authorizes EPA to establish, by rule, fees for certain fee-
triggering activities under TSCA sections 4, 5, and 6. In so doing, the
Agency must set lower fees for small business concerns and establish
the fees at a level such that they will offset approximately but not
more than 25 percent of the Agency's costs to carry out a broader set
of activities under TSCA sections 4, 5, and 6 and relevant information
management activities under TSCA section 14. In addition, in the case
of manufacturer-requested risk evaluations, the Agency is directed to
establish fees sufficient to defray 50 percent of the costs associated
with conducting a manufacturer-requested risk evaluation on a chemical
substance included in the TSCA Work Plan, and 100 percent of the costs
of conducting a manufacturer-requested risk evaluation for all other
chemicals. EPA is also required in TSCA section 26(b)(4)(F) to review
and adjust, as necessary, the fees every three years.
    On January 11, 2021, EPA proposed updates and adjustments to the
2018 Fee Rule (Ref. 2). This included proposed modifications to the
TSCA fees and fee categories for fiscal years (FY) 2023, 2024, and
2025, and explained the methodology by which these TSCA fees were
determined. EPA proposed to add three new fee categories: a Bona Fide
Intent to Manufacture or Import Notice (Bona Fide Notice), a Notice of
Commencement of Manufacture or Import (NOC), and an additional fee
associated with test orders. In addition, EPA proposed exemptions for
entities subject to certain fee triggering activities, including: (1)
an exemption for research and development activities; (2) an exemption
for entities manufacturing less than 2,500 pounds (lbs) of a chemical
subject to an EPA-initiated risk evaluation; (3) an exemption for
manufacturers of chemical substances produced as a non-isolated
intermediate; and (4) exemptions for manufacturers of a chemical
substance subject to an EPA-initiated risk evaluation if the chemical
substance is imported in an article, produced as a byproduct, or
produced or imported as an impurity. EPA proposed to update its cost
estimates for administering TSCA and individual fee calculation
methodologies. EPA also proposed a production volume-based fee
allocation for EPA-initiated risk evaluation fees in any scenario where
a consortium is not formed and proposed to require export-only
manufacturers to pay fees for EPA-initiated risk evaluations. EPA also
proposed various changes to the timing of certain activities required
throughout the fee payment process.
    EPA requested public comments on its proposal through February 25,
2021, and later extended the comment period through March 27, 2021 (86
FR 10918). EPA received a total of 43 comments. Of the 43 submissions,
there were two comment submissions and five oral comments associated
with a public webinar hosted on February 18, 2021 (Ref. 6) and three
requests for a comment period extension. Based on comments received on
the proposed rule, stakeholder engagement, and EPA's continued
experience in implementing the 2018 Fee Rule (e.g., through collection
of fees associated with EPA-initiated risk evaluations for the 20 High
Priority Substances (https://www.epa.gov/tsca-fees/tsca-fees-epa-initiated-risk-evaluations), EPA is supplementing its proposal.

III. Proposed Changes

A. Agency Costs for the Administration of TSCA

    As explained in Unit I.D. of this document, TSCA allows the Agency
to collect approximately but not more than 25 percent of its costs for
eligible TSCA activities via fees; however, fee revenue has been
approximately half of what was estimated in the 2018 Fees Rule.
Therefore, EPA is revising its cost estimates to account for the
resources needed for anticipated implementation efforts. The Lautenberg
amendments of 2016 were the first major overhaul of the TSCA statute in
forty years. The Lautenberg Act promised a broad array of far-reaching
improvements to America's chemical safety infrastructure by requiring
EPA to use strengthened TSCA authorities to protect human health and
the environment more effectively from risks. EPA's early implementation
efforts included establishing key rules laying out the framework under
which EPA would act in implementing the amendments, initiating the
first 10 multi-year risk evaluations of existing chemicals in commerce,
developing a process for making required determinations on all TSCA
section 5 notices, and refreshing the TSCA inventory of chemicals in
commerce. However, EPA faces challenges in TSCA implementation that
stem from new requirements established through the 2016 Lautenberg
amendments.
    The primary reason for these implementation challenges is a lack of
resources. Although EPA has the authority to offset approximately but
not more than 25 percent of the Agency's costs to carry out a broader
set of activities under TSCA sections 4, 5, and 6 and relevant
information management activities under TSCA section 14, the 2018 Fee
Rule did not include the collection of any fees for the first 10 TSCA
risk evaluations [Note: EPA will not be collecting fees for the first
10 TSCA risk evaluation.] and the baseline

cost estimates that drove the fee amounts in that rule were selected by
using the costs for implementing TSCA before the law was amended and
thus before EPA was required to carry out any of its new
responsibilities. In other words, the baseline cost estimates EPA chose
were based on what EPA spent on implementing TSCA before it was amended
in 2016, not what it would cost the Agency to implement the revised law
in the manner envisioned and directed by Congress, resulting in an
artificially-low baseline cost estimate. In the first four years
following the 2016 law's enactment, EPA also did not conduct a
comprehensive budget analysis designed to estimate the actual costs of
implementing the amended law until the spring of 2021. Thus, the 2018
Fee Rule, and particularly, the Rule's failure to collect any fees
associated with any of the first 10 risk evaluations resulted in
collection of roughly half of the (artificially-low) baseline costs EPA
has the authority to collect, resulting in additional implementation
challenges discussed in the following paragraphs.
    Under TSCA section 5, EPA conducts risk assessments and risk
management activities for hundreds of new chemical submissions per year
to assess the safety of such chemicals before they enter commerce and
take action to prevent unreasonable risk. However, due to resource
constraints, EPA has a backlog of delayed reviews. The backlog of
delayed cases continues to increase and drives competition for Agency
resources with new incoming cases. The backlog is due to both a change
made by the 2016 amendments, which shifted the Agency's past practice
of conducting initial ``screening'' reviews of chemicals for risk and
only making risk determinations on about 20 percent of the new chemical
submittals it received to the new statutory requirement to make such
determinations on 100 percent of submittals, and the absence of the
additional resources required to implement 2016 amendments. This will
ensure that new chemicals entering commerce do not present an
unreasonable risk to human health and the environment under the
conditions of use.
    Additional funding collected through TSCA fees will help EPA reduce
the backlog of delayed reviews, support additional work for new cases,
and provide necessary support to address new chemicals-related, such as
those for chemicals like per- and polyfluoroalkyl substances (PFAS)
actions.
    Under TSCA section 6, EPA is responsible for developing existing
chemical risk evaluations, including for chemicals designated as High-
Priority Substances through prioritization. TSCA requires evaluations
to be completed in three and a half years from the date of initiation
of the risk evaluation. EPA experienced significant implementation
challenges and missed the statutory deadlines for nine of the first 10
chemical substance risk evaluations, which primarily resulted from the
start-up time needed to develop an approach for implementing the
Lautenberg Act and scaling up to handle 10 simultaneous risk
evaluations. Additionally, as previously noted, no fees were collected
for the first 10 risk evaluations, further limiting the resources
available to conduct this work. Going forward, EPA has a statutory
requirement to ensure that risk evaluations are being conducted on at
least 20 High-Priority Substances and an additional number of
manufacturer-requested chemicals. Experience has shown that at current
funding and staffing levels, 20 risk evaluations will not be completed
within the statutory timeframe. Collecting additional resources through
TSCA fees will enable EPA to significantly improve on-time performance
and quality.
    Improved performance (timeliness and quality) in developing risk
evaluations is also contingent on obtaining needed data in a timely
manner. Increased resources will support issuance of additional TSCA
section 4 test orders to close any relevant data gaps identified in the
Prioritization process or the Scoping stage of the risk evaluation
process for High-Priority Substances or to advance additional
information development activities through TSCA section 4, such as the
issuance of test order for certain PFAS, as informed by the National
PFAS Testing Strategy (Ref. 7). Delivering data that enables the
completion of risk evaluations on a timelier basis may also improve
EPA's delivery of the risk reduction benefits through earlier
development and issuance of risk management actions and may thereby
increase benefits to human health and the environment.
    Under TSCA section 14, EPA is required to review and make
determinations regarding the validity of a significant portion of CBI
claims. EPA reviews, processes, and provides access to and/or protects
CBI from disclosure, as appropriate, on information reported under
TSCA. The CBI review requirements of TSCA section 14 apply to
submissions to EPA under TSCA, including sections 4, 5, 6, 8, and 12.
Increased resources will ensure EPA continues to establish improved
processes, systems, and procedures to enable submitters to provide the
information required when making CBI claims and to facilitate EPA's
review, where applicable, under TSCA section 14.
    To offset approximately but not more than 25 percent of the
Agency's costs, and for the various reasons listed throughout this
document and in Unit III.B., EPA is proposing to revise its costs
estimates to adequately account for the anticipated costs of meeting
its statutory mandates, which are based on a comprehensive analysis
conducted in 2021. The estimate includes anticipated implementation
efforts and resources, which EPA sees as consistent with
recommendations and statements made previously by the Office of
Inspector General (OIG), the Government Accountability Office (GAO) and
Congress. For example, the 2020 EPA OIG report, titled ``Lack of
Planning Risks EPA's Ability to Meet Toxic Substances Control Act
Deadlines,'' recommends that EPA include the ``anticipated''
implementation efforts and financial and staff resources when planning
for work conducted under the Lautenberg amendments of 2016,
particularly for existing chemicals work (Ref. 8). The GAO, in its 2021
report titled ``Dedicated Leadership Needed to Address Limited Progress
in Most High-Risk Areas,'' acknowledged that a lack of resources has
impacted EPA's ability to successfully implement TSCA. The report also
stated that EPA needs to conduct planning to make sure it has the
resources and plans in place to facilitate progress on risk evaluations
and other work implementing TSCA (Ref. 9). In a joint explanatory
statement in Congress's FY 2022 omnibus spending bill, Congress
reminded the Agency that the Lautenberg Act established a shared
responsibility for the taxpayer and industry to contribute their share
to support the TSCA program. In addition, Congress encouraged the
Agency to properly consider full costs in its deliberations, in line
with the Lautenberg Act's intent (Ref. 10).

B. Program Cost Estimates and Activity Assumptions

    EPA calculated fees by estimating the total annual costs of
carrying out relevant activities under TSCA sections 4, 5, and 6
(excluding the costs of manufacturer-requested risk evaluations) and
conducting relevant information management activities under TSCA
section 14; identifying the full cost amount to be defrayed by fees
under TSCA section 26(b) (i.e., 25 percent of those annual costs); and
allocating that amount across the fee-triggering events in TSCA
sections 4, 5,

and 6. In addition, EPA affords small businesses an approximately 80
percent discount, in accordance with TSCA section 26(b)(4)(A).
    The estimated annual Agency costs of carrying out relevant
activities under TSCA sections 4, 5, and 6 and relevant information
management activities under TSCA section 14 in the 2021 Proposal were
based on cost data from FY 2019 and 2020 which were the first full FY
after EPA implemented a time reporting system that tracks employee
hours worked on administering TSCA. However, this estimate did not
include any costs of TSCA section 6(a) risk management activities that
are now required to be underway for the first 10 chemical substances or
that will be required for any of the 20 High Priority Substances for
which the Agency finds unreasonable risks. Since the proposed rule was
published, EPA has developed a more accurate estimate of its
anticipated costs to implement TSCA in the manner envisioned by
Congress when it amended the law in 2016. The estimate is informed by
the Agency's experience administering TSCA since 2016, factors in the
Agency's failure to meet the statutory deadlines for 9 of the first 10
existing chemical risk evaluations and consistent challenges meeting
the requirements associated with reviewing new chemicals, and thus
includes what the Agency believes is a much more reliable estimate of
the resources needed for the anticipated implementation efforts than
the inaccurate cost estimate that was previously used. Changes to
program cost estimates are discussed in the following sections and in
more detail in the 2022 TSCA Fees Technical Support Document (TSD)
(Ref. 11).
    Total Agency costs of carrying out relevant activities under TSCA
sections 4, 5, 6 and relevant information management activities under
TSCA section 14 are estimated at approximately $181.9 million each year
(which differs from the $87.5 million discussed in the 2021 Proposal).
Based on the new cost estimates, EPA anticipates collecting
approximately 25 percent of that, or $45.5 million each year (which
differs from the $22 million discussed in the 2021 Proposal) in fees
collected from all fee-triggering events, except manufacturer-requested
risk evaluations (MRREs). The increase in costs from the 2021 Proposal
is due to multiple factors on top of the lack of a comprehensive
analysis of baseline costs until 2021 as has already been discussed in
this Unit. For example, estimates in the 2021 Proposal did not include
any costs of TSCA section 6(a) risk management activities that are now
required to be underway for the first 10 chemical substances or that
will be required for any of the 20 High Priority Substances for which
the Agency finds unreasonable risks, which resulted in EPA
significantly underestimating TSCA section 6 Agency costs. In addition,
the estimate from the 2021 Proposal did not include costs for EPA's
plan to develop and implement a multi-year collaborative research
program under section 5, which is explained in more detail in this
Unit.
    For new chemical submissions under TSCA section 5, EPA has now
formulated a per unit cost estimate that was not included in the 2021
Proposal. The updated estimate provides a more comprehensive accounting
of program implementation, which includes, but is not limited to: (1)
costs incurred by EPA for multiple rounds of revisions to the risk
assessment due to late submission of information or rebuttals by
companies, (2) multiple rounds of risk management actions, redactions
and posting of final reports to meet transparency commitments while
safeguarding CBI, (3) IT infrastructure maintenance and enhancement to
ensure the quality and safeguard of data collection, storage and
reporting, staffing and contractor support from supporting offices such
as the Office of General Counsel (OGC), the Office of Enforcement and
Compliance Assurance (OECA), and the Office of Research and Development
(ORD), among others, and (4) other operational costs that were not
previously captured or fully itemized. The anticipated direct and
indirect program costs associated with relevant activities under TSCA
sections 4, 5, and 6 and relevant information management activities
under TSCA section 14 for FY 2023 through FY 2025, are listed in Table
1 below.

                 Table 1--Estimated Annual Costs to EPA
                        [FY 2023 through FY 2025]
------------------------------------------------------------------------
                                                           Annual costs
------------------------------------------------------------------------
TSCA section 4..........................................      $7,383,300
TSCA section 5..........................................      54,162,600
TSCA section 6 (excluding manufacturer-requested risk         88,251,500
 evaluations)...........................................
TSCA section 14.........................................       1,783,800
Agency Indirect Costs...................................      30,316,200
                                                         ---------------
    Total...............................................    $181,897,400
------------------------------------------------------------------------
Table Note: The indirect cost rate is estimated at 20 percent for the
  purposes of this analysis.

1. Program Costs
    To determine the program costs for implementing relevant activities
under TSCA sections 4, 5, and 6 and relevant information management
activities under TSCA section 14, the Agency accounted for the direct
costs, both intramural and extramural, for those activities.
    Intramural costs are those costs related to the efforts exerted by
EPA staff and management in operating the program, collecting and
processing information and funds, conducting reviews, and related
activities. Extramural costs are those costs related to the acquisition
of contractors to conduct activities such as analyzing data, developing
IT systems, and supporting the TSCA Help Desk.
    The Agency then added indirect costs to the direct program cost
estimates. The Agency used an indirect cost rate of 20 percent to
calculate the indirect costs associated with all direct program cost
estimates for TSCA sections 4, 5, and 6 and relevant information
management activities under TSCA section 14 based on EPA's indirect
cost methodology as required by Federal Accounting Standards Advisory
Board's Statement of Federal Financial Accounting Standards No. 4:
Managerial Cost Accounting Standards and Concepts (Ref. 12).
a. TSCA Section 4 Program Costs
    TSCA permits the Agency to undertake test rules, test orders, and
enforceable consent agreements (ECA). Developing these regulatory
actions is a complex, time-consuming, and

resource-intensive process involving many scientific and regulatory
considerations. EPA must establish what information is required,
inventory what reasonably available information EPA has that would
address EPA's needs, what testing will provide such information, and
what test protocols--such as the Organisation for Economic Co-operation
and Development (OECD) test guidelines--can generate such information.
Standard globally recognized test guidelines may sometimes be
appropriate to inform certain data needs, however, other times, EPA may
need to look elsewhere such as at New Approach Methods or even develop
new protocols because of the spectrum of data needs and multiple
technical considerations that go into determining testing requirements.
Additionally, the Agency must satisfy the requirements of the statute
to reduce vertebrate testing (i.e., the use of vertebrate animals in
testing to generate chemical information to assess risks to health or
the environment posed by substances or mixtures), which may involve the
use of New Approach Methods. Ultimately, EPA seeks to ensure that the
testing required generates useful, high-quality data. For example,
depending on the complexity of the chemical substance(s) or mixture(s)
that is(are) the subject of a test order, EPA estimates that developing
and issuing a test order generally takes a minimum six months of
personnel fully allocated (assuming one to two personnel depending on
the complexity of the test order and the number of recipients of the
test order) and an array of technical personnel from different
disciplines partially allocated to doing test order work. The
complexity associated with a chemical substance(s) or mixture(s) made
the subject of a test order is influenced by EPA's grasp of the
scientific and market data on and analytical methods applicable to the
chemical(s). Further resources are also needed to administer the test
orders after they have been issued (e.g., answering questions related
to its requirements, reviewing submissions, etc.); the number of
resources needed for such activities varies depending on the complexity
of the testing requirements and the number of recipients.
    EPA's limited resources have hampered the Agency from effectively
exercising those authorities (e.g., in support of the prioritization of
the 20 High-priority Substances). In addition, EPA intends to expand
the use of Section 4 authorities significantly moving forward to inform
prioritization of substances for risk evaluation and develop the most
scientifically-sound risk evaluations of those chemical substances.
Additional resources will facilitate the Agency's exercise of these
authorities under TSCA. Therefore, to estimate the costs associated
with TSCA section 4 activities, the Agency relied upon prior experience
with the past test orders, test rules and ECAs, and considered
anticipated costs to cover future TSCA section 4 activities. Based on
past experience and anticipated costs, EPA has calculated the total
program costs for TSCA section 4 activities to be approximately $7.38
million annually. More information about EPA's estimated TSCA section 4
costs basis can be found in the TSD (Ref. 11).
b. TSCA Section 5 Program Costs
    Under the 2016 amendments to TSCA, EPA must review and make a
determination pertaining to all new chemical substances or significant
new uses of chemicals submitted under TSCA section 5(a) before they can
proceed to the marketplace. Previously, EPA conducted initial reviews
of TSCA section 5 notices and determined whether further review was
needed, and made an interim finding following the initial review.
Before the 2016 amendments, about 80 percent of new chemical reviews
were halted at this `interim' stage and were allowed into commerce
without further review. Following the 2016 amendments to TSCA, EPA
modified its review processes such that all TSCA section 5 notices go
through a full risk assessment and receive a risk determination, and
therefore the Agency no longer makes interim findings.
    EPA estimates that it will receive 210 premanufacture notices
(PMNs), significant new use notices (SNUNs), and microbial commercial
activity notices (MCANs) per year, and another 290 exemption notices
and applications per year. EPA's cost estimates for administering TSCA
section 5 include the costs associated with processing and retaining
records related to NOC submissions, as well as the costs of pre-notice
consultations, processing and reviewing applications, retaining
records, and related activities. This estimate is based on a projected
185 full-time equivalents (FTEs) and extramural support needed for
these actions. Costs estimates for administering TSCA section 5
activities also include EPA's plan to develop and implement a multi-
year collaborative research program to modernize the information used
in performing risk assessments for new chemical substances under TSCA
and bring innovative science to the review of the new chemicals before
they can enter the marketplace. More information related to this
research program can be found in the TSD (Ref. 11). These activities
and additional funding needs resulted in EPA proposing higher fees for
TSCA section 5 activities in this document.
    Based on past experience and anticipated costs, EPA has estimated
the total program costs for TSCA section 5 activities to be
approximately $54.2 million annually in FY 2023 through FY 2025. More
information about EPA's estimated TSCA section 5 costs basis can be
found in the TSD (Ref. 11).
c. TSCA Section 6 Program Costs
    EPA has the authority under TSCA section 26(b) to collect fees to
recover costs for TSCA section 6 activities including prioritization,
risk evaluations, and risk management rulemaking. TSCA section 6 cost
estimates have been informed by the Agency's experience conducting
evaluations for the first 10 chemical substances to undergo risk
evaluation under amended TSCA, by the Agency's experience prioritizing
and developing the scope of the risk evaluations of the 20 chemicals
designated as High-Priority Substances in December 2019, and by the
Agency's initial and ongoing experience with risk management actions
addressing unreasonable risks identified in the first 10 chemical
substance risk evaluations. Cost estimates for risk management
activities have also been informed by EPA's recent risk management
actions on several chemicals under TSCA section 26(l)(4) authority,
including development of the proposed rules regarding the use of N-
methylpyrrolidone and methylene chloride in paint and coating removal,
and the use of trichloroethylene in both commercial vapor and aerosol
degreasing and for spot cleaning in dry cleaning facilities, and the
development of the final rule regarding methylene chloride in consumer
paint and coating removal.
    During the public comment period on the 2021 Proposal, EPA received
comments stating that EPA underestimated the TSCA section 6 costs. For
example, commenters stated that EPA inappropriately relied on narrow,
partially completed risk management actions to inform the cost of its
current and future risk management actions (Docket Number EPA-HQ-OPPT-
2020-0493). Commenters also raised concerns stating that EPA had not
reconciled the costs for administering section 6 activities

which had been reduced compared to the 2018 Fee Rule despite the
increase in risk management workload. Additionally, EPA's estimates did
not include any costs of TSCA section 6(a) risk management activities
for the first 10 chemical substances or 20 High Priority Substances in
the proposal which resulted in EPA underestimating TSCA section 6
Agency costs. Therefore, EPA is proposing to include recent risk
management activities into the TSCA section 6 program cost estimates.
Although section 6 cost estimates were informed by risk management and
risk evaluation activities for the first 10 chemicals, EPA will not be
recovering fees for those chemicals. Adding more recent and
comprehensive risk management costs and the anticipated increases
associated with prioritization and risk evaluation costs, as described
previously and in more detail in the TSD, would result in the estimated
annual cost to administer TSCA section 6 to be approximately $88
million per year, except the MRREs.
    In the case of manufacturer-requested risk evaluations, the Agency
is directed to establish fees sufficient to defray 50 percent of the
costs associated with conducting a manufacturer-requested risk
evaluation on a chemical substance included in the TSCA Work Plan, and
100 percent of the costs of conducting a manufacturer-requested risk
evaluation for all other chemicals. EPA is also required in TSCA
section 26(b)(4)(F) to review and adjust, as necessary, the fees every
three years. The Agency intends to collect fees to recover 50 percent
or 100 percent of the actual costs incurred by EPA in conducting
chemical risk evaluations requested by manufacturers, depending on
whether the chemical substance is included in the TSCA Work Plan. EPA
expects the amount collected will be approximately $4.40 million per
risk evaluation for chemicals on the TSCA Work Plan and $8.98 million
per risk evaluation for chemicals not on the TSCA Work Plan.
d. Costs of Collecting, Processing, Reviewing, and Providing Access to
and Protecting From Disclosure as Appropriate Under TSCA Section 14
Information on Chemical Substances
    EPA is making minimal changes to estimates of program costs of
collecting, processing, reviewing, and providing access to and
protecting from disclosure as appropriate under TSCA section 14
information on chemical substances that were previously described in
the 2021 Proposal. More information about specific activities
considered when developing this estimate for activities under section
14 can be found in the 2021 Proposal (Ref. 3).
    The annual cost estimate of collecting, processing, reviewing, and
providing access to and protecting from disclosure as appropriate
information on chemical substances under section 14 of TSCA, including
8.6 FTE and extramural costs, from FY 2023 through FY 2025 is
approximately $1.8 million (Ref. 4).
2. Indirect Costs
    Indirect costs are the intramural and extramural costs that are not
accounted for in the direct program costs, but are important to capture
because of their necessary enabling and supporting nature, and so that
EPA's proposed fees will accomplish full cost recovery up to that
provided by law. Indirect costs typically include such cost items as
accounting, budgeting, payroll preparation, personnel services,
purchasing, centralized data processing, and rent.
    EPA included indirect costs in its estimate of total Agency costs
pursuant to OMB Circular A-25 (Ref. 13) which states that agencies
should collect the full costs when setting fees. In addition, section
6(d)(1) explains that full costs include all direct and indirect costs
to the Federal Government. EPA describes how an indirect cost rate is
determined annually according to EPA's indirect cost methodology and as
required by Federal Accounting Standards Advisory Board's Statement of
Federal Financial Accounting Standards No. 4: Managerial Cost
Accounting Standards and Concepts in the 2021 Proposal. An indirect
cost rate of 20 percent was applied to direct program costs of work
conducted by EPA's Office of Chemical Safety and Pollution Prevention.
Some of the direct program costs included in the estimates for TSCA
sections 4, 5, and 6 and collecting, processing, reviewing, and
providing access to and protecting from disclosure as appropriate under
TSCA section 14 information on chemical substances are for work
performed in other Agency offices (e.g., the Office of Research and
Development and the Office of General Counsel). Appropriate indirect
cost rates were applied to those cost estimates and are based on EPA's
existing indirect cost methodology. Indirect cost rates are calculated
each year and therefore subject to change. Indirect costs of
approximately $30 million were included in the program cost estimates
in the previous sections.
3. Total Costs of Fee-Triggering Events
    The annual estimated costs for fee categories under TSCA section 4,
including both direct and indirect program costs, are shown in Table 2.
Note that the costs presented in Tables 2 through 4 include only the
costs of fee triggering events and do not include costs associated with
activities such as CBI reviews and alternative testing methods
development. Costs associated with those activities are part of the
overall costs of administering relevant activities under TSCA sections
4, 5, and 6 and relevant information management activities under TSCA
section 14 and, as such, are included in the overall cost estimates
provided previously in Table 1.
    The Agency believes it is reasonable to assume that approximately
75 test orders per year will be initiated between FY 2023 and FY 2025.
Approximately 45 of these test orders are expected to be associated
with the Agency's actions on PFAS. In addition, the EPA assumed two
test rules and two ECAs between FY 2023 and FY 2025.

                                         Table 2--TSCA Section 4 Costs *
----------------------------------------------------------------------------------------------------------------
                                               $ Total costs       Payroll       $ Non-payroll         FTE
----------------------------------------------------------------------------------------------------------------
TSCA Section 4 Activities...................      $7,383,300       $4,878,000       $2,505,300             27.9
----------------------------------------------------------------------------------------------------------------
* Table Note: Numbers may not add due to rounding.

    The estimated annual costs for fee categories under TSCA section 5,
including both direct and indirect program costs are shown in Table 3.
EPA estimates that it will receive 210 PMNs, SNUNs, and MCANs per year,
and another 290 exemption applications per year. EPA's cost estimates
for administering TSCA section 5 include the costs associated with
processing and retaining records related to a NOC submission, as well
as the costs of pre-notice consultations, processing and reviewing
applications, retaining records, and related activities.

                                         Table 3--TSCA Section 5 Costs *
----------------------------------------------------------------------------------------------------------------
                                               $ Total costs       Payroll       $ Non-payroll         FTE
----------------------------------------------------------------------------------------------------------------
TSCA Section 5 Activities...................     $54,162,600      $32,370,000      $21,792,600            185.2
----------------------------------------------------------------------------------------------------------------
* Table Note: Numbers may not add due to rounding.

    The estimated annual costs for fee categories under TSCA section 6,
including both program and indirect costs are shown in Table 4. EPA
estimates that the EPA's workforce will be involved in at least 3 MRRE
and at least 20 EPA[hyphen]initiated chemical risk evaluations at all
times.

                                         Table 4--TSCA Section 6 Costs *
----------------------------------------------------------------------------------------------------------------
                                                   $ Total costs      Payroll      $ Non-payroll        FTE
----------------------------------------------------------------------------------------------------------------
                                                 TSCA Section 6
----------------------------------------------------------------------------------------------------------------
TSCA Section 6 Prioritization...................      $8,820,900      $6,254,000      $2,566,900            35.9
EPA-initiated Risk Evaluation...................      54,877,100      28,291,100      26,585,900          161.40
Manufacturer-requested Risk Evaluation..........       7,483,200       3,857,900       3,625,400            22.0
TSCA Section 6 Risk Management..................      24,553,500      13,536,000      11,017,500            77.3
                                                 ---------------------------------------------------------------
    Totals......................................      95,734,700      51,939,000      43,795,700           296.6
----------------------------------------------------------------------------------------------------------------
* Table Note: Numbers may not add due to rounding.

C. Fee Amounts

    While TSCA allows the Agency to collect approximately but not more
than 25 percent of its costs for eligible TSCA activities via fees, to
date, EPA has collected roughly half of that amount due to the
insufficiencies of the current fees rule. These proposed revisions are
designed to ensure fee amounts capture approximately but not more than
25 percent of the costs of TSCA activities, fees are distributed
equitably, and fee payers are identified via a transparent process.
Although TSCA allows EPA to recover approximately but not more than 25
percent of its costs of implementing certain provisions of TSCA, the
percentage applies to the total aggregate cost and does not preclude
EPA from recovering an amount above or below 25 percent of the costs
for each section of TSCA.
    As discussed in the 2021 Proposal, the existing and proposed fee
categories are fee-triggering events that result in obligations to pay
fees but do not encompass all activities under TSCA sections 4, 5, 6,
and 14 that incur costs to the Agency (e.g., costs of administering
TSCA section 14, risk management activities under section 6,
prioritization of chemicals for evaluation, support for alternative
testing and methods development and enhancement). However, costs for
all relevant activities are included in the total Agency costs
estimate, even those not discussed in this document (e.g., specific
TSCA work with other EPA offices). Therefore, EPA is proposing fee
amounts to ensure these costs would be captured, not just the costs of
the fee-triggering events. EPA is also proposing new fee amounts to
capture the higher proportion (in percentage) of the estimated costs of
TSCA section 6 activities and ensure EPA fees are set to recover
approximately but not more than 25 percent of the total cost for
implementing the relevant sections of TSCA.
    After estimating the annual costs of administering relevant
activities under TSCA sections 4, 5, 6, and relevant information
management activities under TSCA section 14, the Agency had to
determine how the costs would be allocated over the narrower set of
activities under TSCA sections 4, 5, and 6 that trigger a fee. The
Agency took an approach to determining fees that tied the payment of
fees to individual distinct activity types or ``fee-triggering
events.''
    The proposed fee amounts are described in Table 5.

                                  Table 5--Proposed Changes to TSCA Fee Amounts
----------------------------------------------------------------------------------------------------------------
                                                                                2022 Supplemental
             Fee category                   2018 Fee rule           Current fees \1\          proposed rule
----------------------------------------------------------------------------------------------------------------
Test order...........................  $9,800 \2\.............  $11,650................  $25,000.
Test rule............................  $29,500................  $35,080................  $50,000.
Enforceable consent agreement........  $22,800................  $27,110................  $50,000.
PMN and consolidated PMN, SNUN, MCAN   $16,000................  $19,020................  $45,000.
 and consolidated MCAN.
LoREX, LVE, TME, Tier II exemption,    $4,700.................  $5,590.................  $13,200.
 TERA, Film Articles.
EPA-initiated risk evaluation........  $1,350,000.............  Two payments resulting   Two payments resulting
                                                                 in $2,560,000.           in $5,081,000.
Manufacturer-requested risk            Initial payment of       Two payments of          Two payments of
 evaluation on a chemical included in   $1.25M, with final       $945,000, with final     $1,497,000, with final
 the TSCA Work Plan.                    invoice to recover 50%   invoice to recover 50%   invoice to recover 50%
                                        of actual costs.         of actual costs.         of actual costs.
Manufacturer-requested risk            Initial payment of       Two payments of $1.89M,  Two payments of
 evaluation on a chemical not           $2.5M, with final        with final invoice to    $2,993,000, with final
 included in the TSCA Work Plan.        invoice to recover       recover 100% of actual   invoice to recover
                                        100% of actual costs.    costs.                   100% of actual costs.
----------------------------------------------------------------------------------------------------------------
\1\ The current fees reflect an adjustment for inflation required by TSCA. The adjustment went into effect on
  January 1, 2022.

\2\ In 2018 final rule, the fees for TSCA section 4 test orders and test rules were incorrectly listed as
  $29,500 for test orders and $9,800 for test rules. The 2021 Proposal proposes to correct this error by
  changing the fees for TSCA section 4 test orders to $9,800 and TSCA section 4 test rules to $29,500.

1. Fee Amounts for TSCA Section 4 Activities
    EPA is proposing changes to the fees associated with TSCA section 4
activities. Additional justification for fee triggering activities
associated with each TSCA section is discussed within this Unit. In
addition, in the 2021 Proposal, EPA proposed an additional fee category
under TSCA section 4 for amended test orders. EPA is proposing to
remove this new fee category (discussed in further detail in Unit
III.D).
    EPA is proposing fees that, based on the expected activity levels
of the three fee categories for TSCA section 4 activities, will defray
26.4 percent of the program costs described in the previous paragraphs,
or approximately $1.94 million. The proportion (in percentage) of the
estimated cost of the activity is slightly higher for fees for TSCA
section 4 (26.3 percent) to ensure EPA is recovering the required 25
percent of the total cost for implementing the relevant sections of
TSCA in light of collecting less than 25 percent of costs for section 5
activities as explained in Unit III.C.2.
2. Fee Amounts for TSCA Section 5 Activities
    EPA currently sets two fee amounts for TSCA section 5 activities--
one for notices (PMNs, SNUNs, and MCANs), and one for exemptions which
include low exposure/low release exemptions (LoREXs), low volume
exemptions (LVEs), test-marketing exemptions (TMEs), certain
microorganism Tier II exemptions (Tier II), and TSCA experimental
release applications (TERAs). In the 2021 Proposal, EPA proposed two
additional fee categories under TSCA section 5, one for Bona Fide
Notices and the other for NOCs. EPA is proposing to remove those two
new fee categories (discussed in further detail in Unit III.D), as well
as proposing to increase the fee amounts under TSCA section 5
activities. Specifically, EPA is proposing an increase to the fees for
PMNs, consolidated PMNs, SNUNs, MCANs, consolidated MCANs, LoREXs,
LVEs, TMEs, Tier II, TERAs, and film article exemptions.
    Additional funding collected through TSCA section 5 fees will help
EPA reduce the backlog of delayed reviews and support additional work
for new cases. As previously noted, these delays result from a years-
long absence of the additional resources required to implement the 2016
amendments, which shifted the Agency's past practice of making risk
determinations on about 20 percent of the new chemical submittals it
received to a requirement to make such determinations on 100 percent of
submittals. The fee increases for TSCA section 5 activities, if
finalized as proposed in this document, would also shift costs for
administering TSCA section 5 away from fees for TSCA section 6 actions.
EPA proposed to increase TSCA section 6 fees to recover costs for TSCA
section 5 activities in the 2021 Proposal. As newly proposed, the fees
for TSCA section 5 activities amount to approximately 18 percent of the
estimated costs of the activities and are described in Table 5. EPA is
proposing to collect less than 25 percent of the costs for section 5
activities to lessen the impact due to the increase in section 5 fee
amounts since 2018. For example, before the 2018 Fee Rule the fee for a
PMN was $2,500. The fee was increased to $16,000 in the 2018 Fee Rule
and will be increased further to $45,000 under this proposal. Due to
the significant increase since 2018, is proposing to reduce the impact
of increased section 5 fees by collecting less than 25 percent of the
implementation costs for section 5. EPA is requesting comment on its
proposal to recover less than 25 percent of the costs for implementing
TSCA section 5.
    EPA also accounted for full (100 percent) refunds that may be
provided when estimating the total fees collected and in setting the
fee amounts. Full refunds may be provided for notices or exemptions
when EPA determines a submission is not a new chemical substance, new
microorganism, or significant new use, or when the Agency fails to make
a determination on a notice by the end of the applicable notice review
period. In addition, EPA is proposing to refund 20 percent of the user
fee to the submitter if a notice is withdrawn after 10 business days
after the beginning of the applicable review period, but prior to EPA
initiating risk management on the chemical substance. The 20 percent
refund is based on the allocation of resources needed for risk
assessment and risk management of chemical substances under TSCA
section 5 where 80 percent of costs are associated with risk assessment
and 20 percent with risk management. Based on the number of PMNs
withdrawn during FY 2020 and 2021, EPA estimates that approximately 23
percent of PMNs are withdrawn during review (discussed in further
detail in Unit III.E).
3. Fee Amounts for TSCA Section 6 Activities
    EPA collects one fee amount for EPA-initiated risk evaluations.
Based on the expected activity levels of this fee category, this will
defray 38.4 percent of the estimated program costs. As explained in
Unit III.C.2, EPA is collecting under 25 percent of the costs for
section 5 activities. For this reason and to ensure EPA is recovering
the required 25 percent of the total cost for implementing the relevant
sections of TSCA, the proportion (in percentage) of the estimated cost
of EPA-initiated risk evaluations that are recovered by fees is higher
(38.4 percent) than the other fee triggering activities. EPA takes an
actual cost approach for manufacturer-requested risk evaluations,
whereby the requesting manufacturer (or requesting consortia of
manufacturers) would be obligated to pay either 50 percent or 100
percent of the actual costs of the activity, depending on whether the
chemical was listed on the TSCA Work Plan or not, respectively.
    Based on additional cost estimates for risk management and
anticipated increases associated with prioritization and risk
evaluation costs, as described in Unit III.B.1.a., estimated Agency
costs for TSCA section 6 activities have increased to $88,251,500 per
year with fee collections of $33,890,270 for EPA-initiated risk
evaluations. EPA is proposing to increase the EPA-initiated risk
evaluation fees from the 2021 Proposal of $2,560,000 to $5,081,000 (or
from $1.35 million in the 2018 Fee Rule). This payment would be
collected over two installments, the first payment of 50 percent to be
due 180 days after EPA publishes the final scope of a chemical risk
evaluation and the second payment due not later than 545 days after EPA
publishes the final scope of a chemical risk evaluation, as proposed in
the 2021 Fee Proposal.
    As stated previously, EPA takes an actual cost approach for
manufacturer-requested risk evaluations. In addition, EPA proposed in
the 2021 Proposal to separate the manufacturer-requested risk
evaluation payments into three installments with the total fee paid
reflecting the actual cost. Based on that proposed installment plan and
the estimated costs of these risk evaluations, two payments of
$1,497,000 then invoiced for the remainder is being

proposed for chemicals on the TSCA Work Plan and two payments of
$2,993,000 with final invoice for the remainder is being proposed for
chemicals not listed on the TSCA Work Plan.

D. Fee Categories

    Under the 2018 Fee Rule, EPA has eight distinct fee categories: (1)
test orders, (2) test rules, and (3) Enforceable Consent Agreements
(ECAs), all under TSCA section 4; (4) notices and (5) exemptions, both
under TSCA section 5; and (6) EPA-initiated risk evaluations; (7)
manufacturer-requested risk evaluations for chemicals on the TSCA Work
Plan; and (8) manufacturer-requested risk evaluations for chemicals not
on the TSCA Work Plan, all under TSCA section 6. The activities in
these categories are fee-triggering events (other than the first 10
risk evaluations) that result in obligations to pay fees under the 2018
Fee Rule.
    In the 2021 Proposal, EPA proposed two additional fee categories
under TSCA section 5, Bona Fide Notices and NOCs, and one additional
fee category for TSCA section 4 amended test orders. After considering
public comments received on the 2021 Proposal, and in an effort to keep
the fee structure simple by reducing the number of fee categories, EPA
is proposing not to finalize the new fee categories for Bona Fide
Notices, NOCs, and amended test orders.
    The cost associated with NOCs will continue to be captured with
those of PMNs, MCANs, and SNUNs, as they were under the 2018 Fee Rule.
EPA believes these fees are better captured under the proposed fee
increase for existing TSCA section 5 categories. In addition, while EPA
envisioned the additional fee for amended test orders to create an
incentive for manufacturers to submit facially complete data outlined
under TSCA section 4, in order to simplify the TSCA section 4 fee
structure EPA is proposing to remove the amended test order fees.
Because the costs incurred by EPA to review resubmitted data are
included in the Agency's total program cost estimate, these costs will
be captured under other fees.

E. Refund for Withdrawal During Review

    In addition to increasing the TSCA section 5 fees for PMNs, SNUNs,
and MCANs, EPA is proposing to refund 20 percent of the user fee to the
submitter if a notice is withdrawn after 10 business days after the
beginning of the applicable review period, but prior to EPA initiating
risk management on the chemical substance. In the 2018 Fee Rule, EPA
established a partial refund (i.e., 75 percent of the fee amount) for
TSCA section 5 submissions withdrawn during the first 10 business days
after the beginning of the applicable review period (83 FR 52694,
October 17, 2019). EPA is proposing an amendment to add a partial
refund of 20 percent for TSCA section 5 submissions withdrawn after the
first 10 business days during the assessment period of the chemical but
before EPA begins any necessary risk management. This newly proposed
refund is in addition to the already existing refund of 75% for notices
withdrawn in the first 10 business days established under the 2018 Fee
Rule. After EPA concludes the risk assessment for a TSCA section 5
submission, the Agency will provide the submitter notice that the risk
assessment has been completed and the submitter will then have five
business days to withdraw their notice for a partial refund of 20
percent. After 5 business days from receiving the notice that the risk
assessment has been completed, if the company wishes to withdraw a
notice, no refund will be given.
    When EPA's review leads to a determination that one or more
conditions of use may present an unreasonable risk and EPA lacks
sufficient information to permit a reasoned evaluation of the health
and environmental effects of the PMN substance, or on the basis of
insufficient information alone, the Agency will issue a section 5(e)
order to address potential risks and may require testing for additional
information. After learning of the Agency's determination and risk
management actions, a submitter may no longer wish to pursue the
commercialization of the chemical substance, depending on the potential
risks identified and any risk mitigation likely required to address
those risks.
    EPA's proposal to refund 20 percent of the fee is based on the
allocation of resources needed for risk assessment and risk management
of chemical substances under TSCA section 5. EPA's cost estimates for
administering TSCA section 5 include the costs of processing,
reviewing, and making determinations, and the Agency's costs of taking
any regulatory action such issuing an order and a TSCA section 5
significant new use rule (SNUR). Approximately 80 percent of the cost
associated with reviewing a new chemical substance is due to activities
associated with risk assessment, while approximately 20 percent of the
cost is associated with risk management activities. EPA is not able to
issue refunds for the entire fee amount because significant work begins
as soon as EPA receives the PMN. As described in the 2018 Proposed Fee
Rule (83 FR 8212; February 26, 2018), up to three significant
milestones of the PMN review process can take place within 10 business
days (Ref. 14). The Chemical Review/Search Strategy Meeting occurs
between Day 8 and 12; the Structure Activity Team Meeting occurs
between Day 9 and 13; and Development of Exposure/Release Assessments
occurs between Day 10 and 19. Due to concerns with administrative
burden and potential delays in issuing refunds, EPA will not calculate
and refund a unique amount for each withdrawn submission. By adding
this option for a refund of 20 percent, submitters will be able to
recoup part of the cost associated with submitting a notice for
chemicals they decide to withdraw during the review period. Based on
the cases withdrawn during FY 2020 and 2021, EPA estimates that
approximately 23 percent of cases are withdrawn during review. However,
EPA anticipates this percentage could be much higher if submitters had
the opportunity to obtain a partial refund when risk assessment results
and likely risk management actions are known. Withdrawals and refunds
provided under such circumstances would prevent the need for EPA to
conduct risk assessment rework and executing unneeded risk management
actions. Risk assessment rework requires EPA to re-analyze some or all
the information supporting a risk assessment in order to factor in new
information, causing substantial delay to the review process for that
substance and delays staff from initiating or completing risk
assessment work on other new chemical substances. The Agency requests
comment on this new partial refund process for the review of TSCA
section 5 notices.

F. Methodology for Calculating Fees for EPA-Initiated Risk Evaluations

    In 2018, the TSCA Fee Rule established a methodology for allocating
fees to manufacturers of chemicals subject to EPA-initiated risk
evaluations in which EPA distributes the fees evenly among
manufacturers, while giving an 80 percent discount for manufacturers
that qualify as a small business concern. In January 2021, EPA proposed
a production volume-based approach for fee allocation for EPA-initiated
risk evaluations under TSCA section 6. Specifically, EPA proposed to
reallocate the remaining fee, after allocating the fees for small
businesses, across the remaining manufacturers, based on their
percentage of total volume produced of that chemical minus the amount
produced by the small businesses. EPA

continues to believe that using production volume in calculating TSCA
section 6 fee allocations will result in a more equitable distribution
of fees and better account for the wide variation in production volume
sometimes associated with a particular chemical substance, but is
proposing modifications to the methodology included in the 2021
Proposal as described in the following section.
1. Description of the Proposed Regulatory Action
    While 10 commenters supported EPA's proposed volume-based fee
allocation methodology, nine commenters did not support the proposed
methodology or expressed concern over unintentional disclosure of CBI
under the proposed methodology, stating that collecting and reporting
production volumes to EPA could force companies to involuntarily
disclose CBI. In response to these comments, EPA is proposing to modify
the proposed fee allocation methodology to protect potential
submissions of CBI. The modified approach includes ranking the fee-
payers that do not qualify as a small business concern by their
reported production volume, then assigning fees based on those
rankings. The non-small business manufacturers in the top 20th
percentile ranking would pay 80 percent of the total fee, distributed
evenly among these manufacturers. EPA believes this methodology is
equitable, accounts for various fee payer scenarios, protects CBI, and
ensures EPA is collecting approximately but not more than 25 percent of
applicable program costs. These proposed changes would ensure that the
manufacturers of the largest quantity of production volume for a
chemical undergoing risk evaluation pay the majority of the obligated
fee. In addition, this proposed approach reflects EPA's review of the
distribution of production volume data reported across individual
producers for the 20 High-Priority Substances and the first 10 chemical
substances, and EPA believes it is consistent with the distribution of
fee payers expected for any one EPA-initiated risk evaluation expected
in the future. EPA is requesting comment on the methodology outlined
below, including whether the approach is a more equitable way of
distributing fees.
    In any scenario where all manufacturers of the chemical substance
undergoing the EPA-initiated risk evaluation do not form a single
consortium, EPA would take the following steps to allocate fees:
    Step 1: Count the total number of manufacturers, including the
number of manufacturers within any consortia.
    Step 2: Divide the total fee amount by the total number of
manufacturers to generate a base fee.
    Step 3: Provide all small businesses who are either (a) not
associated with a consortium, or (b) associated with an all-small
business consortium, with an 80 percent discount from the base fee.
    Step 4: Calculate the total remaining fee amount and the total
number of remaining manufacturers that will share the fee by
subtracting out the discounted fees and the number of small businesses
identified.
    Step 5: Place remaining manufacturers in ascending order (from
lowest to highest production volume based on their average annual
production volume from the three calendar years prior to the
publication of the preliminary list).
    Step 6: Assign each remaining manufacturer a number with 1 for
lowest production volume, 2 for second lowest production volume, etc.
    Step 7: Multiply the total number of remaining manufacturers by
0.8.
    Step 8: Determine the manufacturer(s) in the top 20th percentile
spot by comparing the number derived from Step 7 to the manufacturer(s)
with the assigned number derived in Step 5. Manufacturers with an
assigned number under Step 6 that is equal to or larger than the number
in Step 7 are in the top 20th percentile.
    Step 9: Reallocate 80 percent of the remaining fee evenly across
manufacturers in the top 20th percentile determined in Step 8, counting
each manufacturer in a consortium as one person.
    Step 10: Reallocate the remaining fee evenly across the remaining
manufacturers, counting each manufacturer in a consortium as one
person.
    In addition, EPA is proposing to require reporting of average
production volume over the past three years instead of four years as
stated in the 2021 Proposal (Ref. 3). This proposed change would
alleviate additional concerns over potential CBI disclosure by further
separating the production volume submissions under this rule from other
potentially public production volume reporting (e.g., CDR) which could
be used in conjunction with data reported under this proposal to
estimate a manufacturer's production volume. The reduction to 3-year
production volume average would address multiple commenters' concerns
that collecting and reporting production volume is burdensome. In
addition, EPA is proposing that the production volume calculation be
based on the three previous calendar years prior to the publication of
the preliminary list, instead of the year self-identification and/or
certification was made. This change is being made to alleviate
potential confusion that may arise due to inconsistencies with other
timeframe provisions in this rulemaking (additional discussion on those
timeframes can be found in Unit III.G). If finalized as proposed,
applicable manufacturers would be required to report their average
production volume using the past three calendar years of production
volume data.
    These proposed changes would eliminate all expected potential
disclosure of production volume that may be claimed as CBI. However, in
the rare event of multiple fee payers submitting under the same parent
company and asserting a CBI claim for production volume, and/or
multiple companies reporting the exact same amount of a competitor, EPA
would mask the company names on the final list for that chemical to
protect disclosure.
    EPA is not proposing these calculation and methodology changes for
the fee allocations under TSCA section 4 activities. Fees for section 4
activities are significantly lower than those for a risk evaluation
and, therefore, less burdensome, obviating the need to allocate the
fees based on production volume. As described in steps one through
three previously in this Unit, EPA is also not proposing the production
volume-based methodology for manufacturers of a chemical substance
undergoing an EPA-initiated risk evaluation that qualify as a small
business concern. These entities would be provided an 80 percent
discount from the ``base fee'' calculated as described in the 2018 Fee
Rule (40 CFR 700.45(f)).
2. Description of the Primary Alternative Regulatory Action Considered
    Commenters have expressed concerns over the burden of calculating
and reporting production volume in order to comply with the self-
identification and recordkeeping requirements in the 2021 Proposal. As
a primary alternative regulatory action, EPA is considering the use of
the ranking methodologies as described previously but requiring
reporting of production volume ranges instead of averages. These ranges
would be consistent with those ranges used to show aggregate national
production volume of a chemical under EPA's Chemical Data Reporting
(CDR). EPA

believes reporting these ranges would be easier for industry to
calculate and would ensure CBI is always protected since only ranges
would be used. However, these ranges are large, which could result in
many manufacturers paying the same share of the fees, negating the
point of creating a production volume-based fee to improve distribution
of fees and to make fees more equitable. EPA is requesting comment on
this alternative and on whether ranges narrower than the ones used for
CDR would be feasible or appropriate to use under the described
circumstances.

G. Exemptions for Fees Associated With EPA-Initiated Risk Evaluations

    In the 2021 Proposal, EPA proposed six fee exemptions for
manufacturers of chemical substances undergoing EPA-initiated risk
evaluation. These proposed exemptions would apply to: (1) Importers of
articles containing a chemical substance; (2) Producers of a chemical
substance as a byproduct; (3) Manufacturers (including importers) of a
chemical substance as an impurity; (4) Producers of a chemical as a
non-isolated intermediate; (5) Manufacturers (including importers) of
small quantities of a chemical substance solely for research and
development; and (6) Manufacturers (including importers) of chemical
substances with production volume less than 2,500 lbs. EPA proposed
that the volume threshold exemption would not apply when all
manufacturers of that chemical substance manufacture in quantities
below 2,500 lbs (See 40 CFR 700.45(a)(3)(vi) of the 2021 Proposal). EPA
is proposing modifications to the exemptions included in the 2021
Proposal as described in the following section.
    Twenty-seven industry commenters supported one or more of EPA's
proposed exemptions for EPA-initiated risk evaluation fees for
byproducts, impurities, and non-isolated intermediates and many also
suggested that EPA use existing TSCA definitions to identify those that
are subject to exemptions (e.g., conform the byproducts definition to
match other TSCA programs and use 40 CFR 720.30(g) or 720.30(h)(2))
(EPA-HQ-OPPT-2020-0493). EPA is proposing regulatory action aimed to
narrow one of the six proposed exemptions (producers of a chemical
substance as a byproduct) and to include self-identification
requirements for manufacturers (including importers) of chemical
substances with production volume less than 2,500 lbs. EPA is proposing
to modify the byproduct exemption to, ``producers of a chemical
substance as a byproduct that is not later used for commercial purposes
or distributed for commercial use.'' By narrowing the byproduct
exemption to include only manufacturers of byproducts that are not
later used for commercial purposes or distributed for commercial use,
EPA could still collect fees from producers of chemicals that are then
sold or used for commercial purposes. In addition, EPA believes those
producers of byproducts that are later used in commerce or distributed
for commercial use by that manufacturer will not encounter the same
issues and concerns with the self-identification requirements as
described in EPA's memorandum issued on March 18, 2020 (Ref. 15)
previously discussed in the 2021 Proposal since those producers
knowingly produce the byproduct before it is introduced into the market
(86 FR 1899) (Ref. 3). The byproduct exemption, with these proposed
changes, would address challenges with self-identification raised by
stakeholders as it relates to identifying and tracking byproducts that
are unintentionally or coincidentally produced (40 CFR 700.45(b)(5)).
    Twelve industry commenters specifically supported the 2,500 lbs
production volume exemption for EPA-initiated risk evaluation fees.
However, three of those commenters requested additional clarification
or modification of the provision where the exemption would not apply
for the EPA-initiated risk evaluation fee for that chemical substance
because all manufacturers are low-volume manufacturers (described in
the proposed regulations at 40 CFR 700.45(a)(3)(vi)) (EPA-HQ-OPPT-2020-
0493). Specifically, one commenter requested clarification of whether,
in this case, additional time to make fee payments would be granted to
low-volume manufacturers that would otherwise have qualified for this
exemption. The commenter asked if low-volume producers would be subject
to reduced fees considering the financial burden risk evaluation fees
would impose on low-volume manufacturers. Finally, the commenter sought
clarification of the procedural steps that will occur and how
manufacturers would be notified if they are all low-volume
manufacturers (EPA-HQ-OPPT-2020-0493-0034). Another commenter requested
that EPA clarify the timeframes associated with the 2,500 lb exemption,
specifically on the proposed provision where all identified
manufacturers meet the exemption criteria (EPA-HQ-OPPT-2020-0493-0059).
    In response to these comments, EPA is proposing self-identification
requirements for manufacturers (including importers) of chemical
substances with production volume less than 2,500 lbs. Specifically,
EPA is proposing to require manufacturers that qualify for the 2,500 lb
exemption to self-identify, as described in the 2021 Proposal at 40 CFR
700.45 (b)(5), to report the average annual production volume from the
three calendar years prior to the publication of the preliminary list.
Requiring self-identification of those manufacturers that qualify for
the 2,500 lbs exemption would allow EPA to allocate fees based on
production volume and collect fees in a timely manner in the situation
where all fee payers have production volumes below 2,500 lbs. In this
situation, as described in the 2021 Proposal and not affected by this
document, the exemption would not apply for the fee for that chemical
substance (described in the proposed regulations at 40 CFR
700.45(a)(3)(vi)). EPA would mask the company names on the final list
for that chemical to protect disclosure of potential CBI and notify
subject manufacturers of their obligation to pay fees prior to the 90-
day consortium deadline (see 40 CFR 700.45(f)(2) and (3) of the 2021
Proposal). For EPA-initiated risk evaluations, the applicable fee would
be paid in two installments, with the first payment due 180 days after
publishing the final scope of a risk evaluation (see 40 CFR
700.45(g)(3) of the 2021 Proposal). Additional discussion on how these
exemptions would apply to test rules is in the following section, Unit
III.H.
    In addition, EPA recognizes that requiring reporting of a three-
year production volume average (discussed in Unit III.F) differs from
the timeframes associated with this exemption for low volume producers
in new 40 CFR part 700.45(a) which requires a manufacturer to meet the
exemption for the five-year period preceding publication of the
preliminary list and the successive five years. In response to comments
on the timeframe and to avoid confusion, EPA has made changes to the
definition of production volume in new 40 CFR 700.43, as discussed in
Unit III.F. EPA has also provided clarification on how to determine if
the exemption criteria is met in the following paragraph.
    To calculate whether a manufacturer produces low enough amounts of
a chemical substance to qualify for the exemption, manufacturers would
determine their annual production volume for the five calendar years
prior to the publication of the preliminary list

and their annual projected production volume for the successive five
years (as described in new 40 CFR 700.45(a)). To qualify for the
exemption for low volume producers, manufacturers would need to produce
below 2,500 lbs. for EPA-initiated risk evaluations and below 1,100
lbs. for test rules (see Unit III.H for more details) for those
applicable years. If finalized as proposed, manufacturers would not
qualify if they produce 2,500 lbs. or 1,100 lbs. or above for EPA-
initiated risk evaluations and test orders respectively for any of the
applicable years.
    EPA is not proposing a reduced fee amount for test rules and/or
fees for EPA-initiated risk evaluations for manufacturers reporting a
production volume less than 2,500 lbs or 1,100 lbs, respectively, in
the event the exemption does not apply. However, EPA is proposing to
utilize the production volume-based fee allocation for EPA-initiated
risk evaluation fees. The 80% discount for manufacturers that qualify
as a small business concern still applies to both test rules and the
EPA-initiated risk evaluation fees. EPA requests comments on the
proposed changes, as well as the procedural steps EPA plans to take in
implementing this provision.
    EPA is requesting comment on all six exemptions, including whether
any modifications to the exemptions are warranted and whether any
additional CBI concerns are present given EPA's proposed approach. EPA
is also requesting comment on whether the exemptions, as described in
the proposed, new 40 CFR 700.45(a), should be modified based on other
TSCA programs like CDR.

H. Exemptions for Fees Associated With TSCA Section 4 Test Rules

    The 2018 Fee Rule and the 2021 Proposal did not establish any
exemptions related to TSCA section 4 test rules. Currently,
manufacturers subject to test rules (and thereby required to pay fees
for such rules) are identified using the same process for identifying
fee payers for TSCA section 6 EPA-initiated risk evaluations, which
involves publishing preliminary and final lists of manufacturers.
Including exemptions for TSCA section 4 rules would prevent similar
challenges experienced with the self-identification requirements
associated with EPA-initiated risk evaluation fees (Refs. 2 and 3).
1. Description of the Proposed Regulatory Action
    Based on comments received during the public comment period for the
2021 Proposal, EPA is proposing and requesting comment on applying the
EPA-initiated Risk Evaluation fee exemptions to fees for TSCA section 4
test rules. EPA is proposing this change to TSCA section 4 test rules
to reduce confusion and prevent challenges regarding the self-
identification requirements which apply to fees for both test rules and
EPA-initiated risk evaluations. The self-identification requirements do
not apply to test orders or ECA's. For this reason, the exemptions will
not be applied to those actions. The exemptions outlined earlier in
this Unit will remain the same for test rule fees except the annual
production volume threshold will change to 1,100 lbs. Manufacturers
with an annual production volume of less than 1,100 lbs will qualify
for the exemption for the TSCA section 4 test rule fee. This change is
necessary to conform to the regulations at 40 CFR 790.42 (a)(4) which
specifies a potential annual production volume threshold exemption of
less than 1,100 lbs for chemicals subject to TSCA section 4 test rules.
EPA is conforming the regulations to avoid possible confusion by
manufacturers regarding the TSCA section 4 test rule requirements.
    The proposed exemptions for TSCA section 4 test rule fees include:
(1) importers of articles containing a chemical substance; (2)
producers of a chemical substance as a byproduct; (3) manufacturers
(including importers) of a chemical substance as an impurity; (4)
producers of a chemical as a non-isolated intermediate; (5)
manufacturers (including importers) of small quantities of a chemical
substance solely for research and development and; (6) manufacturers
(including importers) of chemical substances with production volume
less than 1,100 lbs of a chemical subject to a TSCA section 4 test
rule. EPA believes these exemptions will provide greater consistency
and fairness between TSCA section 4 and TSCA section 6 fees. Including
such exemptions for TSCA section 4 will also prevent challenges
regarding the self-identification requirements associated with risk
evaluation fees for manufacturers similar to what occurred in March
2020 (Ref. 15).
    Under these proposed exemptions, appropriate record keeping must be
conducted by affected manufacturers as it relates to each listed
exemption. Accordingly, EPA is proposing that these manufacturers must
maintain production volume records and ordinary business records
related to compliance with the six proposed exemptions as outlined in
40 CFR 700.45 (b)(10)(i)-(iv).
2. Description of the Primary Alternative Regulatory Action Considered
    The primary alternative to the proposed regulatory action above is
to finalize the 2021 Proposal, which did not establish any exemptions
related to TSCA section 4 test rules.

I. Expansion of Fee Requirements To Include Companies Required To
Submit Information Under TSCA Section 4

    The 2018 Fee Rule does not reflect all circumstances in which a
manufacturer subject to a TSCA section 4 test order could be required
to pay fees. Specifically, fees are required for manufacturers that
conduct testing. However, TSCA section 26(b)(1) provides for the
collection of fees ``from any person required to submit information''
under TSCA section 4. There are circumstances in which a manufacturer
subject to information development requirements under TSCA section 4
may not need to conduct any testing. For instance, a manufacturer may
have already conducted the testing prior to the issuance of a TSCA
section 4 test order, in which case the manufacturer may submit the
information they have already produced. As explained in greater detail
in Unit III.B.1, developing test orders is a complex, time-consuming,
and resource-intensive process involving many scientific and regulatory
considerations. EPA must establish what information is required, what
testing will provide such information, and what test protocols can
inform the generation of such information. Further resources are also
needed to administer the test orders after they have been issued; the
amount of resources needed for such activities varies depending on the
complexity of the testing requirements and the number of recipients.
    Regardless of whether a manufacturer conducts testing to comply
with a test order, EPA incurs costs for developing the test order and
administering the test order after it has been issued, including
reviewing the data submitted by test order recipients. To ensure that a
portion of these costs will be recovered, EPA proposes to require
payment from manufacturers subject to TSCA section 4 test order fees
that submit information under TSCA section 4 that do not need to
conduct any testing.
1. Description of the Proposed Regulatory Action
    EPA is proposing and requesting comment on revising the 2018 Fee
Rule language under 40 CFR 700.45(a)(2) to

refer to manufacturers required to submit information rather than
manufacturers ``required to test.'' Making this change would extend fee
obligations to manufacturers who collect and submit existing data. This
proposed change would include all manufacturers of a certain chemical
regardless of when data was procured, and would create a more equitable
fee allocation. Without this proposed change, in situations where test
orders are issued to manufacturers which have already completed testing
and procured data, those manufacturers would not be subject to fees
despite their submission of data to EPA under that test order and
despite the costs incurred by EPA for the resource intensive process of
developing and administering a test order as explained further in Unit
III.B.1.
2. Description of the Primary Alternative Regulatory Action Considered
    The primary alternative action to the proposed regulatory action
above is to retain the 2018 Fee Rule language under 40 CFR
700.45(a)(2).

J. Payment by Processors Subject to Test Orders and ECAs

    The 2018 Fee Rule established that only manufacturers are required
to pay fees for TSCA section 4 test orders and ECAs. As a result, in
the event that no manufacturers are identified as recipients, EPA would
be required to absorb the entire cost of administering TSCA section 4
test orders and ECAs. As an example, in the TSCA section 4 test order
issued in January 2021 for o-dichlorobenzene, because only processors
were responsible for submitting information, EPA did not collect fees
to support the administration of the test order.
    EPA is proposing and requesting comment on modifying the fee
payment obligations in 40 CFR 700.45(a) to require payment by
processors identified in the TSCA section 4 test orders and ECAs who
submit information. In the event that there are no manufacturers
receiving a test order or ECA, requiring fee payments by processors
would allow EPA to recoup the costs of administering such test orders
and ECAs. This proposed change would expand the universe of fee payers
for these section 4 actions to include both manufacturers and, in some
circumstances, processors subject to TSCA section 4 test orders and
ECAs. Increasing the scope of fee payers included in TSCA section 4
test orders and ECAs would prevent situations where no manufacturer was
identified, thus leaving EPA responsible for the entire cost of
administering the test order or ECA.

K. Timeframe for Test Order and Test Rule Payments

    The 2018 Fee Rule established a 120-day timeline for TSCA section 4
test order and test rule payments. This 120-day timeline has been found
to be too short for the creation of invoice payments and other Agency
work related to allocating such payments before any fees are assessed
for entities submitting data. It is difficult to calculate such
assessed fees quickly under the current timeline which includes various
steps such as allocating fees across a number of different
manufacturers, issuing invoices, and notifying consortia of those fees
within 120 days.
    EPA is proposing and requesting comment on extending the timeframe
for test order and test rule payments to 180 days after the effective
date of the order or rule. This timeframe aligns with the proposed
timeframe for the initial fee payment associated with EPA-initiated
risk evaluations under section 6, which is also 180 days. The change
would provide EPA with sufficient time to review fee payments, identify
and allocate fees across a number of different entities, and issue
invoices.

L. Requests for Comment

    EPA is issuing this supplemental notice and is requesting comments
on the proposed provisions and primary alternative provisions described
herein that would add to or modify the 2021 Proposal. In addition to
the areas on which EPA has specifically requested comment, EPA requests
comment on all other aspects of this proposed rule. This includes
feedback on potential flexibilities to address small business concerns
especially with regard to their ability to pay.
    EPA is proposing to refund 20 percent of the user fee to the
submitter if a notice is withdrawn after 10 business days after the
beginning of the applicable review period, but prior to EPA initiating
risk management on the chemical substance. The Agency requests comment
on this new partial refund process for the review of TSCA section 5
notices. EPA is also requesting comment on its proposal to recover less
than 25 percent of the costs for implementing TSCA section 5.
    EPA is proposing a new approach to allocating fees for EPA-
initiated risk evaluations, as discussed in Unit III.F. EPA is
requesting comment on the methodology outlined below, including whether
the approach is a more equitable way of distributing fees. EPA also
considered an alternative approach to allocating those fees using
production volume ranges. EPA is requesting comment on this alternative
and on whether ranges narrower than the ones used for CDR would be
feasible or appropriate to use under the described circumstances.
    EPA is proposing to require manufacturers that qualify for the
2,500 lb exemption to self-identify, as described in the 2021 Proposal
at 40 CFR 700.45 (b)(5), to report the average annual production volume
from the three calendar years prior to the publication of the
preliminary list. Unit III.G also outlines steps EPA will take to
implement this provision while protecting CBI disclosure. EPA requests
comments on the proposed changes, as well as the procedural steps EPA
plans to take in implementing this provision.
    EPA is requesting comment on all six exemptions, including whether
any modifications to the exemptions are warranted and whether any
additional CBI concerns are present given EPA's proposed approach. EPA
is also requesting comment on whether the exemptions, as described in
the proposed, new 40 CFR 700.45(a), should be modified based on other
TSCA programs like CDR, as well as whether the EPA-initiated Risk
Evaluation fee exemptions should apply to fees for TSCA section 4 test
rules.
    Lastly, EPA is proposing and requesting comment on revising the
2018 Fee Rule language under 40 CFR 700.45(a)(2) to refer to
manufacturers required to submit information rather than manufacturers
``required to test,'' as well as extending the timeframe for test order
and test rule payments to 180 days after the effective date of the
order or rule.

IV. 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. The Frank R. Lautenberg Chemical Safety for the 21st Century Act.
June 22, 2016. Public Law 114-182.
2. EPA. Final Rule; Fees for the Administration of the Toxic
Substances Control Act. Federal Register. 83 FR 52694, October 17,
2018 (FRL-9984-41).

3. EPA. Proposed Rule; Fees for the Administration of the Toxic
Substances Control Act. Federal Register. 86 FR 1890, January 11,
2021 (FRL-10018-40).
4. EPA. Economic Analysis of the Supplemental Notice of Proposed
Rulemaking for Fees for the Administration of the Toxic Substances
Control Act. October 2022.
5. EPA. TSCA Work Plan Chemicals: Methods Document. February 2012.
https://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf.
6. EPA. Outreach for the TSCA Administration Fees Rule. February
2021. https://www.epa.gov/tsca-fees/outreach-tsca-administration-fees-rule.
7. EPA. National PFAS Testing Strategy: Identification of Candidate
Per- and Poly- fluoroalkyl Substances (PFAS) for Testing. October
2021. https://www.epa.gov/system/files/documents/2021-10/pfas-natl-test-strategy.pdf.
8. EPA. Office of Inspector General (OIG). Lack of Planning Risks
EPA's Ability to Meet Toxic Substances Control Act Deadlines (No.
20-P-0247). August 2020. https://www.epa.gov/sites/default/files/2020-08/documents/_epaoig_20200817-20-p-0247.pdf.
9. U.S. Government Accountability Office (GAO). Report to
Congressional Committees. High-Risk Series: Dedicated Leadership
Needed to Address Limited Progress in Most High-Risk Areas. https://www.gao.gov/assets/gao-21-119sp.pdf.
10. Joint Explanatory Statement from the House and Division G--
Department of Interior, Environment, and Related Agencies
Appropriations Act, 2022, https://docs.house.gov/billsthisweek/20220307/BILLS-117RCP35-JES-DIVISION-G.pdf.
11. EPA. Technical Background Document for TSCA Fees. October 2022.
12. EPA. Interagency Agreement and Oil Indirect Cost Rates for FY
2022 and Beyond. November 2021.
13. OMB. Circular A-25 (Revised). July 8, 1993. https://www.whitehouse.gov/wp-content/uploads/2017/11/Circular-025.pdf.
14. EPA. Proposed Rule; User Fees for the Administration of the
Toxic Substances Control Act. Federal Register. 83 FR 8212, February
26, 2018 (FRL-9974-31).
15. EPA. Request for No Action Assurance Regarding Self-
Identification Requirement for Certain ``Manufacturers'' Subject to
the TSCA Fees Rule. March 2020. https://www.epa.gov/sites/production/files/2020-03/documents/tsca_fees_-_naa_request_final.pdf.
16. EPA. Information Collection Request (ICR) Supporting Statement
under the Paperwork Reduction Act entitled: ``Reporting Requirements
Associated with the Payment of Fees under Section 26(b) of the Toxic
Substances Control Act (TSCA); Supplemental Proposed Rule (RIN 2070-
AK64).'' EPA ICR No. 2569.05; OMB Control No. 2070-0208. October 20,
2022.
17. EPA. Information Collection Request (ICR) Supporting Statement
under the Paperwork Reduction Act entitled: ``User Fees for the
Administration of the Toxic Substances Control Act (TSCA); Proposed
Rule (RIN 2070-AK64).'' EPA ICR No. 2569.05; OMB Control No. 2070-
0208. Submitted January 31, 2021.
18. OMB. Notice of Office of Management and Budget Action under the
Paperwork Reduction Act on ICR entitled: ``User Fees for the
Administration of the Toxic Substances Control Act (TSCA) (Proposed
Rule).'' EPA ICR No. 2569.03; OMB Control No. 2070-0208; OMB ICR
Reference No.<PHONE_NUMBER>-002. April 5, 2021. https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202101-2070-002#.

V. Statutory and Executive Order Reviews

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

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review under Executive
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011). Any changes made in response to OMB recommendations
have been documented in the docket for this action as required by
section 6(a)(3)(E) of Executive Order 12866.
    EPA prepared an economic analysis of the potential costs and
benefits associated with this action (Ref. 4). A copy of this economic
analysis is available in the docket.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this supplemental proposed
rule have been submitted to OMB under the PRA, 44 U.S.C. 3501 et seq.
The Information Collection Request (ICR) that EPA prepared for this
supplemental proposed rule has been assigned EPA ICR No. 2569.05 (Ref.
16). EPA also prepared and submitted an ICR for the 2021 proposed rule
(Ref. 17), and on April 5, 2021, the Notice of OMB Action was issued on
that submission that identified the OIRA Conclusion Action as ``Comment
filed on proposed rule and continue'' (Ref. 18). EPA intends for the
final rule ICR to amend an existing ICR that is currently approved
under OMB Control No. 2070-0208 through February 28, 2025. You can find
a copy of the ICR for this supplemental proposal (Ref. 16) in the
docket for this action, and it is briefly summarized here.
    The information collection activities associated with the
supplemental proposed rule include familiarization with the regulation;
reduced fee eligibility determination; CDX registration; formation,
management and notification to EPA of participation in consortia; self-
identification and certification; and electronic payment of fees
through Pay.gov.
    Respondents/affected entities: Persons who manufacture or process a
chemical substance (or any combination of such activities) and are
required to submit information to EPA under TSCA sections 4 or 5, or
manufacture a chemical substance that is the subject of a risk
evaluation under TSCA section 6(b).
    Respondent's obligation to respond: Mandatory. TSCA section 26(b).
    Estimated number of respondents: 960.
    Frequency of response: On occasion.
    Total estimated burden: 496 hours (per year). Burden is defined at
5 CFR 1320.3(b).
    Total estimated cost: $31,046 (per year), includes $0 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 EPA's
regulations in 40 CFR part 700 are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates and any suggested methods for
minimizing respondent burden to the EPA using the docket identified at
the beginning of this rule. You may also send your ICR-related comments
to OMB's Office of Information and Regulatory Affairs using the
interface at https://www.reginfo.gov/public/do/PRAMain. Find this
particular information collection by selecting ``Currently under
Review--Open for Public Comments'' or by using the search function.
    If you wish to comment on the information collection requirements
in this supplemental proposed rule, please note that OMB is required to
make a decision concerning the collection of information contained in
this supplemental proposed rule between 30 and 60 days after
publication of this supplemental proposed rule in the Federal Register.
    EPA will respond to ICR-related comments received on the 2021
proposed rule and on this supplemental

proposed rule in the context of the final rule.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The small entities expected to be subject to the
requirements of this action are small chemical manufacturers and
processors, small petroleum refineries, and small chemical and
petroleum wholesalers. There may be some potentially affected firms
within other sectors, but not all firms within those sectors will be
potentially affected firms. 306 small businesses, including 256
processors and 50 manufacturers, may be affected annually by TSCA
section 4 actions; 149 small businesses may be affected by section 5
actions; and 31 small businesses may be affected by section 6 actions.
EPA estimates the annual revenue distribution using U.S. Census data
for small businesses likely to be affected by TSCA sections 4, 5, and 6
actions, with the following properties: 92% of parent firms have an
annual revenue greater than $152,800, 7% have an annual revenue between
$152,800 and $50,933, and 1% have revenue less than $50,933. The
average annual incremental cost per affected small business is expected
to be about $392 for TSCA section 4; $2,477 for TSCA section 5, and
$44,559 for TSCA section 6. As a result, EPA estimates that, of the 485
small businesses paying fees every year, 451 will have impacts under
1%, 19 will have impacts between 1% and 3%, and 16 will have impacts
greater than 3%.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The rule is not
expected to result in expenditures by state, local, and tribal
governments, in the aggregate, or by the private sector, of $100
million or more (when adjusted annually for inflation) in any one year.
Accordingly, this proposed rule is not subject to the requirements of
sections 202, 203, or 205 of UMRA. The total quantified annualized
social costs for this supplemental proposal are approximately $85,014
(at both 3% and 7% discount rate), which does not exceed the inflation-
adjusted unfunded mandate threshold of $160 million.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of 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). This rule will
not impose substantial direct compliance costs on Indian Tribal
Governments. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health 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 the EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order. This
action is not subject to Executive Order 13045 because it does not
establish an environmental standard intended to mitigate environmental
health risks or safety risks.

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

    This action is not a ``significant energy action'' as specified in
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy and has not otherwise been designated by the
Administrator of the Office of Information and Regulatory Affairs as a
significant energy action.

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14008: Tackling the Climate Crisis at Home and Abroad

    In accordance with Executive Order 12898 (59 FR 7629, February 16,
1994) and Executive Order 14008 (86 FR 7619, January 27, 2021), EPA
finds that this action will not result in disproportionately high and
adverse human health, environmental, climate-related, or other
cumulative impacts on disadvantaged communities. The documentation for
this decision is contained in the Economic Analysis (Ref. 4), which is
in the docket for this action. Although not directly impacting
environmental justice-related concerns, the fees will enable the Agency
to better protect human health and the environment, including in low-
income and minority communities. The fees also provide for fair
treatment and meaningful involvement in the implementation of TSCA.

List of Subjects 40 CFR Part 700

    Chemicals, Environmental protection, Hazardous substances,
Reporting and recordkeeping requirements, User fees.

Michael S. Regan,
Administrator.

    Therefore, for the reasons presented in the preamble, it is
proposed that 40 CFR chapter I, subchapter R, be amended as follows:

PART 700--GENERAL [AMENDED]

0
1. The authority citation for part 700 continues to read as follows:

    Authority:  15 U.S.C. 2625 and 2665, 44 U.S.C. 3504.

0
2. Amend Sec.  700.43 by adding in alphabetical order a definition for
``Production volume'' and ``Small quantities solely for research and
development'' the additions read as follows:

Sec.  700.43   Definitions applicable to this subpart.

* * * * *
    Production volume means manufactured (including imported) amount in
pounds.
* * * * *
    Small quantities solely for research and development (or ``small
quantities solely for purposes of scientific experimentation or
analysis or chemical research on, or analysis of, such substance or
another substance, including such research or analysis for the
development of a product'') means

quantities of a chemical substance manufactured (including imported),
or processed or proposed to be manufactured (including imported), or
processed solely for research and development that are not greater than
reasonably necessary for such purposes.
* * * * *
0
3. Amend Sec.  700.45 by:
0
a. Revising paragraphs (a)(2) and (3).
0
b. In paragraph (b), by:
0
i. Revising the introductory text in paragraph (b)(5) and paragraphs
(b)(5)(ii) and (iii),
0
ii. Adding paragraphs (b)(5)(iv) and (v),
0
iii. Revising paragraph (b)(7), and
0
v. Adding paragraph (b)(10).
0
c. In paragraph (c), by:
0
i. Revising the intro text heading in paragraph (c),
0
ii. Revising paragraphs (c)(1)(i) through (iii) and (iv) through
(viii), and
0
iii. Revising paragraphs (c)(2)(i) through (iii) and (iv) through (xi).
0
d. Revising paragraph (d),
0
e. In paragraph (f), by:
0
i. Revising paragraphs (f)(2)(i), (3)(i), (4) and (5), and
0
ii. Adding paragraph (f)(6).
0
f. In paragraph (g) by:
0
i. Revising paragraphs (g)(3)(i) and (iv),
0
ii. Revising paragraph (g)(5), and (6).
0
g. In paragraph (i), by:
0
i. Revising paragraphs (i)(1) through (3), and
0
ii. Adding paragraph (i)(4).
    The revisions and additions read as follows.

Sec.  700.45   Fee payments.

    (a) * * *
    (2) Manufacturers and processors of chemical substances and
mixtures required to submit information for these chemical substances
and mixtures under a TSCA section 4(a) test order or enforceable
consent agreement, or manufacturers of chemical substances and mixtures
required to submit information for these chemical substance and
mixtures under a TSCA section 4(a) test rule, shall remit for each such
test rule, order, or enforceable consent agreement the applicable fee
identified in paragraph (c) of this section in accordance with the
procedures in paragraphs (f) and (g) of this section. Manufacturers of
a chemical substance subject to a test rule under section 4(a) of the
Act are exempted from fee payment requirements in this section, if they
meet one or more of the exemptions under this paragraph (a)(2)(i)
through (vi) for the five-year period preceding publication of the
preliminary list and do not conduct manufacturing outside of those
exemptions during the five-year period preceding publication of the
preliminary list; and will meet one or more of the exemptions in
paragraph (a)(2)(i) through (vi) of this section in the successive five
years and will not conduct manufacturing outside of those exemptions in
the successive five years:
    (i) import articles containing that chemical substance;
    (ii) produce that chemical substance as a byproduct that is not
later used for commercial purposes or distributed for commercial use;
    (iii) manufacture (including import) that chemical substance as an
impurity as defined in Sec.  704.3;
    (iv) manufacture that chemical substance as a non-isolated
intermediate as defined in 40 Sec.  [thinsp]704.3;
    (v) manufacture (including import) small quantities of that
chemical substance solely for research and development, as defined in
Sec.  700.43; and/or
    (vi) manufacture (including import) that chemical substance in
quantities below a 1,100 lbs annual production volume as described in
Sec.  700.43, unless all manufacturers of that chemical substance
manufacture that chemical in quantities below a 1,100 lbs annual
production volume as described in Sec.  700.43, in which case this
exemption is not applicable.
    (3) Manufacturers of a chemical substance that is subject to a risk
evaluation under section 6(b) of the Act, shall remit for each such
chemical risk evaluation the applicable fee identified in paragraph (c)
of this section in accordance with the procedures in paragraphs (f) and
(g) of this section. For the purposes of this section, entities that
manufacture a chemical substance subject to a risk evaluation under
section 6(b) of the Act solely for export are subject to fee
requirements in this section whenever such substance is manufactured,
processed, or distributed in commerce by any other entity for any
purpose other than export from the United States. Manufacturers of a
chemical substance subject to risk evaluation under section 6(b) of the
Act are exempted from fee payment requirements in this section, if they
meet one or more of the exemptions under this paragraph (a)(3)(i)
through (vi) for the five-year period preceding publication of the
preliminary list and do not conduct manufacturing outside of those
exemptions during the five-year period preceding publication of the
preliminary list; and will meet one or more of the exemptions in
paragraph (a)(3)(i) through (vi) of this section in the successive five
years and will not conduct manufacturing outside of those exemptions in
the successive five years:
    (i) import articles containing that chemical substance;
    (ii) produce that chemical substance as a byproduct that is not
later used for commercial purposes or distributed for commercial use;
    (iii) manufacture (including import) that chemical substance as an
impurity as defined in Sec.  704.3;
    (iv) manufacture that chemical substance as a non-isolated
intermediate as defined in[thinsp]Sec.  [thinsp]704.3;
    (v) manufacture (including import) small quantities of that
chemical substance solely for research and development, as defined in
Sec.  700.43; and/or
    (vi) manufacture (including import) that chemical substance in
quantities below a 2,500 lbs annual production volume as described in
Sec.  700.43, unless all manufacturers of that chemical substance
manufacture that chemical in quantities below a 2,500 lbs annual
production volume as described in Sec.  700.43, in which case this
exemption is not applicable.
* * * * *
    (b) * * *
* * * * *
    (5) Self-identification. All manufacturers other than those listed
in paragraph (a)(2)(i) through (iii) and (a)(3)(i) through (iii) of
this section who have manufactured (including imported) the chemical
substance in the previous five years must submit notice to EPA,
irrespective of whether they are included in the preliminary list
specified in paragraph (b)(3) of this section. The notice must be
submitted electronically via EPA's Central Data Exchange (CDX), the
Agency's electronic reporting portal, using the Chemical Information
Submission System (CISS) reporting tool, and must contain the following
information:
    (i) * * *
    (ii) Certification of cessation. If a manufacturer has manufactured
in the five-year period preceding publication of the preliminary list,
but has ceased manufacture prior to the certification cutoff dates
identified in paragraph (b)(6) of this section and will not manufacture
the substance again in the successive five years, the manufacturer may
submit a certification statement attesting to these facts. If EPA
receives such a certification statement from a manufacturer, the
manufacturer will not be included in the final list of manufacturers
described in paragraph (b)(7) of this section and will not be obligated
to pay the fee under this section.

    (iii) Certification of no manufacture. If a manufacturer is
identified on the preliminary list but has not manufactured the
chemical in the five-year period preceding publication of the
preliminary list, the manufacturer may submit a certification statement
attesting to these facts. If EPA receives such a certification
statement from a manufacturer, the manufacturer will not be included in
the final list of manufacturers described in paragraph (b)(7) of this
section and will not be obligated to pay the fee under this section.
    (iv) Certification of meeting exemption. If a manufacturer is
identified on the preliminary list and exclusively meets one or more of
the exemptions in paragraph (a)(2)(i) through (vi) or (a)(3)(i) through
(vi) of this section for the five-year period preceding publication of
the preliminary list and will exclusively meet one of more of the
exemptions in paragraph (a)(2)(i) through (vi) or (a)(3)(i) through
(vi) of this section in the successive five years, the manufacturer
must submit a certification statement attesting to these facts in order
to not be included in the final list of manufacturers described in
paragraph (b)(7) of this section. If a manufacturer is not on a
preliminary list and exclusively meets one or more of the exemptions in
paragraph (a)(2)(i) through (vi) or (a)(3)(i) through (vi) of this
section for the five-year period preceding publication of the
preliminary list and will exclusively meet one of more of the
exemptions in paragraph (a)(2)(i) through (vi) or (a)(3)(i) through
(vi) of this section in the successive five years, the manufacturer may
submit a certification statement attesting to these facts. If EPA
receives such a certification statement from a manufacturer, the
manufacturer will not be included in the final list of manufacturers
described in paragraph (b)(7) of this section and will not be obligated
to pay the fee under this section, unless all manufacturers of that
chemical substance meet the exemption as described in (a)(2)(vi) or
(a)(3)(vi) of this section.
    (v) Production volume. If a manufacturer has not submitted
certification of cessation, as described in paragraph (b)(5)(ii) of
this section, or certification of no manufacture, as described in
paragraph (b)(5)(iii) of this section, for purposes of identifying
manufacturers subject to fees for section 6 EPA-initiated risk
evaluations and does not meet one or more of the exemptions in
paragraph (a)(3)(i) through (v) of this section, the manufacturer must
submit their production volume as defined in Sec.  700.43 for the
applicable substance for the three calendar years prior to publication
of the preliminary list. Only production volume reported to EPA prior
to the final list being published will be used in determining fees
described in Sec.  700.45(f).
* * * * *
    (7) Publication of final list. EPA expects to publish a final list
of manufacturers to identify the specific manufacturers subject to the
applicable fee. This list will indicate if additional manufacturers
self-identified pursuant to paragraph (b)(5) of this section, if other
manufacturers were identified through credible public comment, and if
manufacturers submitted certification of cessation, no manufacture, or
meeting exemption pursuant to paragraph (b)(5)(ii), (iii), or (iv) of
this section. The final list will be published no later than
concurrently with the final scope document for risk evaluations
initiated by EPA under section 6, and with the final test rule for test
rules under section 4.
* * * * *
    (10) Recordkeeping. After [date 60 calendar days after the date of
publication of the final rule]:
    (i) All manufacturers other than those listed in paragraph
(a)(2)(i) through (v) or (a)(3)(i) through (v) of this section must
maintain production volume records related to compliance with paragraph
(b)(5)(v) of this section. These records must be maintained for a
period of five years from the date notice is submitted pursuant to
paragraph (b)(5) of this section.
    (ii) Those manufacturers that are exempt from fee payment
requirements pursuant to paragraph (a)(2)(iv) or (3)(iv) of this
section must maintain ordinary manufacturing and other business records
related to compliance with the exemption criteria described in
paragraph (a)(2)(iv) or (3)(iv) of this section, respectively. These
records must be maintained for a period of five years from the date the
record is generated.
    (iii) Those manufacturers that are exempt from fee payment
requirements pursuant to paragraph (a)(2)(v) or (3)(v) of this section
must maintain ordinary manufacturing and other business records related
to compliance with the exemption criteria described in paragraph
(a)(2)(v) or (3)(v) of this section respectively, such as production
volume, plans of study, information from research and development
notebooks, study reports, or notice solely for research and development
use. These records must be maintained for a period of five years from
the date the record is generated.
    (iv) Those manufacturers that are exempt from fee payment
requirements pursuant to paragraph (a)(2)(vi) or (3)(vi) of this
section must maintain production volume records related to compliance
with the exemption criteria described in paragraph (a)(2)(vi) or
(3)(vi) of this section, respectively. These records must be maintained
for a period of five years from the date the exemption is claimed.
* * * * *
    (c) Fees for the 2023, 2024, and 2025 fiscal years.
    (1) * * *
    (i) Premanufacture notice and consolidated premanufacture notice.
Persons shall remit a fee totaling $7,880 for each premanufacture