[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Proposed Rules]
[Pages 68647-68667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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premanufacture notices withdrawn at any time after the first 10 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: (202) 566-0758; 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.

[[Page 68648]]

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

[[Page 68649]]

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

[[Page 68650]]

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,

[[Page 68651]]

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

[[Page 68652]]

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

[[Page 68653]]

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.

[[Page 68654]]



                                         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.

[[Page 68655]]

 
\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

[[Page 68656]]

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

[[Page 68657]]

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

[[Page 68658]]

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

[[Page 68659]]

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

[[Page 68660]]

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).

[[Page 68661]]

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. 202101-2070-002. 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

[[Page 68662]]

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

[[Page 68663]]

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.

[[Page 68664]]

    (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 
notice (PMN) or consolidated PMN submitted in accordance with part 720 
of this chapter.
    (ii) Significant new use notice. Persons shall remit a fee totaling 
$7,880 for each significant new use notice (SNUN) submitted in 
accordance with part 721 of this chapter.
    (iii) Exemption application. Persons shall remit a fee totaling 
$2,650 for each of the following exemption requests submitted under 
section 5 of the Act:
    (A) * * *
    (iv) Instant photographic film article exemption notice. Persons 
shall remit a fee totaling $2,650 for each instant photographic film 
article exemption notice submitted in accordance with Sec.  
[thinsp]723.175 of this chapter.
    (v) Microbial commercial activity notice and consolidated microbial 
commercial activity notice. Persons shall remit a fee totaling $7,880 
for each microbial commercial activity notice (MCAN) or consolidated 
MCAN submitted in accordance with Sec. Sec.  725.25 through 725.36 of 
this chapter.
    (vi) Test rule, test order, or enforceable consent agreement. 
Persons shall remit a total of twenty percent of the applicable fee 
under paragraph (c)(2)(vi), (vii) or (viii) of this section for a test 
rule, test order, or enforceable consent agreement.
    (vii) EPA-initiated risk evaluation. Persons shall remit a total 
fee of twenty percent of the applicable fee under paragraphs (c)(2)(ix) 
of this section for an EPA-initiated risk evaluation.
    (viii) Manufacturer-requested risk evaluation. Persons shall remit 
the total fee under paragraph (c)(2)(x) or (xi) of this section, as 
applicable, for a manufacturer-requested risk evaluation.
    (2) * * *
    (i) PMN and consolidated PMN. Persons shall remit a fee totaling

[[Page 68665]]

$45,000 for each PMN or consolidated PMN submitted in accordance with 
part 720 of this chapter.
    (ii) SNUN. Persons shall remit a fee totaling $45,000 for each 
significant new use notice submitted in accordance with part 721 of 
this chapter.
    (iii) Exemption applications. Persons shall remit a fee totaling 
$13,230 for each of the following exemption requests, and modifications 
to previous exemption requests, submitted under section 5 of the Act:
    (A) * * *
    (iv) Instant photographic film article exemption notice. Persons 
shall remit a fee totaling $13,230 for each exemption notice submitted 
in accordance with Sec.  [thinsp]723.175 of this chapter.
    (v) MCAN and consolidated MCAN. Persons shall remit a fee totaling 
$45,000 for each MCAN or consolidated MCAN submitted in accordance with 
Sec. Sec.  [thinsp]725.25 through 725.36 of this chapter.
    (vi) Test rule. Persons shall remit a fee totaling $50,000 for each 
test rule.
    (vii) Test order. Persons shall remit a fee totaling $25,000 for 
each test order.
    (viii) Enforceable consent agreement. Persons shall remit a fee 
totaling $50,000 for each enforceable consent agreement.
    (ix) EPA-initiated chemical risk evaluation. Persons shall remit a 
fee totaling $5,081,000.
    (x) Manufacturer-requested risk evaluation of a Work Plan Chemical. 
Persons shall remit an initial fee of $1,497,000, a second payment of 
$1,497,000, and final payment to total 50% of the actual costs of this 
activity, in accordance with the procedures in paragraph (g) of this 
section. The final payment amount will be determined by EPA, and 
invoice issued to the requesting manufacturer.
    (xi) Manufacturer-requested risk evaluation of a non-work plan 
chemical. Persons shall remit an initial fee of $2,993,000, a second 
payment of $2,993,000, and final payment to total 100% of the actual 
costs of the activity, in accordance with the procedures in paragraph 
(g) of this section. The final payment amount will be determined by 
EPA, and invoice issued to the requesting manufacturer.
* * * * *
    (d) Fees for 2025 fiscal year and beyond.
    (1) Fees for the 2025 and later fiscal years will be adjusted on a 
three-year cycle by multiplying the fees in paragraph (c) of this 
section by the current PPI index value with a base year of 2023 using 
the following formula:

FA = F x I

Where:

FA = the inflation-adjusted future year fee amount.
F = the fee specified in paragraph (c) of this section.
I = Producer Price Index for Chemicals and Allied Products inflation 
value with 2023 as a base year.

    (2) Updated fee amounts for PMNs, SNUNs, MCANs, exemption notices, 
exemption applications, and manufacturer-requested risk evaluation 
requests apply to submissions received by the Agency on or after 
October 1 of every three-year fee adjustment cycle beginning in fiscal 
year 2023 (October 1, 2022). Updated fee amounts also apply to test 
rules, test orders, enforceable consent agreements and EPA-initiated 
risk evaluations that are ``noticed'' on or after October 1 of every 
three-year fee adjustment cycle, beginning in fiscal year 2025.
    (3) The Agency will initiate public consultation through notice-
and-comment rulemaking prior to making fee adjustments beyond 
inflation. If it is determined that no additional adjustment is 
necessary beyond for inflation, EPA will provide public notice of the 
inflation-adjusted fee amounts through posting to the Agency's web page 
by the beginning of each three-year fee adjustment cycle (October 1, 
2025, October 1, 2028, etc.). If the Agency determines that adjustments 
beyond inflation are necessary, EPA will provide public notice of that 
determination and the process to be followed to make those adjustments.
* * * * *
    (f) * * *
    (2) * * *
    (i) The consortium must identify a principal sponsor and provide 
notification to EPA that a consortium has formed. The notification must 
be accomplished within 90 days of the publication date of a test rule 
under section 4 of the Act, or within 90 days of the effective date of 
a test order under section 4 of the Act, or within 90 days of the 
signing of an enforceable consent agreement under section 4 of the Act. 
EPA may permit additional entities to join an existing consortium after 
the expiration of the notification period if the principal sponsor 
provides updated notification.
* * * * *
    (3) * * *
    (i) Notification must be provided to EPA that a consortium has 
formed. The notification must be accomplished within 90 days of the 
publication of the final scope of a chemical risk evaluation under 
section 6(b)(4)(D) of the Act or within 90 days of EPA providing 
notification to a manufacturer that a manufacturer-requested risk 
evaluation has been granted. EPA may permit additional entities to join 
an existing consortium after the expiration of the notification period 
if the principal sponsor provides updated notification.
* * * * *
    (4) If multiple persons are subject to fees triggered by section 4 
or 6(b) of the Act and no consortium is formed, EPA will determine the 
portion of the total applicable fee to be remitted by each person 
subject to the requirement.
    (i) Each person's share of the applicable fees triggered by section 
4 of the Act specified in paragraph (c) of this section shall be in 
proportion to the total number of manufacturers and/or processors of 
the chemical substance, with lower fees for small businesses:
[GRAPHIC] [TIFF OMITTED] TP16NO22.005

Where:

Ps = the portion of the fee under paragraph (c) of this 
section that is owed by a person who qualifies as a small business 
concern under Sec.  700.43 of this chapter.
    Po = the portion of the fee owed by a person other 
than a small business concern.
    F = the total fee required under paragraph (c) of this section.
    Mt = the total number of persons subject to the fee 
requirement.
    Ms = the number of persons subject to the fee 
requirement who qualify as a small business concern.

    (ii) Each person's share of the applicable fees triggered by 
section 6(b) of the Act specified in paragraph (c) of this section 
shall be in proportion to the total number of manufacturers and their 
reported production volume as described in Sec.  700.45(b)(v) of the 
chemical substance, with lower fees for small businesses:
[GRAPHIC] [TIFF OMITTED] TP16NO22.006

    (iii) Remaining manufacturers (i.e., those that do not qualify as a 
small business concern) are then ranked in ascending order (from lowest 
to highest) based on reported production volume as described in Sec.  
700.45(b)(v). Each remaining manufacturer is assigned a number with 1 
for lowest production volume, 2 for second lowest production volume, 
etc.

[[Page 68666]]



Table 1--Example of Placing Manufacturers That Do Not Qualify as a Small
                   Business Concern in Ascending Order
------------------------------------------------------------------------
                                                                Assigned
                        Manufacturer(s)                          No. (N)
------------------------------------------------------------------------
Manufacturer with lowest production volume....................         1
Manufacturer with 2nd lowest production volume................         2
Manufacturer with 3rd lowest production volume................         3
* * * etc.....................................................  ........
------------------------------------------------------------------------

                                                                [GRAPHIC] [TIFF OMITTED] TP16NO22.007
                                                                
Where:

Ps = the portion of the fee under paragraph (c) of this 
section that is owed by a person who qualifies as a small business 
concern under Sec.  700.43 of this chapter.
P>=20th = the portion of the fee owed by a person other 
than a small business concern in the top 20th percentile.
P<20th = the portion of the fee owed by a person other 
than a small business concern not in the top 20th percentile.
F = the total fee required under paragraph (c) of this section.
Mt = the total number of persons subject to the fee 
requirement.
Ms = the number of persons subject to the fee requirement 
who qualify as a small business concern.
N20th = The assigned number as illustrated in Table 1 to 
the manufacturer(s) with a production volume as described in Sec.  
700.45(b)(v) at which the manufacturers with production volume 
greater than or equal to are in the top 20th percentile.
M>=20th = the total number of persons with production 
volume as described in Sec.  700.45(b)(v) greater than or equal to 
the manufacturer(s) with a production volume as N20th.
M<20th = the total number of persons with production 
volume as described in Sec.  700.45(b)(v) less than the 
manufacturer(s) with a production volume as N20th.
    Fo = the total fee required under paragraph (c) of 
this section by all person(s) other than a small business concern.

    (vi) In the event there are three or less manufacturers identified 
for a chemical substance, EPA will distribute the fee evenly among 
those three or less fee payers, regardless of production volume.
    (v) In the event the number assigned to the top 20th percentile is 
not an integer, EPA will round to the nearest integer to determine the 
manufacturer(s) with the reported production volume as described in 
Sec.  700.45(b)(v) greater than or equal to the top 20th percentile.
    (vi) In the event multiple manufacturers report the same production 
volume as described in Sec.  700.45(b)(v) and are greater than or equal 
to the top 20th percentile, EPA will include all manufacturers with 
that same production volume in the fee calculation for the top 20th 
percentile group.
    (5) If multiple persons are subject to fees triggered by section 4 
of the Act and some inform EPA of their intent to form a consortium 
while others choose not to associate with the consortium, EPA will take 
the following steps to allocate fee amounts:
    (i) Count the total number of manufacturers, including the number 
of manufacturers within any consortia; divide the total fee amount by 
the total number of manufacturers; and allocate equally on a per capita 
basis to generate a base fee;
    (ii) Provide all small businesses who are either not associated 
with a consortium, or associated with an all- small business 
consortium, with an 80% discount from the base fee referenced 
previously;
    (iii) Calculate the total remaining fee and total number of 
remaining manufacturers by subtracting out the discounted fees and the 
number of small businesses identified;
    (iv) Reallocate the remaining fee across those remaining 
individuals and groups in equal amounts, counting each manufacturer in 
a consortium as one person; and
    (v) Inform consortia and individuals of their requisite fee amount. 
Small businesses in a successfully-formed consortium, other than a 
consortium of all small businesses, will not be afforded the 80% 
discount by EPA, but consortia managers are strongly encouraged to 
provide a discount for small business concerns.
    (6) If multiple persons are subject to fees triggered by section 
6(b) of the Act and some inform EPA of their intent to form a 
consortium while others choose not to associate with the consortium, 
EPA will take the following steps to allocate fee amounts:
    (i) Count the total number of manufacturers, including the number 
of manufacturers within any consortia; divide the total fee amount by 
the total number of manufacturers; and allocate equally on a per capita 
basis to generate a base fee;
    (ii) Provide all small businesses who are either not associated 
with a consortium, or associated with an all-small business consortium, 
with an 80% discount from the base fee referenced previously;
    (iii) Calculate the total remaining fee and total number of 
remaining manufacturers by subtracting out the discounted fees and the 
number of small businesses identified;
    (iv) Place remaining manufacturers in ascending order (from lowest 
to highest) based on reported production volume as described in Sec.  
700.45(b)(v). Assign each remaining manufacturer a number with 1 for 
lowest production volume, 2 for second lowest production volume, etc.;
    (v) Determine the manufacturer(s) in the top 20th percentile by 
multiplying the total number of remaining manufacturers by 0.8. then 
comparing that number to the manufacturer(s) with that assigned number 
as described in paragraph (iv) of this section;
    (vi) Reallocate 80% of the total remaining fee evenly across that 
manufacturer(s) with a production volume amount equal to or larger than 
that manufacturer(s) (the top 20th percentile), counting each 
manufacturer in a consortium as one person;
    (vii) Reallocate the remaining fee evenly across the remaining 
manufacturers, counting each manufacturer in a consortium as one 
person; and
    (v) Inform consortia and individuals of their requisite fee amount. 
Small businesses in a successfully-formed consortium, other than a 
consortium of all small businesses, will not be afforded the 80% 
discount by EPA, but consortia managers are strongly encouraged to 
provide a discount for small business concerns.
* * * * *
    (g) * * *
    (3) * * *
    (i) Test orders and test rules. The applicable fee specified in 
paragraph (c) of this section shall be paid in full not later than 180 
days after the effective date of a test rule or test order under 
section 4 of the Act.
* * * * *
    (iv) Risk evaluations. (A) For EPA-initiated risk evaluations, the 
applicable fee specified in paragraph (c) of this section shall be paid 
in two installments, with the first payment of 50% due 180 days after 
publishing the final scope of a risk evaluation and the second payment 
for the remainder of the fee due 545 days after publishing the final 
scope of a risk evaluation under section 6(b)(4)(D) of the Act.
    (B) For manufacturer-requested risk evaluations under section 
6(b)(4)(C)(ii) of the Act, the applicable fees specified

[[Page 68667]]

in paragraph (c) of this section shall be paid as follows:
    (1) The applicable fee specified in paragraph (c) of this section 
shall be paid in three installments. The first payment shall be due no 
later than 180 days after EPA provides the submitting manufacture(s) 
notice that it has granted the request.
    (2) The second payment shall be due no later than 545 days after 
EPA provides the submitting manufacturer(s) notice that it has granted 
the request.
    (3) The final payment shall be due no later than 30 days after EPA 
publishes the final risk evaluation.
* * * * *
    (5) Small business certification. (i) Each person who remits the 
fee identified in paragraph (c)(1) of this section for a PMN, 
consolidated PMN, or SNUN shall insert a check mark for the statement, 
``The company named in part 1, section A is a small business concern 
under 40 CFR 700.43 and has remitted a fee of $7,880 in accordance with 
40 CFR 700.45(c).'' under ``CERTIFICATION'' on page 2 of the 
Premanufacture Notice for New Chemical Substances (EPA Form 7710-25).
    (ii) Each person who remits the fee identified in paragraph (c)(1) 
of this section for a LVE, LoREX, TERA, TME, or Tier II exemption 
request under TSCA section 5 shall insert a check mark for the 
statement, ``The company named in part 1, section A is a small business 
concern under 40 CFR 700.43 and has remitted a fee of $2,650 in 
accordance with 40 CFR 700.45(c).'' in the exemption application.
    (iii) Each person who remits the fee identified in paragraph (c)(1) 
of this section for an exemption notice under Sec.  723.175 of this 
chapter shall include the words, ``The company or companies identified 
in this notice is/are a small business concern under 40 CFR 700.43 and 
has/have remitted a fee of $2,650 in accordance with 40 CFR 
700.45(c).'' in the certification required in Sec.  723.175(i)(1)(x) of 
this chapter.
    (iv) Each person who remits the fee identified in paragraph (c)(1) 
of this section for a MCAN or consolidated MCAN for a microorganism 
shall insert a check mark for the statement, ``The company named in 
part 1, section A is a small business concern under 40 CFR 700.43 and 
has remitted a fee of $7,880 in accordance with 40 CFR 700.45(c).'' in 
the certification required in Sec.  [thinsp]725.25(b) of this chapter.
    (6) Payment certification statement. (i) Each person who remits a 
fee identified in paragraph (c)(2) of this section for a PMN, 
consolidated PMN, or SNUN shall insert a check mark for the statement, 
``The company named in part 1, section A has remitted the fee of 
$45,000 specified in 40 CFR 700.45(c).'' under ``CERTIFICATION'' on 
page 2 of the Premanufacture Notice for New Chemical Substances (EPA 
Form 7710-25).
    (ii) Each person who remits a fee identified in paragraph (c)(2) of 
this section for a LVE, LoREX, TERA, TME, or Tier II exemption request 
under TSCA section 5 shall insert a check mark for the statement, ``The 
company named in part 1, section A has remitted the fee of $13,230 
specified in 40 CFR 700.45(c).'' in the exemption application.
    (iii) Each person who remits the fee identified in paragraph (c)(2) 
of this section for an exemption notice under Sec.  723.175 of this 
chapter shall include the words, ``The company or companies identified 
in this notice has/have remitted a fee of $13,230 in accordance with 40 
CFR 700.45(c).'' in the certification required in Sec.  
723.175(i)(1)(x) of this chapter.
    (iv) Each person who remits the fee identified in paragraph (c)(2) 
of this section for a MCAN for a microorganism shall insert a check 
mark for the statement, ``The company named in part 1, section A has 
remitted the fee of $45,000 in accordance with 40 CFR 700.45(c).'' in 
the certification required in Sec.  725.25(b) of this chapter.
* * * * *
    (i) Partial fee refunds.
    (1) If a TSCA section 5 notice is withdrawn during the first 10 
business days after the beginning of the applicable review period under 
Sec.  720.75(a) of this chapter, the Agency will refund all but 25% of 
the fee as soon as practicable.
    (2) If a TSCA section 5 notice is withdrawn during the period 
beginning 10 business days after the beginning of the applicable review 
period under Sec.  [thinsp]720.75(a) of this chapter and ending 5 
business days after EPA has provided the submitter notice that the risk 
assessment on the chemical substance(s) has concluded, the Agency will 
refund all but 80% of the fee as soon as practicable.
    (3) Once withdrawn, any future submission related to the TSCA 
section 5 notice must be submitted as a new notice.
    (4) If EPA determines that the initial payment for a manufacturer-
requested risk evaluation exceeds the applicable fee in paragraph (c) 
of this section, EPA will refund the difference.
* * * * *
[FR Doc. 2022-24137 Filed 11-15-22; 8:45 am]
 BILLING CODE 6560-50-P