[Federal Register Volume 89, Number 35 (Wednesday, February 21, 2024)]
[Rules and Regulations]
[Pages 12961-12979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02735]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 700
[EPA-HQ-OPPT-2020-0493; FRL-7911-05-OCSPP]
RIN 2070-AK64
Fees for the Administration of the Toxic Substances Control Act
(TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA) is finalizing
amendments to the 2018 final rule that established fees for the
administration of the Toxic Substances Control Act (TSCA).
Specifically, EPA is finalizing changes to the fee amounts and EPA's
total costs for administering TSCA; exemptions for entities subject to
the EPA-initiated risk evaluation fees; exemptions for test rule fee
activities; modifications to the self-identification and reporting
requirements of EPA-initiated risk evaluation and test rule fees;
modifications to EPA's proposed methodology for the production-volume-
based fee allocation for EPA-initiated risk evaluation fees in any
scenario in which a consortium is not formed; expanded fee requirements
to companies required to submit information for test orders;
modifications to the fee payment obligations of processors subject to
test orders and enforceable consent agreements (ECA); and extended
timeframes for certain fee payments and notices.
DATES: This rule is effective on April 22, 2024.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0493, is available online at
https://www.regulations.gov. Additional instructions on visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: 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].
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 final rule under TSCA section
26(b), 15 U.S.C. 2625(b).
C. What action is the Agency taking?
After establishing fees under TSCA section 26(b), TSCA requires EPA
to review and, if necessary, adjust the fees every three years, after
consultation with parties potentially subject to fees. This document
describes the final changes to 40 CFR part 700, subpart C as
promulgated in the final rule entitled ``Fees for the Administration of
the Toxic Substances Control Act (TSCA)'' (2018 Fee Rule) (83 FR 52694)
(Ref. 2) and explains the methodology by which these changes to TSCA
fees were determined.
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]''
(15 U.S.C. 2625(b)(1)). In 2021, EPA proposed changes to the TSCA fee
requirements established in the 2018 Fee Rule (2021 Proposal) (Ref. 3)
based upon TSCA implementation experience. In the 2021 Proposal, EPA
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 public webinars in February
2021 and December 2022. Additional information on the stakeholder
engagement can be found in the 2021 Proposal, Unit III.A.1. (Ref. 3)
and in Unit II.B. of this final rule.
This final rule takes into consideration comments received in
response to the 2021 Proposal and a 2022 Supplemental Notice of
Proposed Rulemaking (2022 Supplemental Notice) (87 FR 68647) (Ref. 4).
A summary of those comments and the responses can be found in the
Response to Comments (RtC) document for this rulemaking (Ref. 5). Based
on the comments received, EPA experience implementing TSCA, adjustments
to EPA's cost estimates, and experience implementing the 2018 Fee Rule,
EPA is issuing this final rule to amend the 2018 Fee Rule.
[[Page 12962]]
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 the 2022 Supplemental Notice for FY 2023
through FY 2025, and the economic analysis for this final rule,
entitled ``Economic Analysis of the Final Rule; Fees for the
Administration of the Toxic Substances Control Act (TSCA)'' (Economic
Analysis) (Ref. 6) is available in the docket and is briefly summarized
here.
1. Benefits. The principal benefit of the 2021 Proposal, as
modified by the 2022 Supplemental Notice, is to provide EPA with 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 final rule are approximately
$36.69 million (after refunds) at both 3 percent and 7 percent discount
rates (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 (Refs. 6 and 7). Total annual fee
collection for manufacturer-requested risk evaluations (MRREs) is
estimated to be $2.84 million for chemicals included in the 2014 TSCA
Work Plan (TSCA Work Plan) (Ref. 7) (based on the assumed potential for
two requests over the three-year period) and approximately $2.83
million for chemicals not included in the TSCA Work Plan (based on the
assumed potential for one request over the three-year period) (Ref. 7).
EPA analyzed a three-year period because the statute requires EPA to
reevaluate and adjust the fees, as necessary, every three years.
3. Small entity impact. EPA estimates that 31.7 percent of TSCA
section 5 submissions will be from small businesses in the 33
industries anticipated to be affected by this rulemaking (from the
petroleum manufacturing, chemical manufacturing, and merchant
wholesalers, and nondurable goods sectors with three-digit NAICS codes
324, 325, and 424) that are eligible to pay the TSCA section 5 small
business fee because they meet the definition of ``small business
concern'' as defined in 40 CFR 700.43. Total annualized fee collection
from small businesses submitting notices under TSCA section 5 is
estimated to be $583,104 (Ref. 6). For TSCA 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 required to share the total fee 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 TSCA sections 4 and 6 would be
approximately $20,427 and $1,827,483, respectively (Ref. 6). For each
of the three years covered by this final rule, EPA estimates that total
fee revenue collected from small businesses will account for about 6
percent of the approximately $36.69 million total fee collection, for
an annual average total of approximately $2.4 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. 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, or Tribal governments. The final rule
will not have any significant or unique effects on small governments,
or federalism or tribal implications.
II. Background
A. Rule History
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 MRREs, the Agency is directed to establish fees sufficient to defray
50 percent of the costs associated with conducting the MRRE on a
chemical substance included in the TSCA Work Plan and 100 percent of
the costs of conducting the MRRE 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.
1. 2021 Proposal. On January 11, 2021 (Ref. 3), 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
non-isolated intermediates; 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 proposed a production volume-based fee allocation
for EPA-initiated risk evaluation fees in any scenario in which 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, February 23, 2021 (FRL-10020-69)). EPA received a total of 43
comments. Of the 43 submissions, two written comment submissions and
five oral comments were associated with a public webinar hosted on
February 18, 2021 (Ref. 5), and three were requests for a comment
period extension.
2. 2022 Supplemental Notice. Based on comments received on the
proposed rule, stakeholder engagement, experience implementing TSCA,
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 supplemented
its January 2021 Proposal in November 2022 with the publication of a
Supplemental Notice (Ref. 4).
[[Page 12963]]
EPA published the 2022 Supplemental Notice 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 amended the
law, as well as subsequent appropriations bills and associated
explanatory statements. Additionally, the purposes of the Supplemental
Notice were: To propose changes to the fee amounts and EPA's total
costs for administering TSCA; to narrow 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 in which 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); and to propose extending the timeframe for test order
and test rule payments.
EPA requested public comments on its 2022 Supplemental Notice
through January 17, 2023. EPA received a total of 32 comments. Among
the 32 comments, two were written comments and five were oral comments
associated with a public webinar hosted on December 6. 2022 (Ref. 5).
Three were requests for a comment period extension. The comments and
EPA responses, as well as a more thorough summary of the comments
received, are presented in the Response to Public Comments document
(Ref. 5) available in the docket for this rulemaking. After considering
the public comments, EPA made changes to the EA and rulemaking as
discussed in Unit III.
B. Stakeholder Engagement
Under TSCA section 26(b)(4)(E), EPA is required to consult and meet
with parties potentially subject to the fees or their representatives
prior to establishment or amendment of TSCA fees. Similarly, under TSCA
section 26(b)(4)(F), EPA is required to adjust the fees as necessary
every three years after consulting with parties potentially subject to
the fees and their representatives. Since the 2018 Fee Rule, EPA has
held several outreach meetings with industry stakeholders on
implementation issues. These outreach meetings are summarized at:
https://www.epa.gov/tsca-fees/outreach-materials-tsca-administration-fees-rule.
In fall and winter of 2019, EPA held a series of webinars with
industry to explain changes to EPA's Central Data Exchange (CDX) and
how to pay fees through the system. In December 2019, EPA hosted a
conference call to give a brief overview of the fees associated with an
EPA-initiated risk evaluation, the creation of the preliminary list
that identifies manufacturers and importers subject to fees, and how
fees would be divided among the identified businesses. On February 24,
2020, EPA hosted a conference call to review certain provisions of the
2018 Fee Rule. On April 16, 2020, EPA hosted a call to discuss a
decision to reduce burden for certain stakeholders subject to TSCA Fee
Rule requirements for EPA-initiated risk evaluations via a No Action
Assurance for enforcement of certain provisions of the 2018 Fee Rule.
On February 18, 2021, EPA hosted a webinar to provide an overview of
the 2021 Proposed Fee Rule to stakeholders. On December 6, 2022, EPA
hosted a public webinar to provide an overview to stakeholders about
the 2022 Supplemental Notice. These webinars gave the public an
opportunity to provide comment to EPA on the proposed changes.
EPA is committed to stakeholder outreach and will continue to meet
with federal partners, companies, trade associations and consortia that
represent affected manufacturers and processors, as appropriate. EPA
will consult with the Small Business Administration as needed regarding
engagement with small businesses.
III. Provisions of This Final Rule
A. Program Cost Estimates and Activity Assumptions
As discussed in the 2022 Supplemental Notice, the 2018 Fee Rule has
resulted in collection of roughly half of the (artificially low)
baseline costs EPA has the authority to collect, resulting in
additional TSCA implementation challenges due to insufficient
resources. In addition, the baseline cost estimates in the 2018 Fee
Rule were based on what EPA spent on implementing TSCA before it was
amended in 2016, rather than what it would cost the Agency to implement
the revised law in the manner envisioned and directed by Congress. In
the first four years following the 2016 law's enactment, EPA did not
conduct a comprehensive budget analysis designed to estimate the costs
of implementing the amended law. EPA did not conduct such an analysis
until spring 2021. EPA's 2022 Supplemental Notice included a program
cost estimate based on the 2021 analysis that more adequately accounted
for the anticipated costs of meeting its statutory mandates.
In reviewing comments on the proposals for this rulemaking, EPA has
revisited its budget analysis and the program cost estimates and is
finalizing estimates that differ from the 2022 Supplemental Notice.
Specifically, the total program cost estimate has been reduced by over
19 percent and is now approximately $146.8 million (compared to
approximately $181.9 million in the 2022 Supplemental Notice). EPA has
also included a more granular breakdown of the costs, as requested by
stakeholders, in a separate technical support document (TSD) for this
final rule (Ref. 7). EPA recognizes that the costs associated with
implementing TSCA may be re-evaluated and can change over time (e.g.,
due changes in administrative priorities or insights and changes in
practice gained through experience implementing the law). The cost
estimates discussed in the technical support document and this unit are
based on EPA's estimates at the time the rulemaking and support
materials were developed.
1. Program costs. This unit summarizes the total cost estimates for
TSCA sections 4, 5, 6, and 14 activities. EPA evaluated its costs from
FY 2023, and then, after consideration of the assumptions and
activities discussed in more detail in the TSD, evaluated the projected
increase or decrease of those activities for contract dollars and full-
time equivalents (FTE). Annually, from FY 2024 through FY 2026, the
Agency anticipates a direct need of 383.67 FTE and $55,415,307 in
contract (i.e., non-pay) dollars. The total estimated program costs,
including personnel compensation and benefits (PC&B) applied to each
FTE directly involved in TSCA sections 4, 5, 6 (excluding MRREs) and 14
activities and the indirect cost, is $146,754,074.
Table 1--Estimated Annual Costs to EPA
[FY 2024 through FY 2026]
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Annual costs
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TSCA Section 4.......................................... $7,678,352
TSCA Section 5.......................................... 40,219,461
TSCA Section 6 (excluding MRREs)........................ 70,486,244
[[Page 12964]]
TSCA Section 14......................................... 7,823,436
Agency Indirect Costs................................... 20,546,580
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Total............................................... 146,754,074
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Table Note: The indirect cost rate is estimated at 16.28 percent for the
purposes of this analysis.
a. TSCA section 4 program costs. TSCA, as amended, permits the
Agency to undertake test rules, test orders and enforceable consent
agreements (ECA). The Agency believes it is reasonable to assume that
approximately 14 test orders per year will be initiated between FY 2024
and FY 2026. Approximately 10 of these test orders are expected to be
associated with the Agency's actions on per- and polyfluoroalkyl
substances (PFAS) per EPA's implementation of the National PFAS Testing
Strategy. In addition, the Agency assumed one test rule and one ECA
between FY 2024 and FY 2026. EPA decreased its estimate of the number
of issued test orders from the 2022 Supplemental Notice. For this final
rule, EPA is finalizing an estimated annual cost to EPA of
administering relevant activities under TSCA section 4 of $7,678,352.
Additional information about actions included in this cost estimate can
be found in the TSD for this final rule (Ref. 7).
Table 2--TSCA Section 4 Annual Cost Estimates for FY 2024-FY 2026
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Non-pay Pay FTE Total
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Test Orders--Risk Evaluation.................................... $331,577 $1,177,705 7.00 $1,510,800
Test Orders--PFAS............................................... 124,841 1,445,882 7.50 1,571,300
Test Rules...................................................... 88,870 780,684 4.00 870,000
ECA Issuance.................................................... 14,755 195,171 1.00 210,000
Project Management and Operations............................... 0 312,757 1.64 295,200
IT/IM........................................................... 3,159,555 46,555 0.25 3,221,052
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Total....................................................... 3,719,598 3,958,754 21.39 7,678,352
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b. TSCA section 5 program costs. Under TSCA section 5, EPA conducts
risk assessments and risk management activities for approximately 482
submissions per year to ensure safety of new chemicals before they
enter commerce. EPA estimates it will receive 216 premanufacture
notices (PMNs), significant new use notices (SNUNs), and microbial
commercial activity notices (MCANs) per year, and another 266 exemption
applications, 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) per year. EPA's cost
estimates for administering TSCA section 5 include costs associated
with processing and retaining records related to a Notice of
Commencement of Manufacture or Import (NOC) submission, as well as the
costs of pre-notice consultations, processing and reviewing
applications, retaining records, and related activities. EPA is
finalizing an estimated annual cost to EPA of administering relevant
activities under TSCA section 5 of $40,219,461. Additional information
about actions included in this cost estimate can be found in the TSD
for this final rule (Ref. 7).
Table 3--TSCA Section 5 Annual Cost Estimates for FY 2024-FY 2026
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Non-pay Pay FTE Total
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Risk Assessment........................................ $5,586,677 $11,662,890 63.00 $17,252,116
Risk Management........................................ 1,180,463 5,909,657 32.00 7,091,190
Project Management and Operations...................... 0 358,282 1.89 340,200
IT/IM.................................................. 5,747,093 45,564 0.25 5,797,480
Other.................................................. 6,801,271 2,927,565 15.00 9,738,475
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Total.............................................. 19,351,668 20,903,957 112.14 40,219,461
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c. TSCA section 6 program costs. EPA has the authority under TSCA
section 26(b) to collect fees to recover a portion of the costs for
TSCA section 6 activities including prioritization, risk evaluations,
and risk management. TSCA requires that the EPA have at least 20
High[hyphen]Priority chemical risk evaluations underway by December
2019, and that a new chemical risk evaluation be initiated each time
another concludes. Based on these parameters, the Agency has assumed
that EPA will be undertaking at least 20 EPA[hyphen]initiated chemical
risk evaluations at all times, and that each risk evaluation will take
three and a half years to complete. In the case of MRREs, the Agency is
directed to establish fees sufficient to defray 50 percent of the costs
associated with conducting a MRRE on a chemical included in the TSCA
Work Plan for Chemical Assessments: 2014 Update (Ref. 8), and 100
percent of the costs of conducting a MRRE for all other chemicals.
Based on an overall reduction in the total program cost estimate as
a result of found efficiencies (discussed in more detail in the TSD
(Ref. 7)), the estimated annual cost to EPA of administering relevant
activities under TSCA section 6 is $70,486,244 per year not including
the cost of MRREs. Individual risk evaluations, including MRREs, are
estimated to cost $8,489,541 to complete (including indirect costs).
Additional information about actions included in this cost estimate can
be found in the TSD for this final rule (Ref. 7).
[[Page 12965]]
Table 4--TSCA Section 6 Annual Cost Estimates for FY 2024-FY 2026
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Non-pay Pay FTE Total
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Annual Prioritization Process.......................... $2,737,635 $2,905,161 15.25 $5,645,500
TSCA Section 6 Risk Evaluation......................... 14,782,167 28,517,222 152.00 43,320,378
TSCA Section 6 Risk Management......................... 4,106,513 11,367,735 61.60 15,477,675
Project Management and Operations...................... 0 687,878 3.64 655,200
IT/IM.................................................. 5,197,532 184,401 1.00 5,387,491
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Total.............................................. 26,823,847 43,662,397 233.49 70,486,244
----------------------------------------------------------------------------------------------------------------
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's cost estimates include the
costs of information management for TSCA sections 4, 5, 6 and 14, but
do not include the costs of administering other authorities for
collection such as those in TSCA sections 8 and 11. Activities
considered when developing this estimate for activities under TSCA
section 14 include: Prescreening/initial review; substantive review and
making final determinations; documents review and sanitization;
regulation development; IT systems development; and transparency/
communications. Estimates also include Office of General Counsel (OGC)
costs associated with coordinating, reviewing, issuing, and defending
TSCA Confidential Business Information (CBI) claim final
determinations, and supporting guidance, policy, and regulation
development for TSCA section 14 activities. The annual cost estimate of
collecting, processing, reviewing, and providing access to and
protecting from disclosure as appropriate information on chemical
substances under TSCA section 14, including FTE and extramural costs,
from FY 2024 through FY 2026 is $7,823,436. Additional information
about actions included in this cost estimate can be found in the TSD
for this final rule (Ref.7).
Table 5--TSCA Section 14 Annual Cost Estimates for FY 2024-FY 2026
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Non-pay Pay FTE Total
----------------------------------------------------------------------------------------------------------------
CBI Reviews..................................................... $714,288 $2,237,712 16.40 $2,952,000
IT/IM........................................................... 4,842,070 29,366 0.25 4,871,436
-----------------------------------------------
Total....................................................... 5,556,358 2,267,079 16.65 7,823,436
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2. Indirect costs. The indirect costs included in the estimates for
TSCA sections 4, 5 and 6, and for collecting, processing, reviewing,
and providing access to and protecting CBI from disclosure as
appropriate under TSCA section 14, were calculated by multiplying the
appropriate indirect cost rates for FY 2024 and beyond by the estimated
direct costs. Indirect cost rates are calculated each year by the
Office of the Controller, using the EPA's current indirect methodology.
On an annual basis, each program office is provided with an independent
rate, expressed as a percentage, for use in calculating indirect costs.
For direct TSCA section 4, 5, 6 and 14 costs, an indirect cost rate
of 16.28 percent was applied. Total indirect costs included in the
overall TSCA sections 4, 5, 6 and 14 cost estimates total approximately
$20,546,580 (Table 6).
Table 6--Total Indirect Cost Estimates for TSCA Sections 4, 5, 6 and 14
------------------------------------------------------------------------
Direct costs Indirect costs
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TSCA Section 4.......................... $7,678,352 $1,250,036
TSCA Section 5.......................... 40,219,461 6,547,728
TSCA Section 6.......................... 70,486,244 11,475,161
TSCA Section 14......................... 7,823,436 1,273,655
-------------------------------
Total............................... 126,207,494 20,546,580
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3. Total collections for fee-triggering events. EPA estimated a
total program cost of implementing TSCA sections 4, 5, 6 (excluding
MRREs) and 14 to be $146,754,074. Based on the assumptions previously
discussed and the final fee amounts addressed in Unit III.B, the total
estimated fees collected for all fee categories, excluding the MRRE is
$36,687,346 plus a collection of $5,671,013 from MRREs totaling
$42,358,359. EPA also accounted for refunds for certain TSCA section 5
activities as seen in Table 7.
[[Page 12966]]
Table 7--Summary of Total Estimated Annual Fee Collections and Refunds for FY 2024-2026
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
activity activity Fee-- non- Fee--small Total annual
Fee category levels-- non- levels-- small small business business collections
small business business
----------------------------------------------------------------------------------------------------------------
Test Order...................... 14.0 n/a $25,000 $5,000 350,000
Test Rule....................... 0.33 n/a 50,000 10,000 16,500
ECA............................. 0.33 n/a 50,000 10,000 16,500
----------------------------------------------------------------------------------------------------------------
Total Estimated Annual Fees Collected for Section 4 Activities.............................. 383,000
----------------------------------------------------------------------------------------------------------------
PMN (including intermediate)/ 151.0 65.0 37,000 6,480 6,014,304
MCAN/SNUN......................
LoREX, LVE, TME, Tier II 178.0 88.0 10,870 2,180 2,128,612
exemption, TERA, Film Articles.
Full (100%) refund--Notices..... 8.0 3.0 (37,000) (6,480) (315,440)
Full (100% refund--Exemptions... 10.0 4.0 (10,870) (2,180) (117,420)
75% refund--Notices............. 0 0 (0) (0) (0)
----------------------------------------------------------------------------------------------------------------
Total Estimated Fees Collected for Section 5 Activities..................................... 7,710,056
----------------------------------------------------------------------------------------------------------------
EPA-Initiated Risk Evaluation... 6.67 n/a 4,287,000 857,400 28,594,290
MRRE (work plan chemical)....... 0.67 n/a 4,244,771 n/a 2,843,996
MRRE (non-work plan chemical)... 0.333 n/a 8,489,541 n/a 2,827,017
----------------------------------------------------------------------------------------------------------------
Total Estimated Fees Collected for Section 6 Activities..................................... 34,265,303
----------------------------------------------------------------------------------------------------------------
Total Estimated Fees Collected for All Sections after Refunds (including MRREs)............. 42,358,359
----------------------------------------------------------------------------------------------------------------
Table Note: The ``n/a'' under small business activity levels are a reflection that total annual collections do
not depend on the breakdown of small and non-small businesses because total fee is split between the two
groups.
B. Fee Amounts
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 MRRE), and conducting relevant information
management activities under TSCA section 14; identifying the full cost
amount to be defrayed by fees under TSCA section 26(b) (i.e., 25
percent of those annual costs); and allocating that amount across the
fee-triggering events in TSCA sections 4, 5, and 6. In addition, EPA
affords small businesses an approximately 80 percent discount, in
accordance with TSCA section 26(b)(4)(A).
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 final fee amounts 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. In
addition, 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. Therefore, some fee-triggering
activities account for a larger proportion of the total fee collections
than others.
EPA considers several factors, including comments from
stakeholders, to finalize fee amounts that would result in EPA
collecting 25 percent of those estimated costs, while also setting
lower fees for small businesses. These factors include activity cost
and numbers associated with the individual fee-triggering events,
including fee refunds, proportion of small businesses; the cost to
industry to implement the activity (e.g., test order fees are not as
high due to reduce burden to industry which are already paying for
testing); and the potential burden of the fee to industry (e.g.,
whether a fee is shared by multiple manufacturers).
The final fee amounts as compared to the current fees are provided
in Table 8.
Table 8--Final TSCA Fee Amounts
------------------------------------------------------------------------
Fee category Current fees \1\ Final fees
------------------------------------------------------------------------
Test Order...................... $11,650........... $25,000.
Test Rule....................... 35,080............ 50,000.
ECA............................. 27,110............ 50,000.
PMN and consolidated PMN, SNUN, 19,020............ 37,000.
MCAN and consolidated MCAN.
LoREX, LVE, TME, Tier II 5,590............. 10,870.
exemption, TERA, Film Articles.
EPA-Initiated Risk Evaluation... 1,605,000......... Two payments
resulting in
$4,287,000.
MRRE on a Chemical Included in 50% of total Two payments of
the TSCA Work Plan. actual costs with $1,414,924, with
a $1,490,000 final invoice to
initial payment. recover 50% of
actual costs.
MRRE on a Chemical Not Included 100% of total Two payments of
in the TSCA Work Plan. actual costs with $2,829,847, with
a $2,970,000 final invoice to
initial payment. recover 100% of
actual costs.
------------------------------------------------------------------------
Table Note: \1\ The current fees reflect an adjustment for inflation as
required by TSCA. The adjustment went into effect on January 1, 2022.
[[Page 12967]]
1. Fee amounts for TSCA section 4 activities. EPA is finalizing the
fee amounts proposed in the 2022 Supplemental Notice for TSCA section 4
activities. Specifically, EPA is finalizing $25,000 for test orders,
$50,000 for test rules, and $50,000 for ECAs. EPA is finalizing fees
that, based on the expected activity levels of the three fee categories
for TSCA section 4 activities, will result in a collection of $383,000.
2. Fee amounts for TSCA section 5 activities. EPA sets two fee
amounts for TSCA section 5 activities--one for notices (PMNs, SNUNs,
and MCANs) and one for exemptions (including LoREXs, LVEs, TMEs, Tier
II, and TERAs). EPA received comments on the fee amounts for TSCA
section 5 activities. In response to those comments and the overall
reduction in EPA's program cost estimates, EPA is finalizing fee
amounts lower than those proposed in the 2022 Supplemental Notice
(i.e., $45,000 for notices and $13,200 for exemptions). EPA is
finalizing $37,000 for notices and $10,870 for exemptions. Entities
that qualify as a small business concern receive an approximately 80
percent discount as discussed in Unit III.B.4.
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 in the 2022 Supplemental Notice,
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. These final fee
amounts will result in an annual collection of approximately $7.7
million from TSCA section 5 activities.
3. Fee amounts for TSCA section 6 activities. EPA collects one fee
amount for EPA-initiated risk evaluations that is shared by
manufacturers of that chemical substance. EPA received numerous
comments on the fee amount proposed in the 2022 Supplemental Notice
(i.e., $5,081,000). In response to those comments, as well as an
overall reduction in the total program cost estimate due to found
efficiencies (discussed in more detail in the TSD (Ref.7)), EPA is
finalizing a lower fee amount for EPA-initiated risk evaluations. EPA
is finalizing a fee of $4,287,000 paid over two installments which,
based on the expected activity levels of this fee category, would
result in EPA collecting approximately $29.9 million from TSCA section
6 EPA-initiated risk evaluations.
EPA takes an actual cost approach for MRREs, whereby the requesting
manufacturer (or requesting consortia of manufacturers) is 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 the installment plan and the
estimated costs of these risk evaluations, manufacturers are required
to make two payments of $1,414,924 for a TSCA Work Plan chemical, or
two payments of $2,829,847 for a non-TSCA Work Plan chemical and are
then invoiced for the remainder.
4. Fee amounts for small businesses. The final fee amounts for
small businesses summarized in Table 9 represent an approximate 80
percent reduction compared to the proposed base fee for each category.
For TSCA section 5 notices (i.e., PMNs, MCANs, and SNUNs), the small
business reduction is 82.5 percent. For all fee categories, the reduced
fee is available only when the only entity or entities that owe that
particular fee are small businesses, including when a consortium is
paying the fee and all members of that consortium are small businesses.
Reduced fees are not available for small businesses that request
MRREs, as TSCA requires those fees to be set at a specific percentage
of the actual costs of the activity.
Table 9--Fees for Small Businesses
------------------------------------------------------------------------
Fee category Final fees
------------------------------------------------------------------------
Test Order................................................. $5,000
Test Rule.................................................. 10,000
ECA........................................................ 10,000
PMN and consolidated PMN, SNUN, MCAN and consolidated MCAN. 6,480
LoREX, LVE, TME, Tier II exemption, TERA, Film Articles.... 2,180
EPA-Initiated Risk Evaluation.............................. 857,400
------------------------------------------------------------------------
C. Fee Categories
Under the 2018 Fee Rule, EPA has eight distinct fee categories: (1)
Test orders; (2) test rules; (3) ECAs, all under TSCA section 4; (4)
Notices; (5) exemptions, both under TSCA section 5; (6) EPA-initiated
risk evaluations; (7) MRREs for chemicals on the TSCA Work Plan; and
(8) MRREs for chemicals not on the TSCA Work Plan, all under TSCA
section 6. The activities in these categories (other than the first 10
risk evaluations) are fee-triggering events 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, i.e., for amended test orders. EPA
received several comments supporting the removal of the fee categories
for Bona Fide Notices, NOCs, and amended test orders. A few commenters
stated that these additional fee categories should remain to help
recover the costs of reviewing and responding to these submissions.
After considering public comments received on the 2021 Proposal and the
2022 Supplemental Proposal, and to keep the fee structure simple by
reducing the number of fee categories, EPA is not finalizing the new
fee categories for Bona Fide Notices, NOCs, and amended test orders as
proposed in the 2021 Proposal.
In this final rule, 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 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, to simplify the TSCA section 4 fee
structure, EPA is not finalizing the amended test order fee category
proposed in the 2021 Proposal. 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.
D. Refund for Withdrawal During Review
EPA received several comments expressing opposition of the refund
for 20 percent of the user fee to the submitter if a premanufacture
notice is withdrawn 10 or more business days after the beginning of the
applicable review period, but prior to EPA initiating risk management
on the chemical substance as proposed in the 2022 Supplemental Notice.
Some commenters stated that EPA should not dedicate additional
resources to providing this refund and that this refund would drain
resources. EPA agrees with these commenters and is not finalizing the
proposed refund. The steps required to initiate a refund and to provide
notice that the risk assessment on the chemical substance has
concluded, as outlined in the 2022 Supplemental Notice, would impose
additional burden on EPA. To make an
[[Page 12968]]
informed decision on whether to withdraw their notice, EPA would need
to send submitters details about the risk findings, complete risk
assessments, and/or potential risk management being considered by EPA.
Providing these details or sending final risk assessment documents
require review and redaction prior to transmission and development of
draft risk mitigation terms. To protect CBI, EPA must review and redact
what is known as third-party CBI information from each risk assessment
report. Third-party CBI information is CBI information submitted to EPA
by another submitter as part of a separate notice which may then be
used in the assessment of another chemical (e.g., an analogue). These
steps would further consume limited resources and impose an additional
burden on staff and run contrary to the idea that EPA would not have
spent the final 20% of the fee on risk management.
E. Methodology for Calculating Fees for EPA-Initiated Risk Evaluations
EPA received multiple industry comments supporting the use of
production volume to determine fee obligations for EPA initiated risk
evaluations, stating that this approach would allocate fees more
equitably and minimize burdens to smaller manufacturers. One commenter
recommended a tiered band approach supported by a few other industry
commenters. This commenter recommended that EPA establish ``four bands
of set fees'' based on the EU REACH metric tonnage bands and estimate
the number of manufacturers in each band EPA would expect for future
risk evaluations using historical data. EPA determined this approach
would likely result in EPA not collecting 25 percent of program costs
due to difficulties in estimating future numbers of manufacturers.
Therefore, EPA rejected this alternative method proposed and is
finalizing the approach outlined in the 2022 Supplemental Notice.
The finalized 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 those 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 changes 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 any scenario in which 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 entity.
Step 10: Reallocate the remaining fee evenly across the remaining
manufacturers, counting each manufacturer in a consortium as one
entity.
As stated in the 2022 Supplemental Notice, in the event that three
or fewer manufacturers are identified for a chemical substance, EPA
will distribute the fee evenly among those three or fewer fee payers,
regardless of production volume. 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 greater than or equal to the top 20th percentile. In
the event multiple manufacturers report the same production volume 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.
In addition, EPA is finalizing as proposed in the 2022 Supplemental
Notice the requirement of reporting average production volume based on
the three previous calendar years prior to the publication of the
preliminary list. This change will 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) that could be used in conjunction with
data reported under this proposal to estimate a manufacturer's
production volume.
EPA is also providing additional clarification on production volume
calculations as it applies to certification, meeting exemptions,
recordkeeping, etc. For example, EPA clarifies that two significant
figures should be used when calculating production volume as required
by the CDR rule. Companies with multiple groupings/facilities should
include the total aggregated production volume when calculating the
average for the purposes of 40 CFR 720.75(b)(v) and when calculating
the annual production volume in qualifying for the exemptions related
to production volume in 40 CFR 720.75(a)(2)(vi) or (3)(vi). Production
volume calculations would not require companies to double count
distribution of the same chemical substance within one company when
that chemical mixture is ``manufactured'' more than once (e.g., a
company that manufactures a chemical, then exports for further
processing, then imports the chemical mixture would not need to double
count their production volume). This does not apply if multiple
companies are involved (e.g., a company manufactures a chemical, then
exports it for additional processing, then separate company imports the
mixture). EPA will assess a fee for each of those ``manufacturers''
based on the production volume that they separately manufacture or
import. Regarding ``non-TSCA uses,'' chemicals may be manufactured for
uses that do not fall under TSCA. EPA does not require the inclusion of
non-TSCA chemicals in production volume calculations.
[[Page 12969]]
These changes are expected to eliminate all potential disclosure of
production volume that may be claimed as CBI. 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 as a competitor, EPA would mask the
company names on the final list for that chemical to protect
disclosure.
As described in steps one through three previously in this unit,
EPA is not finalizing 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)).
F. Export-Only Manufacturers
In EPA's 2021 Proposal, EPA proposed to require manufacturers that
exclusively export chemicals subject to EPA-initiated risk evaluations
to pay fees to defray the costs of the risk evaluations. EPA also
acknowledged the ambiguity of TSCA section 12(a) in that rulemaking.
After further review, EPA is not finalizing the proposed provision in
this final rule. EPA agrees with numerous commenters that this is
inconsistent with other TSCA programs. Further, some commenters viewed
EPA's proposed interpretation of section 12(a) as inconsistent with
prior regulatory interpretations. EPA has decided not to exercise any
discretion it may have under TSCA sections 12(a) and 26 to require
export-only manufacturers to make payments to defray the costs of risk
evaluations and is declining to finalize it in the proposal.
G. Exemptions for Certain Fee-Triggering Activities
EPA is finalizing the six exemptions as proposed in the 2021
Proposal and further amended in the 2022 Supplemental Notice. These
exemptions apply to EPA-initiated risk evaluations and/or test rules
for: (1) Importers of articles containing a chemical substance; (2)
producers of a chemical substance as a byproduct that is not later used
for commercial purposes or distributed for commercial use; (3)
manufacturers of a chemical substance as an impurity as defined in 40
CFR 704.3; (4) producers of a chemical as a non-isolated intermediate
as defined in 40 CFR 704.3; (5) manufacturers of small quantities of a
chemical substance used solely for research and development as defined
in 40 CFR 700.43; or (6) manufacturers of chemical substances with
production volume less than 2,500 lbs for TSCA section 6 activities and
1,100 lbs for TSCA section 4 test rules. For clarification,
``manufacture for commercial purposes'' is defined in 40 CFR 704.3 as
``to import, produce, or manufacture with the purpose of obtaining an
immediate or eventual commercial advantage for the manufacturer, and
includes among other things, such ``'manufacture''' of any amount of a
chemical substance or mixture.''
Based on consideration of public comments to the 2021 Proposal, in
the 2022 Supplemental Notice EPA proposed narrowing the exemption on
byproducts by limiting it to ``producers of a chemical substance as a
byproduct that is not later used for commercial purposes or distributed
for commercial use.'' In this final rule, EPA is finalizing that
exemption as proposed in the 2022 Supplemental Notice. Although
numerous industry trade and advocacy organizations supported the
limited exemption, some commenters expressed opposition to it, stating
that creators of a byproduct should not be subject to TSCA fees (e.g.,
for risk assessment), as the byproducts are not created with separate
commercial intent, and that EPA should revise the exemption to apply as
long as there is no intent for the byproduct to be imparted as useful
property. 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 will still collect fees
from producers of chemicals that are then sold or used for commercial
purposes. In addition, EPA has confidence that producers of byproducts
that are later sold or used for commercial purposes will not encounter
the same issues and self-identification requirements described in EPA's
memorandum from March 18, 2020, since those producers knowingly produce
the byproduct before it is introduced into the market (86 FR 1899). The
finalized byproduct exemption addresses commenter's concerns with
challenges with self-identification as related to identifying and
tracking byproducts that are unintentionally or coincidentally produced
(40 CFR 700.45(b)(5)).
In response to commenters' concerns with the previously proposed
five year look back period associated with the exemptions criteria, EPA
has aligned the requirements for five of the six exemptions (i.e., all
except the exemptions associated with low production volume as
described in 40 CFR 700.45(a)(2)(vi) and (3)(vi)) with the
certification of cessation timeline. A manufacturer is not required to
make or contribute to a fee payment if it meets one or more of the five
exemptions on or after the applicable certification cutoff date
identified in 40 CFR 700.45 (b)(6) and will not conduct manufacturing
outside of those exemptions at any point in time within five years
after the certification cutoff dates. EPA agrees with commenters that
this change will help facilitate the self-identification and
certification of cessation process.
EPA is finalizing the five-year timeline detailed in the 2021
Proposal for the production volume exemptions in this rule, stating
that manufacturers of a chemical substance subject to risk evaluation
are exempt from fee payment requirements if they meet the low
production volume exemptions for the five-year period preceding
publication of the preliminary list and will also need to meet one or
more of the exemptions in the successive five years and not conduct
manufacturing outside of those exemptions in the successive five years.
EPA has confidence that this five-year look back period is necessary
for the exemptions based on production volume (manufactured quantities
below a 1,100 lbs annual production volume subject to a test rule under
TSCA section 4(a) and manufactured quantities below a 2,500 lbs annual
production volume that is subject to a risk evaluation under TSCA
section 6(b)) to account for fluctuations in annual production volume
and to better align with the reporting and recordkeeping requirements
associated with this exemption. EPA's intent is to provide this
exemption for manufacturers who produce small amounts of the chemical
and to direct fee obligations to those companies that produce most of
the chemical substance. The five-year look back period helps ensure the
subject manufacturer meets that intent.
Outside of these six exemptions, several commenters proposed
additional exemptions including a concentration-based exemption and a
re-imported substances exemption. EPA has confidence that the final
rule covers the necessary exemptions excluding byproducts, impurities,
small quantities for research and development, low-production volumes,
and imported articles. EPA agrees with commenters that most of the
incidental chemical scenarios in the suggested additional exemptions
would fall under the production volume exemptions. Regarding the
suggested re-imported substances exemption, EPA has clarified
[[Page 12970]]
in the preamble of the final rulemaking how companies should calculate
production volume in situations such as these, but EPA is not
finalizing a separate exemption covering the distribution of a chemical
across multiple companies and re-imports.
Overall, several advocacy organizations opposed the proposed
exemptions, stating that EPA's rationales for the exemptions were
unsupported and not allowed as a justification for exempting fees under
TSCA. TSCA does not preclude EPA from exempting certain manufacturers
from fee-paying activities, states that manufacturers ``may'' be
required to pay (TSCA section 26(b)(1)) and provides EPA the authority
to ``take into account the ability to pay of the person required to pay
such fee and the cost of the Administrator of carrying out the
activities described in this paragraph (TSCA section 26(b)).'' The six
proposed exemptions do not reduce how much EPA collects for each risk
evaluation. Rather, they simply reduce how many participating
manufactures split the fee. Other commenters claimed that the
exemptions outlined in the 2021 Proposal were too broad and lacked
details on how the fee applies to chemical manufacturers. Following the
2021 Proposal, EPA narrowed the exemptions in the 2022 Supplemental
Notice and in this final rule. Finally, a few industry trade
organizations expressed opposition to requiring manufacturers to split
the fee payment when each entity produces less than 2,500 lbs annually,
claiming that splitting the payment would increase the unpredictability
of TSCA fees and penalize low volume producers. This condition applies
because EPA must ensure it receives compensation to carry out a risk
evaluation and meet TSCA requirements.
H. Self-Identification and Certification Requirements
EPA has weighed the various approaches to establishing a final list
of fee payers for the EPA-initiated risk evaluations and TSCA section 4
test rules, including eliminating steps in the self-identification
process. EPA has confidence that the self-identification process (i.e.,
publication of a preliminary list that identifies manufacturers, a
public comment period, and publication of a final list defining the
universe of manufacturers responsible for payment), including changes
discussed in the 2021 Proposal and 2022 Supplemental Notice, best
ensures that all obligated fee payers are identified, thereby reducing
the burden of the shared fees on manufacturers. The process also allows
for correction of errors and certification of no-manufacture or meeting
an exemption to alleviate certain manufacturers of fee payment
obligations. EPA is finalizing changes to 40 CFR 700.45(b) by modifying
who is obligated to pay fees and self-identify through exemptions,
requiring certification of meeting exemption for certain manufacturers,
requiring submission of production for certain manufacturers, and
allowing for changes to the final list if necessary.
Due to significant industry stakeholder feedback as discussed in
more detail in the 2021 Proposal, EPA proposed exemptions for EPA-
initiated risk evaluations and proposed changes to the submission of
self-identification information in 40 CFR 700.45 to accompany those
changes. The 2022 Supplemental Notice expanded those exemptions to
apply to test rules under TSCA section 4 and provided additional
context around certain exemptions by cross referencing (i.e., defining
impurities by referencing 40 CFR 704.3) and narrowing the byproduct
exemption. EPA is finalizing these exemptions as proposed in 2021 and
amended in 2022 and is not requiring manufacturers that meet the
criteria of three of the exemptions (i.e., importers of articles
containing the chemical substance, manufacturers of the substance that
is produced as a byproduct, and manufacturers of the substance that is
produced or imported as an impurity) from self-identification.
Manufacturers of small quantities solely for research and development,
those that manufacture in quantities not to exceed 1,100 lbs or 2,500
lbs depending on whether it is a test rule or EPA-initiated risk
evaluation, and manufacturers of chemical substances produced as a non-
isolated intermediate (i.e., those that meet the exemption in 40 CFR
700.45(a)(2)(iv-vi) and (a)(3)(iv-vi)) are required to certify that
they meet those exemption criteria. In addition, if a manufacturer is
identified on the preliminary list and exclusively meets one or more of
the exemptions, that manufacturer must submit a certification statement
attesting to these facts to not be included in the final list of
manufacturers.
To accompany the production volume-based fee allocation methodology
changes discussed in Unit III.E., EPA is also requiring certain
manufacturers to provide the volume produced by that manufacturer for
the subject chemical undergoing an EPA-initiated risk evaluation.
Applicable manufacturers are required to report their average
production volume using the past three calendar years' worth of
production volume data. Unit III.E. and the RtC (Ref. 5) include
additional discussion on how to calculate production volume for this
provision as well as the exemptions for low producing manufacturers (40
CFR 700.45(a)(2)(vi) and (3)(vi)). As clarified and proposed in the
2022 Supplemental Notice, manufacturers that qualify for the 1,100 lbs
or 2,500 lbs exemption are also required 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 production volume-based
exemptions would allow EPA to allocate fees based on production volume
and collect fees in a timely manner in situations in which all fee
payers have met that exemption criteria.
EPA received comments regarding the 2021 Proposal allowing
additional changes to the final list after it is published. EPA's
intent is to publish the final list no later than concurrently with the
final scope document for risk evaluations initiated by EPA under TSCA
section 6 and with the final rule for test rules under TSCA section 4
with no further modifications. EPA is finalizing changes to 40 CFR
700.45(b)(7) to also state, ``EPA may modify the list after the
publication of the final list'' because this flexibility is needed to
allow for potential modifications of the list upon receipt of
information indicating that a change is warranted. Examples of
potential changes to the final list of fee payers include addressing
potential errors (e.g., self-identification as a manufacturer rather
than meeting an exemption, not registering as a ``small business
concern'' when a company qualifies) and when a manufacturer has not
self-identified as required and is obligated to pay fees.
Lastly, EPA received numerous comments from industry trade
organizations, a chemical manufacturer, advocacy organizations, and
others requesting that EPA revise the requirements to address new
market entrants that enter the market after fee payment for a risk
evaluation has been finalized. Commenters have referred to
manufacturers which fall under this category as ``new entrants'' or
``free riders.'' Commenters have requested EPA address these
manufacturers to prevent a competitive disadvantage for those companies
that have paid a risk evaluation fee and have spent time and resources
supporting those same substances through the risk evaluations. Many of
the commenters also requested that EPA allow manufacturers that had
[[Page 12971]]
previously certified cessation to be allowed to begin manufacturing or
importing the substances within the successive five-year period, or
``re-enter'' the market and pay their portion of the fee after initial
invoicing. An advocacy organization expressed strong opposition to such
approaches, reasoning that they would result in an unnecessary
increased burden to EPA and could create inequities between
manufacturers paying the fees up front relative to those opting back
in.
EPA has considered these comments and provided additional
responses, including to an industry trade organization's alternative
approach, in the RtC (Ref. 5). Generally, EPA concludes that allowing
continued changes to those entities responsible for paying the EPA-
initiated risk evaluation fees after the initial invoicing period would
result in a substantial increase in burden to EPA. The additional
burden to EPA would depend on the approach taken but could include the
need to continue to track manufacturers for years, need to recalculate
invoices and issue multiple refunds, and could have potential CBI
implications. Therefore, EPA is not finalizing changes to the self-
identification requirements to address late entrants or re-entrants.
EPA believes the self-identification process and ability to certify
cessation addresses majority of the concerns raised by commenters. EPA
recognizes that these comments have been raised in past TSCA fee
rulemakings and that the matter is a concern to multiple commenters. To
understand the potential scope of this issue, EPA plans to track
manufacturers that might fall under one of these categories to inform
the need for a provision to address this in future TSCA fee
rulemakings.
I. Companies Required To Submit Information Under TSCA Section 4
As discussed in the 2022 Supplemental Notice, 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. TSCA section
26(b)(1) provides for the collection of fees ``from any person required
to submit information'' under TSCA section 4. In some circumstances, a
manufacturer subject to the information development or submission
requirements under TSCA section 4 may not need to conduct 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 if
it meets the issued requirements. Under TSCA, EPA must establish what
information is required, what testing will provide such information,
and what test protocols can inform the generation of such information.
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 data submitted by test order recipients. To ensure that a
portion of these costs will be recovered, EPA is finalizing as proposed
in the 2022 Supplemental Notice, revisions to 40 CFR 700.45(a)(2) to
refer to manufacturers required to submit information rather than
manufacturers ``required to test.'' This change includes all
manufacturers required to submit information regardless of when data or
other information was procured and creates a more equitable fee
allocation.
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, when
no manufacturers are identified as recipients, EPA would be required to
absorb the entire cost of administering TSCA section 4 test orders and
ECAs. EPA is finalizing its proposal in the 2022 Supplemental Notice
and 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. When no manufacturers receive a
test order or ECA, requiring fee payments by processors would allow EPA
to recoup the costs of administering such test orders and ECAs.
K. Timeframe for Fee Payments and Notifications
The 2018 Fee Rule generally required up-front payment of fees
(i.e., payment due prior to EPA reviewing a TSCA section 5 notice,
within 120 days of publication of final test rule, within 120 days of
issuance of a test order, within 120 days of signing an ECA, within 30
days of granting a MRRE, and within 120 days of publishing the final
scope for an EPA-initiated risk evaluation). For MRREs, payment is
collected in two installments over the course of the activity. In
response to stakeholder engagements, EPA is finalizing several changes
to the timing of specific stages within this fees process. These are
summarized in Table 10 and discussed in more detail throughout this
unit.
After the effective date of this final rule, manufacturers have 90
days from the fee-triggering event (in comparison to the 60 days
established in the 2018 Fee Rule) to notify EPA of their intent to form
a consortium. This revision will allow manufacturers subject to test
orders, test rules, ECAs and EPA-initiated risk evaluations additional
time to associate with a consortium and establish fee payments within
that consortium. EPA believes this additional time will be useful for
businesses to plan for the fee expense.
As previously mentioned, under the 2018 Fee Rule, full payment for
EPA-initiated risk evaluations was due within 120 days of EPA
publishing the final scope of a chemical risk evaluation. EPA is
extending that first payment timeline to 180 days and requiring
payments to be made in two installments instead of one, with the first
payment of 50 percent due 180 days after the EPA publishes the final
scope of a risk evaluation and the second payment for the remainder of
the fee due 18 months (i.e., 545 days) after EPA publishes the final
scope of a risk evaluation. For MRREs, EPA is extending the initial
payment timeframe to within 180 days of when EPA grants the request to
conduct the evaluation, with the total amount to be paid over a series
of three installments.
Similarly, the 2018 Fee Rule established a 120-day timeline for
TSCA section 4 test order and test rule payments. This timeline has
been found to be too short for creating invoice payments and other
Agency work related to allocating such payments before fees are
assessed for entities submitting data. EPA has extended 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 TSCA section 6. The change would provide EPA
with sufficient time to review fee payments, identify and allocate fees
across several different entities, and issue invoices.
[[Page 12972]]
Table 10--Changes to Timing Within the Fee Rule
------------------------------------------------------------------------
Timing under 2018 Final timing
Stage in the fees process fee rule changes
------------------------------------------------------------------------
Payment of fees for EPA- Payment is Payment is
initiated risk evaluations. collected in one collected over
installment 120 two installments,
days after EPA the first payment
publishes the of 50 percent is
final scope of a due 180 days
chemical risk after EPA
evaluation. publishes the
final scope of a
chemical risk
evaluation and
the second
payment is due
not later than
545 days after
EPA publishes the
final scope of a
chemical risk
evaluation.
Payment of fees for manufacturer- Initial payment is Initial payment is
requested risk assessments. due within 30 due within 180
days of EPA days of EPA
providing notice providing notice
of granting a of granting a
MRRE. Payment is MRRE. Payments
collected in two are collected
installments over over three
the course of the installments.
activity.
Payment of fees for test rules Payment is Payment is
and test orders. collected in one collected in one
installment 120 installment 180
days after the days after the
effective date of effective date of
a test rule or a test rule or
test order. test order.
Intent to form a consortia...... Must notify EPA Must notify EPA
within 60 days of within 90 days of
the triggering the triggering
event. event.
------------------------------------------------------------------------
L. Recordkeeping
EPA is finalizing recordkeeping requirements related to the
exemptions and production volume-based fee methodology for EPA-
initiated risk evaluations, as discussed in the 2022 Supplemental
Notice, with slight modifications. These requirements can be found in
40 CFR 700.45(b)(10).
Under this final rule, all manufacturers other than those listed in
40 CFR 700.45(a)(2)(i) through (v) or (a)(3)(i) through (v) (i.e., all
manufacturers other than those which qualify for the exemptions related
to articles, byproducts, impurities, non-isolated intermediates, and/or
research and development) must maintain production volume records
related to their production volume submission (discussed in Unit
III.H.). These records must be maintained for a period of five years
from the date the notice is submitted to EPA.
Manufacturers that manufacture or import a chemical substance in
quantities below a 1,100 lbs annual production volume for test rules or
2,500 lbs annual production volume for EPA-initiated risk evaluations
(i.e., those meeting the exemption criteria in 40 CFR 700.45(a)(2)(v)
or (a)(3)(v)) must maintain production volume records related to
compliance with the exemption criteria. These records must be
maintained for a period of five years from the date notice is submitted
to EPA.
Manufactures of a chemical substance as a non-isolated intermediate
(i.e., those meeting the exemption criteria in 40 CFR 700.45(a)(2)(iv)
or (a)(3)(iv)) must maintain manufacturing and other business records
related to compliance with that exemption criteria.
Manufacturers of small quantities of a chemical substance solely
for research and development (i.e., the exemption criteria in 40 CFR
700.45(a)(2)(v) or (a)(3)(v)) must also maintain manufacturing and
other business records related to compliance with that exemption, 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 notice is submitted to EPA.
IV. References
The following is a listing of the documents 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. U.S. EPA. Final Rule; Fees for the Administration of the Toxic
Substances Control Act. Federal Register. 83 FR 52694, October 17,
2018 (FRL-9984-41).
3. U.S. 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. U.S. EPA. Supplemental Notice of Proposed Rulemaking; Fees for
the Administration of the Toxic Substances Control Act. Federal
Register. 86 FR 1890, November 16, 2022 (FRL-10018-40).
5. U.S. EPA. Response to Public Comments on the 2021 Proposed Rule
and 2022 Supplemental Proposed Rule Addressing Fees for the
Administration of the Toxic Substances Control Act (RIN 2070-AK64).
January 23, 2024.
6. U.S. EPA. Economic Analysis of the Final Rule; Fees for the
Administration of the Toxic Substances Control Act (TSCA); RIN 2070-
AK46. January 23, 2024.
7. EPA. Technical Support Document: Final Rulemaking; Fees for the
Administration of the Toxic Substances Control Act (TSCA); RIN 2070-
AK64. January 23, 2024.
8. 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.
9. EPA. Supporting Statement for an Information Collection Request
(ICR) under the Paperwork Reduction Act (PRA): Fees for the
Administration of the Toxic Substances Control Act (TSCA); Final
Rule (RIN 2070-AK64). EPA ICR No. 2569.06; OMB Control No. 2070-
0208. January 23, 2024.
10. EPA. Supporting Statement for an Information Collection Request
(ICR) under the Paperwork Reduction Act (PRA): User Fees for the
Administration of the Toxic Substances Control Act (TSCA); Proposed
Rule (RIN 2070-AK64). EPA ICR No. 2569.03; OMB Control No. 2070-
0208. January 31, 2021.
11. EPA. Supporting Statement for an Information Collection Request
(ICR) under the Paperwork Reduction Act (PRA): ``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. September 2022.
12. OMB. Notice of Office of Management and Budget Action under the
Paperwork Reduction Act on the 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#.
13. OMB. Notice of Office of Management and Budget Action under the
Paperwork
[[Page 12973]]
Reduction Act on the ICR entitled: ``User Fees for the
Administration of the Toxic Substances Control Act (TSCA)
(Supplemental Proposed Rule).'' EPA ICR No. 2569.05; OMB Control No.
2070-0208; OMB ICR Reference No. 202211-2070-001. January 11, 2023.
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202211-2070-001#.
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 14094: Modernizing Regulatory Review
This action is a ``significant regulatory action'' as defined in
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA,
submitted this action to the Office of Management and Budget (OMB) for
Executive Order 12866 Review. Documentation of any changes made in
response to the Executive Order 12866 Review is available in the
docket.
EPA prepared an economic analysis of the potential impacts
associated with this action (Ref. 6), which is available in the docket
and is summarized in Unit I.E.
B. Paperwork Reduction Act (PRA)
The information collection activities in this rule have been
submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared has
been assigned EPA ICR No. 2569.06 (Ref. 9). EPA previously prepared and
submitted ICRs for the 2021 Proposed Rule (Ref. 10) and the 2022
Supplemental Notice (Ref. 11), and in both cases, the Notice of OMB
Action that was issued identified the OIRA Conclusion Action as
``Comment filed on proposed rule and continue'' (Refs. 12 and 13). EPA
intends for the final rule ICR to amend and replace the existing ICR
that is currently approved under OMB Control No. 2070-0208 through
February 28, 2025. You can find a copy of the ICR (Ref. 9) in the
docket for this rule, and it is briefly summarized in this unit.
The information collection activities associated with this final
rule include familiarization with the revised regulation; reduced fee
eligibility determination; CDX registration (for new entrants);
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. See also Unit I.A.
Respondent's obligation to respond: Mandatory under TSCA section
26(b).
Total estimated number of respondents: 802.
Frequency of response: On occasion.
Total estimated number of responses: 502.
Total estimated burden: 383 hours (per year). Burden is defined at
5 CFR 1320.3(b).
Total estimated cost: $ 555,663 (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
regulations in title 40 of the CFR are listed in 40 CFR part 9. When
OMB approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The small entities 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. The Agency has determined that 58 small
businesses, including 12 processors and 47 manufacturers, may be
affected annually by TSCA section 4 actions; 153 small businesses may
be affected by TSCA section 5 actions; and 31 small businesses may be
affected by TSCA 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, and compares it to
incremental fee amounts to estimate the economic impact. For example,
EPA expects 88 small businesses to pay incremental TSCA section 5
Exemption fees of $1,062. According to the estimated revenue
distribution, 96 percent of parent firms have an annual revenue greater
than $106,200, 4 percent have an annual revenue between $106,200 and
$35,400, and no firms have revenues less than $35,400. Accordingly, of
the 88 small businesses affected, 96 percent will have an impact under
1 percent, 4 percent will have an impact between 1 percent and 3
percent, and none will have an impact greater than 3 percent. Estimates
for each fee category are available in section 6.3 of the economic
analysis. The average annual incremental cost per affected small
business is expected to be about $336 for TSCA section 4; $1,748 for
TSCA section 5, and $35,665 for TSCA section 6. As a result, EPA
estimates that, of the 242 small businesses paying fees every year, 217
will have impacts under 1 percent, 15 will have impacts between 1
percent and 3 percent, and 10 will have impacts greater than 3 percent.
Details of this analysis are presented in the economic analysis (Ref.
6), which is available in the docket.
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. This action imposes
no enforceable duty on any state, local or tribal governments.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on Tribal governments, on the
relationship between the Federal government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes. Thus, Executive Order 13175 does not
apply to this action.
[[Page 12974]]
G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it does not concern an environmental health or
safety risk. Since this action does not concern human health, EPA's
2021 Policy on Children's Health also does not apply. Although this
action does not concern human health or environmental conditions, EPA
identifies and addresses children's environmental health concerns in
the risk evaluations conducted under TSCA section 6(b).
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve technical standards under NTTAA
section 12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
This action does not concern human health or environmental
conditions and therefore cannot be evaluated with respect to the
potential for disproportionate and adverse effects on communities with
environmental justice concerns in accordance with Executive Order 12898
(59 FR 7629, February 16, 1994) and Executive Order 14096 (88 FR 25251,
April 26, 2023). Although this action does not concern human health or
environmental conditions, EPA identifies and addresses environmental
justice concerns in the risk evaluations conducted under TSCA section
6(b).
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and the
EPA will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects 40 CFR Part 700
Chemicals, Environmental protection, Hazardous substances,
Reporting and recordkeeping requirements, User fees.
Michael S. Regan,
Administrator.
Therefore, for the reasons stated in the preamble, 40 CFR part 700
is amended as follows:
PART 700--GENERAL
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 the definitions
of ``Production volume'' and ``Small quantities solely for research and
development.''
The additions read as follows:
Sec. 700.43 Definitions applicable to this subpart.
* * * * *
Production volume means manufactured (including imported) amount in
pounds.
* * * * *
Small quantities solely for research and development (or ``small
quantities solely for purposes of scientific experimentation or
analysis or chemical research on, or analysis of, such substance or
another substance, including such research or analysis for the
development of a product'') means quantities of a chemical substance
manufactured (including imported), or processed or proposed to be
manufactured (including imported), or processed solely for research and
development that are not greater than reasonably necessary for such
purposes.
* * * * *
0
3. Amend Sec. 700.45 by:
0
a. Revising paragraphs (a)(2) and (3);
0
b. Revising paragraphs (b)(5) and (7) and adding (b)(10);
0
c. Revising paragraphs (c) and (d);
0
d. Revising paragraphs (f)(2)(i), (3)(i), (4), and (5) and adding
paragraph (f)(6); and
0
e. Revising paragraphs (g)(3)(i) and (iv), (5) and (6).
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 TSCA section 4(a) are
exempted from fee payment requirements in this section, if they meet
one or more of the exemptions under this paragraphs (a)(2)(i) through
(v) of this section on or after the certification cutoff date
identified in paragraph (b)(6) of this section and do not conduct
manufacturing outside of those exemptions after the certification
cutoff dates or if they meet the exemptions under paragraph (a)(2)(vi)
of this section for the five-year period preceding publication of the
preliminary list and do not conduct manufacturing outside of that
exemption during the five-year period preceding publication of the
preliminary list; and the exemptions are only available if the
manufacturer will meet one or more of the exemptions in this paragraph
(a)(2)(i) through (vi) in the successive five years; and will not
conduct manufacturing outside of the exemptions in paragraphs (a)(2)(i)
through (v) of this section in the successive five years or will meet
the exemption in paragraph (a)(2)(vi) of this section 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 that chemical substance as an impurity as defined
in 40 CFR 704.3;
(iv) Manufacture that chemical substance as a non-isolated
intermediate as defined in 40 CFR 704.3;
(v) Manufacture small quantities of that chemical substance solely
for research and development, as defined in 40 CFR 700.43; or
(vi) Manufacture 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 defined 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,
[[Page 12975]]
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. 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 paragraphs (a)(3)(i)
through (v) of this section on or after the certification cutoff date
identified in paragraph (b)(6)(i) of this section and do not conduct
manufacturing outside of those exemptions after the certification
cutoff dates or if they meet the exemptions under paragraph (a)(3)(vi)
of this section for the five-year period preceding publication of the
preliminary list and do not conduct manufacturing outside of that
exemption during the five-year period preceding publication of the
preliminary list; and the exemptions are only available if the
manufacturer will meet one or more of the exemptions in paragraphs
(a)(3)(i) through (vi) of this section in the successive five years and
will not conduct manufacturing outside of the exemptions in paragraphs
(a)(3)(i) through (v) of this section in the successive five years or
will meet the exemption in paragraph (a)(3)(vi) of this section 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 that chemical substance as an impurity as defined
in 40 CFR 704.3;
(iv) Manufacture that chemical substance as a non-isolated
intermediate as defined in 40 CFR 704.3;
(v) Manufacture small quantities of that chemical substance solely
for research and development, as defined in Sec. 700.43; or
(vi) manufacture 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 defined in
Sec. 700.43, in which case this exemption is not applicable.
* * * * *
(b) * * *
(5) Self-identification. All manufacturers other than those listed
in paragraphs (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) Contact information. The name and address of the submitting
company, the name and address of the authorized official for the
submitting company, and the name and telephone number of a person who
will serve as technical contact for the submitting company and who will
be able to answer questions about the information submitted by the
company to EPA.
(ii) Certification of cessation. If a manufacturer has manufactured
in the five-year period preceding publication of the preliminary list
but has ceased manufacture prior to the certification cutoff dates
identified in paragraph (b)(6) of this section and will not manufacture
the substance again in the successive five years, the manufacturer may
submit a certification statement attesting to these facts. If EPA
receives such a certification statement from a manufacturer, the
manufacturer will not be included in the final list of manufacturers
described in paragraph (b)(7) of this section and will not be obligated
to pay the fee under this section.
(iii) Certification of no manufacture. If a manufacturer is
identified on the preliminary list but has not manufactured the
chemical in the five-year period preceding publication of the
preliminary list, the manufacturer may submit a certification statement
attesting to these facts. If EPA receives such a certification
statement from a manufacturer, the manufacturer will not be included in
the final list of manufacturers described in paragraph (b)(7) of this
section and will not be obligated to pay the fee under this section.
(iv) Certification of meeting exemption. If a manufacturer is
identified on the preliminary list and exclusively meets one or more of
the exemptions as described in paragraph (a)(2) or (a)(3) of this
section, 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 as described in paragraph (a)(2) or (a)(3) of
this section, 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 TSCA 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 40 CFR 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 TSCA section 6, and with the final test rule for
test rules under TSCA section 4. EPA may modify the list after the
publication of the final list.
* * * * *
(10) Recordkeeping. After April 22, 2024:
(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
[[Page 12976]]
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 (a)(3)(iv) of this
section must maintain manufacturing and other business records related
to compliance with the exemption criteria described in paragraph
(a)(2)(iv) or (a)(3)(iv) of this section, respectively. These records
must be maintained for a period of five years from the date the notice
is submitted pursuant to paragraph (b)(5) of this section.
(iii) Those manufacturers that are exempt from fee payment
requirements pursuant to paragraph (a)(2)(v) or (a)(3)(v) of this
section must maintain manufacturing and other business records related
to compliance with the exemption criteria described in paragraph
(a)(2)(v) or (a)(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 notice is submitted pursuant to paragraph
(b)(5) of this section.
(iv) Those manufacturers that are exempt from fee payment
requirements pursuant to paragraph (a)(2)(vi) or (a)(3)(vi) of this
section must maintain production volume records related to compliance
with the exemption criteria described in paragraph (a)(2)(vi) or
(a)(3)(vi) of this section, respectively. These records must be
maintained for a period of five years from the date the notice is
submitted pursuant to paragraph (b)(5) of this section.
* * * * *
(c) Fees for the 2024, 2025, and 2026 fiscal years. Persons shall
remit fee payments to EPA as follows:
(1) Small business concerns. Small business concerns shall remit
fees as follows:
(i) Premanufacture notice and consolidated premanufacture notice.
Persons shall remit a fee totaling $6,480 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
$6,480 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
$2,180 for each of the following exemption requests submitted under
TSCA section 5:
(A) Low releases and low exposures exemption or LoREX request
submitted to EPA pursuant to section 5(a)(1) of the Act in accordance
with Sec. 723.50(a)(1)(ii) of this chapter.
(B) Low volume exemption or LVE request submitted to EPA pursuant
to section 5(a)(1) of the Act in accordance with Sec. 723.50(a)(1)(i)
of this chapter.
(C) Test marketing exemption or TME application submitted to EPA
pursuant to section 5 of the Act in accordance with Sec. Sec. 725.300
through 725.355 of this chapter.
(D) TSCA experimental release application or TERA application
submitted to EPA pursuant to section 5 of the Act for research and
development activities involving microorganisms in accordance with
Sec. Sec. 725.200 through 725.260 of this chapter.
(E) Tier II exemption application submitted to EPA pursuant to
section 5 of the Act in accordance with Sec. Sec. 725.428 through
725.455 of this chapter.
(iv) Instant photographic film article exemption notice. Persons
shall remit a fee totaling $2,180 for each instant photographic film
article exemption notice submitted in accordance with Sec. 723.175 of
this chapter.
(v) Microbial commercial activity notice and consolidated microbial
commercial activity notice. Persons shall remit a fee totaling $6,480
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) 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) 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) 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) Others. Persons other than small business concerns shall remit
fees as follows:
(i) PMN and consolidated PMN. Persons shall remit a fee totaling
$37,000 for each PMN or consolidated PMN submitted in accordance with
part 720 of this chapter.
(ii) SNUN. Persons shall remit a fee totaling $37,000 for each
significant new use notice submitted in accordance with part 721 of
this chapter.
(iii) Exemption applications. Persons shall remit a fee totaling
$10,870 for each of the following exemption requests, and modifications
to previous exemption requests, submitted under section 5 of the Act:
(A) Low releases and low exposures exemption or LoREX request
submitted to EPA pursuant to section 5(a)(1) of the Act in accordance
with Sec. 723.50(a)(1)(ii) of this chapter.
(B) Low volume exemption or LVE request submitted to EPA pursuant
to section 5(a)(1) of the Act in accordance with Sec. 723.50(a)(1)(i)
of this chapter.
(C) Test marketing exemption or TME application submitted to EPA
pursuant to section 5 of the Act in accordance with Sec. Sec. 725.300
through 725.355 of this chapter, unless the submitting company has
graduated from EPA's Sustainable Futures program, in which case this
exemption fee is waived.
(D) TSCA experimental release application or TERA application
submitted to EPA pursuant to section 5 of the Act for research and
development activities involving microorganisms in accordance with
Sec. Sec. 725.200 through 725.260 of this chapter.
(E) Tier II exemption application submitted to EPA pursuant to
section 5 of the Act in accordance with Sec. Sec. 725.428 through
725.455 of this chapter.
(iv) Instant photographic film article exemption notice. Persons
shall remit a fee totaling $10,870 for each exemption notice submitted
in accordance with Sec. 723.175 of this chapter.
(v) MCAN and consolidated MCAN. Persons shall remit a fee totaling
$37,000 for each MCAN or consolidated MCAN submitted in accordance with
Sec. Sec. 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 $4,287,000.
(x) Manufacturer-requested risk evaluation of a Work Plan Chemical.
Persons shall remit an initial fee of $1,414,924, a second payment of
$1,414,924, 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 $2,829,847, a second
payment of
[[Page 12977]]
$2,829,847, 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 2026 fiscal year and beyond. (1) Fees for the 2026 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 2024 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 2024 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 2024 (October 1, 2023). 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 2026.
(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,
2026, October 1, 2029, 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] TR21FE24.000
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.
[[Page 12978]]
(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] TR21FE24.001
(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.
Table 1 to Paragraph (f)(4)(iii)--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] TR21FE24.002
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
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 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 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.
(iv) 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
[[Page 12979]]
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 (f)(6)(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
(viii) 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 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 $6,480 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 $2,180 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 $2,180 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 $6,480 in accordance with 40 CFR 700.45(c).'' in
the certification required in Sec. 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
$37,000 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 $10,870
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 $10,870 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 $37,000 in accordance with 40 CFR 700.45(c).'' in
the certification required in Sec. 725.25(b) of this chapter.
* * * * *
[FR Doc. 2024-02735 Filed 2-20-24; 8:45 am]
BILLING CODE 6560-50-P