Federal Register / Vol. 89, No. 35 / Wednesday, February 21, 2024 / Rules and Regulations 12961 

disbursed, and settled more quickly 

than checks and, accordingly, Treasury 

may assess a charge to the agency 

pursuant to 31 U.S.C. 3335. 

David Lebryk, 

Fiscal Assistant Secretary. 

[FR Doc. 2024–03204 Filed 2–20–24; 8:45 am] 

BILLING CODE P 

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. 

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 selfidentification and reporting 

requirements of EPA-initiated risk 

evaluation and test rule fees; 

modifications to EPA’s proposed 

methodology for the productionvolume-based fee allocation for EPAinitiated 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: edmonds.

marc@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

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. 


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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 threeyear 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 EPAinitiated risk evaluation; (3) An 

exemption for manufacturers of 

chemical substances produced as nonisolated intermediates; and (4) 

Exemptions for manufacturers of a 

chemical substance subject to an EPAinitiated 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 EPAinitiated 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-epainitiated-risk-evaluations)), EPA 

supplemented its January 2021 Proposal 

in November 2022 with the publication 

of a Supplemental Notice (Ref. 4). 


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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/outreachmaterials-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 reevaluated 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 fulltime 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., nonpay) 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] 

Annual costs 

TSCA Section 4 .................... $7,678,352 

TSCA Section 5 .................... 40,219,461 

TSCA Section 6 (excluding 

MRREs) ............................. 70,486,244 


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TABLE 1—ESTIMATED ANNUAL COSTS

TO EPA—Continued 

[FY 2024 through FY 2026] 

Annual costs 

TSCA Section 14 .................. 7,823,436 

Agency Indirect Costs .......... 20,546,580 

Total ............................... 146,754,074 

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 

Non-pay Pay FTE Total 

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 

Total .................................................................................................................................. 3,719,598 3,958,754 21.39 7,678,352 

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 prenotice 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 

Non-pay Pay FTE Total 

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 

Total ...................................................................................................................... 19,351,668 20,903,957 112.14 40,219,461 

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-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-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). 


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TABLE 4—TSCA SECTION 6 ANNUAL COST ESTIMATES FOR FY 2024–FY 2026 

Non-pay Pay FTE Total 

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 

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 

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 

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 

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 

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. 


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TABLE 7—SUMMARY OF TOTAL ESTIMATED ANNUAL FEE COLLECTIONS AND REFUNDS FOR FY 2024–2026 

Fee category 

Estimated 

activity 

levels— 

non-small 

business 

Estimated 

activity 

levels— 

small business 

Fee— 

non-small 

business 

Fee—small 

business 

Total annual 

collections 

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)/MCAN/SNUN ......................................................... 151.0 65.0 37,000 6,480 6,014,304 

LoREX, LVE, TME, Tier II exemption, TERA, Film Articles ................................. 178.0 88.0 10,870 2,180 2,128,612 

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 feetriggering 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 feetriggering 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, MCAN and consolidated MCAN 19,020 ............................................ 37,000. 

LoREX, LVE, TME, Tier II exemption, TERA, Film Articles ................... 5,590 .............................................. 10,870. 

EPA-Initiated Risk Evaluation ................................................................. 1,605,000 ....................................... Two payments resulting in 

$4,287,000. 

MRRE on a Chemical Included in the TSCA Work Plan ........................ 50% of total actual costs with a 

$1,490,000 initial payment.

Two payments of $1,414,924, with 

final invoice to recover 50% of 

actual costs. 

MRRE on a Chemical Not Included in the TSCA Work Plan ................. 100% of total actual costs with a 

$2,970,000 initial payment.

Two payments of $2,829,847, with 

final invoice to recover 100% of 

actual costs. 

Table Note: 1The current fees reflect an adjustment for inflation as required by TSCA. The adjustment went into effect on January 1, 2022. 


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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 EPAinitiated 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 


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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. Thirdparty 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 ‘‘nonTSCA 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. 


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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 EPAinitiated 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 FeeTriggering 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 selfidentification 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 selfidentification 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 concentrationbased 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, lowproduction 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 


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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 nomanufacture 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 EPAinitiated 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)(ivvi)) 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 EPAinitiated 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 selfidentified 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 


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previously certified cessation to be 

allowed to begin manufacturing or 

importing the substances within the 

successive five-year period, or ‘‘reenter’’ 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 selfidentification 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 EPAinitiated 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 EPAinitiated 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. 


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TABLE 10—CHANGES TO TIMING WITHIN THE FEE RULE

Stage in the fees process Timing under 2018 fee rule Final timing changes 

Payment of fees for EPA-initiated risk evaluations.Payment is collected in one installment 120 

days after EPA publishes the final scope of 

a chemical risk evaluation.

Payment is collected over two installments, 

the first payment of 50 percent is due 180 

days after EPA 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-requested 

risk assessments.

Initial payment is due within 30 days of EPA 

providing notice of granting a MRRE. Payment is collected in two installments over 

the course of the activity.

Initial payment is due within 180 days of EPA 

providing notice of granting a MRRE. Payments are collected over three installments. 

Payment of fees for test rules and test orders .. Payment is collected in one installment 120 

days after the effective date of a test rule or 

test order.

Payment is collected in one installment 180 

days after the effective date of a test rule or 

test order. 

Intent to form a consortia ................................... Must notify EPA within 60 days of the triggering event.Must notify EPA within 90 days of the triggering 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, nonisolated 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 


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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/lawsregulations/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. 


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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 

■ 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. 

■ 2. Amend § 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: 

§ 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. 

* * * * * 

■ 3. Amend § 700.45 by: 

■ a. Revising paragraphs (a)(2) and (3); 

■ b. Revising paragraphs (b)(5) and (7) 

and adding (b)(10); 

■ c. Revising paragraphs (c) and (d); 

■ d. Revising paragraphs (f)(2)(i), (3)(i), 

(4), and (5) and adding paragraph (f)(6); 

and 

■ e. Revising paragraphs (g)(3)(i) and 

(iv), (5) and (6). 

The revisions and additions read as 

follows: 

§ 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 § 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 

§ 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, 


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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 

§ 700.43; or 

(vi) manufacture that chemical 

substance in quantities below a 2,500 

lbs annual production volume as 

described in § 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 

§ 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 fiveyear 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 § 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 


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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 § 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 § 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 §§ 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 §§ 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 

§§ 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 

§ 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 §§ 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 § 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 § 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 §§ 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 §§ 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 

§§ 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 

§ 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 

§§ 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 


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$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 threeyear 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 × 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-andcomment 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: 

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 § 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. 


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Ps = 0.2 x [!J 

F-[0.2 x [; ]x Ms] 

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12978 Federal Register / Vol. 89, No. 35 / Wednesday, February 21, 2024 / Rules and Regulations 

(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 § 700.45(b)(v) of the 

chemical substance, with lower fees for 

small businesses: 

(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 § 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

Manufacturer(s) 

Assigned 

No. 

(N) 

Manufacturer with lowest production volume ................................ 1 

Manufacturer with 2nd lowest production volume .......................... 2 

TABLE 1 TO PARAGRAPH (f)(4)(iii)— 

EXAMPLE OF PLACING MANUFACTURERS THAT DO NOT QUALIFY AS A

SMALL BUSINESS CONCERN IN ASCENDING ORDER—Continued 

Manufacturer(s) 

Assigned 

No. 

(N) 

Manufacturer with 3rd lowest production volume .......................... 3 

. . . etc. 

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 § 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 § 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 

§ 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 allsmall 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 


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Federal Register / Vol. 89, No. 35 / Wednesday, February 21, 2024 / Rules and Regulations 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 allsmall 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 § 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 EPAinitiated 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 

§ 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 

§ 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 

§ 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 

§ 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 

§ 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 § 725.25(b) of this chapter. 

* * * * * 

[FR Doc. 2024–02735 Filed 2–20–24; 8:45 am] 

BILLING CODE 6560–50–P 


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