1890 Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Proposed Rules 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

G. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications as specified in Executive 

Order 13175. No tribal facilities are 

known to be engaged in the industries 

that would be affected by this action nor 

are there any adverse health or 

environmental effects from this action. 

Thus, Executive Order 13175 does not 

apply to this action. 

H. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This action is not subject to Executive 

Order 13045 because it is not 

economically significant as defined in 

Executive Order 12866, and because the 

EPA does not believe the environmental 

health or safety risks addressed by this 

action present a disproportionate risk to 

children. This action’s health and risk 

assessments are contained in sections 

III.A, IV.B, and IV.C of this preamble. 

I. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211 because it is not a 

significant regulatory action under 

Executive Order 12866. 

J. National Technology Transfer and 

Advancement Act (NTTAA) 

This rulemaking does not involve 

technical standards. 

K. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes that this action does 

not have disproportionately high and 

adverse human health or environmental 

effects on minority populations, lowincome populations, and/or indigenous 

peoples, as specified in Executive Order 

12898 (59 FR 7629, February 16, 1994). 

The documentation for this decision 

is contained in sections IV.B and IV.C 

of this preamble. As discussed in 

sections IV.B and IV.C of this preamble, 

we performed a demographic analysis 

for the Flexible Polyurethane Foam 

Fabrication Operations major source 

category, which is an assessment of 

risks to individual demographic groups, 

of the population close to the facilities 

(within 50 km and within 5 km). In our 

analysis, we evaluated the distribution 

of HAP-related cancer risks and 

noncancer hazards from the Flexible 

Polyurethane Foam Fabrication 

Operations major source category across 

different social, demographic, and 

economic groups within the populations 

living near operations identified as 

having the highest risks. Results of the 

demographic analysis performed for the 

Flexible Polyurethane Foam Fabrication 

Operations major source category 

indicate that the minority population is 

slightly higher within 5 km of the three 

facilities than the national percentage 

(40 percent versus 38 percent). This 

difference is accounted for by the larger 

African American population around 

the facilities (17 percent versus 12 

percent nationally). In addition, the 

percentage of the population living 

within 5 km of facilities in the source 

category is greater than the 

corresponding national percentage for 

the demographic groups, ‘‘Ages 0 to 17’’ 

and ‘‘Below the Poverty Level.’’ When 

examining the risk levels of those 

exposed to emissions from flexible 

polyurethane foam fabrication facilities, 

we find that no one is exposed to a 

cancer risk at or above 1-in-1 million or 

to a chronic noncancer TOSHI greater 

than 1. 

List of Subjects in 40 CFR Part 63 

Environmental protection, Air 

pollution control, Hazardous 

substances, Reporting and 

recordkeeping requirements. 

Andrew Wheeler, 

Administrator. 

[FR Doc. 2021–00250 Filed 1–8–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 700 

[EPA–HQ–OPPT–2020–0493; FRL–10018– 

40] 

RIN 2070–AK64 

Fees for the Administration of the 

Toxic Substances Control Act (TSCA) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing updates and 

adjustments to the 2018 fees rule 

established under the Toxic Substances 

Control Act (TSCA). 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 proposed 

modifications to the TSCA fees and fee 

categories for fiscal years 2022, 2023 

and 2024, and explains the methodology 

by which these TSCA fees were 

determined. EPA is proposing to add 

three new fee categories: A Bona Fide 

Intent to Manufacture or Import Notice, 

a Notice of Commencement of 

Manufacture or Import, and an 

additional fee associated with test 

orders. In addition, EPA is proposing 

exemptions for entities subject to certain 

fee triggering activities; including: An 

exemption for research and 

development activities, an exemption 

for entities manufacturing less than 

2,500 lbs. of a chemical subject to an 

EPA-initiated risk evaluation fee; an 

exemption for manufacturers of 

chemical substances produced as a nonisolated intermediate; and exemptions 

for manufacturers of a chemical 

substance subject to an EPA-initiated 

risk evaluation if the chemical 

substance is imported in an article, 

produced as a byproduct, or produced 

or imported as an impurity. EPA is 

updating its cost estimates for 

administering TSCA, relevant 

information management activities and 

individual fee calculation 

methodologies. EPA is proposing a 

volume-based fee allocation for EPAinitiated risk evaluation fees in any 

scenario where a consortium is not 

formed and is proposing to require 

export-only manufacturers to pay fees 

for EPA-initiated risk evaluations. EPA 

is also proposing various changes to the 

timing of certain activities required 

throughout the fee payment process. 

DATES: Comments must be received on 

or before February 25, 2021. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2020–0493, 

through the Federal eRulemaking Portal 

at http://www.regulations.gov. Follow 

the online instructions for submitting 

comments. Do not submit electronically 

any information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

Please note that due to the public 

health emergency the EPA Docket 

Center (EPA/DC) and Reading Room 

was closed to public visitors on March 

31, 2020. Our EPA/DC staff will 

continue to provide customer service 

via email, phone, and webform. For 

further information on EPA/DC services, 

docket contact information and the 

current status of the EPA/DC and 

Reading Room, please visit https://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Marc 


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Edmonds, Existing Chemicals Risk 

Management Division, 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), 

distribute in commerce, 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 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 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 proposed rule under TSCA 

section 26(b), 15 U.S.C. 2625(b). 

C. What action is the Agency taking? 

Pursuant to TSCA section 26(b), EPA 

is issuing this proposed rule to 

establish, update and/or revise fees 

collected from manufacturers (including 

importers) and, in some cases, 

processors, to defray some of the 

Agency’s costs related to activities 

under TSCA sections 4, 5, and 6, and 

collecting, processing, reviewing, and 

providing access to and protecting from 

disclosure as appropriate under TSCA 

section 14 information on chemical 

substances. EPA is proposing updates 

and changes to the 2018 Fee Rule (Ref. 

2), including: (a) The addition of three 

new fee categories—a Bona Fide Intent 

to Manufacture or Import Notice (bona 

fide notice), Notice of Commencement 

of Manufacture or Import (NOC), and an 

additional fee related to test orders; (b) 

The addition of exemptions for 

manufacturers subject to fees for EPAinitiated risk evaluations under TSCA 

section 6(b), including: Exemptions for 

manufacturers if the chemical substance 

is imported in an article, produced as a 

byproduct, or produced or imported as 

an impurity (as discussed in the March 

25, 2020 EPA Press Release announcing 

its plan and summarized at https://

www.epa.gov/tsca-fees/informationplan-reduce-tsca-fees-burden-and-noaction-assurance (Ref. 3)), an exemption 

for research and development activities, 

an exemption for manufacturers of 

chemical substances produced as a nonisolated intermediate, and an exemption 

for entities manufacturing less than 

2,500 lbs. of a chemical; (c) Updates to 

TSCA sections 4, 5, and 6 costs and 

costs of relevant information 

management activities as well as fee 

calculation methodology; and (d) 

Various changes to how the fee 

regulations are implemented including 

certain timing requirements throughout 

the fee payment process. EPA is not 

proposing to change the ‘‘small business 

concerns’’ definition. Although EPA is 

required to review and, if necessary, 

amend the TSCA fees every three years, 

EPA may propose additional 

amendments to TSCA fees, when 

warranted, based on its experience with 

implementing the requirements or 

analysis of future cost and revenue data. 

D. Why is the Agency taking this action? 

The proposed fees 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. These activities include 

designating applicable substances as 

High- and Low-Priority for future risk 

evaluation, conducting risk evaluations 

to determine whether a chemical 

substance presents an unreasonable risk 

of injury to health or the environment, 

requiring testing of chemical substances 

and mixtures, and evaluating and 

reviewing new chemical submissions, as 

required under TSCA sections 4, 5 and 

6, as well as collecting, processing, 

reviewing, and providing access to and 

protecting from disclosure as 

appropriate under TSCA section 14 

information on chemical substances 

under TSCA. EPA reviewed fees 

established in the 2018 Fee Rule and 

determined that it is necessary to adjust 

the fees. EPA is proposing changes to 

the TSCA fee requirements established 

in the 2018 Fee Rule based upon over 

two years of TSCA fee implementation 

and is proposing to adjust the fees based 

on changes to program costs and 

inflation and address certain issues 

related to implementation of the fee 

requirements. 

E. What are the estimated incremental 

impacts of this action? 

EPA has evaluated the potential 

incremental economic impacts of this 

proposed rule for FY 2022 through FY 

2024. The ‘‘Economic Analysis of the 

Proposed Rule for Fees for the 

Administration of the Toxic Substances 

Control Act’’ (Economic Analysis) (Ref. 

4), which is available in the docket, is 

discussed in Unit IV., and is briefly 

summarized here. 

1. Benefits. The principal benefit of 

the proposed rule is to provide EPA a 

sustainable source of funding necessary 

to administer certain provisions of 

TSCA. 

2. Cost. The fees collected from 

industry for this proposed rule under 

the proposed options, annualized over 

the period from fiscal year 2022–2024, 

are approximately $22 million (at both 

3% and 7% discount rates), excluding 

fees collected for manufacturerrequested risk evaluations. Total 

annualized fee collection was calculated 

by multiplying the estimated number of 

fee-triggering events anticipated each 

year by the corresponding fees. Total 

annual fee collection for manufacturerrequested risk evaluations is estimated 

to be $1.9 million for chemicals 

included in the 2014 TSCA Work Plan 

(TSCA Work Plan) (based on two 

requests over the three-year period) and 

approximately $5.7 million for 

chemicals not included in the TSCA 

Work Plan (based on three requests over 

the three-year period) (Ref. 4). EPA 

analyzed a three-year period because the 


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statute requires EPA to reevaluate and 

adjust, as necessary, the fees every three 

years. 

3. Small entity impact. EPA estimates 

that 35% of section 5 submissions will 

be from small businesses that are 

eligible to pay the section 5 small 

business fee because they meet the 

definition of ‘‘small business concern.’’ 

‘‘Small business concern’’ means a 

manufacturer or processor who meets 

the size standards at 40 CFR 700.43. 

Total annualized fee collection from 

small businesses submitting notices 

under section 5 is estimated to be 

$411,000 (Ref. 4). For sections 4 and 6, 

reduced fees paid by eligible small 

businesses and fees paid by non-small 

businesses may differ because the fee 

paid by each entity would be dependent 

on the number of entities identified per 

fee-triggering event and production 

volume of that chemical substance. EPA 

estimates that average annual fee 

collection from small businesses for feetriggering events under section 4 and 

section 6 would be approximately 

$8,000 and $922,000, respectively. For 

each of the three years covered by this 

proposed rule, EPA estimates that total 

fee revenue collected from small 

businesses will account for about 6 

percent of the approximately $22 

million total fee collection, for an 

annual average total of approximately 

$1.3 million. 

4. Environmental justice. The fees will 

enable the Agency to better protect 

human health and the environment, 

including in low-income and minority 

communities. 

5. Effects on State, local, and Tribal 

governments. The rule would not have 

any significant or unique effects on 

small governments, or federalism or 

tribal implications. 

F. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through http://

www.regulations.gov or email. Clearly 

mark the part or all of the information 

that you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

http://www.epa.gov/dockets/ 

comments.html. 

II. Background 

A. Statutory Requirements for TSCA 

Fees 

The proposed Fee Rule (83 FR 8212, 

February 26, 2018) (FRL–9974–31) 

provides a robust overview of the 

history of fees under TSCA and the 2016 

amendments to TSCA. 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 25% 

of the Agency’s costs to carry out a 

broader set of activities under sections 

4, 5, and 6 and relevant information 

management activities. In addition, in 

the case of manufacturer-requested risk 

evaluations, the Agency is directed to 

establish fees sufficient to defray 50% of 

the costs associated with conducting a 

manufacturer-requested risk evaluation 

on a chemical included in the TSCA 

Work Plan for Chemical Assessments: 

2014 Update, and 100% of the costs of 

conducting a manufacturer-requested 

risk evaluation for all other chemicals. 

EPA is also required in TSCA section 

26(b)(4)(F) to review and adjust, as 

necessary, the fees every three years. 

EPA is fulfilling that obligation with 

this rulemaking. 

B. History of TSCA Fees 

On October 17, 2018, EPA finalized 

the TSCA Fee Rule (Ref. 2), following 

the issuance of a proposed Fee Rule on 

February 26, 2018 and a 60-day 

comment period. As required by TSCA 

26(b)(4)(E), EPA also consulted and met 

with stakeholders that were potentially 

subject to fees, including as part of 

several meetings with individual 

stakeholders through the development 

of the final rule. 

In the 2018 Fee Rule, EPA established 

eight distinct fee categories: (1) Test 

orders, (2) test rules and (3) enforceable 

consent agreements (ECA), all under 

TSCA section 4; (4) notices and (5) 

exemptions, both under TSCA section 5; 

and (6) EPA-initiated risk evaluations, 

(7) manufacturer-requested risk 

evaluations for chemicals on the TSCA 

Work Plan, and (8) manufacturerrequested risk evaluations for chemicals 

not on the TSCA Work Plan, all under 

TSCA section 6. The activities in these 

categories are fee-triggering events that 

result in obligations to pay fees. 

In addition, EPA established 

standards for determining which 

persons qualify as ‘‘small business 

concerns’’ and thus would be subject to 

lower fee payments. As discussed in the 

2018 Fees Rule, EPA adopted an 

employee-based size standard modeled 

after the SBA’s standards. EPA is not 

proposing to change the ‘‘small business 

concerns’’ definition in this rule. 

EPA calculated fees by estimating the 

total annual costs of carrying out 

relevant activities under TSCA sections 

4, 5, and 6 (excluding the costs of 

manufacturer-requested risk 

evaluations) and conducting relevant 

information management activities; 

identifying the full cost amount to be 

defrayed by fees under TSCA section 

26(b) (i.e., 25% of those annual costs); 

and allocating that amount across the 

fee-triggering events in TSCA sections 4, 

5, and 6, weighted more heavily toward 

TSCA section 6 based on early industry 

feedback. EPA afforded small businesses 

an approximate 80% discount, in 

accordance with TSCA section 

26(b)(4)(A), and established, for the two 

fee-triggering events where 

manufacturers would not already be 

self-identified (TSCA section 4 test rules 

and TSCA section 6 EPA-initiated risk 

evaluations), a process to identify 

manufacturers (including importers) 

subject to these fees. 

At the time of promulgation of the 

2018 Fee Rule, EPA had many new 

responsibilities under amended TSCA 

and relatively little information and 

experience to inform assumptions on 

costs or activity levels. EPA has gained 

valuable experience over two years of 

implementing the initial fee structure 

and has used this initial experience and 

information gained from tracking actual 

costs to refine methodologies for 

calculating fees and to inform the 

development of proposed revisions to 

the fee structure. These proposed 

updates are discussed in Unit III. 

Additional discussion on the updates to 

program cost estimates is discussed in 

Unit II.C. 

C. Program Cost Estimates and Activity 

Assumptions 

The estimated annual Agency costs of 

carrying out relevant activities under 

TSCA sections 4, 5, and 6 and relevant 

information management activities are 

based on cost data from fiscal years 

2019 and 2020 which are the first full 

fiscal years after EPA implemented a 

time reporting system that tracks 

employee hours worked on 

administering TSCA. Total Agency costs 

of carrying out those relevant activities 

are estimated at approximately $87.5 

million each year. Based on these cost 


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estimates, EPA anticipates collecting 

approximately $22 million in fees 

collected from all fee-triggering events, 

except manufacturer-requested risk 

evaluations. In addition, the Agency 

intends to collect fees to recover 50% or 

100% of the actual costs incurred by 

EPA in conducting chemical risk 

evaluations requested by manufacturers, 

depending on whether the chemical 

substance is included in the TSCA Work 

Plan. EPA expects the amount collected 

will be approximately $2.84 million per 

chemical for chemicals on the TSCA 

Work Plan and $5.67 million per 

chemical for chemicals not on the TSCA 

Work Plan. 

EPA determined the anticipated costs 

associated with relevant activities under 

TSCA sections 4, 5, and 6 and relevant 

information management activities, 

including both direct program costs and 

indirect costs (see Table 1). For fiscal 

year 2022 through fiscal year 2024, 

these costs were estimated to be 

approximately $87.5 million per year. 

TABLE 1—ESTIMATED ANNUAL COSTS

TO EPA 

[Fiscal year 2022 through fiscal year 2024] 

Annual costs 

TSCA section 4 .................... $3,543,000 

TSCA section 5 .................... 34,713,248 

TSCA section 6 .................... 41,998,820 

TSCA section 8 .................... 3,974,522 

TSCA section 14 .................. 1,873,443 

Other sections ...................... 1,432,967 

Total ............................... 87,536,000 

Table Note: Numbers may not add due to 

rounding. The indirect cost rate is estimated at 

19.5% for the purposes of this analysis. 

After estimating the annual costs of 

administering relevant activities under 

TSCA sections 4, 5, and 6 and relevant 

information management activities, the 

Agency had to determine how the costs 

would be allocated over the narrower 

set of activities under TSCA sections 4, 

5 and 6 that trigger a fee. The Agency 

took an approach to determining fees 

that tied the payment of fees to 

individual distinct activity types or 

‘‘fee-triggering events’’. This allows 

allocation of costs more equitably 

among the activity types and their 

related costs. 

1. Program Costs 

To determine the program costs for 

implementing relevant activities under 

TSCA sections 4, 5, and 6 and relevant 

information management activities, the 

Agency accounted for the intramural 

and extramural costs for those activities. 

Intramural costs are those costs 

related to the efforts exerted by EPA 

staff and management in operating the 

program, collecting and processing 

information and funds, conducting 

reviews, and related activities. 

Extramural costs are those costs related 

to the acquisition of contractors to 

conduct activities such as analyzing 

data, developing IT systems and 

supporting the TSCA Help Desk. 

The Agency then added indirect costs 

to the direct program cost estimates. The 

Agency used an indirect cost rate of 

19.5% to calculate the indirect costs 

associated with all direct program cost 

estimates for TSCA sections 4, 5, and 6 

and relevant information management 

activities. 

a. TSCA Section 4 Program Costs 

TSCA section 4 gives EPA the 

authority to require (by rule, order, or 

ECA) manufacturers and processors to 

conduct testing of identified chemical 

substances or mixtures. EPA plans to 

utilize section 4 authorities in 

connection with the development of 

section 6(b) risk evaluations which 

would affect the number of section 4 

rules, orders, and ECAs that may be 

underway at any given time. These 

activity level assumptions represent 

EPA’s best professional judgment on 

how the program will be implemented. 

EPA estimates that, on average, it will 

undertake work associated with 10 test 

orders, one test rule and one ECA each 

year. While EPA expects to work on one 

test rule and one ECA each year, EPA 

expects to initiate each of these 

activities about every other year as it 

takes approximately two years to 

complete the work associated with both 

activities. 

EPA estimated TSCA section 4 costs 

based on prior experience with 

developing test orders, test rules and 

ECAs, with consideration given to the 

information needs under amended 

TSCA for section 4 activities. 

Specifically, costs were based on: The 

Agency’s general experience with the 

rulemaking process; experience with 

developing an ECA for 

Octamethylcyclotetrasiloxane (D4); 

costs associated with reviewing study 

plans and information received; 

administration of the High Production 

Volume Voluntary Testing Program; and 

information from the development of 

one test order for pigment violet 29. 

EPA’s cost estimates included a full 

suite of activities related to developing 

and implementing actions under TSCA 

section 4 authorities including 

reviewing screening-level hazard and 

environmental fate information 

submitted in response to a section 4 

rule, order, or ECA, such as tests that 

provide information on the toxicity of a 

chemical (e.g., aquatic toxicity, and 

mammalian toxicity) or occupational 

monitoring data. EPA also included 

estimates of the costs of reviewing 

physical/chemical properties and 

environmental fate and pathways data 

and tests. 

Based on previous experience and 

expected work under TSCA as 

amended, EPA assumes that testing 

required by test orders is likely to be 

completed in under a year, and test 

rules and ECAs are likely to take two 

years to complete. To estimate the costs 

of reviewing test data, we assume that, 

on average, data will be submitted to 

EPA to conduct 10 test orders per year 

over the course of a three-year period, 

with approximately 120 companies 

potentially subject to the orders. 

Unlike activities conducted under 

sections 5 and 6, EPA does not have 

enough data on actual implementation 

costs with which to base future cost 

estimates. As a result, EPA is relying on 

the section 4 cost estimate from the 

2018 Fees Rule. Based on this approach, 

the estimated cost to the Agency of each 

test order is approximately $279,000. 

Each test rule is estimated to cost 

approximately $844,000 and each ECA 

is estimated to cost approximately 

$652,000. These cost estimates include 

submission review and are based on 

projected full-time equivalent (FTE) and 

extramural support needed for each 

activity divided by the number of 

orders, rules and ECAs that EPA 

assumes will be issued over a three-year 

period. As noted earlier, several of these 

activities (rules and ECAs) are expected 

to span two years, so those estimates are 

based on the annual estimated costs 

multiplied by two. The annual cost 

estimate of administering TSCA section 

4 in fiscal year 2022 through fiscal year 

2024 is $3,543,000. 

b. TSCA Section 5 Program Costs 

TSCA section 5 requires that 

manufacturers and processors provide 

EPA with notice before initiating the 

manufacture of a new chemical 

substance or initiating the 

manufacturing or processing for a 

significant new use of a chemical 

substance. Examples of the notices or 

other information that manufacturers 

and processors are required to submit 

under TSCA section 5 are 

premanufacture notices (PMNs), 

significant new use notifications 

(SNUNs), microbial commercial activity 

notices (MCANs), and exemption 

notices and applications including lowvolume exemptions (LVEs), testmarketing exemptions (TMEs), low 

exposure/low release exemptions 

(LoREXs), TSCA experimental release 


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applications (TERAs), certain new 

microorganism (Tier II) exemptions, and 

film article exemptions. EPA is required 

to review and make a determination on 

whether the chemical presents an 

unreasonable risk of injury to health or 

the environment and take risk 

management action, as needed. Recent 

data on the number of annual 

submissions is found at https://

www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/ 

statistics-new-chemicals-review. 

EPA estimates that it will receive 301 

PMNs, SNUNs and MCANs per year, 

and another 320 exemption notices and 

applications per year, most of which are 

LVEs. EPA used the average number of 

section 5 submissions received in 

FY2019 and FY 2020 for each category 

of submission as the estimate of the 

annual number of submissions per 

section 5 fee category for the next three 

years. Cost estimates were developed 

based on information from the Agency’s 

time reporting system that tracks 

employee hours and contract 

expenditures for administering TSCA 

section 5 in FY 2019 and FY 2020. 

EPA’s cost estimates for administering 

TSCA section 5 also include the costs 

associated with processing and retaining 

records related to a Notice of 

Commencement of Manufacture or 

Import (NOC) submission. NOC costs 

also include the cost of registering the 

chemical with the Chemical Abstracts 

Service. EPA has lumped the costs 

associated with NOCs with those of 

PMNs, MCANs, and SNUNs. Estimated 

costs associated with TSCA section 5 

exemption notices and applications 

include the costs of pre-notice 

consultations, processing and reviewing 

applications, retaining records, and 

related activities. This estimate is based 

on projected FTE and extramural 

support needed for these actions 

divided by the number of submissions 

the Agency assumes will be received 

each year. 

The annual cost estimate of 

administering TSCA section 5 in fiscal 

year 2022 through fiscal year 2024 is 

$34,713,248 and is attributed to PMNs, 

SNUNs and MCANs as well as section 

5 exemption notices and applications 

for LVEs, LoREXs, TMEs, TERAs, Tier II 

exemptions and film article exemptions. 

c. TSCA Section 6 Program Costs 

TSCA section 6 directs the EPA to 

establish a process for assessing and 

managing existing chemical substances 

under TSCA. TSCA section 6 addresses: 

(a) Prioritizing chemicals for evaluation; 

(b) Evaluating risks from chemicals; and 

(c) Addressing unreasonable risks 

identified through the risk evaluation. 

Under TSCA, EPA is required to 

regularly undertake a risk-based 

prioritization process to designate 

existing chemicals on the TSCA 

Inventory as either high-priority for risk 

evaluation or low-priority. For 

chemicals designated as High-Priority 

Substances, as well as certain chemicals 

not subject to prioritization, such as 

those in manufacturer-requested risk 

evaluations, EPA must evaluate those 

chemicals to determine whether they 

present an unreasonable risk of injury to 

health or the environment under the 

conditions of use. The first step in the 

risk evaluation process, as outlined in 

TSCA, is to issue a scoping document 

for each chemical substance within six 

months of initiation of the risk 

evaluation (e.g., designation of a HighPriority Substance as announced in the 

Federal Register). The scoping 

document includes information about 

the chemical substance, such as 

conditions of use, hazards, exposures, 

and potentially exposed or susceptible 

subpopulations that the Agency expects 

to consider in the risk evaluation. TSCA 

requires that these chemical risk 

evaluations be completed within three 

years of initiation, allowing for a 6- 

month extension. During the Risk 

Evaluation scoping process, EPA will 

identify the ‘‘conditions of use’’ that the 

Agency expects to consider during the 

evaluation. If EPA determines that a 

chemical substance presents 

unreasonable risk under its conditions 

of use, EPA must proceed to risk 

management action under TSCA section 

6(a). For each risk evaluation that the 

Agency completes (other than a 

manufacturer-requested risk evaluation), 

TSCA requires that EPA identify 

another High-Priority Substance. The 

Agency expects to have at least 20 risk 

evaluations (other than manufacturerrequested risk evaluations) ongoing at 

any time in any given year at different 

stages in the evaluation process. 

TSCA section 6 cost estimates have 

been informed: By the Agency’s 

experience conducting and in some 

cases completing evaluations for the 

first 10 chemicals undergoing risk 

evaluation under amended TSCA, 

which consist of 1,4 dioxane, 1- 

bromopropane, asbestos, carbon 

tetrachloride, cyclic aliphatic bromide 

cluster (HBCD), methylene chloride, Nmethylpyrrolidone, pigment violet 29, 

trichloroethylene, and 

tetrachloroethylene; by the Agency’s 

experience developing the scope of the 

risk evaluations of the 20 chemicals 

designated as high-priority in December 

2019; and by the Agency’s experience 

with risk management actions 

addressing unreasonable risks identified 

from particular chemical activities. 

TSCA section 6 risk evaluations include 

the cost of information gathering 

(distinct from data collection via section 

4), evaluating human and 

environmental hazards and 

environmental fate, and conducting 

exposure assessments. Costs also 

include the use of the ECOTOX 

knowledge and Health and 

Environmental Research Online (HERO) 

databases, scoping, developing and 

publishing the draft risk evaluation, 

conducting and responding to peer 

review and public comment, and 

developing the final evaluation, which 

includes risk determinations. 

Under TSCA section 6, the Agency 

also must take action to address the 

unreasonable risks identified during risk 

evaluation. Cost estimates for risk 

management activities have been 

informed, in part, by EPA’s recent risk 

management actions on several 

chemicals, including development of 

the proposed rules regarding the use of 

N-methylpyrrolidone and methylene 

chloride in paint and coating removal, 

and the use of trichloroethylene in both 

commercial vapor and aerosol 

degreasing and for spot cleaning in dry 

cleaning facilities, and the development 

of the final rule regarding methylene 

chloride in consumer paint and coating 

removal. 

The estimated annual cost to EPA of 

administering relevant activities under 

TSCA section 6 in fiscal year 2022 

through 2024 is $41,998,820. The costs 

are attributed to risk evaluation work on 

chemical risk evaluations (other than 

manufacturer-requested risk 

evaluations); risk management efforts; 

support from the Office of Research and 

Development (ORD) for alternative 

animal testing and methods 

development and enhancement, data 

integration, meta-analysis of studies, 

and providing access to other models, 

tools and information already developed 

by ORD; and the process of prioritizing 

chemical substances. 

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 sections 

4, 5, 6 and 14 but do not include the 

costs of administering other authorities 

for collection such as those in TSCA 

section 8 and 11. EPA does not believe 

that Congress intended EPA to offset 

costs associated with administering 

authorities under these other sections. 

The statutory text clearly points to the 


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authorities of TSCA sections 4, 5, 6 and 

14. If the costs of administering 

activities under TSCA sections 8 and 11 

were intended to be defrayed with fees, 

Congress would have specifically 

included those authorities in the 

statutory text. Cost estimates in the 

proposed rule consider costs associated 

with managing information that, for 

instance, was received pursuant to a 

TSCA section 8 rule but not the costs of 

developing the TSCA section 8 rule. 

Specific activities considered when 

developing this estimate for activities 

under 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 costs associated with 

coordinating, reviewing, issuing, and 

defending TSCA CBI claim final 

determinations, and supporting 

guidance, policy and regulation 

development for TSCA section 14 

activities, e.g., implementing the unique 

identifier provisions, ensuring access to 

TSCA CBI for emergency personnel, 

states, tribes and local governments, and 

developing the TSCA CBI sunset 

provisions, among others. 

Other chemical information 

management activities included in the 

analysis are: Costs for implementing the 

requirements in TSCA section 14(d); 

costs for implementing the CBI sunset 

requirements; costs for Notice of 

Activity chemical identity CBI claim 

reviews; costs for Freedom of 

Information Act-Related CBI claim 

reviews; costs for providing public 

access to Non-CBI Data; and IT costs for 

operating and maintaining the CBI Local 

Area Network (LAN). The annual cost 

estimate of collecting, processing, 

reviewing, and providing access to and 

protecting from disclosure as 

appropriate information on chemical 

substances under section 14 of TSCA, 

including FTE and extramural costs, 

from fiscal year 2022 through fiscal year 

2024 is $1,873,443 (Ref. 4). 

2. Indirect Costs 

Indirect costs are the intramural and 

extramural costs that are not accounted 

for in the direct program costs, but are 

important to capture because of their 

necessary enabling and supporting 

nature, and so that EPA’s proposed fees 

will accomplish full cost recovery up to 

that provided by law. Indirect costs 

typically include such cost items as 

accounting, budgeting, payroll 

preparation, personnel services, 

purchasing, centralized data processing, 

and rent. 

Indirect costs are disparate and more 

difficult to track than the other cost 

categories, because they are typically 

incurred as part of the normal flow of 

work (e.g., briefings and decision 

meetings involving upper management) 

at many offices across the Agency. EPA 

accounts for some indirect costs in the 

costs associated with carrying out 

relevant activities under TSCA sections 

4, 5, and 6, and costs of collecting, 

processing, reviewing, and providing 

access to and protecting from disclosure 

as appropriate under TSCA section 14 

information on chemical substances, by 

the inclusion of an indirect cost factor. 

This rate is multiplied by and then 

added to the program costs. An indirect 

cost rate is determined annually 

according to EPA’s indirect cost 

methodology and as required by Federal 

Accounting Standards Advisory Board’s 

Statement of Federal Financial 

Accounting Standards No. 4: Managerial 

Cost Accounting Standards and 

Concepts. An indirect cost rate of 19.5% 

was applied to direct program costs of 

work conducted by EPA’s Office of 

Chemical Safety and Pollution 

Prevention, based on FY 2019 data. 

Some of the direct program costs 

included in the estimates for TSCA 

sections 4, 5, and 6 and collecting, 

processing, reviewing, and providing 

access to and protecting from disclosure 

as appropriate under TSCA section 14 

information on chemical substances are 

for work performed in other Agency 

offices (e.g., the Office of Research and 

Development and the Office of General 

Counsel). Appropriate indirect cost rates 

were applied to those cost estimates and 

are based on EPA’s existing indirect cost 

methodology. Indirect cost rates are 

calculated each year and therefore 

subject to change. Indirect costs were 

included in the program cost estimates 

in the previous sections. 

3. Total Costs of Fee-Triggering Events 

The annual estimated costs for fee 

categories under TSCA section 4, 

including both direct and indirect 

program costs, are shown in Table 2. 

Note that the costs presented in Tables 

2, 3, and 4 include only the costs of feetriggering events and so do not include 

costs associated with activities such as 

CBI reviews, alternative testing methods 

development, risk management for 

existing chemicals, or prioritization of 

existing chemicals. Costs associated 

with those activities are part of the 

overall costs of administering relevant 

activities under TSCA sections 4, 5, and 

6 and relevant information management 

activities and, as such, are included in 

the overall cost estimates provided 

previously in Table 1. 

TABLE 2—TSCA SECTION 4 COSTS * 

Fee category 

Estimated 

number of 

ongoing 

actions/year 

Estimated 

cost to 

Agency/action 

Estimated 

annual cost 

to Agency 

Test Order .................................................................................................................................... 10 $279,000 $2,795,000 

Test Rule ..................................................................................................................................... 1 844,000 422,000 

Enforceable Consent Agreement ................................................................................................ 1 652,000 326,000 

* Table Note: Numbers may not add due to rounding. 

The estimated annual costs for fee 

categories under TSCA section 5, 

including both direct and indirect 

program costs are shown in Table 3. 


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TABLE 3—TSCA SECTION 5 COSTS * 

Fee category 

Estimated 

number of 

ongoing 

actions/year 

Total 

estimated 

annual cost 

to Agency 

PMN and consolidated PMN, SNUN, MCAN and consolidated MCAN .................................................................. 301 ........................

Bona Fide Notice ..................................................................................................................................................... 207 

Notice of Commencement ....................................................................................................................................... 175 

LoREX, LVE, TME, Tier II exemption, TERA, Film Article ..................................................................................... 320 

$34,713,428 

* Table Note: Numbers may not add due to rounding. Costs were not broken out and therefore are not shown in the Total estimated annual 

cost to Agency column. 

The estimated annual costs for fee 

categories under TSCA section 6, 

including both program and indirect 

costs are shown in Table 4. 

TABLE 4—TSCA SECTION 6 COSTS * 

Fee category 

Estimated 

number of 

ongoing 

actions/year 

Estimated 

cost to 

Agency/action 

Estimated 

annual cost 

to Agency 

EPA-initiated risk evaluation ........................................................................................................ 20 $5,671,000 $41,998,820 

Manufacturer-requested risk evaluation: Work Plan chemical .................................................... 2 5,671,000 3,783,000 

Manufacturer-requested risk evaluation: Non-Work Plan chemical ............................................ 3 5,671,000 5,671,000

* Table Note: Numbers may not add due to rounding. 

III. Overview of the Proposed Rule 

A. Regulatory Approach 

Pursuant to TSCA section 26(b), EPA 

is issuing this proposed rule to update 

and revise the fee collection from 

manufacturers (including importers) 

and, in some cases, processors, to defray 

approximately 25% of the Agency’s 

costs related to relevant activities under 

TSCA sections 4, 5, and 6, and relevant 

information management activities. The 

proposed rule applies to manufacturers 

and processors who are required to 

submit information under TSCA section 

4, manufacturers and processors who 

submit certain notices and exemptions 

under TSCA section 5, and 

manufacturers who are subject to risk 

evaluation under TSCA section 6(b), 

including manufacturers who submit 

requests for risk evaluation under TSCA 

section 6(b)(4)(C)(ii). 

1. 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. All of these 

outreach meetings are summarized at 

https://www.epa.gov/tsca-fees/outreachmaterials-tsca-administration-fees-rule. 

In fall and winter 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. 

EPA is committed to continued 

stakeholder outreach and intends to 

meet with companies, trade associations 

and consortia that represent affected 

manufacturers and processors. EPA will 

also consult with the Small Business 

Administration regarding engagement 

with small businesses. 

2. Request for Comment on Proposed 

and Alternative Regulatory Actions 

EPA requests comment on all aspects 

of the proposed and alternative 

regulatory actions discussed in this unit, 

including comment on whether the 

proposed regulatory actions would 

improve fee collection processes and 

ensure fair fee distribution among fee 

payers. EPA is also seeking additional 

information and data that could 

facilitate EPA’s further evaluation of the 

potentially affected industries and 

firms, including data related to potential 

impacts on those small businesses that 

would be subject to fees. 

B. Methodology for Calculating Fees 

1. Description of the Proposed 

Regulatory Action 

EPA does not implement an actual 

cost approach for TSCA sections 4, 5, 

and 6 (excluding the costs of 

manufacturer-requested risk 

evaluations) fee-triggering events and is 

not proposing to do so through this 

proposed rule. EPA does, however, 

implement an actual cost approach for 

calculating fees for manufacturerrequested risk evaluations. Specifically, 

EPA currently requires an initial 

payment of $1,250,000 (for a chemical 

on the TSCA Work Plan) or $2,500,000 

(for a chemical not on the TSCA Work 

Plan), and a final invoice to total either 

50% or 100% of the remaining actual 

costs in line with the percentage 


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requirements in TSCA, or a refund to 

achieve these requirements, if 

warranted. 

The 2018 Fee Rule established a twopayment approach for manufacturerequested risk evaluations—an initial 

payment, followed by a final invoice at 

the conclusion of the risk evaluation for 

the total remaining due, or a refund to 

achieve these requirements, if 

warranted. EPA is proposing a change to 

this approach by proposing a payment 

plan that enables entities to pay 

approximately 1⁄3 each year with a final 

invoice at the conclusion of the risk 

evaluation. Specifically, EPA is 

proposing to allow an initial payment of 

$945,000 and a second payment by the 

end of the second year of $945,000 (for 

a chemical on the TSCA Work Plan) or 

an initial payment of $1,890,000 and a 

second payment of $1,890,000 by the 

end of the second year (for a chemical 

not on the TSCA Work Plan), followed 

by a final invoice at the conclusion of 

the risk evaluation, or a refund, if 

warranted. 

EPA is proposing this change to allow 

manufacturers to budget and better 

prepare for paying the manufacturerequested risk evaluation fees. These fee 

payments are in line with the estimated 

cost of a manufacturer-requested risk 

evaluation of approximately $5,671,000. 

EPA is requesting comments on the 

proposed modifications to the payment 

plan. 

EPA is also proposing changes to how 

EPA would allocate fees for EPAinitiated risk evaluations under TSCA 

section 6. Specifically, EPA is proposing 

to reallocate the remaining fee, after 

allocating the fees for small businesses, 

across the remaining manufacturers 

based on their percentage of total 

volume produced of that chemical 

minus the amount produced by the 

small businesses. This differs from the 

2018 Fee Rule allocation by considering 

volume produced. EPA believes this 

approach for calculating TSCA section 6 

fee allocations will result in a more 

representative distribution of fees and 

better account for the wide variation in 

production volume sometimes 

associated with a particular chemical 

substance. 

In any scenario where there is not a 

single consortium comprised of all 

manufacturers of the chemical 

undergoing the EPA-initiated risk 

evaluation, EPA would take the 

following steps to allocate fees: 

• 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 to 

generate a base fee. 

• 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% discount from the base fee 

referenced previously. 

• Calculate the total fee amount to be 

split among the total number of small 

manufacturers and distribute it based on 

their percentage of the average annual 

production volume from the four 

calendar years prior to the year 

certification was made. 

• Calculate the total remaining fee 

amount to be split among the total 

number of remaining manufacturers by 

subtracting out the discounted fees and 

the number of small businesses 

identified. 

• Reallocate the remaining fee across 

those remaining manufacturers based on 

their percentage of average annual 

production volume from the four 

calendar years prior to the year 

certification was made minus the 

amount produced by the small 

businesses, counting each manufacturer 

in a consortium as one person. 

EPA is not proposing these 

calculation and methodology changes 

for the fee allocations under TSCA 

section 4 activities. Fees for section 4 

activities are significantly lower than 

those for a risk evaluation and, 

therefore, less burdensome, obviating 

the need to allocate the fees based on 

production volume. 

TABLE 5—PROPOSED CHANGES TO TSCA SECTION 6(B) FEE ALLOCATIONS

2018 Fee rule 2020 Proposed fee rule 

In any scenario where there is not a single consortium comprised of all 

manufacturers of the chemical undergoing the EPA-initiated risk evaluation, EPA will take the following steps to allocate fees: 

In any scenario where there is not a single consortium comprised of all 

manufacturers of the chemical undergoing the EPA-initiated risk 

evaluation, EPA will take the following steps to allocate fees: 

• Count the total number of manufacturers, including the number 

of manufacturers within any consortia.

• 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.

• Divide the total fee amount by the total number of manufacturers to generate a base fee for the purpose of calculating the fee 

for small businesses. 

• 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% discount from the base fee referenced 

previously.

• 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% discount from the base fee referenced 

previously. 

• Calculate the total remaining fee and total number of remaining 

manufacturers by subtracting out the discounted fees and the 

number of small businesses identified.

• Calculate the total fee amount to be split among the total number of small manufacturers and distribute it based on their percentage of the average annual production volume from the four 

calendar years prior to the year certification was made. 

• Reallocate the remaining fee across those remaining individuals 

and groups in equal amounts, counting each manufacturer in a 

consortium as one person.

• Calculate the total remaining fee amount to be split among the 

total number of remaining manufacturers by subtracting out the 

discounted fees and the number of small businesses identified. 

• Reallocate the remaining fee across those remaining manufacturers based on their percentage of average annual production 

volume from the four calendar years prior to the year certification was made minus the amount produced by the small businesses, counting each manufacturer in a consortium as one person. 

EPA recognizes that the incorporation 

of production volume into the fee 

calculation methodologies changes the 

current relationship between individual 

small business fees and other 

manufacturer fees and may even result 

in some small businesses paying higher 

fees if they produce significantly more 

than other manufacturers, dependent on 


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the number of entities identified per feetriggering event and their production 

volume of that chemical substance. EPA 

is requesting comments on this 

proposed methodology, how it impacts 

the small business fee payments, and 

whether caps for fees for small business 

entities should be considered. 

EPA requests comment on the use of 

production volume and the 

methodology used in assigning fee 

amounts in TSCA section 6 activities. 

EPA is requesting comment on EPA’s 

proposed calculation using production 

volume to determine fee allocations 

(i.e., the average annual production 

volume from the four calendar years 

prior to the year certification was made). 

Additional information on the fee 

amounts can be found in Unit III.G. 

Lastly, EPA is proposing 

modifications to the time allowed for 

payment established under the 2018 Fee 

Rule for EPA-initiated risk evaluation 

fees, enabling the fee payer to pay in 

installments. This proposed change 

includes a two-payment process—first 

payment of 50% to be due 180 days 

after EPA publishes the final scope of a 

chemical risk evaluation and the second 

payment for the remainder no later than 

545 days after EPA publishes the final 

scope of a chemical risk evaluation. EPA 

believes that a two-payment process 

will reduce the burden on fee payers 

and allow them to have more money on 

hand for operating and other expenses 

that are incurred between payments. 

2. Description of the Primary Alternative 

Regulatory Action Considered 

EPA is requesting comment on 

alternative approaches for calculating 

average volume and assigning fees based 

on volume produced. For example, EPA 

could calculate fees based on average 

volume over the last five years or based 

on the most recent year of reporting. 

Alternatively, EPA could use 

production volume ranges and calculate 

fees based on those ranges. In addition, 

EPA has considered caps for fee payers, 

including those that qualify as a ‘‘small 

business concern.’’ However, EPA 

believes imposing a cap on fees for 

individual entities could result in EPA 

not collecting the full cost associated 

with that risk evaluation. EPA requests 

comment on alternative approaches for 

calculating and assigning fees based on 

production volume. 

C. Fee Categories 

EPA has eight distinct fee categories: 

(1) Test orders, (2) test rules and (3) 

ECAs, all under TSCA section 4; (4) 

notices and (5) exemptions, both under 

TSCA section 5; and (6) EPA-initiated 

risk evaluations, (7) manufacturerrequested risk evaluations for chemicals 

on the TSCA Work Plan, and (8) 

manufacturer- requested risk 

evaluations for chemicals not on the 

TSCA Work Plan, all under TSCA 

section 6. The activities in these 

categories are fee-triggering events that 

result in obligations to pay fees under 

the 2018 Fee Rule. EPA is proposing 

three additional categories, as discussed 

in the following subsections of this unit. 

If a recipient of a test order fails to 

follow terms or conditions in the order, 

including testing protocols outlined in 

TSCA section 4, EPA may give the test 

order recipient the option to redo the 

testing and submit the new data. Under 

the current rule, the Agency would 

incur extra costs from reviewing this 

resubmitted data, costs that would not 

be accounted for via the original fee 

payment by the recipient of the test 

order. To address this, EPA is proposing 

to create a new fee for test orders 

payable by recipients that elect to 

resubmit data per request of the Agency 

if EPA determines that the recipient did 

not comply with the terms or conditions 

of the order, such as the testing 

protocols, or if a company later 

determines that data submitted under a 

testing order is incomplete, 

inconsistent, or deficient. As presented 

in the Economic Analysis (Ref. 4), EPA 

estimated that 10 test orders will be 

issued annually with one being 

amended. EPA requests public comment 

on these estimates. EPA also requests 

public comment on whether this new 

fee will incentivize companies to 

correctly follow section 4 test order 

guidelines. 

Companies that do not comply with 

section 4 test orders may be subject to 

enforcement action by EPA. If a 

company does not comply with the 

terms or conditions of the test order but 

subsequently resubmits the data 

required under the testing order, EPA is 

proposing to charge a fee associated 

with the submission of the new testing 

data. This new fee would be equal to the 

initial fee levied on the recipient of the 

initial test order. EPA is proposing 

changes to the regulations so that any 

submission of data intended to comport 

with a test order for which the order 

recipient was found to be in 

noncompliance. Additional fees will be 

levied on companies which 

subsequently resubmit such data, each 

time they resubmit the data until EPA 

determines that the testing is consistent 

with the requirements of the original 

test order and the data are acceptable for 

purposes of the data need identified in 

the order. Because of the amount of time 

it takes for a testing order to be issued 

and implemented (upwards of one year), 

levying a fee for this purpose would 

further incentivize companies to fully 

understand and follow the terms and 

conditions of the order, including 

testing guidelines under section 4. 

Additionally, EPA is correcting an 

error with the section 4 fees of the 2018 

Fee Rule regulations in which the fees 

for test orders and test rules were 

reversed. The amount of the fees that 

would be charged under section 4 was 

incorrect in the regulations, making the 

distinctions between test rule and test 

order fees unclear. In this proposal, EPA 

is proposing changes in the regulatory 

language to reflect the correct fees for 

test orders and test rules. 

Under regulations implementing 

TSCA section 5, a company that intends 

to manufacture (including import) a 

chemical substance not listed by 

specific chemical name in the public 

portion of the TSCA Inventory may 

submit a Bona Fide Intent to 

Manufacture or Import Notice (‘‘bona 

fide notice’’) to obtain written 

determination from EPA whether the 

chemical substance is included in the 

confidential Inventory (40 CFR 720.25). 

The costs of the review process for bona 

fide notices were not recovered under 

the 2018 Fee Rule. To recover the costs 

of reviewing bona fide notices, EPA is 

proposing changes to the regulations to 

require a fee for bona fide notices. EPA 

requests public comment on whether 

these fees for bona fide notices will 

result in a more equitable allocation of 

fees. 

TSCA section 26(b)(1) states that 

‘‘[t]he Administrator may, by rule, 

require the payment from any person 

required to submit . . . a notice or other 

information to be reviewed by the 

Administrator under section [5], . . . of 

a fee that is sufficient and not more than 

reasonably necessary to defray the cost 

related to such chemical substance of 

administering section[ 5] . . .’’ Bona 

fide notices submitted under regulations 

that are part of EPA’s implementation of 

section 5. EPA is proposing to utilize its 

authority under section 26(b)(1) to 

collect section 5 fees for bona fide 

notices. Assessing a fee for bona fide 

notices will allow allocation of fees that 

will more equitably account for the 

costs of carrying out all relevant section 

5 activities. The proposed fee amount 

for a bona fide notice is $500 and $90 

for small businesses. 

After PMN review has been 

completed under TSCA section 5, the 

submitters of the PMN must provide a 

Notice of Commencement of 

Manufacture or Import (NOC) to EPA 

within 30 calendar days of the date the 

chemical substance is first 

manufactured or imported for 


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nonexempt commercial purposes (40 

CFR 720.102). Once a complete NOC is 

received by EPA, the reported chemical 

substance is considered to be on the 

TSCA Inventory and becomes an 

existing chemical. 

As described in Unit II.C., under the 

2018 Fee Rule, EPA grouped the costs 

associated with NOCs with those of 

PMNs, MCANs, and SNUNs. EPA is 

proposing changes to the 2018 Fee Rule 

to include a separate fee for NOC 

submissions. TSCA section 26(b)(1) 

states that ‘‘[t]he Administrator may, by 

rule, require the payment from any 

person required to submit. . .a notice or 

other information to be reviewed by the 

Administrator under section [5], . . . of 

a fee that is sufficient and not more than 

reasonably necessary to defray the cost 

related to such chemical of 

administering section [5] . . .’’ NOC 

submissions are part of EPA’s 

implementation of section 5; they 

ensure that chemical substances 

manufactured after TSCA section 5(a)(3) 

review appear on the TSCA Inventory. 

EPA is proposing to utilize its authority 

under section 26(b)(1) to collect section 

5 fees for NOC submissions. NOC fees 

will help defray the costs of reviewing, 

processing, and retaining NOC records 

and the costs of registering the chemical 

substance with the Chemical Abstract 

Service. The proposed fee amount for 

NOC submissions is $500 and $90 for 

small businesses. 

D. Entities Subject to Fees 

The 2018 Fee Rule applies to 

manufacturers and processors who are 

required to submit information under 

TSCA section 4, manufacturers and 

processors who submit certain notices 

and exemptions under TSCA section 5, 

and to manufacturers who are subject to 

risk evaluation under TSCA section 

6(b), including manufacturers who 

submit requests for risk evaluation 

under TSCA section 6(b)(4)(C)(ii). 

EPA is proposing modifications to 

certain groups of manufacturers subject 

to TSCA section 6 fee activity 

requirements; including the addition of 

manufacturers that exclusively export 

chemicals subject to EPA-initiated risk 

evaluations whenever such chemical 

substances are manufactured, processed, 

or distributed in commerce (by any 

other entity) for any purpose other than 

export from the United States, as well as 

five additional exclusions to entities 

subject to the fees for TSCA section 6 

activities. 

1. Description of the Proposed 

Regulatory Action 

EPA is proposing to add 

manufacturers that exclusively export 

chemicals subject to EPA-initiated risk 

evaluations whenever such chemical 

substances are manufactured, processed, 

or distributed in commerce (by any 

other entity) for any purpose other than 

export from the United States. This 

change recognizes that manufactures 

that exclusively export High-Priority 

Substances are part of the risk 

evaluation process and should, 

therefore, share in defraying the cost of 

EPA-initiated risk evaluations. This 

regulatory action remains consistent 

with TSCA section 12(a)(1). 

Specially, TSCA section 12(a)(1) 

states that except as provided in 

paragraph (2) and subsections (b) and 

(c), TSCA (other than TSCA section 8) 

‘‘shall not apply to any chemical 

substance, mixture, or to an article 

containing a chemical substance or 

mixture, if—(A) it can be shown that 

such substance, mixture, or article is 

being manufactured, processed, or 

distributed in commerce for export from 

the United States, unless such 

substance, mixture, or article was, in 

fact, manufactured, processed, or 

distributed in commerce, for use in the 

United States, and (B) such substance, 

mixture, or article (when distributed in 

commerce), or any container in which it 

is enclosed (when so distributed), bears 

a stamp or label stating that such 

substance, mixture, or article is 

intended for export.’’ 

TSCA section 12(a) exempts 

manufacturers from TSCA coverage only 

when such substance, mixture, or article 

is being manufactured, processed, or 

distributed in commerce solely for 

export from the United States. EPA does 

not anticipate that this exemption 

would generally apply to chemical 

substances designated as High-Priority 

Substances for risk evaluation since 

those chemical substances are 

anticipated to have a range of conditions 

of use outside of export-only 

manufacture, processing, and 

distribution. EPA acknowledges the 

ambiguity of this aspect of TSCA section 

12(a) and believes the statutory context 

here (i.e., fee collection for risk 

evaluations for under TSCA section 

6(b)) supports interpreting the exportonly exemption narrowly. Therefore, 

export-only manufacturers of such 

chemical substances will be subject to 

fee payment obligations under this 

proposal. 

EPA is also proposing to exclude 

certain manufacturers from EPAinitiated risk evaluation fee 

requirements. On January 27, 2020, EPA 

released the preliminary list of 

manufacturers subject to fee payments 

for manufacture of chemicals subject to 

EPA-initiated risk evaluations and 

received significant stakeholder 

feedback regarding the practicalities of 

self-identifying under the TSCA Fee 

Rule given its broad definition of 

‘‘manufacture.’’ As stated in EPA’s 

memorandum issued on March 18, 

2020, concerns were raised regarding fee 

payment obligations for ‘‘importers of 

articles containing any one of the 

twenty listed chemicals . . .’’ and that 

these entities ‘‘could potentially be 

required to test thousands of imported 

articles and [it]would be difficult if not 

impossible to complete in the time 

allotted for self-identification under the 

TSCA Fee Rule’’ (Ref. 3). EPA 

recognizes that manufacturers of 

chemicals as byproducts or impurities 

may face similar challenges to 

pinpointing and tracking when 

impurities and byproducts are 

produced, particularly because the 

‘manufacture’ of even very small 

amounts of a high-priority chemical 

triggers the TSCA Fee Rule requirement 

to self-identify. 

In response to these concerns, EPA 

recognized that the current TSCA Fee 

Rule may unintentionally impose 

potentially significant burdens on three 

categories of manufacturers, causing 

compliance challenges with selfidentification and inconsistencies with 

other TSCA regulatory contexts (Ref. 3). 

EPA also announced its plan to consider 

a proposed rule that would look at 

potential exemptions to the TSCA Fee 

Rule in response to stakeholder 

concerns about implementation 

challenges. Consequently, EPA proposes 

to exempt these three categories of 

manufacturers from EPA-initiated Risk 

Evaluation fees and associated 

regulatory requirements: (1) Importers of 

articles containing a chemical substance 

subject to an EPA-initiated risk 

evaluation; (2) manufacturers of a 

substance subject to an EPA-initiated 

risk evaluation that is produced as a 

byproduct; and (3) manufacturers 

(including importers) of a substance 

subject to an EPA-initiated risk 

evaluation that is produced or imported 

as an impurity. More information on 

byproducts and impurities can be found 

here: https://www.epa.gov/tsca-fees/ 

frequent-questions-about-tsca-fees-epainitiated-risk-evaluations. 

EPA is also proposing to exempt 

manufacturers of a substance subject to 

an EPA-initiated risk evaluation that is 

produced as a non-isolated 

intermediate. A non-isolated 

intermediate, as defined in 40 CFR part 

704.3, referenced by 40 CFR part 711.3., 

is ‘‘any intermediate that is not 

intentionally removed from the 

equipment in which it is manufactured, 

including the reaction vessel in which 


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it is manufactured, equipment which is 

ancillary to the reaction vessel, and any 

equipment through which the substance 

passes during a continuous flow 

process, but not including tanks or other 

vessels in which the substance is stored 

after its manufacture. Mechanical or 

gravity transfer through a closed system 

is not considered to be intentional 

removal, but storage or transfer to 

shipping containers isolates the 

substance by removing it from process 

equipment in which it is 

manufactured.’’ 

EPA believes exempting 

manufacturers of substances produced 

as a non-isolated intermediate is 

consistent with other TSCA programs, 

including the Chemical Data Reporting 

(CDR) described in 40 CFR 711.10(c) 

and the TSCA section 5 notice 

requirements described in 40 CFR 

720.30. 

In addition, EPA is proposing an 

exemption from EPA-initiated risk 

evaluation fees and associated 

regulatory requirements for 

manufacturers (including importers) of 

small quantities of a chemical solely for 

research and development, as to be 

defined in 40 CFR 700.43. Small 

quantities solely for research and 

development is defined to mean 

quantities of a chemical substance 

manufactured, imported, or processed 

or proposed to be manufactured, 

imported, or processed solely for 

research and development that are not 

greater than reasonably necessary for 

such purposes. This exemption will 

avoid imposing burdensome costs to 

those manufacturers of small quantities 

of a chemical solely for research and 

development, given the critical 

importance of this activity to the 

detection, quantification and control of 

chemical substances. Manufacturers that 

meet the research and development 

exemption must meet it for the five-year 

period preceding publication of the 

preliminary list and meet it in the 

successive five years. 

Finally, EPA is proposing an 

exemption from EPA-initiated risk 

evaluation fees and associated 

regulatory requirements for entities that 

manufacture (including import) a 

chemical substance in quantities not to 

exceed 2,500 lbs. This limit is consistent 

with requirements in the CDR described 

in 40 CFR 711.8(b) and 40 CFR 711.15, 

where the reporting threshold is 2,500 

lbs. (1,134 kg) for any person who 

manufactured a chemical substance that 

is the subject of certain rules, orders, or 

relief under TSCA section 5, 6, and 7. 

This exception does not apply if all 

manufacturers of a chemical substance 

manufacture that chemical in quantities 

below a 2,500 lbs. annual production 

volume. EPA is proposing this 

exemption to reduce the burden on 

entities producing small amounts of the 

chemical substance undergoing an EPAinitiated risk evaluation. 

EPA is not proposing a concentrationbased exemption. EPA believes the 

exemption should be based on the 

amount of a chemical instead of the 

concentration to ensure that the 

exemption only applies to the 

manufacture of small quantities of a 

chemical. A concentration-based 

exemption could result in 

manufacturers of large quantities of 

chemicals being exempt from fee 

obligations. For this reason, EPA’s 

proposal contains an exemption based 

on a volume limit. EPA requests public 

comment on the previously discussed 

exemptions, any other exemptions that 

EPA should consider, and any data 

related to potential impacts. 

Manufacturers of a chemical 

substance undergoing TSCA section 6 

EPA-initiated risk evaluations that 

would meet one or more of the 

exemptions previously discussed for the 

five-year period preceding publication 

of the preliminary list and would meet 

one of more of the exemptions in the 

successive five years would be exempt 

from fee those payment requirements. 

This five-year period is consistent with 

the current criteria under the 2018 

TSCA Fees rule for certification of 

cessation. 

2. Description of the Primary 

Alternative Regulatory Action 

Considered 

EPA has considered an alternative 

regulatory action of no exemptions and 

requests comment on this approach. 

TSCA requires EPA to evaluate 

chemicals under their conditions of use, 

and conditions of use evaluated may 

involve manufacture of chemicals that 

are exempt under this proposal 

including impurities or byproducts, 

chemicals imported in articles, or 

chemicals in small amounts solely for 

the purposes of research and 

development. In addition, EPA does not 

consider these exemptions in 

designating chemical substances as high 

priority substances for risk evaluation, 

and there may be chemicals designated 

where that chemical’s primary 

condition of use is covered under one of 

the five exemptions listed within this 

Unit, resulting in little to no 

manufacturers obligated to pay the fee. 

This could result in higher fees for 

entities that do not meet the exemption 

or no fee payments for a chemical 

substance risk evaluation. 

E. Self-Identification 

1. Description of the Proposed 

Regulatory Action 

Under the 2018 Fee Rule, after the 

close of a comment period for the 

preliminary list of manufacturers 

subject to a fee obligation for chemicals 

subject to EPA-initiated risk 

evaluations, EPA makes any associated 

updates or corrections, and then 

publishes a final list of manufacturers. 

This list indicates if any manufacturers 

were identified in error, if any 

additional manufacturers were 

identified through the comment period 

and/or reporting form, and if any 

manufacturers certified that they have 

already ceased manufacture prior to the 

applicable cutoff date described in the 

regulations and will not manufacture 

the subject chemical substance for five 

years into the future. The final list is 

published concurrently with the final 

scope document for risk evaluations 

initiated by EPA under TSCA section 6, 

and with the final test rule under TSCA 

section 4. Currently, there is no added 

flexibility to modify the list of fee 

payers in the event of receipt of 

additional information after publication 

of the final list. 

EPA is proposing added flexibility to 

allow for potential changes to the list of 

fee payers after it is finalized. 

Specifically, EPA is proposing to allow 

for modification of the list upon receipt 

of information indicating that such a 

change is warranted. 

EPA believes that this proposed 

process is largely consistent with 

comments on the 2018 Proposed Fee 

Rule (83 FR 8212) requiring EPA to 

publish a preliminary list and engage 

with stakeholders to identify others who 

may be missing, correct errors, and 

provide an opportunity for 

manufacturers to be removed from the 

list under certain circumstances. 

In addition, EPA has received 

industry stakeholder feedback regarding 

the identification of manufacturers on 

the preliminary and final list of 

manufacturers subject to fees for the 20 

high priority substances undergoing 

TSCA risk evaluations. Stakeholders 

recommended EPA create an avenue for 

manufacturers to identify other 

manufacturers that may be subject to 

these fees not present on the 

preliminary list of fee payers. EPA 

appreciates this feedback but is not 

proposing changes to the issuance of a 

preliminary list followed by a public 

comment period. EPA believes this 

process (i.e., publication of a 

preliminary list that identifies 

manufacturers, a public comment 

period, and publication of a final list 


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defining the universe of manufacturers 

responsible for payment) allows for selfidentification, correction of errors, and 

certification of no-manufacture and no 

intention to manufacture in the next five 

years. EPA also plans to continue 

communication with manufacturers and 

importers that contact EPA with 

questions or concerns. Manufacturers 

may also utilize the existing EPA portal 

to report a tip or complaint to EPA, 

found here https://www.epa.gov/ 

enforcement/report-environmentalviolation-general-information, including 

to report manufacturers once the final 

list of manufacturers subject to the fees 

is published. 

EPA is also proposing changes to the 

submission of self-identification 

information in 40 CFR 700.45 to 

accompany the proposed changes to the 

TSCA section 6 fee activities as well as 

changes to which types of 

manufacturers are required to selfidentify. These changes include 

exempting manufacturers that meet the 

criteria of three of the exemptions 

discussed in Unit III.D. (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. 

Additionally, EPA is proposing to 

require manufacturers of small 

quantities solely for research and 

development and those that 

manufacture in quantities not to exceed 

2,500 lbs., and manufacturers of 

chemical substances produced as a nonisolated intermediate to certify that they 

meet those exemption criteria. EPA is 

also proposing to require all other nonexempted manufacturers to provide the 

volume produced by that manufacturer 

for the subject chemical. More 

discussion on the use of production 

volume in the methodology for 

calculating fees is in Unit III.B. EPA is 

also proposing to require all 

manufacturers that self-identify as 

meeting the production volume 

exemption of 2,500 lbs. to maintain 

production volume records related to 

compliance with the exemption. EPA is 

also proposing to require those 

manufacturers of substances produced 

as a non-isolated intermediate to 

maintain ordinary business records 

related to compliance with this 

exemption criteria. Additionally, EPA is 

proposing that all manufacturers that 

self-identify as meeting the research and 

development exemption maintain 

ordinary business records related to 

compliance, such as plans of study, 

information from research and 

development notebooks, study reports, 

or notice solely for research and 

development use. EPA is proposing that 

these required records be kept for a 

period of five years. EPA has authority 

under section 6 to require reporting and 

recordkeeping related to the regulatory 

requirements imposed by EPA under 

section 6. This is particularly important 

where, as here, such records and reports 

are necessary for effective enforcement 

of the section 6 rule. 

2. Description of the Primary 

Alternative Regulatory Action 

Considered 

EPA has considered an alternative 

regulatory approach of allowing 

manufacturers that had previously 

certified cessation, as described in 40 

CFR 700.45 (b)(5)(ii), to then begin 

manufacturing or importing that 

chemical within the successive five-year 

period. Those manufacturers would be 

required to pay their portion of the fee 

associated with that chemical substance 

risk evaluation, but it would occur after 

the initial invoicing period. EPA 

believes this would result in a 

substantial increase in burden to EPA, 

allowing continued changes to those 

entities responsible for paying the EPAinitiated risk evaluation fees after the 

initial invoicing period. In addition, 

EPA believes this may result in inequity 

between those manufacturers paying the 

fees at the time of initial invoicing and 

those companies being allowed to opt 

back in any time after that period. 

Therefore, EPA is not proposing changes 

to the five-year period associated with 

the certification of cessation. As 

currently drafted, a manufacturer may 

certify cessation if it has ceased 

manufacturing prior to the certification 

cutoff dates and will not manufacture 

the substance again in the successive 

five years. Manufacturers that have 

certified cessation for a substance that 

then manufacture that substance again 

within the successive five years would 

be engaging in a prohibited act under 

TSCA section 15(1) and therefore would 

be subject to a penalty under TSCA 

section 16. Nonetheless, EPA is 

requesting comment on a regulatory 

approach that would allow 

manufacturers that previously certified 

cessation to begin manufacturing or 

importing the chemical within the 

successive five-year period. EPA is 

particularly interested in suggestions for 

decreasing the burden associated with 

allowing changes to manufacturing 

status (including potential recalculation 

and reimbursement of fees to 

manufacturers that were subject to 

initial fee payments) and comments 

from entities that might be subject to 

initial payments and therefore potential 

inequities. 

Additionally, alternatives were 

considered in regard to EPA’s authority 

to collect fees from processors under 

section 4 and 6 of TSCA. Although EPA 

has authority to collect fees from both 

manufacturers and processors of 

chemical substances, the 2018 Fee Rule 

and this subsequent update focus fee 

collection primarily on manufacturers. 

EPA will collect fees from processors 

only when processors submit a SNUN or 

test-marketing exemptions (TME) under 

section 5, when a section 4 activity is 

tied to a SNUN submission by a 

processor, or when a processor 

voluntarily joins a consortium and 

therefore agrees to provide payment as 

part of the consortium. This approach is 

consistent with most comments 

received during the 2018 Fee Rule. EPA 

believes the allocation primarily to 

manufacturers, and, in limited 

circumstances, to processors, is an 

appropriate balance of the authorities 

provided by TSCA. As stated in past 

rules and notices, the effort of trying to 

identify relevant processors for all feetriggering actions would be overly 

burdensome and EPA expected that 

many processors would be missed. 

Generally limiting fee obligations to 

manufacturers is the simplest and most 

straightforward way to assess fees for 

conducting risk evaluations under 

TSCA section 6 and most TSCA section 

4 testing activities. Furthermore, EPA 

expects that manufacturers required to 

pay fees will have a better sense of the 

universe of processors and will pass 

some of the costs on to them. 

F. Timing 

The 2018 Fee Rule generally requires 

upfront 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 manufacturerrequested risk evaluation, and within 

120 days of publishing the final scope 

of a risk evaluations). However, for 

manufacturer-requested risk 

evaluations, payment is collected in two 

installments over the course of the 

activity. EPA is proposing several 

changes to the timing of specific stages 

within this fees process. These are 

summarized in table 6 and discussed in 

more detail throughout this unit. 


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TABLE 6—PROPOSED CHANGES TO TIMING WITHIN THE FEE RULE * 

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

Payment of fees ............................ Initial payment within 30 days of EPA providing notice of granting a manufacturer- requested risk 

evaluation. Payment is collected in two installments over the course of the activity.

Initial payment within 180 days of EPA providing notice of granting a manufacturer- requested risk 

evaluation. Payments are collected over three installments. 

For EPA-initiated risk evaluations, payment is collected in one installment 120 days after EPA publishes the final scope of a chemical risk evaluation.For EPA-initiated risk evaluation, payment is collected over two installments, the first payment of 

50% to be due 180 days after EPA publishes the 

final scope of a chemical risk evaluation and the 

second payment due not later than 545 days after 

EPA publishes the final scope of a chemical risk 

evaluation. 

Consortia ....................................... 60 days to notify EPA of intent to form a consortium 

from the triggering event.

90 days to notify EPA of intent to form a consortium 

from the triggering event. 

Currently, manufacturers have 60 

days to notify EPA of their intent to 

form a consortium from the triggering 

event, and 120 days total from the 

triggering event for payment. EPA is 

proposing to allow manufacturers 

subject to test orders, test rules, ECAs 

and EPA-initiated risk evaluations 

additional time to associate with a 

consortium and work out fee payments 

within that consortium. Specifically, 

EPA is proposing to extend the amount 

of time for manufacturers to notify EPA 

of their intent to form a consortium to 

90 days. EPA believes this additional 

time will be useful for businesses to 

financially plan for the additional 

expense. 

For EPA-initiated risk evaluations, 

full payment is currently due within 

120 days of EPA publishing the final 

scope of a chemical risk evaluation. EPA 

is proposing to extend that first payment 

timeline to 180 days and to provide for 

payment to be made in two installments 

instead of one, as discussed in Unit 

III.B. EPA is also proposing an extension 

to the amount of time for these 

manufacturers to join a consortium, 

from 60 days to 90 days to notify EPA 

of their intent. EPA believes this 

additional time will assist 

manufacturers with the process of 

joining a consortium, if they so choose, 

and deciding on the partial fee 

payments each member of the 

consortium will be responsible for. 

Manufacturers will have ample warning 

that a risk evaluation is underway, well 

before the final scope is published in 

the Federal Register. For manufacturerrequested risk evaluations, EPA is 

proposing that the initial payment be 

made 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 

as indicated in Unit III.B. of the 

proposed rule. 

G. Fee Amounts 

Because the eight existing fee 

categories and three additional fee 

categories do not span all of the relevant 

activities under TSCA sections 4, 5, and 

6 and relevant information management 

activities (e.g., costs of administering 

TSCA section 14, risk management 

activities under section 6, prioritization 

of chemicals for evaluation, support for 

alternative testing and methods 

development and enhancement), EPA is 

proposing fee amounts to ensure these 

costs would be captured. 

As discussed in Unit II, EPA must 

recover 25% of the costs related to the 

relevant activities under of TSCA 

sections 4, 5, 6 and 14. EPA did not 

propose changes to the fees associated 

with TSCA section 4 and 5 established 

under the 2018 Fees Rule. EPA is, 

however, proposing higher fees for 

TSCA section 6 activities. The 

proportion (in percentage) of the 

estimated cost of the activity is higher 

for TSCA section 6 fees to ensure EPA 

is recovering the required 25% of the 

total cost for implementing the relevant 

sections of TSCA. Additional 

justification for each TSCA section is 

discussed within this Unit. EPA 

requests public comment on this 

approach with higher fees for section 6 

activities and no changes to section 4 

and 5 fees established under the 2018 

Fees Rule. 

1. Fee Amounts for TSCA Section 4 

Activities 

EPA issues three fee amounts—one 

for each of the TSCA section 4 fee 

categories: Test orders, test rules and 

ECAs. As proposed, the fees for section 

4 activities amount to approximately 

4.1% of the total estimated activity cost. 

The lower fee relative to program costs 

takes into account that manufacturers 

will be responsible for paying to 

develop the test information in addition 

to paying the TSCA fee and is reflected 

in assigning lower proposed fee 

amounts. EPA is not proposing changes 

to the section 4 fees established under 

the 2018 Fees Rule at this time. 

However, EPA may modify these in the 

future with more implementation 

experience. 

2. Fee Amounts for TSCA Section 5 

Activities 

EPA currently issues two fee amounts 

for TSCA section 5 activities—one for 

notices (PMNs, SNUNs and MCANs), 

and one for exemptions (LVEs, LoREX, 

TME, Tier II, TERA and film articles). 

EPA is proposing two additional fee 

amounts for bona fide notices and 

NOCs. As proposed, the fees for section 

5 activities amount to approximately 

13% of the estimated cost of the 

activities. EPA is currently working on 

process improvements for the review of 

section 5 submissions, which are 

anticipated to lower agency costs. Since 

EPA does not want to stifle economic 

development in the chemical industry, 

EPA is not proposing changes to the 

section 5 fees established under the 

2018 Fees Rule at this time. However, 

EPA may modify these in the future 

with more implementation experience. 

3. Fee Amounts for TSCA Section 6 

Activities 

EPA issues one fee amount for EPAinitiated risk evaluations at 

approximately 35% of the estimated 

cost of the activity. EPA takes an actual 

cost approach for manufacturerrequested risk evaluations, whereby the 

requesting manufacturer (or requesting 

consortia of manufacturers) would be 

obligated to pay either 50% or 100% of 

the actual costs of the activity, 

depending on whether or not the 

chemical was listed on the TSCA Work 

Plan, respectively. 

Due to the increases to TSCA section 

6 program cost estimates, decreases in 

the activity assumptions for TSCA 

section 5 submissions, early feedback 


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received from industry stakeholders 

during the 2018 rulemaking, and to 

ensure EPA is able to defray 25% of the 

Agency’s costs, EPA is proposing higher 

fees for TSCA section 6 activities (Ref. 

2; Ref. 4). 

The proposed fee amounts are 

described in Table 7. EPA is requesting 

comment on the changes discussed in 

Unit II.C. 

TABLE 7—PROPOSED CHANGES TO TSCA FEE AMOUNTS

Fee category 2018 fee rule 2020 Proposed fee rule 

TSCA section 4: 

Test order .................................................... $9,800 .............................................................. $9,800. 

Amended test order .................................... $0 ..................................................................... $9,800. 

Test rule ...................................................... $29,500 ............................................................ $29,500. 

Enforceable consent agreement ................. $22,800 ............................................................ $22,800. 

TSCA section 5: 

PMN and consolidated PMN, SNUN, 

MCAN and consolidated MCAN.

$16,000 ............................................................ $16,000. 

LoREX, LVE, TME, Tier II exemption, TERA, 

Film Articles.

$4,700 .............................................................. $4,700. 

Bona Fide Notice ................................................ $0 ..................................................................... $500. 

Notice of Commencement .................................. $0 ..................................................................... $500. 

TSCA section 6: 

EPA-initiated risk evaluation ....................... $1,350,000 ....................................................... $2,560,000. 

Manufacturer-requested risk evaluation on 

a chemical included in the TSCA Work 

Plan.

Initial payment of $1.25M, with final invoice to 

recover 50% of Actual Costs.

Two payments of $945,000, with final invoice 

to recover 50% of Actual Costs. 

Manufacturer-requested risk evaluation on a 

chemical not included in the TSCA Work 

Plan.

Initial payment of $2.5M, with final invoice to 

recover 100% of Actual Costs.

Two payments of $1.89M, with final invoice to 

recover 100% of Actual Costs. 

4. Fee Amounts for Small Businesses 

The proposed fee amounts for small 

businesses summarized in Table 8 

represent an approximate 80% 

reduction compared to the proposed 

base fee for each category. In one case, 

for TSCA section 5 notices (i.e., PMNs, 

MCANs and SNUNs), the small business 

reduction is 82.5%. For all fee 

categories, the proposed reduced fee is 

only available when the only entity or 

entities are small businesses, including 

when a consortium is paying the fee and 

all members of that consortium are 

small businesses. Consistent with the 

2018 Fee Rule, reduced fees are not 

available for small business 

manufacturers requesting a risk 

evaluation, as TSCA requires those fees 

to be set at a specific percentage of the 

actual costs of the activity. 

These discounts were established in 

the 2018 Fees Rule and were the result 

of stakeholder input. EPA believes the 

approximate 80% discount in the 2018 

Fee Rule is appropriate and that the 

discount is generally in line with EPA’s 

discount for small businesses in the 

pesticides program (i.e., 75%), but 

slightly higher based on significant 

stakeholder input regarding the need to 

minimize impacts on small businesses. 

EPA is not proposing changes to these 

discounts. 

EPA is requesting comment on the 

small business discount as it relates to 

the proposed volume-based fee 

calculations changes discussed in Unit 

III.B. 

TABLE 8—PROPOSED CHANGES TO TSCA FEE AMOUNTS FOR SMALL BUSINESSES

Fee category 2018 fee rule 2020 Proposed fee rule 

TSCA section 4: 

Test order .................................................... $1,950 .............................................................. $1,960. 

Amended test order .................................... $0 ..................................................................... $1,960. 

Test rule ...................................................... $5,900 .............................................................. $5,900. 

Enforceable consent agreement ................. $4,600 .............................................................. $4,600. 

TSCA section 5: 

PMN and consolidated PMN, SNUN, 

MCAN and consolidated MCAN.

$2,800 .............................................................. $2,800. 

LoREX, LVE, TME, Tier II exemption, 

TERA, Film Articles.

$940 ................................................................. $940 

Bona Fide Notice ........................................ $0 ..................................................................... $90. 

Notice of Commencement ........................... $0 ..................................................................... $90. 

TSCA section 6: 

EPA-initiated risk evaluation ....................... $270,000 .......................................................... $512,000.

Manufacturer-requested risk evaluation on 

a chemical included in the TSCA Work 

Plan..

$1,250,000 initial payment + 50% of total actual costs.Two payments of $945,000 with final invoice 

to recover 50% of actual costs. 

Manufacturer-requested risk evaluation on 

a chemical not included in the TSCA 

Work Plan.

$2,500,000 initial payment + 100% of total actual costs.Two payments of $1.89M with final invoice to 

recover 100% of actual costs. 


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5. Description of the Primary 

Alternative Regulatory Action 

Considered 

EPA has considered an alternative 

regulatory action where the fees remain 

unchanged except for an adjustment for 

inflation. In the absence of any 

substantive adjustments or updates, the 

2018 TSCA Fees Rule provides for 

adjusting the fee structure of the current 

period (fiscal years 2019–2021) 

according to inflation rate, in setting a 

fee structure for the next period. This 

adjustment occurs automatically if no 

other updates are put forth by EPA. EPA 

has considered this regulatory 

alternative, but has found it unsuitable, 

because it would not recoup the 

statutorily required 25% of estimated 

EPA costs for TSCA related actions. EPA 

requests public comment on this 

approach. 

IV. Projected Economic Impacts 

EPA has evaluated the potential costs 

for entities potentially subject to this 

proposed rule. More details can be 

found in the Economic Analysis (Ref. 4). 

For the baseline, EPA used the number 

of section 5 submissions received in 

FY2019 and 2020 for each of the types 

of fee-triggering section 5 categories to 

estimate the number of submissions per 

section 5 fee category for the next three 

years in the absence of the rule. The 

average numbers of test orders, test 

rules, and ECAs per year represent an 

EPA estimate based on previous 

experience and expected work under 

TSCA as amended. Amended TSCA 

specifies the minimum number of risk 

evaluations that EPA must have ongoing 

over the next three years. The Agency 

expects to have between 20 and 30 risk 

evaluations ongoing in any given year at 

different stages in the review process, 

including manufacturer-requested 

evaluations. 

Various alternative fee structures were 

considered in the original fee rule but 

are not being revisited in this proposal. 

This proposed rule would establish a 

few new fees and would revise existing 

fee levels based on actual cost 

information and updated estimates but 

would not re-open the fee structure. 

EPA also requests public comment on 

this approach. 

EPA calculated fees by estimating the 

total annual costs of administering 

relevant activities under TSCA sections 

4, 5, and 6 (excluding the costs of 

manufacturer-requested risk 

evaluations) and relevant information 

management activities; identifying the 

full amount to be defrayed by fees under 

TSCA section 26(b) (i.e., 25% of those 

annual costs); and allocating that 

amount across the fee-triggering events 

in sections 4, 5, and 6, weighted more 

heavily toward section 6 based on 

industry feedback on the 2018 Fees Rule 

Proposal. EPA estimates the total fee 

collection by multiplying the fees with 

the number of expected fee-triggering 

events under full implementation for 

each fee category, for a total of 

approximately $22 million in average 

annual fee revenue. This total does not 

include the fees collected for 

manufacturer-requested risk 

evaluations. EPA estimates that section 

4 fees account for less than one percent 

of the total fee collection, section 5 fees 

for approximately 25 percent, and 

section 6 fees for approximately 74 

percent. 

Total annual fee collection for 

manufacturer-requested risk evaluations 

is estimated to be $1.9 million for 

chemicals included in the TSCA Work 

Plan (based on two requests over the 

three- year period) and approximately 

$5.67 million for chemicals not 

included in the TSCA Work Plan (based 

on three requests over the three-year 

period). 

For small businesses, EPA estimates 

that 35 percent of section 5 submissions 

will be from small businesses that are 

eligible to pay the small business fee 

because they are classified as small 

businesses based on the SBA small 

business thresholds. 

Total annualized fee collection from 

small businesses submitting notices 

under section 5 is estimated to be 

$411,000 (Ref. 4). For sections 4 and 6, 

reduced fees paid by eligible small 

businesses and fees paid by non-small 

businesses may differ because the fee 

paid by each entity is dependent on the 

number of entities identified per feetriggering event. EPA relied on past 

experience with Test Rules for HPV 

chemicals under section 4 as well as 

work to date on the first 10 chemicals 

to undergo risk evaluation under section 

6 to inform its estimates of the average 

number of small businesses impacted 

per action. EPA estimates that average 

annual fee collection from small 

businesses impacted by section 4 

activities would be approximately 

$8,000, and the average annual fee 

collection from small businesses 

impacted by section 6 would be 

approximately $922,000. For each of the 

three years covered by this proposed 

rule, EPA estimates that total fee 

revenue collected from small businesses 

will account for about 6 percent of the 

approximately $22 million total fee 

collection, for an annual average total of 

approximately $1.3 million. 

This proposed rule would establish 

fee requirements for affected 

manufacturers (including importers) 

and, in some cases, processors of 

chemical substances. The proposed fees 

to be paid by industry would defray the 

cost for EPA to administer relevant 

activities under TSCA sections 4, 5, and 

6 and relevant information management 

activities. Absent this proposed rule, 

EPA costs to administer these sections 

of TSCA would be solely borne by 

taxpayers through budget 

appropriations from general revenue. As 

a result of this proposed rule, 25% of 

EPA costs to administer relevant 

activities under TSCA sections 4, 5, and 

6 and relevant management activities, 

and activities paid from general revenue 

would be transferred to industry via fee 

payments. 

Although these fees may be perceived 

by industry as direct private costs, from 

an economic perspective, they are 

transfer payments from industry to 

taxpayers rather than real social costs. 

Therefore, the total social cost of this 

proposed rule does not include the fees 

collected from industry by EPA. Rather, 

it includes the opportunity costs 

incurred by industry, such as the cost to 

read and familiarize themselves with 

the rule; determine their eligibility for 

paying reduced fees; register for Central 

Data Exchange (CDX); form, manage and 

notify EPA of participation in consortia; 

notify EPA and certify whether they will 

be subject to the action or not; and 

arrange to submit fee payments via 

Pay.gov. Total social costs also include 

the additional costs to EPA to 

administer fee assessment and 

collection for relevant activities under 

TSCA sections 4, 5, and 6, and relevant 

information management activities. The 

total additional annualized opportunity 

cost to industry, relative to the 2018 

TSCA Fees Rule, is approximately 

$12,000. It is estimated that the EPA 

will incur no additional burden, relative 

to the 2018 TSCA Fees Rule, as a result 

of the proposed Fee Rule amendments. 

Thus, it is estimated that the agency will 

incur no additional opportunity costs, 

and that total annual opportunity costs 

amount to approximately $12,000. 

V. References 

The following is a listing of the 

documents that are specifically 

referenced in this document. The docket 

includes these documents and other 

information considered by EPA, 

including documents that are referenced 

within the documents that are included 

in the docket, even if the referenced 

document is not physically located in 

the docket. For assistance in locating 

these other documents, please consult 

the technical person listed under FOR

FURTHER INFORMATION CONTACT. 


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1. The Frank R. Lautenberg Chemical Safety 

for the 21st Century Act. June 22, 2016. 

2. EPA. Final Rule; Fees for the 

Administration of the Toxic Substances 

Control Act. Federal Register. 83 FR 

52694, October 17, 2018 (FRL–9984–41). 

3. EPA. Request for No Action Assurance 

Regarding Self-Identification 

Requirement for Certain 

‘‘Manufacturers’’ Subject to the TSCA 

Fees Rule. March 2020. https://

www.epa.gov/sites/production/files/ 

2020-03/documents/tsca_fees_-_naa_

request_final.pdf. 

4. EPA. Economic Analysis of the Proposed 

Rule for Fees for the Administration of 

the Toxic Substances Control Act. 

September 2020. 

5. EPA. TSCA Work Plan Chemicals: 

Methods Document. February 2012. 

https://www.epa.gov/sites/production/ 

files/2014-03/documents/work_plan_

methods_document_web_final.pdf. 

6. EPA. Information Collection Request for 

the TSCA section 26(b) Proposed 

Reporting Requirements Associated with 

the Payment of TSCA Fees (EPA ICR No. 

2569.01; OMB Control No. 2070–[NEW]). 

November 2020. 

VI. 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 13563: Improving Regulation and 

Regulatory Review 

This action is a significant regulatory 

action that was submitted to the Office 

of Management and Budget (OMB) for 

review under Executive Orders 12866 

(58 FR 51735, October 4, 1993) and 

13563 (76 FR 3821, January 21, 2011). 

Any changes made in response to OMB 

recommendations have been 

documented in the docket for this action 

as required by section 6(a)(3)(E) of 

Executive Order 12866. 

EPA prepared an economic analysis of 

the potential costs and benefits 

associated with this action (Ref. 4). A 

copy of this economic analysis is 

available in the docket and is briefly 

summarized in Unit IV. 

B. Executive Order 13771: Reducing 

Regulation and Controlling Regulatory 

Costs 

This action is considered a regulatory 

action under Executive Order 13771 (82 

FR 9339, February 3, 2017). Details on 

the estimated costs of this rule can be 

found in the Economic Analysis (Ref. 4), 

which briefly summarized in Unit IV. 

C. Paperwork Reduction Act (PRA) 

The information collection activities 

in this rule have been submitted for 

approval to OMB under the PRA, 44 

U.S.C. 3501 et seq. The Information 

Collection Request (ICR) document that 

the EPA prepared has been assigned 

EPA ICR No. 2569.03 and OMB Control 

No. 2070–0208. A copy of the ICR is 

available in the docket for this proposed 

rule (Ref. 6), and it is briefly 

summarized here. The information 

collection requirements are not 

enforceable until OMB approves them. 

The information collection activities 

associated with the rule include 

familiarization with the regulation; 

reduced fee eligibility determination; 

CDX registration; formation, 

management and notification to EPA of 

participation in consortia; selfidentification and certification; and 

electronic payment of fees through 

Pay.gov. 

Respondents/affected entities: 

Persons who manufacture, or process a 

chemical substance (or any combination 

of such activities) and are required to 

submit information to EPA under TSCA 

sections 4 or 5, or manufacture a 

chemical substance that is the subject of 

a risk evaluation under TSCA section 

6(b). 

Respondent’s obligation to respond: 

Mandatory—TSCA section 26(b). 

Estimated number of respondents: 

1,348. 

Frequency of response: On occasion. 

Total estimated burden: 581 hours 

(per year). Burden is defined at 5 CFR 

1320.3(b). 

Total estimated cost: $273,388 (per 

year), includes $0 annualized capital or 

operation and maintenance costs. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in 40 

CFR part 700 are listed in 40 CFR part 

9. Submit your comments on the 

Agency’s need for this information, the 

accuracy of the provided burden 

estimates and any suggested methods 

for minimizing respondent burden to 

the EPA using the docket identified at 

the beginning of this rule. You may also 

send your ICR-related comments to 

OMB’s Office of Information and 

Regulatory Affairs via email to OIRA_

submission@omb.eop.gov, Attention: 

Desk Officer for the EPA. 

D. 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. 84 small 

businesses may be affected annually by 

section 4 actions; 190 small businesses 

may be affected by section 5 actions; 

and 24 small businesses may be affected 

by section 6 actions. 

EPA estimates the median annual 

sales for small businesses likely to be 

affected by TSCA section 4 and TSCA 

section 6 actions to be approximately 

$5,445,000; and $3,475,000 for small 

businesses likely to be affected by TSCA 

section 5 actions. The average annual 

incremental cost per affected small 

business is expected to be about $150 

for section 4; $120 for section 5, and 

$16,200 for section 6. As a result, EPA 

estimates that, of the 429 small 

businesses paying fees every year, all 

may have annual cost-revenue impacts 

less than 1%. 

E. 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 will not significantly or 

uniquely affect small governments. The 

rule is not expected to result in 

expenditures by State, local, and Tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(when adjusted annually for inflation) 

in any one year. Accordingly, this 

proposed rule is not subject to the 

requirements of sections 202, 203, or 

205 of UMRA. The total quantified 

annualized social costs for this 

proposed rule are approximately 

$12,000 (at both 3% and 7% discount 

rate), which does not exceed the 

inflation-adjusted unfunded mandate 

threshold of $160 million. 

F. Executive Order 13132: Federalism 

This action does not have federalism 

implications because it is not expected 

to 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 as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). Thus, Executive Order 

13132 does not apply to this action. 

G. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications because it is not expected 

to have substantial direct effects on 


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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, as specified in Executive Order 

13175 (65 FR 67249, November 9, 2000). 

Thus, Executive Order 13175 does not 

apply to this rule. 

H. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

EPA interprets Executive Order 13045 

(62 FR 19885, April 23, 1997), as 

applying only to those regulatory 

actions that concern environmental 

health or safety risks that EPA has 

reason to believe may 

disproportionately affect children, per 

the definition of ‘‘covered regulatory 

action’’ in section 2–202 of Executive 

Order 13045. This action is not subject 

to Executive Order 13045 because it 

does not establish an environmental 

standard intended to mitigate 

environmental health risks or safety 

risks. 

I. 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 energy 

supply, distribution, or use of energy 

and has not been designated by the 

Administrator of the Office of 

Information and Regulatory Affairs as a 

significant energy action. 

J. National Technology Transfer and 

Advancement Act (NTTAA) 

This rulemaking does not involve any 

technical standards. Therefore, NTTAA 

section 12(d), 15 U.S.C. 272 note, does 

not apply to this action. 

K. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

EPA believes that this action does not 

have disproportionately high and 

adverse health or environmental effects 

on minority populations, low-income 

populations and/or indigenous peoples, 

as specified in Executive Order 12898 

(59 FR 7629, February 16, 1994). The 

documentation for this decision is 

contained in the Economic Analysis 

(Ref. 4), which is in the public docket 

for this action. 

List of Subjects 40 CFR Part 700 

Chemicals, Environmental protection, 

Hazardous substances, Reporting and 

recordkeeping requirements, User fees. 

Andrew Wheeler, 

Administrator. 

Therefore, for the reasons presented 

in this document, the Environmental 

Protection Agency proposes to amend 

40 CFR part 700 as follows: 

PART 700—GENERAL 

■ 1. The authority citation for part 700 

is revised to read as follows: 

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

U.S.C. 3504. 

■ 2. Amend Section 700.43 by: 

■ a. Adding in alphabetical order a 

definition for ‘‘Production volume’’; 

■ b. Revising the definition of ‘‘Section 

5 notice’’; and 

■ c. Adding in alphabetical order a 

definition for ‘‘Small quantities solely 

for research and development’’. 

The additions and revisions read as 

follows: 

§ 700.43 Definitions applicable to this 

subpart. 

* * * * * 

Production volume means average 

annual manufactured (or imported) 

amount in pounds from the four 

calendar years prior to the year 

certification was made. 

* * * * * 

Section 5 notice means any PMN, 

consolidated PMN, intermediate PMN, 

significant new use notice, exemption 

notice, exemption application, MCAN, 

consolidated MCAN, bona fide intent to 

manufacture (including import) a 

chemical substance under § 720.25(b)(2) 

of this chapter, or notice of 

commencement of manufacture or 

import under § 720.102 of this chapter. 

* * * * * 

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, imported, or processed 

or proposed to be manufactured, 

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 paragraph (a)(3); 

■ b. Revising the paragraph (b) subject 

heading and paragraphs (b)(5)(ii) and 

(iii): 

■ c. Adding paragraphs (b)(5)(iv) 

through (vi); 

■ d. Revising paragraph (b)(7); 

■ e. Revising the paragraph (c) subject 

heading and paragraphs (c)(1)(i) and 

(c)(1)(vi) through (viii); 

■ f. Adding paragraphs (c)(1)(ix) and (x); 

■ g. Revising paragraphs (c)(2)(vi) 

through (xi); 

■ h. Adding paragraphs (c)(2)(xii) 

through (xiv); 

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

(f)(3)(i), (f)(4), (f)(5)(iv), (g)(3)(iv), and 

(g)(5)(ii); 

■ j. Adding paragraphs (g)(5)(v) and (vi); 

■ k. Revising paragraph (g)(6)(ii); and 

■ l. Adding paragraphs (g)(6)(v) and (vi). 

The revisions and additions read as 

follows: 

§ 700.45 Fee payments. 

(a) * * * 

(3) Manufacturers of a chemical 

substance that is subject to a risk 

evaluation under section 6(b) of the Act, 

shall remit for each such chemical risk 

evaluation the applicable fee identified 

in paragraph (c) of this section in 

accordance with the procedures in 

paragraphs (f) and (g) of this section. For 

the purposes of this section, entities that 

manufacture a chemical substance 

subject to a risk evaluation under 

section 6(b) of the Act solely for export 

are subject to fee requirements in this 

section whenever such substance is 

manufactured, processed, or distributed 

in commerce by any other entity for any 

purpose other than export from the 

United States. Manufacturers of a 

chemical substance subject to risk 

evaluation under section 6(b) of the Act 

are exempted from fee payment 

requirements in this section, if they 

meet one or more of the exemptions 

under paragraphs (a)(3)(i) through (v) of 

this section for the five-year period 

preceding publication of the 

preliminary list and will meet one of 

more of the exemptions in paragraph 

(a)(3)(i) through (v) in the successive 

five years. Those manufacturers are 

excluded from fee payment 

requirements in this section, if they 

exclusively: 

(i) Import articles containing that 

chemical substance; 

(ii) Produce that chemical substance 

as a byproduct; 

(iii) Manufacture (including import) 

that chemical substance as an impurity; 

(iv) Manufacture that chemical 

substance as a non-isolated intermediate 

as defined in § § 704.3 

(v) Manufacture (including import) 

small quantities of that chemical 


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substance solely for research and 

development, as defined in § 700.43; 

and/or 

(vi) Manufacture (including import) 

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 described in 

§ 700.43, in which case this exemption 

is not applicable. 

* * * * * 

(b) Identifying manufacturers subject 

to fees for section 4 test rules and 

section 6 EPA-initiated risk evaluations 

* * * * * 

(5) Self-identification. All 

manufacturers other than those listed in 

paragraph (a)(3)(i) through (iii) of this 

section who have manufactured or 

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: 

* * * * * 

(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) 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) 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 

meets one or more of the exemptions in 

paragraphs (a)(3)(i) through (vi) of this 

section for the five-year period 

preceding publication of the 

preliminary list and will meet one of 

more of the exemptions in paragraphs 

(a)(3)(i) through (vi) in the successive 

five years, the manufacturer must 

submit a certification statement attesting 

to these facts in order to not be included 

in the final list of manufacturers 

described in paragraph (b)(7) of this 

section and to not be obligated to pay 

the fee under this section. If a 

manufacturer is not on a preliminary list 

and meets one or more of the 

exemptions in paragraphs (a)(3)(i) 

through (vi) for the five-year period 

preceding publication of the 

preliminary list and will meet one of 

more of the exemptions in paragraphs 

(a)(3)(i) through (vi) 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) and will not be obligated to pay 

the fee under this section. 

(v) Recordkeeping. After [DATE 60 

CALENDAR DAYS AFTER THE DATE 

OF PUBLICATION OF THE FINAL 

RULE]: 

(A) All manufacturers other than 

those listed in paragraphs (a)(3)(i) 

through (vi) of this section must 

maintain production volume records 

related to compliance with paragraph 

(vi) of this section. These records must 

be maintained for a period of five years 

from the date notice is submitted 

pursuant to paragraph (b)(5) of this 

section. 

(B) Those manufacturers that are 

exempt from fee payment requirements 

pursuant to paragraph (a)(3)(vi) of this 

section must maintain production 

volume records related to compliance 

with the exemption criteria described in 

paragraph (a)(3)(vi). These records must 

be maintained for a period of five years 

from the date the exemption is claimed. 

(C) Those manufacturers that are 

exempt from fee payment requirements 

pursuant to paragraph (a)(3)(v) of this 

section must maintain ordinary business 

records related to compliance with the 

exemption criteria described in 

paragraph (a)(3)(v), such as plans of 

study, information from research and 

development notebooks, study reports, 

or notice solely for research and 

development use. These records must be 

maintained for a period of five years 

from the date the record is generated. 

(D) Those manufacturers that are 

exempt from fee payment requirements 

pursuant to paragraph (a)(3)(iv) of this 

section must maintain ordinary business 

records related to compliance with the 

exemption criteria described in 

paragraph (a)(3)(iv). These records must 

be maintained for a period of five years 

from the date the record is generated. 

(vi) Production volume. A 

manufacturer submitting notice to EPA 

under paragraph (b)(5) of this section, 

other than those manufacturers listed in 

paragraphs (a)(3)(i) through (v) of this 

section, must submit to EPA its 

production volume as defined in 

§ 700.43 for the applicable chemical 

substance. 

* * * * * 

(7) Publication of final list. EPA will 

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 or no manufacture pursuant to 

paragraph (b)(5)(ii) or (iii). The final list 

will be published no later than 

concurrently with the final scope 

document for risk evaluations initiated 

by EPA under section 6, and with the 

final test rule for test rules under section 

4. EPA may modify the list after the 

publication of the final list. 

* * * * * 

(c) Fees for the 2022, 2023, and 2024 

fiscal years. Persons shall remit fee 

payments to EPA as follows: 

(1) * * * 

(i) Premanufacture notice and 

consolidated premanufacture notice. 

Persons shall remit a fee totaling $2,800 

for each premanufacture notice (PMN) 

or consolidated PMN submitted in 

accordance with part 720 of this 

chapter. 

* * * * * 

(vi) Bona fide intent to manufacture 

(including import) a chemical 

substance. Persons shall remit a fee 

totaling $90 for each bona fide intent to 

manufacture (including import) 

submitted in accordance with § 720.25 

of this chapter. 

(vii) Notice of commencement of 

manufacture or import. Persons shall 

remit a fee totaling $90 for each notice 

of commencement of manufacture or 

import submitted in accordance with 

§ 720.102 of this chapter. 

(viii) Persons shall remit a total of 

twenty percent of the applicable fee 

under paragraph (c)(2)(viii), (ix) or (x) of 


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this section for a test rule, test order, or 

enforceable consent agreement. 

(ix) Persons shall remit a total fee of 

twenty percent of the applicable fee 

under paragraphs (c)(2)(xii) of this 

section for an EPA-initiated risk 

evaluation. 

(x) Persons shall remit the total fee 

under paragraph (c)(2)(xiii) or (xiv) of 

this section, as applicable, for a 

manufacturer-requested risk evaluation. 

(2) * * * : 

(vi) Bona fide intent to manufacture 

(including import) a chemical 

substance. Persons shall remit a fee 

totaling $500 for each bona fide intent 

to manufacture (including import) 

submitted in accordance with § 720.25 

of this chapter. 

(vii) Notice of commencement of 

manufacture or import. Persons shall 

remit a fee totaling $500 for each notice 

of commencement of manufacture or 

import submitted in accordance with 

§ 720.102 of this chapter. 

(viii) Test rule. Persons shall remit a 

fee totaling $29,500 for each test rule. 

(ix) Test order. Persons shall remit a 

fee totaling $9,800 for each test order. 

(x) Resubmitted data. Persons shall 

remit a fee totaling $9,800 for data 

submitted following submission of 

deficient data in response to a test order. 

(xi) Enforceable consent agreement. 

Persons shall remit a fee totaling 

$22,800 for each enforceable consent 

agreement. 

(xii) EPA-initiated chemical risk 

evaluation. Persons shall remit a fee 

totaling $2,560,000. 

(xiii) Manufacturer-requested risk 

evaluation of a Work Plan Chemical. 

Persons shall remit an initial fee of 

$945,000, a second payment of $945,000 

and final payment to total 50% of the 

actual costs of this activity, in 

accordance with the procedures in 

paragraph (g) of this section. The final 

payment amount will be determined by 

EPA, and EPA will issue an invoice to 

the requesting manufacturer. 

(xiv) Manufacturer-requested risk 

evaluation of a non-work plan chemical. 

Persons shall remit an initial fee of 

$1,890,000, a second payment of 

$1,890,000, and final payment to total 

100% of the actual costs of the activity, 

in accordance with the procedures in 

paragraph (g) of this section. The final 

payment amount will be determined by 

EPA, and EPA will issue an invoice to 

the requesting manufacturer. 

* * * * * 

(d) Fees for 2025 fiscal year and 

beyond. (1) Fees for the 2025 and later 

fiscal years will be adjusted on a threeyear cycle by multiplying the fees in 

paragraph (c) of this section by the 

current PPI index value with a base year 

of 2022 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 

2022 as a base year. 

(2) Updated fee amounts for PMNs, 

SNUNs, MCANs, exemption notices, 

exemption applications, bona fide 

intent to manufacture (including 

import) a chemical substance, notice of 

commencement of manufacture or 

import, and manufacturer-requested 

chemical 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 2022 (October 1, 2021). Updated 

fee amounts also apply to test rules, test 

orders, enforceable consent agreements 

and EPA-initiated chemical evaluations 

that are ‘‘noticed’’ on or after October 1 

of every three-year fee adjustment cycle, 

beginning in fiscal 2022. 

(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 most likely through posting to 

the Agency’s web page by the beginning 

of each three-year fee adjustment cycle 

(October 1, 2024, October 1, 2027, 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 issuance 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 prior to 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. 

* * * * * 

(4)(i) 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. 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: 

(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 of the 

chemical substance, with lower fees for 

small businesses: 

Where: 

Fs = the total fee required under paragraph 

(c) of this section by a person(s) who 

qualifies as a small business concern 

under § 700.43 of this chapter. 

Fo = the total fee required under paragraph 

(c) of this section by person(s) other than 

a small business concern. 

Vs = the production volume of a person who 

qualifies as a small business concern 

under paragraph (c) as a percentage of 

the total production volume as defined 

in § 700.43 of person(s) who qualify as a 

small business concern under paragraph 

(c) of this section. 

Vo = the production volume of a person other 

than a small business concern as a 

percentage of the total production 

volume as defined in § 700.43 of 

person(s) other than a small business 

concern. 


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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. 

(5) * * * 

(iv) Reallocate the remaining fee 

across those remaining individuals and 

groups based on the portion of total 

production volume as defined in 

§ 700.43, considering the production 

volume of each manufacturer not in a 

consortium and the total production 

volume of the manufacturers in a 

consortium; and 

* * * * * 

(g) * * * 

(3) * * * 

(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) * * * 

(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) * * * 

(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 § 700.43 and 

has remitted a fee of $940 in accordance 

with § 700.45(c).’’ in the exemption 

application. 

* * * * * 

(v) Each person who remits the fee 

identified in paragraph (c)(1) of this 

section for a bona fide intent to 

manufacture (including import) a 

chemical substance shall insert a check 

mark for the statement, ‘‘The company 

named in part 1, section A is a small 

business concern under § 700.43 and 

has remitted a fee of $90 in accordance 

with § 700.45(c).’’ when submitting a 

request in accordance with 

§ 720.25(b)(2) of this chapter. 

(vi) Each person who remits the fee 

identified in paragraph (c)(1) of this 

section for a notice of commencement of 

manufacture or import shall insert a 

check mark for the statement, ‘‘The 

company named in part 1, section A is 

a small business concern under § 700.43 

and has remitted a fee of $90 in 

accordance with § 700.45(c).’’ when 

submitting a notice in accordance with 

§ 720.102(d)(2) of this chapter. 

(6) * * * 

(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 $4,700 specified in 

§ 700.45(c).’’ in the exemption 

application. 

* * * * * 

(v) Each person who remits the fee 

identified in paragraph (c)(2) of this 

section for a bona fide intent to 

manufacture (including import) a 

chemical substance shall insert a check 

mark for the statement, ‘‘The company 

named in part 1, section A has remitted 

the fee of $500 in accordance with 

§ 700.45(c).’’ when submitting a request 

in accordance with § 720.25(b)(2) of this 

chapter. 

(vi) Each person who remits the fee 

identified in paragraph (c)(2) of this 

section for a notice of commencement of 

manufacture or import shall insert a 

check mark for the statement, ‘‘The 

company named in part 1, section A has 

remitted the fee of $500 in accordance 

with § 700.45(c).’’ when submitting a 

notice in accordance with 

§ 720.102(d)(2) of this chapter. 

* * * * * 

[FR Doc. 2020–28585 Filed 1–8–21; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 74 

[MB Docket Nos. 20–401, 17–105; RM– 

11854; FCC 20–166; FRS 17341] 

FM Broadcast Booster Stations; 

Modernization of Media Initiative 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: In this document the Federal 

Communications Commission proposes 

to amend its rules to enable FM 

broadcasters to use FM booster stations 

to air geo-targeted content (e.g., news, 

weather, and advertisements) 

independent of the signals of its primary 

station within different portions of the 

primary station’s protected service 

contour for a limited period of time 

during the broadcast hour. 

DATES: Comments may be filed on or 

before February 10, 2021 and reply 

comments may be filed on or before 

March 12, 2021. 

ADDRESSES: You may submit comments, 

identified by MB Docket No. 20–401, by 

any of the following methods: 

• Electronic Filers: Comments may be 

filed electronically using the internet by 

accessing the Commission’s Electronic 

Comment Filing System (ECFS) at: 

http://apps.fcc.gov/ecfs/. 

• Paper Filers: Parties who choose to 

file by paper must file an original and 

one copy of each filing. 

• Filings can be sent by commercial 

overnight courier, or by first-class or 

overnight U.S. Postal Service mail. All 

filings must be addressed to the 

Commission’s Secretary, Office of the 

Secretary, Federal Communications 

Commission. 

Æ Commercial overnight mail (other 

than U.S. Postal Service Express Mail 

and Priority Mail) must be sent to 9050 

Junction Drive, Annapolis Junction, MD 

20701. 

Æ Postal Service first-class, Express, 

and Priority mail must be addressed to 

45 L Street NE, Washington DC 20554 

• Effective March 19, 2020, and until 

further notice, the Commission no 

longer accepts any hand or messenger 

delivered filings. This is a temporary 

measure taken to help protect the health 

and safety of individuals, and to 

mitigate the transmission of COVID–19. 

• During the time the Commission’s 

building is closed to the general public 

and until further notice, if more than 

one docket or rulemaking number 

appears in the caption of a proceeding, 

paper filers need not submit two 

additional copies for each additional 


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