Fees for the Administration of the Toxic Substances Control Act (TSCA), 1890-1909 [2020-28585]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 86, Number 6 (Monday, January 11, 2021)]
[Proposed Rules]
[Pages 1890-1909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28585]


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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.

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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 non-isolated 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 EPA-initiated 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 https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute.
    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

[[Page 1891]]

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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA/[email protected].

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 EPA-
initiated 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/information-plan-reduce-tsca-fees-burden-and-no-action-assurance (Ref. 
3)), an exemption for research and development activities, an exemption 
for manufacturers of chemical substances produced as a non-isolated 
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 manufacturer-requested risk 
evaluations. Total annualized fee collection was calculated by 
multiplying the estimated number of fee-triggering events anticipated 
each year by the corresponding fees. Total annual fee collection for 
manufacturer-requested 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

[[Page 1892]]

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

[[Page 1893]]

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 low-volume exemptions (LVEs), test-marketing exemptions 
(TMEs), low exposure/low release exemptions (LoREXs), TSCA experimental 
release

[[Page 1894]]

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-chemicals-under-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 High-Priority 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 manufacturer-requested 
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, N-
methylpyrrolidone, 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

[[Page 1895]]

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 fee- triggering 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 *
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
                                                                     number of    Estimated cost     Estimated
                          Fee category                                ongoing       to Agency/    annual cost to
                                                                   actions/year       action          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.

[[Page 1896]]



                     Table 3--TSCA Section 5 Costs *
------------------------------------------------------------------------
                                             Estimated         Total
                                             number of       estimated
              Fee category                    ongoing     annual cost to
                                           actions/year       Agency
------------------------------------------------------------------------
PMN and consolidated PMN, SNUN, MCAN and             301  ..............
 consolidated MCAN......................
Bona Fide Notice........................             207
Notice of Commencement..................             175
LoREX, LVE, TME, Tier II exemption,                  320
 TERA, Film Article.....................
                                         -------------------------------
                                                             $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 *
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
                                                                     number of       Estimated       Estimated
                          Fee category                                ongoing         cost to       annual cost
                                                                   actions/year    Agency/action     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/outreach-materials-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 manufacturer-requested 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

[[Page 1897]]

requirements in TSCA, or a refund to achieve these requirements, if 
warranted.
    The 2018 Fee Rule established a two-payment approach for 
manufacture-requested 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 manufacture-requested 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 
EPA-initiated 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     In any scenario where there is
 single consortium comprised of all       not a single consortium
 manufacturers of the chemical            comprised of all manufacturers
 undergoing the EPA-initiated risk        of the chemical undergoing the
 evaluation, EPA will take the            EPA-initiated risk evaluation,
 following steps to allocate fees:        EPA will take the following
                                          steps to allocate fees:
     Count the total number of       Count the total
     manufacturers, including the            number of manufacturers,
     number of manufacturers within any      including the number of
     consortia.                              manufacturers within any
                                             consortia.
     Divide the total fee            Divide the total
     amount by the total number of           fee amount by the total
     manufacturers and allocate equally      number of manufacturers to
     on a per capita basis to generate       generate a base fee for the
     a base fee.                             purpose of calculating the
                                             fee for small businesses.
     Provide all small               Provide all small
     businesses who are either (a) not       businesses who are either
     associated with a consortium, or        (a) not associated with a
     (b) associated with an all-small        consortium, or (b)
     business consortium with an 80%         associated with an all-
     discount from the base fee              small business consortium,
     referenced previously.                  with an 80% discount from
                                             the base fee referenced
                                             previously.
     Calculate the total             Calculate the total
     remaining fee and total number of       fee amount to be split
     remaining manufacturers by              among the total number of
     subtracting out the discounted          small manufacturers and
     fees and the number of small            distribute it based on
     businesses identified.                  their percentage of the
                                             average annual production
                                             volume from the four
                                             calendar years prior to the
                                             year certification was
                                             made.
     Reallocate the remaining        Calculate the total
     fee across those remaining              remaining fee amount to be
     individuals and groups in equal         split among the total
     amounts, counting each                  number of remaining
     manufacturer in a consortium as         manufacturers by
     one person.                             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

[[Page 1898]]

the number of entities identified per fee-triggering 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) manufacturer-requested risk evaluations for chemicals 
on the TSCA Work Plan, and (8) manufacturer- requested risk evaluations 
for chemicals not on the TSCA Work Plan, all under TSCA section 6. The 
activities in these categories are fee-triggering events 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

[[Page 1899]]

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 export-only 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 EPA-
initiated 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 
self-identification 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-epa-initiated-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

[[Page 1900]]

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 EPA-initiated 
risk evaluation.
    EPA is not proposing a concentration-based 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

[[Page 1901]]

defining the universe of manufacturers responsible for payment) allows 
for self-identification, 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-environmental-violation-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 self-identify. 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 non-isolated intermediate to 
certify that they meet those exemption criteria. EPA is also proposing 
to require all other non-exempted 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 EPA-initiated 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 fee-triggering 
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 manufacturer- requested 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.

[[Page 1902]]



                            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      Initial payment within 180
                                                     days of EPA providing notice   days of EPA providing notice
                                                     of granting a manufacturer-    of granting a manufacturer-
                                                     requested risk evaluation.     requested risk evaluation.
                                                     Payment is collected in two    Payments are collected over
                                                     installments over the course   three installments.
                                                     of the activity.
                                                    For EPA-initiated risk         For EPA-initiated risk
                                                     evaluations, payment is        evaluation, payment is
                                                     collected in one installment   collected over two
                                                     120 days after EPA publishes   installments, the first
                                                     the final scope of a           payment of 50% to be due 180
                                                     chemical risk evaluation.      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       90 days to notify EPA of
                                                     intent to form a consortium    intent to form a consortium
                                                     from the triggering event.     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 manufacturer-requested 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 EPA-initiated risk evaluations at 
approximately 35% of the estimated cost of the activity. EPA takes an 
actual cost approach for manufacturer-requested risk evaluations, 
whereby the requesting manufacturer (or requesting consortia of 
manufacturers) would be obligated to pay either 50% 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

[[Page 1903]]

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
------------------------------------------------------------------------
                                                      2020 Proposed fee
        Fee category              2018 fee rule             rule
------------------------------------------------------------------------
TSCA section 4:                                     ....................
    Test order..............  $9,800..............  $9,800.
    Amended test order......  $0..................  $9,800.
    Test rule...............  $29,500.............  $29,500.
    Enforceable consent       $22,800.............  $22,800.
     agreement.
TSCA section 5:
    PMN and consolidated      $16,000.............  $16,000.
     PMN, SNUN, MCAN and
     consolidated MCAN.
LoREX, LVE, TME, Tier II      $4,700..............  $4,700.
 exemption, TERA, Film
 Articles.
Bona Fide Notice............  $0..................  $500.
Notice of Commencement......  $0..................  $500.
TSCA section 6:
    EPA-initiated risk        $1,350,000..........  $2,560,000.
     evaluation.
    Manufacturer-requested    Initial payment of    Two payments of
     risk evaluation on a      $1.25M, with final    $945,000, with
     chemical included in      invoice to recover    final invoice to
     the TSCA Work Plan.       50% of Actual Costs.  recover 50% of
                                                     Actual Costs.
Manufacturer-requested risk   Initial payment of    Two payments of
 evaluation on a chemical      $2.5M, with final     $1.89M, with final
 not included in the TSCA      invoice to recover    invoice to recover
 Work Plan.                    100% of Actual        100% of Actual
                               Costs.                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
------------------------------------------------------------------------
                                                      2020 Proposed fee
        Fee category              2018 fee rule             rule
------------------------------------------------------------------------
TSCA section 4:
    Test order..............  $1,950..............  $1,960.
    Amended test order......  $0..................  $1,960.
    Test rule...............  $5,900..............  $5,900.
    Enforceable consent       $4,600..............  $4,600.
     agreement.
TSCA section 5:
    PMN and consolidated      $2,800..............  $2,800.
     PMN, SNUN, MCAN and
     consolidated MCAN.
    LoREX, LVE, TME, Tier II  $940................  $940
     exemption, TERA, Film
     Articles.
    Bona Fide Notice........  $0..................  $90.
    Notice of Commencement..  $0..................  $90.
TSCA section 6:
    EPA-initiated risk        $270,000............  $512,000.
     evaluation.
    Manufacturer-requested    $1,250,000 initial    Two payments of
     risk evaluation on a      payment + 50% of      $945,000 with final
     chemical included in      total actual costs.   invoice to recover
     the TSCA Work Plan..                            50% of actual
                                                     costs.
    Manufacturer-requested    $2,500,000 initial    Two payments of
     risk evaluation on a      payment + 100% of     $1.89M with final
     chemical not included     total actual costs.   invoice to recover
     in the TSCA Work Plan.                          100% of actual
                                                     costs.
------------------------------------------------------------------------


[[Page 1904]]

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 fee-
triggering 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.


[[Page 1905]]


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/laws-regulations/laws-and-executive-orders.

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

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget (OMB) for review under Executive 
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, 
January 21, 2011). Any changes made in response to OMB recommendations 
have been documented in the docket for this action as required by 
section 6(a)(3)(E) of Executive Order 12866.
    EPA prepared an economic analysis of the potential costs and 
benefits associated with this action (Ref. 4). A copy of this economic 
analysis is available in the docket 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; self-identification and 
certification; and electronic payment of fees through Pay.gov.
    Respondents/affected entities: Persons who manufacture, or process 
a chemical substance (or any combination of such activities) and are 
required to submit information to EPA under TSCA sections 4 or 5, or 
manufacture a chemical substance that is the subject of a risk 
evaluation under TSCA section 6(b).
    Respondent's obligation to respond: Mandatory--TSCA section 26(b).
    Estimated number of respondents: 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 
[email protected], 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

[[Page 1906]]

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

0
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.

0
2. Amend Section 700.43 by:
0
a. Adding in alphabetical order a definition for ``Production volume'';
0
b. Revising the definition of ``Section 5 notice''; and
0
c. Adding in alphabetical order a definition for ``Small quantities 
solely for research and development''.
    The additions and revisions read as follows:


Sec.  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 Sec.  720.25(b)(2) of this chapter, 
or notice of commencement of manufacture or import under Sec.  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.
* * * * *
0
3. Amend Sec.  700.45 by:
0
a. Revising paragraph (a)(3);
0
b. Revising the paragraph (b) subject heading and paragraphs (b)(5)(ii) 
and (iii):
0
c. Adding paragraphs (b)(5)(iv) through (vi);
0
d. Revising paragraph (b)(7);
0
e. Revising the paragraph (c) subject heading and paragraphs (c)(1)(i) 
and (c)(1)(vi) through (viii);
0
f. Adding paragraphs (c)(1)(ix) and (x);
0
g. Revising paragraphs (c)(2)(vi) through (xi);
0
h. Adding paragraphs (c)(2)(xii) through (xiv);
0
i. Revising paragraphs (d), (f)(2)(i), (f)(3)(i), (f)(4), (f)(5)(iv), 
(g)(3)(iv), and (g)(5)(ii);
0
j. Adding paragraphs (g)(5)(v) and (vi);
0
k. Revising paragraph (g)(6)(ii); and
0
l. Adding paragraphs (g)(6)(v) and (vi).
    The revisions and additions read as follows:


Sec.  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 Sec.  Sec.  704.3
    (v) Manufacture (including import) small quantities of that 
chemical

[[Page 1907]]

substance solely for research and development, as defined in Sec.  
700.43; and/or
    (vi) Manufacture (including import) that chemical substance in 
quantities below a 2,500 lbs. annual production volume as described in 
Sec.  700.43, unless all manufacturers of that chemical substance 
manufacture that chemical in quantities below a 2,500 lbs. annual 
production volume as described in Sec.  700.43, in which case this 
exemption is not applicable.
* * * * *
    (b) 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 five-year period preceding publication of the 
preliminary list, the manufacturer may submit a certification statement 
attesting to these facts. If EPA receives such a certification 
statement from a manufacturer, the manufacturer will not be included in 
the final list of manufacturers described in paragraph (b)(7) 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 Sec.  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 
Sec.  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 Sec.  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

[[Page 1908]]

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 
Sec.  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 Sec.  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 three-year 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 x I

Where:

FA = the inflation-adjusted future year fee amount.
F = the fee specified in paragraph (c) of this section.
I = Producer Price Index for Chemicals and Allied Products inflation 
value with 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-
and-comment rulemaking prior to making fee adjustments beyond 
inflation. If it is determined that no additional adjustment is 
necessary beyond for inflation, EPA will provide public notice of the 
inflation-adjusted fee amounts 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:

[GRAPHIC] [TIFF OMITTED] TP11JA21.020

    (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:
[GRAPHIC] [TIFF OMITTED] TP11JA21.021

Where:

Fs = the total fee required under paragraph (c) of this 
section by a person(s) who qualifies as a small business concern 
under Sec.  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 Sec.  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 Sec.  700.43 of person(s) other than a small business 
concern.

[[Page 1909]]

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

    (5) * * *
    (iv) Reallocate the remaining fee across those remaining 
individuals and groups based on the portion of total production volume 
as defined in Sec.  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 EPA-initiated risk evaluations, the 
applicable fee specified in paragraph (c) of this section shall be paid 
in two installments, with the first payment of 50% due 180 days after 
publishing the final scope of a risk evaluation and the second payment 
for the remainder of the fee due 545 days after publishing the final 
scope of a risk evaluation under section 6(b)(4)(D) of the Act.
    (B) * * *
    (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 Sec.  700.43 and has remitted a fee of $940 in accordance 
with Sec.  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 Sec.  700.43 and has remitted a fee of $90 in accordance 
with Sec.  700.45(c).'' when submitting a request in accordance with 
Sec.  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 Sec.  700.43 and 
has remitted a fee of $90 in accordance with Sec.  700.45(c).'' when 
submitting a notice in accordance with Sec.  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 Sec.  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 Sec.  700.45(c).'' when submitting a 
request in accordance with Sec.  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 Sec.  
700.45(c).'' when submitting a notice in accordance with Sec.  
720.102(d)(2) of this chapter.
* * * * *
[FR Doc. 2020-28585 Filed 1-8-21; 8:45 am]
BILLING CODE 6560-50-P