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[Federal Register Volume 89, Number 250 (Tuesday, December 31, 2024)]
[Proposed Rules]
[Pages 107099-107103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30930]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 700

[EPA-HQ-OPPT-2024-0501; FRL-12463-01-OCSPP]

Preliminary Lists Identifying Manufacturers Subject to Fee 
Obligations for Five Chemical Substances Undergoing EPA-Initiated Risk 
Evaluations Under the Toxic Substances Control Act (TSCA); Notice of 
Availability and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Determination; request for comments.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) is 
announcing the availability of and soliciting comment on the 
preliminary lists of manufacturers (including importers) of five 
chemical substances that have been designated as High-Priority 
Substances for risk evaluation under the Toxic Substances Control Act 
(TSCA) and for which fees will be charged. As required by TSCA, EPA 
established fees to defray a portion of the costs associated with 
administering certain provisions of TSCA. The comment period provides 
an opportunity for the public to provide comments, self-identify, or 
correct errors on the preliminary lists. In addition, manufacturers 
(including importers) are required to self-identify as a manufacturer 
(or importer) of one or more the five identified High-Priority 
Substances irrespective of whether they are included on the preliminary 
lists, and may use this period to do so. Where appropriate, entities 
may also avoid or reduce fee obligations by making certain 
certifications consistent with the TSCA Fees Rule. EPA expects to 
publish final lists of manufacturers (including importers) subject to 
fees no later than concurrently with the publication of the final scope 
documents for risk evaluations of these five High-Priority Substances. 
Manufacturers (including importers) identified on the final lists will 
be subject to the applicable fees.

DATES: Comments must be received on or before March 3, 2025.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2024-0501, online 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.

[[Page 107100]]

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information: Kathleen Ferry, Existing Chemicals Risk 
Management Division (7404M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-2214; email address: 
[email protected].
    For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South 
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; 
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    This action applies to entities that manufacture (including import) 
a chemical substance undergoing a risk evaluation under TSCA section 
6(b) (e.g., entities identified under North American Industrial 
Classification System (NAICS) codes 325 and 324110). The action may 
also be of interest to chemical processors, distributors in commerce, 
and users; non-governmental organizations in the environmental and 
public health sectors; state and local government agencies; and members 
of the public. Since other entities may also be interested, the Agency 
has not attempted to describe all the specific entities and 
corresponding NAICS codes for entities that may be interested in or 
affected by this action. If you have 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 section 26(b), 15 U.S.C. 2625(b), provides EPA with authority 
to establish fees to defray a portion of the costs associated with 
administering EPA-initiated TSCA section 6 risk evaluations. The 
implementing fee regulations, which are codified in 40 CFR part 700, 
subpart C, imposes a fee for any person who manufactures (including 
imports) a chemical substance that is the subject of an EPA-initiated 
risk evaluation under TSCA section 6 (Ref. 1). The requirements for 
those fee payments are codified in 40 CFR 700.45. See also https://www.epa.gov/tsca-fees.

C. What action is the Agency taking?

    EPA is publishing preliminary lists identifying manufacturers 
(including importers) that may be subject to fee obligations under 40 
CFR 700.45, associated with each EPA-initiated risk evaluation of the 
following five High-Priority Substances under TSCA section 6 (Refs. 2):
     Acetaldehyde (CASRN 75-07-0);
     Acrylonitrile (CASRN 107-13-1);
     Benzenamine (CASRN 62-53-3);
     Vinyl chloride (CASRN 75-01-4); and
     4,4'-Methylene bis(2-chloroaniline) (CASRN 101-14-4).
    EPA is also providing an opportunity for public comment during 
which manufacturers (including importers) are required to self-identify 
as a manufacturer (including importer) of a High-Priority Substance, 
irrespective of whether they are listed on the preliminary list, unless 
they meet one or more of the exemptions listed in 40 CFR 
700.45(a)(3)(i) through (iii) (i.e., importing articles, producing as a 
byproduct that is not later used or distributed for commercial 
purposes, and manufacturing as an impurity). During this comment 
period, manufacturers and importers may make certain certifications to 
EPA to avoid or reduce fee obligations. The public will also have the 
opportunity to correct errors or provide comments on the preliminary 
lists. EPA is providing a 60-day comment period, which exceeds the 
minimum 30-day comment period established in 40 CFR 700.45(b)(4), to 
maximize public participation during the comment period for the 
preliminary lists. EPA expects to publish final lists of manufacturers 
(including importers) subject to fees no later than concurrently with 
the publication of the final scope document for risk evaluations of 
these five High-Priority Substances. Manufacturers (including 
importers) identified on the final lists will be subject to applicable 
fees under 40 CFR 700.45.

D. Why is the Agency taking this action?

    TSCA section 26 authorizes EPA to establish, by rule, a fee 
structure to defray some of the costs of administering certain 
provisions of TSCA. Established in 2018 and amended in 2024, pursuant 
to the TSCA Fee Rule EPA will collect payment from manufacturers 
(including importers) who manufacture (including import) a chemical 
substance that is the subject of a risk evaluation under TSCA section 
6(b). As intended by Congress, these fees are a sustainable source of 
funds for EPA to fulfill its legal obligations such as conducting risk 
evaluations to determine whether a chemical substance presents an 
unreasonable risk of injury to health or the environment, as required 
under TSCA section 6.
    Pursuant to TSCA section 6(b) and its implementing regulations, EPA 
designated the five chemical substances listed in Unit I.C. as High-
Priority Substances for risk evaluation (EPA-HQ-OPPT-2018-0464-0002). 
EPA is now preliminarily identifying the manufacturers (including 
importers) that may be subject to fee obligations associated with the 
risk evaluations of the five High-Priority Substances.

E. What should I consider as I prepare my comments for EPA?

1. Submitting Confidential Business Information (CBI)
    Do not submit CBI to EPA through https://www.regulations.gov or 
email. If you wish to include CBI in your comment, please follow the 
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all of the information that 
you claim to be 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 
parts 2 and 703.
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

    TSCA section 6(b)(3)(C) requires EPA to designate at least one new 
High-Priority Substance for risk evaluation upon completion of each 
risk evaluation for a High-Priority Substance. Because EPA generally 
expects to complete five risk evaluations per year over the next 
several years, in December 2024, EPA designated the five chemical 
substances listed in Unit I.C. as High-Priority Substances for risk 
evaluation. Under TSCA section 6(b)(1)(B) and its implementing 
regulations (40 CFR 702.3), a High-Priority Substance is defined as a 
chemical substance that EPA determines, without consideration of costs 
or other non-risk factors, may present an unreasonable risk of injury 
to health or the environment because of a potential hazard and a 
potential route of exposure under the conditions of use,

[[Page 107101]]

including an unreasonable risk to potentially exposed or susceptible 
subpopulations identified as relevant by EPA. EPA is now announcing the 
availability of the preliminary lists of fee payers for the risk 
evaluations for these five High-Priority Substances.
    In addition, in February 2024, EPA amended the 2018 TSCA Fees Rule 
to revise the fee amounts, which entities are obligated to pay fees, 
and the requirements for self-identification (Ref. 1 and 3). 
Specifically, EPA 2024 final rule established fee amounts based on 
EPA's total costs for administering TSCA; provided six exemptions for 
entities subject to the EPA-initiated risk evaluation fees; modified 
the self-identification and reporting requirements; established a 
production-volume-based fee allocation for EPA-initiated risk 
evaluations; and extended timeframes for certain fee payments and 
notices, among other changes. The TSCA Fee Rule is codified in 40 CFR 
part 700, subpart C.

III. Preliminary Lists and Requirements for Self-Identification

A. The Preliminary Lists

    This document announces the availability of EPA's preliminary lists 
of manufacturers (including importers) associated with each TSCA 
section 6 risk evaluation for the five High-Priority Substances who are 
potentially responsible for payment of fees, as required by 40 CFR 
700.45. The preliminary lists are available at in the docket (Ref. 4, 
5, 6, 7, and 8). EPA developed the preliminary lists using the most up-
to-date information available, including information submitted to the 
Agency (e.g., information submitted under TSCA section 8(a) (including 
the Chemical Data Reporting (CDR) Rule), TSCA section 8(b), and to the 
Toxics Release Inventory (TRI)).
    This documents initiates a 60-day comment period during which 
manufacturers (including importers) of the chemical substance must 
self-identify as a manufacturer (or importer) to EPA (40 CFR 
700.45(b)(5)). Where appropriate, entities may also certify as to ``no 
manufacture'', ``cessation'' of manufacture or to meeting an exemption, 
in accordance with 40 CFR 700.45(b)(5)(ii)-(iv). Manufacturers 
(including importers) are required to provide EPA with the contact 
information as described in 40 CFR 700.45(b)(5)(i). The public will 
also have the opportunity to correct errors in the preliminary lists 
during the comment period. EPA expects to publish a final list of 
manufacturers subject to fees for each chemical substance following the 
comment period and no later than the date EPA issues the final scope 
document for these five High-Priority Substances. Manufacturers listed 
on the final lists will be subject to applicable fees under 40 CFR 
700.45.
    EPA is soliciting public comments that would inform the final lists 
by defining the universe of manufacturers (including importers) 
obligated to pay fees associated with each TSCA section 6 EPA-initiated 
risk evaluation for the five chemical substances identified in Unit 
I.C.

B. Self-Identifying as a Manufacturer or Importer

    In accordance with 40 CFR 700.45(b)(5), all persons who have 
manufactured or imported any of the five chemical substances designated 
as High-Priority Substances in the five years preceding publication of 
this preliminary list, other than those meeting the article, byproduct, 
and impurity exemptions listed in 40 CFR 700.45(a)(3)(i) through (iii), 
must submit notice to EPA, irrespective of whether they are included in 
the preliminary list specified in paragraph (b)(3) of this section. The 
manufacturers (including importers) of a chemical substance as a non-
isolated intermediate as defined in 40 CFR 704.3, for research and 
development described under 40 CFR 700.45(a)(3)(v), and those who 
manufacture (including import) quantities below a 2,500 lbs annual 
production volume described under 40 CFR 700.45(a)(3)(vi) must still 
self-identify even though they meet an exemption. In addition, as 
discussed in more detail in Unit III.B.4., certain manufacturers 
(including importers) must submit their production volume for the 
applicable substance for the calendar years 2022, 2023 and 2024.
    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: Name and address of the submitting 
company, the name and address of the authorized official for the 
submitting company, and the name and telephone number of a person who 
will serve as technical contact for the submitting company and who will 
be able to answer questions about the information submitted by the 
company to EPA.
    Manufacturers (including importers) on the preliminary lists have 
an opportunity to certify through CDX that: (1) they have already 
ceased manufacturing prior to the defined cutoff dates and will not 
manufacture (including import) in the successive five years; (2) they 
have not manufactured the chemical substance in the five-year period 
preceding publication of the preliminary lists; or (3) they meet one of 
the six exemptions at 40 CFR 700.45(a)(3)(i) through (vi). If EPA 
receives such a certification statement from a manufacturer, then the 
manufacturer will not be obligated to pay the fee, unless all 
manufacturers of a chemical substance manufacture the chemical in 
quantities below a 2,500 lbs annual production volume, in which case 
the exemption is not applicable, and those manufacturers are obligated 
to pay the fee. Manufacturers (including importers) who are not listed 
on the preliminary lists and otherwise believe they can certify that 
they are not subject to fee obligations as described in this Unit and 
in 40 CFR 700.45(b)(5) may choose to attest to these facts to EPA. In 
addition, entities will have the opportunity to certify as to whether 
they meet the definition of a ``small business concern'' as defined in 
40 CFR 700.43 and qualify for a reduced fee amount.
1. Certifying an Exit From the Market
    Manufacturers (including importers) certifying an exit from the 
market (i.e., cessation of manufacture and import) of any of the five 
High-Priority substances must have ceased manufacture prior to the 
certification cutoff date of December 18, 2023, and are prohibited from 
manufacturing the substance again in the successive five years. If EPA 
receives a certification attesting to these facts, the manufacturer 
will not be included in the final list of manufacturers and will not be 
obligated to pay the fee under this section. Manufacturers (including 
importers) planning to cease manufacture (including import) in the 
future (but have not yet done so), or those which have already ceased 
but may re-enter the market within the next five years, would not be 
permitted to certify out of the fee obligation. Manufacturers 
(including importers) which certify cessation are not required to 
provide production volume as discussed in B.4. of this Unit.
2. Certification of no Manufacture
    Manufacturers (including importers) identified on the preliminary 
list but have not manufactured the chemical in the five-year period 
preceding publication of this preliminary list, should submit a 
certification statement attesting to these facts. If EPA receives such 
a certification statement from a manufacturer, the manufacturer will 
not

[[Page 107102]]

be included in the final list of manufacturers and will not be 
obligated to pay the fee under this section.
3. Certification of Meeting Exemptions
    Manufacturers (including importers) of a chemical substance which 
exclusively qualify for one or more of the following exemptions will 
not be obligated to pay fees: (i) import of articles containing the 
chemical substance; (ii) produce the chemical substance as a byproduct 
that is not later used for commercial purposes or distributed for 
commercial use; (iii) manufacture the chemical substance as an impurity 
as defined in 40 CFR 704.3; (iv) manufacture the chemical substance as 
a non-isolated intermediate as defined in 40 CFR 704.3; (v) manufacture 
small quantities of the chemical substance solely for research and 
development, as defined in 40 CFR 700.43; or (vi) manufacture the 
chemical substance in quantities below a 2,500 lbs annual production 
volume as described in 40 CFR 700.43, unless all manufacturers of a 
chemical substance manufacture the chemical in quantities below a 2,500 
lbs annual production volume in which case the exemption is not 
applicable and those manufacturers are obligated to pay the fee.
    In order to avoid fee payment based on an exemption for all but the 
production volume exemption under 40 CFR 700.45(a)(3)(vi), the 
manufacturer must meet one or more exemptions, and not conduct 
manufacturing outside of those exemptions, on or after the 
certification cutoff date of December 18, 2023, and meet one or more of 
the exemptions in the successive five years. To meet the requirements 
for the production volume exemption under 40 CFR 700.45(a)(3)(vi), the 
manufacturer must meet that exemption for the five-year period 
preceding publication of the preliminary list (i.e., have had a 
production volume below 2,500 lbs annually for the previous five 
years), does not conduct manufacturing of that chemical substance 
outside of the exemption, and will meet the exemption in the successive 
five years.
    If a manufacturer is identified on the preliminary list and 
exclusively meets one or more of these exemptions, the manufacturer 
must submit a certification statement attesting to these facts in order 
to not be included in the final list of manufacturers. Regardless of 
whether they are included on the preliminary list or not, manufacturers 
(including importers) of a chemical substance as a non-isolated 
intermediate (i.e., the exemption under 40 CFR 700.45(a)(3)(iv)), for 
research and development (i.e., the exemption under 40 CFR 
700.45(a)(3)(v)), and manufacturers (including importers) of a chemical 
substance in quantities below a 2,500 lbs annual production volume 
(i.e., the exemption under 40 CFR 700.45(a)(3)(vi)), must self-identify 
to EPA. Requiring self-identification of manufacturers that qualify for 
the production volume-based exemption allows EPA to allocate fees based 
on production volume and collect fees in a timely manner in situations 
in which all fee payers have met that exemption criteria. In addition, 
those manufacturers (including importers) meeting the production volume 
exemption under 40 CFR 700.45(a)(3)(vi) must report their production 
volume for the three calendar years prior to publication of the 
preliminary list.
4. Reporting Production Volume
    Manufacturers (including importers) that do not submit a 
certification of cessation, a certification of no manufacture, or does 
not meet one or more of the exemptions, other than the production 
volume exemption in 40 CFR 700.45(a)(3)(vi), must submit their 
production volume for the applicable substance for the three calendar 
years prior to publication of the preliminary list (40 CFR 
700.45(b)(5)(v)). Similar to the requirements in the CDR rule, two 
significant figures should be used when calculating production volume. 
Companies with multiple facilities producing the same chemical 
substance should include the total aggregated production volume from 
all facilities when calculating the average production volume. Such 
companies should also not double count distribution of the same 
chemical substance within one company when that chemical mixture is 
``manufactured'' more than once (e.g., a company that manufactures a 
chemical, then exports for further processing, then imports the 
chemical mixture would not need to double count its production volume). 
Note, this does not apply if multiple companies are involved (e.g., a 
company manufactures a chemical, then exports it for additional 
processing, then a separate company imports the mixture). EPA will 
assess a fee for each of those manufacturers based on the production 
volume that they separately manufacture or import. EPA does not require 
the inclusion of non-TSCA chemicals in production volume calculations.

C. Failure To Self-Identify

    Manufacturers (including importers) who fail to self-identify as 
manufacturers subject to fee obligations, as required by the Fees Rule 
(Ref. 1), may be subject to a penalty under TSCA section 16. Each day 
of failed self-identification by a manufacturer (including importer) 
past the publication of the final list is a separate TSCA violation 
subject to penalty. Likewise, manufacturers (including importers) who 
falsely certify to having ceased manufacture (including import) or not 
re-initiating manufacture (including import) within five years will 
also be subject to penalty, as described in Unit III.H. of the 2018 
Fees Rule (Ref. 3).

D. Fee Obligations

    Fee obligations are set forth in 40 CFR 700.45 and include a total 
fee of $4,287,000 for each chemical substance undergoing EPA-initiated 
risk evaluation, with a reduced fee amount for small business concerns 
(Ref. 1). The total fee is shared amongst all identified manufacturers 
(including importers). The Fees Rule provides more detailed information 
on how EPA determined the fee amounts (Ref. 1). As required by 40 CFR 
700.45(g)(3)(iv)(A), fees will 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 
after 545 days after publishing the final scope of a risk evaluation. 
Manufacturers may also form a consortium to pay fees in accordance with 
40 CFR 700.45(f)(3). The consortium must notify EPA that a consortium 
has formed within 90 days of the publication of the final scope of a 
risk evaluation (40 CFR 700.45(f)(3)(i)). Once established, the 
consortium would determine how the fee would be split among the 
members, and ultimately paid to EPA. For the consortium to qualify for 
the reduced small business fee, each person in the consortium must 
qualify as a small business concern under 40 CFR 700.43.

E. Providing Public Comments

    With publication of the preliminary lists, EPA is providing a 60-
day comment period for manufacturers (including importers) and the 
public to correct errors, self-identify as a manufacturer, or certify 
that they have already exited the market and that they will not resume 
manufacture (including import) for a period of five years. After the 
comment period for the preliminary lists of entities subject to a fee 
obligation, EPA expects to make any necessary updates or corrections 
before publishing final lists of manufacturers for each of the five 
High-Priority Substances. If information received during the public 
comment period

[[Page 107103]]

would prompt the addition of manufacturers (including importers) to the 
final lists, then EPA plans to first notify those manufacturers 
(including importers).
    EPA expects the final lists will indicate whether any manufacturers 
were identified in error, any additional manufacturers that were 
identified through the comment period or self-identification process, 
and whether any manufacturers have certified that they have already 
ceased manufacture (including import) prior to the cutoff date of 
December 18, 2023, and will not manufacture the subject chemical 
substance for five years. The final list will be published no later 
than concurrently with the final scope document for each risk 
evaluation initiated by EPA under TSCA section 6 for these five High-
Priority Substances.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this notice. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Final Rule: Fees for Administration of Toxic Substances 
Control Act; Final Rule. Federal Register. 89 FR 12961, February 21, 
2024 (FRL-7911-05-OCSPP).
2. EPA. Notice: High-Priority Substance Designations Under the Toxic 
Substances Control Act (TSCA) and Initiation of Risk Evaluation on 
High-Priority Substances; Notice of Availability. Federal Register. 
89 FR 102903, December 18, 2024 (FRL-11581-07-OCSPP) (Docket ID No. 
EPA-HQ-OPPT-2023-0601).
3. EPA. Final Rule: Fees for Administration of Toxic Substances 
Control Act. Federal Register. 83 FR 52694, October 17, 2018 (FRL-
9984-41).
4. EPA. Preliminary List Identifying Manufacturers Subject to Fee 
Obligations for EPA-Initiated Risk Evaluations of Chemical, 
Acetaldehyde, CASRN 75-07-0. December 2024.
5. EPA. Preliminary List Identifying Manufacturers Subject to Fee 
Obligations for EPA-Initiated Risk Evaluations of Chemical, 
Acrylonitrile, CASRN 107-13-1. December 2024.
6. EPA. Preliminary List Identifying Manufacturers Subject to Fee 
Obligations for EPA-Initiated Risk Evaluations of Chemical, 
Benzenamine, CASRN 62-53-3. December 2024.
7. EPA. Preliminary List Identifying Manufacturers Subject to Fee 
Obligations for EPA-Initiated Risk Evaluations of Chemical, Vinyl 
Chloride, CASRN 75-01-4. December 2024.
8. EPA. Preliminary List Identifying Manufacturers Subject to Fee 
Obligations for EPA-Initiated Risk Evaluations of Chemical, 4,4'-
Methylene bis(2-chloroaniline) (MBOCA), CASRN 101-14-4. December 
2024.

    Authority: 15 U.S.C. 2601 et seq.

Michael S. Regan,
Administrator.
[FR Doc. 2024-30930 Filed 12-30-24; 8:45 am]
BILLING CODE 6560-50-P
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