[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]
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