Proposed Rule2024-27914
Significant New Use Rules on Certain Chemical Substances (22-1.5e)
Primary source
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Published
November 29, 2024
Issuing agencies
Environmental Protection Agency
Abstract
EPA is issuing this supplemental proposal to update the significant new use rules (SNURs) previously proposed under the Toxic Substances Control Act (TSCA) for seventeen chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to an Order issued by EPA pursuant to TSCA. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of these seventeen chemical substances for an activity that is proposed as a significant new use by this rulemaking to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination.
Full Text
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[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Proposed Rules]
[Pages 94642-94649]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27914]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2021-0847; FRL-9972-05-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (22-
1.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Supplemental notice of proposed rulemaking.
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SUMMARY: EPA is issuing this supplemental proposal to update the
significant new use rules (SNURs) previously proposed under the Toxic
Substances Control Act (TSCA) for seventeen chemical substances that
were the subject of premanufacture notices (PMNs) and are also subject
to an Order issued by EPA pursuant to TSCA. The SNURs would require
persons who intend to manufacture (defined by statute to include
import) or process any of these seventeen chemical substances for an
activity that is proposed as a significant new use by this rulemaking
to notify EPA at least 90 days before commencing that activity. The
required notification initiates EPA's evaluation of the conditions of
use for that chemical substance. In addition, the manufacture or
processing for the significant new use may not commence until EPA has
conducted a review of the required notification, made an appropriate
determination regarding that notification, and taken such actions as
required by that determination.
DATES: Comments must be received on or before December 30, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0847, at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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. Additional instructions on commenting and visiting the
docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information: Meg Victor, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 343-9193; email address:
<a href="/cdn-cgi/l/email-protection#d9afb0baadb6abf7b4bcbe99bca9b8f7beb6af"><span class="__cf_email__" data-cfemail="f0869993849f82de9d9597b0958091de979f86">[email protected]</span></a>.
For general information on SNURs: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; email address:
<a href="/cdn-cgi/l/email-protection#710608021e1f165f06181d1d18101c311401105f161e07"><span class="__cf_email__" data-cfemail="c2b5bbb1adaca5ecb5abaeaeaba3af82a7b2a3eca5adb4">[email protected]</span></a>.
For general information on TSCA: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave, Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#b5e1e6f6f498fddac1d9dcdbd0f5d0c5d49bd2dac3"><span class="__cf_email__" data-cfemail="2c787f6f6d01644358404542496c495c4d024b435a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the factors in TSCA section 5(a)(2) (see
also the discussion in Unit II.).
B. What action is the Agency taking?
EPA is proposing SNURs for chemical substances discussed in Unit
III. These SNURs, if finalized as proposed, would require persons who
intend to manufacture or process any of these chemical substances for
an activity that is designated as a significant new use to notify EPA
at least 90 days before commencing that activity.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances contained in this proposed rule. The following list
of North American Industrial 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:
<bullet> Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
[[Page 94643]]
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing
import certification and export notification requirements under TSCA
(<a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>).
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612),
the requirements promulgated at 19 CFR 12.118 through 12.127 (see also
19 CFR 127.28), and the EPA policy in support of import certification
at 40 CFR part 707, subpart B. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA, including regulations issued under TSCA sections
5, 6, 7 and Title IV.
Pursuant to 40 CFR 721.20, any persons who export or intend to
export a chemical substance that is the subject of this proposed rule
on or after December 30, 2024 are subject to the export notification
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing SNUN
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substances subject to these
proposed SNURs. This analysis, which is available in the docket, is
briefly summarized here.
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,000 per SNUN
submission for large business submitters and $14,500 for small business
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central Data Exchange (CDX)),
and the payment of a user fee. Businesses that submit a SNUN would be
subject to either a $37,000 user fee required by 40 CFR
700.45(c)(2)(ii) and (d), or, if they are a small business as defined
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR
700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission
for SNUNs will not be incurred by any company unless a company decides
to pursue a significant new use as defined in these SNURs.
Additionally, these estimates reflect the costs and fees as they are
known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the
export notification requirements under TSCA section 12(b) and the
implementing regulations at 40 CFR part 707, subpart D. For persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical, depending on the number of required notifications (i.e., the
number of countries to which the chemical is exported). While EPA is
unable to make any estimate of the likely number of export
notifications for the chemical substances covered by these SNURs, as
stated in the accompanying economic analysis, the estimated cost of the
export notification requirement on a per unit basis is approximately
$106.
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through email or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you wish to include CBI in your comment, please
follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the information that you
claim to be CBI. 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 <a href="https://www.epa.gov//epa-dockets">https://www.epa.gov//epa-dockets</a>.
II. Background
This unit provides general information about SNURs. For additional
information about EPA's new chemical program go to <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
A. Significant New Use Determination Factors
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
<bullet> The projected volume of manufacturing and processing of a
chemical substance.
<bullet> The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
<bullet> The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
<bullet> The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the substances, in the context of the four bulleted
TSCA section 5(a)(2) factors listed in this unit and discussed in Unit
III.
These proposed SNURs include PMN substances that are subject to
Orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). The proposed SNURs
identify significant new uses consistent with TSCA section 5(f)(4).
B. Rationale and Objectives of the SNURs
1. Rationale
Under TSCA, no person may manufacture a new chemical substance or
manufacture or process a chemical substance for a significant new use
until EPA makes a determination as described in TSCA section 5(a) and
takes any required action. The issuance of a SNUR is not a risk
determination itself, only a notification requirement for ``significant
new uses,'' so that the Agency has the opportunity to review the SNUN
for the significant new use and make a TSCA section 5(a)(3) risk
determination.
During review of the PMNs that are subject to these proposed SNURs,
EPA concluded that regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in the December
2022 proposal (87 FR 74072, December 2, 2022 (FRL-9972-01-OCSPP)).
Based on these findings, TSCA section 5(e) Orders requiring the use of
exposure controls were negotiated with the PMN submitters. As a general
matter, EPA believes it is necessary to follow the TSCA Orders with a
SNUR that identifies the absence of those protective measures as
significant new uses to ensure that all manufacturers and processors--
not just the original submitter--are held to the same standard.
[[Page 94644]]
EPA previously proposed SNURs for these seventeen chemical
substances in the December 2022 proposal. Those SNURs would have
required notice to EPA by any person prior to manufacturing or
processing the chemical substances in a way that does not conform to
the measures in the Order; additionally, EPA proposed to require notice
for annual production volumes greater than 2,500 pounds and for uses
other than the uses described in the PMNs, on the basis that notices of
commencement (NOC) had not been received for these chemical substances
and the substances were not on the TSCA Inventory.
A commenter on the December 2022 proposal stated that EPA should
designate ``any use'' of a substance not on the TSCA Inventory as a
significant new use, stating that the Agency has the authority to do so
given there are currently no ongoing uses. The commenter noted that
this would enable EPA to reassess risks from the substances under any
conditions of use according to current weight-of-evidence on these
substances, stating that the SNURs in the December 2022 proposal may
not be sufficient to prevent unreasonable risk given the substances'
persistent, bioaccumulative, and toxic nature, and noting that based on
analogous substances there may be health risks even at limited
production volumes that may present unreasonable risks to human health.
EPA agrees with the commenter and is issuing this supplemental
proposal for the seventeen chemical substances for which NOCs have not
been received and the substances are not on the TSCA Inventory;
furthermore, EPA has not granted any exemption from full PMN review
(e.g., a low volume exemption) for these chemical substances to any
manufacturer. Because these seventeen chemical substances are not on
the TSCA Inventory (and no exemptions were granted for their
manufacture), EPA proposes to find that there are no ongoing uses of
these chemicals. Therefore, EPA is proposing SNURs that identify
manufacture (which includes import) or processing these chemical
substances for any use as a significant new use, to enable the Agency
to evaluate and manage risks, where appropriate, from activities
associated with use of these chemical substances before manufacture or
processing were to begin.
This proposed rule advances one of the ``key actions'' in the Per-
and Polyfluoroalkyl Substances (PFAS) Strategic Roadmap where EPA
stated it plans to revisit past PFAS regulatory decisions and address
those that are insufficiently protective by imposing additional
notification requirements. In this way, the Agency can ensure it has
the opportunity to review PFAS before they are used in new ways that
might present concerns. To view the PFAS Strategic Roadmap and learn
more about EPA actions to address PFAS, please visit <a href="https://www.epa.gov/pfas/epa-actions-address-pfas">https://www.epa.gov/pfas/epa-actions-address-pfas</a> and <a href="https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf">https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf</a>.
2. Objectives
EPA is proposing these SNURs because the Agency wants:
<bullet> To identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal of these
chemical substances for any use.
<bullet> To have an opportunity to review and evaluate data
submitted in a SNUN before the submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
<bullet> To be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use. The Agency will either determine under TSCA section 5(a)(3)(C)
that the significant new use is not likely to present an unreasonable
risk, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant by the Administrator
under the conditions of use, or make a determination under TSCA section
5(a)(3)(A) or (B) and take the required regulatory action associated
with the determination, before manufacture or processing for the
significant new use of the chemical substance can occur.
Issuance of a proposed SNUR for a chemical substance does not
signify that the chemical substance is listed on the TSCA Chemical
Substance Inventory (TSCA Inventory). Guidance on how to determine if a
chemical substance is on the TSCA Inventory is available at https://
www.epa.gov/tsca-inventory.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to SNURs, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA sections 5(b)
and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720.
In addition, provisions relating to user fees appear at 40 CFR part
700.
Once EPA receives a SNUN, EPA must either determine that the
significant new use is not likely to present an unreasonable risk of
injury under the conditions of use for the chemical substance or take
such regulatory action as is associated with an alternative
determination under TSCA section 5 before the manufacture (including
import) or processing for the significant new use can commence. If EPA
determines that the significant new use of the chemical substance is
not likely to present an unreasonable risk, EPA is required under TSCA
section 5(g) to make public, and submit for publication in the Federal
Register, a statement of EPA's findings.
As discussed in Unit I.C.2., persons who export or intend to export
a chemical substance identified in a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b), and
persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements. See
also <a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>.
EPA is proposing that the general reporting exemption described in
40 CFR 721.45(i) not apply to these SNURs. 40 CFR 721.45(i) provides
that the notification requirements of 40 CFR 721.25 do not apply,
unless otherwise specified in a specific SNUR, if: ``The person is
operating under the terms of a consent order issued under section 5(e)
of the Act applicable to that person. If a provision of such section
5(e) order is inconsistent with a specific significant new use
identified in subpart E of this part, abiding by the provision of the
section 5(e) order exempts the person from submitting a significant new
use notice for that specific significant new use.'' EPA is proposing to
make that exemption inapplicable to each SNUR in this document to
ensure that persons subject to the Order would also be subject to the
significant new use notification requirements in the proposed SNURs.
D. Applicability of the Proposed SNURs to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have
[[Page 94645]]
undergone premanufacture review and received determinations under TSCA
section 5(a)(3)(C). Further, the seventeen substances in this proposed
rule are not on the TSCA Inventory (and EPA has not granted any
exemption from full PMN review for these chemical substances to any
manufacturer). Based on this, the Agency finds that the significant new
uses identified in the proposed SNURs are not ongoing.
E. Important Information About SNUN Submissions
1. SNUN Submissions
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-
PMN software, and submitted to the Agency in accordance with the
procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is
available electronically at <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
2. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A)
requires such information to be submitted to EPA at the time of
submission of the SNUN.
In the absence of a rule, TSCA order, or consent agreement under
TSCA section 4 covering the chemical substance, persons are required
only to submit information in their possession or control and to
describe any other information known to or reasonably ascertainable by
them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the
Agency has the authority to require appropriate testing. To assist with
EPA's analysis of the SNUN, submitters are encouraged, but not
required, to provide the potentially useful information that was
identified for the chemical substances in the December 2022 proposal.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h). For more
information on alternative test methods and strategies to reduce
vertebrate animal testing, visit <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce</a>.
The potentially useful information described in the December 2022
proposal may not be the only means of providing information to evaluate
the chemical substance associated with the significant new uses.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA sections 5(e) or 5(f).
EPA recommends that potential SNUN submitters contact EPA early enough
so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on the following:
<bullet> Human exposure and environmental release that may result
from the significant new use of the chemical substances.
III. Chemical Substances Subject to These Proposed SNURs
A. What is the designated cutoff date for ongoing?
EPA designates November 29, 2024 as the cutoff date for determining
whether the new use is ongoing. This designation is explained in more
detail in Unit II.D.
B. What information is provided for each chemical substance?
For each chemical substance identified in Unit III.C., EPA provides
the following information:
<bullet> PMN number (the proposed CFR citation assigned in the
regulatory text section of the proposed rule).
<bullet> Chemical name (generic name, if the specific name is
claimed as CBI).
<bullet> Chemical Abstracts Service Registry Number (CASRN) (if
assigned for non-confidential chemical identities).
<bullet> Basis for the action and potentially useful information.
The regulatory text section of this document specifies the
activities proposed to be designated as significant new uses. The
proposed SNURs identify as significant new uses manufacture (including
import) or processing for any use.
C. Which chemical substances are subject to this proposed rule?
The 17 substances subject to the proposed rules in this document
are as follows:
PMN Numbers (proposed CFR citation): P-05-491 (40 CFR 721.11735),
P-05-492 (40 CFR 721.11736), P-05-503 (40 CFR 721.11737), P-05-504 (40
CFR 721.11738), P-05-505 (40 CFR 721.11739), P-05-838 (40 CFR
721.11740), P-06-206 (40 CFR 721.11741), P-06-207 (40 CFR 721.11742),
P-06-208 (40 CFR 721.11743), P-06-211 (40 CFR 721.11744), P-06-212 (40
CFR 721.11745), P-06-213 (40 CFR 721.11746), P-06-214 (40 CFR
721.11747), P-06-215 (40 CFR 721.11748), P-06-216 (40 CFR 721.11749),
P-06-217 (40 CFR 721.11750), and P-06-224 (40 CFR 721.11751).
Chemical Names: Fluoroalkylacrylate copolymer (generic) (P-05-491,
P-05-492, P-05-504, P-05-505, P-05-838, P-06-207, P-06-208, P-06-211,
P-06-212, P-06-213, P-06-214, P-06-215, P-06-216, P-06-217, and P-06-
224), Fluorochemical urethane; (generic) (P-05-503), and Fluoroalkyl
acrylate (generic) (P-06-206).
CASRN or Accession Numbers: Not Available.
Basis for the action and potentially useful information: The
December 2022 proposal provided the basis for and effective date of the
TSCA Order for each of these substances, and also identified
potentially useful information.
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at <a href="https://www.epa.gov/laws-regulations-and-executive-orders">https://www.epa.gov/laws-regulations-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review
This action proposes to establish SNURs for new chemical substances
that were the subject of PMNs. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive
Order 14094 (88 FR 21879, April 11, 2023).
B. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA,
[[Page 94646]]
unless it has been approved by OMB and displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations in title
40 of the CFR, after appearing in the Federal Register, are listed in
40 CFR part 9, and included on the related collection instrument or
form, if applicable.
The information collection requirements related to SNURs have
already been approved by OMB pursuant to PRA under OMB control number
2070-0038 (EPA ICR No. 1188). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per submission. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
EPA always welcomes your feedback on the burden estimates. Send any
comments about the accuracy of the burden estimate, and any suggested
methods for improving the collection instruments or instruction or
minimizing respondent burden, including through the use of automated
collection techniques.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA (5
U.S.C. 601 et seq.). The requirement to submit a SNUN applies to any
person (including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, EPA has concluded that no small or large entities
presently engage in such activities.
A SNUR requires that any person who intends to engage in such
activity in the future must first notify EPA by submitting a SNUN.
Although some small entities may decide to pursue a significant new use
in the future, EPA cannot presently determine how many, if any, there
may be. However, EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was 16 in Federal fiscal year (FY) 2018, five
in FY2019, seven in FY2020, 13 in FY2021, 11 in FY2022, and 15 in
FY2023, and only a fraction of these submissions were from small
businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $37,000 to 6,480.
This lower fee reduces the total reporting and recordkeeping cost of
submitting a SNUN to about $14,500 per SNUN submission for qualifying
small firms. Therefore, the potential economic impacts of complying
with these proposed SNURs are not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published in the Federal Register on June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented its general determination that SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C.
1531-1538, and does not significantly or uniquely affect small
governments. Based on EPA's experience with proposing and finalizing
SNURs, State, local, and Tribal governments have not been impacted by
SNURs, and EPA does not have any reasons to believe that any State,
local, or Tribal government will be impacted by these SNURs. In
addition, the estimated costs of this action to the private sector do
not exceed $183 million or more in any one year (the 1995 dollars are
adjusted to 2023 dollars for inflation using the GDP implicit price
deflator). The estimated costs for this action are discussed in Unit
I.D.
E. Executive Order 13132: Federalism
This action will not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not
expected to have a substantial direct effect on 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. Accordingly, the requirements of Executive Order 13132 do
not apply to this action.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action will not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is
not expected to have substantial direct effects on Indian Tribes,
significantly or uniquely affect the communities of Indian Tribal
governments and does not involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
do not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it does not concern an environmental health or
safety risk. Since this action does not concern a human health risk,
EPA's 2021 Policy on Children's Health also does not apply. Although
the establishment of these SNURs do not address an existing children's
environmental health concern because the chemical uses involved are not
ongoing uses, SNURs require that persons notify EPA at least 90 days
before commencing manufacture (defined by statute to include import) or
processing of any of these chemical substances for an activity that is
designated as a significant new use by this rulemaking. This
notification allows EPA to assess the intended uses to identify
potential risks and take appropriate actions before the activities
commence.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
EPA believes that this type of action does not concern human health
or environmental conditions and therefore cannot be evaluated with
respect to potentially disproportionate and adverse effects on
communities with environmental justice concerns in accordance with
Executive Order 12898 (59 FR 7629, February 16, 1994) and
[[Page 94647]]
Executive Order 14096 (88 FR 25251, April 26, 2023). Although this
action does not concern human health or environmental conditions, the
premanufacture notifications required by these SNURs allows EPA to
assess the intended uses to identify potential disproportionate risks
and take appropriate actions before the activities commence.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: November 22, 2024.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR chapter I as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. Sec. 721.11735 through 721.11751 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11735 Fluoroalkylacrylate copolymer (generic).
721.11736 Fluoroalkylacrylate copolymer (generic).
721.11737 Fluorochemical urethane (generic).
721.11738 Fluoroalkylacrylate copolymer (generic).
721.11739 Fluoroalkylacrylate copolymer (generic).
721.11740 Fluoroalkylacrylate copolymer (generic).
721.11741 Fluoroalkyl acrylate (generic).
721.11742 Fluoroalkylacrylate copolymer (generic).
721.11743 Fluoroalkylacrylate copolymer (generic).
721.11744 Fluoroalkylacrylate copolymer (generic).
721.11745 Fluoroalkylacrylate copolymer (generic).
721.11746 Fluoroalkylacrylate copolymer (generic).
721.11747 Fluoroalkylacrylate copolymer (generic).
721.11748 Fluoroalkylacrylate copolymer (generic).
721.11749 Fluoroalkylacrylate copolymer (generic).
721.11750 Fluoroalkylacrylate copolymer (generic).
721.11751 Fluoroalkylacrylate copolymer (generic).
* * * * *
Sec. 721.11735 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-05-491) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11736 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-05-492) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11737 Fluorochemical urethane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluorochemical urethane (PMN P-05-503) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11738 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-05-504) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11739 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-05-505) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11740 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-05-838) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
[[Page 94648]]
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11741 Fluoroalkyl acrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkyl acrylate (PMN P-06-206) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11742 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-207) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11743 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-208) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11744 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-211) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11745 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-212) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11746 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-213) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11747 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-214) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11748 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-215) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The
[[Page 94649]]
provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11749 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-216) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11750 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-217) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11751 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-224) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are manufacture (including import) or
processing for any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(2) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
[FR Doc. 2024-27914 Filed 11-27-24; 8:45 am]
BILLING CODE 6560-50-P
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