Significant New Use Rules on Certain Chemical Substances (22-1.5e), 94642-94649 [2024-27914]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[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 [www.gpo.gov]
[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 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. Additional instructions on commenting and 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: 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: 
[email protected].
    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: 
[email protected].
    For general information on TSCA: 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. 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:
     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 
(https://www.epa.gov/tsca-import-export-requirements).
    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 https://www.regulations.gov. 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 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 https://www.epa.gov//epa-dockets.

II. Background

    This unit provides general information about SNURs. For additional 
information about EPA's new chemical program go to https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

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:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     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 https://www.epa.gov/pfas/epa-actions-address-pfas and https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf.
2. Objectives
    EPA is proposing these SNURs because the Agency wants:
     To identify as significant new uses any manufacturing, 
processing, use, distribution in commerce, or disposal of these 
chemical substances for any use.
     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.
     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 https://www.epa.gov/tsca-import-export-requirements.
    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 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
    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:
     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:
     PMN number (the proposed CFR citation assigned in the 
regulatory text section of the proposed rule).
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service Registry Number (CASRN) (if 
assigned for non-confidential chemical identities).
     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 https://www.epa.gov/laws-regulations-and-executive-orders.

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