Significant New Use Rules on Certain Chemical Substances (24-1.F), 94635-94642 [2024-27913]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Proposed Rules]
[Pages 94635-94642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27913]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2024-0359; FRL-12342-01-OCSPP]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (24-1.F)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for certain chemical substances 
that were the subject of premanufacture notices (PMNs). The chemical 
substances received ``not likely to present an unreasonable risk'' 
determinations pursuant to TSCA. The SNURs require persons who intend 
to manufacture (defined by statute to include import) or process any of 
these 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 that use, under 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-2024-0359, 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: Geraldine Hilton, New Chemicals Division 
(7405M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-8986; 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 that were the 
subject of PMNs as 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.
 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, 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 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.

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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 received a ``not 
likely to present an unreasonable risk'' determination in TSCA section 
5(a)(3)(c). During its review of these chemicals, EPA identified 
certain conditions of use that are not intended by the submitters, but 
reasonably foreseen to occur. EPA is proposing to designate those 
conditions of use as significant new uses.

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 submitted for the chemical substances 
that are the subject of these proposed SNURs and as further discussed 
in Unit III., EPA identified certain other conditions of use, in 
addition to those conditions of use intended by the submitter. EPA has 
determined that the chemical under the conditions of use is not likely 
to present an unreasonable risk. However, EPA has not assessed risks 
associated with certain conditions of use. EPA is proposing to 
designate these other circumstances of use as significant new uses. As 
a result, those significant new uses cannot occur without going through 
a separate, subsequent EPA review and determination process associated 
with a SNUN.
2. Objectives
    EPA is proposing these SNURs because the Agency wants:
     To be able to complete its review and determination on 
each of the PMN substances, while deferring analysis on the significant 
new uses proposed in these rules unless and until the Agency receives a 
SNUN.
     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. Significant New Uses Claimed as CBI

    EPA is proposing to establish certain significant new uses which 
have been claimed as CBI subject to Agency confidentiality regulations 
at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final 
determination or other disposition of the confidentiality claim under 
40 CFR part 2 procedures, EPA is required to keep this information 
confidential. EPA promulgated a procedure to deal with the situation 
where a specific significant new use is CBI, at 40 CFR 721.11.
    Under these procedures a manufacturer or processor may request EPA 
to identify the confidential significant new use under the rule. The 
manufacturer or processor must show that it has a bona fide intent to 
manufacture or process the chemical substance and must identify the 
specific use for which it intends to manufacture or process the 
chemical substance. If EPA concludes that the person has shown a bona 
fide intent to manufacture or process the chemical substance, EPA will 
identify the confidential significant new use to that person. Since 
most of the chemical identities of the chemical substances subject to 
these SNURs are also CBI, manufacturers and processors can combine the 
bona fide submission under the procedure in 40 CFR 721.11 into a single 
step.

D. 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

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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.

E. 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 undergone premanufacture review. In cases where EPA has not 
received a notice of commencement (NOC) and the chemical substance has 
not been added to the TSCA Inventory, no person may commence such 
activities without first submitting a PMN. Therefore, for chemical 
substances for which an NOC has not been submitted EPA concludes that 
the designated significant new uses are not ongoing. The identities of 
many of the chemical substances subject to this proposed rule have been 
claimed as confidential per 40 CFR 720.85 and the PMN submitter did not 
intend to engage in the other circumstances of use that are designated 
as significant new uses for the chemical substances subject to this 
proposed rule. Based on this, the Agency believes that it is highly 
unlikely that any of the significant new uses identified in Unit III. 
are ongoing.
    When the chemical substances identified are added to the TSCA 
Inventory, EPA recognizes that, before the rule is effective, other 
persons might engage in a use that has been identified as a significant 
new use. Persons who begin manufacture or processing of the chemical 
substances for a significant new use identified on or after the 
designated cutoff date specified in Unit III.A. would have to cease any 
such activity upon the effective date of the final rule. To resume 
their activities, these persons would have to first comply with all 
applicable SNUR notification requirements and EPA would have to take 
action under TSCA section 5 allowing manufacture or processing to 
proceed.

F. 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 identified for 
the chemical substance in Unit III.C.
    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 Unit III. 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 which 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 determining whether the new 
use is ongoing for these chemical substances?

    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.E.

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 this document).
     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 SNUR.
     Potentially useful information.
    The regulatory text section of this document specifies the 
activities designated as significant new uses. Certain new uses, 
including production volume limits and other uses designated

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in the proposed rules, may be claimed as CBI.
    The chemical substances have undergone premanufacture review. In 
addition to those conditions of use intended by the submitter, EPA has 
identified certain other circumstances of use. EPA has preliminarily 
determined that the chemicals under their conditions of use are not 
likely to present an unreasonable risk. However, EPA has not assessed 
risks associated with the other circumstances of use for these 
chemicals. EPA is proposing to designate these other circumstances of 
use as significant new uses. As a result, those significant new uses 
cannot occur without first going through a separate, subsequent EPA 
review and determination process associated with a SNUN.

C. Which chemical substances are subject to this proposed rule?

    The substances subject to the proposed rules in this document are 
as follows:
PMN Number (Proposed CFR Citation): P-20-168 (40 CFR 721.11955)
    Chemical Name: Polyolefin polyamine succinimide, carbopolycycle 
alkoxylated (generic).
    CASRN: Not available.
    Basis for Action: The PMN states that the use of the PMN substance 
will be as a lubricating additive for engine oils, transmission and 
hydraulic fluid, and gear oil applications. Based on comparison to 
analogous chemical substances and the structural alert for aliphatic 
amines, EPA has identified concerns for irritation to the eyes, skin, 
and respiratory tract if the chemical substance is not used following 
the limitation noted. The conditions of use of the PMN substance as 
described in the PMN include the following protective measure:
     Use of the PMN substance only as a lubricating additive 
for engine oils, transmission and hydraulic fluid, and gear oil 
applications.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the health 
effects of the PMN substance if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of skin 
irritation testing may be potentially useful to characterize the health 
effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-21-5 (40 CFR 721.11956)
    Chemical Name: Carbonmonocyclic alkene polymer with alkyl 
alkenoate, alkyl alkenoate, alkyl alkenoate and polyalkyldiene 
alkenoate (generic).
    CASRN: Not available.
    Basis for Action: The PMN states that the use of the PMN substance 
will be as a polymeric additive in gear oils. Based on comparison to 
analogous chemical substances, information provided in the Safety Data 
Sheet (SDS), and physical/chemical properties, EPA has identified 
concerns for skin and eye irritation and lung effects (lung overload) 
if the chemical substance is not used following the limitation noted. 
The conditions of use of the PMN substance as described in the PMN 
include the following protective measure:
     No manufacture, processing, or use of the PMN substance in 
any manner that results in worker inhalation exposure to the PMN 
substance.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the health 
effects of the PMN substance if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of skin 
irritation, eye irritation, and specific target organ toxicity testing 
may be potentially useful to characterize the health effects of the PMN 
substance.
PMN Number (Proposed CFR Citation): P-21-95 (40 CFR 721.11957)
    Chemical Name: 1-tetradecene, homopolymer, hydrogenated, by-
products from, C28-42 fraction.
    CASRN: 2263959-83-5.
    Basis for Action: The PMN states that the use of the PMN substance 
will be as a base oil for crankcase motor oil, transmission oil, and 
other industrial applications such as compressor and gear fluids and 
consumer use as a carrier fluid for additives to motor oils and 
automatic transmission fluids. Based on comparison to an analogous 
chemical substance and on physical/chemical properties, EPA has 
identified concerns for blood, respiratory tract, and lung effects 
including aspiration hazard if the chemical substance is not used 
following the limitation noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measure:
     No processing of the PMN substance other than in an 
enclosed system when heated.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the health 
effects of the PMN substance if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity and pulmonary effects testing may be 
potentially useful to characterize the health effects of the PMN 
substance.
PMN Number (Proposed CFR Citation): P-21-174 (40 CFR 721.11958)
    Chemical Name: Carbonic acid, ester, polymer with alkanediol 
(C=4,5) (generic).
    CASRN: Not available.
    Basis for Action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a raw material for 
polyurethane. Based on test data submitted on the PMN substance, EPA 
has identified concerns for aquatic toxicity if the chemical substance 
is not used following the limitation noted. The condition of use of the 
PMN substance as described in the PMN includes the following protective 
measure:
     No release of the PMN substance resulting in surface water 
concentrations that exceed 200 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the environmental 
effects of the PMN substance if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of chronic 
aquatic toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-23-17 (40 CFR 721.11959)
    Chemical Name: Hydrolyzed collagen, polymer with aromatic 
isocyanate, N-triethoxysylil-alkanamine, pectic polysaccharide and poly 
alkyl alcohol (generic).
    CASRN: Not available.
    Basis for Action: The PMN states that the use of the PMN substance 
will be as an encapsulant for time-released delivery of fragrance. 
Based on potential changes to the molecular weight or composition of 
the PMN substance, EPA has identified concerns for lung toxicity

[[Page 94640]]

if the chemical substance is not used following the limitation noted. 
The conditions of use of the PMN substance as described in the PMN 
include the following protective measure:
     Use of the PMN substance only as an encapsulant for time-
released delivery of fragrance.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the health 
effects of the PMN substance if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
pulmonary effects testing may be potentially useful to characterize the 
health effects of the PMN substance.

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, 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) FY2018, 
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 of 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

[[Page 94641]]

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

    This action does not concern human health or environmental 
conditions and therefore cannot be evaluated with respect to the 
potential for disproportionate impacts on non-white and low-income 
populations in accordance with Executive Order 12898 (59 FR 7629, 
February 16, 1994) and 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.  721.11955 through 721.11959 to Subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11955 Polyolefin polyamine succinimide, carbopolycycle 
alkoxylated (generic).
721.11956 Carbonmonocyclic alkene polymer with alkyl alkenoate, 
alkyl alkenoate, alkyl alkenoate and polyalkyldiene alkenoate 
(generic).
721.11957 1-Tetradecene, homopolymer, hydrogenated, by-products 
from, C28-42 fraction.
721.11958 Carbonic acid, ester, polymer with alkanediol (C=4,5) 
(generic).
721.11959 Hydrolyzed collagen, polymer with aromatic isocyanate, N-
triethoxysylil-alkanamine, pectic polysaccharide and poly alkyl 
alcohol (generic).
* * * * *


Sec.  721.11955  Polyolefin polyamine succinimide, carbopolycycle 
alkoxylated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyolefin polyamine succinimide, carbopolycycle alkoxylated (PMN P-20-
168) 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:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a lubricating 
additive for engine oils, transmission and hydraulic fluid, and gear 
oil applications.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11956  Carbonmonocyclic alkene polymer with alkyl alkenoate, 
alkyl alkenoate, alkyl alkenoate and polyalkyldiene alkenoate 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carbonmonocyclic alkene polymer with alkyl alkenoate, alkyl alkenoate, 
alkyl alkenoate and polyalkyldiene alkenoate (PMN P-21-5) 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:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in worker inhalation exposure to the substance.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11957  1-Tetradecene, homopolymer, hydrogenated, by-products 
from, C28-42 fraction.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-tetradecene, 
homopolymer, hydrogenated, by-products from, C28-42 fraction (PMN P-21-
95; CASRN 2263959-83-5) 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:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to process the substance other than in an enclosed 
system when heated.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are

[[Page 94642]]

applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11958  Carbonic acid, ester, polymer with alkanediol (C=4,5) 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carbonic acid, ester, polymer with alkanediol (C=4,5) (PMN P-21-174) 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:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=200.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11959  Hydrolyzed collagen, polymer with aromatic isocyanate, 
N-triethoxysylil-alkanamine, pectic polysaccharide and poly alkyl 
alcohol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
hydrolyzed collagen, polymer with aromatic isocyanate, N-
triethoxysylil-alkanamine, pectic polysaccharide and poly alkyl alcohol 
(PMN P-23-17) 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:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as an encapsulant 
for time-released delivery of fragrance.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
* * * * *
[FR Doc. 2024-27913 Filed 11-27-24; 8:45 am]
BILLING CODE 6560-50-P