Significant New Use Rules on Certain Chemical Substances (21-4.F), 24398-24415 [2024-07262]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 89, Number 68 (Monday, April 8, 2024)]
[Proposed Rules]
[Pages 24398-24415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07262]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2021-0228; FRL-11762-01-OCSPP]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (21-4.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 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 the 
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

[[Page 24399]]

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 May 8, 2024.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2021-0228, through the Federal eRulemaking 
Portal 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 contact: 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 contact: 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 rules under TSCA (https://www.epa.gov/tsca-import-export-requirements).
    Chemical importers are subject to the import provisions in 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 May 8, 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 significant 
new use notice (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 $26,700 per SNUN 
submission for large business submitters and $11,000 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 $19,020 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 $3,300 (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 704.
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

[[Page 24400]]

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 
reasonably foreseen conditions of use as well as certain other 
circumstances 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 721.1725(b)(1) 
and has referenced it to apply to other SNURs.
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a specific use would be a 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 tell the person whether the use identified in the 
bona fide submission would be a significant new use under the rule. 
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 
721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

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

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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 
intended 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 intended 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 the 
proposed rule. Based on this, the Agency believes that it is highly 
unlikely that any of the significant new uses described in the 
regulatory text of this proposed rule are ongoing.
    When the chemical substances identified in this proposed rule 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. Unit IV. lists 
potentially useful information for all SNURs listed here. Descriptions 
are provided for informational purposes. The potentially useful 
information identified in Unit IV. will be useful to EPA's evaluation 
in the event that someone submits a SNUN for the significant new use. 
Companies who are considering submitting a SNUN are encouraged, but not 
required, to develop the information on the substance, which may assist 
with EPA's analysis of the SNUN.
    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 April 8, 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 this document).
     Chemical name (generic name if the specific name is 
claimed as CBI).

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     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 in the 
proposed rules, may be claimed as CBI.
    The chemical substances that are the subject of these proposed 
SNURs 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-16-449 (40 CFR 721.11799)
    Chemical Name: 2,7-Decadienal, (2E,7Z)-.
    CASRN: 52711-52-1.
    Basis for action: The PMN states that the use of the PMN substance 
will be in cosmetics and as a fragrance for scented papers, detergents, 
candles, etc. Based on estimated physical/chemical properties of the 
PMN substance, submitted test data on the new chemical substance, 
comparison to analogous aldehydes, and comparison to structurally 
analogous chemical substances, EPA has identified concerns for systemic 
and developmental effects, skin sensitization, skin irritation, eye 
irritation, severe respiratory tract irritation, and aquatic toxicity 
if the chemical substance is not used following the limitations noted. 
The conditions of use of the PMN substance as described in the PMN 
include the following protective measures:
     No processing of the PMN substance to a concentration of 
greater than or equal to 1.0% in the final end use formulation; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human health 
and 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 specific target organ toxicity, reproductive toxicity, and 
aquatic toxicity testing may be potentially useful to characterize the 
health and environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-16-512 (40 CFR 721.11800)
    Chemical Name: Fatty acid dimers, polymer with acrylic acid and 
pentaerythritol reaction products (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a component of UV curable printing inks. Based on estimated 
physical/chemical properties of the PMN substance, test data on a 
component of the new chemical substance and a potential metabolite, and 
comparison to structurally analogous chemical substances, EPA has 
identified concerns for skin and eye corrosion, skin and respiratory 
tract sensitization, systemic effects, nasal effects, and reproductive 
and developmental toxicity if the chemical substance is not used 
following the limitations noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measures:
     Use of the PMN substance only as a component of UV curable 
printing inks; and
     Use of a National Institute for Occupational Safety and 
Health (NIOSH)-certified respirator with an Assigned Protection Factor 
(APF) of at least 50, or 1,000 in spray applications, where there is a 
potential for inhalation exposure.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human 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 eye 
damage, reproductive toxicity (developmental effects), skin 
sensitization, 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-17-115 (40 CFR 721.11801)
    Chemical Name: Aminoalkyl alkoxysilane (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as an adhesion promoter for coating formulations. Based on the 
estimated physical/chemical properties of the PMN substance and 
comparison to analogous chemical substances, EPA has identified 
concerns for eye and respiratory tract irritation, developmental 
toxicity, and lung toxicity if the chemical substance is not used 
following the limitations noted. The condition of use of the PMN 
substance as described in the PMN includes the following protective 
measure:
     No consumer use of 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 human 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 reproductive/developmental toxicity 
testing may be potentially useful to characterize the health effects of 
the PMN substance.
PMN Number (Proposed CFR Citation): P-18-36 (40 CFR 721.11802)
    Chemical Name: Siloxanes and Silicones, di-Me, 3-[3-carboxy-2(or 
3)-(octenyl)-1-oxopropoxy]propyl group-terminated.
    CASRN: 403616-34-2.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a water repellant. 
Based on estimated physical/chemical properties of the PMN substance 
and comparison to structurally analogous chemical substances, EPA has 
identified concerns for lung effects, systemic effects, and skin 
irritation if the chemical substance is not used following the 
limitations noted. The condition of use of the PMN substance as 
described in the PMN

[[Page 24403]]

includes the following protective measure:
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure.
    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 human 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 skin irritation testing may be 
potentially useful to characterize the health effects of the PMN 
substance.
PMN Number (Proposed CFR Citation): P-18-263 (40 CFR 721.11803)
    Chemical Name: Mixed alkyl esters-, polymer with N1-(2-aminoethyl)- 
l,2-ethanediamine, aziridine, N-acetyl derivs., acetates (salts) 
(generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a solution additive. 
Based on estimated physical/chemical properties of the PMN substance, 
comparison to structurally analogous chemical substances, and 
comparison to analogous polycationic polymers, EPA has identified 
concerns for lung effects, irritation to the skin, eyes, and 
respiratory tract, and aquatic toxicity if the new 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 5 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 human health 
and 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 specific target organ toxicity, pulmonary effects, and 
aquatic toxicity testing may be potentially useful to characterize the 
health and environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-18-336 (40 CFR 721.11804)
    Chemical Name: Propanedioic acid, 2,2-bis(hydroxymethyl)-, 1,3-
dihexyl ester.
    CASRN: 2222732-45-6.
    Basis for action: The PMN states that the use of the PMN substance 
will be as an intermediate. Based on estimated physical/chemical 
properties of the PMN substance, comparison to analogous chemical 
substances, and comparison to analogous esters, EPA has identified 
concerns for systemic effects, eye irritation, and aquatic toxicity if 
the new chemical substance is not used following the limitations 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 54 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 human health 
and 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 eye irritation, specific target organ toxicity, and aquatic 
toxicity testing may be potentially useful to characterize the health 
and environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-18-355 (40 CFR 721.11805)
    Chemical Name: Alkanediol, substituted alkyl, polymer with 
carbomonocyle, alkanedioate substituted carbomonocycle, ester with 
substituted alkanoate (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as paint. Based on the 
estimated physical/chemical properties of the PMN substance and 
comparison to analogous chemical substances, EPA has identified 
concerns for irritation to the skin, eyes, and respiratory tract, and 
lung effects if the chemical substance is not used following the 
limitations noted. The condition of use of the PMN substance as 
described in the PMN includes the following protective measure:
     No consumer use of 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 human 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 pulmonary effects testing may be 
potentially useful to characterize the health effects of the PMN 
substance.
PMN Number (Proposed CFR Citation): P-18-359 (40 CFR 721.11806)
    Chemical Name: Ethene, 1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-
trifluoro-, polymer with 1,1-difluoroethene.
    CASRN: 874290-13-8.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be for molded or extruded 
items. Based on estimated physical/chemical properties of the PMN 
substance and comparison to structurally analogous chemical substances, 
EPA has identified concerns for lung overload, lung waterproofing, 
systemic effects, neurotoxicity, and aquatic toxicity if the chemical 
substance is not used following the limitations noted. The conditions 
of use of the PMN substance as described in the PMN include the 
following protective measures:
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure; and
     No disposal of the PMN substance to media other than 
landfill.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human health 
and 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 specific target organ toxicity and aquatic toxicity testing 
may be potentially useful to characterize the health and environmental 
effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-18-369 (40 CFR 721.11807)
    Chemical Name: Maleic anhydride--substituted alkene copolymer 
(generic).
    CASRN: Not available.

[[Page 24404]]

    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a processing aid. 
Based on estimated physical/chemical properties of the PMN substance 
and comparison to structurally analogous chemical substances, EPA has 
identified concerns for corrosion to all tissues and aquatic toxicity 
if the chemical substance is not used following the limitations noted. 
The condition of use of the PMN substance as described in the PMN 
includes the following protective measure:
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure.
    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 human health 
and 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 skin irritation and aquatic toxicity testing may be 
potentially useful to characterize the health and environmental effects 
of the PMN substance.
PMN Number (Proposed CFR Citation): P-18-382 (40 CFR 721.11808)
    Chemical Name: Xanthylium, bis[dicarboxycyclic]sulfonylamino-
alkylcyclicamino-disulfo-sulfocyclic-, inner salt, monocationic salt 
(generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a dye for printing 
ink. Based on estimated physical/chemical properties of the PMN 
substance, submitted test data on the new chemical substance, 
comparison to structurally analogous chemical substances, and 
comparison to analogous acid dyes and amphoteric dyes, EPA has 
identified concerns for systemic effects and aquatic toxicity if the 
chemical substance is not used following the limitations noted. The 
condition of use of the PMN substance as described in the PMN includes 
the following protective measure:
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure.
    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 human health 
and 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 specific target organ toxicity and aquatic toxicity may be 
potentially useful to characterize the health and environmental effects 
of the PMN substance.
PMN Number (Proposed CFR Citation): P-19-147 (40 CFR 721.11809)
    Chemical Name: Alkoxylated butyl alkyl ester (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a cleaning additive. 
Based on estimated physical/chemical properties of the PMN substance, 
submitted test data on the new chemical substance, comparison to 
structurally analogous chemical substances, and comparison to analogous 
esters, EPA has identified concerns for systemic, reproductive, and 
developmental effects, and aquatic toxicity if the chemical substance 
is not used following the limitations noted. The conditions of use of 
the PMN substance as described in the PMN include the following 
protective measures:
     Use of the PMN substance only for the confidential use 
described in the PMN;
     No use of the PMN substance in formulations at a higher 
percentage than the confidential percentage stated in the PMN; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 16 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human health 
and 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 specific target organ toxicity, reproductive/developmental 
toxicity, and aquatic toxicity testing may be potentially useful to 
characterize the health and environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-19-162 (40 CFR 721.11810)
    Chemical Name: Fatty acid alkyl amide, (dialkyl) amino alkyl, alkyl 
quaternized, salts (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a component in oil 
production. Based on estimated physical/chemical properties of the PMN 
substance, comparison to structurally analogous chemical substances, 
and comparison to analogous cationic surfactants, EPA has identified 
concerns for lung effects (surfactancy), irritation to all tissues, 
skin sensitization, neurological, systemic, reproductive, and 
developmental effects, corrosion to skin and eyes, and aquatic toxicity 
if the chemical substance is not used following the limitations noted. 
The conditions of use of the PMN substance as described in the PMN 
include the following protective measures:
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure;
     No release of the PMN substance resulting in freshwater 
surface water concentrations that exceed 1 ppb; and
     No release of the PMN substance resulting in marine 
surface water concentrations that exceed 17 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human health 
and 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 specific target organ toxicity, reproductive toxicity, skin 
irritation, skin corrosion, eye irritation, skin sensitization, and 
freshwater aquatic toxicity testing may be potentially useful to 
characterize the health and environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-20-11 (40 CFR 721.11811)
    Chemical Name: Tetraoxaspiro[5.5]alkyl-3,9-diylbis(alkyl-2,1-diyl) 
bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate) (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a light stabilizer. 
Based on estimated physical/

[[Page 24405]]

chemical properties of the PMN substance, submitted test data on the 
new chemical substance, comparison to analogous esters and vinyl 
nitriles, and comparison to structurally analogous chemical substances, 
EPA has identified concerns for neurotoxicity, developmental effects, 
and aquatic toxicity if the chemical substance is not used following 
the limitations noted. The conditions of use of the PMN substance as 
described in the PMN include the following protective measures:
     Use of the PMN substance only for the confidential use 
described in the PMN; and
     No exceedance of the confidential production volume 
described in the PMN.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human health 
and 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 neurotoxicity, reproductive toxicity (developmental effects 
for potential metabolite), and aquatic toxicity testing may be 
potentially useful to characterize the health and environmental effects 
of the PMN substance.
PMN Numbers (Proposed CFR Citations): P-20-48 and P-20-49 (40 CFR 
721.11812 and 721.11813)
    Chemical Names: Reaction products of alkyl-terminated 
alkylaluminoxanes and 
dihalogeno(alkylcyclopentadienyl)(tetraalkylcyclopentadienyl)transition 
metal coordination compound (generic) (P-20-48) and Reaction products 
of alkyl-aluminoxanes and bis(alkylcyclodialkylene)dihalogenozirconium 
(generic) (P-20-49).
    CASRN: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as catalysts. Based on 
the estimated physical/chemical properties of the PMN substances, 
comparison to analogous aluminum and other structurally analogous 
chemical substances, EPA has identified concerns for lung effects, skin 
sensitization, acute toxicity, developmental effects, systemic effects, 
neurotoxicity, corrosion to skin, eyes, and respiratory tract, lung 
toxicity, kidney toxicity, and aquatic toxicity if the new chemical 
substances are not used following the limitations noted. The conditions 
of use of the PMN substances as described in the PMNs include the 
following protective measures:
     No release of PMN substance P-20-48 resulting in surface 
water concentrations that exceed 6 ppb;
     No release of PMN substance P-20-49 resulting in surface 
water concentrations that exceed 3 ppb; and
     No manufacturing, processing, or use of the PMN substances 
other than in an enclosed process.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human health 
and environmental effects of the PMN substances 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, skin corrosion, skin 
irritation, skin sensitization, eye damage, and aquatic toxicity 
testing may be potentially useful to characterize the health and 
environmental effects of the PMN substances.
PMN Number (Proposed CFR Citation): P-20-61 (40 CFR 721.11814)
    Chemical Name: Formaldehyde, polymer with alkylphenols, alkyl ether 
(generic).
    CASRN: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a coating resin crosslinking agent. Based on estimated 
physical/chemical properties of the PMN substance, comparison to 
structurally analogous chemical substances, and comparison to analogous 
phenols, EPA has identified concerns for irritation, sensitization, 
reproductive toxicity, and systemic effects if the new 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 330 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 human 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, reproductive/developmental toxicity, 
skin sensitization, endocrine effects, skin irritation, and eye damage 
testing may be potentially useful to characterize the health effects of 
the PMN substance.
PMN Number (Proposed CFR Citation): P-20-66 (40 CFR 721.11815)
    Chemical Name: 2-Propenoic acid, 2-hydroxyethyl ester, reaction 
products with dialkyl hydrogen heterosubstituted phosphate and dimethyl 
phosphonate (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an antiwear additive 
for lubricants. Based on estimated physical/chemical properties of the 
PMN substance, submitted test data on the new chemical substance, and 
comparison to structurally analogous chemical substances, EPA has 
identified concerns for skin and eye irritation, systemic toxicity, 
reproductive/developmental toxicity, and aquatic toxicity if the 
chemical substance is not used following the limitations noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measures:
     Use of the PMN substance only for the confidential use 
described in the PMN;
     No manufacture or processing of the PMN substance in 
consumer products at a concentration greater than 3% (by weight); and
     No release of the PMN substance from manufacturing or 
processing sites resulting in surface water concentrations that exceed 
6 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human health 
and 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 specific target organ toxicity, reproductive/developmental 
toxicity, and aquatic toxicity testing may be potentially useful to 
characterize the health and environmental effects of the PMN substance.

[[Page 24406]]

PMN Number (Proposed CFR Citation): P-20-86 (40 CFR 721.11816)
    Chemical Name: 2-Oxepanone, homopolymer, ester with hydroxyalkyl 
trioxo heteromonocyclic (3:1) (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a component of 
polymers. Based on estimated physical/chemical properties of the PMN 
substance, comparison to structurally analogous chemical substances, 
and comparison to analogous esters, EPA has identified concerns for 
aquatic toxicity if the new 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 92 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 aquatic 
toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-20-90 (40 CFR 721.11817)
    Chemical Name: Poly(oxy-1,2-ethanediyl), .alpha.-(alkyl-
hydroxyalkyl)-.omega.-hydroxy-, .omega.-alkyl ethers (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a surfactant for use in dishwashing detergents. Based on 
estimated physical/chemical properties of the PMN substance, submitted 
test data on the new chemical substance, comparison to structurally 
analogous chemical substances, and comparison to analogous nonionic 
surfactants, EPA has identified concerns for lung effects 
(surfactancy), irritation to the eyes and respiratory tract, and 
aquatic toxicity if the new 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 77 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 human health 
and 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 specific target organ toxicity, pulmonary effects, and 
aquatic toxicity testing may be potentially useful to characterize the 
health and environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-20-97 (40 CFR 721.11818)
    Chemical Name: Butanedioic acid, monopolyisobutylene derivs, mixed 
dihydroxyalkyl and hydroxyalkoxyalkyl diesters (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as an emulsifier for applications in explosives. Based on 
estimated physical/chemical properties of the PMN substance, comparison 
to structurally analogous chemical substances, and comparison to 
analogous esters, EPA has identified concerns for lung effects 
(surfactancy), irritation to the skin, eyes, and respiratory tract, 
systemic toxicity, developmental toxicity, and aquatic toxicity if the 
chemical substance is not used following the limitations noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measures:
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure to workers; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 6 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human health 
and 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 metabolism or pharmacokinetics, skin irritation/corrosion, 
eye irritation/corrosion, specific target organ and aquatic toxicity 
testing may be potentially useful to characterize the health and 
environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-20-99 (40 CFR 721.11819)
    Chemical Name: Mixed metal oxide (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a material used for the production of lithium ion conductive 
separators for rechargeable batteries. Based on the estimated physical/
chemical properties of the PMN substance and comparison to analogous 
chemical substances, EPA has identified concerns for lung effects 
including lung cancer, neurotoxicity, reproductive and development 
effects, and systemic effects if the chemical substance is not used 
following the limitations noted. The condition of use of the PMN 
substance as described in the PMN includes the following protective 
measure:
     No manufacture of the PMN substance with greater than 1% 
of particles less than 10 microns.
    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 human 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 testing may be potentially useful to 
characterize the health effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-20-102 (40 CFR 721.11820)
    Chemical Name: Coal, brown, ammoxidized.
    CASRN: 2413186-32-8.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a fertilizer/soil amendment. Based on estimated physical/
chemical properties of the PMN substance and comparison to structurally 
analogous chemical substances, EPA has identified concerns for systemic 
effects, reproductive/developmental effects, lung toxicity, and 
carcinogenicity if the chemical substance is not used following the 
limitations noted. The conditions of use of the PMN substance as 
described in the PMN include the following protective measures:
     No domestic manufacture (i.e., import only); and
     Use of the PMN substance only as a fertilizer/soil 
amendment.

[[Page 24407]]

    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human 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 
reproductive/developmental, carcinogenicity 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-20-103 (40 CFR 721.11821)
    Chemical Name: Cycloalphatic amine formate (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an onsite 
intermediate for the production of finished goods. Based on estimated 
physical/chemical properties of the PMN substance, comparison to 
structurally analogous chemical substances, and comparison to analogous 
aliphatic amines, EPA has identified concerns for irritation/corrosion 
to the skin, eyes, and respiratory tract, potential lung and 
respiratory tract toxicity, acute toxicity (mortality), systemic 
effects, neurotoxicity, reproductive/developmental effects and aquatic 
toxicity if the chemical substance is not used following the 
limitations noted. The conditions of use of the PMN substance as 
described in the PMN include the following protective measures:
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 66 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human health 
and 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 specific target organ, reproductive/developmental, and 
aquatic toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-20-107 (40 CFR 721.11822)
    Chemical Name: Carbimide, polyalkylenepolyarylene ester, polymer 
with 1,2-alkanediol, 2-alkoxyalkyl methacrylate- and 3-(2-alkoxyalkyl)-
2-heterocycle-blocked (generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a crosslinking 
polymer. Based on estimated physical/chemical properties of the PMN 
substance, comparison to analogous acrylates/methacrylates, and 
comparison to structurally analogous chemical substances, EPA has 
identified concerns for skin and respiratory sensitization and skin, 
eye, and respiratory tract irritation if the chemical substance is not 
used following the limitations noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measures:
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure; and
     No consumer use of the PMN substance.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human 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/corrosion, and sensitization testing may be 
potentially useful to characterize the health effects of the PMN 
substance.
PMN Number (Proposed CFR Citation): P-20-132 (40 CFR 721.11823)
    Chemical Name: 1H-Pyrrole-2,5-dione, 3-methyl-, 1,1'-C36-
alkylenebis.
    CASRN: 2414071-06-8.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an adhesive 
component. Based on estimated physical/chemical properties of the PMN 
substance, comparison to analogous imides, and comparison to 
structurally analogous chemical substances, EPA has identified concerns 
for acute toxicity, liver, and kidney effects, genotoxicity, skin and 
respiratory sensitization, skin and eye irritation, systemic effects, 
and reproductive/developmental effects if the chemical substance is not 
used following the limitations noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measures:
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure; and
     No consumer use of the PMN substance.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human 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, reproductive/developmental, and genetic toxicity 
testing may be potentially useful to characterize the health effects of 
the PMN substance.
PMN Number (Proposed CFR Citation): P-20-136 (40 CFR 721.11824)
    Chemical Name: Arylcarboxylic acid, alkyl ester, polymer with 
alkanediol, ester with methyloxirane polymer with oxirane alkyl ether 
(generic).
    CASRN: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a surface treatment compound for textiles. Based on 
estimated physical/chemical properties of the PMN substance and 
comparison to structurally analogous chemical substances, EPA has 
identified concerns for lung surfactancy, cardiovascular effects, 
systemic effects, and neurotoxicity if the chemical substance is not 
used following the limitations noted. The condition of use of the PMN 
substance as described in the PMN includes the following protective 
measure:
     No manufacturing or processing of the PMN substance in a 
manner that results in inhalation exposures to workers.
    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 human 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, neurotoxicity, and pulmonary effects 
testing may be

[[Page 24408]]

potentially useful to characterize the health effects of the PMN 
substance.
PMN Number (Proposed CFR Citation): P-20-143 (40 CFR 721.11825)
    Chemical Name: Cyclohexanemethanamine, 5-amino-1,3,3-trimethyl-, 
polymer with a-hydro-w-hydroxypoly(oxy-1,4-butanediyl), 5- isocyanato-
1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and 1,1-methylenebis[4-
isocyanatobenzene].
    CASRN: 2417925-50-7.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a binder for thermoplastic coatings and inks/adhesives. 
Based on the estimated physical/chemical properties of the PMN 
substance and comparison to analogous polycationic polymers, EPA has 
identified concerns for irritation to the eyes, skin, and respiratory 
tract if the chemical substance is not used following the limitations 
noted. The condition of use of the PMN substance as described in the 
PMN includes the following protective measure:
     No consumer use of 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 human 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 and eye damage testing may be potentially useful to 
characterize the health effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-20-146 (40 CFR 721.11826)
    Chemical Name: Alkanoic acid, alkyl, carbopolycyclic alkyl ester 
(generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an insulating 
material for electrical parts. Based on estimated physical/chemical 
properties of the PMN substance, comparison to structurally analogous 
chemical substances EPA has identified concerns for corrosion, skin, 
eye, respiratory tract irritation, skin sensitization, and aquatic 
toxicity if the chemical substance is not used following the 
limitations noted. The conditions of use of the PMN substance as 
described in the PMN include the following protective measures:
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in worker inhalation exposure; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 13 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the human health 
and 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 skin sensitization and aquatic toxicity testing may be 
potentially useful to characterize the health and environmental effects 
of the PMN substance.
PMN Number (Proposed CFR Citation): P-20-161 (40 CFR 721.11827)
    Chemical Name: Propanedioic acid, 2-methylene-, 1,3-diethyl ester, 
polymer with 1,4-butanediol.
    CASRN: 2364431-09-2.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a crosslinker additive used in waterborne emulsions and as a 
film former or crosslinker additive used in coatings and adhesives. 
Based on the estimated physical/chemical properties of the PMN 
substance, comparison to analogous chemical substances, and comparison 
to analogous acrylates/methacrylates, EPA has identified concerns skin, 
respiratory tract, and eye irritation, skin sensitization, local 
stomach effects, and acute inhalation toxicity if the chemical 
substance is not used following the limitations noted. The condition of 
use of the PMN substance as described in the PMN includes the following 
protective measure:
     No consumer use of 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 human 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, sensitization, and eye damage testing may be potentially 
useful to characterize the health effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-21-12 (40 CFR 721.11828)
    Chemical Name: Multialkylbicycloalkenyl substituted propanenitrile 
(generic).
    CASRN: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a fragrance 
ingredient. Based on estimated physical/chemical properties of the PMN 
substance, submitted test data on the new chemical substance, 
comparison to analogous neutral organics, and comparison to 
structurally analogous chemical substances, EPA has identified concerns 
for eye irritation, acute toxicity, liver effects, and aquatic toxicity 
if the chemical substance is not used following the limitations noted. 
The condition of use of the PMN substance as described in the PMN 
includes the following protective measure:
     No manufacture for any use greater than 10,000 kilograms 
per year of 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 human health 
and 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 acute toxicity, specific target organ toxicity, and chronic 
aquatic toxicity testing may be potentially useful to characterize the 
health and environmental 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).

[[Page 24409]]

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, and 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 $19,020 to $3,330. 
This lower fee reduces the total reporting and recordkeeping cost of 
submitting a SNUN to about $11,164 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)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this action. As 
such, EPA has determined that this action does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1531-1538 et seq.).

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 human health, 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

    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

[[Page 24410]]

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: April 1, 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.  721.11799 through 721.11828 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances


Sec.  721.11799  2,7-Decadienal, (2E,7Z)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2,7-decadienal, 
(2E,7Z)- (PMN P-16-449; CASRN 52711-52-1) 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 PMN substance to a concentration of 
greater than or equal to 1.0% in the final end use formulation.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=1.
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11800  Fatty acid dimers, polymer with acrylic acid and 
pentaerythritol reaction products (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as fatty 
acid dimers, polymer with acrylic acid and pentaerythritol reaction 
products (PMN P-16-512) 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) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) and (5), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(4), 
engineering control measures (e.g., enclosure of confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50, or 1,000 when spray-applied.
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the PMN substance other than as a component 
of UV curable printing inks.
    (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 (d), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11801  Aminoalkyl alkoxysilane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
aminoalkyl alkoxysilane (PMN P-17-115) 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. Requirements 
as specified in Sec.  721.80(o).
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11802  Siloxanes and Silicones, di-Me, 3-[3-carboxy-2(or 3)-
(octenyl)-1-oxopropoxy]propyl group-terminated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as siloxanes and 
silicones, di-Me, 3-[3-carboxy-2(or 3)-(octenyl)-1-oxopropoxy]propyl 
group-terminated (PMN P-18-36; CASRN 403616-34-2) 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 PMN substance 
in a manner that results in inhalation exposure.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11803  Mixed alkyl esters-, polymer with N1-(2-aminoethyl)- 
l,2-ethanediamine, aziridine, N-acetyl derivs., acetates (salts) 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as mixed 
alkyl esters-, polymer with N1-(2-aminoethyl)- l,2-ethanediamine, 
aziridine, N-acetyl derivs., acetates (salts) (PMN P-18-263) 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=5.
    (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

[[Page 24411]]

applicable to manufacturers and processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11804  Propanedioic acid, 2,2-bis(hydroxymethyl)-, 1,3-
dihexyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as propanedioic acid, 
2,2-bis(hydroxymethyl)-, 1,3-dihexyl ester (PMN P-18-336; CASRN 
2222732-45-6) 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=54.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11805  Alkanediol, substituted alkyl, polymer with 
carbomonocyle, alkanedioate substituted carbomonocycle, ester with 
substituted alkanoate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkanediol, substituted alkyl, polymer with carbomonocyle, alkanedioate 
substituted carbomonocycle, ester with substituted alkanoate (PMN P-18-
355) 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. Requirements 
as specified in Sec.  721.80(o).
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11806  Ethene, 1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-
trifluoro-, polymer with 1,1-difluoroethene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as Ethene, 
1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-trifluoro-, polymer with 
1,1-difluoroethene (PMN P-18-359; CASRN 874290-13-8) 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 PMN substance 
in a manner that results in inhalation exposure.
    (ii) Disposal. Requirements as specified in Sec.  721.85(a)(2), 
(b)(2), and (c)(2).
    (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), (i), (k), and (j) are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11807  Maleic anhydride--substituted alkene copolymer 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as maleic 
anhydride--substituted alkene copolymer (PMN P-18-369) 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 PMN substance 
in a manner that results in inhalation exposure.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11808  Xanthylium, bis[dicarboxycyclic]sulfonylamino-
alkylcyclicamino-disulfo-sulfocyclic-, inner salt, monocationic salt 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
xanthylium, bis[dicarboxycyclic]sulfonylamino-alkylcyclicamino-disulfo-
sulfocyclic-, inner salt, monocationic salt (PMN P-18-382) 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 PMN substance 
in a manner that results in inhalation exposure.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11809  Alkoxylated butyl alkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkoxylated butyl alkyl ester (PMN P-19-147) 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. Requirements 
as specified in Sec.  721.80(j). It is a significant new use to use the 
PMN substance in formulation at a higher percentage than the 
confidential percentage stated in the PMN.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=16.
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.

[[Page 24412]]

    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11810  Fatty acid alkyl amide, (dialkyl) amino alkyl, alkyl 
quaternized, salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as fatty 
acid alkyl amide, (dialkyl) amino alkyl, alkyl quaternized, salts (PMN 
P-19-162) 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 PMN substance 
in a manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=1 (freshwater) and N=17 
(marine).
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11811  Tetraoxaspiro[5.5]alkyl-3,9-diylbis(alkyl-2,1-diyl) 
bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
tetraoxaspiro[5.5]alkyl-3,9-diylbis(alkyl-2,1-diyl) bis(2-cyano-3-(3,4-
dimethoxyphenyl)acrylate) (PMN P-20-11) 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. Requirements 
as specified in Sec.  721.80(j). It is a significant new use to exceed 
the confidential production volume stated in the PMN.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11812  Reaction products of alkyl-terminated 
alkylaluminoxanes and dihalogeno (alkylcyclopentadienyl) 
(tetraalkylcyclopentadienyl) transition metal coordination compound 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
reaction products of alkyl-terminated alkylaluminoxanes and dihalogeno 
(alkylcyclopentadienyl) (tetraalkylcyclopentadienyl) transition metal 
coordination compound (generic) (PMN P-20-48) 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. Requirements 
as specified in Sec.  721.80(a), (b), and (c).
    (ii) Releases to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=6.
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11813  Reaction products of alkyl-aluminoxanes and 
bis(alkylcyclodialkylene) dihalogenozirconium (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
reaction products of alkyl-aluminoxanes and 
bis(alkylcyclodialkylene)dihalogenozirconium (generic) (PMN P-20-49) 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. Requirements 
as specified in Sec.  721.80(a), (b), and (c).
    (ii) Releases to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=3.
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11814  Formaldehyde, polymer with alkylphenols, alkyl ether 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
formaldehyde, polymer with alkylphenols, alkyl ether (PMN P-20-61) 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=330.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11815  2-Propenoic acid, 2-hydroxyethyl ester, reaction 
products with dialkyl hydrogen heterosubstituted phosphate and dimethyl 
phosphonate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 2-
propenoic acid, 2-hydroxyethyl ester, reaction products with dialkyl 
hydrogen heterosubstituted phosphate and dimethyl phosphonate (PMN P-
20-66) 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. Requirements 
as specified in Sec.  721.80(j). It is a significant new use to 
manufacture or process the PMN substance in consumer products at a 
concentration greater than 3% (by weight).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4) and (b)(4), where N=6.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).

[[Page 24413]]

    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11816  2-Oxepanone, homopolymer, ester with hydroxyalkyl 
trioxo heteromonocyclic (3:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 2-
oxepanone, homopolymer, ester with hydroxyalkyl trioxo heteromonocyclic 
(3:1) (PMN P-20-86) 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=92.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11817  Poly(oxy-1,2-ethanediyl), .alpha.- (alkyl-
hydroxyalkyl)- .omega.-hydroxy-, .omega.-alkyl ethers (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
poly(oxy-1,2-ethanediyl), .alpha.- (alkyl-hydroxyalkyl)- .omega.-
hydroxy-, .omega.-alkyl ethers (PMN P-20-90) 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=77.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11818  Butanedioic acid, monopolyisobutylene derivs., mixed 
dihydroxyalkyl and hydroxyalkoxyalkyl diesters (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as alkyl 
oil, polymer with butanedioic acid, monopolyisobutylene derivs., mixed 
dihydroxyalkyl and hydroxyalkoxyalkyl diesters (PMN P-20-97) 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 PMN substance 
in a manner that results in inhalation exposure to workers.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=6.
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11819  Mixed metal oxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as a mixed 
metal oxide (PMN P-20-99) 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 the PMN substance with greater than 
1% of particles less than 10 microns.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11820  Coal, brown, ammoxidized.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as coal, brown, 
ammoxidized (PMN P-20-102; CASRN 2413186-32-8) 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. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
PMN substance other than as a fertilizer/soil amendment.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11821  Cycloalphatic amine formate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
cycloalphatic amine formate (PMN P-20-103) 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 PMN substance 
in a manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=66.
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 24414]]

Sec.  721.11822  Carbimide, polyalkylenepolyarylene ester, polymer with 
1,2-alkanediol, 2-alkoxyalkyl methacrylate- and 3-(2-alkoxyalkyl)-2-
heterocycle-blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
carbimide, polyalkylenepolyarylene ester, polymer with 1,2-alkanediol, 
2-alkoxyalkyl methacrylate- and 3-(2-alkoxyalkyl)-2-heterocycle-blocked 
(PMN P-20-107) 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. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the PMN substance in a manner that results 
in inhalation exposure.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11823  1H-Pyrrole-2,5-dione, 3-methyl-, 1,1'-C36-
alkylenebis-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1H-pyrrole-2,5-
dione, 3-methyl-, 1,1'-C36-alkylenebis- (PMN P-20-132; CASRN 2414071-
06-8) 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. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the PMN substance in a manner that results 
in inhalation exposure.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11824  Arylcarboxylic acid, alkyl ester, polymer with 
alkanediol, ester with methyloxirane polymer with oxirane alkyl ether 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
arylcarboxylic acid, alkyl ester, polymer with alkanediol, ester with 
methyloxirane polymer with oxirane alkyl ether (PMN P-20-136) 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 or process the PMN substance in a 
manner that results in inhalation exposures to workers.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11825  Cyclohexanemethanamine, 5-amino-1,3,3-trimethyl-, 
polymer with a-hydro-w-hydroxypoly(oxy-1,4-butanediyl), 5- isocyanato-
1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and 1,1-methylenebis[4-
isocyanatobenzene].

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 
cyclohexanemethanamine, 5-amino-1,3,3-trimethyl-, polymer with a-hydro-
w-hydroxypoly(oxy-1,4-butanediyl), 5- isocyanato-1-(isocyanatomethyl)-
1,3,3-trimethylcyclohexane and 1,1-methylenebis[4-isocyanatobenzene] 
(PMN P-20-143; CASRN 2417925-50-7) 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. Requirements 
as specified in Sec.  721.80(o).
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11826  Alkanoic acid, alkyl, carbopolycyclic alkyl ester 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkanoic acid, alkyl, carbopolycyclic alkyl ester (PMN P-20-146) 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 PMN substance 
in a manner that results in worker inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=13.
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11827  Propanedioic acid, 2-methylene-, 1,3-diethyl ester, 
polymer with 1,4-butanediol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as propanedioic acid, 
2-methylene-, 1,3-diethyl ester, polymer with 1,4-butanediol (PMN P-20-
161; CASRN 2364431-09-2) 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. Requirements 
as specified in Sec.  721.80(o).
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The

[[Page 24415]]

provisions of Sec.  721.185 apply to this section.


Sec.  721.11828  Multialkylbicycloalkenyl substituted propanenitrile 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
multialkylbicycloalkenyl substituted propanenitrile (PMN P-21-12) 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 more than 10,000 kilograms per year 
for any use.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2024-07262 Filed 4-5-24; 8:45 am]
BILLING CODE 6560-50-P