Significant New Use Rules on Certain Chemical Substances (21-3.F), 79203-79220 [2024-22168]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 89, Number 188 (Friday, September 27, 2024)]
[Proposed Rules]
[Pages 79203-79220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22168]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2021-0221; FRL-12141-01-OCSPP]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (21-3.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 
conditions of use for that chemical substance. In addition, the 
manufacture or processing for the significant new use may not commence 
until EPA has conducted a review of the required notification, made an 
appropriate determination regarding that notification, and taken such 
actions as required by that determination.

DATES: Comments must be received on or before October 28, 2024.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2021-0221, 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: 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: The TSCA-Hotline, ABVI-Goodwill, 422 South

[[Page 79204]]

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 the chemical substances discussed in 
Unit III. These SNURs, if finalized as proposed, would require persons 
who intend to manufacture or process any of these chemical substances 
for an activity that is designated as a significant new use to notify 
EPA at least 90 days before commencing that activity.

C. Does this action apply to me?

1. General Applicability
    This action applies to you if you manufacture, process, or use the 
chemical substances identified in Unit III. This may include entities 
in North American Industrial Classification System (NAICS) codes 325 
and 324110, e.g., chemical manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
    This action may also apply to certain entities through pre-existing 
import certification and export notification requirements under TSCA 
(https://www.epa.gov/tsca-import-export-requirements).
    Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), 
the requirements promulgated at 19 CFR 12.118 through 12.127 (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 October 28, 2024 are subject to the export notification 
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply 
with the export notification requirements in 40 CFR part 707, subpart 
D.

D. What are the incremental economic impacts of this action?

    EPA has evaluated the potential costs of establishing SNUN 
reporting requirements for potential manufacturers (including 
importers) and processors of the chemical substances subject to these 
proposed SNURs. This analysis, which is available in the docket, is 
briefly summarized here.
1. Estimated Costs for SNUN Submissions
    If a SNUN is submitted, costs are an estimated $45,000 per SNUN 
submission for large business submitters and $14,500 for small business 
submitters. These estimates include the cost to prepare and submit the 
SNUN (including registration for EPA's Central Data Exchange (CDX)), 
and the payment of a user fee. Businesses that submit a SNUN would be 
subject to either a $37,000 user fee required by 40 CFR 
700.45(c)(2)(ii) and (d), or, if they are a small business as defined 
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR 
700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission 
for SNUNs will not be incurred by any company unless a company decides 
to pursue a significant new use as defined in these SNURs. 
Additionally, these estimates reflect the costs and fees as they are 
known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
    EPA has also evaluated the potential costs associated with the 
export notification requirements under TSCA section 12(b) and the 
implementing regulations at 40 CFR part 707, subpart D. For persons 
exporting a substance that is the subject of a SNUR, a one-time notice 
to EPA must be provided for the first export or intended export to a 
particular country. The total costs of export notification will vary by 
chemical, depending on the number of required notifications (i.e., the 
number of countries to which the chemical is exported). While EPA is 
unable to make any estimate of the likely number of export 
notifications for the chemical substances covered by these SNURs, as 
stated in the accompanying economic analysis, the estimated cost of the 
export notification requirement on a per unit basis is approximately 
$106.

E. What should I consider as I prepare my comments for EPA?

1. Submitting CBI
    Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please 
follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you 
claim to be CBI. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR parts 2 and 703.
2. Tips for Preparing Your Comments
    When preparing and submitting your comments, see the commenting 
tips at https://www.epa.gov//epa-dockets.

II. Background

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

A. Significant New Use Determination Factors

    TSCA section 5(a)(2) states that EPA's determination that a use of 
a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In determining what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, and 
potential human exposures and environmental releases that may be 
associated with the substances, in the context of the four bulleted 
TSCA section 5(a)(2) factors listed in this unit and discussed in Unit 
III.
    These proposed SNURs include PMN substances that 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

[[Page 79205]]

conditions of use that are not intended by the submitters, EPA is 
proposing to designate those conditions of use as 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 at 40 CFR 721.11 to deal with 
the situation where a specific significant new use is CBI.
    Under these procedures a manufacturer or processor may request EPA 
to identify the confidential significant new use under the rule. The 
manufacturer or processor must show that it has a bona fide intent to 
manufacture or process the chemical substance. If EPA concludes that 
the person has shown a bona fide intent to manufacture or process the 
chemical substance, EPA will identify the confidential significant new 
use to that person. Since most of the chemical identities of the 
chemical substances subject to these SNURs are also CBI, manufacturers 
and processors can combine the bona fide submission under the procedure 
in 40 CFR 721.11 into a single step.

D. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to SNURs, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with 
the same requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA sections 5(b) 
and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. 
In addition, provisions relating to user fees appear at 40 CFR part 
700.
    Once EPA receives a SNUN, EPA must either determine that the 
significant new use is not likely to present an unreasonable risk of 
injury under the conditions of use for the chemical substance or take 
such regulatory action as is associated with an alternative 
determination under TSCA section 5 before the manufacture (including 
import) or processing for the significant new use can commence. If EPA 
determines that the significant new use of the chemical substance is 
not likely to present an unreasonable risk, EPA is required under TSCA 
section 5(g) to make public, and submit for publication in the Federal 
Register, a statement of EPA's findings.
    As discussed in Unit I.C.2., persons who export or intend to export 
a chemical substance identified in a proposed or final SNUR are subject 
to the export notification provisions of TSCA section 12(b), and 
persons who import a chemical substance identified in a final SNUR are 
subject to the TSCA section 13 import certification requirements. See 
also https://www.epa.gov/tsca-import-export-requirements.

E. Applicability of the Proposed SNURs to Uses Occurring Before the 
Effective Date of the Final Rule

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this proposed rule 
have undergone premanufacture review. In cases where EPA has not 
received a notice of commencement (NOC) and the chemical substance has 
not been added to the TSCA Inventory, no person may commence such 
activities without first submitting a PMN. Therefore, for chemical 
substances for which an NOC has not been submitted, EPA concludes that 
the designated significant new uses are not ongoing. The identities of 
many of the chemical substances subject to this proposed rule have been 
claimed as confidential per 40 CFR 720.85 and the PMN submitter did not 
intend to engage in the other circumstances of use that are designated 
as significant new uses for the chemical substances subject to this 
proposed rule. Based on this, the Agency believes that it is highly 
unlikely that any of the significant new uses identified in Unit III. 
are ongoing.
    When the chemical substances identified in Unit III. 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.

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Persons who begin manufacture or processing of the chemical substances 
for a significant new use identified on or after the designated cutoff 
date specified in Unit III.A. would have to cease any such activity 
upon the effective date of the final rule. To resume their activities, 
these persons would have to first comply with all applicable SNUR 
notification requirements and EPA would have to take action under TSCA 
section 5 allowing manufacture or processing to proceed.

F. Important Information About SNUN Submissions

1. SNUN Submissions
    SNUNs must be submitted on EPA Form No. 7710-25, generated using e-
PMN software, and submitted to the Agency in accordance with the 
procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is 
available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
2. Development and Submission of Information
    EPA recognizes that TSCA section 5 does not require development of 
any particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is required to 
submit information for a chemical substance pursuant to a rule, order 
or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) 
requires such information to be submitted to EPA at the time of 
submission of the SNUN.
    In the absence of a rule, TSCA order, or consent agreement under 
TSCA section 4 covering the chemical substance, persons are required 
only to submit information in their possession or control and to 
describe any other information known to or reasonably ascertainable by 
them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the 
Agency has the authority to require appropriate testing. To assist with 
EPA's analysis of the SNUN, submitters are encouraged, but not 
required, to provide the potentially useful information identified for 
the chemical substance in Unit III.C.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency pertaining to protocol selection. Furthermore, 
pursuant to TSCA section 4(h), which pertains to reduction of testing 
in vertebrate animals, EPA encourages consultation with the Agency on 
the use of alternative test methods and strategies (also called New 
Approach Methodologies, or NAMs), if available, to generate the 
recommended test data. EPA encourages dialog with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h). For more 
information on alternative test methods and strategies to reduce 
vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
    The potentially useful information described in Unit III. may not 
be the only means of providing information to evaluate the chemical 
substance associated with the significant new uses. However, submitting 
a SNUN without any test data may increase the likelihood that EPA will 
take action under TSCA sections 5(e) or 5(f). EPA recommends that 
potential SNUN submitters contact EPA early enough so that they will be 
able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.

III. Chemical Substances Subject to These Proposed SNURs

A. What is the designated cutoff date for ongoing uses?

    EPA designates September 27, 2024, as the cutoff date for 
determining whether the new use is ongoing. This designation is 
explained in more detail in Unit II.E.

B. What information is provided for each chemical substance?

    For each chemical substance identified in Unit III.C., EPA provides 
the following information:
     PMN number (the proposed CFR citation assigned in the 
regulatory text section of this document).
     Chemical name (generic name if the specific name is 
claimed as CBI).
     Chemical Abstracts Service Registry Number (CASRN) (if 
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Potentially useful information.
    The regulatory text section of this document specifies the 
activities designated as significant new uses. Certain new uses, 
including production volume limits and other uses designated in the 
proposed rules, may be claimed as CBI.
    These chemical substances have undergone premanufacture review. In 
addition to those conditions of use intended by the submitter, EPA has 
identified certain other circumstances of use. EPA has preliminarily 
determined that these 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-15-633 (40 CFR 721.11925)
    Chemical Name: 1(2H)-Naphthalenone,4-ethyloctahydro-8-methyl.
    CAS Number: 870515-09-6.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as part of a fragrance 
formula (dispersive use). Based on estimated physical/chemical 
properties of the PMN substance, submitted test data on the new 
chemical substance, and comparison to analogous neutral organic 
substances, EPA has identified concerns for skin irritation, dermal 
sensitization, systemic effects (liver, spleen, and bone marrow 
effects), and aquatic toxicity if the new chemical substance is not 
used following the limitation noted. The conditions 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 43 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.

[[Page 79207]]

PMN Number (Proposed CFR Citation): P-16-326 (40 CFR 721.11926)
    Chemical Name: Propanoic acid, 2,2-dimethyl-,-1-methyl-2-(1-
methylethoxy)-2-oxoethyl ester.
    CAS Number: 1821051-37-9.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as part of a fragrance 
formula. Based on estimated physical/chemical properties of the PMN 
substance, submitted test data on the new chemical substance, and 
comparison to analogous esters, EPA has identified concerns for 
systemic effects (liver 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 includes the 
following protective measure:
     No processing of the PMN substance above 1% in formulation 
for consumer products.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the health 
effects of the PMN substance if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
systemic effects testing may be potentially useful to characterize the 
health effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-17-195 (40 CFR 721.11927)
    Chemical Name: 1,3-Propanediol,2-methylene-, substituted (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be for manufacturing a 
modified ethylene vinyl alcohol copolymer. Based on the estimated 
physical/chemical properties of the PMN substance, comparison to 
analogous chemical substances, submitted data on the PMN substance, and 
comparison to analogous esters and vinyl esters, EPA has identified 
concerns for acute oral toxicity, systemic effects, developmental 
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 use of the PMN substance other than as a chemical 
intermediate.
    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-17-389 (40 CFR 721.11928)
    Chemical Name: Alkyl oil, polymer with 1,4-cyclohexanedimethanol, 
dehydrated alkyl oil, hydrogenated rosin, phthalic anhydride and 
trimethylolpropane (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a polymer precursor. 
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 bladder 
effects, 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; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 39 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 chronic ecotoxicity, skin absorption, metabolism or 
pharmacokinetics, specific target organ toxicity, developmental 
toxicity, and chronic toxicity/carcinogenicity testing may be 
potentially useful to characterize the health and environmental effects 
of the PMN substance.
PMN Number (Proposed CFR Citation): P-18-98 (40 CFR 721.11929)
    Chemical Name: Polyphosphoric acids, polymers with 
(alkoxyalkoxy)alkanol and substituted heteromonocycle (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a dispersing additive for pigments. Based on estimated 
physical/chemical properties of the PMN substance, comparison to 
structurally analogous chemical substances, and comparison to analogous 
anionic surfactants, EPA has identified concerns for irritation of the 
skin, eyes, and respiratory tract, reproductive and developmental 
effects, lung 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 processing of the PMN substance to greater than 5% by 
weight in the final formulated product for any use; 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 aquatic toxicity, skin irritation, eye irritation, 
reproductive toxicity, and pulmonary effects testing may be potentially 
useful to characterize the health and environmental effects of the PMN 
substance.
PMN Number (Proposed CFR Citation): P-18-150 (40 CFR 721.11930)
    Chemical Name: Tertiary amine, compounds with amino sulfonic acid 
blocked aliphatic isocyanate homopolymer (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a component of an 
industrial coating. 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 diisocyanates, EPA has identified concerns for 
systemic toxicity if the chemical substance is not used following the 
limitations noted. The conditions of use of the PMN substance

[[Page 79208]]

as described in the PMN include the following protective measures:
     No domestic manufacture (i.e., import only);
     Use of the PMN substance only for the confidential use 
described in the PMN; and
     Use of a National Institute for Occupational Safety and 
Health (NIOSH)-certified respirator with an Assigned Protection Factor 
(APF) of at least 10 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 
pulmonary effects 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-18-187 (40 CFR 721.11931)
    Chemical Name: Carboxylic acid-polyamine condensate (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an emulsifier. 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 skin and respiratory sensitization, developmental toxicity, lung 
effects, skin, eye, and lung 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 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 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 absorption, specific target organ toxicity or pulmonary 
effects, reproductive (developmental effects) toxicity, 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-18-211 (40 CFR 721.11932)
    Chemical Name: Alkaneamine, (aminoalkyl)-, polymer with aziridine 
and 1,6-diisocyanatohexane, polyethylene glycol alkyl ether- and 
polyethylene-polypropylene glycol aminoalkyl alkyl ether- and alkenyl 
benzenated polyethylene glycol Ph ether (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a wetting and dispersing agent for pigment formulations, 
paints, and coatings. 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, 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 use of the PMN substance in spray applications;
     No consumer use of the PMN substance; 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 absorption, pulmonary effects, specific target organ 
toxicity, 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-18-267 (40 CFR 721.11933), P-
18-268 (40 CFR 721.11934) and P-18-269 (40 CFR 721.11935)
    Chemical Names: Branched alkanoic acid, epoxy ester, reaction 
products with monocyclic dialkylamine and polycyclic alcohol epoxy 
polymer (generic) (P-18-267), Polycyclic alkane, polymer with 
monocyclic amine, polycyclic epoxide ether, reaction products with 
dialkylamine alkyl amine (generic) (P-18-268), and Polycyclic 
substituted alkane, polymer with epoxide, reaction products with 
cyclicalkylamine and dialkylamine substituted alkyl amine (generic) (P-
18-269).
    CAS Numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as curing agents. Based 
on estimated physical/chemical properties of the PMN substances and 
comparison to structurally analogous chemical substances, EPA has 
identified concerns for lung effects, irritation, and systemic toxicity 
if the chemical substances are not used following the limitations 
noted. The conditions of use of the PMN substances as described in the 
PMNs includes the following protective measure:
     No use of the PMN substances in a spray application method 
where more than 1% of particles are less than 10 microns in diameter.
    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 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 
pulmonary effects, specific target organ toxicity, skin irritation/
corrosion, eye damage, and particle size testing may be potentially 
useful to characterize the health effects of the PMN substances.
PMN Number (Proposed CFR Citation): P-18-376 (40 CFR 721.11936)
    Chemical Name: Thiosulfuric acid, aminoalkyl ester (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be to improve physical properties in rubber products. Based on 
estimated physical/chemical properties of the PMN substance and 
submitted test data on the

[[Page 79209]]

new chemical substance, EPA has identified concerns for irritation to 
the eye and skin, skin sensitization, systemic toxicity, 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 domestic manufacture (i.e., import only); and
     No use of the PMN substance other than for incorporating 
into rubber products.
    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 human exposure 
information would be useful to characterize the potential effects of 
the PMN substance.
PMN Number (Proposed CFR Citation): P-18-380 (40 CFR 721.11937)
    Chemical Name: Butanoic acid ethyl amine (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be for automotive brake 
parts. Based on estimated physical/chemical properties of the PMN 
substance, comparison to structurally analogous chemical substances, 
and comparison to analogous substances, EPA has identified concerns for 
surfactant effects on the lung, eye 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 domestic manufacture (i.e., import only);
     No import of the PMN substance other than in the 
confidential form described in the PMN; and
     No processing of the PMN substance in end use formulations 
to greater than the confidential concentration percentage identified 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 pulmonary effects, eye 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-18-389 (40 CFR 721.11938)
    Chemical Name: Alkenoic acid, alkyl-substituted, epoxy ester, 
polymer with alkyl alkenoate, alkene, and polylactide (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a component in 
package coatings. Based on estimated physical/chemical properties of 
the PMN substance and comparison to structurally analogous chemical 
substances, EPA has identified concerns for lung 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 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 testing may be potentially useful to 
characterize the health effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-18-396 (40 CFR 721.11939)
    Chemical Name: Alkenoic acid, alkyl, polymer with carbomonocyle 
alkyl propenoate and substituted alkyl alkenoate, ester with 
substituted alkyl alkanoate, tertbutyl substituted peroxoate-initiated 
(generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as paint. Based on 
estimated physical/chemical properties of the PMN substance and 
comparison to structurally analogous chemical substances, EPA has 
identified concerns for developmental effects and eye, skin, 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 consumer use of the PMN substance; and
     Use of the PMN substance only for the confidential use 
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 
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 toxicity, skin irritation, and eye irritation testing may 
be potentially useful to characterize the health effects of the PMN 
substance.
PMN Number (Proposed CFR Citation): P-19-134 (40 CFR 721.11940)
    Chemical Name: 5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, poly[oxy(methyl-1,2-ethanediyl), .alpha.-
hydro-.omega.-hydroxy-, polymer with 1,6-diisocyanatohexane, polymer 
with poly(oxy-1,4-butanediyl), .alpha.-hydro-.omega.-hydroxy-, cyclic 
amine--ketone adduct, reduced, and 1,3-propanediol, 2-ethyl-2-
(hydroxymethyl)- (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a binder for moisture cure coatings. Based on the estimated 
physical/chemical properties of the PMN substance and comparison to 
analogous chemical substances, EPA has identified concerns for 
respiratory sensitization, skin sensitization, lung effects, and 
systemic 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 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

[[Page 79210]]

designated by this SNUR. EPA has determined that the results of skin 
sensitization and pulmonary effects testing may be potentially useful 
to characterize the health effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-19-161 (40 CFR 721.11941)
    Chemical Name: Alkanol amine salt mixture (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as an organic amine salt mixture used as a foaming agent in the 
production of urethanes. Based on the estimated physical/chemical 
properties of the PMN substance, data on chemicals identified in the 
chemical structure, and comparison to analogous chemical substances, 
EPA has identified concerns for irritation to skin, eyes, and 
respiratory tract, and systemic 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 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 specific target organ toxicity testing 
may be potentially useful to characterize the health effects of the PMN 
substance.
PMN Number (Proposed CFR Citation): P-19-170 (40 CFR 721.11942)
    Chemical Name: Heteroatom-substituted alkyl triethoxysilane, 
reaction products with methylated formaldehyde-melamine polymer 
(generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a coupling agent in elastomer-based formulations that will 
be used in molding operations to manufacture different types of rubber 
articles including but not limited to rubber tires. Based on estimated 
physical/chemical properties of the PMN substance, comparison to 
analogous alkoxysilanes, and comparison to structurally analogous 
chemical substances, EPA has identified concerns for irritation to all 
exposed tissues, lung effects, systemic effects, carcinogenicity, 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 release of the PMN substance, or any waste stream 
containing the PMN substance, into water;
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure; and
     Use of the PMN substance only as a coupling agent in 
elastomer-based formulations that will be used in molding operations to 
manufacture different types of rubber articles including but not 
limited to rubber tires.
    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 irritation, eye irritation, specific target organ 
toxicity, pulmonary effects, carcinogenicity, 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-19-189 (40 CFR 721.11943)
    Chemical Name: Fatty acids, polymers with alkanediol and 1,1'-
methylenebis[4-isocyanatobenzene] (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a reactive polymer for use in adhesives and sealants. 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 respiratory sensitization 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 reactive polymer for 
use in adhesives and sealants; and
     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 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 human exposure 
information may be potentially useful to characterize the effects of 
the PMN substance.
PMN Number (Proposed CFR Citation): P-20-8 (40 CFR 721.11944)
    Chemical Name: 7-Heteropolycyclicsulfonic acid, 2-[4-[2-[1-[[(2-
methoxy-5-methyl-4-sulfophenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]-6-methyl-, compd. with (alkylamino)alkanol 
and (hydroxyalkyl)amine (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a dye for use with paper, paper products, and nonwoven 
products produced from paper. Based on estimated physical/chemical 
properties of the PMN substance, submitted test data on the new 
chemical substance, comparison with analogous acid dyes, amphoteric 
dyes, and anilines, and comparison to structurally analogous chemical 
substances, EPA has identified concerns for systemic 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:
     No use other than as a dye for use with paper, paper 
products, and nonwoven products produced from paper.
    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

[[Page 79211]]

environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-20-12 (40 CFR 721.11945)
    Chemical Name: Polyol, polymer with alkyl diisocyanate, alkyl 
substituted heterocycle blocked (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an ink additive. 
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 systemic effects (spleen, liver, and blood), and aquatic toxicity 
if the new chemical substance is not used following the limitation 
noted. The conditions of use of the PMN substance as described in the 
PMN include the following protective measure:
     No 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 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-20-22 (40 CFR 721.11946)
    Chemical Name: Polyalkoxycarbopolycycle hydroxy (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a fuel additive for 
combustion improver. Based on estimated physical/chemical properties of 
the PMN substance and comparison to structurally analogous chemical 
substances, EPA has identified concerns for systemic effects, lung 
effects (surfactancy), 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 44 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, pulmonary effects, 
neurotoxicity, 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-20-27 (40 CFR 721.11947) and P-
20-28 (40 CFR 721.11948)
    Chemical Names: Glycols, .alpha., .omega.-, C2-6, polymers with 
adipic acid, dodecanedioic acid, hydracrylic acid polyester, 
isophthalic acid, isophthalic acid, 1,1'-methylenebis[4-
isocyanatobenzene], neopentyl glycol and terephthalic acid (generic) 
(P-20-27) and Glycols, .alpha.,.omega.-, C2-6, polymers with adipic 
acid, aromatic polyester, dodecanedioic acid, hydracrylic acid 
polyester, isophthalic acid, 1,1'-methylenebis[4-isocyanatobenzene], 
neopentyl glycol and terephthalic acid (generic) (P-20-28).
    CAS Numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as industrial 
adhesives. Based on the estimated physical/chemical properties of the 
PMN substances and comparison to structurally analogous chemical 
substances, EPA has identified concerns for irritation to the skin, 
eyes, and respiratory tract, dermal and respiratory sensitization, lung 
effects, and carcinogenicity 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 the PMN substances into the waters of the 
United States;
     No consumer use of the PMN substances; and
     No manufacturing, processing, or use of the PMN substances 
in a manner that results in 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 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 skin 
irritation, eye damage, skin sensitization, specific target organ 
toxicity, pulmonary effects, genetic toxicity, and carcinogenicity 
testing may be potentially useful to characterize the health effects of 
the PMN substances.
PMN Number (Proposed CFR Citation): P-20-50 (40 CFR 721.11949)
    Chemical Name: Benzenepentanol, alpha, gamma-dimethyl.
    CAS Number: 72681-01-7.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an additive in 
consumer products. Based on estimated physical/chemical properties of 
the PMN substance, submitted test data on the new chemical substance, 
and comparison to analogous neutral organic substances, EPA has 
identified concerns for systemic toxicity and aquatic toxicity if the 
new chemical substance is not used following the limitation noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measure:
     No release of the PMN substance resulting in surface water 
concentrations that exceed 71 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-20-54 (40 CFR 721.11950)
    Chemical Name: Nitrile hydratase.
    CAS Number: 82391-37-5.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a catalyst used in a 
closed process. 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

[[Page 79212]]

identified concerns for respiratory sensitization and/or allergic 
reactions and irritation to the eyes and respiratory tract if the 
chemical substance is not used following the limitations noted. The 
conditions 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 
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 and sensitization testing may be potentially useful to 
characterize the health effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-20-56 (40 CFR 721.11951)
    Chemical Name: Polyphosphoric acids, 2-[(alkyl-1-oxo-alkene-1-
yl)oxy]alkyl esters, polymers with acrylic acid, alkyl acrylate, alkyl 
methacrylate, hydroxyalkyl methacrylate and carbomonocycle, 2,2'-(1,2-
diazenediyl)bis[2,4-dialkylalkanenitrogensubstituted]-initiated 
(generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a pigment dispersant. 
Based on estimated physical/chemical properties of the PMN substance, 
comparison to analogous chemical substances, and comparison to 
analogous polyanionic polymers and monomers) and phosphate esters, EPA 
has identified concerns for developmental toxicity, delayed 
neurotoxicity, mutagenicity, and aquatic toxicity if the new chemical 
substance is not used following the limitation noted. The conditions of 
use of the PMN substance as described in the PMN include the following 
protective measure:
     No release of the PMN substance resulting in surface water 
concentrations that exceeds 1 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 developmental toxicity, specific target organ toxicity, 
genetic toxicity, neurotoxicity, 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-20-57 (40 CFR 721.11952)
    Chemical Name: Arene, trimethoxysilyl-, hydrolyzed (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a silane coupling 
agent used in silicone formulations. Based on estimated physical/
chemical properties of the PMN substance and comparison to structurally 
analogous chemical substances, EPA has identified concerns for lung 
toxicity, irritation to the skin, eyes, and respiratory tract, systemic 
and reproductive effects, and neurological and 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 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, neurotoxicity, pulmonary effects, 
reproductive/developmental toxicity, developmental neurotoxicity, 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-20-69 (40 CFR 721.11953)
    Chemical Name: 2-Propenoic acid, 2-methyl-, polymer with 2-
hydroxyethyl 2-methyl-2-propenoate phosphate and 2-propenoic acid salt, 
peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt (1:2)- and sodium 
(disulfite) (2:1)-initiated (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a surface-active 
chemical. Based on the estimated physical/chemical properties of the 
PMN substance, submitted test data on the new chemical substance, 
comparison to analogous polyanionic polymers, and comparison to 
analogous chemical substances, EPA has identified concerns for 
developmental and systemic effects (i.e., blood 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 includes the following protective measure:
     Use of the PMN substance only for the confidential use 
described in the PMN.
    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 reproductive toxicity (developmental effects), 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-20-74 (40 CFR 721.11954)
    Chemical Name: Oxirane, 2-methyl-, polymer with oxirane, 
monoundecyl ether, branched and linear.
    CAS Number: 2222805-23-2.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a surfactant for use in the formulation of pesticide 
products. Based on estimated physical/chemical properties of the PMN 
substance, comparison to analogous nonionic surfactants, and comparison 
to structurally analogous chemical substances, EPA has identified 
concerns for irritation to the skin, eyes, and respiratory tract, 
systemic effects, 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; and

[[Page 79213]]

     Use of the PMN substance only as a surfactant for use in 
the formulation of pesticide products.
    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 irritation, eye irritation/corrosion, reproductive 
toxicity (developmental effects), neurotoxicity, specific target organ 
toxicity, and 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).

B. Paperwork Reduction Act (PRA)

    According to the PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable.
    The information collection requirements related to SNURs have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0038 (EPA ICR No. 1188). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per submission. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    EPA always welcomes your feedback on the burden estimates. Send any 
comments about the accuracy of the burden estimate, and any suggested 
methods for improving the collection instruments or instruction or 
minimizing respondent burden, including through the use of automated 
collection techniques.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA (5 
U.S.C. 601 et seq.). The requirement to submit a SNUN applies to any 
person (including small or large entities) who intends to engage in any 
activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new,'' based on all information currently 
available to EPA, EPA has concluded that no small or large entities 
presently engage in such activities.
    A SNUR requires that any person who intends to engage in such 
activity in the future must first notify EPA by submitting a SNUN. 
Although some small entities may decide to pursue a significant new use 
in the future, EPA cannot presently determine how many, if any, there 
may be. However, EPA's experience to date is that, in response to the 
promulgation of SNURs covering over 1,000 chemicals, the Agency 
receives only a small number of notices per year. For example, the 
number of SNUNs received was 16 in Federal fiscal year (FY) FY2018, 
five in FY2019, seven in FY2020, 13 in FY2021, 11 in FY2022, and 15 in 
FY2023, and only a fraction of these submissions were from small 
businesses.
    In addition, the Agency currently offers relief to qualifying small 
businesses by reducing the SNUN submission fee from $37,000 to $6,480. 
This lower fee reduces the total reporting and recordkeeping cost of 
submitting a SNUN to about $14,500 per SNUN submission for qualifying 
small firms. Therefore, the potential economic impacts of complying 
with these proposed SNURs are not expected to be significant or 
adversely impact a substantial number of small entities. In a SNUR that 
published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented its general determination that SNURs are 
not expected to have a significant economic impact on a substantial 
number of small entities, which was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C. 
1531-1538, and does not significantly or uniquely affect small 
governments. Based on EPA's experience with proposing and finalizing 
SNURs, State, local, and Tribal governments have not been impacted by 
SNURs, and EPA does not have any reasons to believe that any State, 
local, or Tribal government will be impacted by these SNURs. In 
addition, the estimated costs of this action to the private sector do 
not exceed $183 million or more in any one year (the 1995 dollars are 
adjusted to 2023 dollars for inflation using the GDP implicit price 
deflator). The estimated costs for this action are discussed in Unit 
I.D.

E. Executive Order 13132: Federalism

    This action will not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not 
expected to have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government. Accordingly, the requirements of Executive Order 13132 do 
not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action will not have Tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is 
not expected to have substantial direct effects on Indian Tribes, 
significantly or uniquely affect the communities of Indian Tribal 
governments and does not involve or impose any requirements that affect 
Indian Tribes. Accordingly, the requirements of Executive Order 13175 
do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because it does not concern an environmental health or 
safety risk. Since this action does not concern a

[[Page 79214]]

human health risk, EPA's 2021 Policy on Children's Health also does not 
apply. Although the establishment of these SNURs do not address an 
existing children's environmental health concern because the chemical 
uses involved are not ongoing uses, SNURs require that persons notify 
EPA at least 90 days before commencing manufacture (defined by statute 
to include import) or processing of any of these chemical substances 
for an activity that is designated as a significant new use by this 
rulemaking. This notification allows EPA to assess the intended uses to 
identify potential risks and take appropriate actions before the 
activities commence.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve any technical standards subject to 
NTTAA section 12(d) (15 U.S.C. 272 note).

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations and 
Executive Order 14096: Revitalizing Our Nation's Commitment to 
Environmental Justice for All

    This action does not concern human health or environmental 
conditions and therefore cannot be evaluated with respect to the 
potential for disproportionate impacts on non-white and low-income 
populations in accordance with Executive Order 12898 (59 FR 7629, 
February 16, 1994) and Executive Order 14096 (88 FR 25251, April 26, 
2023). Although this action does not concern human health or 
environmental conditions, the premanufacture notifications required by 
these SNURs allows EPA to assess the intended uses to identify 
potential disproportionate risks and take appropriate actions before 
the activities commence.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: September 23, 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.  721.11925 through 721.11954 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11925 1(2H)-Naphthalenone,4-ethyloctahydro-8-methyl.
721.11926 Propanoic acid, 2,2-dimethyl-,-1-methyl-2-(1-
methylethoxy)-2-oxoethyl ester.
721.11927 1,3-Propanediol,2-methylene-, substituted (generic).
721.11928 Alkyl oil, polymer with 1,4-cyclohexanedimethanol, 
dehydrated Alkyl oil, hydrogenated rosin, phthalic anhydride and 
trimethylolpropane (generic).
721.11929 Polyphosphoric acids, polymers with (alkoxyalkoxy)alkanol 
and substituted heteromonocycle (generic).
721.11930 Tertiary amine, compounds with amino sulfonic acid blocked 
aliphatic isocyanate homopolymer (generic).
721.11931 Carboxylic acid-polyamine condensate (generic).
721.11932 Alkaneamine, (aminoalkyl)-, polymer with aziridine and 
1,6-diisocyanatohexane, polyethylene glycol alkyl ether- and 
polyethylene-polypropylene glycol aminoalkyl alkyl ether- and 
alkenyl benzenated polyethylene glycol Ph ether (generic).
721.11933 Branched alkanoic acid, epoxy ester, reaction products 
with monocyclic dialkylamine and polycyclic alcohol epoxy polymer 
(generic).
721.11934 Branched alkanoic acid, epoxy ester, reaction products 
with monocyclicdialkanamine and polycyclic dialkanol ether polymer 
(generic).
721.11935 Branched alkanoic acid, epoxy ester, reaction products 
with monocyclicalkanamine, polycyclic alcohol ether homopolymer, and 
polycyclic alcohol epoxy polymer (generic).
721.11936 Thiosulfuric acid, aminoalkyl ester (generic).
721.11937 Butanoic acid ethyl amine (generic).
721.11938 Alkenoic acid, alkyl-substituted, epoxy ester, polymer 
with alkyl alkenoate, alkene, and polylactide (generic).
721.11939 Alkenoic acid, alkyl, polymer with carbomonocyle alkyl 
propenoate and substituted alkyl alkenoate, ester with substituted 
alkyl alkanoate, tertbutyl substituted peroxoate-initiated 
(generic).
721.11940 [5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane], [Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-
hydro-.omega.-hydroxy-, polymer with 1,6-diisocyanatohexane], 
polymer with [Poly(oxy-1,4-butanediyl), .alpha.-hydro-.omega.-
hydroxy-], [Cyclic amine--ketone adduct, reduced], and [1,3-
Propanediol, 2-ethyl-2-(hydroxymethyl)-] (generic).
721.11941 Alkanol amine salt mixture (generic).
721.11942 Heteroatom-substituted alkyl triethoxysilane, reaction 
products with methylated formaldehyde-melamine polymer (generic).
721.11943 Fatty acids, polymers with alkanediol and 1,1'-
methylenebis[4-isocyanatobenzene] (generic).
721.11944 7-Heteropolycyclicsulfonic acid, 2-[4-[2-[1-[[(2-methoxy-
5-methyl-4-sulfophenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]-
6-methyl-, compd. with (alkylamino)alkanol and (hydroxyalkyl)amine 
(generic).
721.11945 Polyol, polymer with alkyl diisocyanate, alkyl substituted 
heterocycle blocked (generic).
721.11946 Polyalkoxycarbopolycycle hydroxy (generic).
721.11947 Glycols, .alpha., .omega.-, C2-6, polymers with adipic 
acid, dodecanedioic acid, hydracrylic acid polyester, isophthalic 
acid, isophthalic acid, 1,1'-methylenebis[4-isocyanatobenzene], 
neopentyl glycol and terephthalic acid (generic).
721.11948 Glycols, .alpha., .omega.-, C2-6, polymers with adipic 
acid, aromatic polyester, dodecanedioic acid, hydracrylic acid 
polyester, isophthalic acid, 1,1'-methylenebis[4-isocyanatobenzene], 
neopentyl glycol and terephthalic acid (generic).
721.11949 Benzenepentanol, alpha, gamma-dimethyl.
721.11950 Nitrile hydratase.
721.11951 Polyphosphoric acids, 2-[(alkyl-1-oxo-alkene-1-
yl)oxy]alkyl esters, polymers with acrylic acid, alkyl acrylate, 
alkyl methacrylate, hydroxyalkyl methacrylate and carbomonocycle, 
2,2'-(1,2-diazenediyl)bis[2,4-dialkylalkanenitrogensubstituted]-
initiated (generic).
721.11952 Arene, trimethoxysilyl-, hydrolyzed (generic).
721.11953 2-Propenoic acid, 2-methyl-, polymer with 2-hydroxyethyl 
2-methyl-2-propenoate phosphate and 2-propenoic acid salt, 
peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt (1:2)- and sodium 
(disulfite) (2:1)-initiated (generic).
721.11954 Oxirane, 2-methyl-, polymer with oxirane, monoundecyl 
ether, branched and linear.
* * * * *

[[Page 79215]]

Sec.  721.11925  1(2H)-Naphthalenone,4-ethyloctahydro-8-methyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1(2H)-
naphthalenone,4-ethyloctahydro-8-methy (PMN P-15-633; CAS No. 870515-
09-6) 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=43.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11926  Propanoic acid, 2,2-dimethyl-,-1-methyl-2-(1-
methylethoxy)-2-oxoethyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as propanoic acid, 
2,2-dimethyl-,-1-methyl-2-(1-methylethoxy)-2-oxoethyl ester (PMN P-16-
326; CAS No. 1821051-37-9) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to process the substance above 1% in formulation 
for consumer products.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11927  1,3-Propanediol,2-methylene-, substituted (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 1,3-
propanediol,2-methylene-, substituted (PMN P-17-195) 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(g).
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11928  Alkyl oil, polymer with 1,4-cyclohexanedimethanol, 
dehydrated Alkyl oil, hydrogenated rosin, phthalic anhydride and 
trimethylolpropane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
oil, polymer with 1,4-cyclohexanedimethanol, dehydrated alkyl oil, 
hydrogenated rosin, phthalic anhydride and trimethylolpropane (PMN P-
17-389) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 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=39.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11929  Polyphosphoric acids, polymers with 
(alkoxyalkoxy)alkanol and substituted heteromonocycle (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyphosphoric acids, polymers with (alkoxyalkoxy)alkanol and 
substituted heteromonocycle (PMN P-18-98) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to process the substance to greater than 5% by 
weight in the final formulated product for any use.
    (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.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11930  Tertiary amine, compounds with amino sulfonic acid 
blocked aliphatic isocyanate homopolymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
tertiary amine, compounds with amino sulfonic acid blocked aliphatic 
isocyanate homopolymer (PMN P-18-150) 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 10.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (j).
    (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

[[Page 79216]]

Sec.  721.125(a) through (d), and (i) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11931  Carboxylic acid-polyamine condensate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carboxylic acid-polyamine condensate (PMN P-18-187) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 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.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11932  Alkaneamine, (aminoalkyl)-, polymer with aziridine and 
1,6-diisocyanatohexane, polyethylene glycol alkyl ether- and 
polyethylene-polypropylene glycol aminoalkyl alkyl ether- and alkenyl 
benzenated polyethylene glycol Ph ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkaneamine, (aminoalkyl)-, polymer with aziridine and 1,6-
diisocyanatohexane, polyethylene glycol alkyl ether- and polyethylene-
polypropylene glycol aminoalkyl alkyl ether- and alkenyl benzenated 
polyethylene glycol Ph ether (PMN P-18-211) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to use the 
substance in spray applications.
    (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.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11933  Branched alkanoic acid, epoxy ester, reaction products 
with monocyclic dialkylamine and polycyclic alcohol epoxy polymer 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
branched alkanoic acid, epoxy ester, reaction products with monocyclic 
dialkylamine and polycyclic alcohol epoxy polymer (PMN P-18-267) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance in a spray application method 
where more than 1% of particles are less than 10 microns in diameter.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11934  Branched alkanoic acid, epoxy ester, reaction products 
with monocyclicdialkanamine and polycyclic dialkanol ether polymer 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
branched alkanoic acid, epoxy ester, reaction products with 
monocyclicdialkanamine and polycyclic dialkanol ether polymer (PMN P-
18-268) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance in a spray application method 
where more than 1% of particles are less than 10 microns in diameter.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11935  Branched alkanoic acid, epoxy ester, reaction products 
with monocyclicalkanamine, polycyclic alcohol ether homopolymer, and 
polycyclic alcohol epoxy polymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
branched alkanoic acid, epoxy ester, reaction products with 
monocyclicalkanamine, polycyclic alcohol ether homopolymer, and 
polycyclic alcohol epoxy polymer (PMN P-18-269) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance in a spray application where 
more than 1% of particles are less than 10 microns in diameter.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11936  Thiosulfuric acid, aminoalkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
thiosulfuric acid, aminoalkyl ester (PMN P-18-376) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.

[[Page 79217]]

    (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 
substance other than for incorporating into rubber products.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11937  Butanoic acid ethyl amine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
butanoic acid ethyl amine (PMN P-18-380) 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 import 
the substance other than in the confidential form described in the PMN. 
It is a significant new use to process the substance in end use 
formulations greater than the confidential concentration percentage 
identified 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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11938  Alkenoic acid, alkyl-substituted, epoxy ester, polymer 
with alkyl alkenoate, alkene, and polylactide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, alkyl-substituted, epoxy ester, polymer with alkyl 
alkenoate, alkene, and polylactide (PMN P-18-389) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11939  Alkenoic acid, alkyl, polymer with carbomonocyle alkyl 
propenoate and substituted alkyl alkenoate, ester with substituted 
alkyl alkanoate, tertbutyl substituted peroxoate-initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, alkyl, polymer with carbomonocyle alkyl propenoate and 
substituted alkyl alkenoate, ester with substituted alkyl alkanoate, 
tertbutyl substituted peroxoate-initiated (PMN P-18-396) 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) and (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11940  [5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane], [poly[oxy(methyl-1,2-ethanediyl)], .alpha.-
hydro-.omega.-hydroxy-, polymer with 1,6-diisocyanatohexane], polymer 
with [poly(oxy-1,4-butanediyl), .alpha.-hydro-.omega.-hydroxy-], 
[cyclic amine--ketone adduct, reduced], and [1,3-propanediol, 2-ethyl-
2-(hydroxymethyl)-] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as [5-
isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane], 
[poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-hydroxy-, 
polymer with 1,6-diisocyanatohexane], polymer with [poly(oxy-1,4-
butanediyl), .alpha.-hydro-.omega.-hydroxy-], [cyclic amine--ketone 
adduct, reduced], and [1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-] 
(PMN P-19-134) 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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11941  Alkanol amine salt mixture (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkanol 
amine salt mixture (PMN P-19-161) 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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11942  Heteroatom-substituted alkyl triethoxysilane, reaction 
products with methylated formaldehyde-melamine polymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified

[[Page 79218]]

generically as heteroatom-substituted alkyl triethoxysilane, reaction 
products with methylated formaldehyde-melamine polymer (PMN P-19-170) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in a 
manner that results in inhalation exposure. It is a significant new use 
to use the substance other than as a coupling agent in elastomer-based 
formulations that will be used in molding operations to manufacture 
different types of rubber articles including but not limited to rubber 
tires.
    (ii) Releases to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11943  Fatty acids, polymers with alkanediol and 1,1'-
methylenebis[4-isocyanatobenzene] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acids, polymers with alkanediol and 1,1'-methylenebis[4-
isocyanatobenzene] (PMN P-19-189) 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. It is a significant new use to use the 
substance other than as a reactive polymer for use in adhesives and 
sealants. It is a significant new use to manufacture, process, or use 
the 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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11944  7-Heteropolycyclicsulfonic acid, 2-[4-[2-[1-[[(2-
methoxy-5-methyl-4-sulfophenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]-6-methyl-, compd. with (alkylamino)alkanol 
and (hydroxyalkyl)amine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 7-
heteropolycyclicsulfonic acid, 2-[4-[2-[1-[[(2-methoxy-5-methyl-4-
sulfophenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]-6-methyl-, 
compd. with (alkylamino)alkanol and (hydroxyalkyl)amine (PMN P-20-8) 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. It is a significant new use to use the 
substance other than as a dye for use with paper, paper products, and 
nonwoven products produced from paper.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11945  Polyol, polymer with alkyl diisocyanate, alkyl 
substituted heterocycle blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as polyol, 
polymer with alkyl diisocyanate, alkyl substituted heterocycle blocked 
(PMN P-20-12) 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) 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 applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11946  Polyalkoxycarbopolycycle hydroxy (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyalkoxycarbopolycycle hydroxy (PMN P-20-22) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 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=44.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11947  Glycols, .alpha.,.omega.-, C2-6, polymers with adipic 
acid, dodecanedioic acid, hydracrylic acid polyester, isophthalic acid, 
isophthalic acid, 1,1'-methylenebis[4-isocyanatobenzene], neopentyl 
glycol and terephthalic acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
glycols, .alpha.,.omega.-, C2-6, polymers with adipic acid, 
dodecanedioic acid, hydracrylic acid polyester, isophthalic acid, 
isophthalic acid, 1,1'-methylenebis[4-isocyanatobenzene], neopentyl 
glycol and terephthalic acid (PMN P-20-27) 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 substance in a manner that results in 
inhalation exposure.
    (ii) Releases to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).

[[Page 79219]]

    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11948  Glycols, .alpha.,.omega.-, C2-6, polymers with adipic 
acid, aromatic polyester, dodecanedioic acid, hydracrylic acid 
polyester, isophthalic acid, 1,1'-methylenebis[4-isocyanatobenzene], 
neopentyl glycol and terephthalic acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
glycols, .alpha.,.omega.-, C2-6, polymers with adipic acid, aromatic 
polyester, dodecanedioic acid, hydracrylic acid polyester, isophthalic 
acid, 1,1'-methylenebis[4-isocyanatobenzene], neopentyl glycol and 
terephthalic acid (PMN P-20-28) 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 substance in a manner that results in 
inhalation exposure.
    (ii) Releases to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11949  Benzenepentanol, alpha, gamma-dimethyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenepentanol, 
alpha, gamma-dimethyl (PMN P-20-50; CAS No. 72681-01-7) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=71.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11950  Nitrile hydratase.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as nitrile hydratase 
(PMN P-20-54, CAS No. 82391-37-5) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11951  Polyphosphoric acids, 2-[(alkyl-1-oxo-alkene-1-
yl)oxy]alkyl esters, polymers with acrylic acid, alkyl acrylate, alkyl 
methacrylate, hydroxyalkyl methacrylate and carbomonocycle, 2,2'-(1,2-
diazenediyl)bis[2,4-dialkylalkanenitrogensubstituted]-initiated 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyphosphoric acids, 2-[(alkyl-1-oxo-alkene-1-yl)oxy]alkyl esters, 
polymers with acrylic acid, alkyl acrylate, alkyl methacrylate, 
hydroxyalkyl methacrylate and carbomonocycle, 2,2'-(1,2-
diazenediyl)bis[2,4-dialkylalkanenitrogensubstituted]-initiated (PMN P-
20-56) 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=1.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11952  Arene, trimethoxysilyl-, hydrolyzed (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as arene, 
trimethoxysilyl-, hydrolyzed (PMN P-20-57) 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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11953  2-Propenoic acid, 2-methyl-, polymer with 2-
hydroxyethyl 2-methyl-2-propenoate phosphate and 2-propenoic acid salt, 
peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt (1:2)- and sodium 
(disulfite) (2:1)-initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, polymer with 2-hydroxyethyl 2-methyl-2-
propenoate phosphate and 2-propenoic acid salt, peroxydisulfuric acid 
([(HO)S(O)2]2O2) sodium salt (1:2)- and sodium (disulfite) (2:1)-
initiated (PMN P-20-69) is subject to reporting under this section for 
the significant

[[Page 79220]]

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).
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11954  Oxirane, 2-methyl-, polymer with oxirane, monoundecyl 
ether, branched and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxirane, 2-methyl-, 
polymer with oxirane, monoundecyl ether, branched and linear (PMN P-20-
74; CAS No. 2222805-23-2) 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 use the substance other than as a surfactant for 
use in the formulation of pesticide products. It is a significant new 
use to manufacture, process, or use the 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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
* * * * *
[FR Doc. 2024-22168 Filed 9-26-24; 8:45 am]
BILLING CODE 6560-50-P