[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.
[[Page 79206]]
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