Proposed Rule2024-27913
Significant New Use Rules on Certain Chemical Substances (24-1.F)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 29, 2024
Issuing agencies
Environmental Protection Agency
Abstract
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMNs). The chemical substances received "not likely to present an unreasonable risk" determinations pursuant to TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rulemaking to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of that use, under the conditions of use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination.
Full Text
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<title>Federal Register, Volume 89 Issue 230 (Friday, November 29, 2024)</title>
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[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Proposed Rules]
[Pages 94635-94642]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27913]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2024-0359; FRL-12342-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (24-1.F)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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[[Page 94636]]
SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for certain chemical substances
that were the subject of premanufacture notices (PMNs). The chemical
substances received ``not likely to present an unreasonable risk''
determinations pursuant to TSCA. The SNURs require persons who intend
to manufacture (defined by statute to include import) or process any of
these chemical substances for an activity that is proposed as a
significant new use by this rulemaking to notify EPA at least 90 days
before commencing that activity. The required notification initiates
EPA's evaluation of that use, under the conditions of use for that
chemical substance. In addition, the manufacture or processing for the
significant new use may not commence until EPA has conducted a review
of the required notification, made an appropriate determination
regarding that notification, and taken such actions as required by that
determination.
DATES: Comments must be received on or before December 30, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0359, at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information: Geraldine Hilton, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-8986; email address:
<a href="/cdn-cgi/l/email-protection#b1f9d8ddc5dedf9ff6d4c3d0ddd5d8dfd4f1d4c1d09fd6dec7"><span class="__cf_email__" data-cfemail="fab293968e9594d4bd9f889b969e93949fba9f8a9bd49d958c">[email protected]</span></a>.
For general information on SNURs: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; email address:
<a href="/cdn-cgi/l/email-protection#d2a5aba1bdbcb5fca5bbbebebbb3bf92b7a2b3fcb5bda4"><span class="__cf_email__" data-cfemail="0b7c727864656c257c626767626a664b6e7b6a256c647d">[email protected]</span></a>.
For general information on TSCA: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#1b4f48585a3653746f7772757e5b7e6b7a357c746d"><span class="__cf_email__" data-cfemail="1a4e49595b3752756e7673747f5a7f6a7b347d756c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the factors in TSCA section 5(a)(2) (see
also the discussion in Unit II.).
B. What action is the Agency taking?
EPA is proposing SNURs for chemical substances that were the
subject of PMNs as discussed in Unit III. These SNURs, if finalized as
proposed, would require persons who intend to manufacture or process
any of these chemical substances for an activity that is designated as
a significant new use to notify EPA at least 90 days before commencing
that activity.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances contained in this proposed rule. The following list
of North American Industrial Classification System (NAICS) codes is not
intended to be exhaustive, but rather provides a guide to help readers
determine whether this document applies to them. Potentially affected
entities may include:
<bullet> Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing
import certification and export notification requirements under TSCA
(<a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>).
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612),
the requirements promulgated at 19 CFR 12.118 through 12.127, 19 CFR
127.28, and the EPA policy in support of import certification at 40 CFR
part 707, subpart B. Chemical importers must certify that the shipment
of the chemical substance complies with all applicable rules and orders
under TSCA, including regulations issued under TSCA sections 5, 6, 7
and Title IV.
Pursuant to 40 CFR 721.20, any persons who export or intend to
export a chemical substance that is the subject of this proposed rule
on or after December 30, 2024 are subject to TSCA section 12(b) (15
U.S.C. 2611(b)) and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing SNUN
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substances subject to these
proposed SNURs. This analysis, which is available in the docket, is
briefly summarized here.
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,000 per SNUN
submission for large business submitters and $14,500 for small business
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central Data Exchange (CDX)),
and the payment of a user fee. Businesses that submit a SNUN would be
subject to either a $37,000 user fee required by 40 CFR
700.45(c)(2)(ii) and (d), or, if they are a small business as defined
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR
700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission
for SNUNs will not be incurred by any company unless a company decides
to pursue a significant new use as defined in these SNURs.
Additionally, these estimates reflect the costs and fees as they are
known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the
export notification requirements under TSCA section 12(b) and the
implementing regulations at 40 CFR part 707, subpart D. For persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical, depending on the number of required notifications (i.e., the
number of countries to which the chemical is exported). While EPA is
unable to make any estimate of the likely number of export
notifications for the chemical substances covered by these SNURs, as
stated in the accompanying economic analysis, the estimated cost of the
export notification requirement on a per unit basis is approximately
$106.
[[Page 94637]]
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through email or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you wish to include CBI in your comment, please
follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> 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 <a href="https://www.epa.gov//epa-dockets">https://www.epa.gov//epa-dockets</a>.
II. Background
This unit provides general information about SNURs. For additional
information about EPA's new chemical program go to <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
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:
<bullet> The projected volume of manufacturing and processing of a
chemical substance.
<bullet> The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
<bullet> The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
<bullet> The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the substances, in the context of the four bulleted
TSCA section 5(a)(2) factors listed in this unit and discussed in Unit
III.
These proposed SNURs include PMN substances that received a ``not
likely to present an unreasonable risk'' determination in TSCA section
5(a)(3)(c). During its review of these chemicals, EPA identified
certain conditions of use that are not intended by the submitters, but
reasonably foreseen to occur. EPA is proposing to designate those
conditions of use as significant new uses.
B. Rationale and Objectives of the SNURs
1. Rationale
Under TSCA, no person may manufacture a new chemical substance or
manufacture or process a chemical substance for a significant new use
until EPA makes a determination as described in TSCA section 5(a) and
takes any required action. The issuance of a SNUR is not a risk
determination itself, only a notification requirement for ``significant
new uses,'' so that the Agency has the opportunity to review the SNUN
for the significant new use and make a TSCA section 5(a)(3) risk
determination.
During review of the PMNs submitted for the chemical substances
that are the subject of these proposed SNURs and as further discussed
in Unit III., EPA identified certain other conditions of use, in
addition to those conditions of use intended by the submitter. EPA has
determined that the chemical under the conditions of use is not likely
to present an unreasonable risk. However, EPA has not assessed risks
associated with certain conditions of use. EPA is proposing to
designate these other circumstances of use as significant new uses. As
a result, those significant new uses cannot occur without going through
a separate, subsequent EPA review and determination process associated
with a SNUN.
2. Objectives
EPA is proposing these SNURs because the Agency wants:
<bullet> 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.
<bullet> 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.
<bullet> To be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use. The Agency will either determine under TSCA section 5(a)(3)(C)
that the significant new use is not likely to present an unreasonable
risk, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant by the Administrator
under the conditions of use, or make a determination under TSCA section
5(a)(3)(A) or (B) and take the required regulatory action associated
with the determination, before manufacture or processing for the
significant new use of the chemical substance can occur.
Issuance of a proposed SNUR for a chemical substance does not
signify that the chemical substance is listed on the TSCA Chemical
Substance Inventory (TSCA Inventory). Guidance on how to determine if a
chemical substance is on the TSCA Inventory is available at https://
www.epa.gov/tsca-inventory.
C. Significant New Uses Claimed as CBI
EPA is proposing to establish certain significant new uses which
have been claimed as CBI subject to Agency confidentiality regulations
at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final
determination or other disposition of the confidentiality claim under
40 CFR part 2 procedures, EPA is required to keep this information
confidential. EPA promulgated a procedure to deal with the situation
where a specific significant new use is CBI, at 40 CFR 721.11.
Under these procedures a manufacturer or processor may request EPA
to identify the confidential significant new use under the rule. The
manufacturer or processor must show that it has a bona fide intent to
manufacture or process the chemical substance and must identify the
specific use for which it intends to manufacture or process the
chemical substance. If EPA concludes that the person has shown a bona
fide intent to manufacture or process the chemical substance, EPA will
identify the confidential significant new use to that person. Since
most of the chemical identities of the chemical substances subject to
these SNURs are also CBI, manufacturers and processors can combine the
bona fide submission under the procedure in 40 CFR 721.11 into a single
step.
D. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to SNURs, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA sections 5(b)
and
[[Page 94638]]
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 <a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>.
E. Applicability of the Proposed SNURs to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted EPA concludes that
the designated significant new uses are not ongoing. The identities of
many of the chemical substances subject to this proposed rule have been
claimed as confidential per 40 CFR 720.85 and the PMN submitter did not
intend to engage in the other circumstances of use that are designated
as significant new uses for the chemical substances subject to this
proposed rule. Based on this, the Agency believes that it is highly
unlikely that any of the significant new uses identified in Unit III.
are ongoing.
When the chemical substances identified are added to the TSCA
Inventory, EPA recognizes that, before the rule is effective, other
persons might engage in a use that has been identified as a significant
new use. Persons who begin manufacture or processing of the chemical
substances for a significant new use identified on or after the
designated cutoff date specified in Unit III.A. would have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons would have to first comply with all
applicable SNUR notification requirements and EPA would have to take
action under TSCA section 5 allowing manufacture or processing to
proceed.
F. Important Information About SNUN Submissions
1. SNUN Submissions
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-
PMN software, and submitted to the Agency in accordance with the
procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is
available electronically at <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
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 <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce</a>.
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:
<bullet> Human exposure and environmental release that may result
from the significant new use of the chemical substances.
III. Chemical Substances Subject to These Proposed SNURs
A. What is the designated cutoff date for determining whether the new
use is ongoing for these chemical substances?
EPA designates November 29, 2024 as the cutoff date for determining
whether the new use is ongoing. This designation is explained in more
detail in Unit II.E.
B. What information is provided for each chemical substance?
For each chemical substance identified in Unit III.C., EPA provides
the following information:
<bullet> PMN number (the proposed CFR citation assigned in the
regulatory text section of this document).
<bullet> Chemical name (generic name, if the specific name is
claimed as CBI).
<bullet> Chemical Abstracts Service Registry Number (CASRN) (if
assigned for non-confidential chemical identities).
<bullet> Basis for the SNUR.
<bullet> 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
[[Page 94639]]
in the proposed rules, may be claimed as CBI.
The chemical substances have undergone premanufacture review. In
addition to those conditions of use intended by the submitter, EPA has
identified certain other circumstances of use. EPA has preliminarily
determined that the chemicals under their conditions of use are not
likely to present an unreasonable risk. However, EPA has not assessed
risks associated with the other circumstances of use for these
chemicals. EPA is proposing to designate these other circumstances of
use as significant new uses. As a result, those significant new uses
cannot occur without first going through a separate, subsequent EPA
review and determination process associated with a SNUN.
C. Which chemical substances are subject to this proposed rule?
The substances subject to the proposed rules in this document are
as follows:
PMN Number (Proposed CFR Citation): P-20-168 (40 CFR 721.11955)
Chemical Name: Polyolefin polyamine succinimide, carbopolycycle
alkoxylated (generic).
CASRN: Not available.
Basis for Action: The PMN states that the use of the PMN substance
will be as a lubricating additive for engine oils, transmission and
hydraulic fluid, and gear oil applications. Based on comparison to
analogous chemical substances and the structural alert for aliphatic
amines, EPA has identified concerns for irritation to the eyes, skin,
and respiratory tract if the chemical substance is not used following
the limitation noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measure:
<bullet> Use of the PMN substance only as a lubricating additive
for engine oils, transmission and hydraulic fluid, and gear oil
applications.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation testing may be potentially useful to characterize the health
effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-21-5 (40 CFR 721.11956)
Chemical Name: Carbonmonocyclic alkene polymer with alkyl
alkenoate, alkyl alkenoate, alkyl alkenoate and polyalkyldiene
alkenoate (generic).
CASRN: Not available.
Basis for Action: The PMN states that the use of the PMN substance
will be as a polymeric additive in gear oils. Based on comparison to
analogous chemical substances, information provided in the Safety Data
Sheet (SDS), and physical/chemical properties, EPA has identified
concerns for skin and eye irritation and lung effects (lung overload)
if the chemical substance is not used following the limitation noted.
The conditions of use of the PMN substance as described in the PMN
include the following protective measure:
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in worker inhalation exposure to the PMN
substance.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye irritation, and specific target organ toxicity testing
may be potentially useful to characterize the health effects of the PMN
substance.
PMN Number (Proposed CFR Citation): P-21-95 (40 CFR 721.11957)
Chemical Name: 1-tetradecene, homopolymer, hydrogenated, by-
products from, C28-42 fraction.
CASRN: 2263959-83-5.
Basis for Action: The PMN states that the use of the PMN substance
will be as a base oil for crankcase motor oil, transmission oil, and
other industrial applications such as compressor and gear fluids and
consumer use as a carrier fluid for additives to motor oils and
automatic transmission fluids. Based on comparison to an analogous
chemical substance and on physical/chemical properties, EPA has
identified concerns for blood, respiratory tract, and lung effects
including aspiration hazard if the chemical substance is not used
following the limitation noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measure:
<bullet> No processing of the PMN substance other than in an
enclosed system when heated.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity and pulmonary effects testing may be
potentially useful to characterize the health effects of the PMN
substance.
PMN Number (Proposed CFR Citation): P-21-174 (40 CFR 721.11958)
Chemical Name: Carbonic acid, ester, polymer with alkanediol
(C=4,5) (generic).
CASRN: Not available.
Basis for Action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a raw material for
polyurethane. Based on test data submitted on the PMN substance, EPA
has identified concerns for aquatic toxicity if the chemical substance
is not used following the limitation noted. The condition of use of the
PMN substance as described in the PMN includes the following protective
measure:
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 200 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the environmental
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of chronic
aquatic toxicity testing may be potentially useful to characterize the
environmental effects of the PMN substance.
PMN Number (Proposed CFR Citation): P-23-17 (40 CFR 721.11959)
Chemical Name: Hydrolyzed collagen, polymer with aromatic
isocyanate, N-triethoxysylil-alkanamine, pectic polysaccharide and poly
alkyl alcohol (generic).
CASRN: Not available.
Basis for Action: The PMN states that the use of the PMN substance
will be as an encapsulant for time-released delivery of fragrance.
Based on potential changes to the molecular weight or composition of
the PMN substance, EPA has identified concerns for lung toxicity
[[Page 94640]]
if the chemical substance is not used following the limitation noted.
The conditions of use of the PMN substance as described in the PMN
include the following protective measure:
<bullet> Use of the PMN substance only as an encapsulant for time-
released delivery of fragrance.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substance.
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at <a href="https://www.epa.gov/laws-regulations-and-executive-orders">https://www.epa.gov/laws-regulations-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review
This action proposes to establish SNURs for new chemical substances
that were the subject of PMNs. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive
Order 14094 (88 FR 21879, April 11, 2023).
B. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to SNURs have
already been approved by OMB pursuant to PRA under OMB control number
2070-0038 (EPA ICR No. 1188). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per submission. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
EPA always welcomes your feedback on the burden estimates. Send any
comments about the accuracy of the burden estimate, and any suggested
methods for improving the collection instruments or instruction or
minimizing respondent burden, including through the use of automated
collection techniques.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA (5
U.S.C. 601 et seq.). The requirement to submit a SNUN applies to any
person (including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, EPA has concluded that no small or large entities
presently engage in such activities.
A SNUR requires that any person who intends to engage in such
activity in the future must first notify EPA by submitting a SNUN.
Although some small entities may decide to pursue a significant new use
in the future, EPA cannot presently determine how many, if any, there
may be. However, EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was 16 in Federal fiscal year (FY) FY2018,
five in FY2019, seven in FY2020, 13 in FY2021, 11 in FY2022, and 15 in
FY2023, and only a fraction of these submissions were from small
businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $37,000 to $6,480.
This lower fee reduces the total reporting and recordkeeping cost of
submitting a SNUN to about $14,500 per SNUN submission for qualifying
small firms. Therefore, the potential economic impacts of complying
with these proposed SNURs are not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented its general determination that SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C.
1531-1538, and does not significantly or uniquely affect small
governments. Based on EPA's experience with proposing and finalizing
SNURs, State, local, and Tribal governments have not been impacted by
SNURs, and EPA does not have any reasons to believe that any State,
local, or Tribal government will be impacted by these SNURs. In
addition, the estimated costs of this action to the private sector do
not exceed $183 million or more in any one year (the 1995 dollars are
adjusted to 2023 dollars for inflation using the GDP implicit price
deflator). The estimated costs for this action are discussed in Unit
I.D.
E. Executive Order 13132: Federalism
This action will not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not
expected to have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Accordingly, the requirements of Executive Order 13132 do
not apply to this action.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action will not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is
not expected to have substantial direct effects on Indian Tribes,
significantly or uniquely affect the communities of Indian Tribal
governments and does not involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
do not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it does not concern an environmental health or
safety risk. Since this action does not concern a human health risk,
EPA's 2021 Policy
[[Page 94641]]
on Children's Health also does not apply. Although the establishment of
these SNURs do not address an existing children's environmental health
concern because the chemical uses involved are not ongoing uses, SNURs
require that persons notify EPA at least 90 days before commencing
manufacture (defined by statute to include import) or processing of any
of these chemical substances for an activity that is designated as a
significant new use by this rulemaking. This notification allows EPA to
assess the intended uses to identify potential risks and take
appropriate actions before the activities commence.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
This action does not concern human health or environmental
conditions and therefore cannot be evaluated with respect to the
potential for disproportionate impacts on non-white and low-income
populations in accordance with Executive Order 12898 (59 FR 7629,
February 16, 1994) and Executive Order 14096 (88 FR 25251, April 26,
2023). Although this action does not concern human health or
environmental conditions, the premanufacture notifications required by
these SNURs allows EPA to assess the intended uses to identify
potential disproportionate risks and take appropriate actions before
the activities commence.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: November 22, 2024.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR chapter I as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. Sec. 721.11955 through 721.11959 to Subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11955 Polyolefin polyamine succinimide, carbopolycycle
alkoxylated (generic).
721.11956 Carbonmonocyclic alkene polymer with alkyl alkenoate,
alkyl alkenoate, alkyl alkenoate and polyalkyldiene alkenoate
(generic).
721.11957 1-Tetradecene, homopolymer, hydrogenated, by-products
from, C28-42 fraction.
721.11958 Carbonic acid, ester, polymer with alkanediol (C=4,5)
(generic).
721.11959 Hydrolyzed collagen, polymer with aromatic isocyanate, N-
triethoxysylil-alkanamine, pectic polysaccharide and poly alkyl
alcohol (generic).
* * * * *
Sec. 721.11955 Polyolefin polyamine succinimide, carbopolycycle
alkoxylated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyolefin polyamine succinimide, carbopolycycle alkoxylated (PMN P-20-
168) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a lubricating
additive for engine oils, transmission and hydraulic fluid, and gear
oil applications.
(ii) [Reserved]
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11956 Carbonmonocyclic alkene polymer with alkyl alkenoate,
alkyl alkenoate, alkyl alkenoate and polyalkyldiene alkenoate
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbonmonocyclic alkene polymer with alkyl alkenoate, alkyl alkenoate,
alkyl alkenoate and polyalkyldiene alkenoate (PMN P-21-5) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in worker inhalation exposure to the substance.
(ii) [Reserved]
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11957 1-Tetradecene, homopolymer, hydrogenated, by-products
from, C28-42 fraction.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-tetradecene,
homopolymer, hydrogenated, by-products from, C28-42 fraction (PMN P-21-
95; CASRN 2263959-83-5) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to process the substance other than in an enclosed
system when heated.
(ii) [Reserved]
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are
[[Page 94642]]
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11958 Carbonic acid, ester, polymer with alkanediol (C=4,5)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbonic acid, ester, polymer with alkanediol (C=4,5) (PMN P-21-174) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=200.
(ii) [Reserved]
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11959 Hydrolyzed collagen, polymer with aromatic isocyanate,
N-triethoxysylil-alkanamine, pectic polysaccharide and poly alkyl
alcohol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrolyzed collagen, polymer with aromatic isocyanate, N-
triethoxysylil-alkanamine, pectic polysaccharide and poly alkyl alcohol
(PMN P-23-17) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as an encapsulant
for time-released delivery of fragrance.
(ii) [Reserved]
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
* * * * *
[FR Doc. 2024-27913 Filed 11-27-24; 8:45 am]
BILLING CODE 6560-50-P
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