Significant New Use Rules on Certain Chemical Substances (19-5.F), 567-573 [2024-30964]
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Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Rules and Regulations
567
TABLE 1 TO § 402.12—Continued
Column 1
Column 2
Column 3
Description of charges
Rate ($)
Montreal to or from Lake Ontario
(5 locks)
Rate ($)
Welland Canal—Lake Ontario to or
from Lake Erie
(8 locks)
Item
2. .................
3. .................
4. .................
5. .................
6. .................
7. .................
(1) a charge per gross registered ton of the ship, applicable whether
the ship is wholly or partially laden, or is in ballast, and the gross
registered tonnage being calculated according to prescribed rules
for measurement or under the International Convention on Tonnage Measurement of Ships, 1969, as amended from time to
time: 1
(a) all vessels excluding passenger vessels ...............................
(b) passenger vessels ..................................................................
(2) a charge per metric ton of cargo as certified on the ship’s manifest or other document, as follows:
(a) bulk cargo ...............................................................................
(b) general cargo ..........................................................................
(c) steel slab .................................................................................
(d) containerized cargo ................................................................
(e) government aid cargo .............................................................
(f) grain .........................................................................................
(g) coal .........................................................................................
(3) a charge per passenger per lock ..................................................
(4) a lockage charge per Gross Registered Ton of the vessel, as
defined in item 1(1), applicable whether the ship is wholly or partially laden, or is in ballast, for transit of the Welland Canal in either direction by cargo ships,
Up to a maximum charge per vessel ..................................................
Subject to item 3, for partial transit of the Seaway ....................................
Minimum charge per vessel per lock transited for full or partial transit of
the Seaway.
A charge per pleasure craft per lock transited for full or partial transit of
the Seaway, including applicable Federal taxes 3.
Under the New Business Initiative Program, for cargo accepted as New
Business, a percentage rebate on the applicable cargo charges for
the approved period.
Under the Volume Rebate Incentive program, a retroactive percentage
rebate on cargo tolls on the incremental volume calculated based on
the pre-approved maximum volume.
Under the New Service Incentive Program, for New Business cargo
moving under an approved new service, an additional percentage refund on applicable cargo tolls above the New Business rebate.
0.1311 ..............................................
0.3934 ..............................................
0.2098.
0.6293.
1.3593 ..............................................
3.2753 ..............................................
2.9643 ..............................................
1.3593 ..............................................
n/a ....................................................
0.8351 ..............................................
0.8351 ..............................................
0.0000 ..............................................
n/a ....................................................
0.9278.
1.4849.
1.0630.
0.9278.
n/a.
0.9278.
0.9278.
0.0000.
0.3495.
n/a ....................................................
20 per cent per lock of the applicable charge under items 1(1), 1(2)
and 1(4) plus the applicable
charge under items 1(3).
33.93 2 ..............................................
4,889.00.
13 per cent per lock of the applicable charge under items 1(1), 1(2)
and 1(4) plus the applicable
charge under items 1(3).
33.93.
25.00 4 ..............................................
25.00.
20% ..................................................
20%.
10% ..................................................
10%.
20% ..................................................
20%.
1 Or
under the US GRT for vessels prescribed prior to 2002.
applicable charged under item 3 at the Great Lakes St. Lawrence Seaway Development Corporation’s locks (Eisenhower, Snell) will be collected in U.S. dollars. The collection of the U.S. portion of tolls for commercial vessels is waived by law (33 U.S.C. 988a(a)). The other charges are in Canadian dollars and are for the
Canadian share of tolls.
3 Includes a $5.00 discount per lock with use of online reservation and payment system for Canadian locks.
4 The applicable charge at the Great Lakes St. Lawrence Seaway Development Corporation’s locks (Eisenhower, Snell) for pleasure craft is $30 USD or $30 CAD
per lock.
2 The
Issued at Washington, DC, under authority
delegated at 49 CFR 1.101. Great Lakes St.
Lawrence Seaway Development Corporation.
Carrie Lavigne,
Chief Counsel.
[FR Doc. 2024–31616 Filed 1–3–25; 8:45 am]
BILLING CODE 4910–61–P
ENVIRONMENTAL PROTECTION
AGENCY
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40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2019–0530; FRL–7645–02–
OCSPP]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (19–5.F)
Environmental Protection
Agency (EPA).
AGENCY:
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ACTION:
Final rule.
EPA is issuing 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 SNURs require persons to
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 in the SNUR. The
required notification initiates EPA’s
evaluation of the use, under the
conditions of use for that chemical
substance, within the applicable review
period. Persons may not commence
manufacture or processing for the
significant new use until they have
submitted a Significant New Use Notice
SUMMARY:
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(SNUN), and EPA has conducted a
review of the notice, made an
appropriate determination on the notice,
and has taken any risk management
actions as are required as a result of that
determination.
This rule is effective on March 7,
2025. For purposes of judicial review,
this rule shall be promulgated at 1 p.m.
(EST) on January 21, 2025.
DATES:
The docket for this action,
identified under docket identification
(ID) number EPA–HQ–OPPT–2019–
0530, is available online at https://
www.regulations.gov or in person at the
Office of Pollution Prevention and
Toxics Docket (OPPT Docket) in the
Environmental Protection Agency
Docket Center (EPA/DC). Please review
the visitor instructions and additional
ADDRESSES:
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information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: James Yan,
New Chemicals Division (7405M),
Office of Pollution Prevention and
Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 564–2138; email address:
yan.james@epa.gov.
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:
wysong.william@epa.gov.
For general information: The TSCAHotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620;
telephone number: (202) 554–1404;
email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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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 finalizing SNURs under TSCA
section 5(a)(2) for chemical substances
that were the subject of PMNs P–16–
541, P–17–299, P–18–172, P–19–99, P–
19–118, and P–19–120. The SNURs
require persons who intend to
manufacture or process any of these
chemical substances for an activity that
is designated as a significant new use in
the SNURs to notify EPA at least 90
days before commencing that activity.
Previously, in the Federal Register of
December 6, 2019 (84 FR 66855) (FRL–
10001–48), EPA proposed SNURs for
these chemical substances along with
nineteen other SNURs. EPA finalized
the proposed SNURs for P–17–393, P–
19–86, P–19–87, P–19–89, P–19–90, P–
19–91, P–19–92, P–19–93, P–19–97, P–
19–100, P–19–101, P–19–102, P–19–
103, P–19–104, P–19–105, P–19–106, P–
19–107, P–19–108, and P–19–110 in a
previous Federal Register notice of
August 18, 2021 (86 FR 46133) (FRL–
8000–02–OCSPP). EPA is not currently
finalizing the SNURs for the chemical
substances which were the subject of
PMNs P–18–387 and P–18–388 and will
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address these SNURs in a future notice
in order to consider new information
about exposures. More information on
the specific chemical substances subject
to this final rule can be found in the
Federal Register document proposing
the SNURs. The docket includes
information considered by the Agency
in developing the proposed and final
rules, including the public comments
received on the proposed rules that are
described in Unit II.
C. Does this action apply to me?
1. General Applicability
This action may apply to you if you
manufacture (defined by statute to
include import), process, or use the
chemical substances addressed in this
Federal Register document. The
following list of North American
Industrial Classification System
(NAICS) codes is not intended to be
exhaustive, but rather provides a guide
to help readers determine whether this
document applies to them. Potentially
affected entities may include:
• Manufacturers or processors of one
or more subject chemical substances
(NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
2. Applicability to Importers and
Exporters
This action may also affect certain
entities through pre-existing import
certification and export notification
requirements under TSCA. Chemical
importers are subject to TSCA section
13 (15 U.S.C. 2612), the import
provisions 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. Importers of chemical
substances in bulk form, as part of a
mixture, or as part of an article (if
required by rule) 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.
In addition, pursuant to 40 CFR
721.20, any persons who export or
intend to export a chemical substance
identified in this document are subject
to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b))
(see 40 CFR 721.20), and must comply
with the export notification
requirements in 40 CFR part 707,
subpart D.
D. What are the estimated incremental
impacts of this action?
EPA has evaluated the potential costs
of establishing SNUN reporting
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requirements for potential
manufacturers (including importers)
and processors of the chemical
substances included in these 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.
II. Background
Unit II. of the proposed rule provides
general information about SNURs, and
additional information about EPA’s new
chemical program is available at https://
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca.
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A. Significant New Uses Claimed as
Confidential Business Information (CBI)
EPA is establishing certain significant
new uses which have been claimed as
CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR
part 703. Absent a final determination
or other disposition of the
confidentiality claim under these
regulations, 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.
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B. Applicability of the Significant New
Use Designation
Any use that EPA determines in the
final rule was ongoing as of the date of
publication of the proposal and did not
cease prior to issuance of the final rule,
will not be designated as a significant
new use in the final rule. EPA has no
information to suggest that any of the
significant new uses identified in this
rule meet those criteria.
As discussed in the Federal Register
of April 24, 1990 (55 FR 17376 (FRL–
3658–5)), EPA believes that the intent of
TSCA section 5(a)(1)(B) is best served by
designating a use as a significant new
use as of the date of publication of the
proposed rule rather than as of the
effective date of the final rule. The
objective of EPA’s approach is to ensure
that a person cannot impede finalization
of a SNUR by initiating a significant
new use after publication of the
proposed rule but before the effective
date of the final rule. Uses arising after
the publication of the proposed rule are
distinguished from uses that are
identified in the final rule as having
been ongoing on the date of publication
of the proposed rule. The former would
be new uses, the latter ongoing uses,
except that uses that are identified as
ongoing as of the publication of the
proposed rule would not be considered
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ongoing uses if they have ceased by the
date of issuance of a final rule.
In the unlikely event that before a
final rule becomes effective a person
begins commercial manufacturing
(including importing) or processing of
the chemical substances for a use that is
designated as a significant new use in
that final rule, such a person 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 wait until all TSCA
prerequisites for the commencement of
manufacture or processing have been
satisfied.
Issuance of a 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 on the
internet at https://www.epa.gov/tscainventory.
C. Important Information About SNUN
Submissions
1. SNUN Submissions
SNUNs must be submitted on EPA
Form No. 7710–25, generated using ePMN 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-chemicalsunder-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
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569
not required, to provide the potentially
useful information identified for the
chemical substance in Unit IV of the
proposed rule.
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-andmanaging-chemicals-under-tsca/
alternative-test-methods-and-strategiesreduce.
The potentially useful information
described in Unit IV of the proposed
rule 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.
D. Public Comments on Proposed Rule
and EPA Responses
EPA received public comments from
two identifying entities and two
confidential entities pertaining to the
SNURs that the Agency is finalizing
with this rule. One comment was
generally critical of the rule but did not
identify specific changes or issues with
the rule requirements; therefore, no
response is required. Two of the
comments identified ongoing uses of
two different chemical substances in the
proposed rule. As a result, EPA is
issuing a modified final rule for those
chemical substances that do not
designate the ongoing uses as significant
new uses. Specifically, for the chemical
substance that was the subject of P–17–
299, EPA will no longer designate as a
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significant new use the use of the
chemical substance in a manner that
generates a dust, mist, or aerosol. EPA
is instead designating as a significant
new use the use of the chemical
substance by workers unless specific
respiratory protection is provided. For
the chemical substance that was the
subject of P–18–172, EPA is not
designating use of the chemical
substance in architectural coatings that
are consumer products as a significant
new use. A summary of all of the
comments and the Agency’s responses
to these comments are presented in the
Response to Public Comments
document. The comments and the
Response to Public Comments are
available in the docket for this rule.
III. Chemical Substances Subject to
These SNURs
A. What is the designated cutoff date for
determining whether the new use is
ongoing for these chemical substances?
EPA designates December 6, 2019, as
the cutoff date for determining whether
the new use is ongoing. This
designation is explained in more detail
in Unit VI of the proposed rule.
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B. What information is provided for
each chemical substance?
In Unit IV. of the proposed rule, EPA
provided the following information for
each chemical substance subject to these
SNURs:
• PMN number (the 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 nonconfidential chemical identities).
• Potentially useful information.
The regulatory text section specifies
the activities designated as significant
new uses. Certain new uses, including
exceeding production volume limits and
other uses designated in the proposed
rules, may be claimed as CBI.
In addition, as discussed in Unit V.A.
of the proposed rule, for the chemical
substances that have undergone
premanufacture review, EPA has
identified certain conditions of use and
other circumstances of use apart from
those intended by the PMN submitter as
significant new uses. All uses identified
as significant new uses in this rule
cannot occur without first going through
a separate EPA review and
determination process associated with a
SNUN.
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IV. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive orders can be
found at https://www.epa.gov/lawsregulations-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 14094: Modernizing Regulatory
Review
This action establishes 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 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 associated with SNURs
have already been approved by OMB
pursuant to the PRA under OMB control
number 2070–0038 (EPA ICR No.
1188.13). 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 estimate. Send any
comments about the accuracy of the
burden estimate, and any suggested
methods for 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
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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 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
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costs for this action are discussed in
Unit I.D.
significant adverse effect on the supply,
distribution, or use of energy.
E. Executive Order 13132: Federalism
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).
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 or 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
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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
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 rule. 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
16:06 Jan 03, 2025
Jkt 265001
K. Congressional Review Act (CRA)
This action is subject to the CRA (5
U.S.C. 801 et seq.), and EPA will submit
a rule report to each House of the
Congress and to the Comptroller General
of the United States. This action is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting
and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: December 20, 2024.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and
Toxics.
Therefore, for the reasons stated in the
preamble, 40 CFR chapter I is amended
as follows:
PART 9—OMB APPROVALS UNDER
THE PAPERWORK REDUCTION ACT
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
VerDate Sep<11>2014
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 allow EPA to assess the
intended uses to identify potential
disproportionate risks and take
appropriate actions before the activities
commence.
1. The authority citation for part 9
continues to read as follows:
■
Authority: 7 U.S.C. 135 et seq., 136–136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
PO 00000
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Fmt 4700
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21 U.S.C. 331j, 346a; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345 (d) and
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971–1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
6901–6992k, 7401–7671q, 7542, 9601–9657,
11023, 11048.
2. Amend the table in § 9.1, by adding
entries for §§ 721.11420 and 721.11421,
721.11423, and 721.11444 through
721.11446 in numerical order under the
undesignated center heading
‘‘Significant New Uses of Chemical
Substances’’ to read as follows:
■
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
*
*
40 CFR citation
*
*
OMB control No.
*
*
*
Significant New Uses of Chemical
Substances
*
*
*
721.11420 .....................
721.11421 .....................
*
*
2070–0012
2070–0012
*
*
*
721.11423 .....................
*
*
2070–0012
*
*
*
721.11444 .....................
721.11445 .....................
721.11446 .....................
*
*
2070–0012
2070–0012
2070–0012
*
*
*
*
*
*
*
*
*
*
PART 721—SIGNIFICANT NEW USES
OF CHEMICAL SUBSTANCES
3. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
Subpart E—Significant New Uses for
Specific Chemical Substances
4. Add §§ 721.11420, 721.11421,
721.11423, and 721.11444 through
721.11446 to Subpart E to read as
follows:
■
Sec.
*
*
*
*
*
721.11420 Soybean meal, reaction products
with phosphoric trichloride.
721.11421 2-propenoic acid, alkyl,
polymers with alkyl acrylate and
polyethylene glycol methacrylate alkyl
ether (generic).
*
*
*
*
*
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Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Rules and Regulations
721.11423 Calcium, carbonate 2ethylhexanoate neodecanoate propionate
complexes.
*
*
*
*
*
721.11444 Propanoic acid, 3-hydroxy-2(hydroxymethyl)-2-methyl-, polymer
with dimethyl carbonate, 1,2ethanediamine, 2-ethyl-2(hydroxymethyl)-1,3-propanediol, 1,6hexanediol and 1,1′-methylenebis[4isocyanatocyclohexane], compd. with
N,N-diethylethanamine.
721.11445 Substituted polyalkylenepoly,
reaction products with alkene polymer
(generic).
721.11446 Alkenoic acid, polymer with
alkanediyl bis substituted alkylene bis
heteromonocycle, substituted
carbomonocycle and (alkylalkenyl)
carbomonocycle, alkali metal salt
(generic).
*
*
*
*
*
§ 721.11420 Soybean meal, reaction
products with phosphoric trichloride.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
soybean meal, reaction products with
phosphoric trichloride (PMN P–16–541,
CASRN 1962913–92–3) 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 § 721.90(a)(4), (b)(4), and
(c)(4), where N=22.
(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
§ 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 § 721.185 apply to this
section.
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§ 721.11421 2-propenoic acid, alkyl,
polymers with alkyl acrylate and
polyethylene glycol methacrylate alkyl ether
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 2-propenoic acid, alkyl,
polymers with alkyl acrylate and
polyethylene glycol methacrylate alkyl
ether (PMN P–17–299) 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
§ 721.63(a)(4) through (6), and (c). When
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16:06 Jan 03, 2025
Jkt 265001
determining which persons are
reasonably likely to be exposed as
required for § 721.63(4), engineering
control measures (e.g., enclosure or
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 § 721.63(a)(5), respirators must
provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 1,000.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f). It is a significant
new use to use the substance other than
as a thickener in paint. It is a significant
new use to use the substance in
concentrations greater than 1% in
formulated products.
(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
§ 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 § 721.185 apply to this
section.
*
*
*
*
*
§ 721.11423 Calcium, carbonate 2ethylhexanoate neodecanoate propionate
complexes.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
calcium, carbonate 2-ethylhexanoate
neodecanoate propionate complexes
(PMN P–18–172) 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
consumer product except for use in
architectural coatings. It is a significant
new use to use the substance other than
as an auxiliary drier for architectural
paints, industrial coatings and stains.
(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
§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of this substance.
PO 00000
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Fmt 4700
Sfmt 4700
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
*
*
*
*
*
§ 721.11444 Propanoic acid, 3-hydroxy-2(hydroxymethyl)-2-methyl-, polymer with
dimethyl carbonate, 1,2-ethanediamine, 2ethyl-2-(hydroxymethyl)-1,3-propanediol,
1,6-hexanediol and 1,1′-methylenebis[4isocyanatocyclohexane], compd. with N,Ndiethylethanamine.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
propanoic acid, 3-hydroxy-2(hydroxymethyl)-2-methyl-, polymer
with dimethyl carbonate, 1,2ethanediamine, 2-ethyl-2(hydroxymethyl)-1,3-propanediol, 1,6hexanediol and 1,1′-methylenebis[4isocyanatocyclohexane], compd. with
N,N-diethylethanamine (PMN P–19–99,
CASRN 1178511–46–0) 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 § 721.80(o). It is a
significant new use to use the substance
other than as a clear coat for wood.
(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
§ 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 § 721.185 apply to this
section.
§ 721.11445 Substituted polyalkylenepoly,
reaction products with alkene polymer
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted
polyalkylenepoly, reaction products
with alkene polymer (PMN P–19–118) 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 inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
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06JAR1
Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Rules and Regulations
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 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 § 721.185 apply to this
section.
§ 721.11446 Alkenoic acid, polymer with
alkanediyl bis substituted alkylene bis
heteromonocycle, substituted
carbomonocycle and (alkylalkenyl)
carbomonocycle, alkali metal salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkenoic acid, polymer
with alkanediyl bis substituted alkylene
bis heteromonocycle, substituted
carbomonocycle and (alkylalkenyl)
carbomonocycle, alkali metal salt (PMN
P–19–120) 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 § 721.90(a)(4), (b)(4), and
(c)(4) where N=78.
(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
§ 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 § 721.185 apply to this
section.
[FR Doc. 2024–30964 Filed 1–3–25; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 372
[EPA–HQ–OPPT–2024–0044; FRL 9427.2–
01–OCSPP]
khammond on DSK9W7S144PROD with RULES
RIN 2070–AL23
Implementing Statutory Addition of
Certain Per- and Polyfluoroalkyl
Substances (PFAS) to Toxics Release
Inventory (TRI) Beginning With
Reporting Year 2025
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is updating the list of
SUMMARY:
VerDate Sep<11>2014
16:06 Jan 03, 2025
Jkt 265001
573
I. General Information
212115, 212220, 212230, 212290*; or
2211*, 221210*, 221330 (limited to
facilities that combust coal and/or oil
for the purpose of generating power for
distribution in commerce) (corresponds
to SIC codes 4911, 4931, and 4939,
Electric Utilities); or 424690, 424710
(corresponds to SIC code 5171,
Petroleum Bulk Terminals and Plants);
425120 (limited to facilities previously
classified in SIC code 5169, Chemicals
and Allied Products, Not Elsewhere
Classified); or 562112 (limited to
facilities primarily engaged in solvent
recovery services on a contract or fee
basis (previously classified under SIC
code 7389, Business Services, NEC)); or
562211*, 562212*, 562213*, 562219*,
562920 (limited to facilities regulated
under the Resource Conservation and
Recovery Act, subtitle C, 42 U.S.C. 6921
et seq.) (corresponds to SIC code 4953,
Refuse Systems). *Exceptions and/or
limitations exist for these NAICS codes.
• Federal facilities.
A more detailed description of the
types of facilities subject to reporting
under EPCRA section 313 can be found
at: https://www.epa.gov/toxics-releaseinventory-tri-program/tri-coveredindustry-sectors. To determine whether
your facility would be affected by this
action, you should carefully examine
the applicability criteria in 40 CFR part
372, subpart B. If you have questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
A. Does this action apply to me?
B. What action is the Agency taking?
You may be potentially affected by
this action if you manufacture, process,
or otherwise use any of the PFAS listed
in this rule, including but not limited to
entities identified with the following
North American Industry Classification
System (NAICS) codes.
• Facilities included in the following
NAICS manufacturing codes
(corresponding to Standard Industrial
Classification (SIC) codes 20 through
39): 311*, 312*, 313*, 314*, 315*, 316,
321, 322, 323*, 324, 325*, 326*, 327*,
331, 332, 333, 334*, 335*, 336, 337*,
339*, 111998*, 113310, 211130*,
212323*, 212390*, 488390*, 512230*,
512250*, 5131*, 516210*, 519290*,
541713*, 541715* or 811490*.
*Exceptions and/or limitations exist for
these NAICS codes.
• Facilities included in the following
NAICS codes (corresponding to SIC
codes other than SIC codes 20 through
39): 211130* (corresponds to SIC code
1321, Natural Gas Liquids, and SIC
2819, Industrial Inorganic Chemicals,
Not Elsewhere Classified); or 212114,
EPA is codifying the addition of the
nine PFAS added to the EPCRA section
313 list of reportable chemicals (more
commonly known as the Toxics Release
Inventory (TRI)) since the last
conforming rule pursuant to the FY2020
NDAA ((89 FR 43331; May 17, 2024)
(FRL–9427.1–01–OCSPP)).
chemicals subject to toxic chemical
release reporting under the Emergency
Planning and Community Right-toKnow Act (EPCRA) and the Pollution
Prevention Act (PPA). Specifically, this
action updates the regulations to
identify nine per- and polyfluoroalkyl
substances (PFAS) that must be reported
pursuant to the National Defense
Authorization Act for Fiscal Year 2020
(FY2020 NDAA) enacted on December
20, 2019. As this action is being taken
to conform the regulations to a
Congressional legislative mandate,
notice and comment rulemaking is
unnecessary.
This final rule is effective
February 5, 2025.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2024–0044, is
available at https://
www.regulations.gov. Additional
instructions on visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Daniel R. Ruedy, Data Gathering,
Management and Policy Division
(7607M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 564–7974; email address:
ruedy.daniel@epa.gov.
SUPPLEMENTARY INFORMATION:
DATES:
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Fmt 4700
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C. What is the Agency’s authority for
taking this action?
This action is issued under authority
of EPCRA section 313 (42 U.S.C. 11001
et seq.), PPA section 6607 (42 U.S.C.
13106), and FY2020 NDAA section 7321
(Pub. L. 116–92).
II. Background
A. What is NDAA Section 7321?
The FY2020 NDAA was signed into
law on December 20, 2019. Among other
provisions, section 7321(c) identifies
certain regulatory activities that
automatically add PFAS or classes of
PFAS to the EPCRA section 313 list of
reportable chemicals. PFAS or classes of
PFAS shall be added to the EPCRA
E:\FR\FM\06JAR1.SGM
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]]>Agencies
[Federal Register Volume 90, Number 3 (Monday, January 6, 2025)]
[Rules and Regulations]
[Pages 567-573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30964]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2019-0530; FRL-7645-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (19-5.F)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is issuing 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 SNURs
require persons to 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 in the SNUR. The required notification initiates
EPA's evaluation of the use, under the conditions of use for that
chemical substance, within the applicable review period. Persons may
not commence manufacture or processing for the significant new use
until they have submitted a Significant New Use Notice (SNUN), and EPA
has conducted a review of the notice, made an appropriate determination
on the notice, and has taken any risk management actions as are
required as a result of that determination.
DATES: This rule is effective on March 7, 2025. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (EST) on
January 21, 2025.
ADDRESSES: The docket for this action, identified under docket
identification (ID) number EPA-HQ-OPPT-2019-0530, is available online
at https://www.regulations.gov or in person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket) in the Environmental
Protection Agency Docket Center (EPA/DC). Please review the visitor
instructions and additional
[[Page 568]]
information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: James Yan, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-2138; email address:
[email protected].
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
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 finalizing SNURs under TSCA section 5(a)(2) for chemical
substances that were the subject of PMNs P-16-541, P-17-299, P-18-172,
P-19-99, P-19-118, and P-19-120. The SNURs require persons who intend
to manufacture or process any of these chemical substances for an
activity that is designated as a significant new use in the SNURs to
notify EPA at least 90 days before commencing that activity.
Previously, in the Federal Register of December 6, 2019 (84 FR
66855) (FRL-10001-48), EPA proposed SNURs for these chemical substances
along with nineteen other SNURs. EPA finalized the proposed SNURs for
P-17-393, P-19-86, P-19-87, P-19-89, P-19-90, P-19-91, P-19-92, P-19-
93, P-19-97, P-19-100, P-19-101, P-19-102, P-19-103, P-19-104, P-19-
105, P-19-106, P-19-107, P-19-108, and P-19-110 in a previous Federal
Register notice of August 18, 2021 (86 FR 46133) (FRL-8000-02-OCSPP).
EPA is not currently finalizing the SNURs for the chemical substances
which were the subject of PMNs P-18-387 and P-18-388 and will address
these SNURs in a future notice in order to consider new information
about exposures. More information on the specific chemical substances
subject to this final rule can be found in the Federal Register
document proposing the SNURs. The docket includes information
considered by the Agency in developing the proposed and final rules,
including the public comments received on the proposed rules that are
described in Unit II.
C. Does this action apply to me?
1. General Applicability
This action may apply to you if you manufacture (defined by statute
to include import), process, or use the chemical substances addressed
in this Federal Register document. The following list of North American
Industrial Classification System (NAICS) codes is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also affect certain entities through pre-existing
import certification and export notification requirements under TSCA.
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the
import provisions 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. Importers of chemical substances in bulk
form, as part of a mixture, or as part of an article (if required by
rule) 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.
In addition, pursuant to 40 CFR 721.20, any persons who export or
intend to export a chemical substance identified in this document are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
D. What are the estimated incremental 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 included in these
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.
II. Background
Unit II. of the proposed rule provides general information about
SNURs, and additional information about EPA's new chemical program is
available at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
[[Page 569]]
A. Significant New Uses Claimed as Confidential Business Information
(CBI)
EPA is establishing certain significant new uses which have been
claimed as CBI subject to Agency confidentiality regulations at 40 CFR
part 2 and 40 CFR part 703. Absent a final determination or other
disposition of the confidentiality claim under these regulations, 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.
B. Applicability of the Significant New Use Designation
Any use that EPA determines in the final rule was ongoing as of the
date of publication of the proposal and did not cease prior to issuance
of the final rule, will not be designated as a significant new use in
the final rule. EPA has no information to suggest that any of the
significant new uses identified in this rule meet those criteria.
As discussed in the Federal Register of April 24, 1990 (55 FR 17376
(FRL-3658-5)), EPA believes that the intent of TSCA section 5(a)(1)(B)
is best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. The objective of EPA's approach is to
ensure that a person cannot impede finalization of a SNUR by initiating
a significant new use after publication of the proposed rule but before
the effective date of the final rule. Uses arising after the
publication of the proposed rule are distinguished from uses that are
identified in the final rule as having been ongoing on the date of
publication of the proposed rule. The former would be new uses, the
latter ongoing uses, except that uses that are identified as ongoing as
of the publication of the proposed rule would not be considered ongoing
uses if they have ceased by the date of issuance of a final rule.
In the unlikely event that before a final rule becomes effective a
person begins commercial manufacturing (including importing) or
processing of the chemical substances for a use that is designated as a
significant new use in that final rule, such a person 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 wait until all TSCA
prerequisites for the commencement of manufacture or processing have
been satisfied.
Issuance of a 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 on the internet at
https://www.epa.gov/tsca-inventory.
C. 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 IV of the proposed rule.
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 IV of the
proposed rule 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.
D. Public Comments on Proposed Rule and EPA Responses
EPA received public comments from two identifying entities and two
confidential entities pertaining to the SNURs that the Agency is
finalizing with this rule. One comment was generally critical of the
rule but did not identify specific changes or issues with the rule
requirements; therefore, no response is required. Two of the comments
identified ongoing uses of two different chemical substances in the
proposed rule. As a result, EPA is issuing a modified final rule for
those chemical substances that do not designate the ongoing uses as
significant new uses. Specifically, for the chemical substance that was
the subject of P-17-299, EPA will no longer designate as a
[[Page 570]]
significant new use the use of the chemical substance in a manner that
generates a dust, mist, or aerosol. EPA is instead designating as a
significant new use the use of the chemical substance by workers unless
specific respiratory protection is provided. For the chemical substance
that was the subject of P-18-172, EPA is not designating use of the
chemical substance in architectural coatings that are consumer products
as a significant new use. A summary of all of the comments and the
Agency's responses to these comments are presented in the Response to
Public Comments document. The comments and the Response to Public
Comments are available in the docket for this rule.
III. Chemical Substances Subject to These SNURs
A. What is the designated cutoff date for determining whether the new
use is ongoing for these chemical substances?
EPA designates December 6, 2019, as the cutoff date for determining
whether the new use is ongoing. This designation is explained in more
detail in Unit VI of the proposed rule.
B. What information is provided for each chemical substance?
In Unit IV. of the proposed rule, EPA provided the following
information for each chemical substance subject to these SNURs:
PMN number (the 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).
Potentially useful information.
The regulatory text section specifies the activities designated as
significant new uses. Certain new uses, including exceeding production
volume limits and other uses designated in the proposed rules, may be
claimed as CBI.
In addition, as discussed in Unit V.A. of the proposed rule, for
the chemical substances that have undergone premanufacture review, EPA
has identified certain conditions of use and other circumstances of use
apart from those intended by the PMN submitter as significant new uses.
All uses identified as significant new uses in this rule cannot occur
without first going through a separate EPA review and determination
process associated with a SNUN.
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 establishes 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 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 associated with SNURs have
already been approved by OMB pursuant to the PRA under OMB control
number 2070-0038 (EPA ICR No. 1188.13). 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 estimate. Send any
comments about the accuracy of the burden estimate, and any suggested
methods for 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 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
[[Page 571]]
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 or
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 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 rule. 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 allow EPA to assess the intended uses to identify potential
disproportionate risks and take appropriate actions before the
activities commence.
K. Congressional Review Act (CRA)
This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: December 20, 2024.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended as follows:
PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a; 31 U.S.C. 9701;
33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. Amend the table in Sec. 9.1, by adding entries for Sec. Sec.
721.11420 and 721.11421, 721.11423, and 721.11444 through 721.11446 in
numerical order under the undesignated center heading ``Significant New
Uses of Chemical Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.11420........................................... 2070-0012
721.11421........................................... 2070-0012
* * * * *
721.11423........................................... 2070-0012
* * * * *
721.11444........................................... 2070-0012
721.11445........................................... 2070-0012
721.11446........................................... 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
Subpart E--Significant New Uses for Specific Chemical Substances
0
4. Add Sec. Sec. 721.11420, 721.11421, 721.11423, and 721.11444
through 721.11446 to Subpart E to read as follows:
Sec.
* * * * *
721.11420 Soybean meal, reaction products with phosphoric
trichloride.
721.11421 2-propenoic acid, alkyl, polymers with alkyl acrylate and
polyethylene glycol methacrylate alkyl ether (generic).
* * * * *
[[Page 572]]
721.11423 Calcium, carbonate 2-ethylhexanoate neodecanoate
propionate complexes.
* * * * *
721.11444 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-,
polymer with dimethyl carbonate, 1,2-ethanediamine, 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1'-
methylenebis[4-isocyanatocyclohexane], compd. with N,N-
diethylethanamine.
721.11445 Substituted polyalkylenepoly, reaction products with
alkene polymer (generic).
721.11446 Alkenoic acid, polymer with alkanediyl bis substituted
alkylene bis heteromonocycle, substituted carbomonocycle and
(alkylalkenyl) carbomonocycle, alkali metal salt (generic).
* * * * *
Sec. 721.11420 Soybean meal, reaction products with phosphoric
trichloride.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as soybean meal,
reaction products with phosphoric trichloride (PMN P-16-541, CASRN
1962913-92-3) 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=22.
(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. 721.11421 2-propenoic acid, alkyl, polymers with alkyl acrylate
and polyethylene glycol methacrylate alkyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, alkyl, polymers with alkyl acrylate and polyethylene
glycol methacrylate alkyl ether (PMN P-17-299) 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) through (6), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(4),
engineering control measures (e.g., enclosure or 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 1,000.
(ii) 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 as a thickener in paint. It is a significant new
use to use the substance in concentrations greater than 1% in
formulated products.
(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. 721.11423 Calcium, carbonate 2-ethylhexanoate neodecanoate
propionate complexes.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as calcium, carbonate
2-ethylhexanoate neodecanoate propionate complexes (PMN P-18-172) 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 consumer product except
for use in architectural coatings. It is a significant new use to use
the substance other than as an auxiliary drier for architectural
paints, industrial coatings and stains.
(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. 721.11444 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-
, polymer with dimethyl carbonate, 1,2-ethanediamine, 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1'-
methylenebis[4-isocyanatocyclohexane], compd. with N,N-
diethylethanamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propanoic acid, 3-
hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with dimethyl carbonate,
1,2-ethanediamine, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 1,6-
hexanediol and 1,1'-methylenebis[4-isocyanatocyclohexane], compd. with
N,N-diethylethanamine (PMN P-19-99, CASRN 1178511-46-0) 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 other than as a clear coat for wood.
(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. 721.11445 Substituted polyalkylenepoly, reaction products with
alkene polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted polyalkylenepoly, reaction products with alkene polymer
(PMN P-19-118) 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 inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
[[Page 573]]
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. 721.11446 Alkenoic acid, polymer with alkanediyl bis
substituted alkylene bis heteromonocycle, substituted carbomonocycle
and (alkylalkenyl) carbomonocycle, alkali metal salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, polymer with alkanediyl bis substituted alkylene bis
heteromonocycle, substituted carbomonocycle and (alkylalkenyl)
carbomonocycle, alkali metal salt (PMN P-19-120) 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=78.
(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.
[FR Doc. 2024-30964 Filed 1-3-25; 8:45 am]
BILLING CODE 6560-50-P
