Proposed Rule2024-29275
Significant New Use Rules on Certain Chemical Substances (24-3.5e)
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
December 17, 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) and are also subject to an Order issued by EPA pursuant to TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rulemaking to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of that 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 242 (Tuesday, December 17, 2024)</title>
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[Federal Register Volume 89, Number 242 (Tuesday, December 17, 2024)]
[Proposed Rules]
[Pages 102046-102074]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-29275]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2024-0079; FRL-12386-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (24-
3.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for certain chemical substances
that were the subject of premanufacture notices (PMNs) and are also
subject to an Order issued by EPA pursuant to TSCA. The SNURs require
persons who intend to manufacture (defined by statute to include
import) or process any of these chemical substances for an activity
that is proposed as a significant new use by this rulemaking to notify
EPA at least 90 days before commencing that activity. The required
notification initiates EPA's evaluation of the conditions of that 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 January 16, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0079, 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: Jordan Garbin, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection
[[Page 102047]]
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: (202) 564-4156; email address: <a href="/cdn-cgi/l/email-protection#1b7c7a69797275357174697f7a755b7e6b7a357c746d"><span class="__cf_email__" data-cfemail="5c3b3d2e3e35327236332e383d321c392c3d723b332a">[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#ec9b959f83828bc29b858080858d81ac899c8dc28b839a"><span class="__cf_email__" data-cfemail="84f3fdf7ebeae3aaf3ede8e8ede5e9c4e1f4e5aae3ebf2">[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#d185829290fc99bea5bdb8bfb491b4a1b0ffb6bea7"><span class="__cf_email__" data-cfemail="8dd9dececca0c5e2f9e1e4e3e8cde8fdeca3eae2fb">[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 the chemical substances discussed in
Unit III. These SNURs, if finalized as proposed, would require persons
who intend to manufacture or process any of these chemical substances
for an activity that is designated as a significant new use to notify
EPA at least 90 days before commencing that activity.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances 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 in 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 January 16, 2025 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.
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/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-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,
[[Page 102048]]
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 are subject to
orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). The TSCA orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed SNURs identify as
significant new uses any manufacturing, processing, use, distribution
in commerce, or disposal that does not conform to the restrictions
imposed by the underlying TSCA orders, consistent with TSCA section
5(f)(4).
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 that are the subject to these
proposed SNURs, EPA concluded that regulation was warranted under TSCA
section 5(e), pending the development of information sufficient to make
reasoned evaluations of the health or environmental effects of the
chemical substances. Based on the findings outlined in Unit III., TSCA
section 5(e) Orders requiring the use of appropriate exposure controls
were negotiated with the PMN submitters. As a general matter, EPA
believes it is necessary to follow the TSCA Orders with a SNUR that
identifies the absence of those protective measures as significant new
uses to ensure that all manufacturers and processors--not just the
original submitter--are held to the same standard.
2. Objectives
EPA is proposing these SNURs because the Agency wants:
<bullet> To identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the restrictions imposed by the underlying TSCA Orders,
consistent with TSCA section 5(f)(4).
<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 <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
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 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.
D. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to SNURs, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA sections 5(b)
and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720.
In addition, provisions relating to user fees appear at 40 CFR part
700.
Once EPA receives a SNUN, EPA must either determine that the
significant new use is not likely to present an unreasonable risk of
injury under the conditions of use for the chemical substance or take
such regulatory action as is associated with an alternative
determination under TSCA section 5 before the manufacture (including
import) or processing for the significant new use can commence. If EPA
determines that the significant new use of the chemical substance is
not likely to present an unreasonable risk, EPA is required under TSCA
section 5(g) to make public, and submit for publication in the Federal
Register, a statement of EPA's findings.
As discussed in Unit I.C.2., persons who export or intend to export
a chemical substance identified in a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b), and
persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements. See
also <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 and
[[Page 102049]]
received determinations under TSCA section 5(a)(3)(C). TSCA Orders have
been issued for these chemical substances and the PMN submitters are
required by the TSCA Orders to submit a SNUN before undertaking
activities that would be designated as significant new uses in these
SNURs. Additionally, the identities of many of the chemical substances
subject to this proposed rule have been claimed as confidential per 40
CFR 720.85, further reducing the likelihood that another party would
manufacture or process the substances for an activity that would be
designated as a significant new use. Based on this, the Agency believes
that it is highly unlikely that any of the significant new uses
identified in Unit III. are ongoing.
When the chemical substances identified in Unit III. are added to
the TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. 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 that provide detailed information on the human exposure
and environmental release that may result from the significant new use
of the chemical substances.
III. Chemical Substances Subject to These Proposed SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates December 17, 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 the proposed rule).
<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 action (effective date of and basis for the
TSCA Order).
<bullet> Potentially useful information.
The regulatory text section of the proposed rule specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
These proposed rules include PMN substances that are subject to
orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). Those TSCA Orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed SNURs identify as
significant new uses any manufacturing, processing, use, distribution
in commerce, or disposal that does not conform to the restrictions
imposed by the underlying TSCA Orders, consistent with TSCA section
5(f)(4).
C. Which chemical substances are subject to these proposed rules?
The substances subject to the proposed rules in this document are
as follows:
PMN Number (Proposed CFR Citation): P-18-127 (40 CFR 721.12043)
Chemical Name: Heptane, 2-methoxy-2-methyl-.
CASRN: 76589-16-7.
Effective Date of TSCA Order: December 15, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
fragrance for household and consumer products, mainly laundry
detergents. Based on submitted test data on the PMN substance, EPA has
identified concerns for skin sensitization. Based on comparison to
analogous chemical substances, EPA has also identified concerns for
systemic and developmental effects. Based on submitted test data on the
PMN substance, EPA predicts toxicity to
[[Page 102050]]
aquatic organisms may occur at concentrations that exceed 210 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
<bullet> Manufacture of the PMN substance only by import into the
United States in a solution of no greater than 5% by weight (i.e., no
domestic manufacture);
<bullet> Processing of the PMN substance only in a solution of no
greater than 5% by weight of the PMN substance;
<bullet> Processing for use or use of the PMN substance in consumer
products only if the concentration of the PMN substance is less than 1%
by weight;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 210 ppb;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
developmental toxicity, specific target organ toxicity, and pulmonary
effects testing may be potentially useful to characterize the health
and environmental effects of the PMN substance. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
PMN Number (Proposed CFR Citation): P-18-325 (40 CFR 721.12044)
Chemical Name: Benzenesulfonic acid, alkyl-, compd. with 1,1'-
iminobis[2-propanol] (1:1) (generic).
CASRN: Not available.
Effective Date of TSCA Order: January 9, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
industrial crosslinking catalyst. Based on the structure of the anion,
EPA identified concerns for lung toxicity (surfactant effects). Based
on test data for the neutral form of the cation and analogues for the
anion, EPA also identified concerns for skin and eye irritation, and
systemic and reproductive effects. Based on comparison to analogous
anionic surfactants, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 0.4 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
<bullet> No processing for use or use of the PMN substance other
than as an industrial cross-linking catalyst;
<bullet> No release of the PMN substances, or any waste stream
containing the PMN substances, into waters of the United States;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or 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/corrosion, eye irritation/corrosion, pulmonary effects,
specific target organ toxicity, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
PMN Number (Proposed CFR Citation): P-20-14 (40 CFR 721.12045)
Chemical Name: Sugars, polymer with alkanetriamine (generic).
CASRN: Not available.
Effective Date of TSCA Order: January 27, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a water resistant resin additive. Based on
comparison to analogous chemical substances, EPA has identified
concerns for systemic effects (body weight). Based on potential
chelation to nutrient metals, EPA has also identified concerns for
developmental and systemic effects. Based on submitted test data on the
PMN substance, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 191 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To protect against these risks, the
Order requires:
<bullet> No use of the PMN substance in a consumer product;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 191 ppb;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
reproductive toxicity and specific target organ toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
PMN Number (Proposed CFR Citation): P-21-86 (40 CFR 721.12046)
Chemical Name: Isooctadecanamide, N,N-bis(2-ethylhexyl)-.
CASRN: 1616494-50-8.
Effective Date of TSCA Order: February 6, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an automotive engine
[[Page 102051]]
additive. Based on test data for the metabolite, EPA has identified
concerns for systemic effects. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
<bullet> No processing for use of the PMN substance in a consumer
product where the concentration of the PMN substance in the consumer
product formulation exceeds the confidential percentage listed in the
Order;
<bullet> No use of the PMN substance in a consumer product where
the concentration of the PMN substance exceeds the confidential
percentage listed in the Order;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
metabolism or pharmacokinetics and specific target organ toxicity
testing may be potentially useful to characterize the health effects of
the PMN substance. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
PMN Number (Proposed CFR Citation): P-21-164 (40 CFR 721.12047)
Chemical Name: 2-Butanone, oxime, reaction products with
trimethoxymethylsilane.
CASRN: 2639393-45-4.
Effective Date of TSCA Order: November 13, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
crosslinker for waterproofing. Based on comparison to analogous
chemical substances, EPA has identified concerns for irritation to skin
and eyes and systemic effects. Based on test data for hydrolysis
products, EPA has also identified concerns for acute toxicity, skin
irritation, eye corrosion, respiratory tract irritation and corrosion,
skin sensitization, systemic effects, developmental effects,
neurotoxicity and carcinogenicity. Based on test data for hydrolysis
products, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 102 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To protect against these risks, the
Order requires:
<bullet> No use of the PMN substance unless at 4% or less by weight
in formulation;
<bullet> No loading or unloading of the PMN substance for
manufacture, processing, or use unless under a gas (e.g., nitrogen)
blanket;
<bullet> Application of the PMN substance for use only by roll,
brush, or dip coating;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 50 where there is a potential
for inhalation exposure;
<bullet> Disposal of the PMN substance, or waste streams containing
the PMN substance, only by incineration;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, carcinogenicity, eye damage, pulmonary effects, skin
irritation, specific target organ toxicity, and aquatic toxicity
testing may be potentially useful to characterize the health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number (Proposed CFR Citation): P-21-170 (40 CFR 721.12048)
Chemical Name: 2,6-Bis(dialkyl)-4-[2-(1-alkyl-4(1H)-
pyridinylidene)alkylidene]-2,5-cycloalkyladien-1-one (generic).
CASRN: Not available.
Effective Date of TSCA Order: January 27, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
color indicator for frying oil breakdown. Based on comparison to
analogous chemical substances, EPA has identified concerns for
irritation to skin and eyes, skin sensitization, neurotoxicity,
systemic effects (respiratory tract, lung, liver, kidney, spleen, and
body weight effects), reproductive and developmental effects,
genotoxicity, carcinogenicity, and acute toxicity (mortality). Based on
OECD Toolbox results, EPA identified concerns for skin sensitization
and based on information provided in the SDS, EPA has also identified
concerns for acute toxicity and irritation to skin, eyes, and
respiratory tract. Based on comparison to analogous chemical
substances, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To protect against these risks, the
Order requires:
<bullet> Manufacture of the PMN substance only below an annual
volume of 10 kg;
<bullet> No manufacture, processing, or use of the PMN substance
resulting in releases to air except with the use of a HEPA filtration
system;
<bullet> No processing for use or use of the PMN substance other
than as a color indicator for frying oil breakdown;
<bullet> No processing for use or use of the PMN substance where
the concentration of the PMN substance in the final product exceeds
0.008%;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States;
<bullet> Use of a NIOSH-certified particulate respirator with an
APF of at least 10 where there is a potential for inhalation exposure;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
[[Page 102052]]
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or 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
biodegradation, bioaccumulation, log P, and aquatic toxicity testing
may be potentially useful to characterize the physical/chemical
properties and environmental fate/effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-21-184 (40 CFR 721.12049)
Chemical Name: Fatty acids, soya, reaction products with ammonia-
ethanolamine reaction by-products.
CASRN: 2378512-59-3.
Effective Date of TSCA Order: November 16, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be in asphalt emulsion applications. Based on
comparison to analogous chemical substances, EPA has identified
concerns for acute toxicity, skin and eye irritation/corrosion, skin
sensitization, point-of-contact effects, lung effects, and systemic
effects. Based on the surfactant-like properties of the PMN substance
and its use as an emulsifier, EPA has also identified concerns for lung
effects (surfactancy). Based on information in the SDS, EPA has also
identified concerns for skin irritation, eye corrosion, and respiratory
irritation. Based on comparison to analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 2 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in the generation of vapor, mist, dust, or
aerosol;
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 2 ppb; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, specific target organ toxicity, pulmonary effects, skin
irritation/corrosion, eye damage, neurotoxicity, skin sensitization,
and aquatic toxicity testing may be potentially useful to characterize
the health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Numbers (Proposed CFR Citations): P-22-3 (40 CFR 721.12050), P-22-4
(40 CFR 721.12051), P-22-5 (40 CFR 721.12052), and P-22-6 (40 CFR
721.12053)
Chemical Names: 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:2)
(P-22-3), 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:1) (P-22-4),
Formic acid, compd. with 2-methyl-1,5- pentanediamine (2:1) (P-22-5),
and Formic acid, compd. with 2-methyl-1,5-pentanediamine (1:1) (P-22-
6).
CASRNs: 34813-63-3 (P-22-3), 1840915-04-9 (P-22-4), 1836131-73-7
(P-22-5), and 1836131-75-9 (P-22-6).
Effective Date of TSCA Order: December 4, 2023.
Basis for TSCA Order: The PMNs state that the uses will be as clay
stabilizers for oil and gas fracking. Based on submitted test data on
the P-22-3 substance, comparison to analogous chemical substances,
structure and expected acidity or basicity of components, physical/
chemical properties of components, and information provided in the SDS,
EPA has identified concerns for acute toxicity, irritation or corrosion
to skin, eyes, and respiratory tract, and systemic effects. Based on
submitted test data for the P-22-3 substance, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 570 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substances may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
<bullet> No processing for use or use of the PMN substances in
consumer products;
<bullet> No manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure to the PMN
substances;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No release of the PMN substances, or any waste stream
containing the PMN substances, in surface water concentrations that
exceed 570 ppb combined; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation/corrosion, skin irritation/corrosion, specific target organ
toxicity, pulmonary effects, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substances. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
PMN Number (Proposed CFR Citation): P-22-11 (40 CFR 721.12054)
Chemical Name: Alkadiene, homopolymer, hydroxy-terminated, bis[N-
[2-[(1-oxo-2-propen-1- yl)oxylethyl]carbamates] (generic).
CASRN: Not available.
Effective Date of TSCA Order: November 27, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a functionalized rubber in the resin side
of two component epoxy
[[Page 102053]]
modified acrylic adhesive and as a functionalized rubber in the resin
side of two component acrylic adhesive. Based on test data on one or
both of the two components in the formulation, EPA has identified
concerns for skin sensitization, and systemic, reproductive, and
developmental effects. Based on the weight of the scientific evidence,
EPA has also identified concerns for respiratory sensitization. Based
on information in the SDS, EPA has also identified concerns for skin
sensitization and reproductive toxicity. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health. To protect against these risks, the Order
requires:
<bullet> No use of the PMN substance in a consumer product;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
sensitization, developmental toxicity, reproductive toxicity, and
specific target organ toxicity testing may be potentially useful to
characterize the health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-25 (40 CFR 721.12055)
Chemical Name: Oxirane, 2-(chloromethyl)-, homopolymer, ether with
dialkyl-alkanediol (2:1) (generic).
CASRN: Not available.
Effective Date of TSCA Order: February 20, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
chemical intermediate. Based on comparison to analogous chemical
substances and structural alerts, EPA has identified concerns for acute
toxicity, irritation to the respiratory tract, skin, and eyes, systemic
effects, genetic toxicity, and carcinogenicity. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health. To protect against these risks, the Order
requires:
<bullet> No exceedance of the confidential annual production volume
listed in the Order;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in the generation of a vapor, mist, dust, or
aerosol;
<bullet> Use of the PMN substance only as a chemical intermediate;
<bullet> Disposal of the PMN substance, or waste streams containing
the PMN substance, only by hazardous waste incineration;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, specific target organ toxicity, pulmonary effects, eye
irritation, skin irritation, genetic toxicity, and carcinogenicity
testing may be potentially useful to characterize the health effects of
the PMN substance. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
PMN Number (Proposed CFR Citation): P-22-49 (40 CFR 721.12056)
Chemical Name: Aryl, polymer with formaldehyde, glycidyl ether,
reaction products with amino alkyl-alkane diamine, cyclohexanediamine
and alkylene (alkylcyclohexanamine) (generic).
CASRN: Not available.
Effective Date of TSCA Order: January 11, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
hardener in coatings for oil and gas, power, and chemical/petrochemical
industries for tank and pipe linings and for asset protection, in
coatings in wastewater applications industries for tank and pipe
linings and for asset protection, in coatings used in manufacturing
industries for tank and pipe linings and for asset protection, and in
OEM automotive and heavy industrial machinery coatings. Based on
submitted test data on the PMN substance, EPA has identified concerns
for acute toxicity. Based on residual data, EPA has also identified
concerns for irritation to the skin, eye, and respiratory tract, skin
and respiratory sensitization, systemic, developmental, and
reproductive effects, corrosion to all tissues, and genetic toxicity.
Based on submitted test data on the PMN substance and comparison to
analogous polycationic polymers, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 2 ppb. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health or the environment. To protect against
these risks, the Order requires:
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 2 ppb;
<bullet> Use of a NIOSH-certified particulate respirator with an
APF of at least 1,000 where there is a potential for inhalation
exposure;
<bullet> No use of the PMN substance in a consumer product;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has
[[Page 102054]]
determined that the results of skin irritation, skin corrosion, eye
irritation, eye corrosion, specific target organ toxicity, pulmonary
effects, and aquatic toxicity testing may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-50 (40 CFR 721.12057)
Chemical Name: Alkene, alkoxy-, polymer with alkoxyalkene
(generic).
CASRN: Not available.
Effective Date of TSCA Order: January 8, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a lubricant. Based on comparison to
analogous chemical substances, EPA has identified concerns for skin,
eye, and respiratory tract irritation and systemic effects. Based on
comparison to analogous neutral organics, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 32 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
<bullet> No processing for use or use of the PMN substance other
than for the confidential use listed in the Order;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, skin irritation, eye irritation,
pulmonary effects, and aquatic toxicity testing may be potentially
useful to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-58 (40 CFR 721.12058)
Chemical Name: Methanesulfonamide, 1,1,1-trifluoro-N-
[(trifluoromethyl)sulfonyl]-, sodium salt (1:1).
CASRN: 91742-21-1.
Effective Date of TSCA Order: February 13, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a process chemical. Based on submitted
test data on the PMN substance, EPA has identified concerns for acute
toxicity and serious eye damage. Based on comparison to analogous
chemical substances, EPA has also identified concerns for respiratory
tract and skin irritation, neurotoxicity, systemic, reproductive, and
developmental effects. Based on comparison to analogous chemical
substances, EPA has also identified concerns for respiratory, systemic,
and neurological effects for the potential incineration product of the
anion. Based on submitted test data on the PMN substance and comparison
to analogous substances, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 140 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
<bullet> No manufacture of the PMN substance other than in an
enclosed process;
<bullet> No processing or use of the PMN substance other than in a
manner that does not generate a vapor, mist, dust, or aerosol that
results in inhalation exposure to workers;
<bullet> No use of the PMN substance other than for the
confidential use listed in the Order;
<bullet> No use of the PMN substance other than in the form of a
liquid;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 100 ppb;
<bullet> Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 50 where there is a potential
for inhalation exposure;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, reproductive
toxicity, developmental toxicity, neurotoxicity, sediment toxicity, and
aquatic toxicity testing may be potentially useful to characterize the
health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-75 (40 CFR 721.12059)
Chemical Name: 1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-
(2-hydroxyethyl)-.
CASRN: 15458-48-7.
Effective Date of TSCA Order: January 19, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
monomer used to produce an unsaturated polyester resin. Based on
comparison to analogous chemical substances, EPA has identified
concerns for acute toxicity, skin and eye irritation, and systemic
effects. Based on comparison to analogous imides, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 21 ppb.
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
[[Page 102055]]
<bullet> Manufacture of the PMN substance only at or below an
annual volume of 3,000 kg;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> No use of the PMN substance other than as a monomer used
to produce an unsaturated polyester resin;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, eye irritation, skin irritation, pulmonary effects, specific
target organ toxicity, and aquatic toxicity testing may be potentially
useful to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-78 (40 CFR 721.12060)
Chemical Name: Oxirane, 2-methyl-, polymer with oxirane, mono-
isoalkyl ethers, phosphates, salt (generic).
CASRN: Not available.
Effective Date of TSCA Order: November 27, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
dispersing agent for pesticide formulations. Based on structure, EPA
has identified concerns for lung effects (surfactancy). Based on
comparison to analogous chemical substances, EPA has also identified
concerns for skin irritation and systemic effects. Based on comparison
to analogous anionic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 23 ppb. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
<bullet> No processing for use or use of the PMN substance other
than as a dispersing agent for pesticide formulations;
<bullet> No manufacture or processing of the PMN substance in any
manner that results in the generation of a vapor, mist, dust, or
aerosol;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 23 ppb; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or 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, skin irritation, specific target organ toxicity, and
aquatic toxicity testing may be potentially useful to characterize the
health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-80 (40 CFR 721.12061)
Chemical Name: Poly(oxy-1,2-ethanediyl), .alpha.-(2-
aminoethyl)-.omega.-(2-aminoethoxy)- and Poly(oxy-1,2-ethanediyl),
.alpha.,.alpha.',-(iminodi-2,1- ethanediyl)bis[.omega.-(2-
aminoethoxy)-.
CASRNs: 24991-53-5 and 90350-34-8.
Effective Date of TSCA Order: December 1, 2023.
Basis for TSCA Order: The PMN states that the use will be as an
industrial intermediate used in the manufacture of polyamides as a
monomer. Based on the pH of the PMN substance, EPA has identified
concerns for skin, eye, and respiratory tract corrosion. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for acute toxicity and skin sensitization. Based on comparison
to analogous polycationic polymers, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 0.7 ppb. The Order
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 0.7 ppb;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, skin corrosion, eye corrosion, pulmonary effects, skin
sensitization, and aquatic toxicity testing may be potentially useful
to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-82 (40 CFR 721.12062)
Chemical Name: Alkenoic acid, alkyl, carbopolycyclic alkyl ester,
polymer with trihalo (trihaloalkyl) alkyl alkyl alkenoate (generic).
CASRN: Not available.
Effective Date of TSCA Order: November 3, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component of photoresist. Based on test
data on the degradation product and an analogue of the degradation
product, EPA has identified concerns for neurotoxicity, reproductive,
developmental, and systemic effects. Based on the potential
incineration product, EPA has also identified concerns for systemic
effects, and neurotoxicity. The Order was issued under TSCA sections
[[Page 102056]]
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
<bullet> No manufacture of the PMN substance other than by import
into the United States (i.e., no domestic manufacture) in a liquid
formulation;
<bullet> No processing or use of the PMN substance other than in a
liquid formulation;
<bullet> Use of the PMN substance only for the confidential use
listed in the Order;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States;
<bullet> Disposal of the PMN substance, or waste streams containing
the PMN substance, only by incineration;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or 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, reproductive and developmental effects, and
neurotoxicity testing may be potentially useful to characterize the
health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number (Proposed CFR Citation): P-22-121 (40 CFR 721.12063)
Chemical Name: Polychloroalkene (generic).
CASRN: Not available.
Effective Date of TSCA Order: February 6, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a process intermediate. Based on submitted
test data on the PMN substance and information in the SDS, EPA has
identified concerns for acute toxicity (oral) and skin sensitization.
Based on test data for analogues, EPA identified concerns for acute
toxicity (oral, inhalation), skin irritation, eye corrosion,
respiratory irritation, genotoxicity, carcinogenicity, and systemic
effects. Based on submitted acute test data and comparison to analogous
chemical substances, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 0.15 ppb. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> No processing, use, loading, or unloading of the PMN
substance unless under a gas (e.g., nitrogen) blanket or in a closed
system except that sampling may occur outside the closed system
resulting in exposures;
<bullet> No use of the PMN substance other than for the
confidential use listed in the Order;
<bullet> Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 50 where there is a potential
for inhalation exposure;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 0.15 ppb; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or 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
carcinogenicity, eye irritation/corrosion, genetic toxicity, pulmonary
effects, skin irritation, specific target organ toxicity,
toxicokinetics, and aquatic toxicity testing may be potentially useful
to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-145 (40 CFR 721.12064)
Chemical Name: Alkanoic acid, trialkyl-, diester with
carbomonocycle bis(alkyleneoxy)]bis[alkanediol] (generic).
CASRN: Not available.
Effective Date of TSCA Order: February 21, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
reactive-diluent in a polyol component of a 2K (Isocyanate-Polyol)
Urethane coating system for interior concrete floor sealant or
interior/exterior paver sealer. Based on the physical/chemical
properties of the PMN substance (as described in the New Chemical
Program's PBT category at 64 FR 60194; November 1999) and test data on
structurally similar substances, the PMN substance is a potentially
persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates
that the PMN substance will persist in the environment for more than
six months and estimates a bioconcentration factor of greater than or
equal to 5,000. Based on test data for a potential hydrolysis product,
EPA has identified concerns for acute toxicity and systemic,
reproductive, and developmental effects. Based on comparison to
analogous esters, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 0.14 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To protect against these risks, the
Order requires:
<bullet> No use of the PMN substance in any manner that generates a
spray, mist, vapor, or aerosol containing the PMN substance unless the
concentration of the PMN substance is less than 5.7% by weight;
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States;
<bullet> Disposal of the PMN substance, or waste streams containing
the PMN substance, only by incineration;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
[[Page 102057]]
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, reproductive toxicity, developmental toxicity, specific
target organ toxicity, toxicokinetics, and aquatic toxicity testing may
be potentially useful to characterize the health and environmental
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
relevant information.
PMN Number (Proposed CFR Citation): P-22-175 (40 CFR 721.12065)
Chemical Name: Modified Silsesquioxane, alkoxy-terminated
(generic).
CASRN: Not available.
Effective Date of TSCA Order: January 30, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
curable binder resin for composite stone articles (engineered stone).
Based on comparison to analogous alkoxysilanes and other analogous
chemical substances, EPA has identified concerns for lung toxicity.
Based on the reactivity of the PMN substance and the low molecular
weight fraction content, EPA has also identified concerns for
irritation to the skin, eyes, and respiratory tract. Based on
comparison with analogous chemical substances, EPA has also identified
concerns for hematological effects (i.e., increased neutrophils,
eosinophils, lymphocytes) associated with lung toxicity. Based on
comparison to analogous alkoxysilanes, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 7 ppb. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> Use of the PMN substance only if the concentration of the
PMN substance does not exceed 10% by weight in formulation;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 7 ppb;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye irritation, specific target organ toxicity, and aquatic
toxicity testing may be potentially useful to characterize the health
and environmental effects of the PMN substance. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
PMN Number (Proposed CFR Citation): P-23-18 (40 CFR 721.12066)
Chemical Name: Vegetable oil, polymer with pimelin ketone,
oxymethylene and polymethylenepolyphenylene isocyanate (generic).
CASRN: Not applicable.
Effective Date of TSCA Order: February 23, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
industrial adhesive. Based on the weight of the scientific evidence,
EPA has identified concerns for skin and respiratory sensitization and
lung toxicity for the PMN substance and the low molecular weight
fraction. Based on test data for residuals and comparison to analogous
chemical substances of the residuals, EPA has also identified acute
toxicity, irritation to the skin, eyes, and respiratory tract, skin
sensitization, respiratory sensitization, neurotoxicity, lung effects,
systemic effects, reproductive and developmental effects, genetic
toxicity, and carcinogenicity for the residuals. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health. To protect against these risks, the Order
requires:
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or 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, skin sensitization, and pulmonary effects testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-23-20 (40 CFR 721.12067)
Chemical Name: Silsesquioxanes, 3-mercaptopropyl, polymers with
silicic acid (H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]-terminated.
CASRN: 2796383-42-9.
Effective Date of TSCA Order: November 21, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive/intermediate. Based on
comparison to analogous chemical substances and alkoxysilanes, EPA has
identified concerns for lung effects. Based on analogue data for the
hydrolysis product, EPA has also identified concerns for skin
sensitization and systemic effects. Based on comparison to analogous
alkoxysilanes and thiols, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 3 ppb. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may
[[Page 102058]]
present an unreasonable risk of injury to human health and the
environment. To protect against these risks, the Order requires:
<bullet> Use of the PMN substance only for the confidential use
listed in the Order;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 3 ppb; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, skin sensitization,
and aquatic toxicity testing may be potentially useful to characterize
the health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-23-36 (40 CFR 721.12068).
Chemical Name: Castor oil, polymer with dicyclopentadiene, maleic
anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol.
CASRN: 2794200-69-2.
Effective Date of TSCA Order: January 19, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
resin used in an electrical insulation coating to insulate electrical
components (motors) in automobiles. Based on test data for the expected
hydrolysis product and an analogue of the expected hydrolysis product,
EPA has identified concerns for skin irritation, eye irritation,
systemic effects, and reproductive/developmental effects. Based on
comparison to analogous nonionic polymers, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 27 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that generates a vapor, mist, dust, or aerosol;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 27 ppb; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye irritation, specific target organ toxicity,
toxicokinetics, and aquatic toxicity testing may be potentially useful
to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Numbers (Proposed CFR Citations): P-23-37 (40 CFR 721.12069), P-23-
44 (40 CFR 721.12070), P-23-80 (40 CFR 721.12071), and P-23-93 (40 CFR
721.12072)
Chemical Names: Monoaromatic cyclic alkylene sulfonium fluoroalkyl
sulfonic acid salt (generic) (P-23-37 and P-23-44), Aromatic sulfonium
tricyclo fluoroalkyl sulfonic acid salt (generic) (P-23-80), and
Aromatic dibenzothiophenium fluoroalkyl carbopolycycle sulfonic acid
salt (generic) (P-23-93).
CASRNs: Not available.
Effective Date of TSCA Order: December 22, 2023.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as photoacid generators
(PAGs) for use in electronics industry. Based on the physical/chemical
properties of the PMN substances (as described in the New Chemical
Program's PBT category at 64 FR 60194; November 1999) and test data on
structurally similar substances, the PMN substance are potentially
persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates
that the PMN substances will persist in the environment for more than
six months and have unknown bioaccumulation. Based on comparison to
analogous chemical compounds, EPA has identified concerns for acute
toxicity, irritation to the skin and respiratory tract, neurological
effects, and systemic effects for the cation of the PMN substances, as
well as eye corrosion for P-23-44, P-23-80, and P-23-93. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for genetic toxicity for the PMN substances, and skin
sensitization and portal-of-entry (respiratory) effects for P-23-93.
Based on the photoreactivity of the PMN substances, EPA has also
identified concerns for photosensitization. Based on comparison to
analogous compounds, EPA has also identified concerns for systemic and
reproductive effects for the anion of P-23-44 and P-23-93. Based on
data on a potential incineration product, EPA identified concerns for
local and systemic effects via inhalation exposure. Based on a lack of
scientific data, there is unknown toxicity to aquatic organisms. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substances may present
an unreasonable risk of injury to human health or the environment. To
protect against these risks, the Order requires:
<bullet> No manufacture of the PMN substances beyond the time
limits specified in the Order without submittal to EPA the results of
certain testing described in the Testing section of the Order;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
<bullet> No modification of the processing or use of the PMN
substances in any way that generates a vapor, dust, mist, or aerosol in
a non-enclosed process;
[[Page 102059]]
<bullet> Use of the PMN substances only for the confidential uses
listed in the Order;
<bullet> No domestic manufacture of the PMN substances (i.e.,
import only);
<bullet> Import of the PMN substances only in solution or in sealed
containers weighing 5 kilograms or less; and
<bullet> No exceedance of the confidential annual importation
volumes listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substances may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
PMN Number (Proposed CFR Citation): P-23-64 (40 CFR 721.12073)
Chemical Name: Alkanediol, substituted, polymer with
diisocyanatoalkane, substituted heterocycle-modified (generic).
CASRN: Not available.
Effective Date of TSCA Order: February 21, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component in aerospace coatings. Based
on comparison to analogous chemical substances, EPA has identified
concerns for pulmonary effects, systemic effects, and skin
sensitization. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
<bullet> No processing for use or use of the PMN substance in
consumer products;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in the generation of a vapor, mist, dust, or
aerosol;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects and specific target organ toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-23-72 (40 CFR 721.12074)
Chemical Name: Halosubstituted carbopolycycle, polymer with
substituted carbomonocycles and oxybis[alkanol] (generic).
CASRN: Not available.
Effective Date of TSCA Order: February 22, 2024.
Basis for TSCA Order: The PMN states that the use will be as a UV
resin for offset lithographic printing on plastic substrates. Based on
the physical/chemical properties of the PMN substance (as described in
the New Chemical Program's PBT category at 64 FR 60194; November 1999)
and test data on structurally similar substances, the PMN substance is
a potentially persistent, bioaccumulative, and toxic (PBT) chemical.
EPA estimates that the PMN substance will persist in the environment
for more than six months and estimates a bioaccumulation factor of
greater than or equal to 5,000. Based on test data for hydrolysis
products of the low molecular weight fraction of the PMN substance, EPA
has identified concerns for genetic toxicity, carcinogenicity, and
systemic, reproductive, and developmental effects. Based on comparison
to analogous esters, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 0.4 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> No processing for use or use of the PMN substance other
than in an enclosed roll-coating lithographic printing machine;
<bullet> No processing for use or use of the PMN substance in a
final coating formulation that exceeds 40% by weight;
<bullet> Disposal of the PMN substance only by landfill;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or 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
carcinogenicity, developmental toxicity, genetic toxicity, reproductive
toxicity, specific target organ toxicity, toxicokinetics, and aquatic
toxicity testing may be potentially useful to characterize the health
and environmental effects of the PMN substance. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
PMN Number (Proposed CFR Citation): P-23-94 (40 CFR 721.12075)
Chemical Name: Polymer of benzenedicarboxylic acid, substituted-
benzenedicarboxylic acid, branched-alkyldiol, alkyldiol and
triisocyanate (generic).
CASRN: Not available.
Effective Date of TSCA Order: January 9, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
reactive polymer for use in surface pre-treatment. Based on test data
for the feedstock residual, EPA has identified concerns for lung
effects for the residual. Based on OECD QSAR Toolbox results and the
structural alert for diisocyanates, EPA has also identified
[[Page 102060]]
concerns for dermal and respiratory sensitization. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health. To protect against these risks, the Order
requires:
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, and skin
sensitization testing may be potentially useful to characterize the
health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number (Proposed CFR Citation): P-23-172 (40 CFR 721.12076)
Chemical Name: Sulfonium, tricarbocyclic-, alkylcarbomonocyclic-
polyfluoro-heteropolycyclic-alkyl sulfonate (1:1), polymer with
alkylaryl and carbomonocyclic alkylalkanoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-alkylalkanoate]-initiated (generic).
CASRN: Not available.
Effective Date of TSCA Order: January 29, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be for photolithography.
Based on the physical/chemical properties of the PMN substance (as
described in the New Chemical Program's PBT category at 64 FR 60194;
November 1999) and test data on structurally similar substances, the
PMN substance is a potentially persistent, bioaccumulative, and toxic
(PBT) chemical. EPA estimates that the PMN substance will persist in
the environment for more than six months and estimates unknown
bioaccumulation. Based on comparison to analogous sulfonium compounds,
EPA has identified concerns for acute toxicity, irritation to the skin
and respiratory tract, eye corrosion, neurological effects, and
systemic effects for the sulfonium cation. Based on comparison to
analogous chemical substances, EPA has also identified concerns for
genetic toxicity. Based on the photoreactivity of the PMN substance,
EPA has also identified concerns for photosensitization. Based on a
potential incineration product (trifluroacetate), EPA has also
identified concerns for local, neurological, developmental and systemic
effects via inhalation exposure. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
<bullet> No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
<bullet> No modification of the processing of the PMN substance in
any way that generates a vapor, dust, mist, or aerosol in a non-
enclosed process;
<bullet> Use of the PMN substance only for the confidential use
listed in the Order;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> Import of the PMN substance only in solution or in sealed
containers weighing 5 kilograms or less; and
<bullet> No exceedance of the confidential annual importation
volume listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substance may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
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,
[[Page 102061]]
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 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
EPA believes that this type of action does not concern human health
or environmental conditions and therefore cannot be evaluated with
respect to the potentially disproportionate and adverse effects on
communities with environmental justice concerns in accordance with
Executive Orders 12898 (59 FR 7629, February 16, 1994) and 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 will allow 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.
Kevin DeBell,
Acting 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).
[[Page 102062]]
0
2. Add Sec. Sec. 721.12043 through 721.12076 to Subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.12043 Heptane, 2-methoxy-2-methyl-.
721.12044 Benzenesulfonic acid, alkyl-, compd. with 1,1'-iminobis[2-
propanol] (1:1) (generic).
721.12045 Sugars, polymer with alkanetriamine (generic).
721.12046 Isooctadecanamide, N,N-bis(2-ethylhexyl)-.
721.12047 2-Butanone, oxime, reaction products with
trimethoxymethylsilane.
721.12048 2,6-Bis(dialkyl)-4-[2-(1-alkyl-4(1H)-
pyridinylidene)alkylidene]-2,5-cycloalkyladien-1-one (generic).
721.12049 Fatty acids, soya, reaction products with ammonia-
ethanolamine reaction by-products.
721.12050 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:2).
721.12051 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:1).
721.12052 Formic acid, compd. with 2-methyl-1,5- pentanediamine
(2:1).
721.12053 Formic acid, compd. with 2-methyl-1,5-pentanediamine
(1:1).
721.12054 Alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-[(1-
oxo-2-propen-1-yl)oxylethyl]carbamates] (generic).
721.12055 Oxirane, 2-(chloromethyl)-, homopolymer, ether with
dialkyl-alkanediol (2:1) (generic).
721.12056 Aryl, polymer with formaldehyde, glycidyl ether, reaction
products with amino alkyl-alkane diamine, cyclohexanediamine and
alkylene (alkylcyclohexanamine) (generic).
721.12057 Alkene, alkoxy-, polymer with alkoxyalkene (generic).
721.12058 Methanesulfonamide, 1,1,1-trifluoro-N-
[(trifluoromethyl)sulfonyl]-, sodium salt (1:1).
721.12059 1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl).
721.12060 Oxirane, 2-methyl-, polymer with oxirane, mono-isoalkyl
ethers, phosphates, salt (generic).
721.12061 Poly(oxy-1,2-ethanediyl), .alpha.-(2-aminoethyl)-.omega.-
(2-aminoethoxy)- and Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.',-
(iminodi-2,1- ethanediyl)bis[.omega.-(2-aminoethoxy)-.
721.12062 Alkenoic acid, alkyl, carbopolycyclic alkyl ester, polymer
with trihalo (trihaloalkyl) alkyl alkyl alkenoate (generic).
721.12063 Polychloroalkene (generic).
721.12064 Alkanoic acid, trialkyl-, diester with carbomonocycle
bis(alkyleneoxy)]bis[alkanediol] (generic).
721.12065 Modified Silsesquioxane, alkoxy-terminated (generic).
721.12066 Vegetable oil, polymer with pimelin ketone, oxymethylene
and polymethylenepolyphenylene isocyanate (generic).
721.12067 Silsesquioxanes, 3-mercaptopropyl, polymers with silicic
acid (H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]-terminated.
721.12068 Castor oil, polymer with dicyclopentadiene, maleic
anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol.
721.12069 Monoaromatic cyclic alkylene sulfonium fluoroalkyl
sulfonic acid salt (generic).
721.12070 Monoaromatic cyclic alkylene sulfonium fluoroalkyl
sulfonic acid salt (generic).
721.12071 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt
(generic).
721.12072 Aromatic dibenzothiophenium fluoroalkyl carbopolycycle
sulfonic acid salt (generic).
721.12073 Alkanediol, substituted, polymer with diisocyanatoalkane,
substituted heterocycle-modified (generic).
721.12074 Halosubstituted carbopolycycle, polymer with substituted
carbomonocycles and oxybis[alkanol] (generic).
721.12075 Polymer of benzenedicarboxylic acid, substituted-
benzenedicarboxylic acid, branched-alkyldiol, alkyldiol and
triisocyanate (generic).
721.12076 Sulfonium, tricarbocyclic-, alkylcarbomonocyclic-
polyfluoro-heteropolycyclic-alkyl sulfonate (1:1), polymer with
alkylaryl and carbomonocyclic alkylalkanoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-alkylalkanoate]-initiated (generic).
* * * * *
Sec. 721.12043 Heptane, 2-methoxy-2-methyl-.
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as Heptane, 2-methoxy-2-
methyl- (PMN P-18-127; CASRN 76589-16-7) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization and specific
target organ toxicity. For purposes of Sec. 721.72(g)(3), this
substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to
manufacture the substance unless by import into the United States in a
solution of no greater than 5% by weight (i.e., no domestic
manufacture). It is a significant new use to process the substance
unless in a solution of no greater than 5% by weight of the substance.
It is a significant new use to process for use or use the substance in
consumer products unless the concentration of the substance is less
than 1% by weight.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=210.
(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 (i), 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. 721.12044 Benzenesulfonic acid, alkyl-, compd. with 1,1'-
iminobis[2-propanol] (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as
benzenesulfonic acid, alkyl-, compd. with 1,1'-iminobis[2-propanol]
(1:1) (PMN P-18-325) 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)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (3) and (5). For
[[Page 102063]]
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, eye irritation, and specific target organ toxicity. For
purposes Sec. 721.72(g)(3), this substance may be: toxic to aquatic
life. Alternative hazard and warning statements that meet the criteria
of the Globally Harmonized System and OSHA Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance. It is a significant new use to
process for use or use the substance other than as an industrial cross-
linking catalyst.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), 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. 721.12045 Sugars, polymer with alkanetriamine (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as sugars,
polymer with alkanetriamine (PMN P-20-14) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: reproductive toxicity and
specific target organ toxicity. For purposes of Sec. 721.72(g)(3),
this substance may be: toxic to aquatic life. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=191.
(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 (i), 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. 721.12046 Isooctadecanamide, N,N-bis(2-ethylhexyl)-.
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as isooctadecanamide, N,N-
bis(2-ethylhexyl)- (PMN P-21-86; CASRN 1616494-50-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been entrained
in a polymer.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to process the substance for use in a consumer
product where the concentration of the substance in the consumer
product formulation exceeds the confidential percentage listed in the
Order. It is a significant new use to use the substance in a consumer
product where the concentration of the substance exceeds the
confidential percentage listed in the Order.
(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 (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. 721.12047 2-Butanone, oxime, reaction products with
trimethoxymethylsilane.
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as 2-butanone, oxime,
reaction products with trimethoxymethylsilane (PMN P-21-164; CASRN
2639393-45-4) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (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 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a)
[[Page 102064]]
through (d), (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity,
carcinogenicity, serious eye damage, reproductive toxicity, skin
irritation, skin sensitization, and specific target organ toxicity. For
purposes of Sec. 721.72(g)(3), this substance may be: toxic to aquatic
life. Alternative hazard and warning statements that meet the criteria
of the Globally Harmonized System and OSHA Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to load or unload the substance for manufacture,
processing, or use in any manner unless under a gas (e.g. nitrogen)
blanket. It is a significant new use to use the substance unless at 4%
or less by weight in formulation. It is a significant new use to apply
the substance for use unless by roll, brush, or dip coating.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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. 721.12048 2,6-Bis(dialkyl)-4-[2-(1-alkyl-4(1H)-
pyridinylidene)alkylidene]-2,5-cycloalkyladien-1-one (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as 2,6-
bis(dialkyl)-4-[2-(1-alkyl-4(1H)-pyridinylidene)alkylidene]-2,5-
cycloalkyladien-1-one (generic) (PMN P-21-170) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (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 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, skin sensitization, genetic toxicity,
carcinogenicity, reproductive toxicity, and specific target organ
toxicity. For purposes of Sec. 721.72(g)(3), this substance may be:
toxic to aquatic life. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k), (t). It is a significant new use to
manufacture the substance in excess of an annual volume of 10 kg. It is
a significant new use to process for use or use the substance other
than as a color indicator for frying oil breakdown. It is a significant
new use to manufacture, process, or use the substance in any manner
that results in the release of the substance to air except with the use
of a HEPA filtration system.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), 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. 721.12049 Fatty acids, soya, reaction products with ammonia-
ethanolamine reaction by-products.
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as fatty acids, soya,
reaction products with ammonia-ethanolamine reaction by-products (PMN
P-21-184; CASRN 2378512-59-3) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin corrosion,
skin irritation, serious eye damage, eye irritation, skin
sensitization, and specific target organ toxicity. For purposes of
Sec. 721.72(g)(3), this substance may be: toxic to aquatic life.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o), and (y)(1) and (2). It is a
significant new use to manufacture, process, or use the substance in
any manner that results in the generation of vapor, mist, aerosol, or
dust.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), 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. 721.12050 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:2).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as 1,5-pentanediamine, 2-
methyl-, hydrochloride (1:2) (PMN P-22-3; CASRN 34813-63-3) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), (b), and (c). When determining which persons are
[[Page 102065]]
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, and eye irritation. For purposes of Sec. 721.72(g)(3),
this substance may be: toxic to aquatic life. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=570 of P-22-3, P-22-4, P-22-
5, and P-22-6 combined.
(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 (i), 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. 721.12051 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:1).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as 1,5-pentanediamine, 2-
methyl-, hydrochloride (1:1) (PMN P-22-4; CASRN 1840915-04-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, serious eye damage, skin corrosion, and
specific target organ toxicity. For purposes of Sec. 721.72(g)(3),
this substance may be: toxic to aquatic life. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=570 of P-22-3, P-22-4, P-22-
5, and P-22-6 combined.
(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 (i), 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. 721.12052 Formic acid, compd. with 2-methyl-1,5- pentanediamine
(2:1).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as formic acid, compd. with
2-methyl-1,5- pentanediamine (2:1) (PMN P-22-5; CASRN 1836131-73-7) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, and specific target organ toxicity. For
purposes of Sec. 721.72(g)(3), this substance may be: toxic to aquatic
life. Alternative hazard and warning statements that meet the criteria
of the Globally Harmonized System and OSHA Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=570 of P-22-3, P-22-4, P-22-
5, and P-22-6 combined.
(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 (i), 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. 721.12053 Formic acid, compd. with 2-methyl-1,5-pentanediamine
(1:1).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as formic acid, compd. with
2-methyl-1,5-pentanediamine (1:1) (PMN P-22-6; CASRN 1836131-75-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general
[[Page 102066]]
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(b),
the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin corrosion,
skin irritation, serious eye damage, eye irritation, and specific
target organ toxicity. For purposes of Sec. 721.72(g)(3), this
substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=570 of P-22-3, P-22-4, P-22-
5, and P-22-6 combined.
(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 (i), 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. 721.12054 Alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-
[(1-oxo-2-propen-1- yl)oxylethyl]carbamates] (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as alkadiene,
homopolymer, hydroxy-terminated, bis[N-[2-[(1-oxo-2-propen-1-
yl)oxylethyl]carbamates] (PMN P-22-11) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization, respiratory
sensitization, reproductive toxicity, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(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 (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. 721.12055 Oxirane, 2-(chloromethyl)-, homopolymer, ether with
dialkyl-alkanediol (2:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as oxirane, 2-
(chloromethyl)-, homopolymer, ether with dialkyl-alkanediol (2:1) (PMN
P-22-25) 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)(1), (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), and (5). For purposes of Sec.
721.72(e), the concentration is set at 0.1%. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, genetic toxicity, carcinogenicity, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g), (t), (y)(1), and (2). It is a
significant new use to manufacture, process, or use the substance in
any manner that generates a vapor, mist, aerosol, or dust.
(iv) Disposal. It is a significant new use to dispose of the
substance, or waste streams containing the substance, other than by
hazardous waste incineration.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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. 721.12056 Aryl, polymer with formaldehyde, glycidyl ether,
reaction products with amino alkyl-alkane diamine, cyclohexanediamine
and alkylene (alkylcyclohexanamine) (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as aryl, polymer
with formaldehyde, glycidyl ether, reaction products with amino alkyl-
alkane diamine, cyclohexanediamine and alkylene (alkylcyclohexanamine)
(PMN P-22-49) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (4), engineering control measures (e.g.,
[[Page 102067]]
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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, skin corrosion, serious eye damage,
respiratory sensitization, skin sensitization, genetic toxicity,
reproductive toxicity, and specific target organ toxicity. For purposes
of Sec. 721.72(g)(3), this substance may be: toxic to aquatic life.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), 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. 721.12057 Alkene, alkoxy-, polymer with alkoxyalkene (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as alkene,
alkoxy-, polymer with alkoxyalkene (PMN P-22-50) 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)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), 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. 721.12058 Methanesulfonamide, 1,1,1-trifluoro-N-
[(trifluoromethyl)sulfonyl]-, sodium salt (1:1).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as Methanesulfonamide, 1,1,1-
trifluoro-N-[(trifluoromethyl)sulfonyl]-, sodium salt (1:1) (PMN P-22-
58; CASRN 91742-21-1) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the
substance after they have been incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (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 50. For purposes of Sec.
721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, serious eye
damage, skin irritation, reproductive toxicity, and specific target
organ toxicity. For purposes of Sec. 721.72(g)(3), this substance may
be: toxic to aquatic life. Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(b), (k), (v)(2), and (y)(1) and (2). It is
a significant new use to process the substance in a manner that
generates a vapor, mist, aerosol, or dust that results in inhalation to
workers.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=100.
(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 (i), 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. 721.12059 1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-.
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as 1H-Isoindole-1,3(2H)-
dione, 3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)- (PMN P-22-75; CASRN
15458-48-7) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured.
(2) The significant new uses are:
[[Page 102068]]
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, and specific target organ toxicity. For
purposes of Sec. 721.72(g)(3), this substance may be: toxic to aquatic
life. Alternative hazard and warning statements that meet the criteria
of the Globally Harmonized System and OSHA Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to manufacture the substance in excess of an annual volume of 3,000
kg. It is a significant new use to use the substance other than as a
monomer used to produce an unsaturated polyester resin.
(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 (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. 721.12060 Oxirane, 2-methyl-, polymer with oxirane, mono-
isoalkyl ethers, phosphates, salt (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as oxirane, 2-
methyl-, polymer with oxirane, mono-isoalkyl ethers, phosphates, salt
(PMN P-22-78) 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)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation and specific
target organ toxicity. For purposes of Sec. 721.72(g)(3), this
substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture or process the substance in a manner that generates a
vapor, mist, aerosol, or dust. It is a significant new use to process
for use or use the substance other than as a dispersing agent for
pesticide formulations.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=23.
(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 (i), 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. 721.12061 Poly(oxy-1,2-ethanediyl), .alpha.-(2-
aminoethyl)-.omega.-(2-aminoethoxy)- and Poly(oxy-1,2-ethanediyl),
.alpha.,.alpha.',-(iminodi-2,1- ethanediyl)bis[.omega.-(2-
aminoethoxy)-.
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as poly(oxy-1,2-ethanediyl),
.alpha.-(2-aminoethyl)-.omega.-(2-aminoethoxy)- and poly(oxy-1,2-
ethanediyl), .alpha.,.alpha.',-(iminodi-2,1- ethanediyl)bis[.omega.-(2-
aminoethoxy)- (PMN P-22-80; CAS Nos. 24991-53-5 and 90350-34-8) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or destroyed.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin corrosion,
serious eye damage, and skin sensitization. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) 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 to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=0.7.
(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 (i), 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. 721.12062 Alkenoic acid, alkyl, carbopolycyclic alkyl ester,
polymer with trihalo (trihaloalkyl) alkyl alkyl alkenoate (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as alkenoic acid,
alkyl, carbopolycyclic alkyl ester, polymer with trihalo (trihaloalkyl)
alkyl alkyl alkenoate (PMN P-22-82) is subject to reporting under this
section for the significant new uses described in
[[Page 102069]]
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been entrained
in dried photoresist.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: reproductive toxicity and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), (v)(1), (2) and (4), (w)(1), (2)
and (4), and (x)(1), (2) and (4). It is a significant new use to
manufacture the substance other than by import into the United States
(i.e., no domestic manufacture) in a liquid formulation.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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. 721.12063 Polychloroalkene (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as
polychloroalkene (PMN P-22-121) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (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 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, serious eye damage, skin sensitization, genetic toxicity,
carcinogenicity, and specific target organ toxicity. For purposes of
Sec. 721.72(g)(3), this substance may be: toxic to aquatic life.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k). It is a significant new use to
process, use, load, or unload the substance unless under a gas (e.g.,
nitrogen) blanket or in a closed system except that sampling may occur
outside the closed system resulting in exposures.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=0.15.
(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 (i), 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. 721.12064 Alkanoic acid, trialkyl-, diester with carbomonocycle
bis(alkyleneoxy)]bis[alkanediol] (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as alkanoic acid,
trialkyl-, diester with carbomonocycle bis(alkyleneoxy)]bis[alkanediol]
(PMN P-22-145) 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)(1), (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, reproductive
toxicity, and specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance in any manner that may generate a spray, mist, vapor, or
aerosol containing the substance unless the concentration of the
substance is less than 5.7% by weight.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
[[Page 102070]]
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12065 Modified Silsesquioxane, alkoxy-terminated (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as modified
silsesquioxane, alkoxy-terminated (PMN P-22-175) 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)(1), (3) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (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 10. For purposes of Sec.
721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance unless the concentration of the substance does not exceed 10%
by weight in formulation.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=7.
(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 (i), 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. 721.12066 Vegetable oil, polymer with pimelin ketone,
oxymethylene and polymethylenepolyphenylene isocyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as vegetable oil,
polymer with pimelin ketone, oxymethylene and
polymethylenepolyphenylene isocyanate (PMN P-23-18) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, respiratory sensitization, skin
sensitization, genetic toxicity, carcinogenicity, reproductive
toxicity, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(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 (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. 721.12067 Silsesquioxanes, 3-mercaptopropyl, polymers with
silicic acid (H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]-terminated.
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as silsesquioxanes, 3-
mercaptopropyl, polymers with silicic acid (H4SiO4) tetra-Et ester,
[(trimethylsilyl)oxy]-terminated (PMN P-23-20; CASRN 2796383-42-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization and specific
target organ toxicity. For purposes of Sec. 721.72(g)(3), this
substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture, process, or use the substance in any manner that results
inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=3.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), 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.
[[Page 102071]]
Sec. 721.12068 Castor oil, polymer with dicyclopentadiene, maleic
anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol.
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as castor oil, polymer with
dicyclopentadiene, maleic anhydride, 2-methyl-1,3-propanediol,
3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)-1H-isoindole-1,3(2H)-dione and
triethylene glycol (PMN P-23-36; CASRN 2794200-69-2) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o), (y)(1), and (2). It is a significant
new use to manufacture or process the substance in a manner that
generates a vapor, mist, aerosol, or dust.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=27.
(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 (i), 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. 721.12069 Monoaromatic cyclic alkylene sulfonium fluoroalkyl
sulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as monoaromatic
cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt (PMN P-23-37)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), 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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). For purposes of Sec. 721.72(g)(1), this substance
may cause: acute toxicity, skin irritation, skin sensitization, genetic
toxicity, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing or use of the substance in any way that generates
dust, mist, or aerosol in a non-enclosed process. It is a significant
new use to manufacture the substance longer than 18 months.
(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 (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. 721.12070 Monoaromatic cyclic alkylene sulfonium fluoroalkyl
sulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as monoaromatic
cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt (PMN P-23-44)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), 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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). For purposes of Sec. 721.72(g)(1), this substance
may cause: acute toxicity, skin irritation, serious eye damage,
reproductive toxicity, skin sensitization, genetic toxicity, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing or use of the substance in any way that generates
[[Page 102072]]
dust, mist, or aerosol in a non-enclosed process. It is a significant
new use to manufacture the substance longer than 18 months.
(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 (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. 721.12071 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid
salt (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as aromatic
sulfonium tricyclo fluoroalkyl sulfonic acid salt (PMN P-23-80) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), 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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). For purposes of Sec. 721.72(g)(1), this substance
may cause: acute toxicity, skin irritation, serious eye damage, skin
sensitization, genetic toxicity, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing or use of the substance in any way that generates
dust, mist, or aerosol in a non-enclosed process. It is a significant
new use to manufacture the substance longer than 18 months.
(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 (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. 721.12072 Aromatic dibenzothiophenium fluoroalkyl carbopolycycle
sulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as aromatic
dibenzothiophenium fluoroalkyl carbopolycycle sulfonic acid salt (PMN
P-23-93) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), 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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). For purposes of Sec. 721.72(g)(1), this substance
may cause: acute toxicity, skin irritation, serious eye damage,
reproductive toxicity, skin sensitization, genetic toxicity, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing or use of the substance in any way that generates
dust, mist, or aerosol in a non-enclosed process. It is a significant
new use to manufacture the substance longer than 18 months.
(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 (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. 721.12073 Alkanediol, substituted, polymer with
diisocyanatoalkane, substituted heterocycle-modified (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as alkanediol,
substituted, polymer with diisocyanatoalkane, substituted heterocycle-
modified (PMN P-23-64) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA
[[Page 102073]]
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o), and (y)(1) and (2). It is a
significant new use to manufacture or process the substance in a manner
that generates a vapor, mist, aerosol, or dust.
(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 (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. 721.12074 Halosubstituted carbopolycycle, polymer with
substituted carbomonocycles and oxybis[alkanol] (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as
halosubstituted carbopolycycle, polymer with substituted
carbomonocycles and oxybis[alkanol] (PMN P-23-72) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (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 10. For purposes of Sec.
721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 0.1%. For purposes of Sec.
721.72(g)(1), this substance may cause: genetic toxicity,
carcinogenicity, and specific target organ toxicity. For purposes of
Sec. 721.72(g)(3), this substance may be: toxic to aquatic life.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to process
for use or use the substance other than in an enclosed roll-coating
lithographic printing machine. It is a significant new use to process
for use or use the substance to a final formulation for coating
application that exceeds 40% by weight.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(2),
(b)(2), and (c)(2).
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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. 721.12075 Polymer of benzenedicarboxylic acid, substituted-
benzenedicarboxylic acid, branched-alkyldiol, alkyldiol and
triisocyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as polymer of
benzenedicarboxylic acid, substituted-benzenedicarboxylic acid,
branched-alkyldiol, alkyldiol and triisocyanate (PMN P-23-94) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization, respiratory
sensitization, and specific target organ toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
inhalation exposure.
(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 (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) L
[…truncated; see source link]Indexed from Federal Register on December 17, 2024.
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