Proposed Rule2024-27912
Significant New Use Rules on Certain Chemical Substances (24-2.5e)
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 2, 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
<html>
<head>
<title>Federal Register, Volume 89 Issue 231 (Monday, December 2, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 231 (Monday, December 2, 2024)]
[Proposed Rules]
[Pages 95688-95716]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27912]
[[Page 95687]]
Vol. 89
Monday,
No. 231
December 2, 2024
Part VI
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Part 721
Significant New Use Rules on Certain Chemical Substances (24-2.5e);
Proposed Rule
Federal Register / Vol. 89 , No. 231 / Monday, December 2, 2024 /
Proposed Rules
[[Page 95688]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2024-0077; FRL-12348-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (24-
2.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
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 2, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0077 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: Punam Tyagi, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-1176; email address:
<a href="/cdn-cgi/l/email-protection#f7838e96909ed9878299969ab7928796d9909881"><span class="__cf_email__" data-cfemail="7c08051d1b15520c09121d113c190c1d521b130a">[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#8ff8f6fce0e1e8a1f8e6e3e3e6eee2cfeaffeea1e8e0f9"><span class="__cf_email__" data-cfemail="c4b3bdb7abaaa3eab3ada8a8ada5a984a1b4a5eaa3abb2">[email protected]</span></a>.
For general information: 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#9bcfc8d8dab6d3f4eff7f2f5fedbfeebfab5fcf4ed"><span class="__cf_email__" data-cfemail="c89c9b8b89e580a7bca4a1a6ad88adb8a9e6afa7be">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the factors in TSCA section 5(a)(2) (see
also the discussion in Unit II.).
B. What action is the Agency taking?
EPA is proposing SNURs for chemical substances discussed in Unit
III. These SNURs, if finalized as proposed, would require persons who
intend to manufacture or process any of these chemical substances for
an activity that is designated as a significant new use to notify EPA
at least 90 days before commencing that activity.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances contained in this proposed rule. The following list
of North American Industrial Classification System (NAICS) codes is not
intended to be exhaustive, but rather provides a guide to help readers
determine whether this document applies to them. Potentially affected
entities may include:
<bullet> Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing
import certification and export notification requirements under TSCA
(<a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>).
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612),
the requirements promulgated at 19 CFR 12.118 through 12.127, 19 CFR
127.28, and the EPA policy in support of import certification at 40 CFR
part 707, subpart B. Chemical importers must certify that the shipment
of the chemical substance complies with all applicable rules and orders
under TSCA, including regulations issued under TSCA sections 5, 6, 7
and Title IV.
Pursuant to 40 CFR 721.20, any persons who export or intend to
export a chemical substance that is the subject of this proposed rule
on or after January 2, 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
[[Page 95689]]
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, 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 720, subpart E. Absent a final
determination or other disposition of the confidentiality claim under
40 CFR part 2 procedures, EPA is required to keep this information
confidential. EPA promulgated a procedure at 40 CFR 721.11 to deal with
the situation where a specific significant new use is CBI. Under these
procedures, a manufacturer or processor may request for 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.
[[Page 95690]]
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 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 following:
<bullet> Human exposure and environmental release that may result
from the significant new use of the chemical substances.
III. Chemical Substances Subject to These Proposed SNURs
A. What is the designated cutoff date for determining whether the new
use is ongoing for these chemical substances?
EPA designates December 2, 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:
[[Page 95691]]
<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).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA Order usually requires that potentially exposed
employees wear specified respirators unless actual measurements of the
workplace air show that air-borne concentrations of the PMN substance
are below a New Chemical Exposure Limit (NCEL). The comprehensive NCELs
provisions in TSCA Orders include requirements addressing performance
criteria for sampling and analytical methods, periodic monitoring,
respiratory protection, and recordkeeping. No comparable NCEL
provisions currently exist in 40 CFR part 721, subpart B, for SNURs.
Therefore, for these cases, the individual SNURs in 40 CFR part 721,
subpart E, will state that persons subject to the SNUR who wish to
pursue NCELs as an alternative to the 40 CFR 721.63 respirator
requirements may request to do so under 40 CFR 721.30. EPA expects that
persons whose 40 CFR 721.30 requests to use the NCELs approach for
SNURs that are approved by EPA will be required to comply with NCELs
provisions that are comparable to those contained in the corresponding
TSCA Order.
C. Which chemical substances are subject to this proposed rule?
The substances subject to the proposed rules in this document are
as follows:
PMN Numbers (Proposed CFR Citations): P-16-377 (40 CFR 721.11960) and
P-16-378 (40 CFR 721.11961)
Chemical Names: Polyester polyol (generic).
CASRN: Not available.
Effective Date of TSCA Order: August 8, 2023.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as film components. Based on meeting the
criteria of the PMN substances being insoluble in water, non-reactive,
respirable, and being high molecular weight polymers, EPA has
identified concerns for lung effects (lung overload). 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.
To protect against these risks, the Order requires:
<bullet> No manufacture, processing, or use of the PMN substances
in a manner that would result in respirable particle sizes below 10
microns; 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 testing may be potentially useful to
characterize the health 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-18-346 (40 CFR 721.11962)
Chemical Name: 2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane,
3,9-bis-[2-(1-methyl-1- phenylethyl)-4-(1,1,3,3-
tetramethylbutyl)phenoxy]-.
CASRN: 1507339-21-0.
Effective Date of TSCA Order: July 25, 2023.
Basis for TSCA Order: The PMN states that the use will be as an
antioxidant compounded into various polymers to be used in extrusion
processes to fabricate articles. Based on submitted test data on the
PMN substance, EPA has identified concerns for eye irritation and skin
sensitization. Based on comparison to analogous chemical substances,
EPA has also identified concerns for neurotoxicity, liver, spleen,
reproductive, and developmental effects. Based on comparison to
analogous neutral organic chemicals, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 18 parts per billion
(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 release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 18 ppb;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation 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
neurotoxicity, specific target organ toxicity, reproductive toxicity,
developmental 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.
[[Page 95692]]
PMN Number (Proposed CFR Citation): P-20-44 (40 CFR 721.11963)
Chemical Name: 1-Propanamine, 3-methoxy-N,N-dimethyl-.
CASRN: 20650-07-1.
Effective Date of Modified TSCA Order: June 14, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a curing additive for automotive paint, an
additive for industrial polyurethane dispersions, a solubilizer for
high acid value styrene acrylic polymers for use in ink applications,
for neutralization, solubilization, and stability in commercial
waterborne and solvent borne coatings and varnishes used for wood,
metal, composites, and other substrates. Based on submitted test data
on the new chemical substance, EPA has identified concerns for skin and
respiratory irritation and serious eye damage. Based on comparison to
structurally analogous chemical substances, EPA has also identified
concerns for systemic toxicity, respiratory tract effects, and
reproductive/developmental toxicity. Based on comparison to analogous
aliphatic amines, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 1000 ppb. EPA issued an Order 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. The Order was also issued under TSCA
sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding
that the substance is or will be produced in substantial quantities and
that the substance either enters or may reasonably be anticipated to
enter the environment in substantial quantities, or there is or may be
significant (or substantial) human exposure to the substance. The
Order, effective October 1, 2020, required the submitter of P-20-44 to
submit to EPA the results of certain toxicity testing before any
manufacturing (which includes import), processing, or use of the PMN
substance. On May 25, 2021, the PMN submitter provided the results of
three environmental toxicity studies in accordance with the
requirements of the Order. EPA reviewed those studies and determined
the studies to be valid. EPA subsequently modified the terms of the
Order to mitigate any unreasonable risks to human health and the
environment and issued a modified Order, effective June 14, 2023. To
protect against these potential risks, the modified Order requires:
<bullet> No use of the PMN substance in consumer products;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 1000 ppb;
<bullet> Use of a NIOSH-certified gas/vapor particulate respirator
with an APF of at least 1000 where there is a potential for inhalation
exposure or compliance with a NCEL of 1.1388mg/m3 as an 8-hour time-
weighted average to prevent 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
irritation, serious eye damage, 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-21-21 (40 CFR 721.11964)
Chemical Name: Soybean oil, mixed esters with diethylene glycol,
phthalic acid and terephthalic acid.
CASRN: Not available.
Effective Date of TSCA Order: July 5, 2023.
Basis for TSCA Order: The PMN states that use will be as a raw
material to be blended into R-side components of the polyurethane and
polyisocyanurate industry (specifically used in slabstock/bunstock
processing of foam). Based on the acid groups, EPA has identified
concerns for irritation to the skin, eyes, and respiratory tract. Based
on test data for a feedstock and potential metabolite, diethylene
glycol, EPA has also identified concerns for systemic (body weight,
bladder, kidney) and developmental 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 use of the PMN substance in consumer products;
<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 3000 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, skin irritation, eye damage, 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-21-151 (40 CFR 721.11965)
Chemical Name: Soybean oil, epoxidized, polymer with bisphenol A,
alkyl glycidyl ether, epichlorohydrin, polyethylene glycol and
trihydroxyalkane (generic).
CASRN: Not available.
Effective Date of TSCA Order: August 16, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be in polyurethane applications. Based on the
surfactant properties of the PMN substance, EPA has identified concerns
for lung effects (surfactancy) if inhaled. Based on the potential
protein crosslinking of multifunctional reactive groups and epoxides
present in the feedstocks, EPA has also identified concerns for dermal
and respiratory sensitization. Based on comparison to analogous
nonionic surfactants, EPA predicts toxicity to aquatic organisms
[[Page 95693]]
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 use of the PMN substance for use 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 140 ppb;
<bullet> No processing or use of the PMN substance in a spray
application;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 1,000 where there is a potential for inhalation 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, specific target organ toxicity, 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-21-168 (40 CFR 721.11966)
Chemical Name: Metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino]
sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium
salts (generic).
CASRN: Not available.
Effective Date of TSCA Order: September 22, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a colorant. Based on submitted test data
on the PMN substance, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 178 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 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 178 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 chronic
aquatic toxicity testing may be potentially useful to characterize the
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-21-173 (40 CFR 721.11967)
Chemical Name: Siloxanes and silicones polyether, polymer with
aliphatic isocyanate, 2-dimethylaminoethanol and polyglycol ether
(generic).
CASRN: Not available.
Effective Date of TSCA Order: June 29, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive for finishing of textiles/
fabrics. Based on structure, EPA has identified concerns for lung
effects due to surfactancy. Based on comparison to analogous chemical
substances, EPA has also identified concerns for developmental and
systemic effects. Based on comparison to analogous polycationic
polymers, 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> 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;
<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 1 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
developmental toxicity, 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-21-194 (40 CFR 721.11968)
Chemical Name: Siloxanes and Silicones, di-Me,
[gluconoylamino)alkyl]dialkylammonio]- hydroxyalkoxy]alkyl group-
terminated, (salts) (generic).
CASRN: Not available.
Effective Date of TSCA Order: September 15, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
textile softening agent. Based on the siloxane moieties, EPA has
identified concerns for lung waterproofing. Based on comparison to
analogous chemical substances, EPA has also identified concerns for
irritation to skin and eyes. Based on comparison to analogous
polycationic polymers, EPA predicts toxicity to 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
[[Page 95694]]
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 as a
consumer product;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 210 ppb;
<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
metabolism or pharmacokinetics, skin irritation, eye 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 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-21-202 (40 CFR 721.11969)
Chemical Name: Sulfonium, carbomonocycle
bis((trihaloalkyl)carbomonocycle), substituted carbomonocyclic ester
(generic).
CASRN: Not available.
Effective Date of TSCA Order: December 21, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an ingredient used in
the manufacture of photoresist. 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's cation photolysis product will persist in the
environment for more than six months and estimates a bioaccumulation
factor of greater than or equal to 1,000. EPA also estimates that the
PMN substance's cation will persist in the environment for more than
six months and estimates an unknown bioaccumulation potential based on
uncertainty about bioaccumulation. Based on the photoreactivity of the
PMN substance, EPA has identified concerns for photosensitization for
the cation of the PMN substance. Based on comparison to chemical
substances analogous to the sulfonium cation of the PMN substance and
supported by information provided in the SDS, EPA has also identified
concerns for acute toxicity, irritation to the skin, eyes, and
respiratory tract, eye corrosion, ocular lethality, neurological
effects, and systemic effects for the cation. Based on information
provided in the SDS, EPA has also identified concerns for irritation to
the skin, eyes, and respiratory tract and neurotoxicity. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for mutagenicity for the cation. Based on a potential
incineration by-product, EPA has also identified concerns for both
local and systemic effects via inhalation exposure. Based on test data
for salicylic acid and sodium salicylate, EPA has also identified
concerns for acute toxicity (mortality), eye irritation, neurotoxicity,
and reproductive and developmental effects for the anion. Based on
potential for chelation and irritation based on acid groups, EPA has
also identified concerns for developmental effects for the anion. 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 or use 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 any
form 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.
PMN Numbers (Proposed CFR Citations): P-21-208 (40 CFR 721.11970), P-
21-209 (40 CFR 721.11971), and P-21-210 (40 CFR 721.11972)
Chemical Names: Aromatic diacids, polymer with alkyldiacids,
alkyldiols, benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (generic) (P-21-208), Aromatic diacid, polymer with
alkyldiacid, alkyldiols, polypropylene glycol, benzofurandione,
caprolactone and 1,1'-methylenebis[4-isocyanatobenzene] (generic) (P-
21-209), and Aromatic diacids, polymer with alkyldiacids, alkyldiols,
benzofurandione, polypropylene, alkylhydroxyacid glycolester,
caprolactone and 1,1'-methylenebis[4- isocyanatobenzene] (generic) (P-
21-210).
CASRN: Not available.
Effective Date of TSCA Order: May 26, 2023.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as adhesives for profile wrapping. Based on
the structure of the PMN substances, EPA has identified concerns for
skin sensitization, respiratory sensitization, and genotoxicity. Based
on test data for a feedstock residual, EPA has also identified concerns
for acute toxicity, acute neurotoxicity, irritation to the skin, eyes,
and respiratory tracts, skin sensitization, respiratory sensitization,
[[Page 95695]]
genotoxicity, carcinogenicity, and portal-of-entry systemic,
reproductive, and developmental effects. Based on information provided
in the SDSs for the feedstock residual, EPA also identified acute
toxicity (inhalation), skin sensitization, respiratory sensitization,
skin irritation, respiratory irritation, and eye corrosion. Based on
Organisation for Economic Co-operation and Development (OECD Toolbox
results for the feedstock residual, EPA also identified skin
sensitization and respiratory sensitization. Based on test data for a
hydrolysis product of feedstock residual, EPA also identified acute
toxicity, genotoxicity, carcinogenicity, eye irritation, skin
irritation, skin sensitization, and systemic and reproductive 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 substances 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 substances
in any manner that results in inhalation exposure;
<bullet> No release of the PMN substances, or any waste stream
containing the PMN substances, into waters of the United States;
<bullet> No processing for use or use of the PMN substances in
consumer products;
<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, carcinogenicity, developmental toxicity, serious eye damage,
genetic toxicity, reproductive toxicity, skin irritation, skin
sensitization, pulmonary effects, and specific target organ toxicity
testing may be potentially useful to characterize the health 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-21-212 (40 CFR 721.11973)
Chemical Name: Diketone compound metal complex (generic).
CASRN: Not available.
Effective Date of TSCA Order: August 2, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
luminescent material for security ink. Based on submitted test data,
EPA has identified concerns for acute toxicity and neurotoxicity. Based
on the structure as a europium complex, EPA has also identified
concerns for chelation to nutrient metals. Based on test data for
analogues of the cation, EPA has also identified concerns for eye
irritation, irritation/hypersensitivity reactions, and systemic
effects. Based on test data for analogues of the anion, EPA has also
identified concerns for acute toxicity, neurotoxicity, and systemic and
developmental effects. Based on test data for an incineration product,
EPA has also identified concerns for neurotoxicity, portal-of-entry,
and systemic effects. Based on comparison to analogous lanthanides or
rare earth metals, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 13 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 in exceedance of an
annual volume of 1,000 kg/yr;
<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, in surface water concentrations that
exceed 13 ppb;
<bullet> The PMN substance, or waste streams containing the PMN
substance, must be disposed of by hazardous waste incineration;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation 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, skin irritation/corrosion, eye irritation, specific
target organ toxicity, pulmonary effects, developmental 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-21-214 (40 CFR 721.11974)
Chemical Name: Poly(oxy-1,2-ethanedlyl),
.alpha.,.alpha.',.alpha.''-(trialkylamino)tris[omega-hydroxy-, alkyl
(ester) (generic).
CASRN: Not available.
Effective Date of TSCA Order: June 29, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a textile finishing agent. Based on the
structure and intended use as an emulsifier, EPA has identified
concerns for lung toxicity (surfactant effects), and skin, eye, and
respiratory tract irritation. Based on test data for alcohol
ethoxylates, EPA has also identified concerns for developmental and
systemic effects. Based on comparison to analogous aliphatic amines and
polycationic polymers, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 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 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;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 4 ppb; and
[[Page 95696]]
<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, skin irritation, eye irritation, 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-22-18 (40 CFR 721.11975)
Chemical Name: Substituted polyalkylenepoly, reaction products with
substituted heteromonocycle substituted heteromonocycle polyalkylene
derivs. (generic).
CASRN: Not available.
Effective Date of TSCA Order: June 23, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component of a lubricant. Based on the
structure of the PMN substance, EPA has identified concerns for lung
toxicity via cationic binding. Based on the use of the PMN substance,
EPA has also identified concerns for surfactant effects on the lungs.
Based on comparison to analogous chemical substances, EPA has also
identified concerns for irritation. 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 at a concentration greater than 3%;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that generates a dust, mist, or aerosol;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No use of the PMN substance other than for the
confidential use listed in the Order; 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 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-22-21 (40 CFR 721.11976)
Chemical Name: Alkylphosphonic acid, calcium salt (generic).
CASRN: Not available.
Effective Date of TSCA Order: June 14, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a nucleating agent for polyolefins. Based
on comparison to analogous chemical substances, EPA has identified
concerns for systemic (decreased body weight and blood effects) and
reproductive (male) 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
and the environment. To protect against these risks, the Order
requires:
<bullet> No use of the PMN substance in consumer products other
than in plastic articles and other plastic parts;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation 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 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-22-32 (40 CFR 721.11977)
Chemical Name: Isocyanic acid, polymethylenepolyphenylene ester,
polymer with .alpha.-hydro-.omega.-hydroxypoly[oxy(alkanediyl)], 1,1'-
methylenebis[4-isocyanatobenzene] and .alpha.-alkane[.omega.-
hydroxypoly[oxy(alkanediyl)]] (generic).
CASRN: Not available.
Effective Date of TSCA Order: October 5, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
reactive polymer for use in adhesives and sealants. Based on the weight
of 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
analogues of the residuals of the PMN substance, EPA has also
identified concerns for acute toxicity, irritation to the skin, eyes,
and respiratory tract, skin sensitization, respiratory sensitization,
lung effects, systemic effects, reproductive and developmental 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 manufacture, processing, or use of the PMN substance in
any manner that generates vapor, mist, aerosol, or dust;
<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
[[Page 95697]]
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
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-22-33 (40 CFR 721.11978)
Chemical Name: Alkylamine, alkoxysilyl-, hydrolyzed (generic).
CASRN: Not available.
Effective Date of TSCA Order: October 5, 2023.
Basis for TSCA Order: The PMN states that the use will be as an
adhesion promoter for use in industrial manufacturing operations. Based
on the amine content, EPA has identified concerns for irritation to the
skin, eye, and respiratory tract. Based on potential for cationic
binding to lung membranes, waterproofing, and comparison to analogous
alkoxysilanes, EPA has also identified concerns for lung effects. Based
on the expected release of a hydrolysis product, EPA has also
identified concerns for neurotoxicity and developmental effects. Based
on comparison to analogous polycationic polymers, 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> No manufacture, processing, or use of the PMN substance in
any manner that generates vapor, mist, aerosol, or dust;
<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> 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, skin irritation/
corrosion, eye irritation/corrosion, reproductive/developmental
toxicity, neurotoxicity, 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-22-34 (40 CFR 721.11979)
Chemical Name: Alkylphosphonic acid, disodium salt (generic).
CASRN: Not available.
Effective Date of TSCA Order: June 14, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a precursor to a nucleating agent for
polyolefins. Based on comparison to analogous chemical substances, 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 and the environment. 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
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-22-35 (40 CFR 721.11980)
Chemical Name: Alkenoic acid, alkanediyl ester, polymer with
bis(substituted alkyl)-alkanediol polymer with alkylene oxides
alkenoate, and alkanamine (generic).
CASRN: Not available.
Effective Date of TSCA Order: June 1, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
component of flexographic ink formulations to improve reactivity when
cured under LED UV light. Based on comparison to analogous acrylates/
methacrylates and cross-linking potential, EPA has identified concerns
for irritation to the skin, eyes and respiratory tract, and skin and
respiratory sensitization. Based on the structure of the PMN substance,
EPA has also identified concerns for lung effects (cationic binding).
Based on comparison to analogues of both the low molecular weight
fraction and the residual, EPA also identified concerns for acute
toxicity, skin irritation/corrosion, eye irritation/corrosion,
respiratory tract irritation/corrosion, skin sensitization,
neurotoxicity, and systemic and reproductive (male) effects. Based on
comparison to analogous polycationic polymers, 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
[[Page 95698]]
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 consumer products;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 3 ppb;
<bullet> Use of a NIOSH-certified particulate respirator with an
APF of at least 1000 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 aquatic
toxicity, specific target organ toxicity, pulmonary effects,
reproductive/developmental toxicity, skin sensitization, skin
irritation/corrosion, eye irritation/corrosion, acute toxicity, and
neurotoxicity 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-22-38 (40 CFR 721.11981)
Chemical Name: Siloxanes and silicones, di-Me, mixed (polyhydro-
substituted heterocyclic) alkyl group and
[(polyalkylsilyl)substituted]-terminated (generic).
CASRN: Not available.
Effective Date of TSCA Order: September 29, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive. Based on comparison to
analogous chemical substances, EPA has identified lung, reproductive,
and 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 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;
<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
pulmonary effects, specific target organ toxicity, and reproductive
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-22-94 (40 CFR 721.11982)
Chemical Name: Cadmium tin oxide (Cd<INF>2</INF>Sn0<INF>4</INF>).
CASRN: 12185-56-7.
Effective Date of TSCA Order: October 25, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be for a contained use as a sputtering material.
Based on comparison to analogous respirable, poorly soluble
particulates, EPA has identified concerns for lung effects (lung
overload and subsequent carcinogenicity). Based on test data for
components and information provided in the SDS, EPA has also identified
concerns for acute toxicity, irritation to the skin, eyes, and
respiratory tract, systemic effects, reproductive and developmental
effects, genotoxicity, and carcinogenicity. Based on comparison to
analogous chemical substances, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 0.2 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 domestic manufacture of the PMN substance (i.e., import
only);
<bullet> No 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;
<bullet> No 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; 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 aquatic
toxicity, sediment toxicity, specific target organ toxicity, acute
toxicity, pulmonary effects, reproductive toxicity, developmental
toxicity, skin irritation, eye damage, carcinogenicity, and genetic
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-22-119 (40 CFR 721.11983) and
P-22-120 (40 CFR 721.11984)
Chemical Names: Polyhydroxyalkanoate (generic).
CASRN: Not applicable.
Effective Date of TSCA Order: September 29, 2023.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as resins for packaging materials and for
use as binders. Based on comparison to analogous chemical substances,
EPA has identified concerns
[[Page 95699]]
for skin, eye, and respiratory tract irritation. 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. To protect against these risks, the Order
requires:
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.
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, pulmonary effects, and skin irritation testing may be
potentially useful to characterize the health 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-22-151 (40 CFR 721.11985)
Chemical Name: Glycolipids, sophorose-contg., yeast-fermented, from
glycerides and carbohydrates (generic).
CASRN: Not available.
Effective Date of TSCA Order: August 29, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a surfactant for commercial applications.
Based on the intended use of the new chemical substance as well as
submitted surface tension data, EPA has identified concerns for lung
effects (surfactancy). Based on test data for components and
information provided in the SDS, EPA has identified concerns for eye
and respiratory tract irritation and systemic effects. Based on
comparison to analogous aliphatic amines, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 550 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;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 550 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
pulmonary effects, 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-22-178 (40 CFR 721.11986)
Chemical Name: Aromatic diacid, polymer with alkyldiols,
hexanedioic acid, benzofurandione, and 1,1'- methylenebis[4-
isocyanatobenzene] (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 an adhesive for lamination. Based on
comparison to analogous diisocyanates, EPA has identified concerns for
skin sensitization, respiratory sensitization, and pulmonary toxicity.
Based on test data for the feedstock residual, EPA has also identified
concerns for acute toxicity, skin and respiratory sensitization,
irritation to the skin, eyes, and respiratory tract, and systemic,
pulmonary, and developmental effects. Based on test data for a
hydrolysis product of a residual, EPA has also identified concerns for
genetic toxicity, carcinogenicity, and portal-of-entry, systemic, and
reproductive 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 manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
<bullet> No manufacture, processing, or use of the PMN substance
with residual MDI greater than 5% by weight;
<bullet> No processing for use or use of the PMN substance in
consumer products;
<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, 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
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-23-13 (40 CFR 721.11987)
Chemical Name: Phenol, polymer with 4,4'- bis(chloromethyl)-1,1'-
biphenyl.
CASRN: 208254-04-0.
Effective Date of TSCA Order: November 2, 2023.
Basis for TSCA Order: The PMN states that the use will be as an
epoxy molding compound for electronic devices. Based on comparison to
analogous chemical substances, EPA has identified concerns for portal-
of-entry effects (GI effects).
[[Page 95700]]
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> Manufacture of the PMN substance other than by import into
the United States (i.e., no domestic manufacture) at concentrations
equal to or less than the confidential concentration percentage listed
in the Order;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 260 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 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 Numbers (Proposed CFR Citations): P-23-49 (40 CFR 721.11988) and P-
23-124 (40 CFR 721.11989)
Chemical Names: Sulfonium, tricarbocyclic-, 2-aryl-
polyfluoropolyhydro-alkano -heteropolycycle-alkanesulfonate (1:1),
polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-
alkanoate, di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated
(generic) (P-23-49) and Sulfonium, tricabocyclic-, 2-heteroatom-
substituted-(halocarbocyclic)carboxylate (1:1) (generic) (P-23-124).
CASRN: Not available.
Effective Date of TSCA Order: September 25, 2023.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be for photolithography.
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 estimates a
bioaccumulation factor of greater than or equal to 1,000. Based on the
presence of 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 of
the PMN substances. Based on comparison to analogous chemical
substances, EPA has also identified concerns for genetic toxicity for
the cation of the PMN substances. Based on the photoreactivity of the
PMN substances, EPA has also identified concerns for photosensitization
for the cation of the PMN substances. Based on a structural alert and
OECD QSAR (Quantitative Structure-Activity Relationship) Toolbox
results, EPA has also identified concerns for skin sensitization for
the anion of P-23-124. Based on a potential incineration product, EPA
has also identified concerns for local and systemic effects for the
incineration product. 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 of the PMN substances in
any way that generates a vapor, dust, mist, or aerosol in a non-
enclosed process;
<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-23-50 (40 CFR 721.11990)
Chemical Name: Substitutedheterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1),
polymer with 3-ethenylphenol and heterosubstitutedaromaticalkyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-
methylpropanoate]-initiated (generic).
CASRN: Not available.
Effective Date of TSCA Order: September 20, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be for contained use for
microlithography for electronic device manufacturing. 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 1,000. Based on comparison to chemical substances
analogous to the cation compounds of the PMN substance and supported by
information provided in the SDS, EPA has identified concerns for acute
toxicity, irritation to the skin and respiratory tract, eye corrosion,
neurological effects, and systemic effects for the cation of the PMN
substance. Based on comparison to analogous chemical substances, EPA
has also identified concerns for genetic toxicity for the cation of the
PMN substance. Based on the photoreactivity
[[Page 95701]]
of the PMN substance, EPA has also identified concerns for
photosensitization for the cation of the PMN substance. Based on a
potential incineration product, EPA has also identified concerns for
local and systemic effects for the incineration product. 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 or use 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.
PMN Numbers (Proposed CFR Citations): P-23-83 (40 CFR 721.11991), P-23-
125 (40 CFR 721.11992), and P-23-147 (40 CFR 721.11993)
Chemical Names: Sulfonium, tricarbocyclic-, [polyhydro-alkyl-
(polyfluoro-2-heteroatom substituted)- alkano-heteromonocyclic] alkyl
ester (1:1) (generic) (P-23-83), Sulfonium, tricarbocyclic-,
polyfluoropolyhydro-heteroatom substituted carbomonocyclic-2-heteroatom
substituted carbomonocyclic heteropolycycle-5-alkanesulfonate (1:1)
(generic) (P-23-125), and Sulfonium, tris(heteroatom-substituted
carbomonocyclic), salt with polyhydro-polyfluoro-heteroatom-substituted
alkyl heteropolycyclic-heteroatom-substituted aryl heteroatom-
substituted benzoate (1:1) (generic) (P-23-147).
CASRN: Not available.
Effective Date of TSCA Order: October 27, 2023.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be for photolithography.
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 substances 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 estimates a
bioaccumulation factor of greater than or equal to 1,000. Based on the
presence of 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 of
the PMN substances. Based on comparison to analogous chemical
substances, EPA has also identified concerns for genetic toxicity for
the sulfonium cation of the PMN substances. Based on the
photoreactivity of the PMN substances, EPA has also identified concerns
for photosensitization for the sulfonium cation of the PMN substances.
Based on comparison to analogous chemical substances, EPA has also
identified concerns for systemic and developmental effects for the
anion component of the PMN substances. Based on a potential
incineration product, EPA has also identified concerns for local and
systemic effects via inhalation exposure for the incineration product
of the PMN substances. Based on OECD Toolbox results, EPA also
identified concerns for skin sensitization for the anion component of
P-23-147. 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 of the PMN substances in
any way that generates a vapor, dust, mist, or aerosol in a non-
enclosed process;
<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-23-104 (40 CFR 721.11994)
Chemical Name: Sulfonium, carbomonocycle
bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic ester
(generic).
CASRN: Not available.
Effective Date of TSCA Order: September 29, 2023.
[[Page 95702]]
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be an ingredient used in
the manufacture of photoresist. 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 1,000. Based on the presence of 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 cation of the PMN substance. Based on comparison to
analogous chemical substances, EPA has also identified concerns for
genetic toxicity for the cation of the PMN substance. Based on the
photoreactivity of the PMN substance, EPA has also identified concerns
for photosensitization for the cation of the PMN substance. Based on a
potential incineration product, EPA has also identified concerns for
local and systemic effects for the incineration product. 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 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, 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
[[Page 95703]]
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 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.
Dated: November 22, 2024.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR chapter I as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. Sec. 721.11960 through 721.11994 to Subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11960 Polyester polyol (generic).
721.11961 Polyester polyol (generic).
721.11962 2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane, 3,9-
bis-[2-(1-methyl-1- phenylethyl)-4-(1,1,3,3-
tetramethylbutyl)phenoxy]-.
721.11963 1-Propanamine, 3-methoxy-N,N-dimethyl-.
721.11964 Soybean oil, mixed esters with diethylene glycol, phthalic
acid and terephthalic acid.
721.11965 Soybean oil, epoxidized, polymer with bisphenol A, alkyl
glycidyl ether, epichlorohydrin, polyethylene glycol and
trihydroxyalkane (generic).
721.11966 Metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino]
sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium
salts (generic).
721.11967 Siloxanes and silicones polyether, polymer with aliphatic
isocyanate, 2-dimethylaminoethanol and polyglycol ether (generic).
721.11968 Siloxanes and Silicones, di-Me,
[gluconoylamino)alkyl]dialkylammonio]- hydroxyalkoxy]alkyl group-
terminated, (salts) (generic).
721.11969 Sulfonium, carbomonocycle
bis((trihaloalkyl)carbomonocycle), substituted carbomonocyclic ester
(generic).
721.11970 Aromatic diacids, polymer with alkyldiacids, alkyldiols,
benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (generic).
721.11971 Aromatic diacid, polymer with alkyldiacid, alkyldiols,
polypropylene glycol, benzofurandione, caprolactone and 1,1'-
methylenebis[4-isocyanatobenzene] (generic).
721.11972 Aromatic diacids, polymer with alkyldiacids, alkyldiols,
benzofurandione, polypropylene, alkylhydroxyacid glycolester,
caprolactone and 1,1'-methylenebis[4- isocyanatobenzene] (generic).
721.11973 Diketone compound metal complex (generic).
[[Page 95704]]
721.11974 Poly(oxy-1,2-ethanedlyl), alpha,alpha'',alpha''-
(trialkylamino)tris[omega-hydroxy-, alkyl (ester) (generic).
721.11975 Substituted polyalkylenepoly, reaction products with
substituted heteromonocycle substituted heteromonocycle polyalkylene
derivs (generic).
721.11976 Alkylphosphonic acid, calcium salt (generic).
721.11977 Isocyanic acid, polymethylenepolyphenylene ester, polymer
with .alpha.-hydro-.omega.w-hydroxypoly[oxy(alkanediyl)], 1,1'-
methylenebis[4-isocyanatobenzene] and .alpha.-alkane[.omega.w-
hydroxypoly[oxy(alkanediyl)]] (generic).
721.11978 Alkylamine, alkoxysilyl-, hydrolyzed (generic).
721.11979 Alkylphosphonic acid, disodium salt (generic).
721.11980 Alkenoic acid, alkanediyl ester, polymer with
bis(substituted alkyl)-alkanediol polymer with alkylene oxides
alkenoate, and alkanamine (generic).
721.11981 Siloxanes and silicones, di-Me, mixed (polyhydro-
substituted heterocyclic) alkyl group and
[(polyalkylsilyl)substituted]-terminated (generic).
721.11982 Cadmium tin oxide (Cd2Sn04).
721.11983 Polyhydroxyalkanoate (generic).
721.11984 Polyhydroxyalkanoate (generic).
721.11985 Glycolipids, sophorose-contg., yeast-fermented, from
glycerides and carbohydrates (generic).
721.11986 Aromatic diacid, polymer with alkyldiols, hexanedioic
acid, benzofurandione, and 1,1'- methylenebis[4-isocyanatobenzene]
(generic).
721.11987 Phenol, polymer with 4,4'- bis(chloromethyl)-1,1'-
biphenyl.
721.11988 Sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-
alkano -heteropolycycle-alkanesulfonate (1:1), polymer with
heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate,
di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated
(generic).
721.11989 Sulfonium, tricabocyclic-, 2-heteroatom-substituted-
(halocarbocyclic)carboxylate (1:1) (generic).
721.11990 Substitutedheterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate
(1:1), polymer with 3-ethenylphenol and
heterosubstitutedaromaticalkyl 2-methyl-2-propenoate, di-Me 2,2'-
(1,2-diazenediyl)bis[2- methylpropanoate]-initiated (generic).
721.11991 Sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-
alkano -heteropolycycle-alkanesulfonate (1:1), polymer with
heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate,
di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated
(generic).
721.11992 Sulfonium, tricarbocyclic-, polyfluoropolyhydro-heteroatom
substituted carbomonocyclic-2-heteroatom substituted carbomonocyclic
heteropolycycle-5-alkanesulfonate (1:1) (generic).
721.11993 Sulfonium, tris(heteroatom-substituted carbomonocyclic),
salt with polyhydro-polyfluoro-heteroatom-substituted alkyl
heteropolycyclic-heteroatom-substituted aryl heteroatom-substituted
benzoate (1:1) (generic).
721.11994 Sulfonium, carbomonocycle
bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic
ester (generic).
* * * * *
Sec. 721.11960 Polyester polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyester polyol (PMN P-16-377) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (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.
(ii) Industrial, commercial, and consumer use. It is a significant
new use to manufacture, process, or use the substance in any manner
that would result in respirable particle sizes below 10 microns.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (f) 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. 721.11961 Polyester polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyester polyol (PMN P-16-378) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (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.
(ii) Industrial, commercial, and consumer use. It is a significant
new use to manufacture, process, or use the substance in any manner
that would result in respirable particle sizes below 10 microns.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (f) 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. 721.11962 2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane,
3,9-bis-[2-(1-methyl-1- phenylethyl)-4-(1,1,3,3-
tetramethylbutyl)phenoxy]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,4,8,10-tetraoxa-
3,9-diphosphaspiro[5.5]undecane, 3,9-bis-[2-(1-methyl-1- phenylethyl)-
4-(1,1,3,3-tetramethylbutyl)phenoxy]- (PMN P-18-346; CASRN 1507339-21-
0) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), 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), and (g)(1), (3), and (5). For purposes of
Sec. 721.72(g)(1), this
[[Page 95705]]
substance may cause: skin sensitization, eye 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=18.
(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 (h), 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. 721.11963 1-Propanamine, 3-methoxy-N,N-dimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propanamine, 3-
methoxy-N,N-dimethyl- (PMN P-20-44; CASRN 20650-07-1) 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 (5), (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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for this substance. The NCEL is 1.1388mg/m3 as
an 8-hour time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons who Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (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: skin irritation, serious eye
damage, 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 use. 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=1000.
(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. 721.11964 Soybean oil, mixed esters with diethylene glycol,
phthalic acid and terephthalic acid.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as soybean oil, mixed
esters with diethylene glycol, phthalic acid and terephthalic acid (PMN
P-21-21) 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) 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) 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, 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 use. 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.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=3000.
(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. 721.11965 Soybean oil, epoxidized, polymer with bisphenol A,
alkyl glycidyl ether, epichlorohydrin, polyethylene glycol and
trihydroxyalkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as soybean
oil, epoxidized, polymer with bisphenol A, alkyl glycidyl ether,
epichlorohydrin, polyethylene glycol and trihydroxyalkane (PMN P-21-
151) 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 when
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) through (5), 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 95706]]
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), and (g)(1) through (3), and (5). For
purposes of Sec. 721.72(g)(1), this substance may cause: respiratory
sensitization, skin sensitization, and specific target organ toxicity.
For purposes of Sec. 721.72(g)(2), do not spray apply. 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 use. Requirements as
specified in Sec. 721.80(o). It is a significant new use to process or
use the substance in a spray application.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=140.
(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. 721.11966 Metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino]
sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium
salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as metal,
[heteropolycyclic]-, [[[(hydroxyalkyl)amino]
sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium
salts (PMN P-21-168) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(3) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. 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.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=178.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (h), 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. 721.11967 Siloxanes and silicones polyether, polymer with
aliphatic isocyanate, 2-dimethylaminoethanol and polyglycol ether
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones polyether, polymer with aliphatic isocyanate,
2-dimethylaminoethanol and polyglycol ether (PMN P-21-173) 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
embedded into a textile fiber matrix.
(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 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 use. 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.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=1.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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. 721.11968 Siloxanes and Silicones, di-Me,
[gluconoylamino)alkyl]dialkylammonio]- hydroxyalkoxy]alkyl group-
terminated, (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, di-Me, [gluconoylamino)alkyl]dialkylammonio]-
hydroxyalkoxy]alkyl group-terminated, (salts) (PMN P-21-194) 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 when incorporated into a
textile.
(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 purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this
[[Page 95707]]
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 use. 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 the generation of a vapor, mist, dust, or aerosol.
(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. 721.11969 Sulfonium, carbomonocycle
bis((trihaloalkyl)carbomonocycle), substituted carbomonocyclic ester
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, carbomonocycle bis((trihaloalkyl)carbomonocycle),
substituted carbomonocyclic ester (PMN P-21-202) 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), and (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, 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), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process 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 9 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. 721.11970 Aromatic diacids, polymer with alkyldiacids,
alkyldiols, benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic diacids, polymer with alkyldiacids, alkyldiols,
benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (PMN P-21-208) 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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, serious eye damage, 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 use. 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.
(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. 721.11971 Aromatic diacid, polymer with alkyldiacid, alkyldiols,
polypropylene glycol, benzofurandione, caprolactone and 1,1'-
methylenebis[4-isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic diacid, polymer with alkyldiacid, alkyldiols, polypropylene
glycol, benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (PMN P-21-209) 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
[[Page 95708]]
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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, serious eye damage, 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 use. 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.
(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. 721.11972 Aromatic diacids, polymer with alkyldiacids,
alkyldiols, benzofurandione, polypropylene, alkylhydroxyacid
glycolester, caprolactone and 1,1'-methylenebis[4- isocyanatobenzene]
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic diacids, polymer with alkyldiacids, alkyldiols,
benzofurandione, polypropylene, alkylhydroxyacid glycolester,
caprolactone and 1,1'-methylenebis[4- isocyanatobenzene] (PMN P-21-210)
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), and (f), and (g)(1) and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, serious eye damage, 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 use. 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.
(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. 721.11973 Diketone compound metal complex (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
diketone compound metal complex (PMN P-21-212) 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 when completely entrained in dried/cured
ink.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), 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), and (g)(1), (3), and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
corrosion, serious eye damage, skin irritation, eye irritation, skin
sensitization, 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 use. Requirements as
specified in Sec. 721.80(o) and (t). It is a significant new use to
manufacture the substance in excess of an annual volume of 1,000 kg/yr.
(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)(4), (b)(4), and (c)(4), where N=13.
(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. 721.11974 Poly(oxy-1,2-ethanedlyl), alpha,alpha',alpha''-
(trialkylamino)tris[omega-hydroxy-, alkyl (ester) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified
[[Page 95709]]
generically as poly(oxy-1,2-ethanedlyl), alpha,alpha',alpha''-
(trialkylamino)tris[omega-hydroxy-, alkyl (ester) (PMN P-21-214) 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 embedded into a textile fiber matrix.
(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 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, 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 use. 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.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=4.
(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. 721.11975 Substituted polyalkylenepoly, reaction products with
substituted heteromonocycle substituted heteromonocycle polyalkylene
derivs (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted polyalkylenepoly, reaction products with substituted
heteromonocycle substituted heteromonocycle polyalkylene derivs. (PMN
P-22-18) 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) 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. 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 use. Requirements as
specified in Sec. 721.80(k). It is a significant new use to process
for use or use the substance in consumer products at a concentration
greater than 3%. It is a significant new use to manufacture, process,
or use the substance in any manner that results in a dust, mist, or
aerosol.
(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. 721.11976 Alkylphosphonic acid, calcium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylphosphonic acid, calcium salt (PMN P-22-21) 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 fully
reacted, cured, destroyed, or entrained in a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), (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), and (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 use. It is a significant
new use to use the substance in consumer products other than in plastic
articles and other plastic parts.
(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.
[[Page 95710]]
Sec. 721.11977 Isocyanic acid, polymethylenepolyphenylene ester,
polymer with .alpha.-hydro-.omega.- hydroxypoly[oxy(alkanediyl)], 1,1'-
methylenebis[4-isocyanatobenzene] and .alpha.-alkane[.omega.-
hydroxypoly[oxy(alkanediyl)]] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanic acid, polymethylenepolyphenylene ester, polymer with .alpha.-
hydro-.omega.-hydroxypoly[oxy(alkanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene] and .alpha.-alkane[.omega.-
hydroxypoly[oxy(alkanediyl)]] (PMN P-22-32) 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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity (residual), skin
irritation (residual), eye irritation (residual), skin sensitization,
respiratory sensitization, genetic toxicity (residual), carcinogenicity
(residual), reproductive toxicity (residual), 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 use. 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 a vapor, mist, aerosol, or dust.
(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. 721.11978 Alkylamine, alkoxysilyl-, hydrolyzed (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylamine, alkoxysilyl-, hydrolyzed (PMN P-22-33) 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), and (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, specific target organ toxicity, and reproductive 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 use. 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 a vapor, mist, aerosol, or dust.
(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. 721.11979 Alkylphosphonic acid, disodium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylphosphonic acid, disodium salt (PMN P-22-34) 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 fully
reacted, cured, destroyed, or entrained in a polymer matrix.
(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) 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 use. 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.
(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.
[[Page 95711]]
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11980 Alkenoic acid, alkanediyl ester, polymer with
bis(substituted alkyl)-alkanediol polymer with alkylene oxides
alkenoate, and alkanamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, alkanediyl ester, polymer with bis(substituted alkyl)-
alkanediol polymer with alkylene oxides alkenoate, and alkanamine (PMN
P-22-35) 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 (5), 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 1000.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (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, 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 use. 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=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.
Sec. 721.11981 Siloxanes and silicones, di-Me, mixed (polyhydro-
substituted heterocyclic) alkyl group- and
[(polyalkylsilyl)substituted]-terminated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, di-Me, mixed (polyhydro-substituted
heterocyclic) alkyl group- and [(polyalkylsilyl)substituted]-terminated
(PMN P-22-38) 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), and (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 use. 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.
(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. 721.11982 Cadmium tin oxide (Cd2Sn04).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cadmium tin oxide
(Cd<INF>2</INF>Sn0<INF>4</INF>) (PMN P-22-94; CASRN 12185-56-7) 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.
(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 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (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: skin irritation, eye
irritation, genetic toxicity, specific target organ toxicity, acute
toxicity, reproductive toxicity, and carcinogenicity. For purposes of
Sec. 721.72(g)(3), this substance may be: toxicity 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 use. Requirements as
specified in Sec. 721.80(f) and (k). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(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
[[Page 95712]]
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. 721.11983 Polyhydroxyalkanoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyhydroxyalkanoate (PMN P-22-119) 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 plastic
or when completely reacted or cured or when 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 (5), (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), and (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: skin irritation, eye
irritation, 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.
(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 (h) 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. 721.11984 Polyhydroxyalkanoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyhydroxyalkanoate (PMN P-22-120) 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 plastic
or when completely reacted or cured or when 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 (5), (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), and (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: skin irritation, eye
irritation, 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.
(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 (h) 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. 721.11985 Glycolipids, sophorose-contg., yeast-fermented, from
glycerides and carbohydrates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
glycolipids, sophorose-contg., yeast-fermented, from glycerides and
carbohydrates (PMN P-22-151) 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 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: 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 use. 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.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=550.
(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 95713]]
Sec. 721.11986 Aromatic diacid, polymer with alkyldiols, hexanedioic
acid, benzofurandione, and 1,1'- methylenebis[4-isocyanatobenzene]
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic diacid, polymer with alkyldiols, hexanedioic acid,
benzofurandione, and 1,1'- methylenebis[4-isocyanatobenzene] (PMN P-22-
178) 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), and (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 use. 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. It is a significant new use to manufacture,
process, or use the substance with residual MDI greater than 5% by
weight.
(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. 721.11987 Phenol, polymer with 4,4'- bis(chloromethyl)-1,1'-
biphenyl.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, polymer
with 4,4'- bis(chloromethyl)-1,1'-biphenyl (PMN P-23-13; CASRN 208254-
04-0) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (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.
(ii) Industrial, commercial, and consumer use. It is a significant
new use to manufacture the substance other than by import into the
United States (i.e., no domestic manufacture) at concentrations equal
to or greater than the confidential concentration percentage listed in
the Order.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=260.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) 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. 721.11988 Sulfonium, tricarbocyclic-, 2-aryl-
polyfluoropolyhydro-alkano -heteropolycycle-alkanesulfonate (1:1),
polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-
alkanoate, di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-alkano -
heteropolycycle-alkanesulfonate (1:1), polymer with heteroatom
substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, di-Me 2,2-
(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (PMN P-23-49) 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 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 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
[[Page 95714]]
provisions of Sec. 721.185 apply to this section.
Sec. 721.11989 Sulfonium, tricabocyclic-, 2-heteroatom-substituted-
(halocarbocyclic)carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricabocyclic-, 2-heteroatom-substituted-
(halocarbocyclic)carboxylate (1:1) (generic) (PMN P-23-124) 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), and (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 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. 721.11990 Substitutedheterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1),
polymer with 3-ethenylphenol and heterosubstitutedaromaticalkyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-
methylpropanoate]-initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substitutedheterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1),
polymer with 3-ethenylphenol and heterosubstitutedaromaticalkyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-
methylpropanoate]-initiated (PMN P-23-50) 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), and (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 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. 721.11991 Sulfonium, tricarbocyclic-, 2-aryl-
polyfluoropolyhydro-alkano -heteropolycycle-alkanesulfonate (1:1),
polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-
alkanoate, di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-alkano -
heteropolycycle-alkanesulfonate (1:1), polymer with heteroatom
substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, di-Me 2,2-
(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (PMN P-23-83) 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
[[Page 95715]]
considered and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (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, 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), 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 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. 721.11992 Sulfonium, tricarbocyclic-, polyfluoropolyhydro-
heteroatom substituted carbom
[…truncated; see source link]Indexed from Federal Register on December 2, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.