Proposed Rule2024-12764
Significant New Use Rules on Certain Chemical Substances (22-4.5e)
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
June 11, 2024
Issuing agencies
Environmental Protection Agency
Abstract
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to a TSCA Order. 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 rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination.
Full Text
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[Federal Register Volume 89, Number 113 (Tuesday, June 11, 2024)]
[Proposed Rules]
[Pages 49121-49144]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12764]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2022-0771; FRL-11912-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (22-
4.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances that were
the subject of premanufacture notices (PMNs) and are also subject to a
TSCA Order. 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 rule to notify EPA at least 90 days before commencing that
activity. The required notification initiates EPA's evaluation of the
conditions of use for that chemical substance. In addition, the
manufacture or processing for the significant new use may not commence
until EPA has conducted a review of the required notification, made an
appropriate determination regarding that notification, and taken such
actions as required by that determination.
DATES: Comments must be received on or before July 11, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2022-0771, 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 contact: 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#691e101a06070e471e000505000804290c1908470e061f"><span class="__cf_email__" data-cfemail="8bfcf2f8e4e5eca5fce2e7e7e2eae6cbeefbeaa5ece4fd">[email protected]</span></a>.
For general information contact: 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#1e4a4d5d5f3356716a7277707b5e7b6e7f30797168"><span class="__cf_email__" data-cfemail="ecb8bfafadc1a4839880858289ac899c8dc28b839a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the factors in TSCA section 5(a)(2) (see
also the discussion in Unit II.).
B. What action is the Agency taking?
EPA is proposing SNURs for the chemical substances discussed in
Unit III. These SNURs, if finalized as proposed, would require persons
who intend to manufacture or process any of these chemical substances
for an activity that is designated as a significant new use to notify
EPA at least 90 days before commencing that activity.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances identified in Unit III. This may include entities
in North American Industrial Classification System (NAICS) codes 325
and 324110, e.g., chemical manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing
import certification and export notification requirements under TSCA
(<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 (see also
19 CFR 127.28), and the EPA policy in support of import certification
at 40 CFR part 707, subpart B. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA, including regulations issued under TSCA sections
5, 6, 7 and Title IV.
Pursuant to 40 CFR 721.20, any persons who export or intend to
export a chemical substance that is the subject of this proposed rule
on or after July 11, 2024 are subject to TSCA section 12(b) (15 U.S.C.
2611(b)) and must comply with the export notification requirements in
40 CFR part 707, subpart D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing SNUN
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substances subject to these
proposed SNURs. This analysis, which is available in the docket, is
briefly summarized here.
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,000 per SNUN
submission for large business submitters and $14,500 for small business
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central Data Exchange (CDX)),
and the payment of a user fee. Businesses that submit a SNUN would be
subject to either a $37,000 user fee required by 40 CFR
700.45(c)(2)(ii) and (d), or, if they are a small business as defined
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR
700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission
for SNUNs will not be incurred by any company unless a company decides
to pursue a significant new use as defined in these SNURs.
Additionally, these estimates reflect the costs and fees as they are
known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the
export notification requirements under TSCA
[[Page 49122]]
section 12(b) and the implementing regulations at 40 CFR part 707,
subpart D. For persons exporting a substance that is the subject of a
SNUR, a one-time notice to EPA must be provided for the first export or
intended export to a particular country. The total costs of export
notification will vary by chemical, depending on the number of required
notifications (i.e., the number of countries to which the chemical is
exported). While EPA is unable to make any estimate of the likely
number of export notifications for the chemical substances covered by
these SNURs, as stated in the accompanying economic analysis, the
estimated cost of the export notification requirement on a per unit
basis is approximately $106.
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through email or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you wish to include CBI in your comment, please
follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the information that you
claim to be CBI. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR parts 2 and 703.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting
tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
This unit provides general information about SNURs. For additional
information about EPA's new chemical program go to <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
A. Significant New Use Determination Factors
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
<bullet> The projected volume of manufacturing and processing of a
chemical substance.
<bullet> The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
<bullet> The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
<bullet> The reasonably anticipated manner and methods of
manufacturing, 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 for these chemical substances,
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 these chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA 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 EPA
to determine whether a specific use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If
[[Page 49123]]
EPA concludes that the person has shown a bona fide intent to
manufacture or process the chemical substance, EPA will tell the person
whether the use identified in the bona fide submission would be a
significant new use under the rule. 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.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.
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 conditions of use of the chemical substance is not
likely to present an unreasonable risk, EPA is required under TSCA
section 5(g) to publish a statement of EPA's findings in the Federal
Register.
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 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.C. for
these
[[Page 49124]]
chemical substances 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 information 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 to
provide useful information with their SNUN submission.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
<bullet> Human exposure and environmental release that may result
from the significant new use of the chemical substances.
III. Chemical Substances Subject to These Proposed SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates June 11, 2024, as the cutoff date for determining
whether the new use is ongoing. This designation is explained in more
detail in Unit II.E.
B. What information is provided for each chemical substance?
For each chemical substance identified in Unit III.C., EPA provides
the following information:
<bullet> PMN number (the proposed CFR citation assigned in the
regulatory text section of this document).
<bullet> Chemical name (generic name, if the specific name is
claimed as CBI).
<bullet> Chemical Abstracts Service Registry Number (CASRN) (if
assigned for non-confidential chemical identities).
<bullet> Basis for the action or, as applicable, the 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 for SNURs currently exist in 40 CFR part 721, subpart B.
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 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 Number: P-18-398 (40 CFR 721.11860)
Chemical Name: 1,2-Ethanediamine, N-(1-methylethyl)-N-[2-[(1-
methylethyl)amino]ethyl]-.
CASRN: 10507-06-9.
Effective Date of TSCA Order: April 13, 2022.
Basis for TSCA Order: The PMN states that the use will be as an
intermediate. Based on comparison to analogous substances, EPA has
identified concerns for acute toxicity, skin sensitization, eyes, skin,
and respiratory tract corrosion, and systemic, reproductive, and
developmental effects. Based on comparison to analogous aliphatic
amines, EPA predicts that 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 risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified full facepiece gas/vapor
respirator with an APF of at least 50 where there is a potential for
inhalation exposure;
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS; and
<bullet> No use of the PMN substance other than for the
confidential use allowed in 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 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 and skin sensitization 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: P-19-49 (40 CFR 721.11861)
Chemical Name: Fatty acids, polymers with substituted
carbomonocycles, dialkanolamine, alkyl substituted alkanediamine and
halo-substituted heteromonocycle, formates (salts) (generic).
CASRN: Not available.
Effective Date of Modified TSCA Order: May 19, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an isolated intermediate coating resin.
Based on the amine content and the surfactant properties of the PMN
substance, EPA has identified concerns for irritation to all tissues.
Based on formic acid, EPA has also identified concerns for
neurotoxicity, blood toxicity, and developmental toxicity. Based on
test data on the PMN substance, EPA predicts that toxicity to aquatic
organisms may occur at concentrations that exceed 114 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
[[Page 49125]]
to permit a reasoned evaluation, the substance may present an
unreasonable risk of injury to human health or the environment. The
Order, effective October 27, 2020, required the submitter of P-19-49 to
submit to EPA the results of certain toxicity testing before any
manufacturing (which includes import), processing, or use of the PMN
substance. On September 17, 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 May 19, 2022. To
protect against these potential risks, the modified Order requires:
<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 manufacture or processing of the PMN substance in a
manner that generates a vapor, mist, or aerosol;
<bullet> No use of the PMN substance in a manner that generates a
vapor, mist, or aerosol that results in inhalation to industrial or
commercial workers;
<bullet> No manufacture the PMN substance to contain the
confidential residual identified in the Order at greater than 0.1%; and
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 114 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye irritation, developmental/reproductive toxicity,
pulmonary effects, and neurotoxicity testing may be potentially useful
to characterize the health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Number: P-19-160 (40 CFR 721.11862)
Chemical Name: Alkanesulfonic acid, 2-[(2-aminoethyl)heteroatom-
substituted]-, sodium salt (1:1), polymer with .alpha.-[2,2-
bis(hydroxymethyl)butyl]-.omega.-methoxypoly(oxy-1,2-ethanediyl) and
1,1'-methylenebis[4-isocyanatocyclohexane], acrylic acid-
dipenthaerythritol reaction products- and polypropylene glycol ether
with pentaerythritol (4:1) triacrylate-blocked (generic).
CASRN: Not available.
Effective Date of TSCA Order: July 27, 2022.
Basis for TSCA Order: The PMN states that the use will be as a
component of a UV curable printing ink. Based on analogue data and
information provided in the SDS, EPA has identified concerns for skin
irritation and dermal and respiratory sensitization. Based on analogue
data and data on a component of the PMN substance, EPA has identified
concerns for eye irritation/corrosion and genotoxicity. Based on
analogue data, EPA has also identified concerns for systemic toxicity,
developmental toxicity, and neurotoxicity. Based on comparison to
analogous polyanionic polymers, EPA predicts that the PMN substance has
low environmental hazard. 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> 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 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; and
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 302 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, reproductive
toxicity (developmental effects), skin sensitization, skin irritation,
eye damage, carcinogenicity, and genetic 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: P-20-101 (40 CFR 721.11863)
Chemical Name: Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-,
polymer with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-
alkanediyl), (haloalkyl)oxiane polymer (alkylalkylidene)bis[hydroxy-
carbomonocycle] alkenoate and isocyanate-alkyl-carbomonocycle,
hydroxyalkyl acrylate-blocked (generic).
CASRN: Not available.
Effective Date of TSCA Order: July 27, 2022.
Basis for TSCA Order: The PMN states that the use will be as a
coating resin. Based on structural alerts and test data for an analogue
and feedstock component, EPA has identified concerns for skin, eye, and
respiratory tract irritation; skin and respiratory sensitization; acute
neurotoxicity; and systemic and reproductive effects. Based on test
data for a metabolite of the PMN substance, as well as analogues of the
LMW fraction, EPA has identified concerns for eye and respiratory tract
irritation; skin sensitization; portal-of-entry effects; and systemic,
reproductive, and developmental effects. Based on hazard data for an
analogous chemical and comparison to analogous polyanionic polymers
(and monomers), EPA predicts that the substance has moderate
environmental toxicity. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 50 where there is a potential
for inhalation exposure;
[[Page 49126]]
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
<bullet> No manufacture or processing of the PMN substance with
greater than 20% (by weight) oligomer content below 1,000 daltons
(i.e., low molecular weight species);
<bullet> No processing or use of the PMN substance for manual spray
application;
<bullet> No processing of the PMN substance for use in a consumer
product; and
<bullet> No use of the PMN substance in a consumer product.
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 this test, 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: P-20-182 (40 CFR 721.11864)
Chemical Name: 1,4-Benzenedicarboxylic acid, bis[2-(2-
butoxyethoxy)ethyl] ester (9CI).
CASRN: 90430-63-0.
Effective Date of TSCA Order: April 21, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a plasticizer for PVC formulations. Based
on the structural alert for ethylene glycol ethers, EPA has identified
concerns for neurotoxicity, kidney effects, immunotoxicity, and blood
effects. Based on test data on the PMN substance, EPA has identified
concerns for skin sensitization and mutagenicity. Based on test data
for an analogue, EPA has identified concerns for skin sensitization.
Based on test data on potential metabolites, EPA has also identified
concerns for acute toxicity (mortality), lung toxicity, systemic
effects, and developmental effects. Based on test data on the PMN
substance and comparison to analogous chemical substances, EPA predicts
that 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 or
the environment. To protect against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified particulate respirator with an
APF of at least 1,000 where there is a potential for inhalation
exposure, or compliance with an NCEL of 0.01 mg/m\3\ as an 8-hour time-
weighted average to prevent inhalation exposure;
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 4 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
metabolism or pharmacokinetics, skin sensitization, reproductive
toxicity, developmental toxicity, immunotoxicity, neurotoxicity,
specific target organ toxicity, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
PMN Number: P-21-56 (40 CFR 721.11865)
Chemical Name: Isocyanic acid, polyalkylenepolyarylene ester,
polymer with alkyl-hydroxyalkyl-alkanediol, alkoxyalcohol and
alkoxylalkoxyalcohol-blocked (generic).
CASRN: Not available.
Effective Date of TSCA Order: May 11, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component of coatings. Based on data on
an analogous chemical substance, EPA has identified concerns for acute
neurotoxicity and skin sensitization. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified particulate, gas/vapor, or
combination particulate and gas/vapor (as appropriate to the
conditions) respirator with an APF of at least 50, or 1,000 if spray
applied, where there is a potential for inhalation exposure;
<bullet> No manufacture of the PMN substance beyond 24 months
without submittal to EPA of the results of certain testing described in
the Testing section of the Order;
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS; and
<bullet> No use of the PMN substance in a consumer product.
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 and acute 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. In addition, the
submitter has agreed not to exceed the time limit specified in the
Order without performing the required testing outlined in the Testing
section of the Order.
PMN Numbers: P-21-58 (40 CFR 721.11866), P-21-60 (40 CFR 721.11867),
and P-21-61 (40 CFR 721.11868)
Chemical Names: Substituted alkanoic acid, compound with
aminoalkylalkyl-aminoalkylalkoxy-polyoxyalkylalkanediyl, polymer with
haloalkyl-epoxide and alkylalkylidene-cycloarylalcohol (generic) (P-21-
58); Bisphenol A epichlorohydrin polymer with alkylpolyalkene-
polyarylene-hydroxypolyoxyalkyldiyl reaction products with
alkylalkylidenealkylalkylidene-
[[Page 49127]]
aminoalkyl-alkanepolyamine and alkylaminoalkanol (generic) (P-21-60);
and Sulfur based acid, compds. with modified bisphenol A-
epichlorohydrin-polyalkylene polyol ether with bisphenol A polymer-N-
dialkylalkylidene-N- (dialkylalklyidene)aminoalkyl-alkanepolyamine-
alkylaminoalkanol reaction products (generic) (P-21-61).
CASRNs: Not available.
Effective Date of TSCA Order: May 9, 2022.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use will be as a component in coatings (P-21-58 and P-21-
61) and as an isolated intermediate (P-21-60). Based on the surfactant-
like properties of P-21-58, EPA has identified concerns for lung
effects and irritation to the skin, eyes, and respiratory tract. Based
on data for an analogue of the lower molecular weight fraction of P-21-
58, EPA has also identified concerns for neurotoxicity, cardiovascular
effects, and systemic effects. Based on a structural alert for
aliphatic amines and data for the expected hydrolysis product, EPA has
identified concerns for irritation to the skin, eyes, and respiratory
tract; neurotoxicity; mortality; systemic effects; developmental
effects; and carcinogenicity for P-21-60 and P-21-61. Based on
comparison to analogous polycationic polymers, EPA predicts that
toxicity to aquatic organisms may occur at concentrations that exceed
50 ppb for P-21-58. Based on comparison to analogous aliphatic amines
and polycationic polymers, EPA predicts that toxicity to aquatic
organisms may occur at concentrations that exceed 11 ppb for P-21-60.
Based on comparison to analogous aliphatic amines, EPA predicts that
toxicity to aquatic organisms may occur at concentrations that exceed
11 ppb for P-21-61. 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> 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 manufacture, processing, or use the PMN substances in
any manner that results in inhalation exposure;
<bullet> No use of the PMN substances in a consumer product;
<bullet> No release of P-21-58 resulting in surface water
concentrations that exceed 50 ppb;
<bullet> No release of P-21-60, or any waste stream containing P-
21-60, into water; and
<bullet> No release of P-21-61 resulting in surface water
concentrations that exceed 11 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful 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, neurotoxicity, skin irritation, and
aquatic toxicity testing may be potentially useful to characterize the
health and environmental effects of the PMN substances. EPA has also
determined that the results of eye irritation, pulmonary effects,
developmental toxicity, and carcinogenicity testing may be potentially
useful to characterize the health effects of P-21-60 and P-21-61.
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: P-21-66 (40 CFR 721.11869)
Chemical Name: 1,2-Alkanediol, 3-aryloxy, mono phosphate ester
(generic).
CASRN: Not available.
Effective Date of TSCA Order: June 10, 2022.
Basis for TSCA Order: The PMN states that the use will be as a
blended or standalone epoxy curative (hardener) and foaming agent when
blended with certain ingredients. Based on information provided in the
SDS and the low pH of the PMN substance when neat, EPA has identified
concerns for skin, eye, and respiratory tract corrosion. Based on
release of the free phosphate, EPA has also identified concerns for
blood effects and irritation to the skin, eyes, and respiratory tract.
Based on analogue data and the structural alert for phosphate esters,
EPA has identified concerns for acute toxicity, acute neurotoxicity,
corrosion to skin and eyes, and delayed neurotoxicity. Based on test
data for an analogue of the hydrolysis product, EPA has also identified
concerns for acute toxicity, eye irritation, systemic effects, and
developmental effects. Based on comparison to an analogous chemical
substance, EPA predicts that toxicity to aquatic organisms may occur at
concentrations that exceed 3 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
<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 use of the PMN substance in a consumer product;
<bullet> No use of the PMN substance other than as an epoxy
curative;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure or that results in
fugitive air emissions; and
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, into water.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, eye irritation/corrosion, skin corrosion, specific target
organ toxicity, pulmonary effects, 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: P-21-68 (40 CFR 721.11870)
Chemical Name: Metalloxanes, alkyl, alkyl group-terminated,
reaction products with dihalo-dialkylalkylaryl-alkyl-polycyclic-
ylidene(dialkylsilylene)-dialkylalkylaryl-alkylalkyl-polycyclic-
[[Page 49128]]
ylidene, metal oxide and nonmetallic oxide (generic).
CASRN: Not available.
Effective Date of TSCA Order: June 27, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a polymerization catalyst. Based on the
reactivity of the PMN substance and the release of hydrochloric acid,
EPA has identified concerns for an acute handling hazard; irritation
and corrosion to the skin, eyes, and respiratory tract; and lung
overload (if respirable, poorly soluble particulates are inhaled).
Based on analogue data, EPA has identified concerns for irritation to
skin, eyes, and respiratory tract; lung effects; serious eye damage and
ocular corrosion; portal-of-entry effects; mutagenicity; acute
neurotoxicity; systemic effects; reproductive/developmental effects;
and dermal and respiratory sensitization. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these
risks, the Order requires:
<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 manufacture, processing, or use of the PMN substance
other than in an enclosed process;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation or dermal exposure to the PMN
substance; and
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 50 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, skin sensitization, skin corrosion, specific target organ
toxicity, pulmonary effects, reproductive toxicity, and mutagenicity
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: P-21-83 (40 CFR 721.11871)
Chemical Name: Alkenoic acid, reaction products with
pentaerythritol, polymers with diisocyanatoalkane and heteromonocyle
homopolymer esters with alkanoic acid-pentaerythritol reaction products
(generic).
CASRN: Not available.
Effective Date of TSCA Order: June 6, 2022.
Basis for TSCA Order: The PMN states that the use will be as a UV
curable resin. Based on information provided in the SDS and a
structural alert for acrylates, EPA has identified concerns for
irritation to the skin, eyes, and respiratory tract. Based on a
structural alert for acrylates for the low molecular weight fraction,
OECD QSAR Toolbox results for the feedstock present as a residual, and
information provided in the SDS, EPA has also identified concerns for
skin and respiratory sensitization. Based on multifunctional reactive
groups, EPA has identified respiratory sensitization. Based on test
data for the feedstock residual, EPA has identified concerns for skin
irritation, clinical signs, systemic effects, and irritation in the GI
tract. Based on comparison to analogous acrylates/methacrylates and
esters, EPA predicts that 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 or the environment. To protect against these risks, the
Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified Combination Particulate and Gas/
Vapor respirator with an APF of 1,000 where there is a potential for
inhalation exposure;
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
<bullet> No use of the PMN substance in a consumer product; and
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye damage, specific target organ toxicity, 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: P-21-84 (40 CFR 721.11872)
Chemical Name: Carbopolycycle octa-alkene, halo (generic).
CASRN: Not available.
Effective Date of TSCA Order: May 27, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a chemical intermediate. Based on test
data for an analogue, EPA has identified concerns for severe
irritation/corrosion to the skin, eyes, and respiratory tract, acute
toxicity, and mutagenicity. Based on OECD Toolbox results, EPA has also
identified concerns for skin sensitization. Based on comparison to
analogous benzyl halides, EPA predicts that toxicity to aquatic
organisms may occur at concentrations that exceed 7 ppb. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health or the environment. To protect against
these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified Gas/Vapor respirator with an APF
of at least 50 where there is a potential for inhalation exposure;
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 7 ppb; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
[[Page 49129]]
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, specific target organ toxicity, skin corrosion, eye damage,
skin sensitization, genetic 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: P-21-92 (40 CFR 721.11873)
Chemical Name: 2-Propenoic acid, (polyhydro-1,3-dioxo-2H-isoindol-
2-yl)alkyl ester (generic).
CASRN: Not available.
Effective Date of TSCA Order: April 5, 2022.
Basis for TSCA Order: The PMN states that the uses of the PMN
substance will be for thermoset composites, 3D printing, and industrial
coatings. Based on test data for the PMN substance, EPA has identified
concerns for skin irritation. Based on information provided in the SDS,
EPA has also identified concerns for skin irritation and eye
irritation. Based on test data for a hydrolysis product, EPA has
identified concerns for developmental, body weight, and portal-of-entry
(inhalation and oral) effects. Based on test data for an analogue, EPA
has also identified concerns for clinical signs, skin irritation, eye
irritation, and developmental, body weight, and lung effects. Based on
test data for an analogue, EPA identified concerns for portal-of-entry
(inhalation) and liver effects. Based on comparison to analogous
acrylates/methacrylates and imides, EPA predicts that 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 or the environment. To
protect against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 10 to prevent inhalation
exposure where there is a potential for inhalation exposure;
<bullet> Disposal of the PMN substance only by incineration or by
RCRA Subtitle C landfill;
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
<bullet> No use of the PMN substance in a consumer product;
<bullet> No use of the PMN substance where the concentration of the
PMN substance exceeds 40% in formulation when inhalation exposure is
expected; and
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, into water.
The proposed SNUR designates 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 would 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 environmental and human 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: P-21-102 (40 CFR 721.11874)
Chemical Name: Heteromonocycle, polymer, [2-[(1-oxo-2-propen-1-
yl)oxy]alkyl]ester (generic).
CASRN: Not available.
Effective Date of TSCA Order: May 20, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a raw material for industrial additive
manufacturing, UV-curable inks, coatings and adhesives. Based on TSCA
New Chemical Category document for acrylates, EPA has identified
concerns for skin sensitization and irritation to the skin, eyes, and
respiratory tract. Based on test data for an analogue of the low
molecular weight fraction, EPA has also identified concerns for
systemic and developmental effects. Based on comparison to analogous
acrylates/methacrylates and esters, EPA predicts that toxicity to
aquatic organisms may occur at concentrations that exceed 337 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health or the environment. To
protect against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified Combination Particulate and Gas/
Vapor respirator with an APF of at least 10 where there is a potential
for inhalation exposure;
<bullet> No use of the PMN substance in a consumer product;
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 337 ppb; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, skin sensitization, eye damage, developmental toxicity,
specific target organ toxicity, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
[[Page 49130]]
PMN Numbers: P-21-109 (40 CFR 721.11875), P-21-110 (40 CFR 721.11876),
P-21-111 (40 CFR 721.11877), P-21-112 (40 CFR 721.11878), P-21-113 (40
CFR 721.11879), P-21-114 (40 CFR 721.11880), P-21-116 (40 CFR
721.11881), P-21-117 (40 CFR 721.11882), P-21-118 (40 CFR 721.11883),
P-21-119 (40 CFR 721.11884), P-21-121 (40 CFR 721.11885), P-21-122 (40
CFR 721.11886), and P-21-123 (40 CFR 721.11887)
Chemical Names: Hydrocarbons linear and branched, light alkylate
(generic) (P-21-109), Hydrocarbons linear and branched, light catalytic
cracked (generic) (P-21-110), Hydrocarbons linear and branched, heavy
catalytic cracked (generic) (P-21-111), Hydrocarbons linear and
branched, light hydrocracked (generic) (P-21-112), Hydrocarbons linear
and branched, isomerization (generic) (P-21-113), Hydrocarbons linear
and branched, heavy catalytic reformed (generic) (P-21-114),
Hydrocarbons linear and branched, hydrotreated light (generic) (P-21-
116), Hydrocarbons linear and branched, hydrotreated light paraffinic
(generic) (P-21-117), Hydrocarbons linear and branched, light catalytic
cracked (generic) (P-21-118), Hydrocarbons linear and branched, heavy
hydrocracked (generic) (P-21-119), Hydrocarbons linear and branched,
heavy catalytic cracked (generic) (P-21-121), Hydrocarbons linear and
branched, heavy hydrocracked (generic) (P-21-122), and Hydrocarbons
linear and branched, light hydrocracked (generic) (P-21-123).
CASRNs: Not available.
Effective Date of TSCA Order: July 14, 2022.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use will be as a component in fuels (P-21-109, P-21-110,
P-21-111, P-21-112, P-21-113, P-21-114, P-21-116, P-21-117, P-21-121,
and P-21-123) or as a chemical intermediate (P-21-118, P-21-119, and P-
21-122). Based on available information on compositionally analogous
mixtures and on constituents of the PMN substances, EPA has identified
concerns for skin and eye irritation, acute toxicity, systemic toxicity
(neurotoxicity, body weight effects, and liver, kidney, blood, spleen,
and other organ effects), reproductive and developmental toxicity, oral
and inhalation portal entry effects, genetic toxicity, and
carcinogenicity. Based on the chemical composition (petroleum) of the
PMN substances, EPA has also identified concerns for hydrocarbon
pneumonia/aspiration hazard. EPA assumes that respiratory tract
irritation is possible from exposure to the PMN substances. Based on
comparison to analogous chemical substances and data on constituents of
the PMN substances, EPA predicts that toxicity to aquatic organisms may
occur at concentrations that exceed 0.3 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 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, processing, or use of the PMN substances
other than for processing and use as a fuel, fuel additive, fuel
blending stock, or refinery feedstock (including, but not limited to
cracking, coking, hydroprocessing, distillation, or deasphalting)
subject to 40 CFR parts 79 or 1090;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye irritation, respiratory depression/irritation,
hydrocarbon developmental toxicity, systemic toxicity, genetic
toxicity, and aquatic toxicity testing may be potentially useful to
characterize the health and environmental effects of the PMN
substances. Additionally, the results of consumer inhalation exposure
testing/monitoring at gas stations may be potentially useful to
characterize the degree of exposure to 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: P-21-197 (40 CFR 721.11888)
Chemical Name: Imidazole-carboxylic acid, substituted (generic).
CASRN: Not available.
Effective Date of TSCA Order: June 20, 2022.
Basis for TSCA Order: The PMN states that the use will be as an
additive for use in battery electrolyte formulations. Based on analogue
data, EPA has identified concerns for acute neurotoxicity and skin
sensitization. Based on test data for potential metabolites, EPA has
also identified concerns for acute toxicity, skin corrosion, eye
irritation, and systemic, respiratory tract, reproductive, and
developmental effects. Based on acute hazard data for an analogous
chemical substance, EPA predicts that toxicity to aquatic organisms may
occur at concentrations that exceed 380 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these
risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified Combination Particulate and Gas/
Vapor respirator with an APF of 50 where there is a potential for
inhalation exposure;
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> No processing or use of the PMN substance other than in an
enclosed process, except that sampling and equipment cleaning
operations need not occur in an enclosed process; and
<bullet> No disposal of the PMN substance or waste streams
containing the PMN substance other than by incineration with 99.9%
efficiency.
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, acute toxicity, metabolism/pharmacokinetics, specific target
organ toxicity, skin corrosion, eye damage, skin sensitization,
pulmonary effects, reproductive toxicity, and developmental toxicity
testing may be potentially useful to characterize the
[[Page 49131]]
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: P-21-216 (40 CFR 721.11889) and P-21-217 (40 CFR
721.11890)
Chemical Names: Multi-walled carbon nanotubes (generic) (P-21-216
and P-21-217).
CASRNs: Not available.
Effective Date of TSCA Order: May 31, 2022.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use will be as an additive in electrode materials and
plastics (P-21-216) or as an additive in electrode materials and
thermoplastics, and a component in electrodes (P-21-217). Based on
comparison to analogous carbon-based nanomaterials, EPA has identified
concerns for lung toxicity, lung fibrosis, lung cancer, pleural
toxicity (inflammation), pleural fibrosis, and pleural cancer
(mesothelioma). Based on hazard data for a residual and test data for
multi-walled carbon nanotube analogues, EPA has also identified
concerns acute neurotoxicity, skin and respiratory sensitization,
reproductive and developmental toxicity, lung effects, systemic
effects, immunotoxicity, eye and skin irritation, mutagenicity,
genotoxicity, and carcinogenicity. EPA was unable to estimate the
environmental hazard of the PMN substances. 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> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified particulate respirator with an
APF of at least 1,000 if the capture and reduction rate is at least
99.5% but not 99.975% or greater, or an APF of at least 50 if the
capture and reduction rate is at least 99.975%, where there is a
potential for inhalation exposure;
<bullet> No domestic manufacture of the PMN substances (i.e.,
import only);
<bullet> No manufacture of the PMN substances to contain the
confidential impurity listed in the Order at greater than 1% (by
weight);
<bullet> No use of the PMN substances other than for the
confidential use allowed in the Order;
<bullet> No processing or use of the PMN substances other than in
application methods that do not generate a vapor, mist, dust, or
aerosol unless such application method occurs in an enclosed process;
<bullet> No disposal of the PMN substances or waste streams
containing the PMN substances other than by landfill or incineration;
<bullet> No release of the PMN substances directly, either by point
(stack) or non-point (fugitive) sources, to air;
<bullet> No release of the PMN substances, or any waste stream
containing the PMN substances, into water; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
carcinogenicity, eye irritation, skin irritation, genetic toxicity,
developmental toxicity, and aquatic toxicity testing may be potentially
useful to characterize the health and environmental effects of the PMN
substances. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
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
[[Page 49132]]
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 FY 2023, and only a fraction of these
submissions were from small businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $37,000 to $6,480.
This lower fee reduces the total reporting and recordkeeping cost of
submitting a SNUN to about $14,500 per SNUN submission for qualifying
small firms. Therefore, the potential economic impacts of complying
with these proposed SNURs are not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented its general determination that SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more in any one year (in 1995 dollars) 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. 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 human health, 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 conditions of use to identify
potential risks and take appropriate actions before the activities
commence.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
This action does not concern human health or environmental
conditions and therefore cannot be evaluated with respect to the
potential for disproportionate impacts on non-white and low-income
populations in accordance with Executive Order 12898 (59 FR 7629,
February 16, 1994) and Executive Order 14096 (88 FR 25251, April 26,
2023). Although this action does not concern human health or
environmental conditions, the premanufacture notifications required by
these SNURs allow EPA to assess the conditions of use 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: June 6, 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 1 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. 721.11860 through 721.11890 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11860 1,2-Ethanediamine, N-(1-methylethyl)-N-[2-[(1-
methylethyl)amino]ethyl]-.
721.11861 Fatty acids, polymers with substituted carbomonocycles,
dialkanolamine, alkyl substituted alkanediamine and halo-substituted
heteromonocycle, formates (salts) (generic).
721.11862 Alkanesulfonic acid, 2-[(2-aminoethyl)heteroatom-
substituted]-, sodium salt (1:1), polymer with .alpha.-[2,2-
bis(hydroxymethyl)butyl]-.omega.-methoxypoly(oxy-1,2-ethanediyl) and
1,1'-methylenebis[4-isocyanatocyclohexane], acrylic acid-
dipenthaerythritol reaction products- and polypropylene glycol ether
with pentaerythritol (4:1) triacrylate-blocked (generic).
721.11863 Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with
.alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl),
(haloalkyl)oxiane polymer (alkylalkylidene)bis[hydroxy-
[[Page 49133]]
carbomonocycle] alkenoate and isocyanate-alkyl-carbomonocycle,
hydroxyalkyl acrylate-blocked (generic).
721.11864 1,4-Benzenedicarboxylic acid, bis[2-(2-butoxyethoxy)ethyl]
ester (9CI).
721.11865 Isocyanic acid, polyalkylenepolyarylene ester, polymer
with alkyl-hydroxyalkyl-alkanediol, alkoxyalcohol and
alkoxylalkoxyalcohol-blocked (generic).
721.11866 Substituted alkanoic acid, compound with aminoalkylalkyl-
aminoalkylalkoxy-polyoxyalkylalkanediyl, polymer with haloalkyl-
epoxide and alkylalkylidene-cycloarylalcohol (generic).
721.11867 Bisphenol A epichlorohydrin polymer with alkylpolyalkene-
polyarylene-hydroxypolyoxyalkyldiyl reaction products with
alkylalkylidenealkylalkylidene-aminoalkyl-alkanepolyamine and
alkylaminoalkanol (generic).
721.11868 Sulfur based acid, compds. with modified bisphenol A-
epichlorohydrin-polyalkylene polyol ether with bisphenol A polymer-
N-dialkylalkylidene-N- (dialkylalklyidene)aminoalkyl-
alkanepolyamine-alkylaminoalkanol reaction products (generic).
721.118691 2-Alkanediol, 3-aryloxy, mono phosphate ester (generic).
721.11870 Metalloxanes, alkyl, alkyl group-terminated, reaction
products with dihalo-dialkylalkylaryl-alkyl-polycyclic-
ylidene(dialkylsilylene)-dialkylalkylaryl-alkylalkyl-polycyclic-
ylidene, metal oxide and nonmetallic oxide (generic).
721.11871 Alkenoic acid, reaction products with pentaerythritol,
polymers with diisocyanatoalkane and heteromonocyle homopolymer
esters with alkanoic acid-pentaerythritol reaction products
(generic).
721.11872 Carbopolycycle octa-alkene, halo (generic).
721.11873 2-Propenoic acid, (polyhydro-1,3-dioxo-2H-isoindol-2-
yl)alkyl ester (generic).
721.11874 Heteromonocycle, polymer, [2-[(1-oxo-2-propen-1-
yl)oxy]alkyl]ester (generic).
721.11875 Hydrocarbons linear and branched, light alkylate
(generic).
721.11876 Hydrocarbons linear and branched, light catalytic cracked
(generic).
721.11877 Hydrocarbons linear and branched, heavy catalytic cracked
(generic).
721.11878 Hydrocarbons linear and branched, light hydrocracked
(generic).
721.11879 Hydrocarbons linear and branched, isomerization (generic).
721.11880 Hydrocarbons linear and branched, heavy catalytic reformed
(generic).
721.11881 Hydrocarbons linear and branched, hydrotreated light
(generic).
721.11882 Hydrocarbons linear and branched, hydrotreated light
paraffinic (generic).
721.11883 Hydrocarbons linear and branched, light catalytic cracked
(generic).
721.11884 Hydrocarbons linear and branched, heavy hydrocracked
(generic).
721.11885 Hydrocarbons linear and branched, heavy catalytic cracked
(generic).
721.11886 Hydrocarbons linear and branched, heavy hydrocracked
(generic).
721.11887 Hydrocarbons linear and branched, light hydrocracked
(generic).
721.11888 Imidazole-carboxylic acid, substituted (generic).
721.11889 Multi-walled carbon nanotubes (generic).
721.11890 Multi-walled carbon nanotubes (generic).
* * * * *
Sec. 721.11860 1,2-Ethanediamine, N-(1-methylethyl)-N-[2-[(1-
methylethyl)amino]ethyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-ethanediamine,
N-(1-methylethyl)-N-[2-[(1-methylethyl)amino]ethyl]- (PMN P-18-398;
CASRN 10507-06-9) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are: (i) Protection in the workplace.
Requirements as specified in Sec. 721.63(a)(1), (3) 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 substance may cause: acute toxicity; specific
target organ toxicity; reproductive toxicity; skin corrosion; serious
eye damage; skin sensitization. For purposes of Sec. 721.72(g)(3),
this substance may be: toxic to aquatic life. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(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. 721.11861 Fatty acids, polymers with substituted
carbomonocycles, dialkanolamine, alkyl substituted alkanediamine and
halo-substituted heteromonocycle, formates (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, polymers with substituted carbomonocycles, dialkanolamine, alkyl
substituted alkanediamine and halo-substituted heteromonocycle,
formates (salts) (PMN P-19-49) 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
(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%.
(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%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation; eye
irritation; reproductive toxicity; specific organ toxicity. For
purposes of Sec. 721.72(g)(3), this substance may be: toxic to aquatic
life. Alternative hazard and warning statements that meet the criteria
of the Globally Harmonized System and OSHA Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture or process the substance in any
manner that generates a vapor, mist, or aerosol. It is a significant
new use to use the substance in any manner that generates a vapor,
mist, or aerosol that results in inhalation to industrial or commercial
workers. It
[[Page 49134]]
is a significant new use to manufacture the substance to contain the
confidential residual identified in the TSCA Order for this substance
at greater than 0.1%.
(iv) Release to Water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=114.
(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. 721.11862 Alkanesulfonic acid, 2-[(2-aminoethyl)heteroatom-
substituted]-, sodium salt (1:1), polymer with .alpha.-[2,2-
bis(hydroxymethyl)butyl]-.omega.-methoxypoly(oxy-1,2-ethanediyl) and
1,1'-methylenebis[4-isocyanatocyclohexane], acrylic acid-
dipenthaerythritol reaction products- and polypropylene glycol ether
with pentaerythritol (4:1) triacrylate-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanesulfonic acid, 2-[(2-aminoethyl)heteroatom-substituted]-, sodium
salt (1:1), polymer with .alpha.-[2,2-bis(hydroxymethyl)butyl]-.omega.-
methoxypoly(oxy-1,2-ethanediyl) and 1,1'-methylenebis[4-
isocyanatocyclohexane], acrylic acid-dipenthaerythritol reaction
products- and polypropylene glycol ether with pentaerythritol (4:1)
triacrylate-blocked (PMN P-19-160) 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), 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: skin irritation; eye
irritation; serious eye damage; skin sensitization; respiratory
sensitization; reproductive toxicity; specific organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(iv) Release to Water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=302.
(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. 721.11863 Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer
with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl),
(haloalkyl)oxiane polymer (alkylalkylidene)bis[hydroxy-carbomonocycle]
alkenoate and isocyanate-alkyl-carbomonocycle, hydroxyalkyl acrylate-
blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-
[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl),
(haloalkyl)oxiane polymer (alkylalkylidene)bis[hydroxy-carbomonocycle]
alkenoate and isocyanate-alkyl-carbomonocycle, hydroxyalkyl acrylate-
blocked (PMN P-20-101) 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 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 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 substance may cause: acute toxicity; skin
irritation; eye irritation; respiratory sensitization; skin
sensitization; reproductive toxicity; specific target organ toxicity.
For purposes of Sec. 721.72(g)(3), this substance may be: toxic to
aquatic life. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture or process the substance with greater than 20% (by weight)
oligomer content below 1,000 daltons (i.e., low molecular weight
species). It is a significant new use to use the substance in a manual
spray application.
(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. 721.11864 1,4-Benzenedicarboxylic acid, bis[2-(2-
butoxyethoxy)ethyl] ester (9CI).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,4-
benzenedicarboxylic acid, bis[2-(2-butoxyethoxy)ethyl] ester (9CI) (PMN
P-20-182; CASRN 90430-63-0) 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 (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
[[Page 49135]]
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.
(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 0.01 mg/m\3\ 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 whose 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 (d), (f), and (g)(1), (3) and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin sensitization;
reproductive toxicity; 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=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 (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. 721.11865 Isocyanic acid, polyalkylenepolyarylene ester, polymer
with alkyl-hydroxyalkyl-alkanediol, alkoxyalcohol and
alkoxylalkoxyalcohol-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanic acid, polyalkylenepolyarylene ester, polymer with alkyl-
hydroxyalkyl-alkanediol, alkoxyalcohol and alkoxylalkoxyalcohol-blocked
(PMN P-21-56) 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 (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 50 or
1,000 if spray applied.
(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
sensitization. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture the substance beyond 24 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. 721.11866 Substituted alkanoic acid, compound with
aminoalkylalkyl-aminoalkylalkoxy-polyoxyalkylalkanediyl, polymer with
haloalkyl-epoxide and alkylalkylidene-cycloarylalcohol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted alkanoic acid, compound with aminoalkylalkyl-
aminoalkylalkoxy-polyoxyalkylalkanediyl, polymer with haloalkyl-epoxide
and alkylalkylidene-cycloarylalcohol (PMN P-21-58) 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 (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%.
(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%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation; eye
irritation; specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=50.
(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 49136]]
Sec. 721.11867 Bisphenol A epichlorohydrin polymer with
alkylpolyalkene-polyarylene-hydroxypolyoxyalkyldiyl reaction products
with alkylalkylidenealkylalkylidene-aminoalkyl-alkanepolyamine and
alkylaminoalkanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
bisphenol A epichlorohydrin polymer with alkylpolyalkene-polyarylene-
hydroxypolyoxyalkyldiyl reaction products with
alkylalkylidenealkylalkylidene-aminoalkyl-alkanepolyamine and
alkylaminoalkanol (PMN P-21-60) 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
(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 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; carcinogenicity; reproductive toxicity; specific target
organ toxicity. For purposes of Sec. 721.72(g)(3), this substance may
be: toxic to aquatic life. Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(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. 721.11868 Sulfur based acid, compds. with modified bisphenol A-
epichlorohydrin-polyalkylene polyol ether with bisphenol A polymer-N-
dialkylalkylidene-N- (dialkylalklyidene)aminoalkyl-alkanepolyamine-
alkylaminoalkanol reaction products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as sulfur
based acid, compds. with modified bisphenol A-epichlorohydrin-
polyalkylene polyol ether with bisphenol A polymer-N-dialkylalkylidene-
N- (dialkylalklyidene)aminoalkyl-alkanepolyamine-alkylaminoalkanol
reaction products (PMN P-21-61) 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
(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 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; carcinogenicity; reproductive toxicity; specific target
organ toxicity. For purposes of Sec. 721.72(g)(3), this substance may
be: toxic to aquatic life. Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=11.
(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. 721.11869 1,2-Alkanediol, 3-aryloxy, mono phosphate ester
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,2-
alkanediol, 3-aryloxy, mono phosphate ester (PMN P-21-66) 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 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), (3) and (5). For the purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity; skin
corrosion; skin irritation; serious eye damage; eye irritation;
reproductive toxicity; 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
[[Page 49137]]
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure or that results in fugitive air emissions. It is
a significant new use to use the substance other than as an epoxy
curative.
(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. 721.11870 Metalloxanes, alkyl, alkyl group-terminated, reaction
products with dihalo-dialkylalkylaryl-alkyl-polycyclic-
ylidene(dialkylsilylene)-dialkylalkylaryl-alkylalkyl-polycyclic-
ylidene, metal oxide and nonmetallic oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
metalloxanes, alkyl, alkyl group-terminated, reaction products with
dihalo-dialkylalkylaryl-alkyl-polycyclic-ylidene(dialkylsilylene)-
dialkylalkylaryl-alkylalkyl-polycyclic-ylidene, metal oxide and
nonmetallic oxide (PMN P-21-68) 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), 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 corrosion;
skin irritation; serious eye damage; eye irritation; respiratory
sensitization; skin sensitization; germ cell mutagenicity; reproductive
toxicity; 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(a) through (c). It is a significant new
use to manufacture, process, or use the substance in any manner that
results in inhalation or dermal exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=50.
(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. 721.11871 Alkenoic acid, reaction products with pentaerythritol,
polymers with diisocyanatoalkane and heteromonocyle homopolymer esters
with alkanoic acid-pentaerythritol reaction products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, reaction products with pentaerythritol, polymers with
diisocyanatoalkane and heteromonocyle homopolymer esters with alkanoic
acid-pentaerythritol reaction products (PMN P-21-83) 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 (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 1,000.
(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: skin irritation; eye
irritation; respiratory sensitization; skin sensitization; specific
target organ toxicity. For purposes of Sec. 721.72(g)(3), this
substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=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. 721.11872 Carbopolycycle octa-alkene, halo (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbopolycycle octa-alkene, halo (PMN P-21-84) 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)
[[Page 49138]]
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 sensitization; genetic 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=7.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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. 721.11873 2-Propenoic acid, (polyhydro-1,3-dioxo-2H-isoindol-2-
yl)alkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, (polyhydro-1,3-dioxo-2H-isoindol-2-yl)alkyl ester (PMN
P-21-92) 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 PMN
substance after they have been completely reacted (cured).
(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 (a)(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(b), the concentration is set at 1.0%. 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 (f), and (g)(1) and (3). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation; eye
irritation; specific target organ toxicity; reproductive toxicity. For
purposes of Sec. 721.72(g)(3), this substance may be: toxic to aquatic
life. For purposes of Sec. 721.72(e), the concentration is set at
1.0%. Alternative hazard and warning statements that meet the criteria
of the Globally Harmonized System and OSHA Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance at a concentration of greater than 40% in formulation when
inhalation exposure is expected.
(iv) Disposal. It is a significant new use to dispose of the
substance or waste streams containing the substance other than by
incineration or RCRA subtitle C landfill.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11874 Heteromonocycle, polymer, [2-[(1-oxo-2-propen-1-
yl)oxy]alkyl]ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteromonocycle, polymer, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (PMN
P-21-102) 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 (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 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: skin irritation; eye
irritation; specific target organ toxicity; developmental toxicity;
skin sensitization. For purposes of Sec. 721.72(g)(3), this substance
may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. 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=337.
(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. 721.11875 Hydrocarbons linear and branched, light alkylate
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, light alkylate (PMN P-21-109) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been incorporated into a fuel, fuel additive, fuel blending stock, or
used as a refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting).
(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
[[Page 49139]]
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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11876 Hydrocarbons linear and branched, light catalytic
cracked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, light catalytic cracked (PMN P-21-
110) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been incorporated into a fuel, fuel additive, fuel blending stock,
or used as a refinery feedstock (including, but not limited to
cracking, coking, hydroprocessing, distillation, or deasphalting).
(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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11877 Hydrocarbons linear and branched, heavy catalytic
cracked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, heavy catalytic cracked (PMN P-21-
111) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been incorporated into a fuel, fuel additive, fuel blending stock,
or used as a refinery feedstock (including, but not limited to
cracking, coking, hydroprocessing, distillation, or deasphalting).
(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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11878 Hydrocarbons linear and branched, light hydrocracked
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, light hydrocracked (PMN P-21-112) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been incorporated into a fuel, fuel additive, fuel blending stock, or
used as a refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting).
(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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part
[[Page 49140]]
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. 721.11879 Hydrocarbons linear and branched, isomerization
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, isomerization (PMN P-21-113) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been incorporated into a fuel, fuel additive, fuel blending stock, or
used as a refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting).
(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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11880 Hydrocarbons linear and branched, heavy catalytic
reformed (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, heavy catalytic reformed (PMN P-21-
114) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been incorporated into a fuel, fuel additive, fuel blending stock,
or used as a refinery feedstock (including, but not limited to
cracking, coking, hydroprocessing, distillation, or deasphalting).
(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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11881 Hydrocarbons linear and branched, hydrotreated light
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, hydrotreated light (PMN P-21-116) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been incorporated into a fuel, fuel additive, fuel blending stock, or
used as a refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting).
(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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11882 Hydrocarbons linear and branched, hydrotreated light
paraffinic (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, hydrotreated light paraffinic
[[Page 49141]]
(PMN P-21-117) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been incorporated into a fuel, fuel additive,
fuel blending stock, or used as a refinery feedstock (including, but
not limited to cracking, coking, hydroprocessing, distillation, or
deasphalting).
(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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11883 Hydrocarbons linear and branched, light catalytic
cracked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
hydrocarbons linear and branched, light catalytic cracked (PMN P-21-
118) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been incorporated into a fuel, fuel additive, fuel blending stock,
or used as a refinery feedstock (including, but not limited to
cracking, coking, hydroprocessing, distillation, or deasphalting).
(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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11884 Hydrocarbons linear and branched, heavy hydrocracked
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, heavy hydrocracked (PMN P-21-119) 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 incorporated into a fuel, fuel additive, fuel blending stock, or
used as a refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting).
(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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11885 Hydrocarbons linear and branched, heavy catalytic
cracked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, heavy catalytic cracked (PMN P-21-
121) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been incorporated into a fuel, fuel additive, fuel blending stock,
or used as a refinery feedstock (including, but not limited to
cracking, coking, hydroprocessing, distillation, or deasphalting).
(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
[[Page 49142]]
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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11886 Hydrocarbons linear and branched, heavy hydrocracked
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, heavy hydrocracked (PMN P-21-122) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been incorporated into a fuel, fuel additive, fuel blending stock, or
used as a refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting).
(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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11887 Hydrocarbons linear and branched, light hydrocracked
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrocarbons linear and branched, light hydrocracked (PMN P-21-123) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been incorporated into a fuel, fuel additive, fuel blending stock, or
used as a refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting).
(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).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than for processing and use as a fuel, fuel additive, fuel blending
stock, or refinery feedstock (including, but not limited to cracking,
coking, hydroprocessing, distillation, or deasphalting) subject to 40
CFR parts 79 or 1090.
(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. 721.11888 Imidazole-carboxylic acid, substituted (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
imidazole-carboxylic acid, substituted (P-21-197) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
incorporated into an article.
(2) The significant new uses are: (i) Protection in the workplace.
Requirements as specified in Sec. 721.63(a)(1) 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., 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 substance may cause: acute toxicity; skin
corrosion; eye irritation; serious eye damage; skin sensitization;
reproductive toxicity; specific target organ toxicity. For purposes of
Sec. 721.72(g)(3) this substance may be: toxic to aquatic life.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to process
or use the substance other than in an enclosed process, except that
sampling and equipment
[[Page 49143]]
cleaning operations need not occur in an enclosed process.
(iv) Disposal. It is a significant new use to dispose of the
substance or waste streams containing the substance other than by
incineration with 99.9% efficiency.
(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 (j) 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. 721.11889 Multi-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-21-216) 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
(cured), entrained in a polymer, or 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), 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 1,000
if the capture and reduction rate is at least 99.5% but not 99.975% or
greater, or at least 50 if the capture and reduction rate is at least
99.975%.
(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: eye irritation; skin
irritation; respiratory sensitization; skin sensitization; genetic
toxicity; reproductive toxicity; carcinogenicity; specific target organ
toxicity. For purposes of Sec. 721.72(g)(3), this substance may be:
toxic to aquatic life. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to
manufacture the substance to contain the confidential impurity listed
in the Order at greater than 1% (by weight). It is a significant new
use to process or use the substance other than for the confidential use
allowed in the Order. It is a significant new use to process or use the
substance other than in application methods that do not generate a
vapor, mist, dust, or aerosol, unless such application method occurs in
an enclosed process.
(iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and
(2), (b)(1) and (2), and (c)(1) and (2). It is a significant new use to
release the substance directly, whether by point (stack) or non-point
(fugitive) sources, to air.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11890 Multi-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-21-217) 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
(cured), entrained in a polymer, or 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), 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 1,000 if the capture and reduction
rate is at least 99.5% but not 99.975% or greater or of at least 50 if
the capture and reduction rate is at least 99.975%.
(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: eye irritation; skin
irritation; respiratory sensitization; skin sensitization; genetic
toxicity; reproductive toxicity; carcinogenicity; specific target organ
toxicity. For purposes of Sec. 721.72(g)(3), this substance may be:
toxic to aquatic life. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to
manufacture the substance to contain the confidential impurity listed
in the Order at greater than 1% (by weight). It is a significant new
use to process or use the substance other than for the confidential use
allowed in the Order. It is a significant new use to process or use the
substance other than in application methods that do not generate a
vapor, mist, dust, or aerosol, unless such application method occurs in
an enclosed process.
(iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and
(2), (b)(1) and (2), and (c)(1) and (2). It is a significant new use to
release the substance directly, either by point (stack) or non-point
(fugitive) sources, to air.
[[Page 49144]]
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
* * * * *
[FR Doc. 2024-12764 Filed 6-10-24; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on June 11, 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.