Significant New Use Rules on Certain Chemical Substances (24-1.5e), 67368-67394 [2024-18259]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 89, Number 161 (Tuesday, August 20, 2024)]
[Proposed Rules]
[Pages 67368-67394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18259]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 721 and 725

[EPA-HQ-OPPT-2024-0074; FRL-11916-01-OCSPP]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (24-
1.5e)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for chemical substances that were 
the subject of premanufacture notices (PMNs) and a Microbial Commercial 
Activity Notice (MCAN) 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 September 19, 2024.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2024-0074, at https://www.regulations.gov. 
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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: William Wysong, New Chemicals 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental

[[Page 67369]]

Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-
0001; telephone number: (202) 564-4163; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What is the Agency's authority for taking this action?

    TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the factors in TSCA section 5(a)(2) (see 
also the discussion in Unit II.).

B. What action is the Agency taking?

    EPA is 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 
(https://www.epa.gov/tsca-import-export-requirements).
    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, or 40 CFR 725.920 (for the 
microorganism), any persons who export or intend to export a chemical 
substance that is the subject of this proposed rule on or after 
September 19, 2024 are subject to TSCA section 12(b) (15 U.S.C. 
2611(b)) and must comply with the export notification requirements in 
40 CFR part 707, subpart D.

D. What are the incremental economic impacts of this action?

    EPA has evaluated the potential costs of establishing SNUN 
reporting requirements for potential manufacturers (including 
importers) and processors of the chemical substances subject to these 
proposed SNURs. This analysis, which is available in the docket, is 
briefly summarized here.
1. Estimated Costs for SNUN Submissions
    If a SNUN is submitted, costs are an estimated $45,000 per SNUN 
submission for large business submitters and $14,500 for small business 
submitters. These estimates include the cost to prepare and submit the 
SNUN (including registration for EPA's Central Data Exchange (CDX)), 
and the payment of a user fee. Businesses that submit a SNUN would be 
subject to either a $37,000 user fee required by 40 CFR 
700.45(c)(2)(ii) and (d), or, if they are a small business as defined 
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR 
700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission 
for SNUNs will not be incurred by any company unless a company decides 
to pursue a significant new use as defined in these SNURs. 
Additionally, these estimates reflect the costs and fees as they are 
known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
    EPA has also evaluated the potential costs associated with the 
export notification requirements under TSCA section 12(b) and the 
implementing regulations at 40 CFR part 707, subpart D. For persons 
exporting a substance that is the subject of a SNUR, a one-time notice 
to EPA must be provided for the first export or intended export to a 
particular country. The total costs of export notification will vary by 
chemical, depending on the number of required notifications (i.e., the 
number of countries to which the chemical is exported). While EPA is 
unable to make any estimate of the likely number of export 
notifications for the chemical substances covered by these SNURs, as 
stated in the accompanying economic analysis, the estimated cost of the 
export notification requirement on a per unit basis is approximately 
$106.

E. What should I consider as I prepare my comments for EPA?

1. Submitting CBI
    Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please 
follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules 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 https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

    This unit provides general information about SNURs. For additional 
information about EPA's new chemical program go to https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

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:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     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

[[Page 67370]]

listed in this unit and discussed in Unit III.
    These proposed SNURs include PMN and MCAN 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 PMN/MCAN 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/MCAN 
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:
     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).
     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.
     To be obligated to make a determination under TSCA section 
5(a)(3) regarding the use described in the SNUN, under the conditions 
of use. The Agency will either determine under TSCA section 5(a)(3)(C) 
that the significant new use is not likely to present an unreasonable 
risk, including an unreasonable risk to a potentially exposed or 
susceptible subpopulation identified as relevant by the Administrator 
under the conditions of use, or make a determination under TSCA section 
5(a)(3)(A) or (B) and take the required regulatory action associated 
with the determination, before manufacture or processing for the 
significant new use of the chemical substance can occur.
    Issuance of a proposed SNUR for a chemical substance does not 
signify that the chemical substance is listed on the TSCA Chemical 
Substance Inventory (TSCA Inventory). Guidance on how to determine if a 
chemical substance is on the TSCA Inventory is available at https://www.epa.gov/tsca-inventory.

C. Significant New Uses Claimed as CBI

    EPA is proposing to establish certain significant new uses which 
have been claimed as CBI subject to Agency confidentiality regulations 
at 40 CFR part 2, 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 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 
request if a substance is subject to a SNUR and whether a specific use 
would be a significant new use under the rule in a single bona fide 
submission.
    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

[[Page 67371]]

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 https://www.epa.gov/tsca-import-export-requirements.

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/MCAN 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 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
2. Development and Submission of Information.
    EPA recognizes that TSCA section 5 does not require development of 
any particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is required to 
submit information for a chemical substance pursuant to a rule, order 
or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) 
requires such information 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/MCANs 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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
    The potentially useful information described in Unit III.C. for 
these 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:
     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 August 20, 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:
     PMN or MCAN number (the proposed CFR citation assigned in 
the regulatory text section of this document).
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service Registry Number (CASRN) (if 
assigned for non-confidential chemical identities).
     Effective date of and basis for the TSCA Order.
     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 and MCAN substances that are 
subject to orders issued under TSCA section 5(e)(1)(A), as required by 
the determinations made under TSCA section 5(a)(3)(B). Those TSCA 
Orders require protective measures to limit exposures or otherwise 
mitigate the potential unreasonable risk. The proposed SNURs identify 
as significant new uses any manufacturing, processing, use, 
distribution in commerce, or disposal that does not conform to the 
restrictions imposed by the underlying TSCA Orders, consistent with 
TSCA section 5(f)(4).

C. Which chemical substances are subject to this proposed rule?

    The substances subject to the proposed rules in this document are 
as follows:

[[Page 67372]]

PMN Numbers: P-18-356 (40 CFR 721.11894) and P-18-357 (40 CFR 
721.11895)
    Chemical Names: Sulfonated phenolic resin salt, polymer with 
acetone-phenol reaction products, formaldehyde and phenol, sodium salt 
(generic) (P-18-356) and Sulfonated phenolic resin salt, polymer with 
acetone-phenol reaction products, formaldehyde and phenol, potassium 
salt (generic) (P-18-357).
    CASRN: Not available.
    Effective Date of TSCA Order: May 2, 2023.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as adhesives. Based on comparison to 
analogous chemical substances, EPA has identified concerns for 
reproductive and developmental effects, systemic effects, and corrosion 
to the eyes, skin, and respiratory tract. Based on comparison to 
analogous polyanionic polymers and monomers, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 6 ppb. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substances may present 
an unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
     No manufacture, processing, or use of the PMN substances 
in any manner that results in inhalation exposure;
     No processing for use or use of the PMN substances in 
consumer products;
     No release of the PMN substances, or any waste stream 
containing the PMN substances, in surface water concentrations that 
exceed 6 ppb;
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     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 
corrosion, eye damage, specific target organ toxicity, reproductive 
toxicity, developmental toxicity, and aquatic toxicity testing may be 
potentially useful to characterize the health and environmental effects 
of the PMN 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-19-188 (40 CFR 721.11896)
    Chemical Name: Octadecanamide, N,N-dialkyl, salts (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: December 5, 2022.
    Basis for TSCA Order: The PMN states that the use will be as a 
wetting agent and lubricant. Based on the surfactant properties of the 
PMN substance, EPA has identified concerns for irritation and lung 
effects (surfactancy). Based on amines, EPA has also identified 
concerns for irritation to the skin, eyes, and respiratory tract. Based 
on submitted test data on the PMN substance, EPA has also identified 
concerns for severe skin and eye irritation, skin corrosion, and 
scabbing. Based on submitted test data on the PMN substance, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 34 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No use of the PMN substance in a consumer product;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 34 ppb; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity, pulmonary effects, and aquatic toxicity 
testing may be potentially useful to characterize the health and 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
PMN Numbers: P-20-175 (40 CFR 721.11897), P-20-176 (40 CFR 721.11898), 
and P-20-178 (40 CFR 721.11899)
    Chemical Names: Acid N-[4-(4-diarylalkyl]-, carbopolycyclic 
alkenyl, methyl ester (generic) (P-20-175); Acid N-(diarylalkyl)-, 
carbopolycyclic alkenyl, methyl ester (generic) (P-20-176); and 
Carbopolycyclic alkenyl, 2-carboxylic acid, 2-
[[[(diarylalkyl)]carbonyl]oxy]ethyl ester (generic) (P-20-178).
    CASRNs: Not available.
    Effective Date of TSCA Order: May 15, 2023.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as proprietary additive for formulations. 
Based on the structure alert for isocyanates, EPA has identified 
concerns for irritation to the eyes, skin, and respiratory tract. Based 
on comparison to analogous chemical substances, EPA has also identified 
concerns for respiratory effects and skin and respiratory sensitization 
for the residual. For the hydrolysis product of the residual, EPA has 
also identified concerns for systemic effects and cancer. Based on 
comparison to analogous chemical substances, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 0.1 ppb for 
P-20-175 and P-20-176 and 0.2 ppb for P-20-178. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substances may present an unreasonable risk of 
injury to human health and the environment. To protect against these 
risks, the Order requires:
     No manufacture, processing, or use of the PMN substances 
in any manner that results in inhalation exposure;
     No release of the PMN substances, or any waste stream 
containing the PMN substances, in surface water concentrations that 
exceed 0.1 ppb for P-20-175 and P-20-176 and 0.2 ppb for P-20-178;
     No use of the PMN substances in consumer products;

[[Page 67373]]

     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substances. Although the Order does 
not require these tests, the Order's restrictions remain in effect 
until the Order is modified or revoked by EPA based on submission of 
this or other relevant information.
PMN Number: P-21-15 (40 CFR 721.11900)
    Chemical Name: Amines, C36-alkylenedi-, polymers with 5,5'-[(1-
methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione] and 
4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-aminophenol].
    CASRN: 2419899-87-7.
    Effective Date of TSCA Order: May 19, 2021.
    Basis for TSCA Order: The PMN states that the use will be as a raw 
material in a temporary bonding adhesive formulation. The adhesive is 
used to bond completed semiconductor wafers to a backing substrate to 
facilitate mechanical grinding of the wafer to reduce its thickness. 
Based on the high molecular weight and low water solubility of the PMN 
substance, EPA has identified concerns for lung effects (lung 
overload). Based on test data for the potential incineration product, 
EPA has also identified concerns for portal-of-entry effects (lesions 
in the upper respiratory tract and lungs), liver effects, kidney 
effects, body weight loss, and neurotoxicity.
    The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health. To protect against 
these risks, the Order requires:
     No use of the PMN substance other than as a raw material 
in a temporary bonding adhesive formulation. The adhesive is used to 
bond completed semiconductor wafers to a backing substrate to 
facilitate mechanical grinding of the wafer to reduce its thickness;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in worker inhalation exposure; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity, pulmonary effects, and 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 Numbers: P-21-32 (40 CFR 721.11901) and P-21-33 (40 CFR 721.11902)
    Chemical Names: Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-(1-methylethoxy)- (P-21-32) and Poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-butoxy- (P-21-33).
    CASRNs: 2304726-48-3 (P-21-32) and 2304726-50-7 (P-21-33).
    Effective Date of TSCA Order: April 27, 2023.
    Basis for TSCA Order: The PMNs state that the uses will be as 
chemical intermediates for an asphalt emulsified (20%) and ore 
flotation (80%). Based on comparison to analogous chemical substances, 
EPA has identified concerns for acute toxicity, skin and eye corrosion, 
skin sensitization, systemic effects, and lung effects. Based on 
comparison to analogous polycationic polymers and aliphatic amines, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 220 ppb (P-21-32) and 110 ppb (P-21-33). The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health and the environment. To protect against these 
risks, the Order requires:
     No processing or use of the PMN substances in a 
formulation containing the PMN substances at greater than 4%;
     No processing or use of the PMN substances in consumer 
products;
     No release of the PMN substances, or any waste stream 
containing the PMN substances, in surface water concentrations that 
exceed 110 ppb of the PMN substances combined;
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     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 
corrosion, eye damage, skin sensitization, specific target organ 
toxicity, pulmonary effects, and aquatic toxicity testing may be 
potentially useful to characterize the health and environmental effects 
of the PMN substances. Although the Order does not require these tests, 
the Order's restrictions remain in effect until the Order is modified 
or revoked by EPA based on submission of this or other relevant 
information.
PMN Number: P-21-75 (40 CFR 721.11903)
    Chemical Name: Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, 
polymer with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-
alkanediyl), dialkyl carbonate, alkanediol, alkylene[isocyanato-
carbomonocycle] and [oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, 
compd. with dialkyalkanamine (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: May 24, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
curable resin for aqueous coatings. Based on the presence of acrylates, 
EPA has identified concerns for irritation to the skin, eyes, and 
respiratory tract and skin and respiratory sensitization. Based on

[[Page 67374]]

data for the counter ion of the PMN substance, EPA has also identified 
concerns for skin and eye corrosion, acute toxicity, systemic effects, 
male reproductive effects, and respiratory tract effects. Based on data 
for an analogue of the counter ion, EPA also identified concerns for 
neurotoxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
     No use of the PMN substance in consumer products;
     Use of a NIOSH-certified respirator with an APF of at 
least 50 where there is a potential for inhalation exposure, or 1000 if 
spray applied;
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of acute 
toxicity, specific toxic organ toxicity, pulmonary effects, skin 
sensitization, and reproductive/developmental 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-21-80 (40 CFR 721.11904)
    Chemical Name: Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, alkanedioc acid dihydrazide, 
hydroxy-(hydroxyalkyl)-alkylalkanoic acid, isocyanato-
(isocyanatoalkyl)-alkyl substituted carbomonocycle, dialkylalkanediol 
and polyalkylene glycol(hydroxyalkyl)alkyl alkyl ether (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: May 24, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
binder for UV curable coating resin. Based on a structural alert for 
acrylates and information provided in the SDS, EPA has identified 
concerns for irritation to the skin, eyes, and respiratory tract. Based 
on a structural alert for acrylates for the LMW fraction, EPA has also 
identified concerns for skin and respiratory sensitization. Based on 
multifunctional reactive groups, EPA has also identified concerns for 
respiratory sensitization. Based on comparison to analogous chemical 
substances, EPA has also identified concerns for skin irritation, 
clinical signs, systemic effects (decreased body weight and body weight 
gains, reduced food consumption, blood, adrenal, thymus, and brain 
effects), and irritation in the GI tract (stomach, cecum, colon, 
duodenum, ileum, and/or jejunum). The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health. To protect against these risks, the Order requires:
     No use of the PMN substance in consumer products;
     Use of a NIOSH-certified respirator with an APF of at 
least 50 where there is a potential for inhalation exposure, or 1000 if 
spray applied;
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     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, specific toxic organ toxicity, eye damage, 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-21-96 (40 CFR 721.11905)
    Chemical Name: Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 
2,2'-[(1-methylethylidene) bis (4,1-phenyleneoxymethylene)] bis 
[heteromonocycle], bis(2-methyl-2-propenoate) (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: May 17, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component in thermoset composites. Based 
on comparison to analogous chemical substances, EPA has identified 
concerns for dermal, respiratory, and eye irritation, skin 
sensitization, systemic effects, and reproductive and developmental 
effects. Based on the presence of methacrylates, EPA has also 
identified concerns for respiratory sensitization. Based on comparison 
to analogous acrylates/methacrylates, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 2 ppb. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to human health and the environment. To protect against 
these risks, the Order requires:
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 2 ppb;
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of skin 
sensitization, neurotoxicity, specific target organ toxicity, 
developmental toxicity, reproductive toxicity, and aquatic toxicity 
testing may be potentially useful to characterize the health and 
environmental effects of the

[[Page 67375]]

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-21-98 (40 CFR 721.11906)
    Chemical Name: Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-
[2(or 3)-[[substituted benzoyl]oxy]hydroxypropoxyl]-, .alpha., 
.alpha.', .alpha.'' -ether with 2-ethyl-2-(hydroxymethyl)-1,3-
propanediol (3:1) (generic).
    CASRN: Not available
    Effective Date of TSCA Order: May 10, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a co-
initiator for the curing of UV printing inks. Based on comparison to 
analogous chemical substances, EPA has identified concerns for skin 
sensitization and reproductive and systemic effects. Based on the 
surfactant properties of the PMN substance, EPA also identified 
concerns for lung effects and irritation to the skin, eyes, and 
respiratory tract. Based on comparison to analogous esters, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 12 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
     No use of the PMN substance in consumer products;
     No manufacture or processing of the PMN substance in any 
manner that results in inhalation exposure;
     No use of the PMN substance in formulations at 
concentrations greater than 4%;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 12 ppb;
     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;
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity, skin sensitization, skin irritation/corrosion, eye 
irritation/corrosion, pulmonary effects, reproductive toxicity, and 
specific target organ toxicity testing may be potentially useful to 
characterize the health and environmental effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
PMN Number: P-21-126 (40 CFR 721.11907)
    Chemical Name: Substituted heteromonocycle, polymer with haloalkyl 
substituted heteromonocycle, dialkyl-alkanediamine, (alkylalkylidene) 
bis [hydroxycarbomonocycle] and oxybls[alkanol], reaction products with 
metal oxide and dialkanolamine (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: May 1, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
component in several coating resin products that are only applied by 
cathodic electrodeposition and used as additives for corrosion 
protection. Based on submitted test data, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 230 ppb. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to the environment. To protect against 
these risks, the Order requires:
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 230 ppb; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
PMN Number: P-21-175 (40 CFR 721.11908)
    Chemical Name: Carbonic acid, diphenyl ester, polymer with 1,4-
butanediol and 1,10-decanediol.
    CASRN: 1615685-41-0.
    Effective Date of TSCA Order: March 1, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a raw material of 
polyurethane. Based on comparison to analogous esters and test data on 
the PMN substance, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 22 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
the environment. To protect against these risks, the Order requires:
     No release of the PMN substance resulting in surface water 
concentrations that exceed 22 ppb; and
     Establishment of a hazard communication program, including 
precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of chronic 
aquatic toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.

[[Page 67376]]

PMN Number: P-22-7 (40 CFR 721.11909)
    Chemical Name: 3,5,8-Trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-
alkoxy-1-alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: February 3, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
crosslinker in formulating general purpose sealants and adhesives for 
use in consumer and professional markets. Based on test data on the PMN 
substance, EPA has identified concerns for eye irritation. Based on 
comparison to analogous chemical substances, EPA has also identified 
concerns for systemic effects. Based on test data for hydrolysis 
products of the PMN substance, EPA has also identified concerns for 
respiratory tract irritation and reproductive and developmental 
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health. To protect against 
these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No processing or use of the PMN substance other than as a 
crosslinker in formulating general purpose sealants and adhesives;
     No processing for use or use of the PMN substance where 
the concentration of the PMN substance exceeds 6% by weight in consumer 
products;
     No processing for use or use of the PMN substance in 
consumer products other than in the form of a paste;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity, pulmonary effects, reproductive 
toxicity, and developmental 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-22-8 (40 CFR 721.11910)
    Chemical Name: .beta.-N-Acetylhexosaminidase (expressed in 
genetically modified Bacillus licheniformis strain ATJI0138).
    CASRN: 9012-33-3.
    Effective Date of TSCA Order: March 3, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a biocatalyst used in a variety of 
products. Based on comparison to analogous chemical substances, EPA has 
identified concerns for skin irritation, eye irritation, respiratory 
irritation, skin sensitization, respiratory sensitization, portal-of-
entry (oral) effects, and systemic effects. Based on comparison to 
analogous polyamphoteric polymers and test data on the PMN substance, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 1,000 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure;
     No processing of the PMN substance to greater than 1% in 
formulation for use in a consumer product;
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of eye 
irritation, skin irritation, skin sensitization, and pulmonary effects 
testing may be potentially useful to characterize the health effects of 
the PMN substance. Although the Order does not require these tests, the 
Order's restrictions remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other relevant 
information.
PMN Number: P-22-9 (40 CFR 721.11911)
    Chemical Name: Alkanes, C4-9-branched and linear.
    CASRN: 2577172-51-9.
    Effective Date of TSCA Order: January 24, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
gasoline blending component to reduce the average carbon intensity and 
subsequent CO2 emissions of fuel. Based on comparison to analogous 
chemical mixtures, EPA has identified concerns for respiratory tract 
irritation, carcinogenicity, neurotoxicity, ototoxicity, portal-of-
entry (inhalation and oral), systemic (body weight, liver, kidney, 
blood, adrenal, and spleen) toxicity, developmental effects, 
reproductive effects, acute toxicity, skin irritation, eye irritation, 
and aspiration hazard. Based on the chemical composition (petroleum) 
and n-nonane, EPA also identified concerns for hydrocarbon pneumonia 
and aspiration hazard. Based on comparison to analogous neutral organic 
chemicals, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 3 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health and the environment. To protect against these risks, the 
Order requires:
     Manufacture, processing, and use of the PMN substance only 
as a fuel, refinery feedstock, a chemical feedstock, or a fuel blending 
additive or component;
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     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

[[Page 67377]]

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, 
skin irritation, eye irritation, respiratory depression/irritation, 
hydrocarbon pneumonia/aspiration hazard, reproductive/developmental 
toxicity, systemic toxicity, genetic toxicity, carcinogenicity, and 
consumer inhalation exposures at gas stations 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-22-10 (40 CFR 721.11912)
    Chemical Name: Amino alkanoic acid, N-[3-(trimethoxysilyl)propyl]-, 
3-(trimethoxysilyl)propyl ester (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: March 16, 2023.
    Basis for TSCA Order: The PMN states that the use will be as part 
of an industrial adhesive. Based on comparison to analogous 
alkoxysilanes, EPA has identified concerns for lung pathology and 
systemic effects. Based on comparison to analogous chemical substances, 
EPA has also identified concerns for mortality, skin irritation, eye 
corrosion, respiratory irritation, portal-of-entry, neurotoxicity, 
systemic, and reproductive effects. Based on a hydrolysis product, EPA 
has also identified concerns for systemic, neurotoxicity, and 
developmental effects. Based on comparison to analogous alkoxysilanes 
and aliphatic amines, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 80 ppb. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health and the environment. To protect against these 
risks, the Order requires:
     No use of the PMN substance in consumer products;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 80 ppb;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
PMN Number: P-22-13 (40 CFR 721.11913)
    Chemical Name: 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo, aryl ester (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: March 2, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a raw 
material/intermediate, site-limited, destructive use. Based on test 
data for the ester hydrolysis products, EPA has identified concerns for 
skin sensitization, eye irritation, and systemic and neurotoxicity 
effects. Based on comparison to analogous anilines and esters, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 4 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
     Manufacture, processing, and use of the PMN substance only 
in a solid form when using a dust collection system with a capture and 
control efficiency of at least 32% to control dust exposure;
     No use of the PMN substance other than as an intermediate;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, into waters of the United States;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 50 where there is a potential for inhalation exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity, neurotoxicity, eye irritation/corrosion, skin sensitization, 
specific target organ toxicity, and persistence and bioaccumulation 
testing may be potentially useful to characterize the health, 
environmental, and fate effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
PMN Number: P-22-15 (40 CFR 721.11914)
    Chemical Name: 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: March 6, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a raw 
material/intermediate, site-limited, destructive use. Based on 
comparison to analogous chemical substances, EPA has identified 
concerns for eye irritation and systemic effects. Based on comparison 
to analogous anilines, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 14 ppb. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health and the environment. To protect against these 
risks, the Order requires:
     Manufacture, processing, and use of the PMN substance only 
in a solid form when using a dust collection system with a capture and 
control efficiency of at least 32% to control dust exposure;
     No use of the PMN substance other than as an intermediate;

[[Page 67378]]

     No release of the PMN substance, or any waste stream 
containing the PMN substance, into waters of the United States;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 50 where there is a potential for inhalation exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity, eye irritation, specific target organ toxicity, and 
persistence and bioaccumulation testing may be potentially useful to 
characterize the health, environmental, and fate effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
PMN Number: P-22-37 (40 CFR 721.11915)
    Chemical Name: Polyphosphoric acids, esters with heteromonocycle 
homopolymer (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: April 3, 2023.
    Basis for TSCA Order: The PMN states that the use will be as an 
adhesion promoter used in coatings for better adhesion to metals under 
high humidity conditions. Based on comparison to analogous chemical 
substances, EPA has identified concerns for irritation/corrosion to the 
skin, eyes, and respiratory tract, clinical signs, and systemic 
effects. Based on the surfactant-like properties of the PMN substance, 
EPA has also identified concerns for lung effects (surfactancy). Based 
on comparison to analogous phosphates--inorganic and polyanionic 
polymers (& monomers) and the standard toxicity profile for inorganic 
phosphate, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 2 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health and the environment. To protect against these risks, the 
Order requires:
     No processing of the PMN substance to greater than 1% in 
formulation;
     No use of the PMN substance in a formulation containing 
the PMN substance at a concentration greater than 1%;
     No processing for use or use of the PMN substance in 
consumer products;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 2 ppb;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     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; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity, pulmonary effects, skin corrosion, eye 
irritation/corrosion, 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-22-44 (40 CFR 721.11916)
    Chemical Name: Silica gel, reaction products with alkyl metal salt 
(generic).
    CASRN: Not available.
    Effective Date of TSCA Order: February 16, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a site-limited intermediate. Based on the 
reactivity of the parent substance, EPA has identified concerns for eye 
irritation, skin irritation, and respiratory tract irritation. Based on 
test data for analogues of the hydrolysis products, EPA has also 
identified concerns for lung, systemic, reproductive, and developmental 
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health. To protect against 
these risks, the Order requires:
     Manufacture, processing, and use of the PMN substance only 
in an enclosed process;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 50 where there is a potential for inhalation exposure; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of eye 
irritation, skin irritation, and specific target organ toxicity testing 
may be potentially useful to characterize the health effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
PMN Number: P-22-54 (40 CFR 721.11917)
    Chemical Name: Graphene nanoplatelets (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: March 17, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive for paint coatings. Based on 
comparison to analogous chemical substances, EPA has identified 
concerns for lung effects and systemic effects. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable

[[Page 67379]]

risk of injury to human health and the environment. To protect against 
these risks, the Order requires:
     No manufacture of the PMN substance other than by import 
into the United States in the form of a solution (i.e., no domestic 
manufacture);
     No processing of the PMN substance in any manner that 
results in inhalation exposure;
     No processing or use of the PMN substance other than in a 
liquid formulation;
     No use of the PMN substance other than for the 
confidential use listed in the Order;
     No use of the PMN substance in an application method where 
the concentration of the PMN substance in the formulation exceeds the 
confidential concentration listed in the Order;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, into waters of the United States;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     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; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity, pulmonary effects, sediment toxicity, 
and aquatic toxicity testing may be potentially useful to characterize 
the health and environmental effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
PMN Numbers: P-22-86 (40 CFR 721.11918), P-22-122 (40 CFR 721.11919), 
P-22-179 (40 CFR 721.11920), and P-22-180 (40 CFR 721.11921)
    Chemical Names: Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-
(2,4,6-substituted tri-carbopolycycle, hetero-acid)benzenesulfonate 
(1:1) (generic) (P-22-86), Heterotrisubstituted-bile acid, 1-
(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-
phenyldibenzothiophenium (1:1) (generic) (P-22-122), Sulfonium, 
(alkylsubstitutedphenyl)diphenyl-, salt with 1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl 
trisubstitutedbenzoate (1:1) (generic) (P-22-179), and 
Dibenzothiophenium, 5-phenyl-, 4-[1-(heterosubstitutedalkyl)-2,2,2-
triheterosubstitutedalkoxy]-4-oxoalkyl trisubstitutedbenzoate (1:1) 
(generic) (P-22-180).
    CASRNs: Not available.
    Effective Date of TSCA Order: January 24, 2023.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be for contained used for 
microlithography for electronic device manufacturing. Based on the 
physical/chemical properties of the PMN substances (as described in the 
New Chemical Program's PBT category at 64 FR 60194; November 1999), the 
PMN substances are potentially persistent, bioaccumulative, and toxic 
(PBT) chemicals. EPA estimates that the PMN substances will persist in 
the environment for more than two months and estimates a 
bioaccumulation factor of greater than or equal to 1,000. Based on the 
reactivity of the PMN substances, EPA has identified concerns for 
photosensitization and irritation to the skin, eyes, and respiratory 
tract. Based on information provided in the SDS, EPA has also 
identified concerns for acute toxicity and irritation to the skin, 
eyes, and respiratory tract. Based on confidential analogous compounds, 
EPA has also identified concerns for acute toxicity, irritation to the 
skin, eyes, and respiratory tract, eye corrosion, ocular lethality, 
neurological effects, and systemic effects for the confidential cation 
of the PMN substances. Based on comparison to analogous substances, EPA 
has also identified concerns for mutagenicity. Based on a potential 
incineration by-product, EPA has also identified concerns for local, 
neurotoxic, and systemic effects for P-22-122, P-22-179, and P-22-180. 
Based on OECD QSAR Toolbox results, EPA has also identified hazards for 
skin sensitization and carcinogenicity for the anion for P-22-179 and 
P-22-180. 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:
     No manufacture of any of the PMN substances beyond the 
time limits specified in the Order without submittal to EPA the results 
of certain testing described in the Testing section of the Order;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS;
     No processing or use of the PMN substances in any way that 
generates a vapor, dust, mist, or aerosol in a non-enclosed process;
     Use of the PMN substances only for the confidential use 
stated in the Order;
     No domestic manufacture of the PMN substances (i.e., 
import only);
     Import of the PMN substances only in solution, or in any 
form in sealed containers weighing 5 kilograms or less; and
     No exceedance of the confidential annual importation 
volumes listed the Order.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information about the physical/chemical properties, fate, 
bioaccumulation, environmental hazard, and human health effects of the 
PMN substances may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. The submitter has agreed not to exceed the 
time limits specified in the Order without performing the required Tier 
I and Tier II testing outlined in the Testing section of the Order.
PMN Number: P-22-115 (40 CFR 721.11922)
    Chemical Name: .beta.-cyclodextrin, polymer with 2,3,5,6-
tetrafluoro-1,4-benzenedicarbonitrile, hydrolyzed, 2-
(trimethylammonio)ethyl ethers, chlorides.
    CASRN: 2683011-63-2.
    Effective Date of TSCA Order: May 9, 2023.
    Basis for TSCA Order: The PMN states that the uses will be as a 
filter media integrated and encapsulated in block filter articles for 
consumer, industrial, and commercial applications, filter media 
integrated and encapsulated in filter articles for consumer 
applications, and filter media integrated and encapsulated in packed 
bed filters for industrial and commercial applications.

[[Page 67380]]

Based on the high molecular weight polymer and low water solubility, 
EPA has identified concerns for lung effects (lung overload). Based on 
amine content, EPA has also identified concerns for irritation to the 
skin, eyes, and respiratory tract. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health. To protect against these risks, the Order requires:
     No processing for use or use of the PMN substance in 
consumer products except when incorporated into an article;
     No manufacture, processing, or use of the PMN substance 
with a particle size less than 20 microns;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 10 where there is a potential for inhalation exposure; 
and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
pulmonary effects, skin irritation, and eye irritation 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-22-129 (40 CFR 721.11923)
    Chemical Name: Substituted heterocyclic onium compound, salt with 
heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1), 
polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-
ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate, 
hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate 
and 4-hydroxyphenyl 2-methyl-2-propenoate (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: April 24, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be for contained use for 
microlithography for electronic device manufacturing. Based on the 
physical/chemical properties of the PMN substance (as described in the 
New Chemical Program's PBT category at 64 FR 60194, November 4, 1999 
(FRL-6097-7)), the PMN substance is a potentially persistent, 
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN 
substance will persist in the environment for more than six months and 
estimates a bioaccumulation factor of greater than or equal to 1,000. 
Based on the reactivity of the PMN substance, EPA has identified 
concerns for photosensitization, and irritation to the skin, eyes, and 
respiratory tract. Based on the cation of the PMN substance and 
information provided in the SDS, EPA has also identified concerns for 
acute toxicity, irritation to the skin, eyes, and respiratory tract, 
eye corrosion, ocular lethality, neurological effects, and systemic 
effects. Based on comparison to analogous chemical substances, EPA has 
also identified concerns for mutagenicity. Based on a potential 
incineration by-product, EPA has also identified concerns for local, 
neurotoxic, and systemic effects. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. To protect against these risks, the 
Order requires:
     No manufacture of the PMN substance beyond the time limits 
specified in the Order without submittal to EPA the results of certain 
testing described in the Testing section of the Order;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS;
     No modification of the processing or use of the PMN 
substance in any way that generates a vapor, dust, mist, or aerosol in 
a non-enclosed process;
     Use of the PMN substance only for the confidential use 
listed in the Order;
     No domestic manufacture of the PMN substance (i.e., import 
only);
     Import of the PMN substance only in solution, or in any 
form in sealed containers weighing 5 kilograms or less; and
     No exceedance of the confidential annual importation 
volume listed the Order.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information about the physical/chemical properties, fate, 
bioaccumulation, environmental hazard, and human health effects of the 
PMN substance may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. The submitter has agreed not to exceed the 
time limits specified in the Order without performing the required Tier 
I and Tier II testing outlined in the Testing section of the Order.
PMN Number: P-22-162 (40 CFR 721.11924)
    Chemical Name: Haloalkylfurancarboxaldehyde (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: May 8, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
chemical intermediate used in the production of para-xylene and in 
production of FDCA/PET and other specialty chemicals. Based on 
submitted test data on the PMN substance and comparison to analogous 
chemical substances, EPA has identified concerns for acute toxicity, 
skin and respiratory tract irritation, serious eye damage, skin 
sensitization, systemic effects, developmental effects, and 
genotoxicity. Based on comparison to analogous aldehydes and submitted 
acute toxicity data on the PMN substance, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 540 ppb. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
     No processing or use of the PMN substance in consumer 
products;
     No manufacture, processing, or use of the substance in any 
manner that results in inhalation exposure;
     No release of the PMN substance, or any waste stream 
containing the PMN

[[Page 67381]]

substance, in surface water concentrations that exceed 540 ppb;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Disposal of the PMN substance, or any waste steams 
containing the PMN substance, only by hazardous waste incineration 
achieving at least 99.99% destruction of the PMN substance;
     Manufacture, processing, or use of the PMN substance only 
in an enclosed process; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
reproductive toxicity, 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.
MCAN Number: J-23-3 (40 CFR 725.1082)
    Chemical Name: Microorganism expressing enzymes (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: April 21, 2023.
    Basis for TSCA Order: The MCAN states that the generic (non-
confidential) use of the microorganism will be for production of an 
enzyme mixture. EPA determined that certain fermentation conditions, 
other than the typical submerged standard industrial fermentation 
process for enzyme production, could result in increased exposures. 
Specifically, EPA is concerned that where growth on plant material or 
on solid substrates occur, the MCAN microorganism has been shown to 
produce a secondary metabolite known as paracelsin, which is associated 
with a variety of toxic effects to mammalian and bacterial cells. 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 microorganism may 
present an unreasonable risk of injury to human health and the 
environment. To protect against these risks, the Order requires:
     No manufacture, processing, or use of the microorganism 
other than in a fermentation system that meets all of the following 
conditions:
    (1) Enzyme production is conducted under conditions of submerged 
fermentation (i.e., growth of the microorganism occurs beneath the 
surface of the liquid growth medium); and
    (2) Any fermentation of solid plant material or insoluble 
substrate, to which the fermentation broth is added after the submerged 
standard industrial fermentation operations used for enzyme production 
is completed, may be initiated only after the inactivation of the 
microorganism as delineated in 40 CFR 725.422(d).
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that the results 
of the following studies would help characterize any potential human 
health and environmental effects of the MCAN microorganism if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR:
     Investigation of whether paracelsin will be produced, and 
at what levels if the MCAN microorganism is grown on various plant 
biomass materials for different durations under various fermentation 
conditions in cellulosic biomass facilities.
     If paracelsin is produced, a study of whether paracelsin 
would be denatured/inactivated during production and processing.
     If paracelsin is released from the facility, a study of 
whether paracelsin would be degraded/inactivated during wastewater 
treatment.
     If released to the environment, studies on the 
persistence, stability, dissemination, accumulation, and the potential 
resulting biological activity of paracelsin with exposure to aquatic 
and terrestrial organisms in the environment.
     Studies to determine the ability of the MCAN microorganism 
to survive in the environment relative to the survival of the 
unmodified parent or recipient strain, and to assess its 
competitiveness with other fungi in the environment. This study may 
require some supplementation with one or more carbon sources and the 
use of various soil types.
     A study to determine survival of the MCAN microorganism 
during an anaerobic fermentation for production of ethanol by an 
ethanologen, and survival of the MCAN microorganism during ethanol 
distillation or at the distillation temperature for ethanol.
    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 https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 14094: Modernizing Regulatory Review

    This action proposes to establish SNURs for new chemical substances 
that were the subject of PMNs or MCANs. 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

[[Page 67382]]

burden estimate, and any suggested methods for improving the collection 
instruments or instruction or minimizing respondent burden, including 
through the use of automated collection techniques.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA (5 
U.S.C. 601 et seq.). The requirement to submit a SNUN applies to any 
person (including small or large entities) who intends to engage in any 
activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new,'' based on all information currently 
available to EPA, EPA has concluded that no small or large entities 
presently engage in such activities.
    A SNUR requires that any person who intends to engage in such 
activity in the future must first notify EPA by submitting a SNUN. 
Although some small entities may decide to pursue a significant new use 
in the future, EPA cannot presently determine how many, if any, there 
may be. However, EPA's experience to date is that, in response to the 
promulgation of SNURs covering over 1,000 chemicals, the Agency 
receives only a small number of notices per year. For example, the 
number of SNUNs received was 16 in Federal fiscal year (FY) FY2018, 
five in FY2019, seven in FY2020, 13 in FY2021, 11 in FY2022, and 15 in 
FY2023, and only a fraction of these submissions were from small 
businesses.
    In addition, the Agency currently offers relief to qualifying small 
businesses by reducing the SNUN submission fee from $37,000 to $6,480. 
This lower fee reduces the total reporting and recordkeeping cost of 
submitting a SNUN to about $14,500 per SNUN submission for qualifying 
small firms. Therefore, the potential economic impacts of complying 
with these proposed SNURs are not expected to be significant or 
adversely impact a substantial number of small entities. In a SNUR that 
published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented its general determination that SNURs are 
not expected to have a significant economic impact on a substantial 
number of small entities, which was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C. 
1531-1538, and does not significantly or uniquely affect small 
governments. Based on EPA's experience with proposing and finalizing 
SNURs, State, local, and Tribal governments have not been impacted by 
SNURs. 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 rule. 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 and 725

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: August 9, 2024.
Mark Hartman,
Deputy Director, Office of Pollution Prevention and Toxics.
    Therefore, for the reasons stated in the preamble, EPA proposes to 
amend 40 CFR chapter I as follows:

PART 721-SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

0
1. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).


[[Page 67383]]


0
2. Add Sec. Sec.  721.11894 through 721.11924 to subpart E to read as 
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec.
721.11894 Sulfonated phenolic resin salt, polymer with acetone-
phenol reaction products, formaldehyde and phenol, sodium salt 
(generic).
721.11895 Sulfonated phenolic resin salt, polymer with acetone-
phenol reaction products, formaldehyde and phenol, potassium salt 
(generic).
721.11896 Octadecanamide, N,N-dialkyl, salts (generic).
721.11897 Acid N-[4-(4-diarylalkyl]-, carbopolycyclic alkenyl, 
methyl ester (generic).
721.11898 Acid N-(diarylalkyl)-, carbopolycyclic alkenyl, methyl 
ester (generic).
721.11899 Carbopolycyclic alkenyl, 2-carboxylic acid, 2-
[[[(diarylalkyl)]carbonyl]oxy]ethyl ester (generic).
721.11900 Amines, C36-alkylenedi-, polymers with 5,5'-[(1-
methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione] 
and 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-
aminophenol].
721.11901 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-(1-methylethoxy)-.
721.11902 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-butoxy-.
721.11903 Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with 
.alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), 
dialkyl carbonate, alkanediol, alkylene[isocyanato-carbomonocycle] 
and [oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with 
dialkyalkanamine (generic).
721.11904 Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, alkanedioc acid dihydrazide, 
hydroxy-(hydroxyalkyl)-alkylalkanoic acid, isocyanato-
(isocyanatoalkyl)-alkyl substituted carbomonocycle, 
dialkylalkanediol and polyalkylene glycol(hydroxyalkyl)alkyl alkyl 
ether (generic).
721.11905 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 2,2'-
[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)] bis 
[heteromonocycle], bis(2-methyl-2-propenoate) (generic).
721.11906 Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or 3)-
[[substituted benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.', 
.alpha.'' -ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol 
(3:1) (generic).
721.11907 Substituted heteromonocycle, polymer with haloalkyl 
substituted heteromonocycle, dialkyl-alkanediamine, 
(alkylalkylidene)bis[hydroxy-carbomonocycle] and oxybis[alkanol], 
reaction products with metal oxide and dialkanolamine (generic).
721.11908 Carbonic acid, diphenyl ester, polymer with 1,4-butanediol 
and 1,10-decanediol.
721.11909 3,5,8-Trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-alkoxy-1-
alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester (generic).
721.11910 .beta.-N-Acetylhexosaminidase (expressed in genetically 
modified Bacillus licheniformis strain ATJI0138).
721.11911 Alkanes, C4-9-branched and linear.
721.11912 Amino alkanoic acid, N-[3-(trimethoxysilyl)propyl]-, 3-
(trimethoxysilyl)propyl ester (generic).
721.11913 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-
5-halo-6-halo, aryl ester (generic).
721.11914 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-
5-halo-6-halo- (generic).
721.11915 Polyphosphoric acids, esters with heteromonocycle 
homopolymer (generic).
721.11916 Silica gel, reaction products with alkyl metal salt 
(generic).
721.11917 Graphene nanoplatelets (generic)
721.11918 Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-
substituted tri-carbopolycycle, hetero-acid)benzenesulfonate (1:1) 
(generic).
721.11919 Heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-
2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-
phenyldibenzothiophenium (1:1) (generic).
721.11920 Sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt with 1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl 
trisubstitutedbenzoate (1:1) (generic).
721.11921 Dibenzothiophenium, 5-phenyl-, 4-[1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkoxy]-4-
oxoalkyl trisubstitutedbenzoate (1:1) (generic).
721.11922 .beta.-cyclodextrin, polymer with 2,3,5,6-tetrafluoro-1,4-
benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl ethers, 
chlorides.
721.11923 Substituted heterocyclic onium compound, salt with 
heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate 
(1:1), polymer with 1-alkenyl-4-
[(alkylcycloalkyl)oxy]carbomonocycle, 5-ethyloctahydro-4,7-methano-
1H-inden-5-yl 2-methyl-2-propenoate, hexahydro-5-oxo-2,6-
methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate and 4-
hydroxyphenyl 2-methyl-2-propenoate (generic).
721.11924 Haloalkylfurancarboxaldehyde (generic).


Sec.  721.11894  Sulfonated phenolic resin salt, polymer with acetone-
phenol reaction products, formaldehyde and phenol, sodium salt 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonated phenolic resin salt, polymer with acetone-phenol reaction 
products, formaldehyde and phenol, sodium salt (PMN P-18-356) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely reacted or cured.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin corrosion; serious eye 
damage; 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=6.
    (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 67384]]

Sec.  721.11895  Sulfonated phenolic resin salt, polymer with acetone-
phenol reaction products, formaldehyde and phenol, potassium salt 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonated phenolic resin salt, polymer with acetone-phenol reaction 
products, formaldehyde and phenol, potassium salt (PMN P-18-357) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely reacted or cured.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin corrosion; serious eye 
damage; 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=6.
    (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.  721.11896  Octadecanamide, N,N-dialkyl, salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
octadecanamide, N,N-dialkyl, salts (PMN P-19-188) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; specific target organ toxicity; serious eye damage. 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=34.
    (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.  721.11897  Acid N-[4-(4-diarylalkyl]-, carbopolycyclic alkenyl, 
methyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as acid N-
[4-(4-diarylalkyl]-, carbopolycyclic alkenyl, methyl ester (PMN P-20-
175) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section. The requirements of 
this section do not apply to quantities of the substance after they 
have been completely reacted or cured.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; respiratory sensitization; skin sensitization; 
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(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=0.1.
    (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.

[[Page 67385]]

Sec.  721.11898  Acid N-(diarylalkyl)-, carbopolycyclic alkenyl, methyl 
ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as acid N-
(diarylalkyl)-, carbopolycyclic alkenyl, methyl ester (PMN P-20-176) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely reacted or cured.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; respiratory sensitization; skin sensitization; 
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(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=0.1.
    (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.  721.11899  Carbopolycyclic alkenyl, 2-carboxylic acid, 2-
[[[(diarylalkyl)] carbonyl]oxy] ethyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carbopolycyclic alkenyl, 2-carboxylic acid, 2-
[[[(diarylalkyl)]carbonyl]oxy]ethyl ester (PMN P-20-178) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been 
completely reacted or cured.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; respiratory sensitization; skin sensitization; 
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(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=0.2.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11900  Amines, C36-alkylenedi-, polymers with 5,5'-[(1-
methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione] and 
4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-aminophenol].

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as amines, C36-
alkylenedi-, polymers with 5,5'-[(1-methylethylidene)bis(4,1-
phenyleneoxy)]bis[1,3-isobenzofurandione] and 4,4'-[2,2,2-trifluoro-1-
(trifluoromethyl)ethylidene]bis[2-aminophenol] (PMN P-21-15; CASRN 
2419899-87-7) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: specific target organ toxicity. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a raw material 
in a temporary bonding adhesive formulation. The adhesive is used to 
bond completed semiconductor wafers to a backing substrate to 
facilitate mechanical grinding of the wafer to reduce its thickness. It 
is a significant new use to manufacture, process, or use the substance 
in any manner that results in worker inhalation exposure.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11901  Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-(1-methylethoxy)-.

    (a) Chemical substance and significant new uses subject to 
reporting.

[[Page 67386]]

(1) The chemical substance identified as poly[oxy(methyl-1,2-
ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-(1-methylethoxy)- (PMN P-
21-32; CASRN 2304726-48-3) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section do not apply to quantities of 
the substance after they have been completely reacted or destroyed.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity; skin corrosion; 
serious eye damage; 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). It is a significant new use to process 
or use the substance in any manner in formulation containing the 
substance at greater than 4%.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=110. Whenever the substance 
is released together with poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-butoxy- (PMN P-21-33; CASRN 2304726-50-7), N 
should be calculated using the combined number of kilograms of both 
substances released per site per day.
    (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.  721.11902  Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-butoxy-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-butoxy- (PMN P-21-33; 
CASRN 2304726-50-7) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or destroyed.
    (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), (3) and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: acute toxicity; skin 
corrosion; serious eye damage; 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). It is a significant new use to process 
or use the substance in any manner in formulation containing the 
substance at greater than 4%.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=110. Whenever the substance 
is released together with poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-(1-methylethoxy)- (PMN P-21-32; CASRN 2304726-48-
3), N should be calculated using the combined number of kilograms of 
both substances released per site per day.
    (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.  721.11903  Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer 
with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), 
dialkyl carbonate, alkanediol, alkylene[isocyanato-carbomonocycle] and 
[oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with 
dialkyalkanamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-
[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), dialkyl 
carbonate, alkanediol, alkylene[isocyanato-carbomonocycle] and 
[oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with 
dialkyalkanamine (PMN P-21-75) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted or 
cured.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible. For 
purposes of Sec.  721.63(a)(5), respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 50, or 1000 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 corrosion; 
skin irritation; serious eye damage; eye irritation; respiratory 
sensitization; 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.

[[Page 67387]]

    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (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.  721.11904  Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, alkanedioc acid dihydrazide, 
hydroxy-(hydroxyalkyl)-alkylalkanoic acid, isocyanato-
(isocyanatoalkyl)-alkyl substituted carbomonocycle, dialkylalkanediol 
and polyalkylene glycol(hydroxyalkyl)alkyl alkyl ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanedioic acid, polymers with alkanoic acid-dipentaerythritol 
reaction products, alkanedioc acid dihydrazide, hydroxy-(hydroxyalkyl)-
alkylalkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl substituted 
carbomonocycle, dialkylalkanediol and polyalkylene 
glycol(hydroxyalkyl)alkyl alkyl ether (PMN P-21-80) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been 
completely reacted or 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 1000 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: skin irritation; eye 
irritation; respiratory sensitization; skin sensitization; specific 
target organ toxicity. Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (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.  721.11905  Phenol, 4,4'-(1-methylethylidene) bis-, polymer with 
2,2'-[(1-methylethylidene) bis (4,1-phenyleneoxymethylene)] bis 
[heteromonocycle], bis (2-methyl-2-propenoate) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as phenol, 
4,4'-(1-methylethylidene)bis-, polymer with 2,2'-[(1-
methylethylidene)bis(4,1-phenyleneoxymethylene)] bis [heteromonocycle], 
bis (2-methyl-2-propenoate) (PMN P-21-96) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted or 
cured.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: 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. 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=2.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11906  Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or 
3)-[[substituted benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.', 
.alpha.'' -ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or 3)-[[substituted 
benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.', .alpha.'' -ether with 
2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) (PMN P-21-98) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely reacted or cured.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible. For 
purposes of Sec.  721.63(a)(5), respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 10.

[[Page 67388]]

    (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; skin sensitization; specific target organ toxicity; 
reproductive toxicity. For purposes of Sec.  721.72(g)(3), this 
substance may be toxic to aquatic life. Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture or process the substance in any manner or method that 
results in inhalation exposure. It is a significant new use to use the 
substance in formulations at concentrations greater than 4%.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=12.
    (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.  721.11907  Substituted heteromonocycle, polymer with haloalkyl 
substituted heteromonocycle, dialkyl-alkanediamine, 
(alkylalkylidene)bis[hydroxy-carbomonocycle] and oxybis[alkanol], 
reaction products with metal oxide and dialkanolamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted heteromonocycle, polymer with haloalkyl substituted 
heteromonocycle, dialkyl-alkanediamine, (alkylalkylidene)bis[hydroxy-
carbomonocycle] and oxybis[alkanol], reaction products with metal oxide 
and dialkanolamine (PMN P-21-126) 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) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(3) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=230.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (h), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11908  Carbonic acid, diphenyl ester, polymer with 1,4-
butanediol and 1,10-decanediol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as carbonic acid, 
diphenyl ester, polymer with 1,4-butanediol and 1,10-decanediol (PMN P-
21-175; CASRN 1615685-41-0) 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 destroyed.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(3) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=22.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f), 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.  721.11909  3,5,8-Trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-
alkoxy-1-alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 3,5,8-
trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-alkoxy-1-alkyl-2-oxoethoxy)-
2,6-dialkyl-7-oxo-, alkyl ester (PMN P-22-7) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely reacted 
or destroyed.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: eye irritation; 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. It is a 
significant new use to process for use or use the substance other than 
as a crosslinker in formulating general purpose sealants and adhesives. 
It is a significant new use to process for use or use the substance in 
consumer products other than in the form of a paste. It is a 
significant new use to process for use or use the substance where the 
concentration of the substance exceeds 6% by weight in consumer 
products. It is a significant new use to manufacture, process, or use 
the substance in any manner that results in inhalation exposure.
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 67389]]

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.  721.11910  .beta.-N-Acetylhexosaminidase (expressed in 
genetically modified Bacillus licheniformis strain ATJI0138).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as .beta.-N-
acetylhexosaminidase (expressed in genetically modified Bacillus 
licheniformis strain ATJI0138) (PMN P-22-8; CASRN 9012-33-3) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) 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; respiratory sensitization; skin sensitization; specific 
target organ toxicity. Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure. It is a significant new 
use to process the substance to greater than 1% in formulation for use 
in a consumer product.
    (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.  721.11911  Alkanes, C4-9-branched and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, C4-9-
branched and linear (PMN P-22-9; CASRN 2577172-51-9) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been 
incorporated into a fuel or refined or blended into other chemical or 
fuel formulations.
    (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 as a fuel, a refinery feedstock, a chemical feedstock, or a fuel 
blending additive or component.
    (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 (f), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11912  Amino alkanoic acid, N-[3-(trimethoxysilyl)propyl]-, 
3-(trimethoxysilyl)propyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amino 
alkanoic acid, N-[3-(trimethoxysilyl)propyl]-, 3-
(trimethoxysilyl)propyl ester (PMN P-22-10) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely reacted 
or cured.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; serious eye 
damage; 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 generates 
inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=80.
    (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.  721.11913  2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo, aryl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified

[[Page 67390]]

generically as 2-pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo, aryl ester (PMN P-22-13) 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), (g)(1), (3) and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: eye irritation; 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(g). It is a significant new use to 
manufacture, process, or use the substance unless in solid form when 
using a dust collection system with a capture and control efficient of 
at least 32%.
    (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.  721.11914  2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo- (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo- 
(PMN P-22-15) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: eye irritation; 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(g). It is a significant new use to 
manufacture, process, or use the substance unless in solid form when 
using a dust collection system with a capture and control efficient of 
at least 32%.
    (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.  721.11915  Polyphosphoric acids, esters with heteromonocycle 
homopolymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyphosphoric acids, esters with heteromonocycle homopolymer (PMN P-
22-37) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or 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 (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin corrosion; skin 
irritation; serious eye damage; 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 process 
the substance to greater than 1% in formulation. It is a significant 
new use to use the substance in a formulation containing the substance 
at a concentration greater than 1%.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=2.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).

[[Page 67391]]

    (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.  721.11916  Silica gel, reaction products with alkyl metal salt 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as silica 
gel, reaction products with alkyl metal salt (PMN P-22-44) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section. The requirements of this section 
do not apply to quantities of the substance after they have been 
completely destroyed.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: eye irritation; skin 
irritation; 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).
    (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.  721.11917  Graphene nanoplatelets (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
graphene nanoplatelets (PMN P-22-54) 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: (i) Completely 
reacted or cured; or (ii) Embedded into a permanent solid polymer form 
that is not intended to undergo further processing, except mechanical 
processing or physical blending.
    (2) The significant new uses are: (i) Protection in the workplace. 
Requirements as specified in Sec.  721.63(a)(1), (3) through (5), (b), 
and (c). When determining which persons are reasonably likely to be 
exposed as required for Sec.  721.63(a)(1) and (4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 50. For 
purposes of Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: specific target organ toxicity. 
For purposes of Sec.  721.72(g)(3), this substance may be toxic to 
aquatic life. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), (v)(3), and (x)(3). It is a 
significant new use to manufacture the substance other than by import 
into the United States in the form of a solution (i.e., no domestic 
manufacture). It is a significant new use to process the substance in 
any manner that generates inhalation exposure. It is a significant new 
use to use the substance in an application method where the 
concentration of the substance in the formulation exceeds the 
confidential concentration listed in the Order.
    (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.  721.11918  Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-
substituted tri-carbopolycycle, hetero-acid)benzenesulfonate (1:1) 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-substituted tri- 
carbopolycycle, hetero-acid)benzenesulfonate (1:1) (PMN P-22-86) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely reacted or adhered (during photolithographic processes) 
onto a semiconductor wafer surface or similar manufactured article used 
in the production of semiconductor technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (2)(i) through (iii), (v), 
(3)(i) and (ii), and (5). For purposes of Sec.  721.72(g)(1), this 
substance may cause: acute toxicity; skin irritation; serious eye 
damage; skin sensitization; genetic toxicity; specific

[[Page 67392]]

target organ toxicity. Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution or in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates a vapor, dust, mist, or 
aerosol in a non-enclosed process. It is a significant new use to 
manufacture the substance longer than 9 months.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11919  Heterotrisubstituted-bile acid, 1-
(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-
phenyldibenzothiophenium (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-
trifluoroethyl ester, ion(1-), (5)-, 5-phenyldibenzothiophenium (1:1) 
(PMN P-22-122) 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 completely reacted or adhered (during 
photolithographic processes) onto a semiconductor wafer surface or 
similar manufactured article used in the production of semiconductor 
technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (2)(i) through (iii), (v), 
(3)(i) and (ii), and (5). For purposes of Sec.  721.72(g)(1), this 
substance may cause: acute toxicity; skin irritation; serious eye 
damage; skin sensitization; genetic toxicity; specific target organ 
toxicity. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution or in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates a vapor, dust, mist, or 
aerosol in a non-enclosed process. It is a significant new use to 
manufacture the substance longer than 9 months.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11920  Sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt 
with 1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl 
trisubstitutedbenzoate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt with 1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl 
trisubstitutedbenzoate (1:1) (PMN P-22-179) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely reacted 
or adhered (during photolithographic processes) onto a semiconductor 
wafer surface or similar manufactured article used in the production of 
semiconductor technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (2)(i) through (iii), (v), 
(3)(i) and (ii), and (5). For purposes of Sec.  721.72(g)(1), this 
substance may cause: acute toxicity; skin irritation; serious eye 
damage; skin sensitization; genetic toxicity; carcinogenicity; specific 
target organ toxicity. Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution or in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates a vapor, dust, mist, or 
aerosol in a non-enclosed process. It is a significant new use to 
manufacture the substance longer than 9 months.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11921  Dibenzothiophenium, 5-phenyl-, 4-[1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkoxy]-4-oxoalkyl 
trisubstitutedbenzoate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
dibenzothiophenium, 5-phenyl-, 4-[1-(heterosubstitutedalkyl)-2,2,2- 
triheterosubstitutedalkoxy]-4-oxoalkyl trisubstitutedbenzoate (1:1) 
(PMN P-22-180) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or adhered (during 
photolithographic processes) onto a semiconductor wafer surface or 
similar

[[Page 67393]]

manufactured article used in the production of semiconductor 
technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (2)(i) through (iii), (v), 
(3)(i) and (ii), and (5). For purposes of Sec.  721.72(g)(1), this 
substance may cause: acute toxicity; skin irritation; serious eye 
damage; skin sensitization; genetic toxicity; carcinogenicity; specific 
target organ toxicity. Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution or in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates a vapor, dust, mist, or 
aerosol in a non-enclosed process. It is a significant new use to 
manufacture the substance longer than 9 months.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11922  .beta.-cyclodextrin, polymer with 2,3,5,6-tetrafluoro-
1,4-benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl 
ethers, chlorides.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as .beta.-
cyclodextrin, polymer with 2,3,5,6-tetrafluoro-1,4-
benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl ethers, 
chlorides (PMN P-22-115; CASRN 2683011-63-2) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been incorporated into 
an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 10. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; specific target organ toxicity. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance with 
particle size less than 20 microns. It is a significant new use to 
process for use or use the substance in consumer products except when 
incorporated into an article.
    (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.  721.11923  Substituted heterocyclic onium compound, salt with 
heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1), 
polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-
ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate, 
hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate 
and 4-hydroxyphenyl 2-methyl-2-propenoate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted heterocyclic onium compound, salt with 
heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1), 
polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-
ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate, 
hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate 
and 4-hydroxyphenyl 2-methyl-2-propenoate (PMN P-22-129) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been 
completely reacted or adhered (during photolithographic processes) onto 
a semiconductor wafer surface or similar manufactured article used in 
the production of semiconductor technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (2)(i) through (iii), (v), 
(3)(i) and (ii), and (5). For purposes of Sec.  721.72(g)(1), this 
substance may cause: acute toxicity; skin irritation; serious eye 
damage; skin sensitization; genetic toxicity; specific target organ 
toxicity. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution, unless in sealed 
containers weighing 5

[[Page 67394]]

kilograms or less. It is a significant new use to process the substance 
in any way that generates dust, mist, or aerosol in a non-enclosed 
process. It is a significant new use to manufacture the substance 
longer than 18 months.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11924  Haloalkylfurancarboxaldehyde (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
haloalkylfurancarboxaldehyde (PMN P-22-162) 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 
(destroyed).
    (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), (3) and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: acute toxicity; skin 
irritation; serious eye damage; skin sensitization; genetic toxicity; 
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(a) through (c), and (o). It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure.
    (iv) Disposal. It is a significant new use to dispose of the 
substance, or any waste streams containing the substance, other than by 
hazardous waste incineration achieving at least 99.99% destruction of 
the substance.
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=540.
    (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.

PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR 
MICROORGANISMS

0
3. The authority citation for part 725 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, 2613, and 2625.

0
4. Add Sec. Sec.  725.1082 to subpart M to read as follows:

Subpart M--Significant New Uses for Specific Microorganisms

* * * * *


Sec.  725.1082  Microorganism expressing enzymes (generic).

    (a) Microorganism and significant new uses subject to reporting. 
(1) The genetically-modified microorganism identified generically as 
microorganism expressing enzymes (MCAN J-23-3) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) It is a significant new use to manufacture, process, or use the 
microorganism other than in a fermentation system that meets all of the 
following conditions:
    (A) Enzyme production occurs by submerged fermentation (i.e., for 
enzyme production, growth of the microorganism occurs beneath the 
surface of the liquid growth medium); and
    (B) Any fermentation of solid plant material or insoluble substrate 
to which the microorganism fermentation broth is added after the 
standard industrial fermentation is completed is initiated only after 
the inactivation of the microorganism as delineated in Sec.  
725.422(d).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart L of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
725.950(b)(2) through (4) are applicable to manufacturers and 
processors of this microorganism.
    (2) Modification or revocation of certain notification 
requirements. The provisions of Sec.  725.984 apply to this section.

[FR Doc. 2024-18259 Filed 8-19-24; 8:45 am]
BILLING CODE 6560-50-P