Document ID: EPA-HQ-OPPT-2020-0588-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rules on Certain Chemical Substances (21-1.5e)
Posted Date: 2021-06-11T04:00Z

[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Proposed Rules]
[Pages 31239-31262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12147]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 721 and 725

[EPA-HQ-OPPT-2020-0588; FRL-10022-56]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (21-
1.5e)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for chemical substances that were 
the subject of premanufacture notices (PMNs) and a Microbial Commercial 
Activity Notice (MCAN), and are also subject to Orders issued by EPA 
pursuant to TSCA. The SNURs require persons who intend to manufacture 
(defined by statute to include import) or process any of these chemical 
substances for an activity that is proposed as a significant new use by 
this rule to notify EPA at least 90 days before commencing that 
activity. The required notification initiates EPA's evaluation of the 
use, under the conditions of use for that chemical substance, within 
the applicable review period. Persons may not commence manufacture or 
processing for the significant new use until EPA has conducted a review 
of the notice, made an appropriate determination on the notice, and has 
taken such actions as are required by that determination.

DATES: Comments must be received on or before July 12, 2021.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2020-0588, through the Federal eRulemaking 
Portal 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit 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 Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 564-4163; email address: wysong.william@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this proposed 
rule. The following list of North American Industrial Classification 
System (NAICS) codes is not intended to be exhaustive, but rather 
provides a guide to help readers determine whether this document 
applies to them. Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 
127.28. Chemical importers must certify that the shipment of the 
chemical substance complies with all applicable rules and Orders under 
TSCA, which would include the SNUR requirements should these proposed 
rules be finalized. The EPA policy in support of import certification 
appears at 40 CFR part 707, subpart B. In addition, 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 July 12, 2021 are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 
40 CFR 721.20), and must comply with the export notification 
requirements in 40 CFR part 707, subpart D.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    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

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C. 
2604(a)(2)) for chemical substances that were the subject of PMNs and 
an MCAN. These proposed SNURs would require persons to notify EPA at 
least 90 days before commencing the manufacture or processing of any of 
these chemical substances for an activity proposed as a significant new 
use. Receipt of such notices would allow EPA to assess risks and, if 
appropriate, to regulate the significant new use before it may occur.

[[Page 31240]]

    The docket for these proposed SNURs, identified as docket ID number 
EPA-HQ-OPPT-2020-0588, includes information considered by the Agency in 
developing these proposed SNURs.

B. 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 four TSCA section 5(a)(2) factors 
listed in Unit III.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A 
and (for microorganisms) 40 CFR part 725, subpart L. These provisions 
describe persons subject to the rule, recordkeeping requirements, 
exemptions to reporting requirements, and applicability of the rule to 
uses occurring before the effective date of the rule. Provisions 
relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 
721.1(c), persons subject to these SNURs must comply with the same 
significant new use notice (SNUN) requirements and EPA regulatory 
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). 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), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN and before the manufacture or processing 
for the significant new use can commence, EPA must either determine 
that the 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. 
If EPA determines that the use is not likely to present an unreasonable 
risk, EPA is required under TSCA section 5(g) to make public, and 
submit for publication in the Federal Register, a statement of EPA's 
findings.

III. Significant New Use Determination

    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, 
potential human exposures and environmental releases that may be 
associated with possible uses of these chemical substances, in the 
context of the four TSCA section 5(a)(2) factors listed in this unit.
    The 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). The TSCA Orders 
require protective measures to limit exposures or otherwise mitigate 
the potential unreasonable risk. The proposed SNURs identify 
significant new uses as any manufacturing, processing, use, 
distribution in commerce, or disposal that does not conform to the 
restrictions imposed by the underlying TSCA Orders, consistent with 
TSCA section 5(f)(4).
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA Order usually requires that potentially exposed 
employees wear specified respirators unless actual measurements of the 
workplace air show that air-borne concentrations of the PMN substance 
are below a New Chemical Exposure Limit (NCEL), and includes 
requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. No comparable NCEL provisions currently exist in 40 CFR 
part 721, subpart B, for SNURs. Therefore, for these cases, the 
individual SNURs in 40 CFR part 721, subpart E, will state that persons 
subject to the SNUR who wish to pursue NCELs as an alternative to the 
40 CFR 721.63 respirator requirements may request to do so under 40 CFR 
721.30. EPA expects that persons whose 40 CFR 721.30 requests to use 
the NCELs approach for SNURs that are approved by EPA will be required 
to comply with NCELs provisions that are comparable to those contained 
in the corresponding TSCA Order for the same chemical substance.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for certain chemical substances in 40 CFR part 721, subpart E and in 40 
CFR part 725, subpart M (for the microorganism). In this unit, EPA 
provides the following information for each chemical substance that is 
identified in this unit as subject to this proposed rule:
     PMN or MCAN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Effective date of and basis for the TSCA Order.
     Potentially Useful Information.
     CFR citation assigned in the regulatory text section of 
the proposed rule.
    The chemicals subject to these proposed SNURs are as follows:

PMN Number: P-16-167

    Chemical Name: Hindered amine alkyl ester compounds (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: April 24, 2020.
    Basis for TSCA Order: The PMN states that the use will be as a 
light stabilizer for plastic articles. Based on submitted test data, 
EPA has identified concerns for dermal irritation and sensitization. 
Based on comparison to analogous aliphatic amines, EPA predicts that 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a National Institute for Occupational Safety and 
Health (NIOSH)-certified respirator with an Assigned Protection Factor 
(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; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.

[[Page 31241]]

    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 and reproduction/developmental toxicity screening 
testing may be potentially useful to characterize the human 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.
    CFR Citation: 40 CFR 721.11571.

PMN Numbers: P-16-419, P-16-423, and P-16-424

    Chemical Names: N-alkyl-dialkyl piperidine (generic) (P-16-419), 
Tetraalkylpiperidinium halide (generic) (P-16-423), and 
Tetraalkylpiperidinium hydroxide (generic) (P-16-424).
    CAS Numbers: Not available.
    Effective Date of TSCA Order: April 15, 2020.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as an intermediate (P-16-419 and P-16-423) 
and as a directing agent (P-16-424). Based on comparison to analogous 
chemical substances, EPA has identified concerns for acute toxicity, 
corrosion, systemic and respiratory effects (P-16-419). Based on 
comparison to analogous chemical substances and the high pH, EPA has 
identified concerns for acute oral toxicity, developmental/reproductive 
toxicity, neurotoxicity, renal effects, and corrosion to all tissues 
(P-16-423 and P-16-424). Based on comparison to analogous chemical 
substances, EPA predicts that toxicity to aquatic organisms may occur 
at concentrations that exceed 286 ppb for P-16-419 and 20 ppb for P-16-
423 and P-16-424. 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. The Order was also issued under TSCA sections 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substance which was the subject of P-16-424 is or will be produced in 
substantial quantities and that the substance either enters or may 
reasonably be anticipated to enter the environment in substantial 
quantities, or there is or may be a significant (or substantial) human 
exposure to the substance. To protect against these risks, the Order 
requires:
     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 10 where there is a potential for inhalation exposure (P-16-419);
     Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
     Use of P-16-419 only as a site-limited intermediate;
     Use of P-16-423 only as an intermediate;
     Use of P-16-424 only for the confidential use allowed in 
the Order; and
     No release of the PMN substances resulting in surface 
water concentrations that exceed 286 ppb (P-16-419) or 20 ppb (P-16-423 
and P-16-424).
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA as determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity and specific target organ toxicity testing may be potentially 
useful to characterize the human health and environmental effects of 
the PMN substances. Additionally, the results of reproductive toxicity 
testing may be potentially useful to characterize the human health 
effects of PMNs P-16-423 and P-16-424. 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.
    CFR Citations: 40 CFR 721.11572 (P-16-419), 40 CFR 721.11573 (P-16-
423), and 40 CFR 721.11574 (P-16-424).

PMN Numbers: P-17-235 and P-18-226

    Chemical Names: Amidoamino quaternary ammonium salt (generic) (P-
17-235), and Tri alkyl, mono alkoxy, fatty acid ester, ammonium salt 
(generic) (P-18-226).
    CAS Numbers: Not available.
    Effective Date of TSCA Order: April 22, 2020.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as an anti-agglomerant. 
Based on the surfactant properties of the compounds and comparison to 
analogous substances, EPA has identified concerns for surfactant 
effects on the lungs, irritation and possible corrosion to the eyes, 
skin, and respiratory tract. Based on comparison to analogous 
substances, EPA has also identified concerns for developmental 
toxicity. Based on comparison to analogous polycationic polymers, EPA 
predicts that toxicity to aquatic organisms may occur at concentrations 
that exceed 60 ppb for P-17-235 and 44 ppb for P-18-226. 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:
     Use of the PMN substances only for the uses allowed in the 
Order; and
     No release of the PMN substances resulting in surface 
water concentrations that exceed 44 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of chronic 
aquatic toxicity, reproductive toxicity, and pulmonary effects testing 
may be potentially useful to characterize the human 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.
    CFR Citations: 40 CFR 721.11575 (P-17-235) and 40 CFR 721.11576 (P-
18-226).

PMN Number: P-17-259

    Chemical Name: Halogenated aromatic amine (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: August 31, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a curative for 
thermosetting resins. Based on comparison to structurally analogous 
chemical substances, EPA has identified concerns for skin sensitization 
and systemic effects (liver, blood, and spleen). Based on comparison to

[[Page 31242]]

analogous anilines, EPA predicts that toxicity to aquatic organisms may 
occur at concentrations that exceed 1 ppb. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health or the environment. To protect against these 
risks, the Order requires:
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of skin 
sensitization, specific target organ toxicity, and aquatic toxicity 
testing may be potentially useful to characterize the human 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.
    CFR Citation: 40 CFR 721.11577.

PMN Number: P-18-43

    Chemical Name: 1,4-Benzenedicarboxylic acid, 1,4-dipentyl ester, 
branched and linear.
    CAS Number: 2097734-13-7.
    Effective Date of TSCA Order: September 16, 2020.
    Basis for TSCA Order: The PMN states that the use will be as a 
plasticizer or fast fuser in PVC-plastisols for flooring, wall paper, 
coated fabrics, underbody coating; processing aid or fast fuser in PVC 
dry blends for flooring, coated fabrics, films & sheets, tubes & hoses; 
flexibilizing additive for paints and lacquers; use in formulation or 
re-packing; and as a laboratory agent. Based on the potential 
metabolite terephthalic acid, EPA has identified concerns for systemic 
toxicity. Based on comparison to analogous esters, EPA predicts that 
toxicity to aquatic organisms may occur at concentrations that exceed 2 
ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. The 
Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 
5(e)(1)(A)(ii)(II), based on a finding that the substance is expected 
to be produced in substantial quantities, and that there may be a 
significant or substantial human exposure to the substance, and that 
the substance may enter the environment in substantial quantities. To 
protect against these risks, the Order requires:
     No release of the PMN substance resulting in surface water 
concentrations that exceed 2 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 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.
    CFR Citation: 40 CFR 721.11578.

PMN Numbers: P-18-178, P-18-217, and P-18-218

    Chemical Names: Dialkyltin dialkylcarboxylate (generic) (P-18-178), 
Alkyltin dodecylthioester (generic) (P-18-217), and Alkyltin 
tetradecylthioester (generic) (P-18-218).
    CAS Numbers: Not available.
    Effective Date of TSCA Order: May 20, 2020.
    Basis for TSCA Order: The PMNs state that the use of the substances 
will be as stabilizers for PVC compounds. Based on the physical/
chemical properties of the PMN substances and test data on structurally 
similar substances, the PMN substances are potentially persistent, 
bioaccumulative, and toxic (PBT) chemicals (as described in the New 
Chemical Program's PBT category at 64 FR 60194; November 4, 1999; FRL-
6097-7). EPA estimates that the PMN substances will persist in the 
environment for more than 2 months and estimates a bioaccumulation 
factor of greater than or equal to 1,000. Based on comparison to 
analogous chemical substances, EPA has identified concerns for immune, 
reproductive, developmental, and systemic effects. Based on comparison 
to analogous organotins, EPA predicts that 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 substances may present an 
unreasonable risk of injury to human health or the environment. The 
Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 
5(e)(1)(A)(ii)(II), based on a finding that the substances are or will 
be produced in substantial quantities and that the substances either 
enter or may reasonably be anticipated to enter the environment in 
substantial quantities, or there is or may be a significant (or 
substantial) human exposure to the substances. To protect against these 
risks, the Order requires:
     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 10 where there is a potential for inhalation exposure for P-18-
178;
     No use of the PMN substances other than as stabilizers for 
PVC compounds; and
     No release of the PMN substances into the waters of the 
United States.
    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 
persistence, bioaccumulation, aquatic toxicity, reproductive toxicity 
and specific target organ toxicity testing may be potentially useful to 
characterize the human 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.
    CFR Citations: 40 CFR 721.11579 (P-18-178), 40 CFR 721.11580 (P-18-
217), and 40 CFR 721.11581 (P-18-218).

PMN Number: P-18-256

    Chemical Name: Undecanol, branched.
    CAS Number: 203473-00-4.
    Effective Date of TSCA Order: August 18, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a chemical intermediate and

[[Page 31243]]

a solvent. Based on submitted test data on the new chemical substance, 
EPA has identified concerns for skin and eye irritation and systemic 
toxicity. Based on test data for structurally analogous chemical 
substance, EPA has also identified concerns for developmental and 
systemic toxicity. Based on comparison to analogous neutral organics, 
EPA predicts that toxicity to aquatic organisms may occur at 
concentrations that exceed 4 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. The Order was also issued under TSCA 
sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding 
that the substance is expected to be produced in substantial 
quantities, and that there may be significant or substantial human 
exposure to the substance, and that the substance may enter the 
environment in substantial quantities. To protect against these risks, 
the Order requires:
     No use of the PMN substance other than as a chemical 
intermediate; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 4 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific organ toxicity, developmental toxicity, and aquatic toxicity 
testing may be potentially useful to characterize the human 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.
    CFR Citation: 40 CFR 721.11582.

PMN Number: P-18-283

    Chemical Name: Hydroxy alkanoic acid, compds. with 
aminoalkoxyalcohol-epoxy polymer-alkanolamine reaction products 
(generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: March 31, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for open, non-dispersive 
use. Based on comparison to structurally analogous chemical substances 
for the low molecular weight (LMW) fractions of the PMN substance, EPA 
has identified concerns for irritation and sensitization. Based on 
comparison to structurally analogous chemical substances, EPA has also 
identified concerns for reproductive toxicity and systemic effects. 
Based on comparison to analogous aliphatic amines and polycationic 
polymers, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 4 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health and the environment. To protect against these risks, the 
Order requires:
     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; and
     No release of the PMN substance into the waters of the 
United States.
    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 and eye irritation, skin sensitization, reproductive 
toxicity, and specific target organ toxicity testing may be potentially 
useful to characterize the human 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 a submission of this or other relevant 
information.
    CFR Citation: 40 CFR 721.11583.

PMN Number: P-18-298

    Chemical Name: 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer 
with ethyleneamine, 2-(chloromethyl)oxirane, 2-[[4-(1,1-
dimethylethyl)phenoxy]methyl]oxirane, 2,2'-[1,6-
hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxymethyl]oxirane (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: August 4, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an epoxy curing agent. Based on comparison 
to structurally analogous amines and the LMW fractions, EPA has 
identified concerns for skin and eye irritation, dermal and respiratory 
sensitization, and lung effects. Based on the comparison to 
structurally analogous epoxide residuals, EPA has also identified 
concerns for reproductive toxicity and systemic effects. Based on 
comparison to analogous aliphatic amines and polycationic polymers, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 50 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     No manufacturing, processing, or use of the PMN substance 
in an application method that results in inhalation exposure;
     No use of the PMN substance in a consumer product; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 50 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
absorption, eye damage, skin irritation, specific target organ 
toxicity, and aquatic toxicity testing may be potentially useful to 
characterize the human 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.
    CFR Citation: 40 CFR 721.11584.

PMN Number: P-18-310

    Chemical Name: Benzenepropanoic acid, 3-(2H-benzotriazol-2-yl)-5-
(1,1-

[[Page 31244]]

dimethylethyl)-4-hydroxy-2,2-bis(hydroxymethyl)butyl ester.
    CAS Number: 2101609-93-0.
    Effective Date of TSCA Order: August 14, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a polymer additive. Based on test data on 
structurally analogous chemical substances, EPA has identified concerns 
for blood, liver, thyroid and kidney effects, reproductive toxicity, 
and developmental toxicity. Based on comparison to analogous phenols 
and benzotriazoles, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 1 ppb. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health or the environment. To protect against these 
risks, the Order requires:
     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 1,000 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; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if the manufacturer or processor 
is considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
developmental neurotoxicity and aquatic toxicity testing may be 
potentially useful to characterize the human 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.
    CFR Citation: 40 CFR 721.11585.

PMN Number: P-18-318

    Chemical Name: 1-Octadecanaminium, N,N-dimethyl-N- [3-
(triethoxysilyl)propyl]-, chloride (1:1).
    CAS Number: 62117-57-1.
    Effective Date of TSCA Order: September 25, 2020.
    Basis for TSCA Order: The PMN states that the use will be as a 
surface treatment for added lubricity and anti-static purposes. Based 
on comparison to structurally analogous chemical substances, EPA has 
identified concerns for irritation to the eyes, skin, and respiratory 
tract and liver effects. Based on comparison to structurally analogous 
chemical substances and structural alerts for cationic surfactants, EPA 
has also identified concerns for lung effects. Based on comparison to 
analogous polycationic polymers, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 1 ppb. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to human health or the environment. To protect against 
these risks, the Order requires:
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS;
     Use of the PMN substance only as a surface treatment for 
added lubricity and anti-static properties;
     No use of the PMN substance in an application method that 
results in inhalation exposure; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of skin 
irritation, eye irritation, pulmonary effects, and aquatic toxicity 
testing may be potentially useful to characterize the human 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.
    CFR Citation: 40 CFR 721.11586.

PMN Number: P-18-323

    Chemical Name: 2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl 
ester.
    CAS Number: 156291-88-2.
    Effective Date of TSCA Order: March 13, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a raw material for 
polymer manufacturing. Based on submitted test data on the PMN 
substance and structural alerts, EPA has identified concerns for skin 
irritation and skin/respiratory sensitization. Based on comparison to 
structurally analogous chemical substances, EPA has also identified 
concerns for systemic, respiratory, and developmental effects. Based on 
comparison to analogous methacrylates, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 98 ppb. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to human health or the environment. To protect against 
these risks, the Order requires:
     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 to prevent inhalation exposure 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;
     Use of the PMN substance only for the confidential use 
allowed in the Order; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 98 ppb.
    The proposed SNUR designates as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. EPA has determined that the results of chronic 
aquatic toxicity and specific target organ toxicity testing may be 
potentially useful to characterize the environmental and human health 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
relevant information.
    CFR Citation: 40 CFR 721.11587.

[[Page 31245]]

PMN Number: P-18-327

    Chemical Name: Mixed metal oxide (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: August 21, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a filler for non-dispersive resins. Based 
on comparison to structurally analogous chemical substances, EPA has 
identified concerns for dermal and respiratory sensitization. EPA has 
also identified concerns for lung effects (lung overload) if the 
particulate is respirable, based on information for other poorly 
soluble particulates, and carcinogenicity if the PMN substance is 
crystalline and respirable. 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:
     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 1,000 where there is a potential for inhalation exposure, or 
compliance with a NCEL of 0.1 mg/m\3\ as an 8-hour time-weighted 
average (TWA) to prevent 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 toxicity, skin sensitization, and carcinogenicity testing may 
be potentially useful to characterize the human health effects of the 
PMN substance. Although the Order does not require these tests, the 
Order's restrictions remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other relevant 
information.
    CFR Citation: 40 CFR 721.11588.

PMN Number: P-18-347

    Chemical Name: Amines, polyethylenepoly-, triethylenetetramine 
fraction, polymers with guanidine hydrochloride (1:1).
    CAS Number: 1902936-67-7.
    Effective Date of TSCA Order: March 17, 2020.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be as an aldehyde scavenger for the manufacture of polyurethane 
foams. Based on comparison to structurally analogous chemical 
substances, EPA has identified concerns for skin sensitization. Based 
on available test data on the PMN substance, EPA has also identified 
concerns for acute toxicity. Based on structural alerts for 
polycationic binding, EPA has also identified concerns for lung 
effects. Based on comparison to structurally analogous polycationic 
polymers, EPA predicts that 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:
     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; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 2 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information about may be potentially useful in support of a request by 
the PMN submitter to modify the Order, or if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that would be designated by this SNUR. EPA has determined that the 
results of aquatic toxicity, pulmonary effects and skin sensitization 
testing may be potentially useful to characterize the human 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.
    CFR Citation: 40 CFR 721.11589.

PMN Number: P-18-405

    Chemical Name: Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 
3,6,9,12-tetraoxatetradeca-1, 13-diene, glycidyl ether.
    CAS Number: 647028-24-8.
    Effective Date of TSCA Order: August 7, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an adhesive. Based on the epoxide moiety 
for the LMW fraction, EPA has identified concerns for skin and lung 
sensitization, carcinogenicity, developmental toxicity, male 
reproductive toxicity, liver, and kidney toxicity. Based on submitted 
test data, information in the SDS, and analogous epoxides, EPA has also 
identified concerns for skin irritation and genotoxicity. Based on 
comparison to analogous epoxides, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 1 ppb. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to human health or the environment. To protect against 
such risks, the Order requires:
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure;
     No use of the PMN substance in a consumer product; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
pulmonary toxicity, skin sensitization, carcinogenicity, reproductive/
developmental toxicity, skin and eye irritation, specific target organ 
toxicity and aquatic toxicity testing may be potentially useful to 
characterize the human 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.
    CFR Citation: 40 CFR 721.11590.

PMN Number: P-19-36

    Chemical Name: 1,4-Benzenedicarboxylic acid, 1,4-bis(2-
phenoxyethyl) ester.

[[Page 31246]]

    CAS Number: 25900-07-6.
    Effective Date of TSCA Order: July 24, 2020.
    Basis for TSCA Order: The PMN states that the use will be as an 
additive to polymers for improvement in gas barrier performance. Based 
on comparison to structurally analogous chemical substances, EPA has 
identified concerns for irritation to the skin, eyes, and respiratory 
tract. Based on test data for terephthalic acid, EPA has also 
identified concerns for bladder effects and developmental effects. 
Based on test data for 2-phenoxyethanol, EPA has also identified 
concerns for blood effects, kidney effects, bladder effects, and 
respiratory tract effects. Based on comparison to analogous esters, EPA 
predicts that toxicity to aquatic organisms may occur at concentrations 
that exceed 3 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     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 1,000 where there is a potential for inhalation exposure; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 3 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of skin 
irritation, reproductive/developmental toxicity, specific target organ 
toxicity, and aquatic toxicity testing may be potentially useful to 
characterize the human 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.
    CFR Citation: 40 CFR 721.11591.

PMN Number: P-19-52

    Chemical Name: Poly(oxy-1,2-ethanediyl), .alpha.-nonyl-.omega.-
hydroxy-, branched and linear.
    CAS Number: 2242406-13-7.
    Effective Date of TSCA Order: February 14, 2020.
    Basis for TSCA Order: The PMN states that the use of the PMN 
substance will be as a hard surface cleaner and as a component of 
laundry detergent. Based on repeating polyether units, EPA has 
identified concerns for surfactant effects on the lungs. Based on 
comparison to structurally analogous chemical substances, EPA has also 
identified concerns for eye corrosion and mild skin irritation. Based 
on alcohol ethoxylates, EPA has also identified liver, cardiac, and 
systemic effects. Based on comparison to analogous nonionic 
surfactants, 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 or the environment. To protect against these risks, the 
Order requires:
     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 1,000 where there is potential for inhalation exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS;
     No use of the PMN substance where the concentration of the 
PMN substance in the product formulation intended for distribution in 
commerce exceeds 1% by weight; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 34 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of acute 
aquatic toxicity, chronic aquatic toxicity, pulmonary effects, specific 
target organ toxicity, eye damage, and skin irritation testing may be 
potentially useful to characterize the human health and environmental 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions still remain in effect until the Order 
is modified or revoked by EPA based on submission of this or other 
relevant information.
    CFR Citation: 40 CFR 721.11592.

PMN Number: P-19-53

    Chemical Name: 1-Butanamine, N-butyl-N-[(triethoxysilyl)methyl]-.
    CAS Number: 35501-23-6.
    Effective Date of TSCA Order: August 5, 2020.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be as a surface treatment, sealant, caulk, and coating for mineral 
building materials such as concrete, brick, limestone, and plaster, as 
well as on wood, metal, and other substrates. Based on the 
alkoxysilanes category and reactivity of the new chemical substance, 
EPA has identified concerns for lung effects. Based on submitted test 
data, EPA has also identified concerns for skin sensitization and 
developmental effects. Based on comparison to analogous aliphatic 
amines, EPA predicts toxicity to aquatic organisms may occur in 
concentrations that exceed 150 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. To protect against these risks, the 
Order requires:
     Use of dermal protective equipment where there is a 
potential for dermal exposure;
     No import, processing, or use of the PMN substance other 
than in liquid form;
     No domestic manufacture (i.e., import only); and
     No use of the PMN substance in a consumer product.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
pulmonary effects and skin sensitization testing may be potentially 
useful to characterize the human health effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
    CFR Citation: 40 CFR 721.11593.

[[Page 31247]]

PMN Number: P-19-77

    Chemical Name: Alkenylamide (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: March 31, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for agricultural use. Based 
on available test data on a structurally analogous chemical substance, 
EPA has identified concerns for skin irritation, eye irritation, 
reproductive toxicity, and systemic toxicity. Based on information in 
the SDS, EPA has also identified concerns for respiratory tract 
irritation. Based on comparison to analogous amides, 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:
     Use of the PMN substance only for the confidential use 
allowed in the Order; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 4 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. EPA has determined that the results of eye 
damage, skin irritation, specific target organ toxicity, and aquatic 
toxicity testing may be potentially useful to characterize the human 
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.
    CFR Citation: 40 CFR 721.11594.

PMN Number: P-19-131

    Chemical Name: Isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride 
(generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: July 24, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive for horizontal oil drilling. 
Based on comparison to structurally analogous chemical substances, EPA 
has identified concerns for irritation to the eyes and skin, systemic 
effects, lung effects, and developmental effects. Based on comparison 
to analogous chemical substances, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 1 ppb. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to human health or the environment. To protect against 
these risks, the Order requires:
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS;
     No manufacturing, processing, or use of the PMN substance 
in a manner that results in inhalation exposure;
     No use of the PMN substance in consumer products; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of skin 
irritation, eye irritation, specific target organ toxicity, and aquatic 
toxicity testing may be potentially useful to characterize the human 
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.
    CFR Citation: 40 CFR 721.11595.

PMN Numbers: P-19-143 and P-19-144

    Chemical Names: Aldehyde, polymer with mixed alkane polyamines, 
2,2'-[1,4-alkanediylbis(oxyalkylene)]bis[oxirane], 2-
(alkoxyalkyloxirane, 4,4'-(1-alkylidene)bis[phenol], 2,2'-[(1-
alkylidene)bis(4,1-alkyleneoxyalkylene)]bis[oxirane] and 2-
(aryloxyalkyl)oxirane, acetate (salt) (generic) (P-19-143) and 
Alkanedioic acid, compds. with substituted arylalkylamine-arylalcohol 
disubstituted alkane-the diglycidyl ether of a arylalcohol 
disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-[(2-
aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction products 
(generic) (P-19-144).
    CAS Numbers: Not available.
    Effective Date of TSCA Order: February 18, 2020.
    Basis for TSCA Order: The PMNs state that the use of the substances 
will be as a crosslinking agent for use in epoxy resin for water-based 
coating for a variety of substrates and civil applications in 
commercial uses (P-19-143) and a crosslinking agent in epoxy based 
self-leveling floor coatings (P-19-144). EPA has identified concerns 
for lung effects (cationic binding) if respirable particles are 
inhaled. Based on structural alerts for polyamines, EPA has identified 
dermal and respiratory sensitization. Based on comparison to analogous 
chemical substances, EPA has identified concerns for skin and eye 
irritation. Based on the LMW species, EPA has also identified concerns 
for systemic, reproductive, and developmental effects. Based on 
comparison to analogous polycationic polymers, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 1 ppb. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substances may present 
an unreasonable risk of injury to human health or the environment. The 
Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 
5(e)(1)(A)(ii)(II), based on a finding that the substance which was the 
subject of PMN P-19-143 is expected to be produced in substantial 
quantities, and that there may be significant or substantial human 
exposure to the substance, and that the substance may enter the 
environment in substantial quantities. To protect against these risks, 
the Order requires:
     No manufacture, processing, or use of the PMN substances 
in a manner that results in inhalation exposure to either the PMN 
substances or to formaldehyde;
     No use of the PMN substances in consumer products; and
     No release of the PMN substances resulting in surface 
water concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.

[[Page 31248]]

    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, eye irritation, skin irritation, skin sensitization, 
specific target organ toxicity, reproductive and developmental 
toxicity, and aquatic toxicity testing may be potentially useful to 
characterize the human 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.
    CFR Citations: 40 CFR 721.11596 (P-19-143) and 40 CFR 721.11597 (P-
19-144).

PMN Number: P-19-145

    Chemical Name: Polyazaalkane with oxirane and methyloxirane, 
haloalkane (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: July 6, 2020.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be as an oil field drilling fluid additive. Based on structure, 
EPA has identified concerns for lung effects (surfactancy). Based on 
comparison to structurally analogous chemical substances, EPA has also 
identified concerns for neurological, systemic, and reproductive/
developmental effects. Based on comparison to analogous cationic 
polymers, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 26 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. To protect against these risks, the 
Order requires:
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS;
     No manufacture, processing, or use of the PMN substance in 
a manner that results in inhalation exposure; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 26 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
neurotoxicity, specific target organ toxicity, pulmonary effects, 
reproductive/developmental 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.
    CFR Citation: 40 CFR 721.11598.

PMN Number: P-19-153

    Chemical Name: Dibromoalkyl ether tetrabromobisphenol A (generic).
    CAS Number: None available.
    Effective Date of TSCA Order: July 20, 2020.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be as a raw material in flame retardant products. Based on the 
physical/chemical properties of the PMN substance and of the photolysis 
product, the PMN substance and the photolysis product are potentially 
persistent, bioaccumulative, and toxic (PBT) chemicals (as described in 
the New Chemical Program's PBT category at 64 FR 60194; November 4, 
1999; FRL-6097-7). EPA estimates that the PMN substance will persist in 
the environment for more than 6 months and estimates a bioaccumulation 
factor of greater than or equal to 1,000. EPA estimates that the 
photolysis product will persist in the environment for more than 2 
months and estimates a bioaccumulation factor of greater than or equal 
to 1,000. Based on available data on the PMN substance, EPA has 
identified concerns for eye irritation, systemic effects, and 
reproductive/developmental effects. Based on data for the photolysis 
product, EPA has also identified concerns for systemic effects and 
carcinogenicity. Based on comparison to analogous anionic surfactants, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 1 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     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; and
     No release of the PMN substance into surface waters of the 
United States.
    The proposed SNUR would designate as a ``significant new use'' in 
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 
environmental fate, bioaccumulation, specific target organ toxicity and 
carcinogenicity testing may be potentially useful to characterize the 
human health effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
    CFR Citation: 40 CFR 721.11599.

PMN Number: P-20-29

    Chemical Name: Octonal, 7(or 8)-formyl-.
    CAS Number: 1607842-40-9.
    Effective Date of TSCA Order: August 5, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an oil soluble additive. Based on 
submitted test data on the new chemical substance, EPA has identified 
concerns for skin and eye irritation, dermal sensitization, systemic 
toxicity, and neurotoxicity. Based on OECD Toolbox results, EPA has 
identified concerns for respiratory sensitization. Based on comparison 
to structurally analogous chemical substances, EPA has also identified 
concerns for respiratory effects. Based on comparison to analogous 
neutral organics, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 17 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. To protect against these risks, the 
Order requires:

[[Page 31249]]

     No release of the PMN substance resulting in surface water 
concentrations that exceed 17 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 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.
    CFR Citation: 40 CFR 721.115600.

PMN Number: P-20-42

    Chemical Name: Sulfonium, trisaryl-, 7,7-dialkyl-2-
heteropolycyclic-1-alkanesulfonate (1:1) (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: April 29, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a photoacid 
generator. Based on the physical/chemical properties of the PMN 
substances and test data on structurally similar substances, the PMN 
substances are potentially persistent, bioaccumulative, and toxic (PBT) 
chemicals (as described in the New Chemical Program's PBT category at 
64 FR 60194; November 4, 1999; FRL-6097-7). EPA estimates that the PMN 
substances will persist in the environment for more than 2 months and 
estimates a bioaccumulation factor of greater than or equal to 1,000. 
Based on the photoreactivity of the PMN substance, EPA has identified 
concerns for photosensitization. Based on comparison to analogous 
substances, EPA has identified concerns for eye corrosion, irritation, 
acute toxicity, liver toxicity, neurotoxicity, and reproductive 
(developmental) toxicity. EPA has also identified concerns for lung 
overload by insoluble polymers for photoacid generators with polymeric 
anions that have a molecular weight over 10,000 g/mol. 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 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 as described in the PMN;
     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.
    CFR Citation: 40 CFR 721.11601.

PMN Number: P-20-104

    Chemical Name: Alkenoic acid, polymer with (alkyl alkenyl) 
polyether (generic).
    CAS Number: None available.
    Effective Date of TSCA Order: August 25, 2020.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive. Based on structural alerts 
and comparison to structurally analogous chemical substances, EPA has 
identified concerns for lung effects (surfactancy) and irritation to 
the skin, eyes, and respiratory tract. Based on comparison to 
structurally analogous chemical substances, EPA has also identified 
concerns for systemic effects (i.e., neurotoxicity and cardiotoxicity) 
and aquatic toxicity. Based on a residual which is present in the 
substance, EPA has also identified concerns for irritation/corrosion to 
the skin and eyes, skin sensitization, systemic effects, 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. 
The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 
5(e)(1)(A)(ii)(II), based on a finding that the substance is expected 
to be produced in substantial quantities, and that there may be 
significant or substantial human exposure to the substance, and that 
the substance may enter the environment in substantial quantities. To 
protect against these risks, the Order requires:
     No manufacture, processing, or use of the PMN substance in 
a manner that results in inhalation exposure;
     No use of the PMN substance in a consumer product;
     No release of the PMN substance resulting in surface water 
concentrations that exceed 75 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 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.
    CFR Citation: 40 CFR 721.11602.

MCAN Number: J-16-26

    Microorganism name: Trichoderma reesei modified (generic).
    CAS number: Not applicable.
    Effective Date of TSCA Order: April 10, 2017.
    Basis for TSCA Order: The MCAN states that the generic (non-
confidential) use of the microorganism will be for enzyme production. 
EPA determined that certain fermentation conditions, other than the 
typical submerged standard industrial fermentation process

[[Page 31250]]

for enzyme production, could result in increased exposures. 
Specifically, EPA is concerned that where growth on plant material or 
on solid substrates occurs, T. reesei 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 or 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:
    (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 Trichoderma reesei fermentation broth is added 
after the standard industrial fermentation is completed, is 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 substance 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 genetically-modified T. reesei 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 fungus during an 
anaerobic fermentation for production of ethanol by an ethanologen, and 
survival of the fungus 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.
    CFR citation: 40 CFR 725.1081.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs and MCAN submitted for the chemical 
substances that are the subject to these proposed SNURs, EPA concluded 
that regulation was warranted under TSCA section 5(e), pending the 
development of information sufficient to make reasoned evaluations of 
the health or environmental effects of the chemical substances. The 
basis for such findings is outlined in Unit IV. Based on these 
findings, TSCA section 5(e) Orders requiring the use of appropriate 
exposure controls were negotiated with the PMN and 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.

B. Objectives

    EPA is proposing these SNURs for specific chemical substances which 
have undergone premanufacture review 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 notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     To be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.

VI. Applicability of the Proposed Significant New Use Designation

    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. In cases where EPA has not 
received a notice of commencement (NOC) and the chemical substance has 
not been added to the TSCA Inventory, no person may commence such 
activities without first submitting a PMN (or MCAN, as applicable). 
Therefore, for chemical substances for which an NOC has not been 
submitted EPA concludes that the designated significant new uses are 
not ongoing.
    When chemical substances identified in this proposed rule 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. However, TSCA Orders have been issued for 
these chemical substances and the PMN and MCAN submitters are 
prohibited by the TSCA Orders from undertaking activities which would 
be designated as significant new uses. The identities of many of the 
chemical substances subject to this proposed rule have been claimed as 
confidential per 40 CFR 720.85 or 40 CFR 725.85 (for the 
microorganism). Based on this, the Agency believes that it is highly 
unlikely that any of the significant new uses described in the 
regulatory text of this proposed rule are ongoing.
    Therefore, EPA designates June 11, 2021 as the cutoff date for 
determining whether the new use is ongoing. The objective of EPA's 
approach is to ensure that a person cannot defeat a SNUR by initiating 
a significant new use before the effective date of the final rule.
    In the unlikely event that a person began commercial manufacture or 
processing of the chemical substances for a significant new use 
identified as of that date would have to cease any such activity upon 
the effective date of the final rule. To resume their activities, these 
persons would have to first comply with all applicable SNUR 
notification requirements and wait until EPA has conducted a review of 
the

[[Page 31251]]

notice, made an appropriate determination on the notice, and has taken 
such actions as are required with that determination.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the internet at 
https://www.epa.gov/tsca-inventory.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing 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, TSCA 
Order or consent agreement under TSCA section 4, then TSCA section 
5(b)(1)(A) requires such information to be submitted to EPA at the time 
of submission of the SNUN.
    In the absence of a rule, TSCA Order, or consent agreement under 
TSCA section 4 covering the chemical substance, persons are required 
only to submit information in their possession or control and to 
describe any other information known or reasonably ascertainable (see 
40 CFR 720.50 or 40 CFR 725.160 [for the microorganism]). However, upon 
review of PMNs and SNUNs, the Agency has the authority to require 
appropriate testing. Unit IV. lists potentially useful information for 
the SNURs listed in this document. Descriptions of this information is 
provided for informational purposes. The potentially useful information 
identified in Unit IV. will be useful to EPA's evaluation in the event 
that someone submits a SNUN for the significant new use.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency. 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.
    In some of the TSCA Orders for the chemical substances identified 
in this rule, EPA has established time limits in view of the lack of 
data on the potential health and environmental risks that may be posed 
by the significant new uses or increased exposure to the chemical 
substances. These limits cannot be exceeded unless the PMN submitter 
first submits the results of specified tests that would permit a 
reasoned evaluation of the potential risks posed by these chemical 
substances. The SNURs contain the same time limits as the TSCA Orders. 
Exceeding these production limits is defined as a significant new use. 
Persons who intend to exceed the time limit must notify the Agency by 
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described 
in the TSCA Orders was made based on EPA's consideration of available 
screening-level data, if any, as well as other available information on 
appropriate testing for the PMN substances. Further, any such testing 
request on the part of EPA that includes testing on vertebrates was 
made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models.
    The potentially useful information listed in Unit IV. may not be 
the only means of addressing the potential risks of the chemical 
substance. However, submitting a SNUN without any test data or other 
information may increase the likelihood that EPA will take action under 
TSCA section 5(e) or 5(f). EPA recommends that potential SNUN 
submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. 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. According to 40 CFR 725.900, persons 
submitting an MCAN for a significant new use of a microorganism must 
comply with the same notification requirements and EPA regulatory 
procedures as persons submitting an MCAN for a new microorganism, 
including submission of test data on health and environmental effects 
as described in 40 CFR 725.160. E-PMN software is available 
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule. EPA's complete economic 
analysis is available in the docket for this rulemaking.

X. 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 13563: Improving Regulations and Regulatory Review

    This action proposes to establish SNURs for several new chemical 
substances that were the subject of PMNs and an MCAN. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 
13563 (76 FR 3821, January 21, 2011).

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 activities associated with SNURs have 
already

[[Page 31252]]

been approved by OMB under the PRA and assigned OMB control number 
2070-0012 (EPA ICR No. 574). This proposed rule does not contain 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 response. 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.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including using 
automated collection techniques, to the Director, Regulatory Support 
Division, Office of Mission Support (2822T), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please 
remember to include the OMB control number in any correspondence, but 
do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the 
Agency hereby certifies that promulgation of these SNURs would not have 
a significant adverse economic impact on a substantial number of small 
entities. 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, it appears 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. 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 seven in Federal fiscal year (FY) 2013, 13 
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 
and only a fraction of these were from small businesses. In addition, 
the Agency currently offers relief to qualifying small businesses by 
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee 
reduces the total reporting and recordkeeping of cost of submitting a 
SNUN to about $10,116 for qualifying small firms. Therefore, the 
potential economic impacts of complying with this proposed SNUR 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 final 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)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this action. As 
such, EPA has determined that this proposed rule would not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

    This action would not 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, as specified in Executive Order 13132 (64 FR 
43255, August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action would not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
action would not significantly nor uniquely affect the communities of 
Indian Tribal governments, nor would it involve or impose any 
requirements that affect Indian Tribes. Accordingly, the requirements 
of Executive Order 13175 (65 FR 67249, November 9, 2000), 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 this is not an economically significant 
regulatory action as defined by Executive Order 12866, and this action 
does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355, 
May 22, 2001), because this proposed rule is not expected to affect 
energy supply, distribution, or use.

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

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994).

List of Subjects in 40 CFR Parts 721 and 725

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

    Dated: June 4, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, for the reasons stated in the preamble, it is proposed 
that 40 CFR chapter I be amended as follows:

PARTS 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, 2613, and 2625(c).

0
2. Add Sec. Sec.  721.11571 through 721.11603 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

* * * * *
Sec.
* * * * *
721.11571 Hindered amine alkyl ester compounds (generic).
721.11572 N-alkyl-dialkyl piperidine (generic).
721.11573 Tetraalkylpiperidinium halide (generic).
721.11574 Tetraalkylpiperidinium hydroxide (generic).
721.11575 Amidoamino quaternary ammonium salt (generic).
721.11576 Tri alkyl, mono alkoxy, fatty acid ester, ammonium salt 
(generic).
721.11577 Halogenated aromatic amine (generic).

[[Page 31253]]

721.11578 1,4-Benzenedicarboxylic acid, 1,4-dipentyl ester, branched 
and linear.
721.11579 Dialkyltin dialkylcarboxylate (generic).
721.11580 Alkyltin dodecylthioester (generic).
721.11581 Alkyltin tetradecylthioester (generic).
721.11582 Undecanol, branched.
721.11583 Hydroxy alkanoic acid, compds. with aminoalkoxyalcohol-
epoxy polymer-alkanolamine reaction products (generic).
721.11584 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with 
ethyleneamine, 2-(chloromethyl)oxirane, 2-[[4-(1,1-
dimethylethyl)phenoxy]methyl]oxirane, 2,2'-[1,6-
hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxymethyl]oxirane (generic).
721.11585 Benzenepropanoic acid, 3-(2H-benzotriazol-2-yl)-5-(1,1-
dimethylethyl)-4-hydroxy-2,2-bis(hydroxymethyl)butyl ester.
721.11586 1-Octadecanaminium, N,N-dimethyl-N- [3-
(triethoxysilyl)propyl]-, chloride (1:1).
721.11587 2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl ester.
721.11588 Mixed metal oxide (generic).
721.11589 Amines, polyethylenepoly-, triethylenetetramine fraction, 
polymers with guanidine hydrochloride (1:1).
721.11590 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 
3,6,9,12-tetraoxatetradeca-1, 13-diene, glycidyl ether.
721.11591 1,4-Benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl) 
ester.
721.11592 Poly(oxy-1,2-ethanediyl), .alpha.-nonyl-.omega.-hydroxy-, 
branched and linear.
721.11593 1-Butanamine, N-butyl-N-[(triethoxysilyl)methyl]-.
721.11594 Alkenylamide (generic).
721.11595 Isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride 
(generic).
721.11596 Aldehyde, polymer with mixed alkane polyamines, 2,2'-[1,4-
alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane, 
4,4'-(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane, 
acetate (salt) (generic).
721.11597 Alkanedioic acid, compds. with substituted arylalkylamine-
arylalcohol disubstituted alkane-the diglycidyl ether of a 
arylalcohol disubstituted alkane-epichlorohydrin-aldehyde-2,2'(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-
[(2-aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction 
products (generic).
721.11598 Polyazaalkane with oxirane and methyloxirane, haloalkane 
(generic).
721.11599 Dibromoalkyl ether tetrabromobisphenol A (generic).
721.11600 Octonal, 7(or 8)-formyl-.
721.11601 Sulfonium, trisaryl-, 7,7-dialkyl-2-heteropolycyclic-1-
alkanesulfonate (1:1) (generic).
721.11602 Alkenoic acid, polymer with (alkyl alkenyl) polyether 
(generic).
* * * * *

Sec.  721.11571   Hindered amine alkyl ester compounds (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. The chemical substance generically identified as hindered 
amine alkyl ester compounds (PMN P-16-167) is subject to reporting 
under this section for the significant new use 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), (a)(2)(i) through (iv), (a)(3) through (6), and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure of 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(a)(6), the airborne form(s) of the substance 
include particulate (including solids or liquid droplets), gas/vapor 
(all substances in gas form), and combination gas/vapor and particulate 
(gas and liquid/solid physical states are present).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i) 
and (ii), (g)(4)(i) through (iii), and (g)(5). For purposes of Sec.  
721.72(g)(1), this substance may cause: Skin irritation; respiratory 
complications; central nervous system effects; blood effects. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=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 (h), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11572   N-alkyl-dialkyl piperidine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as N-
alkyl-dialkyl piperidine (PMN P-16-419) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), (b), and 
(c). When determining which persons are likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general, and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For purposes of Sec.  721.63(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(a)(6), the airborne form(s) of the substance 
include gas/vapor (all substances in the gas form). For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) through (v), (g)(3)(ii), 
(g)(4), and (g)(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; acute toxicity; specific 
target organ toxicity. For purposes of Sec.  721.72(g)(4), notice to 
users: Water release restrictions apply. 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(h).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=286.
    (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

[[Page 31254]]

applicable to manufacturers and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11573   Tetraalkylpiperidinium halide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
tetraalkylpiperidinium halide (PMN P-16-423) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (b), and (c). When determining which 
persons are likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general, and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(ii), (g)(4), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1.0%. For purposes of Sec.  721.72(g)(1), the 
substance may cause: Acute toxicity; specific target organ toxicity; 
reproductive toxicity. For purposes of Sec.  721.72(g)(4), notice to 
users: Water release restrictions apply. 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).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=20.
    (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 and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11574   Tetraalkylpiperidinium hydroxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
tetraalkylpiperidinium hydroxide (PMN P-16-424) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) through (iii), (a)(3), (b), and (c). When 
determining which persons are likely to be exposed as required for 
Sec.  721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general, and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(b), the concentration is 
set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) through (v), (g)(3)(ii), 
(g)(4), and (g)(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; acute toxicity; specific 
target organ toxicity; reproductive toxicity. For purposes of Sec.  
721.72(g)(4), notice to users: Water release restrictions apply. 
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).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=20.
    (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 and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii).

Sec.  721.11575   Amidoamino quaternary ammonium salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
amidoamino quaternary ammonium salt (PMN P-17-235) is subject to 
reporting under this section for the significant new use described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=44.
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

Sec.  721.11576   Tri alkyl, mono alkoxy, fatty acid ester, ammonium 
salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as tri 
alkyl, mono alkoxy, fatty acid ester, ammonium salt (PMN P-18-226) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=44.
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.

[[Page 31255]]

    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

Sec.  721.11577   Halogenated aromatic amine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
halogenated aromatic amine (PMN P-17-259) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the PMN substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=1.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11578   1,4-Benzenedicarboxylic acid, 1,4-dipentyl ester, 
branched and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,4-
benzenedicarboxylic acid, 1,4-dipentyl ester, branched and linear (PMN 
P-18-43; CAS No. 2097734-13-7) 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 PMN substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=2.
    (ii) [Reserved]
    (b) Specific requirements. The provision of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11579   Dialkyltin dialkylcarboxylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
dialkyltin dialkylcarboxylate (PMN P-18-178) 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 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6), and (c). When determining which 
persons are likely to be exposed as required for Sec.  721.63(a)(1) and 
(a)(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general, and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible. For 
purposes of Sec.  721.63(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(a)(6), the airborne form(s) of the substance include particulate 
(including solids or liquid droplets).
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a stabilizer for 
PVC compounds.
    (iii) 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 (e), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11580   Alkyltin dodecylthioester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkyltin dodecylthioester (PMN P-18-217) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), and (c). When determining which persons are 
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) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a stabilizer for 
PVC compounds.
    (iii) 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 (e), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section

Sec.  721.11581   Alkyltin tetradecylthioester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkyltin tetradecylthioester (PMN P-18-218) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), and (c). When determining which persons are 
likely to be exposed as required for Sec.  721.63(a)(1), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general, and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be

[[Page 31256]]

considered and implemented to prevent exposure, where feasible.
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a stabilizer for 
PVC compounds.
    (iii) 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 (e), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section

Sec.  721.11582   Undecanol, branched.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as undecanol, branched 
(PMN P-18-256) is subject to reporting under this section for the 
significant new use described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the PMN 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=4.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11583   Hydroxy alkanoic acid, compds. with 
aminoalkoxyalcohol-epoxy polymer-alkanolamine reaction products 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as hydroxy 
alkanoic acid, compds. with aminoalkoxyalcohol-epoxy polymer-
alkanolamine reaction products (PMN P-18-283) 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), (a)(2)(i) through (iii), (a)(3), (b), and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For purposes of Sec.  721.63(b), the 
concentration is set at 1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72 (a) through (f), (g)(1), (g)(2)(i) and (v), (g)(3)(ii), 
(g)(4)(iii), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: Skin irritation; skin sensitization; eye 
irritation; specific target organ toxicity; reproductive toxicity. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(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 (h), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11584   1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer 
with ethyleneamine, 2-(chloromethyl)oxirane, 2-[[4-(1,1-
dimethylethyl)phenoxy]methyl]oxirane, 2,2'-[1,6-
hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxymethyl]oxirane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 1,3-
propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with ethyleneamine, 2-
(chloromethyl)oxirane, 2-[[4-(1,1-dimethylethyl)phenoxy]methyl]oxirane, 
2,2'-[1,6-hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxymethyl]oxirane (PMN P-18-298) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the PMN substance after they have been completely 
reacted (cured).
    (2) The significant new uses are:
    (i) 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 PMN substance for an application 
method that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=50.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11585   Benzenepropanoic acid, 3-(2H-benzotriazol-2-yl)-5-
(1,1-dimethylethyl)-4-hydroxy-2,2-bis(hydroxymethyl)butyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenepropanoic 
acid, 3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxy-2,2-
bis(hydroxymethyl)butyl ester (PMN P-18-310; CAS No. 2101609-93-0) is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the PMN substance after they have 
been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), and (c). 
When determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor

[[Page 31257]]

(APF) of at least 1,000. For purposes of Sec.  721.63(a)(6), the 
airborne form(s) of the substance include gas/vapor and particulate.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.16 
mg/m\3\ as an 8-hour time-weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach are approved by EPA will be required 
to follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(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; reproductive toxicity. Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=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 (h), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11586   1-Octadecanaminium, N,N-dimethyl-N- [3-
(triethoxysilyl)propyl]-, chloride (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-octadecanaminium, 
N,N-dimethyl-N- [3-(triethoxysilyl)propyl]-, chloride (1:1) (PMN P-18-
318; CAS No. 62117-57-1) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: Skin irritation; eye 
irritation; specific target organ toxicity. For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a surface 
treatment for added lubricity and anti-static properties. It is a 
significant new use to use the substance in an application method that 
results in inhalation exposure to workers.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11587   2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl 
ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-propenoic acid, 
2-methyl-, 3-methyl-3-buten-1-yl ester (PMN P-18-323; CAS No. 156291-
88-2) 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 PMN 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), and (c). 
When determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For purposes of Sec.  721.63(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(a)(6), the airborne form(s) of the substance 
include particulate (including solids or liquid droplets) and gas/vapor 
(all substances in the gas form).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i) 
and (ii), (g)(4)(i) through (iii), and (g)(5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; developmental 
effects; systemic effects; respiratory effects; skin sensitization; 
respiratory sensitization. Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System and Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer use. Requirements as 
specified in Sec.  721.80(k).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=98.
    (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 and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11588   Mixed metal oxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as mixed 
metal oxide (PMN P-18-327) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section do not apply to quantities of 
the substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators

[[Page 31258]]

must provide a National Institute for Occupational Safety and Health 
(NIOSH) assigned protection factor (APF) of at least 1,000. For 
purposes of Sec.  721.63(a)(6), the airborne form(s) of the substance 
include particulate (including solids or liquid droplets).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.1 mg/
m\3\ as an 8-hour time-weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use NCELs approach are approved by EPA will be required to 
follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (g)(2), and (g)(5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: cancer; skin 
sensitization; respiratory 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. For purposes of Sec.  721.72(g)(2), 
when using this substance: avoid skin contact, avoid breathing 
substance, avoid ingestion, use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.1 mg/m\3\, and use skin protection.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (h) are applicable to manufacturers and processors 
of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11589   Amines, polyethylenepoly-, triethylenetetramine 
fraction, polymers with guanidine hydrochloride (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as amines, 
polyethylenepoly-, triethylenetetramine fraction, polymers with 
guanidine hydrochloride (1:1) (PMN P-18-347; CAS No. 1902936-67-7) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) and (v), (g)(3)(i) and (ii), 
(g)(4)(i), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: acute toxicity; 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) 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 (h), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11590   Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 
3,6,9,12-tetraoxatetradeca-1, 13-diene, glycidyl ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, 4,4'-(1-
methylethylidene)bis-, polymer with 3,6,9,12-tetraoxatetradeca-1, 13-
diene, glycidyl ether (PMN P-18-405; CAS No. 647028-24-8) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the PMN substance after they have been 
completely reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the PMN substance in a manner that results 
in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11591   1,4-Benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl) 
ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,4-
benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl) ester (PMN P-19-36; 
CAS No. 25900-07-6) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the PMN 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3) through (6), and (c). When determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
of confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 1,000. For purposes of 
Sec.  721.63(a)(6), the airborne form(s) of the substance include 
particulate (including solids or liquid droplets).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=3.
    (b) Specific requirements. The provisions of subpart A of this part 
may apply to this section except as modified by this paragraph (b).

[[Page 31259]]

    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11592   Poly(oxy-1,2-ethanediyl), .alpha.-nonyl-.omega.-
hydroxy-, branched and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), .alpha.-nonyl-.omega.-hydroxy-, branched and linear (PMN 
P-19-52; CAS No. 2242406-13-7) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), (b), and 
(c). When determining which persons are reasonably likely to be exposed 
as required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 1,000. 
For purposes of Sec.  721.63(a)(6), the airborne form(s) of the 
substance include particulate (including solids or liquid droplets). 
For purposes of Sec.  721.63(b), the concentration is set at 1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i) and 
(ii), and (g)(5). For purposes of Sec.  721.72(e), the concentration is 
set at 1%. For purposes of Sec.  721.72(g)(1), this substance may 
cause: Skin irritation; respiratory complications; internal organ 
effects; eye corrosion. Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer use. It is a significant 
new use to use the substance where the concentration of the substance 
in the product formulation intended for distribution in commerce 
exceeds 1% by weight.
    (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 and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11593   1-Butanamine, N-butyl-N-[(triethoxysilyl)methyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-Butanamine, N-
butyl-N-[(triethoxysilyl)methyl]- (PMN P-19-53; CAS No. 35501-23-6) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (o). It is a significant new use to 
process and use the substance other than in a liquid formulation.
    (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 (e), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11594   Alkenylamide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkenylamide (PMN P-19-77) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=4.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

Sec.  721.11595   Isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride (PMN P-19-131) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of 
Sec.  721.72(e), the concentration is set at 1%. For purposes of Sec.  
721.72(g)(1), this substance may cause: Skin irritation; eye 
irritation; specific target organ toxicity. 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. Requirements 
as specified in Sec.  721.80(o). It is significant new use to 
manufacture, process, or use the PMN substance in a manner that results 
in inhalation exposure.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).

[[Page 31260]]

    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11596   Aldehyde, polymer with mixed alkane polyamines, 2,2'-
[1,4-alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane, 
4,4'-(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane, acetate 
(salt) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
aldehyde, polymer with mixed alkane polyamines, 2,2'-[1,4-
alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane, 4,4'-
(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane, acetate 
(salt) (PMN P-19-143) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the PMN 
substance after they have been completely reacted (cured) or destroyed.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the PMN substance in a manner that results 
in inhalation exposure to either the PMN substance or to formaldehyde.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11597   Alkanedioic acid, compds. with substituted 
arylalkylamine-arylalcohol disubstituted alkane-the diglycidyl ether of 
a arylalcohol disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-[(2-
aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction products 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkanedioic acid, compds. with substituted arylalkylamine-arylalcohol 
disubstituted alkane-the diglycidyl ether of a arylalcohol 
disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-[(2-
aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction products 
(PMN P-19-144) 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) or destroyed.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the PMN substance in a manner that results 
in inhalation exposure to either the PMN substance or to formaldehyde.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11598   Polyazaalkane with oxirane and methyloxirane, 
haloalkane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
polyazaalkane with oxirane and methyloxirane, haloalkane (PMN P-19-145) 
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), (g)(1), and (g)(5). For purposes of Sec.  
721.72(e), the concentration is set at 1%. For purposes of Sec.  
721.72(g)(1), this substance may cause: 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.
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the PMN substance 
in a manner that results in inhalation exposure.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=26.
    (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), (i) and (k) are applicable to 
manufacturers and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11599   Dibromoalkyl ether tetrabromobisphenol A (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
dibromoalkyl ether tetrabromobisphenol A (PMN P-19-153) 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), (a)(2)(i) and (iii), (a)(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 (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of 
Sec.  721.72(e), the concentration is set at 1%. For purposes of Sec.  
721.72(g)(1), this substance may cause: eye irritation; 
carcinogenicity;

[[Page 31261]]

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) 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 (h), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11600   Octonal, 7(or 8)-formyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as Octonal, 7(or 8)-
formyl- (PMN P-20-29; CAS No. 1607842-40-9) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=17.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11601   Sulfonium, trisaryl-, 7,7-dialkyl-2-heteropolycyclic-
1-alkanesulfonate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
sulfonium, trisaryl-, 7,7-dialkyl-2-heteropolycyclic-1-alkanesulfonate 
(1:1) (PMN P-20-42) 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 
the photolithographic process) 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), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (v), (g)(3)(i) and 
(ii), and (g)(5). For purposes of Sec.  721.72(e), the concentration is 
set at 1%. For purposes of Sec.  721.72(g)(1), this substance may 
cause: Skin irritation; acute toxicity; skin sensitization; serious eye 
damage; specific target organ toxicity; neurotoxicity; genetic 
toxicity; reproductive 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 PMN substance other than in solution, unless in 
sealed containers weighing 5 kilograms or less. It is a significant new 
use to process the PMN substance in any way that generates a dust, 
mist, or aerosol in a non-enclosed process. It is a significant new use 
to manufacture the PMN 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 and processors 
of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11602   Alkenoic acid, polymer with (alkyl alkenyl) polyether 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkenoic acid, polymer with (alkyl alkenyl) polyether (PMN P-20-104) 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) 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 a manner that results in 
inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=75.
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification 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.  725.1081 to read as follows:

Sec.  725.1081   Trichoderma reesei (generic).

    (a) Microorganism and significant new uses subject to reporting. 
(1) The genetically-modified microorganism generically identified as 
Trichoderma reesei modified (MCAN J-16-26) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2)(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 Trichoderma reesei fermentation broth is added after the 
standard industrial fermentation is completed is initiated only after 
the inactivation of the

[[Page 31262]]

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. 2021-12147 Filed 6-10-21; 8:45 am]
BILLING CODE 6560-50-P