[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Proposed Rules]
[Pages 38158-38177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16539]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2019-0359; FRL-9996-62]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (19-2.F)

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 31 chemical substances which 
were the subject of premanufacture notices. 7 of these chemical 
substances are subject to Orders issued by EPA pursuant to TSCA section 
5(e). This action would require persons who intend to manufacture 
(defined by statute to include import) or process any of these 31 
chemical substances for an activity that is proposed as a significant 
new use 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 September 5, 2019.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2019-0359, by one of the following methods:
     Federal eRulemaking Portal: http://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.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-9232; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. 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 
certification requirements 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. Importers of chemicals subject to final SNURs must certify 
their compliance with the SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this proposed rule on or after 
September 5, 2019 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

[[Page 38159]]

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 http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(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 a chemical substance 
for any 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. Additional 
background regarding SNURs is more fully set out in the preamble to 
EPA's first direct final SNUR published in the Federal Register issue 
of April 24, 1990 (55 FR 17376). Consult that preamble for further 
general information on the objectives, rationale, and procedures for 
SNURs and on the basis for significant new use designations, including 
provisions for developing test data.

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

    Section 5(a)(2) of TSCA (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 bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture or process the chemical 
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore 
prohibits such manufacturing or processing from commencing until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, and taken such actions as are required in association 
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)).

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the proposed rule, 
recordkeeping requirements, and 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 Sec.  721.1(c), persons subject to SNURs must 
comply with the same SNUN requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A) (15 U.S.C. 
2604(a)(1)(A)). In particular, these requirements include the 
information submission requirements of TSCA sections 5(b) and 5(d)(1) 
(15 U.S.C. 2604(b) and 2604(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, 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 
before the manufacture or processing for the significant new use can 
commence. In the case of a determination other than not likely to 
present unreasonable risk, the applicable review period must also 
expire before manufacturing or processing for the new use may commence. 
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 significant new use for the 31 chemical substances 
that are the subject of these SNURs, EPA considered relevant 
information about the toxicity of the chemical substances and potential 
human exposures and environmental releases that may be associated with 
the conditions of use for the substances, in addition to the factors in 
TSCA section 5(a)(2). Note that when the Agency issues an order under 
TSCA section 5(e), TSCA section 5(f)(4) requires that the Agency 
consider whether to promulgate a SNUR for any use not conforming to the 
restrictions of the order or publish a statement describing the reasons 
for not initiating the rulemaking.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for 31 chemical substances in 40 CFR part 721, subpart E. In this unit, 
EPA provides the following information for each chemical substance:
     PMN 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).
     Basis for the SNUR or basis for the TSCA 5(e) Order.
     Information identified by EPA that would help characterize 
the potential health and/or environmental effects of the chemical 
substance 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 designated by the SNUR. This information 
may include testing required in a TSCA section 5(e) Order to be 
conducted by the PMN submitter, as well as testing not required to be 
conducted but which would also help characterize the potential health 
and/or environmental effects of the PMN substance. Any recommendation 
for information identified by EPA 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 chemical substance. Further, 
any such testing identified by 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. EPA also recognizes that 
whether testing/further information is needed will depend on the 
specific

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exposure and use scenario in the SNUN. EPA encourages all SNUN 
submitters to contact EPA to discuss any potential future testing. See 
Unit VII. for more information.
     CFR citation assigned in the regulatory text section of 
the proposed rule. The regulatory text section of each proposed rule 
specifies the activities that would be designated as significant new 
uses. Certain new uses, including exceedance of production volume 
limits (i.e., limits on manufacture volume) and other uses designated 
in this proposed rule, may be claimed as CBI.
    These proposed rules include 7 PMN substances that are subject to 
Orders issued under TSCA section 5(e)(1)(A), as required by the 
determinations made under TSCA section 5(a)(3)(B). Those Orders require 
protective measures to limit exposures or otherwise mitigate the 
potential unreasonable risk. The proposed SNURs would 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 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 section 5(e) Order usually requires, among other 
things, 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) that is established by EPA to provide adequate protection 
to human health. In addition to the actual NCEL concentration, the 
comprehensive NCELs provisions in TSCA section 5(e) Orders, which are 
modeled after Occupational Safety and Health Administration (OSHA) 
Permissible Exposure Limits (PELs) provisions, include requirements 
addressing performance criteria for sampling and analytical methods, 
periodic monitoring, respiratory protection, and recordkeeping. 
However, 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 section 5(e) Order for the same chemical 
substance.
    These proposed rules also include 24 PMN substances that received 
``not likely to present an unreasonable risk'' determination in TSCA 
section 5(a)(3)(c). However, during the course of these reviews, EPA 
identified concerns for certain health and/or environmental risks if 
the chemicals were not used following the limitations identified by the 
submitters in the notices but the TSCA section 5(a)(3)(C) 
determinations did not deem those uses as reasonably foreseen. The 
proposed SNURs would identify as significant new uses any 
manufacturing, processing, use, distribution in commerce, or disposal 
that does not conform to those same protection measures.
    The chemicals subject to these proposed SNURs are as follows:

PMN Number: P-16-400

    Chemical Name: Alkanes, C11-16-branched and linear.
    CAS Number: 1809170-78-2.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a chemical intermediate, in cured coatings, cleaning fluids, 
metalworking fluids/rolling oils, and in agrochemicals. Based on the 
estimated physical chemical properties of the PMN substance and analogy 
to structurally similar substances, EPA has identified concerns for 
lung effects and dermal irritation if the chemical substance is not 
used following the limitations noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measures:
    1. No manufacture, processing, or use of the PMN substance other 
than for the uses stated in the PMN; and
    2. No manufacture, processing, or use of the PMN substance for 
consumer use.
    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 human health effects of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of irritation 
and pulmonary effects testing would help characterize the potential 
health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11300.

PMN Number: P-17-119

    Chemical Name: Alkyl alkenoic acid, alkoxyalkyl ester, polymer with 
alkyl alkenoate, alkyl alkyl alkenoate and tris alkyl silyl alkyl 
alkenoate (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a component of 
industrial coatings. Based on the estimated physical chemical 
properties of the PMN substance and test data on the PMN substance, EPA 
has identified concerns for lung effects and irritation to the eyes, 
skins, lung, and mucous membranes if the chemical substance is not used 
following the limitations noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measures:
    1. No domestic manufacture of the PMN substance; and
    2. No manufacture, processing, or use of the PMN substance that 
results in inhalation exposures.
    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 human health effects of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of pulmonary 
effects testing would help characterize the potential health effects of 
the PMN substance.
    CFR Citation: 40 CFR 721.11301.

PMN Number: P-17-191

    Chemical Name: Alkyldiamine, aminoalkyl dimethylaminoalkyl 
dimethyl-, reaction products with propylene oxide (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a polyurethane catalyst. Based on the estimated physical 
chemical properties of the PMN substance and data on analogous 
compounds, EPA has identified concerns for skin, eye, and lung 
corrosion, neurotoxicity, and systemic effects if the chemical 
substance is not used following the limitations noted. The conditions 
of use of the PMN substance as described in the PMN include the 
following protective measure:
     No manufacture, processing, or use of the PMN substance 
that would generate a spray, mist, or aerosol.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.

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    Potentially useful information: EPA has determined that certain 
information about the human health effects of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of skin 
irritation/corrosion and neurotoxicity testing would help characterize 
the potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11302.

PMN Number: P-17-220

    Chemical Name: 2-Oxepanone, reaction products with alkylenediamine-
alkyleneimine polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and tetrahydro-
2H-pyran-2-one (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an additive, open, 
non-dispersive use. Based on the estimated physical chemical properties 
of the PMN substance, comparison with structurally analogous chemical 
substances, and Structure Analysis Relationships (SAR) analysis of test 
data on polycationic polymers, EPA has identified hazards for 
irritation to the eye, lung, and mucous membranes, lung effects, and 
aquatic toxicity if the chemical substance is not used following the 
limitations noted. The conditions of use of the PMN substance as 
described in the PMN include the following protective measures:
    1. No domestic manufacture of the PMN substance;
    2. No manufacture or import of the PMN substance other than in 
liquid form; and
    3. No manufacture, processing, or use of the PMN substance other 
than for the confidential use stated in the PMN.
    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 human health and environmental effects of the PMN 
substance may be potentially useful if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has determined that the results 
of aquatic toxicity and pulmonary effects testing would help 
characterize the potential health and environmental effects of the PMN 
substance.
    CFR Citation: 40 CFR 721.11303.

PMN Numbers: P-17-387 and P-17-388

    Chemical Name: Dicarboxylic acids, polymers with alkanoic acid, 
alkanediol, substituted-alkylalkanoic acid, substituted alkyl 
carbomonocycle, alkanedioic acid, alkanolamine blocked compds with 
alkanolamine (P-17-387 and P-17-388) (generic).
    CAS Numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as paint. Based on the 
estimated physical/chemical properties of the PMN substances and 
available PMN data, EPA has identified developmental and reproductive 
effects, lung toxicity, and nasal and ocular irritation if the chemical 
substances are not used following the limitations noted. The conditions 
of use of the PMN substances as described in the PMNs include the 
following protective measures:
    1. No manufacture (including import) of the PMN substances that 
results in amine counter ions greater than 4% by weight;
    2. No manufacture (including import) of the PMN substances that 
results in isocyanate residuals greater than 0.1% by weight;
    3. No manufacture (including import) of the PMN substances that 
results in a proportion of the acid group greater than 20% by weight; 
and
    4. No manufacture (including import) of the PMN substances that 
results in the average molecular weight smaller than the confidential 
molecular weight specified in the PMNs or proportion of the low 
molecular weight species greater than the confidential values specified 
in the PMNs for the 500 and 1000 dalton species.
    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 human health effects of the PMN substances may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of 
developmental/reproductive and pulmonary effects testing would help 
characterize the potential health effects of the PMN substances.
    CFR Citation: 40 CFR 721.11304.

PMN Number: P-17-419

    Chemical name: Unsaturated polycyclic hydrocarbon (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: February 6, 2019.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a cyclic hydrocarbon 
building block. Based on physical/chemical properties of the PMN 
substance (as described in the New Chemical Program's PBT category at 
64 FR 60194; November 4, 1999) and test data on structurally similar 
substances, the PMN substance is a potentially persistent, 
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN 
substance will persist in the environment more than 2 months and 
estimates a bioaccumulation factor of greater than or equal to 1,000. 
EPA has also identified concern for skin irritation, reproductive and 
developmental toxicity based on analog data and concern for 
sensitization based on Safety Data Sheet (SDS) information. Based on 
SAR analysis of test data on analogous neutral organics, EPA has 
identified concern for aquatic toxicity. The Order was issued under 
5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the available 
information is insufficient to permit a reasoned evaluation of the 
human health and environmental effects of the PMN substance. The Order 
was also issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that the substance may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Submit to EPA certain toxicity testing within 9 months from the 
effective date of the Order.
    2. Submit to EPA certain toxicity testing for within 12 months from 
EPA's direction to proceed with that testing.
    3. Refrain from manufacturing (including import) more than the 
confidential annual production volume limit specified in the Order.
    4. Use of the PMN substance only for the confidential use allowed 
by the Order.
    5. No release of the PMN substance to surface waters.
    6. Use of personal protective equipment to its workers to prevent 
dermal exposure where there is potential for dermal exposure.
    7. 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.
    8. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.

[[Page 38162]]

    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health and environmental 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 would be 
designated by this SNUR. The submitter has agreed to perform certain 
acute aquatic toxicity testing within 9 months of the effect of the 
Order, and certain chronic aquatic toxicity testing within 12 months of 
EPA's direction to proceed. The Agency has determined that specific 
target organ toxicity, reproductive and developmental toxicity, 
sensitization, and fate information would help EPA determine the 
potential health effects of the PMN substance. Although the Order does 
not require this information, 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 721.11305.

PMN Numbers: P-18-7 and P-18-8

    Chemical Names: Glycerides, soya mono- and di-, epoxidized, 
acetates (P-18-7) and Glycerides, C16-18 and C18-unsatd. mono- and di-, 
epoxidized, acetates (P-18-8).
    CAS Numbers: 2097734-14-8 (P-18-7) and 2097734-15-9 (P-18-8).
    Basis for action: The PMNs state that the use of the substances 
will be as plasticizers/stabilizers for flexible polyvinyl chloride. 
Based the estimated physical/chemical properties of the PMN substances 
and comparison with structurally analogous chemical substances, EPA has 
identified skin irritation and kidney and liver hazards if the chemical 
substances are not used following the limitations noted. The conditions 
of use of the PMN substances as described in the PMNs include the 
following protective measures:
    1. No manufacture, processing, or use that results in inhalation 
exposures; and
    2. No release of a manufacturing, processing, or use stream 
associated with any use of the PMN substances into the waters of the 
United States exceeding a surface water concentration of 9,000 parts 
per billion (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 the human effects of the PMN substances may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of specific 
target organ toxicity and skin irritation testing would help 
characterize the potential health effects of the PMN substances.
    CFR Citations: 40 CFR 721.11306 (P-18-7) and 40 CFR 721.11307 (P-
18-8).

PMN Number: P-18-55

    Chemical Name: Mixed metal oxide (generic).
    CAS Number: Not Available.
    Effective date of TSCA section 5(e) Order: April 2, 2019.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
use of the PMN substance will be as a catalyst. EPA identified concerns 
for lung effects including cancer, and respiratory and dermal 
sensitization based on the estimated physical/chemical properties, 
available PMN data, and by comparison to structurally analogous 
chemical substances. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
    1. Use of personal protective equipment where there is a potential 
for dermal exposure;
    2. 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 0.04 mg/m\3\ as an 8-hour time-weighted average to 
prevent inhalation exposure;
    3. Use of the PMN substance only for the confidential use allowed 
by the Order; and
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    The SNUR designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the 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 would be designated by 
this SNUR. EPA has also determined that specific pulmonary toxicity and 
sensitization effects testing of the PMN substance would be useful in 
determining the health effects of the PMN substance. Although the Order 
does not require these tests, the Order's restrictions remain in effect 
until the Order is modified or revoked by EPA based on submission of 
this or other relevant information.
    CFR citation: 40 CFR 721.11308.

PMN Number: P-18-77

    Chemical Name: Urea, reaction products with N-butylphosphorothioic 
triamide and formaldehyde.
    CAS Number: 2093385-47-6.
    Basis for action: The PMN states that the use of the PMN substance 
will be as an additive for urea-containing fertilizer. Based on 
physical-chemical properties, available test data, and test data on 
analogous chemical substances for the PMN substance, EPA has identified 
concerns for neurotoxicity, reproductive toxicity, kidney toxicity, 
irritation and sensitization if the chemical substance is not used 
following the limitations noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measures:
    1. No manufacture, processing, or use of the substance that results 
in inhalation exposure; and
    2. No use of the 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 about the health effects of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of 
neurotoxicity, specific target organ toxicity, irritation, 
sensitization, and reproductive/developmental toxicity testing would 
help characterize the potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11309.

PMN Number: P-18-85

    Chemical Name: Fatty acid reaction products with ethyleneamines and 
dialkyl ester (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be for industrial use in 
oilfields. Based on the estimated physical chemical properties of the 
PMN substance and comparison with structurally analogous chemical 
substances, EPA has identified irritation to the eyes, lungs, and skin, 
and lung effects if the chemical substance is not used following the 
limitation noted. The

[[Page 38163]]

condition of use of the PMN substance as described in the PMN includes 
the following protective measure:
     No manufacture, processing, or use that results in 
inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of pulmonary 
effects testing would help characterize the potential health effects of 
the PMN substance.
    CFR Citation: 40 CFR 721.11310.

PMN Number: P-18-101

    Chemical Name: Pentaerythritol, mixed esters with linear and 
branched fatty acids (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be for industrial use. 
Based on the estimated physical chemical properties of the PMN 
substance and comparison with structurally analogous chemical 
substances, EPA has identified concerns for developmental effects, 
blood and thyroid effects, and skin and eye irritation if the chemical 
substance is not used following the limitations noted. The conditions 
of use of the PMN substance as described in the PMN include the 
following protective measure:
     No manufacturing, processing, or use involving an 
application method that generates a vapor, mist, or aerosol.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of specific 
organ toxicity and reproductive/developmental testing would help 
characterize the potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11311.

PMN Number: P-18-107

    Chemical Name: Alcohol capped polycarbodiimide from 
diethyldiisocyanatobenzene (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a hydrolysis stabilizer. Based on the physical chemical 
properties of the PMN substance and comparison with structurally 
analogous chemical substances, EPA has identified concerns for systemic 
toxicity and developmental toxicity if the chemical substance is not 
used following the limitation noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measure:
     No manufacture (including import) of the PMN substances 
that results in isocyanate residuals greater than 0.1% by weight.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of 
reproductive/development toxicity testing would help characterize the 
potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11312.

PMN Numbers: P-18-118 and P-18-119

    Chemical Names: Oxirane, 2-methyl-, polymer with methoxirane 
homopolymer, 1,1'-methylenebis[4-isocyanatobenzene], and glycerol-
propylene oxide polymer (generic) (P-18-118) and Oxirane, 2-methyl-, 
polymer with methoxirane homopolymer, 1,1'-
methylenebis[isocyanatobenzene], and glycerol-propylene oxide polymer 
(generic) (P-18-119).
    CAS Numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as industrial adhesives. 
Based on the estimated physical chemical properties of the PMN 
substances and comparison with structurally analogous chemical 
substances. EPA has identified concerns for lung effects, irritation, 
and sensitization if the chemical substances are not used following the 
limitations noted. The conditions of use of the PMN substances as 
described in the PMNs include the following protective measures:
    1. No manufacturing, processing, or use that results in inhalation 
exposures;
    2. No manufacturing, processing, or use of the PMN substances with 
isocyanate residuals greater than 0.1%; and
    3. Refrain from using the PMN substance for consumer use.
    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 health effects of the PMN substances may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of skin 
sensitization testing would help characterize the potential health 
effects of the PMN substances.
    CFR Citations: 40 CFR 721.11313 (P-18-118) and 40 CFR 721.11314 (P-
18-119).

PMN Numbers: P-18-123 and P-18-124

    Chemical Name: Lithium nickel hydride oxide (P-18-123) and Lithium 
nickel potassium oxide (P-18-124).
    CAS Numbers: 2081933-92-6 (P-18-123) and 210352-95-7 (P-18-124).
    Effective date of TSCA section 5(e) Order: December 7, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the PMN substances will be as a chemical intermediate used in the 
production of battery electrodes (P-18-123) and a cathode material for 
standard and premium (P-18-124). Based on physical/chemical properties 
and on test data submitted with the PMN, EPA identified concerns for 
pulmonary effects, neurotoxicity, developmental toxicity, kidney 
toxicity, carcinogenicity, skin and respiratory sensitization, and 
irritation to the eye, skin, and respiratory tract. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(I)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation the substances may present an unreasonable 
risk of injury to human health and the environment. The Order was also 
issued under TSCA section 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 significant (or substantial) human 
exposure to the substances. To protect against these risks, the Order 
requires:
    1. Use of personal protective equipment where there is a potential 
for dermal exposure.
    2. Use a NIOSH-certified respirator with an APF of at least 50 
where there is potential for inhalation exposure or

[[Page 38164]]

compliance with a NCEL of 0.05 mg/m\3\ as an 8-hour time-weighted 
average to prevent inhalation exposure.
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. Submit to EPA certain environmental and health hazard testing 
within six months and four years of the first manufacture (including 
import), respectively on P-18-124.
    5. No release of the PMN substances resulting in surface water 
concentrations that exceed 32 ppb.
    The SNUR designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health and environmental effects of the PMN 
substances may be potentially useful in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. The submitter has agreed to submit an algal 
toxicity test 6 months after the date of first manufacture and a 
specific organ toxicity test 4 years after the date of first 
manufacture on PMN substance P-18-124. EPA has also determined that 
information on specific target organ toxicity and reproductive/
developmental toxicity would help characterize the potential health 
effects of the PMN substances. Although the Order does not require 
these tests, the Order's restrictions remain in effect until the Order 
is modified or revoked by EPA based on submission of this or other 
relevant information.
    CFR Citations: 40 CFR 721.11315 (P-18-123) and 40 CFR 721.11316 (P-
18-124).

PMN Number: P-18-152

    Chemical Name: Hydrolyzed functionalized di-amino silanol polymer 
(generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an intermediate. 
Based on the estimated physical chemical properties of the PMN 
substance, data on the PMN substance, comparison with structurally 
analogous chemical substances, and Structure Analysis Relationships 
(SAR) analysis of test data on analogous aliphatic amines, EPA has 
identified irritation and corrosion to all tissues, sensitization, lung 
toxicity, and aquatic toxicity at surface water concentrations 
exceeding 3 parts per billion (ppb) if the chemical substance is not 
used following the limitations noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measures:
    1. No manufacturing, processing, or use of the PMN substance in any 
manner that results in inhalation exposure; and
    2. No release of a manufacturing, processing, or use stream 
associated with any use of the PMN substance exceeding a surface water 
concentration of 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 about the health and environmental effects of the PMN 
substance may be potentially useful if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has determined that the results 
of skin toxicity, sensitization, and aquatic toxicity testing of would 
help characterize the potential health and environmental effects of the 
PMN substance.
    CFR Citation: 40 CFR 721.11317.

PMN Number: P-18-169

    Chemical Name: Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-
methyl-, polymer with dimethyl carbonate, 1,6-hexanediol, diamine and 
1,1'-methylenebis[4-isocyanatocyclohexane], pentaerythritol, 
triacrylate-blocked, compds. with triethylamine (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a protective coating. 
Based on estimated physical chemical properties of the PMN substance 
and comparison with structurally analogous acrylates/methacrylates, EPA 
has identified dermal and respiratory irritation and sensitization, 
developmental toxicity, and neurotoxicity if the chemical substance is 
not used following the limitations noted. The conditions of use of the 
PMN substance as described in the PMN include the following protective 
measures:
    1. Use of personal protective equipment including impervious gloves 
where there is a potential for dermal exposure;
    2. Use of a NIOSH certified respirator with an APF of at least 
1,000 for spray applications and 50 for non-spray applications; and
    3. No manufacture (including import) of the PMN substance with 
triethylamine concentrations greater than the confidential 
concentration described in the PMN.
    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 health effects of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of composition 
of Low Molecular Weight (LMW) species and specific organ toxicity 
testing for the LMW species would help characterize the potential 
health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11318.

PMN Numbers: P-18-200 and P-18-201

    Chemical names: Waste plastics, poly(ethylene terephthalate), 
polymers with diethylene glycol, glycerol, polyerythritol, triethylene 
glycol, trimethylolalkane and polypropylene glycol (P-18-200) (generic) 
and Waste plastics, poly(ethylene terephthalate), polymers with 
diethylene glycol, glycerol, polyerythritol glycol, trimethylolalkane 
and polypropylene glycol (P-18-201) (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: January 20, 2019.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as insulation 
components. Based on analogue data for low molecular weight components 
and metabolites of high molecular weight components, EPA identified 
concerns for bladder and kidney effects. . Based on SAR predictions for 
nonionic polymers EPA also identified concerns for aquatic toxicity at 
concentrations that exceed 280 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 the substances may present an unreasonable risk of injury to human 
health and 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 significant (or substantial) human exposure to the substances. To 
protect against these risks, the Order requires:
    1. Use of personal protective equipment involving impervious gloves 
where there is a potential for dermal exposure;

[[Page 38165]]

    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    3. Use of a NIOSH-certified respirator with an APF of at least 10 
where there is a potential for inhalation exposure;
    4. Refrain from using the PMN substances for consumer use; and
    5. No release of the PMN substances resulting in surface water 
concentrations that exceed 280 ppb.
    The 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 human and environmental health effects of the PMN 
substances may be potentially useful in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. A toxicokinetics test, a specific target organ 
toxicity test, and a chronic aquatic organism toxicity test would help 
EPA determine the potential 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 721.11319 (P-18-200) and 40 CFR 721.11320 (P-
18-201).

PMN Number: P-18-235

    Chemical Name: Naphtha oils (generic).
    CAS Number: Not Available.
    Effective date of TSCA section 5(e) Order: April 10, 2019.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
use of the PMN substance will be as a component in automotive gasoline 
and transportation fuel for consumer use. EPA identified concerns for 
neurological, liver, kidney, developmental, immunological, 
carcinogenic, mutagenic and irritation effects based on estimated 
physical/chemical properties and analysis of test data on structurally 
analogous chemical substances. In addition, based on SAR analysis of 
test data on analogous neutral organics, EPA predicts acute and chronic 
toxicity to aquatic organisms may occur at concentrations greater than 
88 ppb and 3 ppb respectively. 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. The Order was also issued under TSCA sections 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substance is or will be produced in substantial quantities and that the 
substance either enters or may reasonably be anticipated to enter the 
environment in substantial quantities, or there is or may be 
significant (or substantial) human exposure to the substance. To 
protect against these risks, the Order requires:
    1. No domestic manufacture of the PMN substance (import only).
    2. Processing and use of the PMN substance only for the 
confidential use specified in the PMN.
    The SNUR designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health and environmental 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 would be 
designated by this SNUR. EPA has also determined that specific product 
composition testing of the PMN substance would be useful in determining 
the health and environmental effects of the PMN substance. Although the 
Order does not require this test, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citation: 40 CFR 721.11321.

PMN Number: P-18-238

    Chemical Name: Saccharide reaction products with acid anhydride, 
etherified (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a binder for wood panels. Based on the estimated physical 
chemical properties of the PMN substance, structural alerts, data on an 
analogue of a potential metabolites, and test data on analogous esters, 
EPA has identified skin and respiratory sensitization, germ cell 
mutagenicity, carcinogenicity, reproductive/developmental, liver, and 
kidney toxicity if the chemical substance is not used following the 
limitations noted. The conditions of use of the PMN substance as 
described in the PMN include this protective measure:
     No manufacturing, processing, or use that results in 
inhalation exposures.
    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 health effects of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of absorption, 
specific target organ toxicity, sensitization, genetic toxicology, and 
reproductive/developmental toxicity testing would help characterize the 
potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11322.

PMN Number: P-18-307

    Chemical Name: Alkyl alkenoic acid, alkyl ester, telomer with alkyl 
alkenoate, substituted alkyl alkyl alkenoate, alkylthiol, substituted 
carbomonocycle, hydroxyalkyl alkyl alkenoate and alkyl alkyl alkenoate 
(generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a binder resin in 
coatings. Based on the estimated and measured physical chemical 
properties of the PMN substance, data submitted on the new chemical 
substance, and comparison with structurally analogous chemical 
substances, EPA has identified concerns for systemic effects if the 
chemical substance is not used following the limitations noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measure:
     No manufacture (including import) of the PMN substance 
with more than 5% of the molecular weight content less than 1,000 
Daltons.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of 
toxicokinetic and specific target organ toxicity testing would help 
characterize the potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11323.

PMN Number: P-18-312

    Chemical Name: Formaldehyde, polymer with 2-phenoxyalkanol and 
.alpha.-phenyl-.omega.

[[Page 38166]]

hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen phosphate 2-phenoxyalkyl 
hydrogen phosphate, alkaline salt (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a dispersing agent. 
Based on the estimated physical chemical properties of the PMN 
substance and hazard data on chemically analogous substances, EPA has 
identified concerns for lung effects, eye irritation, and systemic 
(blood/kidney) effects, if the chemical substance is not used following 
the limitations noted. The conditions of use of the PMN substance as 
described in the PMN include the following protective measures:
    1. No manufacturing, processing, or use that results in inhalation 
exposures; and
    2. No manufacture of the PMN substance with greater than 20% 
(weight percent) components with molecular weight below 500 Daltons.
    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 health effects of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of composition 
of low molecular weight (LMW) species and specific organ toxicity 
testing for the LMW species would help characterize the potential 
health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11324.

PMN Number: P-19-8

    Chemical Name: Substituted polyalkylenepolycarbomonocycle ester, 
polymer with dialkanolamine, [(hydroxyalkoxy)carbonyl] derivs., 
(alkoxyalkoxy) alkanol-blocked (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a component in coating resin products that are applied by 
cathodic electrodeposition and used as additives for corrosion 
protection. Based on the estimated physical chemical properties of the 
PMN substance and comparison with structurally analogous chemical 
substances, EPA has identified concerns for irritation, lung effects, 
immunotoxicity, and blood effects if the chemical substance is not used 
following the limitations noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measures:
    1. No manufacture (including import) or processing the PMN 
substance in the forms of a powder or solid; and
    2. No use of the PMN substance involving application methods that 
generate inhalation exposures.
    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 health effects of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of pulmonary 
effects and specific target organ toxicity testing would help 
characterize the potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11325.

PMN Number: P-19-9

    Chemical Name: Carbonmonocycles, polymer with haloalkyl substituted 
heteromonocycle and hydro-hydroxypoly[oxy(alkyl-alkanediyl)], dialkyl-
alkanediamineterminated, hydroxyalkylated, acetates (salts) (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a corrosion protection additive in resin for cathodic 
electrodeposition dip coating for metal substrates. Based on the 
estimated physical chemical properties of the PMN substance and 
comparison with structurally analogous chemical substances, EPA has 
identified concerns for lung effects and irritation if the chemical 
substance is not used following the limitations noted. The conditions 
of use of the PMN substance as described in the PMN include the 
following protective measures:
    1. No manufacturing (including import), processing, or use that 
results in inhalation exposures; and
    2. No manufacture beyond an annual production volume of 85,000 kg.
    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 health effects of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of pulmonary 
effects and skin irritation testing would help characterize the 
potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11326.

PMN Number: P-19-26

    Chemical Name: Alkanoic acid, compds. with substituted 
carbomonocycle-dialkyl-alkanediamine-halosubstituted heteromonocycle-
polyalkylene glycol polymerdialkanolamine reaction products (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a component in coating resin products that are applied by 
cathodic electrodeposition and as an additive for corrosion protection. 
Based on the estimated physical chemical properties of the PMN 
substance, comparison with structurally analogous chemical substances, 
and Structure Analysis Relationships (SAR) analysis of test data on 
cationic polymers, EPA has identified concerns for irritation, lung 
effects, and aquatic toxicity at concentrations greater than 15 ppb if 
the chemical substance is not used following the limitation noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measures:
    1. No manufacturing (including import), processing, or use that 
results in inhalation exposures to vapor, particulate, mist or 
aerosols; and
    2. No release of a manufacturing, processing, or use stream 
associated with any use of the PMN substance exceeding a surface water 
concentration of 15 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 the human health and environmental effects of the PMN 
substance may be potentially useful if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has determined that the results 
of pulmonary effects, skin irritation, and aquatic toxicity testing 
would help characterize the potential health effects of the PMN 
substance.
    CFR Citation: 40 CFR 721.11327.

PMN Number: P-19-27

    Chemical Name: Substituted carbomoncycle, polymer with haloalkyl 
substituted heteromonocycle, dialkyl-alkanediamine and hydro-
hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal oxide 
and dialkanolamine, acetates (salt) (generic).

[[Page 38167]]

    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as an isolated intermediate incorporated as a component in 
coating resin products that are applied by cathodic electrodeposition 
and used as additives for corrosion protection. Based on the estimated 
physical chemical properties of the PMN substance, comparison with 
structurally analogous chemical substances, and Structure Analysis 
Relationships (SAR) analysis of test data on analogous cationic 
polymers, EPA has identified lung effects and aquatic toxicity if the 
chemical substance is not used following the limitations noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measures:
    1. No manufacturing, processing, or use that results in inhalation 
exposures to vapor, particulate, mist or aerosols; and
    2. No manufacture (including import) of an annual production volume 
of the PMN substance greater than 95,600 kg.
    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 human health and environmental effects of the PMN 
substance may be potentially useful if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has determined that the results 
of pulmonary effects and aquatic toxicity testing would help 
characterize the potential health and environmental effects of the PMN 
substance.
    CFR Citation: 40 CFR 721.11328.

PMN Number: P-19-45

    Chemical Name: Non-metal tetrakis (hydroxyalkyl)-, halide, polymer 
with amide oxidized (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a component of a 
textile coating. Based on the estimated physical chemical properties of 
the PMN substance and comparison with structurally analogous chemical 
substances, EPA has identified effects concerns for irritation to the 
skin and eyes, skin sensitization, and reproductive and developmental 
toxicity if the chemical substance is not used following the 
limitations noted. The conditions of use of the PMN substance as 
described in the PMN include the following protective measures:
    1. No manufacturing, processing, or use that results in inhalation 
exposures;
    2. No manufacturing that results in unbound formaldehyde residuals 
greater than 0.1%; and
    3. No manufacturing, processing, or use other than the confidential 
use described in the PMN.
    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 human health toxicity of the PMN substance may be 
potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. EPA has determined that the results of skin and eye 
irritation, skin sensitization, and developmental toxicity testing 
would help characterize the potential health effects of the PMN 
substance.
    CFR Citation: 40 CFR 721.11329.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these proposed SNURs, EPA concluded that for 7 
chemical substances 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/MCAN 
submitters. The SNURs would 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 
Orders, consistent with TSCA section 5(f)(4).
    During review of the other 24 chemical substances that are the 
subject of these SNURs and as further discussed in Unit IV, EPA 
identified circumstances different from the intended conditions of use 
identified in the PMNs that raised potential risk concerns. EPA 
determined that deviations from the protective measures identified in 
the submissions could result in changes in the type or form of exposure 
to the chemical substances and/or increased exposures to the chemical 
substances and/or changes in the reasonably anticipated manner and 
methods of manufacturing, processing, distribution in commerce, and 
disposal of the chemical substances, and therefore warranted SNURs. The 
SNURs would identify as significant new uses any manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the protection measures in the submission.

B. Objectives

    EPA is proposing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with respect to the significant new 
uses that would be designated in this proposed rule:
     EPA would receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA would be required 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.
     EPA would be required 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.
    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 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

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. 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.

[[Page 38168]]

However, TSCA section 5(e) Orders have been issued for 7 of the 31 
chemical substances, and the PMN submitters are prohibited by the TSCA 
section 5(e) Orders from undertaking activities which would be 
designated as significant new uses. The identities of 25 of the 31 
chemical substances subject to this proposed rule have been claimed as 
confidential (per Sec. Sec.  720.85 and 725.85) for a chemical 
substance covered by this action. 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 August 6, 2019 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.
    Persons who begin 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 notice, made an 
appropriate determination on the notice, and has taken such actions as 
are required with that determination.

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: Development of test data 
is required where the chemical substance subject to the SNUR is also 
subject to a rule, order or consent agreement under TSCA section 4 (see 
TSCA section 5(b)(1)).
    In the absence of a TSCA section 4 test rule covering the chemical 
substance, persons are required only to submit information in their 
possession or control and to describe any other information known to or 
reasonably ascertainable by them (see 40 CFR 720.50 and 725.155). 
However, upon review of PMNs and SNUNs, the Agency has the authority to 
require appropriate testing. Unit IV. lists potentially useful 
information identified by EPA that would help characterize the 
potential health and/or environmental effects of the PMN/SNUN substance 
for all of the listed SNURs. EPA recognizes that the 2016 Lautenberg 
Amendments have led to modifications in our approach to testing 
requirements, including an increased consideration of alternatives to 
vertebrate testing. Descriptions of tests/information needs are 
provided for informational purposes only and EPA strongly encourages 
persons, before performing any testing, to consult with the Agency 
pertaining to protocol selection. 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 potentially useful information. EPA 
encourages dialogue with Agency representatives to help determine how 
best the submitter can meet both the data needs and the objective of 
TSCA section 4(h). To access the OCSPP test guidelines referenced in 
this document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.'' The Organisation for Economic 
Co-operation and Development test guidelines are available from the 
OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
    The potentially useful information listed in Unit IV. may not be 
the only means of addressing the potential risks of the chemical 
substance. 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.

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 or MCAN, including submission of test data 
on health and environmental effects as described in 40 CFR 720.50 or 
725.160. SNUNs must be submitted on EPA Form No. 7710-25, generated 
using e-PMN software, and submitted to the Agency in accordance with 
the procedures set forth in 40 CFR 720.40 and 721.25 (or 40 CFR 725.25 
and Sec.  725.27). E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

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 under docket ID number EPA-HQ-OPPT-
2019-0359.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for several new chemical 
substances that were the subject of PMNs and TSCA section 5(e) Orders. 
The Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable.
    The information collection requirements related to this proposed 
rule have already been approved by OMB pursuant to PRA under OMB 
control number 2070-0012 (EPA ICR No. 574). This action does not impose 
any burden requiring additional OMB approval. If an entity were to 
submit a SNUN to the Agency, the annual burden is estimated to average 
between 30 and 170 hours per 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 
through the use of 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,

[[Page 38169]]

but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this proposed SNUR 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. Although some small 
entities may decide to pursue a significant new use in the future, EPA 
cannot presently determine how many, if any, there may be. However, 
EPA's experience to date is that, in response to the promulgation of 
SNURs covering over 1,000 chemicals, the Agency receives only a small 
number of notices per year. For example, the number of SNUNs received 
was 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 11632

    This proposed rule 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, 
entitled ``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule 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, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000), do not apply to this action.

G. Executive Order 13045

    This proposed rule is not subject to Executive Order 13045, 
entitled ``Protection of Children from Environmental Health Risks and 
Safety Risks'' (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

    This proposed rule is not subject to Executive Order 13211, 
entitled ``Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), 
because this proposed rule is not expected to affect energy supply, 
distribution, or use and because this proposed rule is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this proposed rule would not involve any 
technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not 
apply to this action.

J. Executive Order 12898

    This proposed rule does not entail special considerations of 
environmental justice related issues as delineated by Executive Order 
12898, entitled ``Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations'' (59 FR 7629, February 
16, 1994).

List of Subjects in 40 CFR Parts 721

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

    Dated: July 26, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PARTS 721--[AMENDED]

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.  721.11300 through 721.11329 to subpart E to read as 
follows:
Subpart E--Significant New Uses for Specific Chemical Substances

Sec.

* * * * *
721.11300 Alkanes, C11-16-branched and linear.
721.11301 Alkyl alkenoic acid, alkoxyalkyl ester, polymer with alkyl 
alkenoate, alkyl alkyl alkenoate and tris alkyl silyl alkyl 
alkenaote (generic).
721.11302 Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-, 
reaction products with propylene oxide (generic).
721.11303 2-Oxepanone, reaction products with alkylenediamine-
alkyleneimine polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and 
tetrahydro-2H-pyran-2-one (generic).
721.11304 Dicarboxylic acids, polymers with alkanoic acid, 
alkanediol, substituted-alkylalkanoic acid, substituted alkyl 
carbomonocycle, alkanedioic acid, alkanolamine blocked compds with 
alkanolamine (generic).
721.11305 Unsaturated polycyclic hydrocarbon (generic).
721.11306 Glycerides, soya mono- and di-, epoxidized, acetates.
721.11307 Glycerides, C16-18 and C18-unsatd. mono- and di-, 
epoxidized, acetates.
721.11308 Mixed metal oxide (generic).
721.11309 Urea, reaction products with N-butylphosphorothioic 
triamide and formaldehyde.
721.11310 Fatty acid reaction products with ethyleneamines and 
dialkyl ester (generic).

[[Page 38170]]

721.11311 Pentaerythritol, mixed esters with linear and branched 
fatty acids (generic).
721.11312 Alcohol capped polycarbodiimide from 
diethyldiisocyanatobenzene (generic).
721.11313 Oxirane, 2-methyl-, polymer with methoxirane homopolymer, 
1,1'-methylenebis[4-isocyanatobenzene], and glycerol-propylene oxide 
polymer (generic).
721.11314 Oxirane, 2-methyl-, polymer with methoxirane homopolymer, 
1,1'-methylenebis[isocyanatobenzene], and glycerol-propylene oxide 
polymer (generic).
721.11315 Lithium nickel hydride oxide.
721.11316 Lithium nickel potassium oxide.
721.11317 Hydrolyzed functionalized di-amino silanol polymer 
(generic).
721.11318 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, 
polymer with dimethyl carbonate, 1,6-hexanediol, diamine and 1,1'-
methylenebis[4-isocyanatocyclohexane], pentaerythritol, triacrylate-
blocked, compds. with triethylamine (generic).
721.11319 Waste plastics, poly(ethylene terephthalate), polymers 
with diethylene glycol, glycerol, polyerythritol, triethylene 
glycol, trimethylolalkane and polypropylene glycol (generic).
721.11320 Waste plastics, poly(ethylene terephthalate), polymers 
with diethylene glycol, glycerol, polyerythritol glycol, 
trimethylolalkane and polypropylene glycol (generic).
721.11321 Naphtha oils (generic).
721.11322 Saccharide reaction products with acid anhydride, 
etherified (generic).
721.11323 Alkyl alkenoic acid, alkyl ester, telomere with alkyl 
alkenoate, substituted alkyl alkyl alkenoate, alkylthiol, 
substituted carbomonocycle, hydroxyalkyl alkyl alkenoate and alkyl 
alkyl alkenoate (generic).
721.11324 Formaldehyde, polymer with 2-phenoxyalkanol and .alpha.-
phenyl-.omega.hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen 
phosphate 2-phenoxyalkyl hydrogen phosphate, alkaline salt 
(generic).
721.11325 Substituted polyalkylenepolycarbomonocycle ester, polymer 
with dialkanolamine, (hydroxyalkoxy)carbonyl] derivs., 
(alkoxyalkoxy) alkanol blocked (generic).
721.11326 Carbonmonocycles, polymer with haloalkyl substituted 
heteromonocycle and hydro-hydroxypoly[oxy(alkyl-alkanediyl)], 
dialkyl-alkanediamineterminated, hydroxyalkylated, acetates (salts) 
(generic).
721.11327 Alkanoic acid, compds. with substituted carbomonocycle-
dialkyl-alkanediamine-halosubstituted heteromonocycle-polyalkylene 
glycol polymerdialkanolamine reaction products (generic).
721.11328 Substituted carbomoncycle, polymer with haloalkyl 
substituted heteromonocycle, dialkyl-alkanediamine and hydro-
hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal 
oxide and dialkanolamine, acetates (salt) (generic).
721.11329 Non-metal tetrakis (hydroxyalkyl)-, halide, polymer with 
amide oxidized (generic).
* * * * *

Subpart E--Significant New Uses for Specific Chemical Substances

* * * * *


Sec.  721.11300  Alkanes, C11-16-branched and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, C11-16-
branched and linear (PMN P-16-400, CAS No. 1809170-78-2) 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(o). It is a significant new use to use the 
substance other than as a chemical intermediate, in cured coatings, 
cleaning fluids, metalworking fluids/rolling oils, and in 
agrochemicals.
    (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 (i), are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11301  Alkyl alkenoic acid, alkoxyalkyl ester, polymer with 
alkyl alkenoate, alkyl alkyl alkenoate and tris alkyl silyl alkyl 
alkenaote (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as alkyl 
alkenoic acid, alkoxyalkyl ester, polymer with alkyl alkenoate, alkyl 
alkyl alkenoate and tris alkyl silyl alkyl alkenoate (PMN P-17-119) 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(f). It is a significant new use to 
manufacture, process, or use the PMN substance in any manner that 
results in inhalation exposures.
    (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 (i), are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11302   Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-
, reaction products with propylene oxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified 
alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-, reaction 
products with propylene oxide (PMN P-17-191) 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. It is a 
significant new use to manufacture, process, or use the PMN substance 
in any manner that generates a spray, mist, or aerosol.
    (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 (i), are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11303  2-Oxepanone, reaction products with alkylenediamine-
alkyleneimine polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and tetrahydro-
2H-pyran-2-one (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 2-
oxepanone, reaction products with alkylenediamine-alkyleneimine 
polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and tetrahydro-2H-pyran-2-one 
(PMN P-17-220) 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(f) and (j). It is a significant new use to 
manufacture or import the PMN substance other than in liquid form.
    (ii) [Reserved]

[[Page 38171]]

    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations 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.  721.11304  Dicarboxylic acids, polymers with alkanoic acid, 
alkanediol, substituted-alkylalkanoic acid, substituted alkyl 
carbomonocycle, alkanedioic acid, alkanolamine blocked compds with 
alkanolamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances generically identified as 
dicarboxylic acids, polymers with alkanoic acid, alkanediol, 
substituted-alkylalkanoic acid, substituted alkyl carbomonocycle, 
alkanedioic acid, alkanolamine blocked compds with alkanolamine (P-17-
387 and P-17-388) are 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. It is a 
significant new use to manufacture, process, or use the PMN substances 
resulting in amine counter ions greater than 4% by weight, isocyanate 
residuals greater than 0.1% by weight, or a proportion of the acid 
group greater than 20% by weight. It is a significant new use to 
manufacture, process, or use the PMN substances that results in the 
average molecular weight smaller than the molecular weight specified in 
the PMNs or proportion of the low molecular weight species greater than 
the values specified in the PMNs for the 500 and 1000 dalton species.
    (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 (i) are applicable to manufacturers and 
processors of these substances.
    (2) Limitations 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.  721.11305  Unsaturated polycyclic hydrocarbon (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
unsaturated polycyclic hydrocarbon (PMN P-17-419) 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), (2)(i), (3), (4), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (5)(respirators 
must provide a National Institute for Occupational Safety and Health 
(NIOSH) assigned protection factor (APF) of at least 50), (6)(v), (vi), 
(b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (vi), (ix), (skin sensitization), (specific target organ 
toxicity), (2)(i), (ii), (iv), (v), (3)(i), (ii), (4)(iii), and (5). 
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(j) and (t). It is a significant new use to 
manufacture the substance for more than 9 months.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations 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.  721.11306  Glycerides, soya mono- and di-, epoxidized, acetates.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as glycerides, soya 
mono- and di-, epoxidized, acetates (P-18-7, CAS No. 2097734-14-8) 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. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposures.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=9,000.
    (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) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11307  Glycerides, C16-18 and C18-unsatd. mono- and di-, 
epoxidized, acetates.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as glycerides, C16-18 
and C18-unsatd. mono- and di-, epoxidized, acetates (P-18-8, CAS No. 
2097734-15-9) 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) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposures.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=9,000.
    (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) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 38172]]

Sec.  721.11308  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-18-55) 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), (2), (3), (4) when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (5)(respirators 
must provide a National Institute for Occupational Safety and Health 
(NIOSH) assigned protection factor (APF) of at least 1,000), 
(6)(particulate), (b)(concentration set at 0.1%), and (c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL is 0.04 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 the EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved]
    (ii) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d) (e)(concentration set at 0.1%), (f), (g)(1)(ii), 
(vii), (allergic skin reaction), (respiratory sensitization), (germ 
cell mutagenicity), (2)(i), (ii), (iii), (iv) (use respiratory 
protection or maintain workplace airborne concentrations at or below an 
8-hour time-weighted average of 0.04 mg/m\3\), (v), and (5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations 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.  721.11309  Urea, reaction products with N-butylphosphorothioic 
triamide and formaldehyde.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as urea, reaction 
products with N-butylphosphorothioic triamide and formaldehyde (P-18-
77, CAS No. 2093385-47-6) 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 (o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposures.
    (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 (f) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11310  Fatty acid reaction products with ethyleneamines and 
dialkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as fatty 
acid reaction products with ethyleneamines and dialkyl ester (P-18-85) 
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. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure.
    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11311  Pentaerythritol, mixed esters with linear and branched 
fatty acids (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
pentaerythritol, mixed esters with linear and branched fatty acids (PMN 
P-18-101) 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 (y)(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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11312  Alcohol capped polycarbodiimide from 
diethyldiisocyanatobenzene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as alcohol 
capped polycarbodiimide from diethyldiisocyanatobenzene (PMN P-18-107) 
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. It is a 
significant new use to manufacture the substance with a residual 
isocyanate level greater than 0.1%.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).

[[Page 38173]]

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


Sec.  721.11313   Oxirane, 2-methyl-, polymer with methoxirane 
homopolymer, 1,1'-methylenebis[4-isocyanatobenzene], and glycerol-
propylene oxide polymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
oxirane, 2-methyl-, polymer with methoxirane homopolymer, 1,1'-
methylenebis[4-isocyanatobenzene], and glycerol-propylene oxide polymer 
(P-18-118) 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 (o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposures. It is a significant new use to manufacture, 
process, or use the substance with isocyanate residuals greater than 
0.1%.
    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11314  Oxirane, 2-methyl-, polymer with methoxirane 
homopolymer, 1,1'-methylenebis[isocyanatobenzene], and glycerol-
propylene oxide polymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
oxirane, 2-methyl-, polymer with methoxirane homopolymer, 1,1'-
methylenebis[isocyanatobenzene], and glycerol-propylene oxide polymer 
(P-18-119) 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 (o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposures. It is a significant new use to manufacture, 
process, or use the substance with isocyanate residuals greater than 
0.1%.
    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11315  Lithium nickel hydride oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as lithium nickel 
hydride oxide (P-18-123, CAS No. 2081933-92-6) 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), (2), (3), (4), (5)(respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 50), 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, (6)(particulate), and (c).
    (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 0.05 
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 (d), (f), (g)(1)(i), (ii), (iii), (iv), (vii), 
(viii), (ix), (eye irritation), (2)(i), (ii), (iii), (iv)(use 
respiratory protection or maintain workplace airborne concentrations at 
or below an 8-hour time-weighted average of 0.05 mg/m\3\), (v), (skin 
irritation), (3)(ii), (4)(i), (5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the substance for more than six 
months.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=32.
    (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) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11316  Lithium nickel potassium oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as lithium nickel 
potassium oxide (P-18-124, CAS No. 210352-95-7) 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), (2), (3), (4), (5)(respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 50), 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, (6)(particulate), and (c).
    (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

[[Page 38174]]

for this substance. The NCEL is 0.05 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 (d), (f), (g)(1)(i), (ii), (iii), (iv), (vii), 
(viii), (ix), (eye irritation), (2)(i), (ii), (iii), (iv)(use 
respiratory protection or maintain workplace airborne concentrations at 
or below an 8-hour time-weighted average of 0.05 mg/m\3\), (v), (skin 
irritation), (3)(ii), (4)(i), (5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the substance for more than six 
months.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=32.
    (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) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11317  Hydrolyzed functionalized di-amino silanol polymer 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
hydrolyzed functionalized di-amino silanol polymer (PMN P-18-152) 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. It is a 
significant new use to manufacture, process, or use the PMN substance 
in any 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=3.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11318  Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, 
polymer with dimethyl carbonate, 1,6-hexanediol, diamine and 1,1'-
methylenebis[4-isocyanatocyclohexane], pentaerythritol, triacrylate-
blocked, compds. with triethylamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 
dimethyl carbonate, 1,6-hexanediol, diamine and 1,1'-methylenebis[4-
isocyanatocyclohexane], pentaerythritol, triacrylate-blocked, compds. 
with triethylamine (PMN P-18-169) 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)(2)(i), (3), (4) and (5) (respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 1,000 for spray applications and of 
at least 50 for non-spray applications). When determining which persons 
are reasonably likely to be exposed as required for in 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.
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture (including import) the PMN substance 
with triethylamine concentration no greater than the confidential 
concentration described in the PMN.
    (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) Limitations 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)(ii) of 
this section.


Sec.  721.11319  Waste plastics, poly(ethylene terephthalate), polymers 
with diethylene glycol, glycerol, polyerythritol, triethylene glycol, 
trimethylolalkane and polypropylene glycol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as waste 
plastics, poly(ethylene terephthalate), polymers with diethylene 
glycol, glycerol, polyerythritol, triethylene glycol, trimethylolalkane 
and polypropylene glycol. (PMN P-18-200) 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), (2), (3), (4), (5)(respirators must provide a National 
Institute for Occupational Safety and Health assigned protection factor 
of at least 10), when determining which persons are reasonably likely 
to be exposed as required for Sec.  721.63(a)(1), (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, (6)(particulate), 
(b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv), 
(2)(i), (iv), (v), (avoid eye contact), (use eye protection), (3)(i), 
(ii), (4)(water releases restrictions apply), and (5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=280.
    (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 38175]]

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


Sec.  721.11320  Waste plastics, poly(ethylene terephthalate), polymers 
with diethylene glycol, glycerol, polyerythritol glycol, 
trimethylolalkane and polypropylene glycol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as waste 
plastics, poly(ethylene terephthalate), polymers with diethylene 
glycol, glycerol, polyerythritol glycol, trimethylolalkane and 
polypropylene glycol (P-18-201) 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), (2), (3), (4), (5)(respirators must provide a National 
Institute for Occupational Safety and Health assigned protection factor 
of at least 10), when determining which persons are reasonably likely 
to be exposed as required for Sec.  721.63(a)(1), (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, (6)(particulate), 
(b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv), 
(2)(i), (iv), (v), (avoid eye contact), (use eye protection), (3)(i), 
(ii), (4)(water releases restrictions apply), and (5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (iv) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) where N=280.
    (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) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11321  Naphtha oils (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as naphtha 
oils (PMN P-18-235) 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 (f) and (j).
    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations 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.  721.11322  Saccharide reaction products with acid anhydride, 
etherified (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
saccharide reaction products with acid anhydride, etherified (PMN P-18-
238) 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. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure.
    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11323  Alkyl alkenoic acid, alkyl ester, telomere with alkyl 
alkenoate, substituted alkyl alkyl alkenoate, alkylthiol, substituted 
carbomonocycle, hydroxyalkyl alkyl alkenoate and alkyl alkyl alkenoate 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as alkyl 
alkenoic acid, alkyl ester, telomer with alkyl alkenoate, substituted 
alkyl alkyl alkenoate, alkylthiol, substituted carbomonocycle, 
hydroxyalkyl alkyl alkenoate and alkyl alkyl alkenoate (PMN P-18-307) 
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. It is a 
significant new use to manufacture (including import) the PMN substance 
with more than 5% of the molecular weight content less than 1,000 
Daltons.
    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11324  Formaldehyde, polymer with 2-phenoxyalkanol and 
.alpha.-phenyl-.omega. hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen 
phosphate 2-phenoxyalkyl hydrogen phosphate, alkaline salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
formaldehyde, polymer with 2-phenoxyalkanol and .alpha.-phenyl-.omega. 
hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen phosphate 2-phenoxyalkyl 
hydrogen phosphate, alkaline salt (PMN P-18-312) 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. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure. It is a significant new 
use to manufacture the PMN substance with greater than 20% (weight 
percent) components with molecular weight below 500 Daltons.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 38176]]

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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11325  Substituted polyalkylenepolycarbomonocycle ester, 
polymer with dialkanolamine, (hydroxyalkoxy)carbonyl] derivs., 
(alkoxyalkoxy) alkanol blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted polyalkylenepolycarbomonocycle ester, polymer with 
dialkanolamine, [(hydroxyalkoxy)carbonyl] derivs., (alkoxyalkoxy) 
alkanol-blocked (PMN P-19-8) 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(w)(1)(2), (x)(1)(2), and (y)(1)(2).
    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11326  Carbonmonocycles, polymer with haloalkyl substituted 
heteromonocycle and hydro-hydroxypoly[oxy(alkyl-alkanediyl)], dialkyl-
alkanediamineterminated, hydroxyalkylated, acetates (salts) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
carbonmonocycles, polymer with haloalkyl substituted heteromonocycle 
and hydro-hydroxypoly[oxy(alkyl-alkanediyl)], dialkyl-
alkanediamineterminated, hydroxyalkylated, acetates (salts) (PMN P-19-
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) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure to vapor, particulate, 
mist or aerosols. It is a significant new use to manufacture the PMN 
substance beyond an annual production volume of 85,000 kg.
    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11327  Alkanoic acid, compds. with substituted 
carbomonocycle-dialkyl-alkanediamine-halosubstituted heteromonocycle-
polyalkylene glycol polymerdialkanolamine reaction products (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkanoic acid, compds. with substituted carbomonocycle-dialkyl-
alkanediamine-halosubstituted heteromonocycle-polyalkylene glycol 
polymerdialkanolamine reaction products (PMN P-19-26) 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. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure to vapor, particulate, 
mist or aerosols.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=15.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11328  Substituted carbomoncycle, polymer with haloalkyl 
substituted heteromonocycle, dialkyl-alkanediamine and hydro-
hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal oxide 
and dialkanolamine, acetates (salt) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted carbomoncycle, polymer with haloalkyl substituted 
heteromonocycle, dialkyl-alkanediamine and hydro-
hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal oxide 
and dialkanolamine, acetates (salt) (PMN P-19-27) 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. It is a 
significant new use to manufacture, process, or use the PMN substance 
in any manner that results in inhalation exposure to vapor, 
particulate, mist or aerosols. It is a significant new use to 
manufacture the PMN substance beyond an annual production volume of 
95,600 kg.
    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11329  Non-metal tetrakis (hydroxyalkyl)-, halide, polymer 
with amide oxidized (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as non-
metal tetrakis (hydroxyalkyl)-, halide, polymer with amide oxidized 
(PMN P-19-45) 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(j). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure. It is a significant new use to manufacture the 
substance that results in unbound formaldehyde residuals greater than 
0.1%.
    (ii) [Reserved]

[[Page 38177]]

    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations 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.

[FR Doc. 2019-16539 Filed 8-5-19; 8:45 am]
BILLING CODE 6560-50-P