Significant New Use Rules on Certain Chemical Substances (19-5.F), 66855-66869 [2019-26226]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 235 (Friday, December 6, 2019)]
[Proposed Rules]
[Pages 66855-66869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26226]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2019-0530; FRL-10001-48]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (19-5.F)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for certain chemical substances 
that were the subject of premanufacture notices (PMNs). They are either 
the subject of Orders issued by EPA under TSCA or have received a ``not 
likely to present an unreasonable risk'' determination pursuant to 
TSCA. This action would require persons who intend to manufacture 
(defined by statute to include import) or process any of these chemical 
substances for an activity that is proposed as a significant new use 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 January 6, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2019-0530, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     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

[[Page 66856]]

delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
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 January 
6, 2020 are subject to the export notification provisions of TSCA 
section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply 
with the export notification requirements in 40 CFR part 707, subpart 
D.

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

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

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 40 CFR 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 uses for the chemical substances 
that are the

[[Page 66857]]

subject of these SNURs, EPA considered relevant information about the 
toxicity of the chemical substances and potential human exposures and 
environmental releases that may be associated with the substances, in 
addition to the factors in TSCA section 5(a)(2). Consistent with TSCA 
section 5(f)(4), for those chemical substances subject to an Order 
issued under TSCA section 5(e), EPA is proposing to identify any use 
not conforming to the restrictions of the order as a significant new 
use. For those chemical substances that EPA has determined ``not 
likely'' to present an unreasonable risk under the conditions of use, 
EPA is proposing to identify other circumstances that, while not 
reasonably foreseen, would warrant further EPA review before 
manufacture or processing for such a use is commenced.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for certain chemical substances with additions to 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.
     Potentially Useful Information. This is 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.
     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 19 PMN substances that are subject to 
Orders issued under TSCA section 5(e)(1)(A), as required by the 
determinations made under 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).
    These proposed rules also include 8 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. EPA did not deem such uses as reasonably 
foreseen the TSCA section 5(a)(3)(C) determinations. 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 limitations.
    The chemicals subject to these proposed SNURs are as follows:

PMN Number: P-16-541

    Chemical Name: Soybean meal, reaction products with phosphoric 
trichloride.
    CAS Number: 1962913-92-3.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a resin for adhesives used to bond wood-based particle/chip/
fiberboard products. Based on estimated physical/chemical properties of 
the PMN substance, comparison to structurally analogous chemical 
substances, and analysis of analogous inorganic phosphates, EPA has 
identified concerns for aquatic toxicity at surface water 
concentrations exceeding 22 parts per billion (ppb) if the chemical 
substance is not used following the limitation noted. The condition of 
use of the PMN substance as described in the PMN includes the following 
protective measure:
     No release of the PMN substance to surface waters that 
exceed 22 ppb.
    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 may be potentially useful to characterize the environmental 
effects of the PMN substance 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 testing would help characterize the potential 
environmental effects of the PMN substance.
    CFR Citation: 40 CFR 721.11420.

PMN Number: P-17-299

    Chemical Name: 2-Propenoic acid, alkyl, polymers with alkyl 
acrylate and polyethylene glycol methacrylate alkyl ether (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 paint additive. 
Based on estimated physical/chemical properties of the PMN substance 
and the comparison to structurally analogous chemical substances, EPA 
has identified concerns for developmental effects, blood clotting, 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 domestic manufacture of the PMN substance;
    2. No use of the PMN substance other than as a thickener in paint;
    3. No use of the PMN substance in concentrations greater than 1% in 
formulated product; and,
    4. No manufacturing, processing, or use of the PMN substance that 
generates a dust, mist, or aerosol.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information may be potentially useful to characterize the health 
effects of the PMN substance 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 acute inhalation toxicity and developmental toxicity testing would 
help characterize the potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11421.

PMN Number: P-17-393

    Chemical name: Alkanediamine, dialkyl-, polymer with .alpha.-
hydro-.omega.-[(1-oxo-2-propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) ether 
with substituted alkyl-substitutedalkanediol, reaction products with 
alkyl-alkanamine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: August 22, 2019.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a UV curable coating 
resin. Based on the physical/chemical properties of the PMN substance 
and comparison to structurally analogous chemical substances, EPA has 
identified concerns

[[Page 66858]]

for lung effects, skin and eye irritation, and respiratory and dermal 
sensitization. Based on Structural Activity Relationships (SAR) 
analysis on analogous substances, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 1 ppb. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to human health and the environment. To protect against 
these risks, the Order requires:
    1. No manufacture the PMN substance with an average molecular 
weight less than 1,000 Daltons and with no more than 10% below 500 
Daltons;
    2. Use of the PMN substance only for the confidential use specified 
in the Order;
    3. Use of National Institute for Occupational Safety and Health 
(NIOSH)-certified respirator with an Applied Protection Factor (APF) of 
at least 1,000 where there is potential for inhalation exposure or 
compliance with a NCEL of 0.039 mg/m\3\ as an 8-hour time-weighted 
average (TWA) to prevent inhalation exposure;
    4. Establishment of a hazard communication program, including human 
health precautionary statements on each label and in the SDS; and
    5. No release of the PMN substance into surface waters of the 
United States in concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful to characterize the health and 
environmental effects of the PMN 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 
that would be designated by this SNUR. EPA has determined that the 
results of aquatic toxicity, pulmonary toxicity, and sensitization 
testing would help EPA determine the potential human and environmental 
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 721.11422.

PMN Number: P-18-172

    Chemical Name: Calcium, carbonate 2-ethylhexanoate neodecanoate 
propionate complexes.
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the PMN substance 
will be as an auxiliary drier for architectural pains, industrial 
coatings and stains. Based on estimated physical/chemical properties of 
the PMN substance, analysis of available data on an analogue of a 
component of the new chemical substance, and analysis of analogous 
chemicals, EPA has identified concerns for liver and developmental 
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. Use of the PMN substance only for the use specified in the PMN; 
and
    2. No use of the PMN substance in a consumer product.
    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 may be potentially useful to characterize the health 
effects of the PMN substance 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 solution pH, specific target organ toxicity, skin irritation, eye 
irritation, and developmental/reproductive toxicity testing would help 
characterize the potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11423.

PMN Numbers: P-18-387 and P-18-388

    Chemical Names: Alkanal, reaction products with alkanediyl 
bis[alkyl-tris(alkyl-heterocycle)-1,3,5-triazine-2,4,6-triamine and 
hydrogen peroxide (generic) (P-18-387) and 1,3,5-Triazine-2,4,6-
triamine, alkanediyl bis[alkyl-tris(alkyl-heterocycle)-, allyl derivs., 
oxidized, hydrogenated (generic) (P-18-388).
    CAS Numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as plastic additives. 
Based on the estimated physical/chemical properties of the PMN 
substances, available data on the new chemical substances, and 
comparison with structurally analogous chemical substances, EPA has 
identified concerns for lung effects if the chemical substances are not 
used following the limitation noted. The conditions of use of the PMN 
substances as described in the PMNs includes the following protective 
measure:
     Use of a NIOSH-certified respirator with an APF of at 
least 50 where there is a potential for inhalation exposure.
    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 may be potentially useful to characterize the health 
effects of the PMN substances 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 substances.
    CFR Citations: 40 CFR 721.11424 (P-18-387) and 40 CFR 721.11425 (P-
18-388).

PMN Numbers: P-19-86, P-19-87, P-19-89, P-19-90, P-19-91, P-19-92, P-
19-93, P-19-97, P-19-100, P-19-101, P-19-102, P-19-103, P-19-104, P-19-
105, P-19-106, P-19-107, P-19-108, P-19-110

------------------------------------------------------------------------
         PMN No.              Chemical name              CAS No.
------------------------------------------------------------------------
P-19-86.................  Halogenated sodium     Not available.
                           benzene alkyl
                           carboxylate
                           (generic).
P-19-87.................  Halogenated sodium     Not available.
                           benzene alkyl
                           carboxylate
                           (generic).
P-19-89.................  Halogenated sodium     Not available.
                           benzene alkyl
                           carboxylate
                           (generic).
P-19-90.................  Halogenated sodium     Not available.
                           benzoate (generic).
P-19-91.................  Halogenated benzene    Not available.
                           alkylcarboxylic acid
                           (generic).
P-19-92.................  Halogenated benzene    Not available.
                           alkylcarboxylic acid
                           (generic).
P-19-93.................  Halogenated benzoic    Not available.
                           acid (generic).
P-19-97.................  Halogenated            Not available.
                           alkylbenzoic acid,
                           ethyl ester
                           (generic).
P-19-100................  Halogenated            Not available.
                           alkylbenzoic acid,
                           ethyl ester
                           (generic).
P-19-101................  Halogenated            Not available.
                           alkylbenzoic acid,
                           ethyl ester
                           (generic).
P-19-102................  Halogenated            Not available.
                           alkylbenzoic acid,
                           ethyl ester
                           (generic).
P-19-103................  Halogenated benzoic    Not available.
                           acid, ethyl ester
                           (generic).

[[Page 66859]]

 
P-19-104................  Halogenated            Not available.
                           alkylbenzoic acid,
                           ethyl ester
                           (generic).
P-19-105................  Halogenated benzoic    Not available.
                           acid, ethyl ester
                           (generic).
P-19-106................  Halogenated            Not available.
                           alkylbenzoic acid,
                           ethyl ester
                           (generic).
P-19-107................  Halogenated            Not available.
                           alkylbenzoic acid,
                           ethyl ester
                           (generic).
P-19-108................  Halogenated            Not available.
                           alkylbenzoic acid,
                           ethyl ester
                           (generic).
P-19-110................  Halogenated benzoic    Not available.
                           acid, ethyl ester
                           (generic).
------------------------------------------------------------------------

    Effective Date of TSCA section 5(e) Order: August 21, 2019.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the PMN substances will be: To monitor oil and gas 
well performance (P-19-86, P-19-87, P-19-89 and P-19-90), as well 
performance tracers (P-19-91 through P-19-93), and as well performance 
monitors (P-19-97, P-19-100 through P-19-108 and P-19-110). Based on 
the estimated physical/chemical properties of the PMN substances and 
comparison with structurally analogous chemical substances, EPA has 
identified concerns for neurotoxicity, irritation to skin, eyes, lungs, 
and mucous membranes, developmental toxicity, kidney toxicity (P-19-86, 
P-19-87, P-19-89, P-19-91 and P-19-92) and aquatic toxicity at 
concentrations that exceed 14 ppb (P-19-97, P-19-100 through P-19-108 
and P-19-110) if the chemical substances are not used following the 
limitation noted. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substances may present an unreasonable risk of injury to human health 
or the environment. To protect against these risks, the Order requires:
    1. No manufacture of the PMN substances without including 
engineering controls processes as described in the PMNs;
    2. Refrain from manufacturing (including import), processing or 
using the PMN substances other than as identified in the Order;
    3. No manufacture beyond the confidential annual manufacture volume 
identified in the Order (P-19-91 through P-19-93);
    4. Submission to EPA of certain toxicity testing before exceeding 
the confidential manufacture volumes identified in the Order (P-19-86, 
P-19-87, P-19-89 through P-19-93, P-19-97, P-19-100 through P-19-108 
and P-19-110);
    5. Use of personal protective equipment for workers where there is 
a potential for dermal exposure for the PMN substances specified in the 
Order (P-19-91 through P-19-93);
    6. Use of NIOSH-certified respirators for workers where there is a 
potential for inhalation exposure for the PMN substances specified in 
the Order or compliance with a NCEL of 0.0273 mg/m\3\ as an 8-hour 
time-weighted average to prevent inhalation exposure (P-19-91 through 
P-19-93);
    7. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    8. No manufacture or use of the PMN substances other than in liquid 
formulations (P-86, P-19-87, P-19-89 and P-19-90); and
    9. No release of the PMN substances resulting in a combined 
concentration of 14 parts per billion (ppb) (P-19-97, P-19-100 through 
P-19-108 and P-19-110).
    The proposed SNUR would designate as a ``significant new use'' the 
absence protective measures.
    Potentially useful information: EPA has determined that certain 
information about the environmental and 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. The submitter has agreed not to exceed certain 
production volume limits without performing specific reproduction/
developmental, inhalation, and aquatic toxicity testing. EPA has also 
determined that the results of specific aquatic toxicity, skin 
irritation, eye damage, neurotoxicity, and reproductive/developmental 
toxicity testing may be potentially useful to characterize the 
environmental and human 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 721.11426 (P-19-86); 40 CFR 721.11427 (P-19-
87); 40 CFR 721.11428 (P-19-89); 40 CFR 721.11429 (P-19-90); 40 CFR 
721.11430 (P-19-91); 40 CFR 721.11431 (P-19-92); 40 CFR 721.11432 (P-
19-93); 40 CFR 721.11433 (P-19-97); 40 CFR 721.11434 (P-19-100); 40 CFR 
721.11435 (P-19-101); 40 CFR 721.11436 (P-19-102); 40 CFR 721.114237 
(P-19-103); 40 CFR 721.11438 (P-19-104); 40 CFR 721.11439 (P-19-105); 
40 CFR 721.11440 (P-19-106); 40 CFR 721.11441 (P-19-107); 40 CFR 
721.11442 (P-19-108); and 40 CFR 721.11443 (P-19-110).

PMN Number: P-19-99

    Chemical Name: Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-
methyl-, polymer with dimethyl carbonate, 1,2-ethanediamine, 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1'-
methylenebis[4-isocyanatocyclohexane], compd. with N,N-
diethylethanamine.
    CAS Number: 1178511-46-0.
    Basis for action: The PMN states that the use of the PMN substance 
will be as a clear coat for wood. Based on estimated physical/chemical 
properties of the PMN substance and analysis of analogous chemicals, 
EPA has identified concerns for irritation and corrosion 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. Use of the PMN substance only for the use specified in the PMN; 
and
    2. No use of the PMN substance in a consumer product.
    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 may be potentially useful to characterize the health 
effects of the PMN substance 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, skin irritation, eye damage, and 
pulmonary effects testing would help characterize the potential health 
effects of the PMN substance.
    CFR Citation: 40 CFR 721.11444.

PMN Number: P-19-118

    Chemical Name: Substituted polyalkylenepoly, reaction products with 
alkene polymer (generic).
    CAS Number: Not available.

[[Page 66860]]

    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a component of 
lubricant. Based on estimated physical/chemical properties of the PMN 
substance, test data on the new chemical substance, and analysis of 
analogous polycationic polymers, EPA has identified concerns for skin 
and eye irritation and lung toxicity if the chemical substance is not 
used following the limitation noted. The condition of use of the PMN 
substance as described in the PMN includes the following protective 
measure:
     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 this protective measure.
    Potentially useful information: EPA has determined that certain 
information may be potentially useful to characterize the health 
effects of the PMN substance 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, eye damage, and pulmonary effects testing would 
help characterize the potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11445.

PMN Number: P-19-120

    Chemical Name: Alkenoic acid, polymer with alkanediyl bis 
substituted alkylene bis heteromonocycle, substituted carbomonocycle 
and (alkylalkenyl) carbomonocycle, alkali metal 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 component of ink. 
Based on estimated physical/chemical properties of the PMN substance, 
comparison to structurally analogous chemical substances, and analysis 
of analogous polyanionic polymers, EPA has identified concerns for 
aquatic toxicity at surface water concentrations exceeding 78 parts per 
billion (ppb) if the chemical substance is not used following the 
limitation noted. The condition of use of the PMN substance as 
described in the PMN includes the following protective measure:
     No release of the PMN substance to surface waters that 
exceed 78 ppb.
    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 may be potentially useful to characterize the environmental 
effects of the PMN substance 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 would help characterize the potential environmental 
effects of the PMN substance.
    CFR Citation: 40 CFR 721.11446.

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 19 
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 submitters. 
As a general matter, EPA believes it is necessary to follow TSCA 
section 5(e) Orders with a SNUR that identifies the absence of those 
protective measures as Significant New Uses to ensure that all 
manufacturers and processors--not just the original submitter--are held 
to the same standard.
    During review of the other eight chemical substances that are the 
subject of these SNURs and as further discussed in Unit IV, EPA 
identified certain circumstances that raised potential risk concerns. 
EPA determined that deviations from the limitations 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 certain limitations 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 
https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

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. However, TSCA section 5(e) Orders have been 
issued for 19 of the 27 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 24 
of the 27 chemical substances subject to this proposed rule have been 
claimed as confidential (per 40 CFR 720.85) 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

[[Page 66861]]

described in the regulatory text of this proposed rule are ongoing.
    Therefore, EPA designates December 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). 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 https://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 
https://www.oecdbookshop.org or SourceOECD at https://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, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. SNUNs 
must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available 
electronically at https://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-
2019-0530.

X. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulations and Regulatory Review

    This 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 Orders 12866 (58 FR 51735, October 
4, 1993) and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to the PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under the PRA, 
unless it has been approved by OMB and displays a currently valid OMB 
control number. The OMB control numbers for EPA's regulations in title 
40 of the CFR, after appearing in the Federal Register, are listed in 
40 CFR part 9, and included on the related collection instrument or 
form, if applicable.
    The information collection activities in this proposed rule have 
already been approved by OMB pursuant to the 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, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b) (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.

[[Page 66862]]

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: Federalism

    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 (64 
FR 43255, August 10, 1999).

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

    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 (65 FR 67249, November 9, 2000), 
do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This proposed rule is not subject to Executive Order 13045 (62 FR 
19885, April 23, 1997), because this is not an economically significant 
regulatory action as defined by Executive Order 12866, and this action 
does not address environmental health or safety risks 
disproportionately affecting children.

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

    This proposed rule is not subject to Executive Order 13211 (66 FR 
28355, May 22, 2001), because this proposed rule is not expected to 
affect energy supply, distribution, or use and because this proposed 
rule is not a significant regulatory action under Executive Order 
12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    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: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

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

List of Subjects in 40 CFR Part 721

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

    Dated: November 21, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

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

PART 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.  721.11420 through 721.11446 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11420 Soybean meal, reaction products with phosphoric 
trichloride
721.11421 2-Propenoic acid, alkyl, polymers with alkyl acrylate and 
polyethylene glycol methacrylate alkyl ether (generic)
721.11422 Alkanediamine, dialkyl-, polymer with .alpha.-
hydro-.omega.-[(1-oxo-2-propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) 
ether with substituted alkyl-substitutedalkanediol, reaction 
products with alkyl-alkanamine (generic)
721.11423 Calcium, carbonate 2-ethylhexanoate neodecanoate 
propionate complexes
721.11424 Alkanal, reaction products with alkanediyl bis[alkyl-
tris(alkyl-heterocycle)-1,3,5-triazine-2,4,6-triamine and hydrogen 
peroxide (generic)
721.11425 1,3,5-Triazine-2,4,6-triamine, alkanediyl bis[alkyl-
tris(alkyl-heterocycle)-, allyl derivs., oxidized, hydrogenated 
(generic)
721.11426 Halogenated sodium benzene alkyl carboxylate (generic) (P-
19-86)
721.11427 Halogenated sodium benzene alkyl carboxylate (generic) (P-
19-87)
721.11428 Halogenated sodium benzene alkyl carboxylate (generic) (P-
19-89)
721.11429 Halogenated sodium benzoate (generic) (P-19-90)
721.11430 Halogenated benzene alkylcarboxylic acid (generic) (P-19-
91)
721.11431 Halogenated benzene alkylcarboxylic acid (generic) (P-19-
92)
721.11432 Halogenated benzoic acid (generic) (P-19-93)
721.11433 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-97)
721.11434 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-100)
721.11435 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-101)
721.11436 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-102)
721.11437 Halogenated benzoic acid, ethyl ester (generic) (P-19-103)

[[Page 66863]]

721.11438 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-104)
721.11439 Halogenated benzoic acid, ethyl ester (generic) (P-19-105)
721.11440 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-106)
721.11441 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-107)
721.11442 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-108)
721.11443 Halogenated benzoic acid, ethyl ester (generic) (P-19-110)
721.11444 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, 
polymer with dimethyl carbonate, 1,2-ethanediamine, 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1'-
methylenebis[4-isocyanatocyclohexane], compd. with N,N-
diethylethanamine
721.11445 Substituted polyalkylenepoly, reaction products with 
alkene polymer (generic)
721.11446 Alkenoic acid, polymer with alkanediyl bis substituted 
alkylene bis heteromonocycle, substituted carbomonocycle and 
(alkylalkenyl) carbomonocycle, alkali metal salt (generic)
* * * * *


Sec.  721.11420  Soybean meal, reaction products with phosphoric 
trichloride.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as soybean meal, 
reaction products with phosphoric trichloride (PMN P-16-541, CAS No. 
1962913-92-3) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=22.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11421  2-Propenoic acid, alkyl, polymers with alkyl acrylate 
and polyethylene glycol methacrylate alkyl ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, alkyl, polymers with alkyl acrylate and polyethylene 
glycol methacrylate alkyl ether (PMN P-17-299) 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 use the 
PMN substance other than as a thickener in paint. It is a significant 
new use to use the PMN substance in concentrations greater than 1% in 
formulated products. It is a significant new use to manufacture, 
process, or use the PMN substance in a manner that generates a dust, 
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.  721.11422  Alkanediamine, dialkyl-, polymer with .alpha.-
hydro-.omega.-[(1-oxo-2-propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) ether 
with substituted alkyl-substitutedalkanediol, reaction products with 
alkyl-alkanamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanediamine, dialkyl-, polymer with .alpha.-hydro-.omega.-[(1-oxo-2-
propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) ether with substituted alkyl-
substitutedalkanediol, reaction products with alkyl-alkanamine (PMN P-
17-393) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the PMN 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4). (5) (respirators must provide a National Institute for 
Occupational Safety and Health assigned protection factor of at least 
1000), (6) (particulate), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(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.
    (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 0.039 
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 who Sec.  721.30 requests 
to use the NCELs approach are approved by EPA will be required to 
follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(i) and (ii) ((eye irritation), (skin 
sensitization)), (2)(i) through (iv) (use respiratory protection or 
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 0.039 mg/m\3\) and (v), (3)(ii) (hazardous to the 
aquatic environment), 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). It is a significant new use to 
manufacture the PMN substance with an average molecular weight less 
than 1000 Daltons and with more than 10% less than 500 Daltons.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d), (f) 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.  721.11423  Calcium, carbonate 2-ethylhexanoate neodecanoate 
propionate complexes.

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

[[Page 66864]]

calcium, carbonate 2-ethylhexanoate neodecanoate propionate complexes 
(PMN P-18-172) 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 an auxiliary drier for architectural paints, 
industrial coatings and stains.
    (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.  721.11424  Alkanal, reaction products with alkanediyl bis[alkyl-
tris(alkyl-heterocycle)-1,3,5-triazine-2,4,6-triamine and hydrogen 
peroxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanal, reaction products with alkanediyl bis[alkyl-tris(alkyl-
heterocycle)-1,3,5-triazine-2,4,6-triamine and hydrogen peroxide (PMN 
P-18-387) is subject to reporting under this section for the 
significant new use described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), (5) (respirators must provide a National Institute for 
Occupational Safety and Health assigned protection factor of at least 
50), and (6) (particulate. When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(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) [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 (d) 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.  721.11425  1,3,5-Triazine-2,4,6-triamine, alkanediyl bis[alkyl-
tris(alkyl-heterocycle)-, allyl derivs., oxidized, hydrogenated 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 1,3,5-
triazine-2,4,6-triamine, alkanediyl bis[alkyl-tris(alkyl-heterocycle)-, 
allyl derivs., oxidized, hydrogenated (PMN P-18-388) is subject to 
reporting under this section for the significant new use described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), (5) (respirators must provide a National Institute for 
Occupational Safety and Health assigned protection factor of at least 
50), and (6) (particulate). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(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) [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 (d) 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.  721.11426  Halogenated sodium benzene alkyl carboxylate (generic) 
(P-19-86).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated sodium benzene alkyl carboxylate (PMN P-19-86) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (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.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture, process, or use the substance other than in a liquid 
formulation. It is a significant new use to manufacture or process the 
substance without including the engineering controls/processes 
described in the premanufacture notice.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (f) through (i) are applicable to 
manufacturers 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.  721.11427  Halogenated sodium benzene alkyl carboxylate (generic) 
(P-19-87).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated sodium benzene alkyl carboxylate (PMN P-19-87) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (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.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture, process, or use the substance other than in a liquid 
formulation. It is a significant new use to manufacture or process the 
substance without including the engineering controls/processes 
described in the premanufacture notice.

[[Page 66865]]

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (f) through (i) are applicable to 
manufacturers 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.  721.11428  Halogenated sodium benzene alkyl carboxylate (generic) 
(P-19-89).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated sodium benzene alkyl carboxylate (PMN P-19-89) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (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.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture, process, or use the substance other than in a liquid 
formulation. It is a significant new use to manufacture or process the 
substance without including the engineering controls/processes 
described in the premanufacture notice.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (f) through (i) are applicable to 
manufacturers 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.  721.11429  Halogenated sodium benzoate (generic) (P-19-90).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated sodium benzoate (PMN P-19-90) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (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.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture, process, or use the substance other than in a liquid 
formulation. It is a significant new use to manufacture or process the 
substance without including the engineering controls/processes 
described in the premanufacture notice.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (f) through (i) are applicable to 
manufacturers 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.  721.11430  Halogenated benzene alkylcarboxylic acid (generic) (P-
19-91).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated benzene alkylcarboxylic acid (PMN P-19-91) 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), (iii) and (iv), (3), (4), (5) (respirators must 
provide a National Institute for Occupational Safety and Health 
assigned protection factor as described in the Order), 
(6)((particulate), (gas/vapor), (combination gas/vapor and 
particulate)), (b)(concentration set at 1.0%), and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible.
    (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 0.0273 
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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (iv) 
(use respiratory protection of maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 0.0273 
mg/m\3\) and (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), (q) and (t). It is a significant new 
use to manufacture or process the substance without including the 
engineering controls/processes described in the premanufacture notice.
    (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.

[[Page 66866]]

Sec.  721.11431  Halogenated benzene alkylcarboxylic acid (generic) (P-
19-92).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated benzene alkylcarboxylic acid (PMN P-19-92) 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), (iii) and (iv), (3), (4), (5) (respirators must 
provide a National Institute for Occupational Safety and Health 
assigned protection factor as described in the Order), (6) 
((particulate), (gas/vapor), (combination gas/vapor and particulate)), 
(b)(concentration set at 1.0%), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (a)(4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (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 0.0273 
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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (iv) 
(use respiratory protection of maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 0.0273 
mg/m\3\) and (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), (q) and (t). It is a significant new 
use to manufacture or process the substance without including the 
engineering controls/processes described in the premanufacture notice.
    (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.  721.11432  Halogenated benzoic acid (generic) (P-19-93).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated benzoic acid (PMN P-19-93) 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), (iii) and (iv), (3), (4), (5) (respirators must 
provide a National Institute for Occupational Safety and Health 
assigned protection factor as described in the Order), (6) 
((particulate), (gas/vapor), (combination gas/vapor and particulate)), 
(b) (concentration set at 1.0%), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (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 0.0273 
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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (iv) 
(use respiratory protection of maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 0.0273 
mg/m\3\) and (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), (q) and (t). It is a significant new 
use to manufacture or process the substance without including the 
engineering controls/processes described in the premanufacture notice.
    (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.  721.11433  Halogenated alkylbenzoic acid, ethyl ester (generic) 
(P-19-97).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-97) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (3)(i) 
and (ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture or process the substance without including the engineering 
controls/processes described in the premanufacture notice.

[[Page 66867]]

    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) 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.  721.11434  Halogenated alkylbenzoic acid, ethyl ester (generic) 
(P-19-100).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-100) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (3)(i) 
and (ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture or process the substance without including the engineering 
controls/processes described in the premanufacture notice.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) 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.  721.11435  Halogenated alkylbenzoic acid, ethyl ester (generic) 
(P-19-101).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-101) 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) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (3)(i) 
and (ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture or process the substance without including the engineering 
controls/processes described in the premanufacture notice.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) 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.  721.11436  Halogenated alkylbenzoic acid, ethyl ester (generic) 
(P-19-102).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-102) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (3)(i) 
and (ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q), It is a significant new use to 
manufacture or process the substance without including the engineering 
controls/processes described in the premanufacture notice.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) 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.  721.11437  Halogenated benzoic acid, ethyl ester (generic) (P-19-
103).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated benzoic acid, ethyl ester (PMN P-19-103) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (3)(i) 
and (ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture or process the substance without including the engineering 
controls/processes described in the premanufacture notice.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The

[[Page 66868]]

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.  721.11438  Halogenated alkylbenzoic acid, ethyl ester (generic) 
(P-19-104).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-104) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (3)(i) 
and (ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture or process the substance without including the engineering 
controls/processes described in the premanufacture notice.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) 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.  721.11439  Halogenated benzoic acid, ethyl ester (generic) (P-19-
105).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated benzoic acid, ethyl ester (PMN P-19-105) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (3)(i) 
and (ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture or process the substance without including the engineering 
controls/processes described in the premanufacture notice.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) 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.  721.11440  Halogenated alkylbenzoic acid, ethyl ester (generic) 
(P-19-106).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-106) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (3)(i) 
and (ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture or process the substance without including the engineering 
controls/processes described in the premanufacture notice.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) 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.  721.11441  Halogenated alkylbenzoic acid, ethyl ester (generic) 
(P-19-107).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-107) 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) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (3)(i) 
and (ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture or process the substance without including the engineering 
controls/processes described in the premanufacture notice.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) 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.  721.11442  Halogenated alkylbenzoic acid, ethyl ester (generic) 
(P-19-108).

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

[[Page 66869]]

(1) The chemical substance identified generically as halogenated 
alkylbenzoic acid, ethyl ester (PMN P-19-108) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (3)(i) 
and (ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture or process the substance without including the engineering 
controls/processes described in the premanufacture notice.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) 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.  721.11443  Halogenated benzoic acid, ethyl ester (generic) (P-19-
110).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated benzoic acid, ethyl ester (PMN P-19-110) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) 
through (iv), (vi), (ix) (eye irritation), (2)(i) through (iii), (3)(i) 
and (ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture or process the substance without including the engineering 
controls/processes described in the premanufacture notice.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) 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.  721.11444  Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, 
polymer with dimethyl carbonate, 1,2-ethanediamine, 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1'-
methylenebis[4-isocyanatocyclohexane], compd. with N,N-
diethylethanamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as propanoic acid, 3-
hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with dimethyl carbonate, 
1,2-ethanediamine, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 1,6-
hexanediol and 1,1'-methylenebis[4-isocyanatocyclohexane], compd. with 
N,N-diethylethanamine (PMN P-19-99, CAS No. 1178511-46-0) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) 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 clear coat for wood.
    (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.  721.11445  Substituted polyalkylenepoly, reaction products with 
alkene polymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted polyalkylenepoly, reaction products with alkene polymer 
(PMN P-19-118) 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. It is a 
significant new use to manufacture, process, or use the substance in 
any manner resulting 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.  721.11446  Alkenoic acid, polymer with alkanediyl bis substituted 
alkylene bis heteromonocycle, substituted carbomonocycle and 
(alkylalkenyl) carbomonocycle, alkali metal salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, polymer with alkanediyl bis substituted alkylene bis 
heteromonocycle, substituted carbomonocycle and (alkylalkenyl) 
carbomonocycle, alkali metal salt (PMN P-19-120) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=78.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2019-26226 Filed 12-5-19; 8:45 am]
 BILLING CODE 6560-50-P