[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]
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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.
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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: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or
[[Page 66856]]
delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to final SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule on or after 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 http://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for
chemical substances that were the subject of PMNs. 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.
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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).
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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
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Applicability of the Proposed Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted EPA concludes that
the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the rule is
effective, other persons might engage in a use that has been identified
as a significant new use. 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 http://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.'' The Organisation for Economic Co-operation and
Development test guidelines are available from the OECD Bookshop at
http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
The potentially useful information listed in Unit IV. may not be
the only means of addressing the potential risks of the chemical
substance. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, 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 http://www.epa.gov/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2019-0530.
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