Significant New Use Rules on Certain Chemical Substances (19-4.F), 59335-59349 [2019-23388]
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Federal Register / Vol. 84, No. 213 / Monday, November 4, 2019 / Proposed Rules
182(b) and (f) and 40 CFR 51.1112(a)
and (b) for the 2008 ozone NAAQS. We
will accept comments from the public
on this proposal until December 4, 2019.
If we take final action to approve the
submitted document, our final action
will incorporate this document into the
federally enforceable SIP.
III. Statutory and Executive Order
Reviews
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
Act and applicable federal regulations.
42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the
EPA’s role is to approve state choices,
if they meet the criteria of the Act.
Accordingly, this proposed action
merely proposes to approve state law as
meeting federal requirements and does
not impose additional requirements
beyond those imposed by state law. For
that reason, this proposed action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• Is not an Executive Order 13771 (82
FR 9339, February 2, 2017) regulatory
action because SIP approvals are
exempted under Executive Order 12866;
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the CAA; and
• Does not provide the EPA with the
discretionary authority to address
disproportionate human health or
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environmental effects with practical,
appropriate, and legally permissible
methods under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where the EPA or
an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the rule does not have
tribal implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Nitrogen dioxide, Ozone, Volatile
organic compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: October 21, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2019–23828 Filed 11–1–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2019–0494; FRL–10000–
54]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (19–4.F)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing significant
new use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for 26
chemical substances which were the
subject of premanufacture notices
(PMNs). Five of these chemical
substances are subject to Orders issued
by EPA pursuant to TSCA, and the
remaining 21 of these chemical
substances 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 26 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
SUMMARY:
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59335
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 December 4, 2019.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2019–0494, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Kenneth
Moss, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 564–9232; email address:
moss.kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substances
contained in this proposed rule. The
following list of North American
Industrial Classification System
(NAICS) codes is not intended to be
exhaustive, but rather provides a guide
to help readers determine whether this
document applies to them. Potentially
affected entities may include:
• Manufacturers or processors of one
or more subject chemical substances
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(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 December 4, 2019 are subject
to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b))
(see 40 CFR 721.20), and must comply
with the export notification
requirements in 40 CFR part 707,
subpart D.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under
TSCA section 5(a)(2) for chemical
substances that were the subject of
PMNs. These proposed SNURs would
require persons to notify EPA at least 90
days before commencing the
manufacture or processing of a chemical
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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?
TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including the four 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 section 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
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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 26 chemical substances that are
the subject of these SNURs, EPA
considered relevant information about
the toxicity of the chemical substances
and potential human exposures and
environmental releases that may be
associated with the substances, in
addition to the factors in TSCA section
5(a)(2). Consistent with TSCA section
5(f)(4), for the five chemical substances
subject to an order 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
the 21 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 26
chemical substances in 40 CFR part 721,
subpart E. In this unit, EPA provides the
following information for each chemical
substance:
• PMN number.
• Chemical name (generic name, if
the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS)
Registry number (if assigned for nonconfidential chemical identities).
• Basis for the SNUR or basis for the
TSCA 5(e) Order.
• Potentially Useful Information. This
is information identified by EPA that
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persistent, bioaccumulative, and toxic
(PBT) chemical. EPA estimates that that
PMN substance will persist in the
environment for more than 2 months
and estimates a bioaccumulation factor
of greater than or equal to 1,000. Based
on comparison to structurally analogous
chemical substances, the estimated
physical/chemical properties of the
PMN, and test data for the PMN
substance, EPA has identified concerns
for eye irritation, systemic,
developmental, blood, and reproductive
effects. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substance may present an unreasonable
risk of injury to human health and the
environment. To protect against these
risks, the Order requires:
1. Refraining from domestic
manufacture in the United States (i.e.,
import only);
2. Use of the PMN substance only for
the confidential use specified in the
Order;
3. No manufacture (including import)
of the PMN substance beyond the
confidential annual manufacture
volume specified in the Order;
4. Refraining from processing or using
the PMN substance in any manner that
generates a mist, vapor, or aerosol; and
5. No release of the PMN substance
into the waters of the United States.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the human health effects of the
PMN substance may be potentially
useful in support of a request by the
PMN submitter to modify the TSCA
section 5(e) 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
PMN Number: P–16–548
has determined that the results of
Chemical Name: Triarylsulfonium salt specific target organ toxicity and
(generic).
reproductive/developmental toxicity
CAS Number: Not available.
testing would help characterize the
Effective date of TSCA section 5(e)
potential health effects of the PMN
Order: July 22, 2019.
substance. Although the TSCA section
Basis for TSCA section 5(e) Order:
5(e) Order does not require this
The PMN states that the generic (noninformation, the TSCA section 5(e)
confidential) use of the PMN substance
Order’s restrictions remain in effect
will be as a resin catalyst. Based on
until the TSCA section 5(e) Order is
physical/chemical properties of the
modified or revoked by EPA based on
PMN substance (as described in the
submission of this or other relevant
New Chemical Program’s PBT category
information.
at 64 FR 60194; November 1999), the
CFR Citation: 40 CFR 721.11383.
PMN substance is a potentially
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 five
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 21
PMN substances that received ‘‘not
likely to present an unreasonable risk’’
determination in TSCA section
5(a)(3)(c). However, during the course of
these reviews, EPA identified concerns
for certain health and/or environmental
risks if the chemicals were not used
following the limitations identified by
the submitters in the notices, but the
TSCA section 5(a)(3)(C) determinations
did not deem such uses as reasonably
foreseen. The proposed SNURs would
identify as significant new uses any
manufacturing, processing, use,
distribution in commerce, or disposal
that does not conform to those same
limitations.
The chemicals subject to these
proposed SNURs are as follows:
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59337
PMN Numbers: P–17–312, P–17–313, P–
17–314, P–17–315, P–17–316, and P–17–
317
Chemical Names: Organic acid,
compds. with bisphenol Aepichlorohydrin-polypropylene glycol
diglycidyl ether polymer-disubstituted
amine-disubstituted polypropylene
glycol reaction products (generic) (P–
17–312); Phenol, 4,4′-(1methylethylidene)bis-, polymer with 2(chloromethyl)oxirane and alpha-(2oxiranylmethyl)-omega-(2oxiranylmethoxy)poly[oxy(methyl-1,2ethanediyl)], reaction products with
disubstituted amine and disubstituted
polypropylene glycol, organic acid salts
(generic) (P–17–313); Organic acid, 2substituted-, compds. with bisphenol Aepichlorohydrin-polypropylene glycol
diglycidyl ether polymer-disubstituted
aminedisubstituted polypropylene
glycol reaction products (generic) (P–
17–314); Phenol, 4,4′-(1methylethylidene)bis-, polymer with
alpha-(2-substituted-methylethyl)omega-(2-substitutedmethylethoxy)poly[oxy(methyl-1,2ethanediyl)], 2-(chloromethyl)oxirane
and alpha-(2-oxiranylmethyl)-omega-(2oxiranylmethoxy)poly[oxy(methyl-1,2ethanediyl)], alkylphenyl ethers,
reaction products with disubstituted
amine, organic acid salts (generic) (P–
17–315); Organic acid, compds. with
bisphenol A-epichlorohydrindisubstituted polypropylene glycolpolypropylene glycol diglycidyl ether
polymer alkylphenyl ethersdisubstituted amine reaction products
(generic) (P–17–316); Organic acid,
compds. with bisphenol Aepichlorohydrin-polypropylene glycol
diglycidyl ether polymer-disubstituted
polypropylene glycol reaction products
(generic) (P–17–317).
CAS Numbers: Not available.
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substances will be as additives for
electrocoat. Based on the estimated
physical/chemical properties of the
PMN substances, comparison with
structurally analogous substances, and
Structural Activity Relationships (SAR)
analysis on analogous polycationic
polymers, EPA has identified concerns
for lung effects, nasal epithelial damage,
skin and eye irritation, and aquatic
toxicity if the chemical substances are
not used following the limitations
noted. The conditions of use of the PMN
substances as described in the PMNs
include the following protective
measures:
1. No modification of the
manufacturing, processing, or use of the
PMN substances that result in the
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generation of a dust, mist, or aerosol;
and
2. No release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance into
the waters of the United States
exceeding a surface water concentration
of 78 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 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, skin
irritation/corrosion, eye damage, and
acute aquatic toxicity testing would
help characterize the potential health
effects of the PMN substances.
CFR Citations: 40 CFR 721.11384 (P–
17–312), 40 CFR 721.11385 (P–17–313),
40 CFR 721.11386 (P–17–314), 40 CFR
721.11387 (P–17–315), 40 CFR
721.11388 (P–17–316), and 40 CFR
721.11389 (P–17–317).
PMN Numbers: P–17–398, P–17–399, P–
18–1, and P–18–28
Chemical names: Branched cyclic and
linear hydrocarbons from plastic
depolymerization (generic) (P–17–398),
Alkane, alkene, styrenic compounds
derived from plastic depolymerization
(generic) (P–17–399), Carbon compound
derived from plastic depolymerization
(generic) (P–18–1), and Branched cyclic
and linear hydrocarbons from plastic
depolymerization (generic) (P–18–28).
CAS numbers: Not available.
Effective date of TSCA section 5(e)
Order: June 10, 2019.
Basis for TSCA section 5(e) Order:
The PMNs state that the use of P–17–
398 and P–17–399 will be as a refinery
feedstock or fuel blending additive, the
generic use of P–18–1 will be as an
additive, and the use of P–18–28 will be
as a chemical feedstock. Based on the
physical/chemical properties of the
PMN substances and comparison to
structurally analogous chemical
substances, EPA has identified concerns
for neurological impairment, and
hematological effects including aplastic
anemia and acute myelogenous
leukemia for PMN substance P–18–28.
There is concern for lung effects for P–
18–1, if respirable, based on the
respirable, poorly soluble particles
category. Based on SAR analysis on
analogous substances, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb for
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P–17–398 and P–17–399, and 15 ppb for
P–18–28. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substances may present an unreasonable
risk of injury to human health and the
environment. The Order was also issued
under TSCA sections 5(a)(3)(B)(ii)(II)
and 5(e)(1)(A)(ii)(II), based on a finding
that the substances are or will be
produced in substantial quantities and
that the substances either enter or may
reasonably be anticipated to enter the
environment in substantial quantities,
or there is or may be significant (or
substantial) human exposure to the
substances. To protect against these
risks, the Order requires:
1. Refraining from manufacturing,
processing, or using P–17–398 and P–
17–399 other than as a refinery
feedstock or a fuel blending additive
and refrain from manufacturing,
processing, and using P–18–28 other
than as a chemical feedstock or a fuel
blending additive;
2. Manufacture of P–18–1 via the
enclosed manufacturing process
described in the PMN; and
3. Manufacture of P–18–1 according
to the particle sizes described in the
PMN: 1% or less of the particles at less
than 75 microns.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the human health and
environmental effects of the PMN
substances may be potentially useful in
support of a request by the PMN
submitter to modify the TSCA section
5(e) 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
additional particle size characterization
testing for P–18–1 and acute and
chronic aquatic toxicity testing for P–
17–398, P–17–399, and P–18–28 would
help EPA determine the potential
human and environmental effects of the
PMN substances. Although the TSCA
section 5(e) 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 citations: 40 CFR 721.11390 (P–
17–398), 40 CFR 721.11391 (P–17–399),
40 CFR 721.11392 (P–18–1), and 40 CFR
721.11393 (P–18–28).
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PMN Number: P–18–9
Chemical Name: Phosphonic acid,
dimethyl ester, polymer with alkyl diols
(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 lubricant
additive. Based on estimated physical/
chemical properties of the PMN
substance, test data on the PMN
substance, comparison to structurally
analogous chemical substances, and
SAR analysis of test data on analogous
esters, EPA has identified concerns for
gastrointestinal and kidney effects,
reproductive/developmental toxicity,
and aquatic toxicity if the chemical
substance is not used following the
limitations noted. The conditions of use
of the PMN substance as described in
the PMN include the following
protective measures:
1. No release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance into
the waters of the United States
exceeding a surface water concentration
of 300 ppb; and
2. No manufacture, process, 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 and 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, specific target
organ toxicity, and reproductive/
developmental toxicity testing would
help characterize the potential health
and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11394.
PMN Number: P–18–11
Chemical Name: 1H-Imidazole,
1,2,4,5-tetramethyl-.
CAS Number: 1739-83-9.
Basis for action: The PMN states that
the use of the PMN substance will be as
a chemical intermediate in the synthesis
of a polymer. Based on estimated
physical/chemical properties of the
PMN substance, test data on analogous
chemical substances, comparison to
structurally analogous chemical
substances, and SAR analysis of test
data on analogous pyrroles/diazoles,
EPA has identified concerns for
irritation and corrosion to all tissues,
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developmental effects, liver toxicity,
and aquatic toxicity if the chemical
substance is not used following the
limitations noted. The conditions of use
of the PMN substance as described in
the PMN include the following
protective measures:
1. Refraining from domestic
manufacture in the United States (i.e.,
import only);
2. No release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance into
the waters of the United States
exceeding a surface water concentration
of 7 ppb; and
3. No use of the PMN substance other
than as a chemical intermediate.
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 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 corrosion,
developmental/reproductive toxicity,
specific target organ toxicity, and
aquatic toxicity testing would help
characterize the potential health and
environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11395.
PMN Number: P–18–170
Chemical Name: 1-Propanaminium,
N,N′-(oxydi-2,1-ethanediyl)bis[3-chloro2-hydroxy-N,N-dimethyl-, chloride
(1:2).
CAS Number: 96320–92–2.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be for use in textile
treatment. Based on the physical/
chemical properties of the PMN
substance, comparison of structurally
analogous chemical substances, and
SAR analysis on cationic surfactants,
EPA has identified concerns for
surfactant effects on the lungs,
developmental effects, mutagenicity,
carcinogenicity, systemic toxicity, skin
and respiratory sensitization, liver and
kidney toxicity and aquatic toxicity if
the chemical substance is not used
following the limitations noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measures:
1. No manufacturing, processing, or
use of the PMN substance that results in
inhalation exposures; and
2. No release of a manufacturing,
processing, or use stream associated
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with any use of the PMN substance into
the waters of the United States
exceeding a surface water concentration
of 164 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 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,
reproductive/developmental toxicity,
and chronic aquatic toxicity testing
would help characterize the potential
health and environmental effects of the
PMN substance.
CFR Citation: 40 CFR 721.11396.
PMN Number: P–18–185
Chemical Name: Fatty acid, polymer
with alkanedioic acid dialkyl ester,
hydroxyl alkyl substituted alkanediol,
substituted carbomonocycle and alkylol
substituted alkane (generic). Polymer
exemption flag: The chemical must be
manufactured such that it meets the
polymer exemption criteria as described
under 40 CFR 723.250(e)(1), in addition
to meeting the definition of polymer at
40 CFR 723.250(b).
CAS Number: Not available.
Basis for action: The PMN states that
the use of the PMN substance will be as
an adhesion-enhancing resin for wood
applications for industrial and
commercial use. Based on estimated
physical/chemical properties of the
PMN substance and comparison to
structurally analogous chemical
substances, EPA has identified concerns
for developmental and reproductive
effects if the chemical substance is not
used following the limitation noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measure:
• No 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 reproductive/
developmental toxicity testing would
help characterize the potential health
effects of the PMN substance.
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CFR Citation: 40 CFR 721.11397.
PMN Numbers: P–18–190 and P–18–191
Chemical Names: 2,5-Furandione,
polymer with ethenylbenzene, 4hydroxy-substituted butyl amide,
polymers with epichlorohydrin and
trimethylolpropane, sodium salts
(generic) (P–18–190); 2,5-Furandione,
polymer with ethenylbenzene, 4hydroxy-substitutedbutyl [3-[2-[1[[(substitutedphenyl)amino]carbonyl]-2oxopropyl]diazenyl]phenyl]methyl
amide, polymers with epichlorohydrin
and trimethylolpropane, sodium salts
(generic) (P–18–191).
CAS Numbers: Not available.
Basis for action: The PMNs state that
the use of the substances will be as a
pigment dispersing aid for pigments in
inkjet printing inks. Based on the
estimated physical/chemical properties,
high pH, chelating potential of the
polyanionic groups and comparison
with structurally analogous chemical
substances, EPA has identified concerns
for developmental and blood effects,
and eye, skin, and lung irritation if the
chemical substances are not used
following the limitation noted. The
conditions of use of the PMN substances
as described in the PMNs include the
following protective measure:
• Use of the PMN substances only as
pigment dispersing aids for pigments in
inkjet printing inks.
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
reproduction/developmental toxicity,
skin irritation, and eye damage testing
would help characterize the potential
health effects of the PMN substances.
CFR Citations: 40 CFR 721.11398 (P–
18–190) and 40 CFR 721.11399 (P–18–
191).
PMN Number: P–18–223
Chemical Name: Alkane,
bis(alkoxymethyl)-dimethyl- (generic).
CAS Number: Not available.
Basis for action: The PMN states that
the use of the PMN substance will be as
a selectivity improver for catalysts used
in polyolefin production. Based on
estimated physical/chemical properties,
comparison to structurally analogous
chemical substances, test data on the
PMN substance, and SAR analysis on
analogous neutral organics, EPA has
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identified concerns for eye irritation,
systemic and developmental toxicity,
neurotoxicity and aquatic toxicity if the
chemical substance is not used
following the limitation noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measure:
• No manufacture of the PMN
substance beyond the confidential
annual production volume specified in
the PMN.
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 and 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 toxicokinetics, specific organ
toxicity, irritation, neurotoxicity,
systemic toxicity, reproductive/
developmental toxicity, and aquatic
toxicity testing would help characterize
the potential health and environmental
effects of the PMN substance.
CFR Citation: 40 CFR 721.11400.
PMN Number: P–18–285
Chemical Name: Butanedioic acid, 2methylene-, polymer with 2-methyl-2[(1-oxo-2-propen-1-yl)amino]-1propanesulfonic acid, sodium zinc salt.
CAS Number: 2220235–78–7.
Basis for action: The PMN states that
the use of the PMN substance will be for
odor neutralization for pet litter and
cleaning/deodorizing hard surfaces,
fabrics, skin and hair, odor
neutralization for air care, and odor
neutralization for waste processing and
solid waste management in paper, oil,
gas, mining, agriculture, and food and
municipal industries. Based on SAR
analysis on analogous polyanionic
polymers, EPA has identified concerns
for aquatic toxicity if the chemical
substance is not used following the
limitation noted. The conditions of use
of the PMN substance as described in
the PMN include the following
protective measure:
• No release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance into
the waters of the United States
exceeding a surface water concentration
of 143 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
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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
chronic aquatic toxicity testing would
help characterize the potential
environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11404.
PMN Number: P–18–300
Chemical Name: Heteromonocycle,
alkenoic 1:1 salt, polymer with alpha-(2methyl-1-oxo-2-propen-1-y)l-omegamethoxypoly(oxy-1,2-ethanediyl) and
methyl-alkenoic acid (generic).
CAS Number: Not available.
Basis for action: The PMN states that
the use of the PMN substance will be as
an additive for automatic dishwashing
detergent. Based on the estimated
physical/chemical properties of the
PMN substance, comparison with
structurally analogous chemical
substances, and available data on the
new chemical substance, EPA has
identified concerns for lung effects if the
chemical substance is not used
following the limitations noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measures:
1. No manufacturing, processing, or
use that results in particles less than 50
microns; and
2. No use that results in consumer
inhalation or dermal exposure and use
only in sealed, single-use packets.
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
pulmonary effects, specific target organ
effects, and developmental/reproductive
toxicity testing would help characterize
the potential health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11405.
PMN Number: P–18–394
Chemical Name: Substituted benzylic
ether polyethylene glycol alkyl ether
derivative (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 chemical
intermediate. Based on estimated
physical/chemical properties of the
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PMN substance, comparison to
structurally analogous chemical
substances, and test data on the PMN
substance, and SAR analysis on
analogous nonionic surfactants, EPA has
identified concerns for ocular, lung and
mucous membrane irritation, lung
effects, skin and respiratory
sensitization, systemic effects,
neurotoxicity, immunotoxicity, and
aquatic 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
measures:
1. No use of the PMN substance
involving application methods that
generate a vapor, mist, or aerosol; and
2. No release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance into
the waters of the United States
exceeding a surface water concentration
of 4 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health and 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 specific target organ toxicity,
neurotoxicity, sensitization, eye
damage, skin irritation, and algal
toxicity testing would help characterize
the potential health and environmental
effects of the PMN substance.
CFR Citation: 40 CFR 721.11406.
PMN Number: P–18–404
Chemical Name:
Alkylmultiheteroatom, 2functionalisedalkyl-2-hydroxyalkyl-,
polymer with alkylheteroatommultialkylfunctionalised
carbomonocycleheteroatom and
multiglycidylether difunctionalised
polyalkylene glycol (generic).
CAS Number: Not available.
Basis for action: The PMN states that
the use of the PMN substance will be as
an epoxy curing agent used in molding
formulations for the manufacture of
wind turbine blades. Based on estimated
physical/chemical properties of the
PMN substance and comparison of
structurally analogous chemical
substances, EPA has identified concerns
for pulmonary effects, skin corrosion,
eye irritation, skin sensitization, and
kidney toxicity if the chemical
substance is not used following the
limitations noted. The conditions of use
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of the PMN substance as described in
the PMN include the following
protective measures:
1. No manufacturing (including
import), processing, or use of the PMN
substance that results in inhalation
exposures; and
2. No release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance into
the waters of the United States.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the health effects of the PMN
substance may be potentially useful if a
manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this proposed SNUR. EPA
has determined that pulmonary toxicity,
specific target organ toxicity, and skin
sensitization testing using the
reconstructed human cornea-like
epithelium test method would help
characterize the potential health effects
of the PMN substance.
CFR Citation: 40 CFR 721.11407.
PMN Number: P–19–12
Chemical Name: Benzenedicarboxylic
acid, reaction products with
isobenzofurandione and diethylene
glycol (generic).
CAS Number: Not available.
Basis for action: The PMN states that
the use of the PMN substance will be as
a resin component for polyisocyanurate
resins and specialty polyurethane kits
and systems for aerospace and military
applications. Based on comparison to
structurally analogous chemical
substances, EPA has identified concerns
for bladder, kidney, and reproductive/
developmental toxicity if the chemical
substance is not used following the
limitation noted. The conditions of use
of the PMN substance as described in
the PMN include the following
protective measure:
• No manufacturing, processing, or
use of the 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
about the health effects of the PMN
substance may be potentially useful if a
manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this proposed SNUR. EPA
has determined that the results of
developmental/reproductive toxicity,
specific target organ toxicity, and eye
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and skin irritation testing would help
characterize the potential health effects
of the PMN substance.
CFR Citation: 40 CFR 721.11408.
PMN Number: P–19–31
Chemical Name: Formaldehyde,
polymer with N1-(2-aminoethyl)alkanediamine, 5-amino-1,3,3trimethylcyclohexanemethanamine, 2(chloromethyl)oxirane, 4,4′-(1methylethylidene)bis[Phenol] and
alpha-hydro-omega-hydroxypoly(oxy1,2-ethanediyl) (generic).
CAS Number: Not available.
Basis for action: The PMN states that
the use of the PMN substance will be as
a curing agent for epoxy coating
systems. Based on the estimated
physical/chemical properties of the
PMN substance, comparison with
structurally analogous chemical
substances, and SAR analysis on
analogous polycationic polymers, EPA
has identified concerns for irritation,
lung effects, carcinogenicity, systemic
toxicity, neurotoxicity, and aquatic
toxicity if the chemical substance is not
used following the limitations noted.
The conditions of use of the PMN
substance as described in the PMN
include the following protective
measures:
1. No release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance into
the waters of the United States
exceeding a surface water concentration
of 1 ppb; and
2. No manufacturing, processing, or
use of the substance that results in
inhalation exposures.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health and 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 specific target organ toxicity,
skin irritation, neurotoxicity,
carcinogenicity and aquatic toxicity
testing would help characterize the
potential health and environmental
effects of the PMN substance.
CFR Citation: 40 CFR 721.11409.
PMN Number: P–19–71
Chemical Name: 2,4-Hexadienoic
acid, 1,1′-[2-ethyl-2-[(1-oxo-2,4hexadien-1-yl)oxy]methyl]-1,3propanediyl] ester.
CAS Number: 2307636–51–5.
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Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be as a physical
property modifier for polymers. Based
on estimated physical/chemical
properties, the comparison of
structurally analogous chemical
substances and SAR analysis on esters,
EPA has identified concerns for liver,
developmental, and aquatic toxicity if
the chemical substance is not used
following the limitation noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measures:
1. Use of the PMN substance only for
the confidential use specified in the
PMN; and
2. No manufacture of the PMN
substance beyond the confidential
annual production volume specified in
the PMN.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health and 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 reproductive toxicity, specific
target organ toxicity, and aquatic
toxicity testing would help characterize
the potential health and environmental
effects of the PMN substance.
CFR Citation: 40 CFR 721.11410.
PMN Number: P–19–72
Chemical Name: 1-Butanol, reaction
products with 2-[(2-propen-1yloxy)methyl]oxirane.
CAS Number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be as a raw material
used in chemical manufacture. Based on
available data on the PMN substance,
EPA has identified concerns for acute
toxicity, corrosion to all exposed
tissues, sensitization, and hematological
and skin changes 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:
• Use of the PMN substance only for
the confidential use specified in the
PMN;
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
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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
toxicity, sensitization, and systemic
effects would help characterize the
potential health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11411.
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 five 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 21
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 receive notice of any person’s
intent to manufacture or process a listed
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chemical substance for the described
significant new use before that activity
begins.
• To review and evaluate data
submitted in a SNUN before the notice
submitter begins manufacturing or
processing a listed chemical substance
for the described significant new use.
• To either determine that the
prospective manufacture or processing
is not likely to present an unreasonable
risk, or to take necessary regulatory
action associated with any other
determination, before the described
significant new use of the chemical
substance occurs.
Issuance of a SNUR for a chemical
substance does not signify that the
chemical substance is listed on the
TSCA Chemical Substance Inventory
(TSCA Inventory). Guidance on how to
determine if a chemical substance is on
the TSCA Inventory is available on the
internet at https://www.epa.gov/opptintr/
existingchemicals/pubs/tscainventory/
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 five of the 26
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
21 of the 26 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
described in the regulatory text of this
proposed rule are ongoing.
Therefore, EPA designates November
4, 2019 as the cutoff date for
determining whether the new use is
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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
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can meet both the data needs and the
objective of TSCA section 4(h). To
access the OCSPP test guidelines
referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’ The
Organisation for Economic Co-operation
and Development test guidelines are
available from the OECD Bookshop at
https://www.oecdbookshop.org or
SourceOECD at https://
www.sourceoecd.org.
The potentially useful information
listed in Unit IV. may not be the only
means of addressing the potential risks
of the chemical substance. EPA
recommends that potential SNUN
submitters contact EPA early enough so
that they will be able to conduct the
appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons
submitting a SNUN must comply with
the same notification requirements and
EPA regulatory procedures as persons
submitting a PMN, including
submission of test data on health and
environmental effects as described in 40
CFR 720.50. SNUNs must be submitted
on EPA Form No. 7710–25, generated
using e-PMN software, and submitted to
the Agency in accordance with the
procedures set forth in 40 CFR 720.40
and 721.25. E–PMN software is
available electronically at https://
www.epa.gov/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
of the chemical substances subject to
this proposed rule. EPA’s complete
economic analysis is available in the
docket under docket ID number EPA–
HQ–OPPT–2019–0494.
X. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations-and-executive-orders.
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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.
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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.).
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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)
In addition, since this proposed rule
would not involve any technical
standards, NTTAA section 12(d) (15
U.S.C. 272 note) does not apply to this
action.
J. Executive Order 12898: 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).
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List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: October 18, 2019.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
PARTS 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add §§ 721.11383 through
721.11411 to subpart E to read as
follows:
■
Subpart E—Significant New Uses for
Specific Chemical Substances
*
*
*
*
*
Secs.
§ 721.11383 Triarylsulfonium salt (generic).
§ 721.11384 Organic acid, compds. with
bisphenol A-epichlorohydrinpolypropylene glycol diglycidyl ether
polymer-disubstituted aminedisubstituted polypropylene glycol
reaction products (generic).
§ 721.11385 Phenol, 4,4′-(1methylethylidene)bis-, polymer with 2(chloromethyl)oxirane and alpha-(2oxiranylmethyl)-omega-(2oxiranylmethoxy)poly[oxy(methyl-1,2ethanediyl)], reaction products with
disubstituted amine and disubstituted
polypropylene glycol, organic acid salts
(generic).
§ 721.11386 Organic acid, 2-substituted-,
compds. with bisphenol Aepichlorohydrin-polypropylene glycol
diglycidyl ether polymer-disubstituted
aminedisubstituted polypropylene glycol
reaction products (generic).
§ 721.11387 Phenol, 4,4′-(1methylethylidene)bis-, polymer with
alpha-(2-substituted-methylethyl)omega-(2-substitutedmethylethoxy)poly[oxy(methyl-1,2ethanediyl)], 2-(chloromethyl)oxirane
and alpha-(2-oxiranylmethyl)-omega-(2oxiranylmethoxy)poly[oxy(methyl-1,2ethanediyl)], alkylphenyl ethers, reaction
products with disubstituted amine,
organic acid salts (generic).
§ 721.11388 Organic acid, compds. with
bisphenol A-epichlorohydrindisubstituted polypropylene glycolpolypropylene glycol diglycidyl ether
polymer alkylphenyl ethersdisubstituted amine reaction products
(generic).
§ 721.11389 Organic acid, compds. with
bisphenol A-epichlorohydrinpolypropylene glycol diglycidyl ether
polymer-disubstituted polypropylene
glycol reaction products (generic).
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§ 721.11390 Branched cyclic and linear
hydrocarbons from plastic
depolymerization (generic).
§ 721.11391 Alkane, alkene, styrenic
compounds derived from plastic
depolymerization (generic).
§ 721.11392 Carbon compound derived
from plastic depolymerization (generic).
§ 721.11393 Branched cyclic and linear
hydrocarbons from plastic
depolymerization (generic).
§ 721.11394 Phosphonic acid, dimethyl
ester, polymer with alkyl diols (generic).
§ 721.11395 1H-Imidazole, 1,2,4,5tetramethyl-.
§ 721.11396 1-Propanaminium, N,N′(oxydi-2,1-ethanediyl)bis[3-chloro-2hydroxy-N,N-dimethyl-, chloride (1:2).
§ 721.11397 Fatty acid, polymer with
alkanedioic acid dialkyl ester, hydroxyl
alkyl substituted alkanediol, substituted
carbomonocycle and alkylol substituted
alkane (generic).
§ 721.11398 2,5-Furandione, polymer with
ethenylbenzene, 4-hydroxy-substituted
butyl amide, polymers with
epichlorohydrin and trimethylolpropane,
sodium salts (generic).
§ 721.11399 2,5-Furandione, polymer with
ethenylbenzene, 4-hydroxysubstitutedbutyl [3-[2-[1[[(substitutedphenyl)amino]carbonyl]-2oxopropyl]diazenyl]phenyl]methyl
amide, polymers with epichlorohydrin
and trimethylolpropane, sodium salts
(generic).
§ 721.11400 Alkane, bis(alkoxymethyl)dimethyl- (generic).
§ 721.11401 [Reserved]
§ 721.11402 [Reserved]
§ 721.11403 [Reserved]
§ 721.11404 Butanedioic acid, 2-methylene, polymer with 2-methyl-2-[(1-oxo-2propen-1-yl)amino]-1-propanesulfonic
acid, sodium zinc salt.
§ 721.11405 Heteromonocycle, alkenoic
(1:1) salt, polymer with alpha-(2-methyl1-oxo-2-propen-1-y)l-omega.methoxypoly(oxy-1,2-ethanediyl) and
methyl-alkenoic acid (generic).
§ 721.11406 Substituted benzylic ether
polyethylene glycol alkyl ether
derivative (generic).
§ 721.11407 Alkylmultiheteroatom, 2functionalisedalkyl-2-hydroxyalkyl-,
polymer with alkylheteroatommultialkylfunctionalised
carbomonocycleheteroatom and
multiglycidylether difunctionalised
polyalkylene glycol (generic).
§ 721.11408 Benzenedicarboxylic acid,
reaction products with
isobenzofurandione and diethylene
glycol (generic).
§ 721.11409 Formaldehyde, polymer with
N1-(2-aminoethyl)-alkanediamine, 5amino-1,3,3trimethylcyclohexanemethanamine, 2(chloromethyl)oxirane, 4,4′-(1methylethylidene)bis[Phenol] and alphahydro-omega-hydroxypoly(oxy-1,2ethanediyl) (generic).
§ 721.11410 2,4-Hexadienoic acid, 1,1′-[2ethyl-2-[(1-oxo-2,4-hexadien-1yl)oxy]methyl]-1,3-propanediyl] ester.
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§ 721.11411 1-Butanol, reaction products
with 2-[(2-propen-1yloxy)methyl]oxirane.
*
*
*
§ 721.11383
(generic).
*
*
Triarylsulfonium salt
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as triarylsulfonium salt
(PMN P–16–548) 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 § 721.80(f), (k), and (t). It is
a significant new use to process or use
the substance in a manner that generates
a vapor, mist, or aerosol.
(ii) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) and (k)
are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11384 Organic acid, compds. with
bisphenol A-epichlorohydrin-polypropylene
glycol diglycidyl ether polymerdisubstituted amine-disubstituted
polypropylene glycol reaction products
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as organic acid, compds.
with bisphenol A-epichlorohydrinpolypropylene glycol diglycidyl ether
polymer-disubstituted aminedisubstituted polypropylene glycol
reaction products (PMN P–17–312) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to modify the manufacture,
process, or use of the substance that
results in the generation of a dust, mist,
or aerosol.
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(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 78.
(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
§ 721.125(a) through (c), (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11385 Phenol, 4,4′-(1methylethylidene)bis-, polymer with 2(chloromethyl)oxirane and alpha-(2oxiranylmethyl)-omega-(2oxiranylmethoxy)poly[oxy(methyl-1,2ethanediyl)], reaction products with
disubstituted amine and disubstituted
polypropylene glycol, organic acid salts
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as phenol, 4,4′-(1methylethylidene)bis-, polymer with 2(chloromethyl)oxirane and alpha-(2oxiranylmethyl)-omega-(2oxiranylmethoxy)poly[oxy(methyl-1,2ethanediyl)], reaction products with
disubstituted amine and disubstituted
polypropylene glycol, organic acid salts
(PMN P–17–313) 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 modify the manufacture,
process, or use of the substance that
results in the generation of a dust, mist,
or aerosol.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 78.
(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
§ 721.125(a) through (c), (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11386 Organic acid, 2-substituted-,
compds. with bisphenol A-epichlorohydrinpolypropylene glycol diglycidyl ether
polymer-disubstituted aminedisubstituted
polypropylene glycol reaction products
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as organic acid, 2substituted-, compds. with bisphenol Aepichlorohydrin-polypropylene glycol
diglycidyl ether polymer-disubstituted
aminedisubstituted polypropylene
glycol reaction products (PMN P–17–
314) 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 modify the manufacture,
process, or use of the substance that
results in the generation of a dust, mist,
or aerosol.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 78.
(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
§ 721.125(a) through (c), (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11387 Phenol, 4,4′-(1methylethylidene)bis-, polymer with alpha(2-substituted-methylethyl)-omega-(2substituted-methylethoxy)poly[oxy(methyl1,2-ethanediyl)], 2-(chloromethyl)oxirane
and alpha-(2-oxiranylmethyl)-omega-(2oxiranylmethoxy)poly[oxy(methyl-1,2ethanediyl)], alkylphenyl ethers, reaction
products with disubstituted amine, organic
acid salts (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as phenol, 4,4′-(1methylethylidene)bis-, polymer with
alpha-(2-substituted-methylethyl)omega-(2-substitutedmethylethoxy)poly[oxy(methyl-1,2ethanediyl)], 2-(chloromethyl)oxirane
and alpha-(2-oxiranylmethyl)-omega-(2oxiranylmethoxy)poly[oxy(methyl-1,2ethanediyl)], alkylphenyl ethers,
reaction products with disubstituted
amine, organic acid salts (PMN P–17–
315) is subject to reporting under this
section for the significant new uses
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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 modify the manufacture,
process, or use of the substance that
results in the generation of a dust, mist,
or aerosol.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 78.
(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
§ 721.125(a) through (c), (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11388 Organic acid, compds. with
bisphenol A-epichlorohydrin-disubstituted
polypropylene glycol-polypropylene glycol
diglycidyl ether polymer alkylphenyl ethersdisubstituted amine reaction products
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as organic acid, compds.
with bisphenol A-epichlorohydrindisubstituted polypropylene glycolpolypropylene glycol diglycidyl ether
polymer alkylphenyl ethersdisubstituted amine reaction products
(PMN P–17–316) 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 modify the manufacture,
process, or use of the substance that
results in the generation of a dust, mist,
or aerosol.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 78.
(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
§ 721.125(a) through (c), (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11389 Organic acid, compds. with
bisphenol A-epichlorohydrin-polypropylene
glycol diglycidyl ether polymerdisubstituted polypropylene glycol reaction
products (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as organic acid, compds.
with bisphenol A-epichlorohydrinpolypropylene glycol diglycidyl ether
polymer-disubstituted polypropylene
glycol reaction products (PMN P–17–
317) 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 modify the manufacture,
process, or use of the substance that
results in the generation of a dust, mist,
or aerosol.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 78.
(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
§ 721.125(a) through (c), (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11390 Branched cyclic and linear
hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as branched cyclic and
linear hydrocarbons from plastic
depolymerization (PMN P–17–398) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance that
have been refined or blended into other
chemical or fuel formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k)(other than as a
refinery feedstock or a fuel blending
additive).
(ii) [Reserved]
(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
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§ 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 § 721.185 apply to this
section.
§ 721.11391 Alkane, alkene, styrenic
compounds derived from plastic
depolymerization (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkane, alkene, styrenic
compounds derived from plastic
depolymerization (PMN P–17–399) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance that
have been refined or blended into other
chemical or fuel formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (other than as a
refinery feedstock or a fuel blending
additive).
(ii) [Reserved]
(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
§ 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 § 721.185 apply to this
section.
§ 721.11392 Carbon compound derived
from plastic depolymerization (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as carbon compound derived
from plastic depolymerization (PMN P–
18–1) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture the substance
containing more than 1% of the
particles less than 75 microns. It is a
significant new use to manufacture the
substance other than by the enclosed
process described in the premanufacture
notice.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
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apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 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 § 721.185 apply to this
section.
§ 721.11393 Branched cyclic and linear
hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as branched cyclic and
linear hydrocarbons from plastic
depolymerization (PMN P–18–28) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance that
have been refined or blended into other
chemical or fuel formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (other than as a
refinery feedstock or a fuel blending
additive).
(ii) [Reserved]
(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
§ 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 § 721.185 apply to this
section.
§ 721.11394 Phosphonic acid, dimethyl
ester, polymer with alkyl diols (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as phosphonic acid,
dimethyl ester, polymer with alkyl diols
(PMN P–18–9) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the PMN substance in a manner that
generates a dust, mist, or aerosol.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 300.
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(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
§ 721.125(a) through (c), (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11395 1H-Imidazole, 1,2,4,5tetramethyl-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1H-Imidazole, 1,2,4,5-tetramethyl(PMN P–18–11, CAS No. 1739–83–9) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (f) and (g).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 7.
(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
§ 721.125(a) through (c), (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11396 1-Propanaminium, N,N′(oxydi-2,1-ethanediyl)bis[3-chloro-2hydroxy-N,N-dimethyl-, chloride (1:2).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-propanaminium, N,N′-(oxydi-2,1ethanediyl)bis[3-chloro-2-hydroxy-N,Ndimethyl-, chloride (1:2) (PMN P–18–
170, CAS No. 96320–92–2) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in any manner that results
in inhalation exposures.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 164.
(b) Specific requirements. The
provisions of subpart A of this part
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apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11397 Fatty acid, polymer with
alkanedioic acid dialkyl ester, hydroxyl alkyl
substituted alkanediol, substituted
carbomonocycle and alkylol substituted
alkane (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid, polymer with
alkanedioic acid dialkyl ester, hydroxyl
alkyl substituted alkanediol, substituted
carbomonocycle and alkylol substituted
alkane (PMN P–18–185) 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 § 721.80 (o).
(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
§ 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 § 721.185 apply to this
section.
§ 721.11398 2,5-Furandione, polymer with
ethenylbenzene, 4-hydroxy-substituted
butyl amide, polymers with epichlorohydrin
and trimethylolpropane, sodium salts
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 2,5-furandione, polymer
with ethenylbenzene, 4-hydroxysubstituted butyl amide, polymers with
epichlorohydrin and
trimethylolpropane, sodium salts (PMN
P–18–190) 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 use the substance other than
as a pigment dispersing aid for pigments
in inkjet printing inks.
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(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
§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11399 2,5-Furandione, polymer with
ethenylbenzene, 4-hydroxy-substitutedbutyl
[3-[2-[1[[(substitutedphenyl)amino]carbonyl]-2oxopropyl]diazenyl]phenyl]methyl amide,
polymers with epichlorohydrin and
trimthylolpropane, sodium salts (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as 2,5-furandione, polymer
with ethenylbenzene, 4-hydroxysubstitutedbutyl [3-[2-[1[[(substitutedphenyl)amino]carbonyl]-2oxopropyl]diazenyl]phenyl]methyl
amide, polymers with epichlorohydrin
and trimthylolpropane, sodium salts
(PMN P–18–191) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to use the substance other than
as a pigment dispersing aid for pigments
in inkjet printing inks.
(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
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11400 Alkane, bis(alkoxymethyl)dimethyl-0 ((generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as alkane, bis(alkoxymethyl)dimethyl- (PMN P–18–223) 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
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new use to manufacture the substance
greater than the confidential annual
production volume specified in the
PMN.
(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
§ 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 § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11401
[Reserved]
§ 721.11402
[Reserved]
§ 721.11403
[Reserved]
§ 721.11404 Butanedioic acid, 2methylene-, polymer with 2-methyl-2-[(1oxo-2-propen-1-yl)amino]-1propanesulfonic acid, sodium zinc salt.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
butanedioic acid, 2-methylene-, polymer
with 2-methyl-2-[(1-oxo-2-propen-1yl)amino]-1-propanesulfonic acid,
sodium zinc salt (PMN P–18–285, CAS
No. 2220235–78–7) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Releases to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) where N = 143.
(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
§ 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 § 721.185 apply to this
section.
§ 721.11405 Heteromonocycle, alkenoic
1:1 salt, polymer with alpha-(2-methyl-1oxo-2-propen-1-y)l-omega.methoxypoly(oxy-1,2-ethanediyl) and
methyl-alkenoic acid (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
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generically as heteromonocycle,
alkenoic 1:1 salt, polymer with alpha-(2methyl-1-oxo-2-propen-1-y)l-omega.methoxypoly(oxy-1,2-ethanediyl) and
methyl-alkenoic acid (PMN P–18–300)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the PMN substance in a manner that
results in particles less than 50 microns.
It is a significant new use to use the
PMN substance in a manner that results
in consumer inhalation or dermal
exposure, and use other than as sealed,
single-use packets.
(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
§ 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 § 721.185 apply to this
section.
§ 721.11406 Substituted benzylic ether
polyethylene glycol alkyl ether derivative
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted benzylic ether
polyethylene glycol alkyl ether
derivative (PMN P–18–394) 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 § 721.80(y)(1).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 4.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11407 Alkylmultiheteroatom, 2functionalisedalkyl-2-hydroxyalkyl-,
polymer with alkylheteroatommultialkylfunctionalised
carbomonocycleheteroatom and
multiglycidylether difunctionalised
polyalkylene glycol (generic).
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkylmultiheteroatom, 2functionalisedalkyl-2-hydroxyalkyl-,
polymer with alkylheteroatommultialkylfunctionalised
carbomonocycleheteroatom and
multiglycidylether difunctionalised
polyalkylene glycol (PMN P–18–404) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in any manner that results
in inhalation exposures.
(ii) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11409 Formaldehyde, polymer with
N1-(2-aminoethyl)-alkanediamine, 5-amino1,3,3-trimethylcyclohexanemethanamine, 2(chloromethyl)oxirane, 4,4′-(1methylethylidene)bis[Phenol] and alphahydro-omega-hydroxypoly(oxy-1,2ethanediyl) (generic).
§ 721.11408 Benzenedicarboxylic acid,
reaction products with isobenzofurandione
and diethylene glycol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as benzenedicarboxylic acid,
reaction products with
isobenzofurandione and diethylene
glycol (PMN P–19–12) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in any manner that results
in inhalation exposures.
(ii) [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
§ 721.125(a) through (c) and (i) are
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(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as formaldehyde, polymer
with N1-(2-aminoethyl)-alkanediamine,
5-amino-1,3,3trimethylcyclohexanemethanamine, 2(chloromethyl)oxirane, 4,4′-(1methylethylidene)bis[Phenol] and
alpha-hydro-omega-hydroxypoly(oxy1,2-ethanediyl) (PMN P–19–31) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in any manner that results
in inhalation exposures.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11410 2,4-Hexadienoic acid, 1,1′-[2ethyl-2-[(1-oxo-2,4-hexadien-1yl)oxy]methyl]-1,3-propanediyl] ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2,4-hexadienoic acid, 1,1′-[2-ethyl-2-[(1oxo-2,4-hexadien-1-yl)oxy]methyl]-1,3propanediyl] ester (PMN P–19–71, CAS
No. 2307636–51–5) 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 § 721.80(j) and (s).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
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59349
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 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 § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11411 1-Butanol, reaction products
with 2-[(2-propen-1-yloxy)methyl]oxirane.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-butanol, reaction products with 2-[(2propen-1-yloxy)methyl]oxirane (PMN
P–19–72) 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 § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 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 § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i).
[FR Doc. 2019–23388 Filed 11–1–19; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 190909–0024]
RIN 0648–BI77
Fisheries of the Northeastern United
States; Habitat Clam Dredge
Exemption Framework
National Marine Fisheries
Service (NMFS), National Oceanic and
AGENCY:
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]]>Agencies
[Federal Register Volume 84, Number 213 (Monday, November 4, 2019)]
[Proposed Rules]
[Pages 59335-59349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23388]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2019-0494; FRL-10000-54]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (19-4.F)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 26 chemical substances which
were the subject of premanufacture notices (PMNs). Five of these
chemical substances are subject to Orders issued by EPA pursuant to
TSCA, and the remaining 21 of these chemical substances 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 26
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 December 4, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2019-0494, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances
[[Page 59336]]
(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
December 4, 2019 are subject to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must
comply with the export notification requirements in 40 CFR part 707,
subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for
chemical substances that were the subject of PMNs. These proposed SNURs
would require persons to notify EPA at least 90 days before commencing
the manufacture or processing of a chemical substance for any activity
proposed as a significant new use. Receipt of such notices would allow
EPA to assess risks and, if appropriate, to regulate the significant
new use before it may occur. Additional background regarding SNURs is
more fully set out in the preamble to EPA's first direct final SNUR
published in the Federal Register issue of April 24, 1990 (55 FR
17376). Consult that preamble for further general information on the
objectives, rationale, and procedures for SNURs and on the basis for
significant new use designations, including provisions for developing
test data.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four 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
section 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 26 chemical substances
that are the subject of these SNURs, EPA considered relevant
information about the toxicity of the chemical substances and potential
human exposures and environmental releases that may be associated with
the substances, in addition to the factors in TSCA section 5(a)(2).
Consistent with TSCA section 5(f)(4), for the five chemical substances
subject to an order 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 the 21 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 26 chemical substances in 40 CFR part 721, subpart E. In this unit,
EPA provides the following information for each chemical substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the SNUR or basis for the TSCA 5(e) Order.
Potentially Useful Information. This is information
identified by EPA that
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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 five 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 21 PMN substances that received
``not likely to present an unreasonable risk'' determination in TSCA
section 5(a)(3)(c). However, during the course of these reviews, EPA
identified concerns for certain health and/or environmental risks if
the chemicals were not used following the limitations identified by the
submitters in the notices, but the TSCA section 5(a)(3)(C)
determinations did not deem such uses as reasonably foreseen. The
proposed SNURs would identify as significant new uses any
manufacturing, processing, use, distribution in commerce, or disposal
that does not conform to those same limitations.
The chemicals subject to these proposed SNURs are as follows:
PMN Number: P-16-548
Chemical Name: Triarylsulfonium salt (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: July 22, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the PMN substance will be as a resin
catalyst. Based on physical/chemical properties of the PMN substance
(as described in the New Chemical Program's PBT category at 64 FR
60194; November 1999), the PMN substance is a potentially persistent,
bioaccumulative, and toxic (PBT) chemical. EPA estimates that that PMN
substance will persist in the environment for more than 2 months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
Based on comparison to structurally analogous chemical substances, the
estimated physical/chemical properties of the PMN, and test data for
the PMN substance, EPA has identified concerns for eye irritation,
systemic, developmental, blood, and reproductive effects. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
1. Refraining from domestic manufacture in the United States (i.e.,
import only);
2. Use of the PMN substance only for the confidential use specified
in the Order;
3. No manufacture (including import) of the PMN substance beyond
the confidential annual manufacture volume specified in the Order;
4. Refraining from processing or using the PMN substance in any
manner that generates a mist, vapor, or aerosol; and
5. No release of the PMN substance into the waters of the United
States.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health effects of the PMN substance may be
potentially useful in support of a request by the PMN submitter to
modify the TSCA section 5(e) 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
specific target organ toxicity and reproductive/developmental toxicity
testing would help characterize the potential health effects of the PMN
substance. Although the TSCA section 5(e) Order does not require this
information, the TSCA section 5(e) Order's restrictions remain in
effect until the TSCA section 5(e) Order is modified or revoked by EPA
based on submission of this or other relevant information.
CFR Citation: 40 CFR 721.11383.
PMN Numbers: P-17-312, P-17-313, P-17-314, P-17-315, P-17-316, and P-
17-317
Chemical Names: Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted amine-disubstituted polypropylene glycol reaction
products (generic) (P-17-312); Phenol, 4,4'-(1-methylethylidene)bis-,
polymer with 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-
omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction
products with disubstituted amine and disubstituted polypropylene
glycol, organic acid salts (generic) (P-17-313); Organic acid, 2-
substituted-, compds. with bisphenol A-epichlorohydrin-polypropylene
glycol diglycidyl ether polymer-disubstituted aminedisubstituted
polypropylene glycol reaction products (generic) (P-17-314); Phenol,
4,4'-(1-methylethylidene)bis-, polymer with alpha-(2-substituted-
methylethyl)-omega-(2-substituted-methylethoxy)poly[oxy(methyl-1,2-
ethanediyl)], 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-
omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl
ethers, reaction products with disubstituted amine, organic acid salts
(generic) (P-17-315); Organic acid, compds. with bisphenol A-
epichlorohydrin-disubstituted polypropylene glycol-polypropylene glycol
diglycidyl ether polymer alkylphenyl ethers-disubstituted amine
reaction products (generic) (P-17-316); Organic acid, compds. with
bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether
polymer-disubstituted polypropylene glycol reaction products (generic)
(P-17-317).
CAS Numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as additives for
electrocoat. Based on the estimated physical/chemical properties of the
PMN substances, comparison with structurally analogous substances, and
Structural Activity Relationships (SAR) analysis on analogous
polycationic polymers, EPA has identified concerns for lung effects,
nasal epithelial damage, skin and eye irritation, and aquatic toxicity
if the chemical substances are not used following the limitations
noted. The conditions of use of the PMN substances as described in the
PMNs include the following protective measures:
1. No modification of the manufacturing, processing, or use of the
PMN substances that result in the
[[Page 59338]]
generation of a dust, mist, or aerosol; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 78 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 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, skin irritation/corrosion, eye
damage, and acute aquatic toxicity testing would help characterize the
potential health effects of the PMN substances.
CFR Citations: 40 CFR 721.11384 (P-17-312), 40 CFR 721.11385 (P-17-
313), 40 CFR 721.11386 (P-17-314), 40 CFR 721.11387 (P-17-315), 40 CFR
721.11388 (P-17-316), and 40 CFR 721.11389 (P-17-317).
PMN Numbers: P-17-398, P-17-399, P-18-1, and P-18-28
Chemical names: Branched cyclic and linear hydrocarbons from
plastic depolymerization (generic) (P-17-398), Alkane, alkene, styrenic
compounds derived from plastic depolymerization (generic) (P-17-399),
Carbon compound derived from plastic depolymerization (generic) (P-18-
1), and Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic) (P-18-28).
CAS numbers: Not available.
Effective date of TSCA section 5(e) Order: June 10, 2019.
Basis for TSCA section 5(e) Order: The PMNs state that the use of
P-17-398 and P-17-399 will be as a refinery feedstock or fuel blending
additive, the generic use of P-18-1 will be as an additive, and the use
of P-18-28 will be as a chemical feedstock. Based on the physical/
chemical properties of the PMN substances and comparison to
structurally analogous chemical substances, EPA has identified concerns
for neurological impairment, and hematological effects including
aplastic anemia and acute myelogenous leukemia for PMN substance P-18-
28. There is concern for lung effects for P-18-1, if respirable, based
on the respirable, poorly soluble particles category. Based on SAR
analysis on analogous substances, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 ppb for P-17-398
and P-17-399, and 15 ppb for P-18-28. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substances may present an unreasonable risk of injury
to human health and the environment. The Order was also issued under
TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a
finding that the substances are or will be produced in substantial
quantities and that the substances either enter or may reasonably be
anticipated to enter the environment in substantial quantities, or
there is or may be significant (or substantial) human exposure to the
substances. To protect against these risks, the Order requires:
1. Refraining from manufacturing, processing, or using P-17-398 and
P-17-399 other than as a refinery feedstock or a fuel blending additive
and refrain from manufacturing, processing, and using P-18-28 other
than as a chemical feedstock or a fuel blending additive;
2. Manufacture of P-18-1 via the enclosed manufacturing process
described in the PMN; and
3. Manufacture of P-18-1 according to the particle sizes described
in the PMN: 1% or less of the particles at less than 75 microns.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health and environmental effects of the PMN
substances may be potentially useful in support of a request by the PMN
submitter to modify the TSCA section 5(e) 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 additional particle size characterization testing for P-18-1
and acute and chronic aquatic toxicity testing for P-17-398, P-17-399,
and P-18-28 would help EPA determine the potential human and
environmental effects of the PMN substances. Although the TSCA section
5(e) 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 citations: 40 CFR 721.11390 (P-17-398), 40 CFR 721.11391 (P-17-
399), 40 CFR 721.11392 (P-18-1), and 40 CFR 721.11393 (P-18-28).
PMN Number: P-18-9
Chemical Name: Phosphonic acid, dimethyl ester, polymer with alkyl
diols (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 lubricant additive.
Based on estimated physical/chemical properties of the PMN substance,
test data on the PMN substance, comparison to structurally analogous
chemical substances, and SAR analysis of test data on analogous esters,
EPA has identified concerns for gastrointestinal and kidney effects,
reproductive/developmental toxicity, and aquatic toxicity if the
chemical substance is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
1. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 300 ppb; and
2. No manufacture, process, 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 and
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, specific target organ toxicity, and
reproductive/developmental toxicity testing would help characterize the
potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11394.
PMN Number: P-18-11
Chemical Name: 1H-Imidazole, 1,2,4,5-tetramethyl-.
CAS Number: 1739[hyphen]83[hyphen]9.
Basis for action: The PMN states that the use of the PMN substance
will be as a chemical intermediate in the synthesis of a polymer. Based
on estimated physical/chemical properties of the PMN substance, test
data on analogous chemical substances, comparison to structurally
analogous chemical substances, and SAR analysis of test data on
analogous pyrroles/diazoles, EPA has identified concerns for irritation
and corrosion to all tissues,
[[Page 59339]]
developmental effects, liver toxicity, and aquatic toxicity if the
chemical substance is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
1. Refraining from domestic manufacture in the United States (i.e.,
import only);
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 7 ppb; and
3. No use of the PMN substance other than as a chemical
intermediate.
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 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 corrosion, developmental/reproductive toxicity,
specific target organ toxicity, and aquatic toxicity testing would help
characterize the potential health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11395.
PMN Number: P-18-170
Chemical Name: 1-Propanaminium, N,N'-(oxydi-2,1-ethanediyl)bis[3-
chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2).
CAS Number: 96320-92-2.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be for use in textile
treatment. Based on the physical/chemical properties of the PMN
substance, comparison of structurally analogous chemical substances,
and SAR analysis on cationic surfactants, EPA has identified concerns
for surfactant effects on the lungs, developmental effects,
mutagenicity, carcinogenicity, systemic toxicity, skin and respiratory
sensitization, liver and kidney toxicity and aquatic toxicity if the
chemical substance is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
1. No manufacturing, processing, or use of the PMN substance that
results in inhalation exposures; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 164 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 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, reproductive/
developmental toxicity, and chronic aquatic toxicity testing would help
characterize the potential health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11396.
PMN Number: P-18-185
Chemical Name: Fatty acid, polymer with alkanedioic acid dialkyl
ester, hydroxyl alkyl substituted alkanediol, substituted
carbomonocycle and alkylol substituted alkane (generic). Polymer
exemption flag: The chemical must be manufactured such that it meets
the polymer exemption criteria as described under 40 CFR 723.250(e)(1),
in addition to meeting the definition of polymer at 40 CFR 723.250(b).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as an adhesion-enhancing resin for wood applications for
industrial and commercial use. Based on estimated physical/chemical
properties of the PMN substance and comparison to structurally
analogous chemical substances, EPA has identified concerns for
developmental and reproductive effects if the chemical substance is not
used following the limitation noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measure:
No 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 reproductive/
developmental toxicity testing would help characterize the potential
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11397.
PMN Numbers: P-18-190 and P-18-191
Chemical Names: 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substituted butyl amide, polymers with epichlorohydrin and
trimethylolpropane, sodium salts (generic) (P-18-190); 2,5-Furandione,
polymer with ethenylbenzene, 4-hydroxy-substitutedbutyl [3-[2-[1-
[[(substitutedphenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]methyl
amide, polymers with epichlorohydrin and trimethylolpropane, sodium
salts (generic) (P-18-191).
CAS Numbers: Not available.
Basis for action: The PMNs state that the use of the substances
will be as a pigment dispersing aid for pigments in inkjet printing
inks. Based on the estimated physical/chemical properties, high pH,
chelating potential of the polyanionic groups and comparison with
structurally analogous chemical substances, EPA has identified concerns
for developmental and blood effects, and eye, skin, and lung irritation
if the chemical substances are not used following the limitation noted.
The conditions of use of the PMN substances as described in the PMNs
include the following protective measure:
Use of the PMN substances only as pigment dispersing aids
for pigments in inkjet printing inks.
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 reproduction/developmental toxicity, skin irritation, and eye damage
testing would help characterize the potential health effects of the PMN
substances.
CFR Citations: 40 CFR 721.11398 (P-18-190) and 40 CFR 721.11399 (P-
18-191).
PMN Number: P-18-223
Chemical Name: Alkane, bis(alkoxymethyl)-dimethyl- (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a selectivity improver for catalysts used in polyolefin
production. Based on estimated physical/chemical properties, comparison
to structurally analogous chemical substances, test data on the PMN
substance, and SAR analysis on analogous neutral organics, EPA has
[[Page 59340]]
identified concerns for eye irritation, systemic and developmental
toxicity, neurotoxicity and aquatic toxicity if the chemical substance
is not used following the limitation noted. The conditions of use of
the PMN substance as described in the PMN include the following
protective measure:
No manufacture of the PMN substance beyond the
confidential annual production volume specified in the PMN.
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 and
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 toxicokinetics, specific organ toxicity, irritation,
neurotoxicity, systemic toxicity, reproductive/developmental toxicity,
and aquatic toxicity testing would help characterize the potential
health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11400.
PMN Number: P-18-285
Chemical Name: Butanedioic acid, 2-methylene-, polymer with 2-
methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium
zinc salt.
CAS Number: 2220235-78-7.
Basis for action: The PMN states that the use of the PMN substance
will be for odor neutralization for pet litter and cleaning/deodorizing
hard surfaces, fabrics, skin and hair, odor neutralization for air
care, and odor neutralization for waste processing and solid waste
management in paper, oil, gas, mining, agriculture, and food and
municipal industries. Based on SAR analysis on analogous polyanionic
polymers, EPA has identified concerns for aquatic toxicity if the
chemical substance is not used following the limitation noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measure:
No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 143 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 chronic aquatic toxicity testing would help characterize the
potential environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11404.
PMN Number: P-18-300
Chemical Name: Heteromonocycle, alkenoic 1:1 salt, polymer with
alpha-(2-methyl-1-oxo-2-propen-1-y)l-omega-methoxypoly(oxy-1,2-
ethanediyl) and methyl-alkenoic acid (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as an additive for automatic dishwashing detergent. Based on
the estimated physical/chemical properties of the PMN substance,
comparison with structurally analogous chemical substances, and
available data on the new chemical substance, EPA has identified
concerns for lung effects if the chemical substance is not used
following the limitations noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measures:
1. No manufacturing, processing, or use that results in particles
less than 50 microns; and
2. No use that results in consumer inhalation or dermal exposure
and use only in sealed, single-use packets.
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 pulmonary effects, specific target organ effects, and developmental/
reproductive toxicity testing would help characterize the potential
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11405.
PMN Number: P-18-394
Chemical Name: Substituted benzylic ether polyethylene glycol alkyl
ether derivative (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 chemical
intermediate. Based on estimated physical/chemical properties of the
PMN substance, comparison to structurally analogous chemical
substances, and test data on the PMN substance, and SAR analysis on
analogous nonionic surfactants, EPA has identified concerns for ocular,
lung and mucous membrane irritation, lung effects, skin and respiratory
sensitization, systemic effects, neurotoxicity, immunotoxicity, and
aquatic 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 measures:
1. No use of the PMN substance involving application methods that
generate a vapor, mist, or aerosol; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 4 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health and
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 specific target organ toxicity, neurotoxicity,
sensitization, eye damage, skin irritation, and algal toxicity testing
would help characterize the potential health and environmental effects
of the PMN substance.
CFR Citation: 40 CFR 721.11406.
PMN Number: P-18-404
Chemical Name: Alkylmultiheteroatom, 2-functionalisedalkyl-2-
hydroxyalkyl-, polymer with alkylheteroatom-multialkylfunctionalised
carbomonocycleheteroatom and multiglycidylether difunctionalised
polyalkylene glycol (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as an epoxy curing agent used in molding formulations for the
manufacture of wind turbine blades. Based on estimated physical/
chemical properties of the PMN substance and comparison of structurally
analogous chemical substances, EPA has identified concerns for
pulmonary effects, skin corrosion, eye irritation, skin sensitization,
and kidney toxicity if the chemical substance is not used following the
limitations noted. The conditions of use
[[Page 59341]]
of the PMN substance as described in the PMN include the following
protective measures:
1. No manufacturing (including import), processing, or use of the
PMN substance that results in inhalation exposures; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the health effects of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that pulmonary toxicity,
specific target organ toxicity, and skin sensitization testing using
the reconstructed human cornea-like epithelium test method would help
characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11407.
PMN Number: P-19-12
Chemical Name: Benzenedicarboxylic acid, reaction products with
isobenzofurandione and diethylene glycol (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a resin component for polyisocyanurate resins and specialty
polyurethane kits and systems for aerospace and military applications.
Based on comparison to structurally analogous chemical substances, EPA
has identified concerns for bladder, kidney, and reproductive/
developmental toxicity if the chemical substance is not used following
the limitation noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measure:
No manufacturing, processing, or use of the 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 about the health effects of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of
developmental/reproductive toxicity, specific target organ toxicity,
and eye and skin irritation testing would help characterize the
potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11408.
PMN Number: P-19-31
Chemical Name: Formaldehyde, polymer with N1-(2-aminoethyl)-
alkanediamine, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-
(chloromethyl)oxirane, 4,4'-(1-methylethylidene)bis[Phenol] and alpha-
hydro-omega-hydroxypoly(oxy-1,2-ethanediyl) (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a curing agent for epoxy coating systems. Based on the
estimated physical/chemical properties of the PMN substance, comparison
with structurally analogous chemical substances, and SAR analysis on
analogous polycationic polymers, EPA has identified concerns for
irritation, lung effects, carcinogenicity, systemic toxicity,
neurotoxicity, and aquatic toxicity if the chemical substance is not
used following the limitations noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measures:
1. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 1 ppb; and
2. No manufacturing, processing, or use of the substance that
results in inhalation exposures.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health and
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 specific target organ toxicity, skin irritation,
neurotoxicity, carcinogenicity and aquatic toxicity testing would help
characterize the potential health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11409.
PMN Number: P-19-71
Chemical Name: 2,4-Hexadienoic acid, 1,1'-[2-ethyl-2-[(1-oxo-2,4-
hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester.
CAS Number: 2307636-51-5.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a physical property
modifier for polymers. Based on estimated physical/chemical properties,
the comparison of structurally analogous chemical substances and SAR
analysis on esters, EPA has identified concerns for liver,
developmental, and aquatic toxicity if the chemical substance is not
used following the limitation noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measures:
1. Use of the PMN substance only for the confidential use specified
in the PMN; and
2. No manufacture of the PMN substance beyond the confidential
annual production volume specified in the PMN.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health and
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 reproductive toxicity, specific target organ toxicity,
and aquatic toxicity testing would help characterize the potential
health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11410.
PMN Number: P-19-72
Chemical Name: 1-Butanol, reaction products with 2-[(2-propen-1-
yloxy)methyl]oxirane.
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a raw material used
in chemical manufacture. Based on available data on the PMN substance,
EPA has identified concerns for acute toxicity, corrosion to all
exposed tissues, sensitization, and hematological and skin changes 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:
Use of the PMN substance only for the confidential use
specified in the PMN;
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
[[Page 59342]]
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 toxicity, sensitization, and systemic effects would
help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11411.
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 five
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 21 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 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.
To review and evaluate data submitted in a SNUN before the
notice submitter begins manufacturing or processing a listed chemical
substance for the described significant new use.
To either determine that the prospective manufacture or
processing is not likely to present an unreasonable risk, or to take
necessary regulatory action associated with any other determination,
before the described significant new use of the chemical substance
occurs.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.
VI. Applicability of the Proposed Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted EPA concludes that
the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the rule is
effective, other persons might engage in a use that has been identified
as a significant new use. However, TSCA section 5(e) Orders have been
issued for five of the 26 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 21 of the 26 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 described in the regulatory text of this proposed rule are
ongoing.
Therefore, EPA designates November 4, 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
[[Page 59343]]
can meet both the data needs and the objective of TSCA section 4(h). To
access the OCSPP test guidelines referenced in this document
electronically, please go to https://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.'' The Organisation for Economic Co-operation
and Development test guidelines are available from the OECD Bookshop at
https://www.oecdbookshop.org or SourceOECD at https://www.sourceoecd.org.
The potentially useful information listed in Unit IV. may not be
the only means of addressing the potential risks of the chemical
substance. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at https://www.epa.gov/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2019-0494.
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. 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.).
[[Page 59344]]
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)
In addition, since this proposed rule would not involve any
technical standards, NTTAA section 12(d) (15 U.S.C. 272 note) does not
apply to this action.
J. Executive Order 12898: 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: October 18, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PARTS 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. Sec. 721.11383 through 721.11411 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Secs.
Sec. 721.11383 Triarylsulfonium salt (generic).
Sec. 721.11384 Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted amine-disubstituted polypropylene glycol reaction
products (generic).
Sec. 721.11385 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-
oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction products
with disubstituted amine and disubstituted polypropylene glycol,
organic acid salts (generic).
Sec. 721.11386 Organic acid, 2-substituted-, compds. with bisphenol
A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted aminedisubstituted polypropylene glycol reaction
products (generic).
Sec. 721.11387 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
alpha-(2-substituted-methylethyl)-omega-(2-substituted-
methylethoxy)poly[oxy(methyl-1,2-ethanediyl)], 2-
(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-
oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl
ethers, reaction products with disubstituted amine, organic acid
salts (generic).
Sec. 721.11388 Organic acid, compds. with bisphenol A-
epichlorohydrin-disubstituted polypropylene glycol-polypropylene
glycol diglycidyl ether polymer alkylphenyl ethers-disubstituted
amine reaction products (generic).
Sec. 721.11389 Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted polypropylene glycol reaction products (generic).
Sec. 721.11390 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
Sec. 721.11391 Alkane, alkene, styrenic compounds derived from
plastic depolymerization (generic).
Sec. 721.11392 Carbon compound derived from plastic
depolymerization (generic).
Sec. 721.11393 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
Sec. 721.11394 Phosphonic acid, dimethyl ester, polymer with alkyl
diols (generic).
Sec. 721.11395 1H-Imidazole, 1,2,4,5-tetramethyl-.
Sec. 721.11396 1-Propanaminium, N,N'-(oxydi-2,1-ethanediyl)bis[3-
chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2).
Sec. 721.11397 Fatty acid, polymer with alkanedioic acid dialkyl
ester, hydroxyl alkyl substituted alkanediol, substituted
carbomonocycle and alkylol substituted alkane (generic).
Sec. 721.11398 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substituted butyl amide, polymers with epichlorohydrin and
trimethylolpropane, sodium salts (generic).
Sec. 721.11399 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substitutedbutyl [3-[2-[1-
[[(substitutedphenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]methyl amide, polymers with
epichlorohydrin and trimethylolpropane, sodium salts (generic).
Sec. 721.11400 Alkane, bis(alkoxymethyl)-dimethyl- (generic).
Sec. 721.11401 [Reserved]
Sec. 721.11402 [Reserved]
Sec. 721.11403 [Reserved]
Sec. 721.11404 Butanedioic acid, 2-methylene-, polymer with 2-
methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium
zinc salt.
Sec. 721.11405 Heteromonocycle, alkenoic (1:1) salt, polymer with
alpha-(2-methyl-1-oxo-2-propen-1-y)l-omega.-methoxypoly(oxy-1,2-
ethanediyl) and methyl-alkenoic acid (generic).
Sec. 721.11406 Substituted benzylic ether polyethylene glycol alkyl
ether derivative (generic).
Sec. 721.11407 Alkylmultiheteroatom, 2-functionalisedalkyl-2-
hydroxyalkyl-, polymer with alkylheteroatom-multialkylfunctionalised
carbomonocycleheteroatom and multiglycidylether difunctionalised
polyalkylene glycol (generic).
Sec. 721.11408 Benzenedicarboxylic acid, reaction products with
isobenzofurandione and diethylene glycol (generic).
Sec. 721.11409 Formaldehyde, polymer with N1-(2-aminoethyl)-
alkanediamine, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-
(chloromethyl)oxirane, 4,4'-(1-methylethylidene)bis[Phenol] and
alpha-hydro-omega-hydroxypoly(oxy-1,2-ethanediyl) (generic).
Sec. 721.11410 2,4-Hexadienoic acid, 1,1'-[2-ethyl-2-[(1-oxo-2,4-
hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester.
[[Page 59345]]
Sec. 721.11411 1-Butanol, reaction products with 2-[(2-propen-1-
yloxy)methyl]oxirane.
* * * * *
Sec. 721.11383 Triarylsulfonium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
triarylsulfonium salt (PMN P-16-548) 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), (k), and (t). It is a significant new
use to process or use the substance in a manner that generates a vapor,
mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (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)(i) of
this section.
Sec. 721.11384 Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted amine-disubstituted polypropylene glycol reaction
products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol
diglycidyl ether polymer-disubstituted amine-disubstituted
polypropylene glycol reaction products (PMN P-17-312) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11385 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 2-
(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-
oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction products
with disubstituted amine and disubstituted polypropylene glycol,
organic acid salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol,
4,4'-(1-methylethylidene)bis-, polymer with 2-(chloromethyl)oxirane and
alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-
ethanediyl)], reaction products with disubstituted amine and
disubstituted polypropylene glycol, organic acid salts (PMN P-17-313)
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 modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11386 Organic acid, 2-substituted-, compds. with bisphenol
A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted aminedisubstituted polypropylene glycol reaction products
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
acid, 2-substituted-, compds. with bisphenol A-epichlorohydrin-
polypropylene glycol diglycidyl ether polymer-disubstituted
aminedisubstituted polypropylene glycol reaction products (PMN P-17-
314) 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 modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11387 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
alpha-(2-substituted-methylethyl)-omega-(2-substituted-
methylethoxy)poly[oxy(methyl-1,2-ethanediyl)], 2-(chloromethyl)oxirane
and alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-
1,2-ethanediyl)], alkylphenyl ethers, reaction products with
disubstituted amine, organic acid salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol,
4,4'-(1-methylethylidene)bis-, polymer with alpha-(2-substituted-
methylethyl)-omega-(2-substituted-methylethoxy)poly[oxy(methyl-1,2-
ethanediyl)], 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-
omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl
ethers, reaction products with disubstituted amine, organic acid salts
(PMN P-17-315) is subject to reporting under this section for the
significant new uses
[[Page 59346]]
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 modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11388 Organic acid, compds. with bisphenol A-
epichlorohydrin-disubstituted polypropylene glycol-polypropylene glycol
diglycidyl ether polymer alkylphenyl ethers-disubstituted amine
reaction products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
acid, compds. with bisphenol A-epichlorohydrin-disubstituted
polypropylene glycol-polypropylene glycol diglycidyl ether polymer
alkylphenyl ethers-disubstituted amine reaction products (PMN P-17-316)
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 modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11389 Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted polypropylene glycol reaction products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol
diglycidyl ether polymer-disubstituted polypropylene glycol reaction
products (PMN P-17-317) 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 modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11390 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
branched cyclic and linear hydrocarbons from plastic depolymerization
(PMN P-17-398) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k)(other than as a refinery feedstock or
a fuel blending additive).
(ii) [Reserved]
(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 (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. 721.11391 Alkane, alkene, styrenic compounds derived from
plastic depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkane,
alkene, styrenic compounds derived from plastic depolymerization (PMN
P-17-399) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (other than as a refinery feedstock or
a fuel blending additive).
(ii) [Reserved]
(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 (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. 721.11392 Carbon compound derived from plastic depolymerization
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as carbon
compound derived from plastic depolymerization (PMN P-18-1) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance containing more than
1% of the particles less than 75 microns. It is a significant new use
to manufacture the substance other than by the enclosed process
described in the premanufacture notice.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
[[Page 59347]]
apply to this section except as modified by this paragraph.
(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. 721.11393 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
branched cyclic and linear hydrocarbons from plastic depolymerization
(PMN P-18-28) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (other than as a refinery feedstock or
a fuel blending additive).
(ii) [Reserved]
(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 (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. 721.11394 Phosphonic acid, dimethyl ester, polymer with alkyl
diols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phosphonic acid, dimethyl ester, polymer with alkyl diols (PMN P-18-9)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in a manner that generates a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 300.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11395 1H-Imidazole, 1,2,4,5-tetramethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1H-Imidazole,
1,2,4,5-tetramethyl- (PMN P-18-11, CAS No. 1739-83-9) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (g).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 7.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11396 1-Propanaminium, N,N'-(oxydi-2,1-ethanediyl)bis[3-
chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propanaminium,
N,N'-(oxydi-2,1-ethanediyl)bis[3-chloro-2-hydroxy-N,N-dimethyl-,
chloride (1:2) (PMN P-18-170, CAS No. 96320-92-2) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposures.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 164.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11397 Fatty acid, polymer with alkanedioic acid dialkyl
ester, hydroxyl alkyl substituted alkanediol, substituted
carbomonocycle and alkylol substituted alkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid, polymer with alkanedioic acid dialkyl ester, hydroxyl alkyl
substituted alkanediol, substituted carbomonocycle and alkylol
substituted alkane (PMN P-18-185) 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).
(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. 721.11398 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substituted butyl amide, polymers with epichlorohydrin and
trimethylolpropane, sodium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2,5-
furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl
amide, polymers with epichlorohydrin and trimethylolpropane, sodium
salts (PMN P-18-190) 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 use the substance other than as a pigment
dispersing aid for pigments in inkjet printing inks.
[[Page 59348]]
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11399 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substitutedbutyl [3-[2-[1-[[(substitutedphenyl)amino]carbonyl]-
2-oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin
and trimthylolpropane, sodium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 2,5-
furandione, polymer with ethenylbenzene, 4-hydroxy-substitutedbutyl [3-
[2-[1-[[(substitutedphenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin
and trimthylolpropane, sodium salts (PMN P-18-191) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a pigment
dispersing aid for pigments in inkjet printing inks.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11400 Alkane, bis(alkoxymethyl)-dimethyl-0 ((generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as alkane,
bis(alkoxymethyl)-dimethyl- (PMN P-18-223) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance greater than the
confidential annual production volume specified in the PMN.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11401 [Reserved]
Sec. 721.11402 [Reserved]
Sec. 721.11403 [Reserved]
Sec. 721.11404 Butanedioic acid, 2-methylene-, polymer with 2-methyl-
2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium zinc
salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as butanedioic acid,
2-methylene-, polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-
propanesulfonic acid, sodium zinc salt (PMN P-18-285, CAS No. 2220235-
78-7) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Releases to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N = 143.
(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. 721.11405 Heteromonocycle, alkenoic 1:1 salt, polymer with
alpha-(2-methyl-1-oxo-2-propen-1-y)l-omega.-methoxypoly(oxy-1,2-
ethanediyl) and methyl-alkenoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteromonocycle, alkenoic 1:1 salt, polymer with alpha-(2-methyl-1-oxo-
2-propen-1-y)l-omega.-methoxypoly(oxy-1,2-ethanediyl) and methyl-
alkenoic acid (PMN P-18-300) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in a manner that results in particles less than 50 microns. It is a
significant new use to use the PMN substance in a manner that results
in consumer inhalation or dermal exposure, and use other than as
sealed, single-use packets.
(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. 721.11406 Substituted benzylic ether polyethylene glycol alkyl
ether derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted benzylic ether polyethylene glycol alkyl ether derivative
(PMN P-18-394) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 4.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 59349]]
Sec. 721.11407 Alkylmultiheteroatom, 2-functionalisedalkyl-2-
hydroxyalkyl-, polymer with alkylheteroatom-multialkylfunctionalised
carbomonocycleheteroatom and multiglycidylether difunctionalised
polyalkylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylmultiheteroatom, 2-functionalisedalkyl-2-hydroxyalkyl-, polymer
with alkylheteroatom-multialkylfunctionalised carbomonocycleheteroatom
and multiglycidylether difunctionalised polyalkylene glycol (PMN P-18-
404) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposures.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11408 Benzenedicarboxylic acid, reaction products with
isobenzofurandione and diethylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenedicarboxylic acid, reaction products with isobenzofurandione and
diethylene glycol (PMN P-19-12) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposures.
(ii) [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. 721.11409 Formaldehyde, polymer with N1-(2-aminoethyl)-
alkanediamine, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-
(chloromethyl)oxirane, 4,4'-(1-methylethylidene)bis[Phenol] and alpha-
hydro-omega-hydroxypoly(oxy-1,2-ethanediyl) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
formaldehyde, polymer with N1-(2-aminoethyl)-alkanediamine, 5-amino-
1,3,3-trimethylcyclohexanemethanamine, 2-(chloromethyl)oxirane, 4,4'-
(1-methylethylidene)bis[Phenol] and alpha-hydro-omega-hydroxypoly(oxy-
1,2-ethanediyl) (PMN P-19-31) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposures.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11410 2,4-Hexadienoic acid, 1,1'-[2-ethyl-2-[(1-oxo-2,4-
hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,4-hexadienoic
acid, 1,1'-[2-ethyl-2-[(1-oxo-2,4-hexadien-1-yl)oxy]methyl]-1,3-
propanediyl] ester (PMN P-19-71, CAS No. 2307636-51-5) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (s).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11411 1-Butanol, reaction products with 2-[(2-propen-1-
yloxy)methyl]oxirane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-butanol, reaction
products with 2-[(2-propen-1-yloxy)methyl]oxirane (PMN P-19-72) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i).
[FR Doc. 2019-23388 Filed 11-1-19; 8:45 am]
BILLING CODE 6560-50-P
