Significant New Use Rules on Certain Chemical Substances (20-6.B), 36175-36182 [2020-12614]
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Federal Register / Vol. 85, No. 115 / Monday, June 15, 2020 / Proposed Rules
7400.11D is publicly available as listed
in the ADDRESSES section of this
document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting
points.
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The Proposal
The FAA is proposing an amendment
to Title 14 Code of Federal Regulations
(14 CFR) part 71 by amending the Class
E airspace extending upward from 700
feet above the surface to within a 6.6mile (increased from 6.4-mile) radius of
Clinton Regional Airport, Clinton, MO;
removing the Golden Valley NDB and
associated extensions from the airspace
legal description; and updating the
name and the geographic coordinates of
the airport (previously Clinton
Memorial Airport) to coincide with the
FAA’s aeronautical database.
This action is due to an airspace
review due to the decommissioning of
the Golden Valley NDB which provided
navigation information to the
instrument procedures at this airport.
Class E airspace designations are
published in paragraph 6005 of FAA
Order 7400.11D, dated August 8, 2019,
and effective September 15, 2019, which
is incorporated by reference in 14 CFR
71.1. The Class E airspace designation
listed in this document will be
published subsequently in the Order.
FAA Order 7400.11, Airspace
Designations and Reporting Points, is
published yearly and effective on
September 15.
Regulatory Notices and Analyses
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current, is non-controversial and
unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified that this rule, when
promulgated, would not have a
significant economic impact on a
substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
Environmental Review
This proposal will be subject to an
environmental analysis in accordance
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with FAA Order 1050.1F,
‘‘Environmental Impacts: Policies and
Procedures’’ prior to any FAA final
regulatory action.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
The Proposed Amendment
Accordingly, pursuant to the
authority delegated to me, the Federal
Aviation Administration proposes to
amend 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting
Points, dated August 8, 2019, and
effective September 15, 2019, is
amended as follows:
■
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
*
*
ACE MO E5 Clinton, MO [Amended]
Clinton Regional Airport, MO
(Lat. 38°21′17″ N, long. 93°40′45″ W.)
The airspace extending upward from 700
feet above the surface within a 6.6-mile
radius of Clinton Regional Airport.
Issued in Fort Worth, Texas, on June 9,
2020.
Steven T. Phillips,
Acting Manager, Operations Support Group,
ATO Central Service Center.
[FR Doc. 2020–12774 Filed 6–12–20; 8:45 am]
BILLING CODE 4910–13–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2020–0251; FRL–10010–
40]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (20–6.B)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
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EPA is proposing significant
new use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for
chemical substances which are the
subject of premanufacture notices
(PMNs). This action would require
persons to notify EPA at least 90 days
before commencing manufacture
(defined by statute to include import) or
processing of any of these chemical
substances for an activity that is
designated as a significant new use by
this proposed rule. This action would
further require that persons not
commence manufacture or processing
for the significant new use until they
have submitted a Significant New Use
Notice, and EPA has conducted a review
of the notice, made an appropriate
determination on the notice under
TSCA, and has taken any risk
management actions as are required as
a result of that determination.
DATES: Comments must be received on
or before July 15, 2020.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2020–0251, 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.
Please note that due to the public
health emergency the EPA Docket
Center (EPA/DC) and Reading Room
was closed to public visitors on March
31, 2020. Our EPA/DC staff will
continue to provide customer service
via email, phone, and webform. For
further information on EPA/DC services,
docket contact information and the
current status of the EPA/DC and
Reading Room, please visit 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.
SUMMARY:
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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
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A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substances
contained in this proposed rule. The
following list of North American
Industrial Classification System
(NAICS) codes is not intended to be
exhaustive, but rather provides a guide
to help readers determine whether this
document applies to them. Potentially
affected entities may include:
• Manufacturers or processors of one
or more subject chemical substances
(NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import provisions. This
action may also affect certain entities
through pre-existing import certification
and export notification rules under
TSCA, which would include the SNUR
requirements should these proposed
rules be finalized. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20,
any persons who export or intend to
export a chemical substance that is the
subject of this proposed rule on or after
July 15, 2020 are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) 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 CBI
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
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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 which are the subjects of
PMNs P–18–151, P–18–271, P–19–19,
P–19–88, P–19–109, P–20–36, P– and
20–37. These proposed SNURs would
require persons who intend to
manufacture or process any of these
chemical substances for an activity that
is designated as a significant new use to
notify EPA at least 90 days before
commencing that activity.
The record for these proposed SNURs,
identified as docket ID number EPA–
HQ–OPPT–2020–0251, includes
information considered by the Agency
in developing these proposed SNURs.
B. What is the Agency’s authority for
taking this action?
TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including the four TSCA section 5(a)(2)
factors listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the rule, recordkeeping requirements,
exemptions to reporting requirements,
and applicability of the rule to uses
occurring before the effective date of the
rule. Provisions relating to user fees
appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to
these SNURs must comply with the
same significant new use notice (SNUN)
requirements and EPA regulatory
procedures as submitters of PMNs under
TSCA section 5(a)(1)(A) (15 U.S.C.
2604(a)(1)(A)). In particular, these
requirements include the information
submission requirements of TSCA
sections 5(b) and 5(d)(1) (15 U.S.C.
2604(b) and 2604(d)(1)), the exemptions
authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(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
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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. If
EPA determines that the use is not
likely to present an unreasonable risk,
EPA is required under TSCA section
5(g) to make public, and submit for
publication in the Federal Register, a
statement of EPA’s findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA’s
determination that a use of a chemical
substance is a significant new use must
be made after consideration of all
relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In determining what would constitute
a significant new use for the chemical
substances that are the subject of these
SNURs, EPA considered relevant
information about the toxicity of the
chemical substances, and potential
human exposures and environmental
releases that may be associated with the
substances, in the context of the four
bulleted TSCA section 5(a)(2) factors
listed in this unit. During its review of
these chemicals, EPA identified certain
conditions of use that are not intended
by the submitters, but reasonably
foreseen to occur. EPA is proposing to
designate those reasonably foreseen
conditions of use as well as certain
other circumstances of use as significant
new uses.
IV. Substances Subject to This Proposed
Rule
EPA is proposing significant new use
and recordkeeping requirements for
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.
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• Potentially Useful Information.
• CFR citation assigned in the
regulatory text section of these proposed
rules.
The regulatory text section of this
document specifies the activities
designated as significant new uses.
Certain new uses, including production
volume limits and other uses designated
in the proposed rules, may be claimed
as CBI.
The chemical substances that are the
subject of these proposed SNURs are
undergoing premanufacture review. In
addition to those conditions of use
intended by the submitter, EPA has
identified certain other reasonably
foreseen conditions of use. EPA has
preliminarily determined that the
chemicals under their intended
conditions of use are not likely to
present an unreasonable risk. However,
EPA has not assessed risks associated
with the reasonably foreseen conditions
of use for these chemicals. EPA is
proposing to designate these reasonably
foreseen conditions of use and other
circumstances of use as significant new
uses. As a result, those significant new
uses cannot occur without first going
through a separate, subsequent EPA
review and determination process
associated with a SNUN.
The substances subject to these
proposed rules are as follows:
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PMN Number: P–18–151
Chemical name: Formaldehyde,
reaction products with 1,3benzenedimethanamine and p-tertbutylphenol.
CAS number: 158800–93–2.
Basis for action: The PMN states that
the use of the substance will be as a
curing agent for epoxy systems. Based
on the physical/chemical properties of
the PMN substance and Structure
Activity Relationships (SAR) analysis of
test data on analogous substances, EPA
has identified concerns for aquatic
toxicity, reproductive/developmental
toxicity, respiratory sensitization, skin
corrosion, skin irritation, skin
sensitization, and systemic effects if the
chemical substance is used in ways
other than as intended by the PMN
submitter. This proposed SNUR
designates the following as ‘‘significant
new uses’’ requiring further review by
EPA:
• Manufacture, processing, or use in
a manner that results in inhalation
exposure.
• Release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance
exceeding a surface water concentration
of 1 ppb.
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Potentially Useful Information: EPA
has determined that certain information
about the environmental and health
effects of the PMN substance may be
potentially useful to characterize the
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, eye damage,
reproductive toxicity, skin corrosion,
skin sensitization, and specific target
organ toxicity testing would help
characterize the potential environmental
and health effects of the PMN substance.
CFR Citation: 40 CFR 721.11498.
PMN Number: P–18–271
Chemical Name: 2-Propanol, 1butoxy-, 2,2′-ester (generic).
CAS Number: Not available.
Basis for Action: The PMN states that
the use of the substance will be as a
film-forming coalescent for architectural
coatings; for automotive OEM coatings;
for can and coil coatings; for industrial
wood coatings; for floor polishes, for
industrial maintenance coatings; for
marine and wood coatings; for
transportation coatings; for use in
printing inks; and as a chemical
intermediate to prepare ester
plasticizers. Based on the physical/
chemical properties of the PMN
substance and Structure Activity
Relationships (SAR) analysis of test data
on analogous substances, EPA has
identified concerns for irritation and
specific target organ toxicity as hazards
based on the expected metabolite
(propylene glycol n-butyl ether) if the
chemical substance is used in ways
other than as intended by the PMN
submitter. The proposed SNUR
designates the following as ‘‘significant
new uses’’ requiring further EPA
review:t.:
• Use other than as a film-forming
coalescent for architectural coatings; for
automotive OEM coatings; for can and
coil coatings; for industrial wood
coatings; for floor polishes, for
industrial maintenance coatings; for
marine and wood coatings; for
transportation coatings; for use in
printing inks; and as a chemical
intermediate to prepare ester
plasticizers, consistent with the
manufacturing, processing, use,
distribution, and disposal information
described in the PMN.
• Processing the PMN substance to a
weight fraction greater than 8% in the
final formulation.
Potentially Useful Information: EPA
has determined that certain information
about the environmental and health
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effects of the PMN substance may be
potentially useful to characterize the
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, skin irritation, eye
damage, specific target organ toxicity,
and aquatic toxicity testing would help
characterize the potential environmental
and health effects of the PMN substance.
CFR Citation: 40 CFR 721.11499.
PMN Number: P–19–19
Chemical Name: Haloalkane (generic).
CAS Number: Not available.
Basis for Action: The PMN states that
the generic use of the substance will be
as a chemical intermediate. Based on
the physical/chemical properties of the
PMN substance and Structure Activity
Relationships (SAR) analysis of test data
on analogous substances, EPA has
identified concerns for skin irritation,
specific target organ toxicity, and
aquatic toxicity if the chemical
substance is used in ways other than as
intended by the PMN submitter. This
proposed SNUR designates the
following as ‘‘significant new uses’’
requiring further review by EPA:
• Release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance
exceeding a surface water concentration
of 23 ppb.
• Use of the PMN substance without
a National Institute for Occupational
Safety and Health (NIOSH) certified
respirator with an assigned protection
factor of at least 1000.
Potentially Useful Information: EPA
has determined that certain information
about the toxicity of the PMN substance
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 irritation, 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 721.11500.
PMN Number: P–19–88
Chemical Name: Ethanamine, Nethyl-, 2-hydroxy-1,2,3propanetricarboxylate (1:?).
CAS Number: 23251–73–2.
Basis for Action: The PMN states that
the generic use of the substance will be
as feedstock for amine recovery. Based
on the physical/chemical properties of
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the PMN substance and Structure
Activity Relationships (SAR) analysis of
test data on analogous substances, EPA
has identified concerns for acute
toxicity, reproductive toxicity, serious
eye damage, skin corrosion, and specific
target organ toxicity if the chemical
substance is used in ways other than as
intended by the PMN submitter. This
proposed SNUR designates the
following as ‘‘significant new uses’’
requiring further review by EPA:
• Manufacture, processing, or use in
a manner that results in inhalation
exposure.
• Release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance
exceeding a surface water concentration
of 46 ppb.
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 skin
corrosion, eye damage, reproductive/
developmental effects, and specific
target organ toxicity testing would help
characterize the potential health effects
of the PMN substance.
CFR Citation: 40 CFR 721.11501.
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PMN Number: P–19–109
Chemical Names: Copper, [[2,2′,2″(nitrilo-.kappa.N)tris[ethanolato.kappa.O]](2-)]- (P–19–109, chemical A)
and copper, bis[2-(amino.kappa.N)ethanolato-.kappa.O]- (P–19–
109, chemical B).
CAS Numbers: 21545–60–8 (P–19–
109, chemical A) and 14215–52–2
(P–19–109, chemical B).
Basis for Action: The PMN states that
the use of the substances will be as
components of a cleaning formulation to
improve the wettability of the overall
cleaning solution on the substrate.
Based on the physical/chemical
properties of the PMN substance and
Structure Activity Relationships (SAR)
analysis of test data on analogous
substances, EPA has identified concerns
for acute toxicity, aquatic toxicity, eye
irritation, reproductive toxicity, skin
irritation, and specific target organ
toxicity if the chemical substance is
used in ways other than as intended by
the PMN submitter. This proposed
SNUR designates the following as
‘‘significant new uses’’ requiring further
review by EPA:
• Use of the PMN substances in
consumer products.
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• Manufacture, processing, or use in
a manner that results in inhalation
exposure.
• Release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance
exceeding a surface water concentration
of 3 ppb.
Potentially Useful Information: EPA
has determined that certain information
about the environmental and health
effects of the PMN substances may be
potentially useful to characterize the
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
aquatic toxicity, developmental toxicity,
neurotoxicity, pulmonary effects,
reproductive toxicity, and specific target
organ toxicity testing would help
characterize the potential environmental
and health effects of the PMN
substances.
CFR Citations: 40 CFR 721.11502 (P–
19–109, chemical A); 40 CFR 721.11503
(P–19–109, chemical B).
PMN Number: P–20–36
Chemical Name: Carbonic acid,
di(lithium-6Li) salt.
CAS Number: 25890–20–4.
Basis for Action: The PMN states that
the generic use of these substance will
be as a chemical intermediate for the
manufacture of Lithium-6 Chloride.
Based on the physical/chemical
properties of the PMN substance and
Structure Activity Relationships (SAR)
analysis of test data on analogous
substances, EPA has identified concerns
for acute toxicity, aquatic toxicity, eye
irritation, reproductive toxicity, skin
irritation, and specific target organ
toxicity if the chemical substance is
used in ways other than as intended by
the PMN submitter. This proposed
SNUR designates the following as
‘‘significant new uses’’ requiring further
review by EPA:
• Use other than for the confidential
use specified in the PMN.
• Release of a manufacturing,
processing, or use stream associated
with any use of the PMN substance
exceeding a surface water concentration
of 35 ppb.
Potentially Useful Information: No
toxicity data are necessary as the moiety
of concern for the new chemical
substance (lithium) is well studied and
has a rich toxicity database. EPA has
determined that the results of workplace
exposure or environmental release
information would help characterize the
potential effects of the PMN substance.
CFR Citation: 40 CFR 721.11504.
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PMN Number: P–20–37
Chemical Name: Lithium Chloride
(6LiCl).
CAS Number: 20227–31–0.
Basis for Action: The PMN states that
the generic use of the substance will be
as a material used in the manufacture of
devices for gamma and neutron
radiation detection. Based on the
physical/chemical properties of the
PMN substance and Structure Activity
Relationships (SAR) analysis of test data
on analogous substances, EPA has
identified concerns for acute toxicity,
eye irritation, reproductive toxicity, skin
irritation, and specific target organ
toxicity if the chemical substance is
used in ways other than as intended by
the PMN submitter. This proposed
SNUR designates the following as
‘‘significant new uses’’ requiring further
review by EPA:
• Use other than for the confidential
use specified in the PMN.
Potentially Useful Information: No
toxicity data are necessary as the moiety
of concern for the new chemical
substance (lithium) is well studied and
has a rich toxicity database. EPA has
determined that the results of workplace
exposure or environmental release
information would help characterize the
potential effects of the PMN substance.
CFR Citation: 40 CFR 721.11505.
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the PMNs submitted
for the chemical substances that are the
subject of these proposed SNURs and as
further discussed in Unit IV, EPA
identified certain other reasonably
foreseen conditions of use, in addition
to those conditions of use intended by
the submitter. EPA has preliminarily
determined that the chemical under the
intended conditions of use is not likely
to present an unreasonable risk.
However, EPA has not assessed risks
associated with the reasonably foreseen
conditions of use. EPA is proposing to
designate these conditions of use as well
as certain other circumstances of use as
significant new uses to ensure that they
are no longer reasonably foreseen to
occur without first going through a
separate, subsequent EPA review and
determination process associated with a
SNUN.
B. Objectives
EPA is proposing these SNURs
because the Agency wants:
• To have an opportunity to review
and evaluate data submitted in a SNUN
before the notice submitter begins
manufacturing or processing a listed
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chemical substance for the described
significant new use.
• To be obligated to make a
determination under TSCA section
5(a)(3) regarding the use described in
the SNUN, under the conditions of use.
The Agency will either determine under
TSCA section 5(a)(3)(C) that the
significant new use is not likely to
present an unreasonable risk, including
an unreasonable risk to a potentially
exposed or susceptible subpopulation
identified as relevant by the
Administrator under the conditions of
use, or make a determination under
TSCA section 5(a)(3)(A) or (B) and take
the required regulatory action associated
with the determination, before
manufacture or processing for the
significant new use of the chemical
substance can occur.
• To be able to complete its review
and determination on each of the PMN
substances, while deferring analysis on
the significant new uses proposed in
these rules unless and until the Agency
receives a SNUN.
Issuance of a proposed SNUR for a
chemical substance does not signify that
the chemical substance is listed on the
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/tscainventory.
VI. Applicability of the Proposed Rules
to Uses Occurring Before the Effective
Date of the Final Rule
To establish a significant new use,
EPA must determine that the use is not
ongoing. The chemical substances
subject to this proposed rule were
undergoing premanufacture review at
the time of signature of this proposed
rule and were not on the TSCA
Inventory. 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 the chemical
substances subject to these proposed
SNURs, EPA concludes that the
proposed significant new uses are not
ongoing.
EPA designates June 2, 2020 (date of
web posting of this proposed rule) 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 on or after that date
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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 EPA would have to
take action under TSCA section 5
allowing manufacture or processing to
proceed. In developing this proposed
rule, EPA has recognized that, given
EPA’s general practice of posting
proposed rules on its website a week or
more in advance of Federal Register
publication, this objective could be
thwarted even before Federal Register
publication of the proposed rule.
VII. Development and Submission of
Information
EPA recognizes that TSCA section 5
does not require development of any
particular new information (e.g.,
generating test data) before submission
of a SNUN. There is an exception: If a
person is required to submit information
for a chemical substance pursuant to a
rule, Order or consent agreement under
TSCA section 4 (15 U.S.C. 2603), then
TSCA section 5(b)(1)(A) (15 U.S.C.
2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of
submission of the SNUN.
In the absence of a rule, Order, or
consent agreement under TSCA section
4 covering the chemical substance,
persons are required only to submit
information in their possession or
control and to describe any other
information known 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 for all SNURs listed here.
Descriptions are provided for
informational purposes. The potentially
useful information identified in Unit IV.
will be useful to EPA’s evaluation in the
event that someone submits a SNUN for
the significant new use. Companies who
are considering submitting a SNUN are
encouraged, but not required, to develop
the information on the substance, which
may assist with EPA’s analysis of the
SNUN.
EPA strongly encourages persons,
before performing any testing, to consult
with the Agency pertaining to protocol
selection. Furthermore, pursuant to
TSCA section 4(h), which pertains to
reduction of testing in vertebrate
animals, EPA encourages consultation
with the Agency on the use of
alternative test methods and strategies
(also called New Approach
Methodologies, or NAMs), if available,
to generate the recommended test data.
EPA encourages dialog with Agency
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representatives to help determine how
best the submitter can meet both the
data needs and the objective of TSCA
section 4(h).
The potentially useful information
described in Unit IV. may not be the
only means of providing information to
evaluate the chemical substance
associated with the significant new
uses. However, submitting a SNUN
without any test data may increase the
likelihood that EPA will take action
under TSCA sections 5(e) or 5(f). EPA
recommends that potential SNUN
submitters contact EPA early enough so
that they will be able to conduct the
appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
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/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca.
IX. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
of the chemical substances subject to
this proposed rule. EPA’s complete
economic analysis is available in the
docket under docket ID number EPA–
HQ–OPPT–2020–0251.
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.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulations
and Regulatory Review
This action proposes to establish
SNURs for new chemical substances
that were the subject of PMNs. The
Office of Management and Budget
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(OMB) has exempted these types of
actions from review under Executive
Orders 12866 (58 FR 51735, October 4,
1993) and 13563 (76 FR 3821, January
21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA, 44 U.S.C. 3501
et seq., an Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA and assigned 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.
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C. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA,
5 U.S.C. 601 et seq., the Agency hereby
certifies that promulgation of this action
will not have a significant 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, EPA has concluded that no small
or large entities presently engage in
such activities.
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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, EPA received 7
SNUNs in Federal fiscal year (FY) 2013,
13 in FY2014, 6 in FY2015, 12 in
FY2016, 13 in FY2017, and 11 in
FY2018, only a fraction of these SNUNs
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 cost of
submitting a SNUN to about $10,116 for
qualifying small firms.
Therefore, the potential economic
impacts of complying with this 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.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
D. Unfunded Mandates Reform Act
(UMRA)
I. National Technology Transfer and
Advancement Act (NTTAA)
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 action does 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. 1531–1538 et
seq.).
In addition, since this action does not
involve any technical standards,
NTTAA section 12(d), 15 U.S.C. 272
note, does not apply to this action.
E. Executive Order 13132: Federalism
This action will 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).
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This action will not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes; will not significantly or
uniquely affect the communities of
Indian Tribal governments; nor does 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
and Safety Risks
This action is not subject to Executive
Order 13045 (62 FR 19885, April 23,
1997), because this is not an
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 (66 FR 28355, May 22,
2001), because this action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898 (59 FR 7629,
February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: May 29, 2020.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, it is proposed that 40 CFR
part 721 is amended as follows:
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PART 721—[AMENDED]
§ 721.11499 2-Propanol, 1-butoxy-, 2,2’ester (generic).
1. The authority citation for part 721
continues to read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as 2-propanol, 1-butoxy-, 2,2’ester (PMN P–18–271) 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 PMN substance other
than as a film-forming coalescent for
architectural coatings; for automotive
OEM coatings; for can and coil coatings;
for industrial wood coatings; for floor
polishes, for industrial maintenance
coatings; for marine and wood coatings;
for transportation coatings; for use in
printing inks; or as a chemical
intermediate to prepare ester
plasticizers. It is a significant new use
to process the PMN substance to a
weight fraction greater than 8% in the
final formulation.
(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.
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add §§ 721.11498 through
721.11506 to subpart E to read as
follows:
■
Subpart E—Significant New Uses for
Specific Chemical Substances
Sec.
*
*
*
*
*
721.11498 Formaldehyde, reaction products
with 1,3-benzenedimethanamine and ptert-butylphenol.
721.11499 2-Propanol, 1-butoxy-, 2,2’-ester
(generic).
721.11500 Haloalkane (generic).
721.11501 Ethanamine, N-ethyl-, 2hydroxy-1,2,3-propanetricarboxylate
(1:?).
721.11502 Copper, [[2,2’,2’’-(nitrilo.kappa.N)tris[ethanolato-.kappa.O]](2-)](P–19–109, chemical A).
721.11503 Copper, bis[2-(amino.kappa.N)ethanolato-.kappa.O]- (P–19–
109, chemical B).
721.11504 Carbonic acid, di(lithium-6Li)
salt.
721.11505 Lithium chloride (6LiCl).
721.11506 [Reserved].
*
*
*
*
*
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§ 721.11498 Formaldehyde, reaction
products with 1,3-benzenedimethanamine
and p-tert-butylphenol.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
formaldehyde, reaction products with
1,3-benzenedimethanamine and p-tertbutylphenol (PMN P–18–151; CASRN
158800–93–2) 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 PMN substance in a manner that
results in inhalation exposure.
(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).
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11500
Haloalkane (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as haloalkane (PMN P–19–19)
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) Workplace protection.
Requirements as specified in
§ 721.63(a)(4) through (6), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(4), engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. For purposes
of § 721.63(a)(5), respirators must
provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 1000. For purposes of
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36181
§ 721.63(a)(6), particulate (including
solids or liquid droplets).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 23.
(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 (d), and (k).
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11501 Ethanamine, N-ethyl-, 2hydroxy-1,2,3-propanetricarboxylate (1:?).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
ethanamine, N-ethyl-, 2-hydroxy-1,2,3propanetricarboxylate (1:?) (PMN P–19–
88; CASRN 23251–73–2) 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 PMN substance in a manner that
results in inhalation exposure.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 46.
(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).
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11502 Copper, [[2,2′,2″-(nitrilo.kappa.N)tris[ethanolato-.kappa.O]](2-)]-(P–
19–109, chemical A).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
copper, [[2,2′,2″-(nitrilo.kappa.N)tris[ethanolato-.kappa.O]](2-)](PMN P–19–109, chemical A; CASRN
21545–60–8) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is a
significant new use to manufacture,
process, or use the PMN substance in
any manner that results in inhalation
exposure.
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(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 3.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k).
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11503 Copper, bis[2-(amino.kappa.N)ethanolato-.kappa.O]- (P–19–109,
chemical B).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
copper, bis[2-(amino.kappa.N)ethanolato-.kappa.O]- (PMN
P–19–109, chemical B; CASRN 14215–
52–2) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is a
significant new use to manufacture,
process, or use the PMN substance in
any matter that results in inhalation
exposure.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 3.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k).
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11504
salt.
Carbonic acid, di(lithium-6Li)
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
carbonic acid, di(lithium-6Li) salt (PMN
P–20–36; CASRN 25890–20–4) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 35.
(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).
(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)(ii) of this section.
§ 721.11505
Lithium chloride (6LiCl).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
lithium chloride (6LiCl) (PMN P–20–37;
CASRN 20227–31–0) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 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).
(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)(ii) of this section.
§ 721.11506
[Reserved].
[FR Doc. 2020–12614 Filed 6–12–20; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
42 CFR Part 136
[Docket No. IHS–FRDOC–0001]
RIN 0917–AA14
Removal of Obsolete Portion of
Regulation Relating to Care and
Treatment of Ineligible Individuals
Indian Health Service,
Department of Health and Human
Services.
ACTION: Notice of proposed rulemaking.
AGENCY:
The Indian Health Service
(IHS) of the Department of Health and
SUMMARY:
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Fmt 4702
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Human Services (HHS or ‘‘the
Department’’) is issuing this Notice of
Proposed Rulemaking (NPRM) to
remove obsolete language appearing in
the Code of Federal Regulations,
regarding the rates charged for the
provision of IHS services to ineligible
individuals.
DATES: Comments due on or before
August 14, 2020.
ADDRESSES: You may submit comments
to this proposed rule, identified by RIN
0917–AA14 by any of the following
methods:
• Federal eRulemaking Portal. You
may submit electronic comments at
https://www.regulations.gov by searching
for the Docket ID number IHS–FRDOC–
0001. Follow the instructions https://
www.regulations.gov online for
submitting comments through this
method.
• Regular, Express, or Overnight Mail:
You may mail comments to Indian
Health Service, Attention: Evonne
Bennett, Acting Director, NPRM, RIN
0917–AA14, Division of Regulatory and
Policy Coordination, Office of
Management Services, Indian Health
Service, 5600 Fishers Lane, Mailstop:
09E70, Rockville, Maryland 20857.
All comments received by the
methods and due date specified above
will be posted without change to
content to https://www.regulations.gov,
including any personal information
provided about the commenter, and
such posting may occur before or after
the closing of the comment period.
Docket: For complete access to
background documents or posted
comments, go to https://
www.regulations.gov and search for
Docket ID number IHS–FRDOC–0001.
FOR FURTHER INFORMATION CONTACT:
Evonne Bennett, Acting Director,
Division of Regulatory and Policy
Coordination, Office of Management
Services, IHS, 5600 Fishers Lane,
Rockville, MD 20857, Mail Stop: 09E70.
Telephone (301) 443–1116 (This is not
a toll-free number).
SUPPLEMENTARY INFORMATION: In
response to Executive Order 13777, Sec.
3(d), which directs agencies to repeal
existing regulations that are ‘‘outdated,
unnecessary or ineffective’’ from the
CFR, HHS proposes to remove outdated
language appearing in the CFR at 42
CFR 136.14. The regulations in this part
establish general principles and
program requirements for carrying out
Indian health programs. Regarding the
provision of IHS services to ineligible
individuals, § 136.14(b) provides that
such individuals should be charged
‘‘rates approved by the Assistant
Secretary for Health and Surgeon
E:\FR\FM\15JNP1.SGM
15JNP1
]]>Agencies
[Federal Register Volume 85, Number 115 (Monday, June 15, 2020)]
[Proposed Rules]
[Pages 36175-36182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12614]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2020-0251; FRL-10010-40]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (20-6.B)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances which are
the subject of premanufacture notices (PMNs). This action would require
persons to notify EPA at least 90 days before commencing manufacture
(defined by statute to include import) or processing of any of these
chemical substances for an activity that is designated as a significant
new use by this proposed rule. This action would further require that
persons not commence manufacture or processing for the significant new
use until they have submitted a Significant New Use Notice, and EPA has
conducted a review of the notice, made an appropriate determination on
the notice under TSCA, and has taken any risk management actions as are
required as a result of that determination.
DATES: Comments must be received on or before July 15, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0251, 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.
Please note that due to the public health emergency the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit 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].
[[Page 36176]]
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions. This action may also affect certain entities through pre-
existing import certification and export notification rules under TSCA,
which would include the SNUR requirements should these proposed rules
be finalized. The EPA policy in support of import certification appears
at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20,
any persons who export or intend to export a chemical substance that is
the subject of this proposed rule on or after July 15, 2020 are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) 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 CBI 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 which are the subjects of PMNs P-18-151, P-18-271,
P-19-19, P-19-88, P-19-109, P-20-36, P- and 20-37. These proposed SNURs
would require persons who intend to manufacture or process any of these
chemical substances for an activity that is designated as a significant
new use to notify EPA at least 90 days before commencing that activity.
The record for these proposed SNURs, identified as docket ID number
EPA-HQ-OPPT-2020-0251, includes information considered by the Agency in
developing these proposed SNURs.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four TSCA section 5(a)(2) factors
listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to these SNURs must comply with the
same significant new use notice (SNUN) requirements and EPA regulatory
procedures as submitters of PMNs under TSCA section 5(a)(1)(A) (15
U.S.C. 2604(a)(1)(A)). In particular, these requirements include the
information submission requirements of TSCA sections 5(b) and 5(d)(1)
(15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions authorized by TSCA
sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(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. If EPA determines that the use is not likely to present an
unreasonable risk, EPA is required under TSCA section 5(g) to make
public, and submit for publication in the Federal Register, a statement
of EPA's findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the substances, in the context of the four bulleted
TSCA section 5(a)(2) factors listed in this unit. During its review of
these chemicals, EPA identified certain conditions of use that are not
intended by the submitters, but reasonably foreseen to occur. EPA is
proposing to designate those reasonably foreseen conditions of use as
well as certain other circumstances of use as significant new uses.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for 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.
[[Page 36177]]
Potentially Useful Information.
CFR citation assigned in the regulatory text section of
these proposed rules.
The regulatory text section of this document specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
The chemical substances that are the subject of these proposed
SNURs are undergoing premanufacture review. In addition to those
conditions of use intended by the submitter, EPA has identified certain
other reasonably foreseen conditions of use. EPA has preliminarily
determined that the chemicals under their intended conditions of use
are not likely to present an unreasonable risk. However, EPA has not
assessed risks associated with the reasonably foreseen conditions of
use for these chemicals. EPA is proposing to designate these reasonably
foreseen conditions of use and other circumstances of use as
significant new uses. As a result, those significant new uses cannot
occur without first going through a separate, subsequent EPA review and
determination process associated with a SNUN.
The substances subject to these proposed rules are as follows:
PMN Number: P-18-151
Chemical name: Formaldehyde, reaction products with 1,3-
benzenedimethanamine and p-tert-butylphenol.
CAS number: 158800-93-2.
Basis for action: The PMN states that the use of the substance will
be as a curing agent for epoxy systems. Based on the physical/chemical
properties of the PMN substance and Structure Activity Relationships
(SAR) analysis of test data on analogous substances, EPA has identified
concerns for aquatic toxicity, reproductive/developmental toxicity,
respiratory sensitization, skin corrosion, skin irritation, skin
sensitization, and systemic effects if the chemical substance is used
in ways other than as intended by the PMN submitter. This proposed SNUR
designates the following as ``significant new uses'' requiring further
review by EPA:
Manufacture, processing, or use in a manner that results
in inhalation exposure.
Release of a manufacturing, processing, or use stream
associated with any use of the PMN substance exceeding a surface water
concentration of 1 ppb.
Potentially Useful Information: EPA has determined that certain
information about the environmental and health effects of the PMN
substance may be potentially useful to characterize the 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,
eye damage, reproductive toxicity, skin corrosion, skin sensitization,
and specific target organ toxicity testing would help characterize the
potential environmental and health effects of the PMN substance.
CFR Citation: 40 CFR 721.11498.
PMN Number: P-18-271
Chemical Name: 2-Propanol, 1-butoxy-, 2,2'-ester (generic).
CAS Number: Not available.
Basis for Action: The PMN states that the use of the substance will
be as a film-forming coalescent for architectural coatings; for
automotive OEM coatings; for can and coil coatings; for industrial wood
coatings; for floor polishes, for industrial maintenance coatings; for
marine and wood coatings; for transportation coatings; for use in
printing inks; and as a chemical intermediate to prepare ester
plasticizers. Based on the physical/chemical properties of the PMN
substance and Structure Activity Relationships (SAR) analysis of test
data on analogous substances, EPA has identified concerns for
irritation and specific target organ toxicity as hazards based on the
expected metabolite (propylene glycol n-butyl ether) if the chemical
substance is used in ways other than as intended by the PMN submitter.
The proposed SNUR designates the following as ``significant new uses''
requiring further EPA review:t.:
Use other than as a film-forming coalescent for
architectural coatings; for automotive OEM coatings; for can and coil
coatings; for industrial wood coatings; for floor polishes, for
industrial maintenance coatings; for marine and wood coatings; for
transportation coatings; for use in printing inks; and as a chemical
intermediate to prepare ester plasticizers, consistent with the
manufacturing, processing, use, distribution, and disposal information
described in the PMN.
Processing the PMN substance to a weight fraction greater
than 8% in the final formulation.
Potentially Useful Information: EPA has determined that certain
information about the environmental and health effects of the PMN
substance may be potentially useful to characterize the 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,
skin irritation, eye damage, specific target organ toxicity, and
aquatic toxicity testing would help characterize the potential
environmental and health effects of the PMN substance.
CFR Citation: 40 CFR 721.11499.
PMN Number: P-19-19
Chemical Name: Haloalkane (generic).
CAS Number: Not available.
Basis for Action: The PMN states that the generic use of the
substance will be as a chemical intermediate. Based on the physical/
chemical properties of the PMN substance and Structure Activity
Relationships (SAR) analysis of test data on analogous substances, EPA
has identified concerns for skin irritation, specific target organ
toxicity, and aquatic toxicity if the chemical substance is used in
ways other than as intended by the PMN submitter. This proposed SNUR
designates the following as ``significant new uses'' requiring further
review by EPA:
Release of a manufacturing, processing, or use stream
associated with any use of the PMN substance exceeding a surface water
concentration of 23 ppb.
Use of the PMN substance without a National Institute for
Occupational Safety and Health (NIOSH) certified respirator with an
assigned protection factor of at least 1000.
Potentially Useful Information: EPA has determined that certain
information about the toxicity of the PMN substance 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 irritation,
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 721.11500.
PMN Number: P-19-88
Chemical Name: Ethanamine, N-ethyl-, 2-hydroxy-1,2,3-
propanetricarboxylate (1:?).
CAS Number: 23251-73-2.
Basis for Action: The PMN states that the generic use of the
substance will be as feedstock for amine recovery. Based on the
physical/chemical properties of
[[Page 36178]]
the PMN substance and Structure Activity Relationships (SAR) analysis
of test data on analogous substances, EPA has identified concerns for
acute toxicity, reproductive toxicity, serious eye damage, skin
corrosion, and specific target organ toxicity if the chemical substance
is used in ways other than as intended by the PMN submitter. This
proposed SNUR designates the following as ``significant new uses''
requiring further review by EPA:
Manufacture, processing, or use in a manner that results
in inhalation exposure.
Release of a manufacturing, processing, or use stream
associated with any use of the PMN substance exceeding a surface water
concentration of 46 ppb.
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 skin
corrosion, eye damage, reproductive/developmental effects, and specific
target organ toxicity testing would help characterize the potential
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11501.
PMN Number: P-19-109
Chemical Names: Copper, [[2,2',2''-
(nitrilo-.kappa.N)tris[ethanolato-.kappa.O]](2-)]- (P-19-109, chemical
A) and copper, bis[2-(amino-.kappa.N)ethanolato-.kappa.O]- (P-19-109,
chemical B).
CAS Numbers: 21545-60-8 (P-19-109, chemical A) and 14215-52-2 (P-
19-109, chemical B).
Basis for Action: The PMN states that the use of the substances
will be as components of a cleaning formulation to improve the
wettability of the overall cleaning solution on the substrate. Based on
the physical/chemical properties of the PMN substance and Structure
Activity Relationships (SAR) analysis of test data on analogous
substances, EPA has identified concerns for acute toxicity, aquatic
toxicity, eye irritation, reproductive toxicity, skin irritation, and
specific target organ toxicity if the chemical substance is used in
ways other than as intended by the PMN submitter. This proposed SNUR
designates the following as ``significant new uses'' requiring further
review by EPA:
Use of the PMN substances in consumer products.
Manufacture, processing, or use in a manner that results
in inhalation exposure.
Release of a manufacturing, processing, or use stream
associated with any use of the PMN substance exceeding a surface water
concentration of 3 ppb.
Potentially Useful Information: EPA has determined that certain
information about the environmental and health effects of the PMN
substances may be potentially useful to characterize the 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 aquatic toxicity,
developmental toxicity, neurotoxicity, pulmonary effects, reproductive
toxicity, and specific target organ toxicity testing would help
characterize the potential environmental and health effects of the PMN
substances.
CFR Citations: 40 CFR 721.11502 (P-19-109, chemical A); 40 CFR
721.11503 (P-19-109, chemical B).
PMN Number: P-20-36
Chemical Name: Carbonic acid, di(lithium-6Li) salt.
CAS Number: 25890-20-4.
Basis for Action: The PMN states that the generic use of these
substance will be as a chemical intermediate for the manufacture of
Lithium-6 Chloride. Based on the physical/chemical properties of the
PMN substance and Structure Activity Relationships (SAR) analysis of
test data on analogous substances, EPA has identified concerns for
acute toxicity, aquatic toxicity, eye irritation, reproductive
toxicity, skin irritation, and specific target organ toxicity if the
chemical substance is used in ways other than as intended by the PMN
submitter. This proposed SNUR designates the following as ``significant
new uses'' requiring further review by EPA:
Use other than for the confidential use specified in the
PMN.
Release of a manufacturing, processing, or use stream
associated with any use of the PMN substance exceeding a surface water
concentration of 35 ppb.
Potentially Useful Information: No toxicity data are necessary as
the moiety of concern for the new chemical substance (lithium) is well
studied and has a rich toxicity database. EPA has determined that the
results of workplace exposure or environmental release information
would help characterize the potential effects of the PMN substance.
CFR Citation: 40 CFR 721.11504.
PMN Number: P-20-37
Chemical Name: Lithium Chloride (6LiCl).
CAS Number: 20227-31-0.
Basis for Action: The PMN states that the generic use of the
substance will be as a material used in the manufacture of devices for
gamma and neutron radiation detection. Based on the physical/chemical
properties of the PMN substance and Structure Activity Relationships
(SAR) analysis of test data on analogous substances, EPA has identified
concerns for acute toxicity, eye irritation, reproductive toxicity,
skin irritation, and specific target organ toxicity if the chemical
substance is used in ways other than as intended by the PMN submitter.
This proposed SNUR designates the following as ``significant new uses''
requiring further review by EPA:
Use other than for the confidential use specified in the
PMN.
Potentially Useful Information: No toxicity data are necessary as
the moiety of concern for the new chemical substance (lithium) is well
studied and has a rich toxicity database. EPA has determined that the
results of workplace exposure or environmental release information
would help characterize the potential effects of the PMN substance.
CFR Citation: 40 CFR 721.11505.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are the subject of these proposed SNURs and as further discussed
in Unit IV, EPA identified certain other reasonably foreseen conditions
of use, in addition to those conditions of use intended by the
submitter. EPA has preliminarily determined that the chemical under the
intended conditions of use is not likely to present an unreasonable
risk. However, EPA has not assessed risks associated with the
reasonably foreseen conditions of use. EPA is proposing to designate
these conditions of use as well as certain other circumstances of use
as significant new uses to ensure that they are no longer reasonably
foreseen to occur without first going through a separate, subsequent
EPA review and determination process associated with a SNUN.
B. Objectives
EPA is proposing these SNURs because the Agency wants:
To have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed
[[Page 36179]]
chemical substance for the described significant new use.
To be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use. The Agency will either determine under TSCA section 5(a)(3)(C)
that the significant new use is not likely to present an unreasonable
risk, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant by the Administrator
under the conditions of use, or make a determination under TSCA section
5(a)(3)(A) or (B) and take the required regulatory action associated
with the determination, before manufacture or processing for the
significant new use of the chemical substance can occur.
To be able to complete its review and determination on
each of the PMN substances, while deferring analysis on the significant
new uses proposed in these rules unless and until the Agency receives a
SNUN.
Issuance of a proposed SNUR for a chemical substance does not
signify that the chemical substance is listed on the TSCA Inventory.
Guidance on how to determine if a chemical substance is on the TSCA
Inventory is available on the internet at https://www.epa.gov/tsca-inventory.
VI. Applicability of the Proposed Rules to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
were undergoing premanufacture review at the time of signature of this
proposed rule and were not on the TSCA Inventory. 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
the chemical substances subject to these proposed SNURs, EPA concludes
that the proposed significant new uses are not ongoing.
EPA designates June 2, 2020 (date of web posting of this proposed
rule) 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 on or after
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
EPA would have to take action under TSCA section 5 allowing manufacture
or processing to proceed. In developing this proposed rule, EPA has
recognized that, given EPA's general practice of posting proposed rules
on its website a week or more in advance of Federal Register
publication, this objective could be thwarted even before Federal
Register publication of the proposed rule.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, Order
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, Order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other information known 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 for all SNURs listed here. Descriptions are provided
for informational purposes. The potentially useful information
identified in Unit IV. will be useful to EPA's evaluation in the event
that someone submits a SNUN for the significant new use. Companies who
are considering submitting a SNUN are encouraged, but not required, to
develop the information on the substance, which may assist with EPA's
analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h).
The potentially useful information described in Unit IV. may not be
the only means of providing information to evaluate the chemical
substance associated with the significant new uses. However, submitting
a SNUN without any test data may increase the likelihood that EPA will
take action under TSCA sections 5(e) or 5(f). EPA recommends that
potential SNUN submitters contact EPA early enough so that they will be
able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
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/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2020-0251.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action proposes to establish SNURs for new chemical substances
that were the subject of PMNs. The Office of Management and Budget
[[Page 36180]]
(OMB) has exempted these types of actions from review under Executive
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA and assigned 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 section 605(b) of the RFA, 5 U.S.C. 601 et seq., the
Agency hereby certifies that promulgation of this action will not have
a significant 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, EPA has concluded 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, EPA
received 7 SNUNs in Federal fiscal year (FY) 2013, 13 in FY2014, 6 in
FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018, only a fraction
of these SNUNs 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 cost of submitting a SNUN to about
$10,116 for qualifying small firms.
Therefore, the potential economic impacts of complying with this
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 action does 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. 1531-1538 et seq.).
E. Executive Order 13132: Federalism
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action will not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes; will not
significantly or uniquely affect the communities of Indian Tribal
governments; nor does 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 and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not expected to affect energy
supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does 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 action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: May 29, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 is amended as
follows:
[[Page 36181]]
PART 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. 721.11498 through 721.11506 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11498 Formaldehyde, reaction products with 1,3-
benzenedimethanamine and p-tert-butylphenol.
721.11499 2-Propanol, 1-butoxy-, 2,2'-ester (generic).
721.11500 Haloalkane (generic).
721.11501 Ethanamine, N-ethyl-, 2-hydroxy-1,2,3-
propanetricarboxylate (1:?).
721.11502 Copper, [[2,2',2''-
(nitrilo-.kappa.N)tris[ethanolato-.kappa.O]](2-)]- (P-19-109,
chemical A).
721.11503 Copper, bis[2-(amino-.kappa.N)ethanolato-.kappa.O]- (P-19-
109, chemical B).
721.11504 Carbonic acid, di(lithium-6Li) salt.
721.11505 Lithium chloride (6LiCl).
721.11506 [Reserved].
* * * * *
Sec. 721.11498 Formaldehyde, reaction products with 1,3-
benzenedimethanamine and p-tert-butylphenol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
reaction products with 1,3-benzenedimethanamine and p-tert-butylphenol
(PMN P-18-151; CASRN 158800-93-2) 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 PMN substance
in a manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11499 2-Propanol, 1-butoxy-, 2,2'-ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 2-
propanol, 1-butoxy-, 2,2'-ester (PMN P-18-271) 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 PMN substance other than as a film-
forming coalescent for architectural coatings; for automotive OEM
coatings; for can and coil coatings; for industrial wood coatings; for
floor polishes, for industrial maintenance coatings; for marine and
wood coatings; for transportation coatings; for use in printing inks;
or as a chemical intermediate to prepare ester plasticizers. It is a
significant new use to process the PMN substance to a weight fraction
greater than 8% in the final formulation.
(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. 721.11500 Haloalkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
haloalkane (PMN P-19-19) 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) Workplace protection. Requirements as specified in Sec.
721.63(a)(4) through (6), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF)
of at least 1000. For purposes of Sec. 721.63(a)(6), particulate
(including solids or liquid droplets).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 23.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), and (k).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11501 Ethanamine, N-ethyl-, 2-hydroxy-1,2,3-
propanetricarboxylate (1:?).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanamine, N-
ethyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:?) (PMN P-19-88; CASRN
23251-73-2) 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 PMN substance
in a manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 46.
(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).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11502 Copper, [[2,2',2''-
(nitrilo-.kappa.N)tris[ethanolato-.kappa.O]](2-)]-(P-19-109, chemical
A).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as copper, [[2,2',2''-
(nitrilo-.kappa.N)tris[ethanolato-.kappa.O]](2-)]- (PMN P-19-109,
chemical A; CASRN 21545-60-8) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the PMN substance in any manner that
results in inhalation exposure.
[[Page 36182]]
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 3.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11503 Copper, bis[2-(amino-.kappa.N)ethanolato-.kappa.O]-
(P-19-109, chemical B).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as copper, bis[2-
(amino-.kappa.N)ethanolato-.kappa.O]- (PMN P-19-109, chemical B; CASRN
14215-52-2) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the PMN substance in any matter that
results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 3.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11504 Carbonic acid, di(lithium-6Li) salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carbonic acid,
di(lithium-6Li) salt (PMN P-20-36; CASRN 25890-20-4) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 35.
(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).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11505 Lithium chloride (6LiCl).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as lithium chloride
(6LiCl) (PMN P-20-37; CASRN 20227-31-0) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11506 [Reserved].
[FR Doc. 2020-12614 Filed 6-12-20; 8:45 am]
BILLING CODE 6560-50-P
