Flame Retardants; Significant New Uses Rules for Certain Non-Ongoing Uses, 40728-40741 [2023-13250]
Download as PDF
40728
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
environmental harms and risks,
including those resulting from the
negative environmental consequences of
industrial, governmental, and
commercial operations or programs and
policies.’’
Ohio EPA did not evaluate
environmental justice considerations as
part of its SIP submittal; the CAA and
applicable implementing regulations
neither prohibit nor require such an
evaluation. EPA did not perform an EJ
analysis and did not consider EJ in this
action. Consideration of EJ is not
required as part of this action, and there
is no information in the record
inconsistent with the stated goal of E.O.
12898 of achieving environmental
justice for people of color, low-income
populations, and Indigenous peoples.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Reporting and recordkeeping
requirements, Sulfur oxides.
Dated: June 15, 2023.
Debra Shore,
Regional Administrator, Region 5.
[FR Doc. 2023–13230 Filed 6–21–23; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2023–0012; FRL–9430–01–
OCSPP]
RIN 2070–AL07
Flame Retardants; Significant New
Uses Rules for Certain Non-Ongoing
Uses
SUPPLEMENTARY INFORMATION:
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
I. Executive Summary
Under the Toxic Substances
Control Act (TSCA), EPA is proposing
significant new use rules (SNURs) for
three flame retardants, tris(2chloroethyl) phosphate (TCEP), 4,4′-(1methylethylidene)bis[2, 6dibromophenol], also known as
‘‘tetrabromobisphenol A,’’ (TBBPA), and
triphenyl phosphate (TPP), which are
all undergoing TSCA risk evaluations.
The proposed significant new uses are
manufacture (including import) or
processing for any use, with the
exception that the conditions of use the
Agency expects to consider within the
scope of the TSCA section 6 risk
evaluations are not proposed as
significant new uses. Persons subject to
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 those listed in TSCA section
5(a)(2) (see Unit II.A.). Once EPA
determines that a use of a chemical
substance is a significant new use,
TSCA section 5(a)(1) requires persons to
submit a significant new use notice
(SNUN) to EPA at least 90 days before
they manufacture (including import) or
process the chemical substance for that
use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA
further provides that such
manufacturing (including import) or
AGENCY:
SUMMARY:
ddrumheller on DSK120RN23PROD with PROPOSALS1
the SNUR would be required to notify
EPA at least 90 days before commencing
any manufacturing (including import) or
processing of the chemical substance for
a significant new use. Once EPA
receives a notification, EPA must review
and make an affirmative determination
on the notification, and take such action
as is required by any such
determination before the manufacture
(including import) or processing for the
significant new use can commence.
DATES: Comments must be received on
or before August 7, 2023.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2023–0012,
using the Federal eRulemaking Portal at
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. Additional
instructions on commenting or visiting
the docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Thomas Groeneveld, Office of Pollution
Prevention and Toxics (7404M),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
566–1188; email address:
existing.chemical.SNUR@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
A. What is the Agency’s authority for
taking this action?
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
processing may not commence until
EPA has conducted a review of the
notice, made an appropriate
determination on the notice, and taken
such actions as are required in
association with that determination (15
U.S.C. 2604(a)(1)(B)(ii)). EPA has long
interpreted the statutory term
‘‘significant new use’’ to include the
resumption of a use that had ceased
prior to promulgation of the proposed
SNUR, for example see, April 25, 2019
(84 FR 17345) (FRL–9991–33)); March 8,
2016 (81 FR 20535 (FRL–9943–83));
December 29, 2014 (79 FR 77891 (FRL–
9915–60)) and October 22, 2013 (78 FR
62443 (FRL–9397–1)), and EPA will not
determine that a use is a ‘‘significant
new use’’ if information reasonably
available to the Agency, including that
received during the period for public
comment, establishes that the use is
ongoing at the time the proposed rule is
published in the Federal Register.
B. What action is the Agency taking?
EPA is proposing SNURs for the
following three flame retardants
undergoing TSCA section 6 risk
evaluations:
• Tris(2-chloroethyl) phosphate
(TCEP), CASRN 115–96–8 (Ref. 1);
• 4,4′-(1-methylethylidene)bis[2, 6dibromophenol], also known as
‘‘tetrabromobisphenol A,’’ (TBBPA),
CASRN 79–94–7 (Ref. 2); and
• Triphenyl phosphate (TPP), CASRN
115–86–6 (Ref. 3).
The proposed significant new uses are
manufacture (including import) or
processing for any use, with the
exception that the conditions of use that
EPA expects to consider within the
scope of the TSCA section 6 risk
evaluations are not proposed as
significant new uses (Refs. 1, 2, and 3).
The conditions of use that EPA
identified for the TSCA section 6 risk
evaluations include all manufacture,
processing, and use the Agency believes
to be ongoing, as well as legacy uses and
associated disposal, in the United States
based on reasonably available
information. The proposed significant
new uses include manufacture and
processing for uses that have ceased;
manufacture and processing for uses
that have not yet ceased but for which
all manufacture and processing has
ceased; and manufacture and processing
for uses for which EPA has no
information demonstrating that the use
has previously commenced in the
United States. EPA will consider any
information received during the period
for public comment suggesting that
particular uses had commenced in the
United States and not ceased prior to
E:\FR\FM\22JNP1.SGM
22JNP1
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
ddrumheller on DSK120RN23PROD with PROPOSALS1
publication date of this notice of
proposed rulemaking.
EPA is not proposing to make
inapplicable the general exemptions
from SNUR notice requirements that are
described in 40 CFR 721.45. These
include, for example, exemptions from
notification requirements for persons
manufacturing or processing the
chemical substance only as an impurity
or certain byproduct, and persons
importing or processing the chemical
substance as part of an article. (See also
the request for comment in Unit II.D.).
EPA is requesting public comment on
all aspects of this proposal and
specifically on the Agency’s description
of the significant new uses for the
chemicals identified, including specific
documentation of ongoing uses not
identified by the Agency, if any (see
details discussed in Unit III.). Please
note that the Agency has listed the
exempted conditions of use from the
significant new use proposed
designation as these conditions of use
appear in the risk evaluation scope
documents, including both
manufacturing and processing for
specific uses and the uses themselves in
the same list of exceptions. EPA is
interested in comments on how these
conditions of use are presented as
exemptions from the significant new
use.
C. Why is the Agency taking this action?
The Agency is proposing these SNURs
to ensure that EPA receives timely
advanced notice of any future
manufacturing (including importing) or
processing of the chemical substances
subject to these proposed SNURs for
uses identified as significant new uses
that may produce changes in human
and environmental exposures, and to
ensure that an appropriate
determination (relevant to the risks
associated with such manufacturing
(including importing), processing,
distribution in commerce, use and
disposal) has been issued prior to the
commencement of such manufacturing
(including importing) or processing. The
proposed SNURs are necessary to
ensure that manufacturing (including
import) or processing for significant
new uses cannot proceed until EPA has
responded to the planned new use
circumstances by taking the required
actions under TSCA sections 5(e) or 5(f)
in the event that EPA determines under
section 5(a)(3) that: (1) The significant
new use presents an unreasonable risk
under the conditions of use (without
consideration of costs or other nonrisk
factors, and including an unreasonable
risk to a potentially exposed or
susceptible subpopulation (PESS)
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
identified as relevant by EPA); (2) The
information available to EPA is
insufficient to permit a reasoned
evaluation of the health and
environmental effects of the significant
new use; (3) In the absence of sufficient
information, the manufacturing
(including importing), processing,
distribution in commerce, use, or
disposal of the substance, or any
combination of such activities, may
present an unreasonable risk (without
consideration of costs or other nonrisk
factors, and including an unreasonable
risk to a PESS identified as relevant by
EPA); or (4) There is substantial
production and sufficient potential for
environmental release or human
exposure (as defined in TSCA section
5(a)(3)(B)(ii)(II)). In order for
manufacturing (including importing) or
processing for the significant new use to
proceed after EPA has made one of these
four determinations, EPA must take
actions under TSCA sections 5(e) or 5(f)
to protect health and the environment.
However, EPA may also determine that
the significant new use is not likely to
present an unreasonable risk under
TSCA section 5(a)(3)(C), after which
manufacturing (including importing) or
processing for the significant new use
may proceed.
EPA is separately conducting risk
evaluations for the chemical substances
subject to this proposed rule under their
respective conditions of use, pursuant to
TSCA section 6(b)(4)(A) (15 U.S.C.
2605(b)(4)(A)). The term ‘‘conditions of
use’’ is defined in TSCA section 3(4) to
mean the circumstances, as determined
by the Administrator, under which a
chemical substance is intended, known,
or reasonably foreseen to be
manufactured, processed, distributed in
commerce, used, or disposed of.
Through scoping and subsequent
information gathering activity for the
risk evaluations, EPA identified
conditions of use to consider in the
TSCA section 6 risk evaluations for
these chemical substances. The
conditions of use identified by EPA for
the TSCA section 6 risk evaluations are
listed for each chemical substance in
Unit III.D. These conditions of use
include (but are not limited to) all
manufacture, processing, and use that
the information available to the Agency
demonstrates to be ongoing in the
United States. EPA is not proposing to
designate these conditions of use as
significant new uses.
Additionally, as part of the
information gathering activity
associated with the risk evaluations for
these chemical substances, EPA
identified certain prior uses that have
ceased, as well as industrial,
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
40729
commercial, or consumer conditions of
use that are ongoing but for which
manufacturing (including import) and
processing have ceased. EPA is
proposing to determine that
manufacture and processing for these
two categories of uses are no longer
ongoing. These uses are also listed for
each chemical substance in Unit III.D.
Manufacture (including import) and
processing of these chemical substances
for these uses, as well as for any other
potential use of these chemical
substances not identified as a condition
of use for the TSCA section 6 risk
evaluations, are within the scope of this
proposed SNUR.
The rationale and objectives for this
proposed SNUR are further explained in
Unit II.B.
D. Does this action apply to me?
1. General applicability.
You may be potentially affected by
this action if you manufacture
(including import), process, or
distribute in commerce chemical
substances and mixtures. 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.
• Textile manufacturing (NAICS code
313).
• Fabric coating mills (NAICS code
313320).
• All other leather good and allied
product manufacturing (NAICS code
316998).
• All other miscellaneous wood
product manufacturing (NAICS code
321999).
• Paper bag and coated treated paper
manufacturing (NAICS code 322220).
• Coated and laminated paper
manufacturing (NAICS code 322222).
• All other converted paper product
manufacturing (NAICS code 322299).
• Other basic inorganic chemical
manufacturing (NAICS code 325180).
• Alkalies and chlorine
manufacturing (NAICS code 325181).
• All other basic inorganic chemical
manufacturing (NAICS code 325188).
• All other basic organic chemical
manufacturing (NAICS code 325199).
• Plastics material and resin
manufacturing (NAICS code 325211).
• Artificial and synthetic fibers and
filaments manufacturing (NAICS code
325220).
E:\FR\FM\22JNP1.SGM
22JNP1
ddrumheller on DSK120RN23PROD with PROPOSALS1
40730
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
• Noncellulosic organic fiber
manufacturing (NAICS code 325222).
• Paint and coating manufacturing
(NAICS code 325510).
• Adhesive manufacturing (NAICS
code 325520).
• Custom compounding of purchased
resins (NAICS code 325991).
• Photographic film, paper, plate, and
chemical manufacturing (NAICS code
325992).
• All other miscellaneous chemical
product and preparation manufacturing
(NAICS code 325998).
• Plastics and rubber products
manufacturing (NAICS code 326).
• Unlaminated plastics film and sheet
(except packaging) manufacturing
(NAICS code 326113).
• Laminated plastics plate, sheet
(except packaging), and shape
manufacturing (NAICS code 326130).
• Polystyrene foam product
manufacturing (NAICS code 326140).
• Urethane and other foam product
(except polystyrene) manufacturing
((NAICS code 326150).
• All other plastics product
manufacturing (NAICS code 326199).
• Other concrete product
manufacturing (NAICS code 327390).
• Other industrial machinery
manufacturing (NAICS code 333249).
• Computer and electronic product
manufacturing (NAICS code 334).
• Bare printed circuit board
manufacturing (NAICS code 334412).
• Semiconductor and related device
manufacturing (NAICS code 334413).
• Electronic connector manufacturing
(NAICS code 334417).
• Other electronic component
manufacturing (NAICS code 334419).
• Current-carrying wiring device
manufacturing (NAICS code 335931).
• Carbon and graphite product
manufacturing (NAICS code 335991).
• Automobile manufacturing (NAICS
code 336111).
• Other motor vehicle parts
manufacturing (NAICS code 336390).
• All other motor vehicle parts
manufacturing (NAICS code 336399).
• Aerospace product and parts
manufacturing (NAICS code 336400).
• Aircraft manufacturing (NAICS
code 336411).
• Other aircraft parts and auxiliary
equipment manufacturing (NAICS code
336413).
• Furniture and related product
manufacturing (NAICS code 337).
• Gasket, packing, and sealing device
manufacturing (NAICS code 339991).
• Other chemical and allied products
merchant wholesalers (NAICS code
424690).
• All other pipeline transportation
(NAICS code 486990).
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
• Testing laboratories and services
(NAICS code 541380).
• Hazardous waste treatment and
disposal (NAICS code 562211).
• Solid waste landfill (NAICS code
562212).
• Other nonhazardous waste
treatment and disposal (NAICS code
562219).
• Materials recovery facilities (NAICS
code 562920).
• All other miscellaneous waste
management services (NAICS code
562998).
• National security (NAICS code
928110).
2. Applicability to importers and
exporters.
This action may also affect certain
entities through pre-existing import,
including import certification, and
export notification rules under TSCA.
Chemical importers are subject to the
import provision of TSCA section 13 (15
U.S.C. 2612), which requires that the
Secretary of the Treasury ‘‘refuse entry
into the customs territory of the United
States’’ of any substance, mixture, or
article containing a chemical substance
or mixture that fails to comply with any
rule issued under TSCA or that ‘‘is
offered for entry in violation’’ of TSCA
or certain rules or orders issued under
TSCA, including rules issued under
TSCA section 5. Persons who import
any chemical substance in bulk form, as
part of a mixture, or as part of an article
(if required by rule) are also subject to
TSCA section 13 import certification
requirements and the corresponding
regulations promulgated at 19 CFR
12.118 through 12.127 (see also 19 CFR
127.28). Chemical importers of the
chemical substances in bulk form, as
part of a mixture, or as part of an article
(if required by rule) must certify that the
shipment of the chemical substance
complies with all applicable rules and
orders under TSCA, including
regulations issued under TSCA sections
5, 6, 7 and Title IV. 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 24, 2023 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.
E. What are the estimated incremental
impacts of this action?
EPA has evaluated the potential costs
of establishing SNUR reporting
requirements for potential
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
manufacturers (including importers)
and processors of the chemical
substances included in this proposed
rule. This analysis (Ref. 4), which is
available in the docket, is briefly
summarized here.
1. Estimated costs for SNUN
submissions.
In the event that a SNUN is
submitted, costs are an estimated
$26,894 per SNUN submission for large
business submitters and $11,204 for
small business submitters. These
estimates include the cost to prepare
and submit the SNUN (including
registration for EPA’s Central Data
Exchange (CDX)), and the payment of a
user fee. Businesses that submit a SNUN
would be subject to either a $19,020
user fee required by 40 CFR
700.45(c)(2)(ii) and (d), or, if they are a
small business as defined at 13 CFR
121.201, a reduced user fee of $3,300
(40 CFR 700.45(c)(1)(ii) and (d)) per
fiscal year 2022. The costs of
submission of SNUNs will not be
incurred by any company unless a
company decides to pursue a significant
new use as defined in this proposed
SNUR. Additionally, these estimates
reflect the costs and fees as they are
known at the time this rulemaking.
2. Estimated costs for export
notifications.
EPA has also evaluated the potential
costs associated with the export
notification requirements under TSCA
section 12(b) and the implementing
regulations at 40 CFR part 707, subpart
D, which require exporters to notify
EPA if they export or intend to export
a chemical substance or mixture for
which, among other things, a rule has
been proposed or promulgated under
TSCA section 5. For persons exporting
a substance that is the subject of a
SNUR, a one-time notice to EPA must be
provided for the first export or intended
export to a particular country. The total
costs of export notification will vary by
chemical, depending on the number of
required notifications (i.e., the number
of countries to which the chemical is
exported). While EPA is unable to make
any estimate of the likely number of
export notifications for the chemical
substances covered by the proposed
SNURs, as stated in the accompanying
economic analysis, the estimated cost of
the export notification requirement on a
per unit basis is approximately $66.
F. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through https://
www.regulations.gov or email. If you
wish to include CBI in your comment,
please follow the instructions at https://
E:\FR\FM\22JNP1.SGM
22JNP1
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
www.epa.gov/dockets and clearly mark
the part or all the information that you
claim to be 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/
commenting-epa-dockets. EPA
welcomes comment on all aspects of
this proposed rule. In providing
comments on an identified condition of
use or a use that EPA proposes to
determine is a significant new use for
the chemical substances subject to this
rule, please provide sufficient
information for EPA to substantiate any
assertions of an ongoing use for the
specific chemical substance(s). EPA has
identified in this notice the conditions
of use that it plans to consider in the
TSCA section 6 risk evaluation. It also
has sought to identify uses that the
information available to EPA
demonstrates have been discontinued in
the United States in Unit III. These lists
are intended to provide examples and
may not be exhaustive. Please note
requests for comment related to specific
aspects of this proposed rule in sections
that follow (see Units III.B. (impurities
and byproducts) and IV. (regulatory
alternatives considered)).
ddrumheller on DSK120RN23PROD with PROPOSALS1
II. Background
A. Significant New Use Determination
1. Determination factors.
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 addition to the factors enumerated
in TSCA section 5(a)(2), the statute
authorizes EPA to consider any other
relevant factors.
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
2. Scientific standards, evidence, and
available information.
EPA has used reasonably available
information, as well as technical
procedures, measures, methods,
protocols, methodologies, and models
consistent with the best available
science, as applicable. These
information sources supply information
relevant to whether a particular use
would be a significant new use, based
on relevant factors including those
listed under TSCA section 5(a)(2).
The clarity and completeness of the
data, assumptions, methods, quality
assurance, and analyses employed in
EPA’s decision are documented, as
applicable and to the extent necessary
for purposes of this proposed significant
new use rule, in Units III.D. and V. and
in the references cited throughout the
preamble of this proposed rule. The
extent to which the various information,
procedures, measures, methods,
protocols, methodologies or models
used in EPA’s decision have been
subject to independent verification or
peer review is adequate to justify their
use, collectively, in the record for a
significant new use rule.
3. Determination for these chemical
substances.
To determine what would constitute a
significant new use of TCEP, TBBPA
and TPP, EPA considered relevant
information about the toxicity or
expected toxicity of these substances,
likely human exposures and
environmental releases associated with
possible uses, and the four factors listed
in TSCA section 5(a)(2). If any entity
were to commence a new use, including
to resume a use of TCEP, TBBPA, and
TPP that had been phased out, that use
could both change the type and form
and increase the magnitude and
duration of human and environmental
exposure to the substances, and thus
EPA believes such uses should be
identified as significant new uses. Based
on consideration of the statutory factors
discussed herein, EPA is proposing to
determine that the following uses
constitute significant new uses:
manufacturing (including importing) or
processing of TCEP, TBBPA, and TPP
for any use, with the exception that the
conditions of use the Agency expects to
consider within the scope of the TSCA
section 6 risk evaluations are not
proposed as significant new uses, as
discussed in Unit III.D.
B. Rationale and Objectives of This
Proposed Rule
1. Rationale.
Under TSCA, no person may
manufacture a new chemical substance
or manufacture or process a chemical
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
40731
substance for a significant new use until
EPA makes a determination as described
in TSCA section 5(a) and takes any
required action. The issuance of a SNUR
is not a risk determination itself, only a
notification requirement for ‘‘significant
new uses,’’ so that the Agency has the
opportunity to review the SNUN for the
significant new use and make a TSCA
section 5(a)(3) risk determination.
Consistent with EPA’s past practice
for issuing SNURs under TSCA section
5(a)(2), EPA’s decision to propose a
SNUR for a particular chemical use
need not be based on an extensive
evaluation of the hazard, exposure, or
potential risk associated with that use.
If a person decides to begin
manufacturing (including importing) or
processing any of these chemicals for
the use, the submission of the SNUN to
EPA allows the Agency to evaluate the
conditions of use.
EPA has identified the potential for
adverse environmental and health
effects from the conditions of use of
TCEP, TBBPA, and TPP based on data
and information sources already
described in the proposed designation
of TCEP, TBBPA, and TPP as high
priority substances for TSCA section 6
risk evaluation and the final scopes of
the risk evaluations for TCEP, TBBPA,
and TPP (Refs. 1, 2, and 3). EPA will
evaluate risk under TSCA section 6 from
the conditions of use of TCEP, TBBPA,
and TPP.
As discussed in this unit and Unit
III.D., based on an extensive review of
reasonably available information, EPA is
proposing to determine that significant
new uses of TCEP, TBBPA, and TPP are
manufacture (including import) or
processing for any use, with the
exception that the conditions of use the
Agency expects to consider within the
scope of the TSCA section 6 risk
evaluations are not proposed as
significant new uses. The conditions of
use that EPA identified for the TSCA
section 6 risk evaluations include all
manufacture, processing, and use that
the information available to the Agency
demonstrates to be ongoing in the
United States. The proposed significant
new uses include manufacture and
processing for uses that have ceased;
manufacture and processing for uses
that have not yet ceased but for which
all manufacture and processing has
ceased; and manufacture and processing
for uses for which EPA has no
information demonstrating that the use
has previously commenced in the
United States. Among other things, EPA
has identified certain uses of TCEP,
TBBPA, and TPP that have ceased as
well as industrial, commercial, or
consumer conditions of use that are
E:\FR\FM\22JNP1.SGM
22JNP1
ddrumheller on DSK120RN23PROD with PROPOSALS1
40732
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
ongoing but for which manufacturing
(including import) or processing have
ceased. In the absence of a SNUR, the
manufacturing (including importing) or
processing of TCEP, TBBPA, and TPP
for the significant new uses proposed in
this rule could begin at any time,
without prior notice to EPA under
section 5 and without providing EPA an
opportunity to review and address
potential risks associated with the new
use. EPA is concerned that
commencement of manufacturing
(including importing) or processing
TCEP, TBBPA, and TPP for the
proposed significant new uses, could
significantly increase the volume of
manufacturing (including importing)
and processing of these chemicals, as
well as the magnitude and duration of
exposure to humans and the
environment over that which would
otherwise exist currently, particularly to
the potentially exposed or susceptible
subpopulations identified by EPA in the
final scopes for risk evaluation or during
risk evaluation. Given the concerns
associated with the conditions of use as
described in Unit III.D., EPA believes
that notification and EPA’s required
review are warranted for these
chemicals prior to the commencement
of a significant new use.
2. Objectives.
Based on the considerations discussed
in Unit III.D., EPA wants to achieve the
following objectives with regard to the
significant new use(s) designated in this
proposed rule:
• EPA would receive notice of any
person’s intent to manufacture
(including import) or process the
chemical substances for the described
significant new use before that activity
begins.
• EPA would have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing (including
importing) or processing the chemical
substances for the described significant
new use.
• EPA would be able to either
determine that the significant new use
is not likely to present an unreasonable
risk of injury, or to take such regulatory
action as is associated with any other
determination under TSCA section 5,
before the manufacture or processing for
the significant new use could
commence.
C. Applicability of General Provisions to
These Proposed SNURs
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
SNURs, recordkeeping requirements,
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
and exemptions to reporting
requirements, among other things.
Provisions relating to user fees appear
at 40 CFR part 700. Pursuant to 40 CFR
721.1(c), persons subject to SNURs must
comply with the same requirements and
EPA regulatory procedures as submitters
of Premanufacture Notices (PMNs)
under TSCA section 5(a)(1)(A). In
particular, these requirements include
the information submission
requirements of TSCA sections 5(b) and
5(d)(1), the exemptions authorized by
TSCA sections 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR
part 720.
Once EPA receives a SNUN, EPA
must either determine that the
significant new use is not likely to
present an unreasonable risk of injury or
take such regulatory action as is
associated with an alternative
determination under TSCA section 5
before the manufacture (including
import) or processing for the significant
new use can commence. If EPA
determines that the significant new use
of the chemical substance 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 finding.
D. Applicability of General Exemptions
to These Proposed SNURs
The general exemptions from SNUR
notice requirements that are described
in 40 CFR 721.45 apply to these
proposed SNURs.
EPA is requesting public comment on
the alternative of making inapplicable
the article exemption at 40 CFR
721.45(f). Under this alternative, the
import and processing of articles
containing TCEP, TBBPA, and TPP
would not be exempt from significant
new use notification requirements. As
EPA collects and reviews information
about the importing or processing of
TCEP, TBBPA, and TPP as part of
articles and the potential exposure to
these chemical substances through
articles, EPA may consider whether to
make inapplicable the articles
exemption at 40 CFR 721.45(f).
EPA also seeks comment on the
potential impact of making inapplicable
the articles exemption on firms that
plan to import or process articles
containing TCEP, TBBPA, and TPP,
because, while not required by the
proposed SNUR, these parties may take
additional steps to determine whether
TCEP, TBBPA, and TPP are part of the
articles that they are considering for
importing or processing.
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
E. Applicability of the Proposed SNURs
to Uses Occurring Before the Effective
Date of the Final Rule
Any use that EPA determines, in the
final rule, was ongoing as of the date of
publication of this proposal and did not
cease prior to issuance of the final rule,
will not be designated as a significant
new use in the final rule.
As discussed in the Federal Register
of April 24, 1990 (55 FR 17376 (FRL–
3658–5)), EPA has decided that the
intent of the TSCA section 5(a)(1)(B) is
best served by designating a use as a
significant new use as of the date of
publication of the proposed rule rather
than as of the effective date of the final
rule. The objective of EPA’s approach is
to ensure that a person cannot defeat a
SNUR by initiating a significant new use
after publication of the proposed rule
but before the effective date of the final
rule. Uses arising after the publication
of the proposed rule are distinguished
from uses that are identified in the final
rule as having been ongoing on the date
of publication of the proposed rule. The
former would be new uses, the latter
ongoing uses, except that uses that are
identified as ongoing as of the
publication of the proposed rule would
not be considered ongoing uses if they
have ceased by the date of issuance of
a final rule.
Any person who begins commercial
manufacturing (including importing) or
processing of the chemical substances
for a use that is designated as a
significant new use in the final rule
would have to cease any such activity
upon the effective date of the final rule.
To resume their activities, these persons
would have to first comply with all
applicable SNUR notification
requirements and wait until all TSCA
prerequisites for the commencement of
manufacture or processing have been
satisfied.
F. Important Information About SNUN
Submissions
1. SNUN submissions.
According to 40 CFR 721.1(c), persons
submitting a SNUN must comply with
the same notice 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 721.25
and 40 CFR 720.40. E–PMN software is
available electronically at https://
www.epa.gov/chemicals-under-tsca.
EPA recommends that SNUN
submitters consult with the Agency if,
E:\FR\FM\22JNP1.SGM
22JNP1
ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
for instance, the chemical substance is
also subject to a rule, order, or consent
agreement under TSCA section 4. Prior
to submitting a SNUN, submitters
should consider what information may
be useful in evaluating a SNUN.
Discussions with the Agency prior to
submission can afford ample time to
conduct any tests that might be helpful
in evaluating risks posed by the
substance.
2. Development and submission of
information with the SNUN.
EPA recognizes that TSCA section 5
does not usually require developing
new information (e.g., generating test
data) before submission of a SNUN.
There is an exception: If a person is
otherwise required to submit
information for a chemical substance
subject to the SNUR pursuant to a rule,
TSCA Order or consent agreement
under TSCA section 4, then TSCA
section 5(b)(1)(A) requires such
information to be submitted to EPA at
the time of submission of the SNUN.
In the absence of a TSCA section 4
test rule, order, or consent agreement
covering the chemical substance,
persons are required to submit only
information in their possession or
control and to describe any other
information known to or reasonably
ascertainable by them (15 U.S.C.
2604(d); 40 CFR 721.25, and 40 CFR
720.50). However, as a general matter,
EPA recommends that SNUN submitters
include information that would permit
a reasoned evaluation of risks posed by
the chemical substance during its
manufacture (including import),
processing, distribution in commerce,
use, or disposal. EPA encourages
persons to consult with the Agency
before submitting a SNUN. As part of
this optional pre-notice consultation,
EPA would discuss specific information
it believes may be useful in evaluating
a significant new use.
Submitting a SNUN that does not
include information sufficient to permit
a reasoned evaluation may increase the
likelihood that EPA will either respond
with a determination that the
information available to the Agency is
insufficient to permit a reasoned
evaluation of the health and
environmental effects of the significant
new use or, alternatively, that in the
absence of sufficient information, the
manufacture, processing, distribution in
commerce, use, or disposal of the
chemical substance may present an
unreasonable risk of injury.
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
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
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). For more information on
alternative test methods and strategies
to reduce vertebrate animal testing, visit
https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/
alternative-test-methods-and-strategiesreduce.
The potentially useful information
listed in Unit III. may not be the only
means of addressing the potential risks
of the chemical substance. However,
submitting a SNUN without any test
data or other information 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 substance.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
III. Chemical Substances Subject to
This Proposed Rule
The proposed SNURs would apply to
manufacturing (including import) or
processing for certain uses of TCEP,
TBBPA, and TPP as described in this
unit.
A. What is the designated cutoff date for
determining whether the use is new or
ongoing for these chemical substances?
As explained in Unit II.D. EPA
proposes to base its determination on
whether a use is an ongoing use, as
opposed to a new use, on information
available to the agency (including
information received during the public
comment period) on whether the use
was ongoing as of June 22, 2023. This
is referred to as the cutoff date for
determining whether a use is ongoing.
B. Do the proposed SNURs apply to
impurities or byproducts?
In accordance with the impurity
exemption at 40 CFR 721.45(d), the
proposed SNURs would not apply to
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
40733
persons who manufacture (including
import) or process TCEP, TBBPA, or
TPP only as an impurity. EPA is not
proposing to lift the impurities
exemption for these SNURs. EPA is
requesting public comment on any
ongoing manufacturing (including
import) or processing of TCEP, TBBPA,
or TPP as an impurity.
There is no broad exemption for
byproducts in EPA’s general SNUR
regulations at 40 CFR 721.45. Rather,
EPA has only exempted byproducts
from SNUR notification requirements in
the limited circumstances where the
person manufactures (including
imports) or processes the substance only
as a byproduct which is used only by
public or private organizations that (1)
burn it as a fuel; (2) dispose of it as a
waste, including in a landfill or for
enriching soil; or (3) extract component
chemical substances from it for
commercial purposes. See 40 CFR
721.45(e). Therefore, without a broader
exemption in the proposed regulatory
text of the SNURs, any other
manufacturing (including importing) or
processing of TCEP, TBBPA, or TPP as
a byproduct that does not fall within a
proposed exemption from the
significant new use designations would
be a significant new use subject to
reporting requirements.
EPA is aware of ongoing activities that
produce TBBPA and TPP as byproducts
and continues to research such
occurrences. EPA is requesting public
comment on any ongoing manufacturing
(including import) or processing of
TCEP, TBBPA, or TPP as a byproduct
that may not fall within the scope of the
byproduct exemption at 40 CFR
721.45(e) and whether to include a
broader exemption for manufacturing
(including import) or processing as a
byproduct in the final SNUR for these
chemicals.
C. What information is provided for
each chemical substance?
1. Chemical specific information.
For each chemical substance, EPA
provides the following information in
Unit III.D.:
• Chemical name and Chemical
Abstracts Service Registry Number
(CASRN);
• Uses EPA proposes to determine are
significant new uses;
• Conditions of use and production
volumes;
• Potential environmental and health
effects; and
• Potential routes and sources of
exposure.
2. Background.
a. Conditions of use and production
volumes.
E:\FR\FM\22JNP1.SGM
22JNP1
ddrumheller on DSK120RN23PROD with PROPOSALS1
40734
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
In the draft scopes of the risk
evaluations under TSCA section 6 for
these chemicals, EPA identified and
described the categories and
subcategories of conditions of use that
EPA expects to consider in the TSCA
risk evaluations based on information
reported to EPA through the Chemical
Data Reporting (CDR) and Toxics
Release Inventory (TRI) reporting,
published literature, public comments
and consultation with stakeholders for
both uses currently in production and
uses for which production may have
ceased. EPA revised the conditions of
use in the final scope of each risk
evaluation based on additional
information and public comments (Refs.
1, 2, and 3). TCEP, TBBPA, and TPP
have conditions of use based on
research conducted by the Agency that
identified circumstances under which
these chemical substances are intended,
known or reasonably foreseen to be
manufactured, processed, distributed in
commerce, used, or disposed of.
In conducting additional research on
the conditions of use described in this
proposed rule, EPA assembled
information from the CDR and TRI
programs, including production
volumes and uses of TCEP, TBBPA, and
TPP. Using this information EPA
identified and described the categories
and subcategories of conditions of use
for the following lifecycle stages:
manufacturing (including import);
processing; distribution in commerce;
industrial, commercial and consumer
use; and disposal. EPA also consulted a
variety of other sources to identify uses
of TCEP, TBBPA, and TPP, including
published literature, company websites,
government and commercial trade
databases and publications. To identify
formulated products, including articles,
EPA searched for safety data sheets
(SDS) using internet searches, EPA
Chemical and Product Categories
(CPCat) data, and other resources in
which SDSs could be found. SDSs were
cross-checked with company websites
to ensure that each product’s SDS was
current. In addition, EPA considered
communications with companies,
industry groups and public comments to
supplement EPA’s understanding of the
conditions of use information.
Production volume is based on data
reported to EPA during the 2020 CDR
submission period for calendar years
2016–2019 and described here as a
range to protect production volumes
that were claimed as CBI.
Finally, the Agency provides lists of
identified conditions of use and uses
proposed to be determined are
significant new uses. In these lists, EPA
specifies where such uses are among
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
industrial, commercial, or consumer
categories based on information in the
final scopes for each chemical (Refs. 1,
2, and 3). In instances where such uses
would include all three categories, EPA
only lists the identified conditions of
use and uses proposed to be determined
as significant new uses.
b. Potential effects and routes of
exposure.
As previously mentioned, certain
phrasings of text and headings used in
the proposed SNURs is identical to that
used in the scope documents for each
chemical. For example, comparable
headings in the scope documents
identify ‘‘Hazards (Effects),’’
‘‘Environmental Hazards,’’ and ‘‘Human
Health Hazards.’’ In this unit, the
Agency is retaining traditional headings
used in SNURs and will discuss such
‘‘effects’’ and ‘‘hazards’’ using text
transferred from the scope documents.
D. Which chemical substances are
subject to this proposed rule?
1. Tris(2-chloroethyl) phosphate
(TCEP), CASRN 115–96–8.
a. Uses EPA proposes to determine
are significant new uses.
EPA is proposing to designate as a
significant new use manufacture
(including import) or processing TCEP
for any use, with the exception that the
conditions of use the Agency expects to
consider within the scope of the TSCA
section 6 risk evaluation are not
proposed as significant new uses. The
conditions of use that EPA identified for
the TSCA section 6 risk evaluation
include all manufacture, processing,
and use that the information available to
the Agency demonstrates to be ongoing,
as well as legacy uses and associated
disposal, in the United States. At this
time, EPA is aware that manufacture
and processing for the following uses of
TCEP have been discontinued and thus
they are among the uses EPA proposes
to determine are significant new uses:
• Domestic manufacturing for any
use;
• Manufacturing (including import)
for use in building and construction
materials (insulation);
• Processing for use in building and
construction materials (insulation);
• Manufacturing (including import)
for use in wood and engineered wood
products (wood resin composites);
• Processing for use in wood and
engineered wood products (wood resin
composites);
• Manufacturing (including import)
for use in fabric and textile products;
• Processing for use in fabric and
textile products;
• Manufacturing (including import)
for use in foam seating and bedding
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
products, except for foam used in
aerospace equipment and products;
• Processing for use in foam seating
and bedding products, except for foam
used in aerospace equipment and
products;
• Processing for incorporation into
formulation, mixture, or reaction
products, except for industrial and
commercial use in polymers used in
aerospace equipment and products; and
• Processing for incorporation into
article, except for industrial or
commercial use in articles used in
aerospace equipment and products.
b. Conditions of use and production
volumes.
EPA is proposing to determine that
the conditions of use of TCEP that EPA
expects to consider in the TSCA section
6 risk evaluation include (but are not
limited to) all ongoing manufacture,
processing, and use of TCEP. EPA is
proposing that the conditions of use that
EPA expects to consider in the risk
evaluation would not be significant new
uses, even if they are not necessarily
‘‘ongoing’’ but are intended, known, or
reasonably foreseen.
According to information reasonably
available to the Agency, TCEP is
imported into the United States and
processed for commercial use in paints
and coatings, which may be present in
unoccupied spaces of consumer homes,
and for industrial or commercial use in
polymers for use in aerospace
equipment and products (Ref. 1). In
addition, TCEP is imported for
commercial use as a laboratory chemical
(Ref. 1). Historically, TCEP was
incorporated into building and
construction materials, such as roofing
insulation and wood resin composites
(Ref. 1). Some of these products may
still be present in consumers’ homes
and in commercial infrastructure and,
therefore, are still listed among the
commercial and consumer conditions of
use EPA has identified for risk
evaluation (Ref. 1). Data reported to EPA
during the 2020 CDR submission period
indicate there is no reported production
volume of 25,000 lbs. or more of TCEP
domestically manufactured or imported
into the United States. Because data
reported to EPA during the 2016 CDR
submission period indicated that TCEP
was being imported, EPA concluded it
is reasonably foreseen that TCEP
continues to be imported below CDR
production volume thresholds.
EPA has identified conditions of use
of TCEP that are undergoing TSCA
section 6 risk evaluation and are
described in this unit in the same format
that appears in the final scope
document (Ref. 1), with minor edits for
readability, supported by Agency
E:\FR\FM\22JNP1.SGM
22JNP1
ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
research being conducted during TSCA
risk evaluation of TCEP and for this
SNUR. Please note that the following
list contains conditions of use for all
lifecycle stages of the chemical
substance considered by TSCA section 6
risk evaluations. The proposed SNUR is
directed at manufacture (including
import) and processing for particular
uses, but not other lifecycle stages such
as distribution in commerce or disposal.
The full list of conditions of use are
included here to provide a
comprehensive scope of conditions of
use identified by the Agency. The
conditions of use of TCEP that EPA has
identified are:
• Import for commercial use as a
laboratory chemical;
• Import for commercial use in paints
and coatings;
• Import for industrial or commercial
use in polymers used in aerospace
equipment and products;
• Import for industrial or commercial
use in articles used in aerospace
equipment and products;
• Processing for commercial use in
paints and coatings;
• Processing for industrial or
commercial use in polymers used in
aerospace equipment and products;
• Processing for industrial or
commercial use in articles used in
aerospace equipment and products;
• Recycling of articles;
• Distribution in commerce;
• Commercial use as a laboratory
chemical;
• Industrial or commercial use in
aerospace equipment and products;
• Commercial use in fabric and textile
products;
• Consumer use in fabric and textile
products;
• Commercial use in building and
construction materials (insulation);
• Consumer use in building and
construction materials (insulation);
• Commercial use in foam seating and
bedding products;
• Consumer use in foam seating and
bedding products;
• Commercial use in wood and
engineered wood products (wood resin
composites);
• Consumer use in wood and
engineered wood products (wood resin
composites);
• Commercial use in paints and
coatings;
• Consumer use in paints and
coatings; and
• Disposal.
c. Potential environmental and health
effects.
During prioritization for TSCA section
6(b) risk evaluation, EPA identified
environmental hazard effects for aquatic
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
and terrestrial organisms, and also
identified the following potential
human health effects associated with
TCEP: acute, repeated dose, genetic,
reproductive, developmental,
toxicokinetic, cancer, and neurological
effects (Ref. 1). Since prioritization and
as captured in the final scope, EPA
applied automated techniques during
the data screening phase of systematic
review to identify the following
additional potential human health
hazards and related information that
may be considered for the risk
evaluation: cardiovascular, endocrine,
gastrointestinal, hematological and
immune, hepatic, mortality,
musculoskeletal, nutritional and
metabolic, ocular and sensory, renal,
respiratory, skin and connective tissue,
absorption, distribution, metabolism
and excretion (ADME), and
physiological based pharmacokinetic
modeling and simulation (Ref. 1).
Additional human health and
environmental hazards may be
considered during TSCA section 6(b)
risk evaluation based on results from
systematic review, as explained in
Appendix A of the TCEP Final Scope
(Ref. 1).
d. Potential routes and sources of
exposure.
As previously mentioned, certain
phrasings of text and headings in this
unit are identical to that used in the
scope documents for each chemical. In
this unit, the Agency notes that certain
discussions of environmental and
general population exposures may list
similar routes and sources of exposure;
however, instead of modifying or
synthesizing such discussions, the
Agency is using text transferred from
the scope documents. In addition, new
or resumed uses would present
potential routes and sources of exposure
that could create concerns and,
therefore, necessitate EPA review.
i. Environmental exposures.
The manufacturing (including
import), processing, distribution, use
and disposal of TCEP can result in
releases to the environment and
exposure to aquatic and terrestrial
receptors (biota) via surface water,
sediment, soil and ambient air.
Environmental exposures to biota are
informed by releases into the
environment, overall persistence,
degradation, bioaccumulation and
partitioning across different media (Ref.
1). Concentrations of chemical
substances in biota provide evidence of
exposure (Ref. 1). TCEP has been
identified in surface water, ground
water and sediment, fish samples,
seabird samples, and herring gull eggs
(Ref. 1).
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
40735
ii. Occupational exposures.
There is a potential for occupational
exposure under various conditions of
use of TCEP (Ref. 1). There is potential
exposure from the processing of the
chemical as it is incorporated into
formulations and products and release
from article components during their
manufacture and industrial/commercial
use, including handling and disposal of
waste during manufacturing, processing
(including recycling), and use (Ref. 1).
iii. Consumer exposures.
TCEP was previously incorporated
into consumer products that may still be
used, specifically fabric, textile, and
leather products, and foam seating and
bedding products, as well as building/
construction materials including roofing
insulation and wood and engineered
wood products (Ref. 1). The main
exposure routes for these uses where
consumers interact with products and
articles containing TCEP are dermal,
inhalation, and dust ingestion,
including children’s mouthing of
articles (e.g., plastics, textiles, wood
products) containing TCEP (Ref. 1).
iv. General population exposures.
Releases of TCEP from certain
conditions of use, such as import,
processing or disposal activities, may
result in general population exposures
(Ref. 1).
2. 4,4′-(1-methylethylidene)bis[2, 6dibromophenol] (TBBPA), CASRN 79–
94–7.
a. Uses EPA proposes to determine
are significant new uses.
EPA is proposing to designate as a
significant new use manufacture
(including import) or processing TBBPA
for any use, with the exception that the
conditions of use the Agency expects to
consider within the scope of the TSCA
section 6 risk evaluation are not
proposed as significant new uses. The
conditions of use that EPA identified for
the TSCA section 6 risk evaluation
include all manufacture, processing,
and use that the information available to
the Agency demonstrates to be ongoing
in the United States. At this time, EPA
is aware that manufacture and
processing for the following uses of
TBBPA have been discontinued and
thus they are among the uses EPA
proposes to determine are significant
new uses:
• Manufacturing (including import)
for use in batteries (e.g., adhesive in
lead-acid battery casing and in lithiumion batteries);
• Processing for use in batteries (e.g.,
adhesive in lead-acid battery casing and
in lithium-ion batteries);
• Manufacturing (including import)
for use in fabric, leather, and textile
E:\FR\FM\22JNP1.SGM
22JNP1
ddrumheller on DSK120RN23PROD with PROPOSALS1
40736
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
products (e.g., carpets, office furniture);
and
• Processing for use in fabric, leather,
and textile products (e.g., carpets, office
furniture).
b. Conditions of use and production
volumes.
EPA is proposing to determine that
the conditions of use of TBBPA that
EPA expects to consider in the TSCA
section 6 risk evaluation include (but
are not limited to) all ongoing
manufacture, processing, and use of
TBBPA. EPA is proposing that the
conditions of use that EPA expects to
consider in the risk evaluation would
not be significant new uses, even if they
are not necessarily ‘‘ongoing’’ but are
intended, known, or reasonably
foreseen.
According to information reasonably
available to the Agency, TBBPA is
manufactured (including imported) in
the United States (Ref. 2). The chemical
is processed as a reactant or
intermediate to create other flame
retardants; incorporated into
formulation, mixture or reaction
products; and incorporated into articles
(Ref. 2). Processing also includes the
recycling of TBBPA and TBBPAcontaining products (Ref. 2). The
predominant uses for TBBPA are as a
reactive flame retardant in electrical and
electronic products (e.g., printed circuit
boards and semiconductor packages)
and as an additive flame retardant in
electrical and electronic products (e.g.,
plastic enclosures) (Ref. 2). The epoxy
resin containing TBBPA can also be
used in adhesives, laminate for aviation
and automobile interiors and building/
construction materials (Ref. 2). Data
reported to EPA during the 2020 CDR
submission period indicate the reported
production volume is between 20
million and 100 million pounds per
year (Ref. 2).
EPA has identified conditions of use
of TBBPA (Ref. 2), which are
undergoing TSCA section 6 risk
evaluation and are described in this unit
in the same format that appears in the
final scope document, with minor edits
for readability, supported by Agency
research being conducted during TSCA
risk evaluation of TBBPA and for this
SNUR. Please note that the following
list contains conditions of use for all
lifecycle stages of the chemical
substance considered by TSCA section 6
risk evaluations. The proposed SNUR is
directed at manufacture (including
import) and processing for particular
uses, but not other lifecycle stages such
as distribution in commerce or disposal.
The full list of conditions of use are
included here to provide a
comprehensive scope of conditions of
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
use identified by the Agency. The
conditions of use of TBBPA that EPA
has identified are:
• Domestic manufacturing;
• Import;
• Processing for use in adhesive
manufacturing;
• Processing for use in plastic
material and resin manufacturing;
• Processing for use in chemical
product and preparation manufacturing;
• Processing for use in electrical
equipment, appliance and component
manufacturing;
• Processing for use in plastics
product manufacturing;
• Processing for use in computer and
electronic product manufacturing;
• Processing for use in electrical and
electronic products;
• Processing for use in printed circuit
boards and semiconductor packages;
• Processing for use in interior
material for transportation equipment;
• Processing for use in plastic
electronic enclosures;
• Recycling of electronic products;
• Distribution in commerce;
• Industrial or commercial use in
electrical and electronic products;
• Consumer use in electrical and
electronic products;
• Industrial or commercial use in
prepreg material for automotive and
aviation interiors;
• Industrial or commercial use in
building and construction materials;
• Industrial or commercial use in
fabric, textile and leather products (e.g.,
carpets, office furniture);
• Consumer use in fabric, textile and
leather products (e.g., carpets, office
furniture);
• Industrial or commercial use as a
laboratory chemical;
• Disposal.
c. Potential environmental and health
effects.
During prioritization for TSCA section
6(b) risk evaluation, EPA identified
environmental hazard effects from
TBBPA for aquatic and terrestrial
organisms, and also identified the
following potential human health
effects: immunological, neurological,
carcinogenic, and developmental (Ref.
2). Since prioritization and as captured
in the final scope, EPA applied
automated techniques during the data
screening phase of systematic review to
identify the following additional
potential human health hazards and
related information that may be
considered for the risk evaluation:
cardiovascular, endocrine,
gastrointestinal, hematological, hepatic,
mortality, nutritional and metabolic
ocular and sensory, renal, reproductive,
respiratory, skin and connective tissue,
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
and ADME (Ref. 2). Additional human
health and environmental hazards may
be considered during TSCA section 6(b)
risk evaluation based on results from
systematic review, as explained in
Appendix A of the TBBPA Final Scope
(Ref. 2).
d. Potential routes and sources of
exposure.
As previously mentioned, certain
phrasings of text and headings in this
unit are identical to that used in the
scope documents for each chemical. In
this unit, the Agency notes that certain
discussions of environmental and
general population exposures may list
similar routes and sources of exposure;
however, instead of modifying or
synthesizing such discussions, the
Agency is using text transferred from
the scope documents. In addition, new
or resumed uses would present
potential routes and sources of exposure
that could create concerns and,
therefore, necessitate EPA review.
i. Environmental exposures.
The manufacturing, processing,
distribution, use and disposal of TBBPA
can result in releases to the environment
and exposure to aquatic and terrestrial
receptors (biota) (Ref. 2). Environmental
exposures to biota are informed by
releases into the environment, overall
persistence, degradation and
bioaccumulation within the
environment and partitioning across
different media (Ref. 2). Concentrations
of chemical substances in biota provide
evidence of exposure (Ref. 2).
ii. Occupational exposures.
Releases of TBBPA from certain
conditions of use, such as
manufacturing, processing, industrial/
commercial uses, and disposal may
result in occupational exposures (Ref.
2). Examples of occupational activities
associated with the conditions of use
identified for TBBPA include, but are
not limited to: unloading and
transferring TBBPA to and from storage
containers to process vessels during
manufacturing; processing and use;
handling and disposing of waste
containing TBBPA during
manufacturing, processing (including
recycling), and use; cleaning and
maintaining equipment during
manufacturing, processing (including
recycling), and use; sampling chemicals,
formulations or products containing
TBBPA for quality control during
manufacturing, processing (including
recycling), and use; and performing
other work activities in or near areas
where TBBPA is used (Ref. 2).
EPA anticipates inhalation of dust
and other respirable particles as an
exposure pathway during the
manufacture and processing of various
E:\FR\FM\22JNP1.SGM
22JNP1
ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
articles containing TBBPA (e.g.,
particulate generated during handling of
plastic resins, finishing operations
associated with the manufacture and
finishing of plastics and plastic articles
and incorporation of plastics and other
article components into finished
products) (Ref. 2). Dermal exposures for
workers are possible during conditions
of use (Ref. 2).
iii. Consumer exposures.
According to CDR reports, TBBPA
appears to be used in consumer
products used in indoor environments,
specifically fabric, textile, and leather
products, electrical and electronic
products (including in the plastic
enclosures), children’s products, and
building/construction materials (Ref. 2).
Several of these products have the
potential to be mouthed by children
(Ref. 2). In addition, handling TBBPAcontaining materials during disposal
can lead to consumer and bystander
exposures (Ref. 2). The main exposure
routes where consumers interact with
products and articles containing TBBPA
are dermal, inhalation and dust
ingestion, including children’s
mouthing of articles (e.g., electronics,
plastics, textiles) containing TBBPA
(Ref. 2).
iv. General population exposures.
Releases of TBBPA from certain
conditions of use, such as
manufacturing, processing or disposal,
may result in general population
exposures (Ref. 2). TBBPA has been
found in drinking water, ground water,
ambient air, indoor air, fish, human
breast milk and dust and soil (Ref. 2).
3. Triphenyl phosphate (TPP), CASRN
115–86–6.
a. Uses EPA proposes to determine
are significant new uses.
EPA is proposing to designate as a
significant new use manufacture
(including import) or processing TPP for
any use, with the exception that the
conditions of use the Agency expects to
consider within the scope of the TSCA
section 6 risk evaluation are not
proposed as significant new uses. The
conditions of use that EPA identified for
the TSCA section 6 risk evaluation
include all manufacture, processing,
and uses that the information available
to the Agency demonstrates to be
ongoing in the United States. At this
time, EPA is aware that manufacture
and processing for the following uses of
TPP have been discontinued and thus
they are among the uses EPA proposes
to determine are significant new uses:
• Manufacturing (including import)
for use in photographic applications;
and
• Processing for use in photographic
applications.
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
b. Conditions of use and production
volumes.
EPA is proposing to determine that
the conditions of use of TPP that EPA
expects to consider in the TSCA section
6 risk evaluation include (but are not
limited to) all ongoing manufacture,
processing, and use of TPP. EPA is
proposing that the conditions of use that
EPA expects to consider in the risk
evaluation would not be significant new
uses, even if they are not necessarily
‘‘ongoing’’ but are intended, known, or
reasonably foreseen.
According to information reasonably
available to the Agency, TPP is
manufactured (including imported) in
the United States (Ref. 3). The chemical
is processed as a reactant; incorporated
into formulation, mixture, or reaction
products; and incorporated into articles
(Ref. 3). Several commercial uses were
identified, mainly in plastic and rubber
products, and in paints and coatings
(Ref. 3). Other uses reported include use
in lubricants and greases. Consumer
uses were reported in foam seating and
bedding products (Ref. 3). Data reported
to EPA during the 2020 CDR submission
period indicate the reported production
volume is between 1 million and 10
million pounds per year (Ref. 3).
EPA has identified conditions of use
of TPP (Ref. 3), which are undergoing
TSCA section 6 risk evaluation and are
described in this unit in the same format
that appears in the final scope
document, with minor edits for
readability, supported by Agency
research being conducted during TSCA
risk evaluation of TPP and for this
SNUR. Please note that the following
list contains conditions of use for all
lifecycle stages of the chemical
substance considered by TSCA section 6
risk evaluations. The proposed SNUR is
directed at manufacture (including
import) and processing for particular
uses, but not other lifecycle stages such
as distribution in commerce or disposal.
The full list of conditions of use are
included here to provide a
comprehensive scope of conditions of
use identified by the Agency. The
conditions of use of TPP that EPA has
identified are:
• Domestic manufacturing;
• Import (including repackaging);
• Processing for use in plastics
material and resin manufacturing;
• Processing for use in plastic
product manufacturing;
• Processing for use in computer and
electronic product manufacturing;
• Processing for use in rubber product
manufacturing;
• Processing for use in textiles,
apparel, and leather manufacturing;
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
40737
• Processing for use in furniture and
related product manufacturing;
• Processing for use in paint and
coating manufacturing;
• Processing for use in all other
chemical product and preparation
manufacturing;
• Processing for use in adhesives,
sealants, lubricants, and greases;
• Processing for use in operational
fluids, maintenance fluids and
semisolids, reactive fluids, and solids
used in aerospace industry;
• Processing for use in turbine engine
oils in aviation;
• Processing for use in turbine engine
oils in non-aviation industries;
• Processing for use in furniture and
related product manufacturing;
• Recycling;
• Distribution in commerce;
• Industrial or commercial use in
paints and coatings;
• Industrial or commercial use in
plastic and rubber products;
• Consumer use in plastic and rubber
products;
• Industrial or commercial use as a
laboratory chemical;
• Industrial or commercial use in
lubricants and greases;
• Consumer use in lubricants and
greases;
• Industrial or commercial use in
operational fluids, maintenance fluids
and semisolids, reactive fluids, and
solids used in aerospace industry;
• Industrial or commercial use in
turbine engine oils used in aviation;
• Industrial or commercial use in
turbine engine oils used in non-aviation
industries;
• Industrial or commercial use in
electrical and electronic products;
• Consumer use in electrical and
electronic products;
• Industrial or commercial use in
foam seating and bedding products;
• Consumer use in foam seating and
bedding products;
• Industrial or commercial use in
furniture and furnishings;
• Industrial or commercial use in
building and construction materials;
and
• Disposal.
c. Potential environmental and health
effects.
During prioritization for TSCA section
6(b) risk evaluation, EPA identified
potential environmental hazard effects
from TPP for aquatic and terrestrial
organisms, and also identified the
following potential human health effects
and related information: developmental,
irritation, corrosion, and repeated dose
(Ref. 3). Since prioritization and as
captured in the final scope, EPA applied
automated techniques during the data
E:\FR\FM\22JNP1.SGM
22JNP1
ddrumheller on DSK120RN23PROD with PROPOSALS1
40738
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
screening phase of systematic review to
identify the following additional
potential human health hazards and
related information that may be
considered for the risk evaluation:
cancer, cardiovascular, endocrine,
gastrointestinal, hematological and
immune, hepatic, mortality,
musculoskeletal, neurological,
nutritional and metabolic, ocular and
sensory, renal, reproductive, skin and
connective tissue, and ADME (Ref. 3).
Additional human health and
environmental hazards may be
considered during TSCA section 6(b)
risk evaluation based on results from
systematic review, as explained in
Appendix A of the TPP Final Scope
(Ref. 3).
d. Potential routes and sources of
exposure.
As previously mentioned, certain
phrasings of text and headings in this
unit are identical to that used in the
scope documents for each chemical. In
this unit, the Agency notes that certain
discussions of environmental and
general population exposures may list
similar routes and sources of exposure;
however, instead of modifying or
synthesizing such discussions, the
Agency is using text transferred from
the scope documents. In addition, new
or resumed uses would present
potential routes and sources of exposure
that could create concerns and,
therefore, necessitate EPA review.
i. Environmental exposures.
The manufacturing, processing,
distribution, use and disposal of TPP
can result in releases to the environment
and exposure to aquatic and terrestrial
receptors (biota) (Ref. 3). TPP was
detected in wastewater effluent, landfill
leachate, sediment, soil, ambient air, as
well as in fish (including shellfish) and
dolphins (Ref. 3).
ii. Occupational exposures.
There is a potential for occupational
exposure under the various conditions
of use (manufacturing (including
import), processing, industrial/
commercial uses, and disposal) (Ref. 3).
Also, there are potential exposures from
the processing of TPP as it is
incorporated into formulations and
products (Ref. 3). There is also potential
for exposure from additive flame
retardants due to release from article
components during their manufacture
and industrial/commercial use (Ref. 3).
EPA anticipates inhalation of mist,
dust, and other respirable particles as an
occupational exposure pathway during
the manufacture, processing, and
commercial/industrial use of various
products containing TPP (e.g.,
particulate generated during
manufacture and handling of foam and
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
plastics and incorporation of foam and
plastics into finished products, and mist
generated during application to textiles
and application of paints and coatings)
(Ref. 3). For the oral route, workers and
occupational non-users may
inadvertently ingest inhaled particles
that deposit in the upper respiratory
tract or may transfer chemicals from
their hands to their mouths (Ref. 3).
Also, there is potential dermal exposure
from contact with solids during
packaging and repackaging operations at
manufacturing and import sites when
TPP is handled as a dry powder (Ref. 3).
EPA also anticipates dermal exposure to
liquid if TPP is formulated with liquid
chemical and handled as a liquid (Ref.
3).
iii. Consumer exposures.
TPP is used in consumer products
used in indoor environments, including
foam seating and bedding products, and
plastic and rubber products (Ref. 3). TPP
use has also been reported in electrical
and electronic products (Ref. 3). Several
of these products have the potential to
be mouthed by children. In addition,
handling during the disposal of TPPcontaining materials can lead to
consumer and bystander exposures (Ref.
3). The main exposure routes for these
uses where consumers interact with
products and articles containing TPP are
dermal, inhalation, and dust ingestion,
including children’s mouthing of
articles (e.g., textiles, wood products
and plastics) containing TPP (Ref. 3).
Therefore, potential sources and
pathways of exposure to consumers
include oral, dermal and inhalation; for
bystanders, only the inhalation route
may result from the conditions of use of
TPP (Ref. 3).
iv. General population exposures.
Releases of TPP from certain
conditions of use, such as
manufacturing, processing, or disposal
activities, may result in general
population exposures (Ref. 3). TPP was
detected in surface water, ground water,
soil, ambient air, indoor air, indoor
dust, as well as in fish (including
shellfish) (Ref. 3).
V. References
The following is a listing of the
documents that are specifically
referenced in this document. The docket
includes these documents and other
information considered by EPA,
including documents that are referenced
within the documents that are included
in the docket, even if the referenced
document is not physically located in
the docket. For assistance in locating
these other documents, please consult
the technical person listed under FOR
FURTHER INFORMATION CONTACT.
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
1. EPA. Final Scope of the Risk Evaluation
for Tris(2-chloroethyl) Phosphate
(TCEP); CASRN 115–96–8. August 2020.
EPA Document # EPA–740–R–20–009.
Available at: https://www.epa.gov/sites/
default/files/2020-09/documents/casrn_
115-96-8_tris2-chloroethyl_phosphate_
tcep_final_scope.pdf.
2. EPA. Final Scope of the Risk Evaluation
for 4,4′-(1-Methylethylidene)bis[2, 6dibromophenol] (TBBPA); CASRN 79–
94–7. August 2020. EPA Document #
EPA–740–R–20–008. Available at:
https://www.epa.gov/sites/default/files/
2020-09/documents/casrn_79-94-7_44-1methylethylidenebis2_6-dibromophenol_
tbbpa_finalscope.pdf.
3. EPA. Final Scope of the Risk Evaluation
for Triphenyl Phosphate (TPP); CASRN
115–86–6. August 2020. EPA Document
# EPA–740–R–20–010. Available at:
https://www.epa.gov/sites/default/files/
2020-09/documents/casrn_115-86-6_
triphenyl_phosphate_tpp_final_
scope.pdf.
4. EPA. Economic Analysis of the Proposed
Significant New Use Rules for Flame
Retardants Undergoing TSCA Section 6
Risk Evaluation. May 9, 2023.
VI. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and 14094:
Modernizing Regulatory Review
This action is not a significant
regulatory action as defined in
Executive Order 12866 (58 FR 51735,
October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879,
April 11, 2023), and was therefore not
subject to a requirement for Executive
Order 12866 review.
B. Paperwork Reduction Act (PRA)
This action does not impose any new
information collection burden under the
PRA, 44 U.S.C. 3501 et seq. OMB has
previously approved the information
collection activities contained in the
existing SNUR regulations under OMB
Control No. 2070–0038 (EPA ICR No.
1188.13). If an entity were to submit a
SNUN to the Agency, the annual burden
is estimated to be less than 100 hours
per response, and the estimated burden
for export notifications is less than 1.5
hours per notification. In both cases, if
the firm submitting either a SNUN or
export notification is already registered
in CDX, the burden would be lower than
the presented estimates.
An agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under the
PRA, unless it has been approved by
E:\FR\FM\22JNP1.SGM
22JNP1
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
ddrumheller on DSK120RN23PROD with PROPOSALS1
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.
Consistent with the PRA, EPA is
interested in comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden or improving the
automated collection techniques.
C. Regulatory Flexibility Act (RFA)
I certify this action will not have a
significant economic impact on a
substantial number of small entities
under the RFA, 5 U.S.C. 601 et seq. The
small entities subject to the
requirements of this action are potential
future manufacturers (defined by statute
to include importers), processors, and
exporters of one or more subject
chemical substances for a significant
new use designated in the proposed
SNURs. 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, the Agency has determined 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.
EPA’s experience to date is that, in
response to the promulgation of SNURs
covering over 1,000 chemicals, the
Agency receives only a small number of
notices per year. For example, the
number of SNUNs received was 10 in
federal fiscal year (FY) FY2016, 14 in
FY2017, 16 in FY2018, five in FY2019,
seven in FY2020, and 13 in FY2021, and
only a fraction of these were from small
businesses. In addition, the Agency
currently offers relief to qualifying small
businesses by reducing the SNUN
submission fee from $19,020 to $3,330.
This lower fee reduces the total
reporting and recordkeeping of cost of
submitting a SNUN to about $11,204 for
qualifying small firms. Therefore, the
potential economic impacts of
complying with this proposed SNUR are
not expected to be significant or
adversely impact a substantial number
of small entities. In a SNUR that
published in the Federal Register of
June 2, 1997 (62 FR 29684) (FRL–5597–
1), the Agency presented its general
determination that final SNURs are not
expected to have a significant economic
impact on a substantial number of small
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
entities, which was provided to the
Chief Counsel for Advocacy of the Small
Business Administration.
D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain any
unfunded mandates as described in
UMRA, 2 U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments. Based on EPA’s
experience with proposing and
finalizing SNURs, state, local, and tribal
governments have not been impacted by
these rulemakings, and EPA does not
have any reasons to believe that any
state, local, or tribal government will be
impacted by this action. As such, EPA
has determined that this proposed rule
would not impose any enforceable duty,
contain any unfunded mandate, or
otherwise have any effect on small
governments subject to the requirements
of UMRA sections 202, 203, 204, or 205
(2 U.S.C. 1501 et seq.).
E. Executive Order 13132: Federalism
This action does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999), because it will not have
substantial direct effect on the 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.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000), because it will not have
substantial direct effects on tribal
governments, on the relationship
between the federal government and the
Indian tribes, or on the distribution of
power and responsibilities between the
federal government and Indian tribes.
This action will not significantly nor
uniquely affect the communities of
tribal governments, nor would it involve
or impose any requirements that affect
Indian tribes.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
EPA interprets Executive Order 13045
(62 FR 19885, April 23, 1997), as
applying only to those regulatory
actions that concern environmental
health or safety risks that EPA has
reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of Executive
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
40739
Order 13045. Since this is not a
‘‘covered regulatory action,’’ Executive
Order 13045 does not apply, and since
this action does not address human
health concerns, EPA’s policy on
Children’s Health also does not apply to
this SNUR. However, the EPA Policy on
Children’s Health will apply to the
consideration of the SNUNs submitted
to EPA in response to a SNUR.
Although this action does not concern
an environmental health or safety risk,
the designation of certain uses of the
subject chemicals as significant new
uses ensures the Agency has an
opportunity to review and address
potential risks associated with such uses
before an entity begins commencing any
manufacture (including import) or
processing of the chemical substance for
that use. Once EPA receives a
notification, EPA must review and make
an affirmative determination on the
notification, and take such action as is
required by any such determination
before the manufacture (including
import) or processing for the significant
new use can commence. Such a review
will assess whether the use identified in
the SNUN may present unreasonable
risk to health or the environment and
ensure that EPA can prevent future
unsafe environmental releases of the
chemical substances subject to the
SNUR. As discussed previously, EPA is
concerned about the potential for
adverse health effects from the
conditions of use of TCEP, TBBPA, and
TPP for children and will evaluate the
risk under TSCA section 6.
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 it is not a ‘‘significant
regulatory action’’ under Executive
Order 12866.
I. National Technology Transfer and
Advancement Act (NTTAA)
This rulemaking does not involve any
technical standards under the NTTAA
section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order 12898 (59 FR 7629,
February 16, 1994) directs federal
agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
E:\FR\FM\22JNP1.SGM
22JNP1
ddrumheller on DSK120RN23PROD with PROPOSALS1
40740
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
environmental effects of their programs,
policies, and activities on minority
populations (people of color and/or
indigenous peoples) and low-income
populations.
EPA believes that it is not practicable
to assess whether the human health or
environmental conditions that exist
prior to this action result in
disproportionate and adverse effects on
people of color, low-income populations
and/or indigenous peoples. The SNURs
do not address any human health or
environmental risks or affect the level of
protection provided to human health or
the environment. Although this action
does not concern human health or
environmental conditions, the
designation of certain uses as significant
new uses subject to this proposed SNUR
ensures the Agency has an opportunity
to review and address potential risks
associated with such uses. As noted
previously, EPA is concerned about the
potential for adverse health effects from
the conditions of use of TCEP, TBBPA,
and TPP and will evaluate those
conditions of use under TSCA section 6,
including health effects associated with
those conditions of use affecting
potentially exposed or susceptible
subpopulations that may be at greater
risk of adverse health effects due to
biological susceptibility based on factors
such as race/ethnicity, life stage,
lifestyle factors, and nutrition status.
The SNUR would require the
submission of a SNUN before the
manufacture (including import) or
processing for the significant new use
can commence. EPA would then review
the SNUN submission to assess whether
the use identified in the SNUN may
present unreasonable risk to health or
the environment and take appropriate
action to prevent unreasonable risk from
the chemical substances subject to the
SNUR. Furthermore, information
submitted under TSCA can also be used
by others to identify potential problems,
set priorities, and take appropriate steps
to reduce any potential risks to human
health and the environment and may
make more information available to the
public and interested communities that
they can use to better assess potential
exposures and risks to minority, lowincome or indigenous populations, or
tribes. For example, EPA provides
public access to the information EPA
receives and develops about chemical
substances regulated under TSCA via
ChemView (https://chemview.epa.gov/
chemview).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
Dated: June 15, 2023.
Denise Keehner,
Director, Office of Pollution Prevention and
Toxics.
Therefore, for the reasons set forth in
the preamble, it is proposed that 40 CFR
chapter I be amended as follows:
PART 721—SIGNIFICANT NEW USES
OF CHEMICAL SUBSTANCES
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add §§ 721.11778 through
721.11780 to subpart E to read as
follows:
■
§ 721.11778
Tris(2-chloroethyl) phosphate.
(a) Chemical substance and
significant new use subject to reporting.
(1) The chemical substance identified
as tris(2-chloroethyl) phosphate (TCEP)
(CASRN 115–96–8) 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 for the
chemical substance identified in
paragraph (a)(1) of this section are:
(i) Any manner or method of
manufacture (excluding import) of the
substance associated with any use; and
(ii) Import or processing of the
substance for any use, except for:
(A) Commercial use as a laboratory
chemical;
(B) Commercial use in paints and
coatings;
(C) Industrial or commercial use in
polymers used in aerospace equipment
and products and in articles in
aerospace equipment and products; or
(D) Recycling of articles.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section.
§ 721.11779 4,4′-(1-methylethylidene)bis[2,
6-dibromophenol].
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
as 4,4′-(1-methylethylidene)bis[2, 6dibromophenol], also known as
‘‘tetrabromobisphenol A,’’ (TBBPA)
(CASRN 79–94–7) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses for the
chemical substance identified in
paragraph (a)(1) of this section are
manufacture (including import) or
processing for any use except in:
(i) Adhesive manufacturing;
(ii) Plastic material and resin
manufacturing;
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
(iii) Chemical product and
preparation manufacturing;
(iv) Electrical equipment, appliance
and component manufacturing;
(v) Plastics product manufacturing;
(vi) Computer and electronic product
manufacturing;
(vii) Electrical and electronic
products;
(viii) Printed circuit boards and
semiconductor packages;
(ix) Interior material for transportation
equipment;
(x) Plastic electronic enclosures;
(xi) Industrial or commercial use in
prepreg material for automotive and
aviation interiors for;
(xii) Industrial or commercial use as
a laboratory chemical for; or
(xiii) Recycling of electronic products.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section.
§ 721.11780
Triphenyl phosphate.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
as Triphenyl phosphate (TPP) (CASRN
115–86–6) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses for the
chemical substance identified in
paragraph (a)(1) of this section are
manufacture (including import) or
processing for any use except in:
(i) Plastics material and resin
manufacturing;
(ii) Plastic product manufacturing;
(iii) Computer and electronic product
manufacturing;
(iv) Rubber product manufacturing;
(v) Textiles, apparel, and leather
manufacturing;
(vi) Furniture and related product
manufacturing;
(vii) Paint and coating manufacturing;
(viii) Chemical product and
preparation manufacturing;
(ix) Adhesives, sealants, lubricants,
and greases;
(x) Electrical and electronic products;
(xi) Plastic and rubber products;
(xii) Industrial or commercial use in
paints and coatings;
(xii) Industrial use in hydraulic fluid;
(xiii) Industrial or commercial use in
turbine engine oils in aviation
industries;
(xiv) Industrial or commercial use in
turbine engine oils in non-aviation
industries;
(xv) Industrial or commercial use in
operational fluids, maintenance fluids
and semisolids, reactive fluids, and
solids used in aerospace industries;
(xvi) Industrial or commercial use in
laboratory chemicals;
E:\FR\FM\22JNP1.SGM
22JNP1
Federal Register / Vol. 88, No. 119 / Thursday, June 22, 2023 / Proposed Rules
(xvii) Foam seating and bedding
products;
(xviii) Industrial or commercial use in
furniture and furnishings;
(xix) Industrial or commercial use in
building and construction materials; or
(xx) Recycling.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section.
[FR Doc. 2023–13250 Filed 6–21–23; 8:45 am]
BILLING CODE 6560–50–P
COMMITTEE FOR PURCHASE FROM
PEOPLE WHO ARE BLIND OR
SEVERELY DISABLED
41 CFR Part 51–9
AbilityOne/OIG–001 Case Management
System
Committee for Purchase From
People Who Are Blind or Severely
Disabled, Office of Inspector General.
ACTION: Notice of proposed rulemaking
(NPRM).
AGENCY:
The Committee for Purchase
From People Who Are Blind or Severely
Disabled (Committee, U.S. AbilityOne
Commission, Commission), Office of
Inspector General (OIG) is seeking
comment on proposed amendments to
agency regulations. This NPRM
proposes that the OIG’s AbilityOne/
OIG–001 Case Management System,
system of records be exempt from
certain sections of the Privacy Act of
1974 pursuant to the general and
specific exemptions listed in the act.
The law enforcement and investigatory
nature of the system of records makes it
inappropriate to allow individual access
to records under the Privacy Act.
DATES: Submit comments on or before
July 21, 2023.
ADDRESSES: You may submit comments,
identified by docket number and title,
by any of the following methods:
• Federal Rulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: U.S. AbilityOne Commission
Office of Inspector General, 355 E Street
SW (OIG Suite 335), Washington, DC
20024.
Instructions: All submissions received
must include the agency name and
docket number for this Federal Register
document. The general policy for
comments and other submissions from
members of the public is to make these
submissions available for public
viewing on the internet at https://
www.regulations.gov as they are
received without change, including any
ddrumheller on DSK120RN23PROD with PROPOSALS1
SUMMARY:
VerDate Sep<11>2014
17:14 Jun 21, 2023
Jkt 259001
personal identifiers or contact
information.
For
general questions, please contact: Kamil
Ali, Attorney-Advisor, U.S. AbilityOne
Commission Office of Inspector General,
355 E Street SW (OIG Suite 335),
Washington, DC 20024. Phone: (202)
603–2248, Email: kali@
oig.abilityone.gov. For privacy
questions, please contact: Ms. Kamil
Ali, Attorney-Advisor, U.S. AbilityOne
Commission Office of Inspector General,
355 E Street SW (OIG Suite 335),
Washington, DC 20024. Phone: (202)
603–2248, Email: kali@
oig.abilityone.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Background
The Privacy Act of 1974, 5 U.S.C.
522a, governs how the Federal
Government collects, maintains, and
uses personally identifiable information
in systems of record. The Privacy Act
requires that federal agencies publish in
the Federal Register a system of records
notice (SORN) that identifies purpose of
data collection, the routine use of its
disclosures, and how individuals may
get access to their own records and
contest it.
The Inspector General Act of 1978, 5
U.S.C. 401–424; 5 U.S.C. App. 3, allows
the U.S. AbilityOne Commission/OIG to
maintain the system to fulfill its
mission. The U.S. AbilityOne
Commission OIG is responsible for
conducting and supervising
independent and objective audits,
inspections, and investigations of the
programs and operations of the
Committee. OIG promotes economy,
efficiency, and effectiveness within the
U.S. AbilityOne Commission/OIG and
prevents and detects fraud, waste, and
abuse in its programs and operations.
OIG’s Office of Investigations
investigates allegations of criminal,
civil, and administrative misconduct
involving U.S. AbilityOne Commission
employees, contractors, grantees, and
Departmental programs and activities.
This includes investigating for
violations of criminal laws by entities
regulated by U.S. AbilityOne
Commission, regardless of whether they
receive Federal funds. These
investigations can result in criminal
prosecutions, fines, civil monetary
penalties, and administrative sanctions.
The investigative and law
enforcement nature of the system of
records makes it necessary for the
system to be exempt from the notice and
access requirements. The Privacy Act
contains general and specific
exemptions for law enforcement
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
40741
purposes that grant these exemptions.
The general exemption, 5 U.S.C.
552a(j)(2), allows exemptions for system
of records that are ‘‘maintained by an
agency or component thereof which
performs as its principal function any
activity pertaining to the enforcement of
criminal laws, including police efforts
to prevent, control, or reduce crime or
to apprehend criminals, and the
activities of prosecutors, courts,
correctional, probation, pardon, or
parole authorities, and which consists of
(A) information compiled for the
purpose of identifying individual
criminal offenders and alleged offenders
and consisting only of identifying data
and notations of arrests, the nature and
disposition of criminal charges,
sentencing, confinement, release, and
parole and probation status; (B)
information compiled for the purpose of
a criminal investigation, including
reports of informants and investigators,
and associated with an identifiable
individual; or (C) reports identifiable to
an individual compiled at any stage of
the process of enforcement of the
criminal laws from arrest or indictment
through release from supervision.’’
Similarly the specific exemption in 5
U.S.C. 552a(k)(2) allows exemptions for
systems of records for ‘‘investigatory
material compiled for law enforcement
purposes, other than material within the
scope of subsection (j)(2) of this section:
Provided, however, That if any
individual is denied any right, privilege,
or benefit that he would otherwise be
entitled by Federal law, or for which he
would otherwise be eligible, as a result
of the maintenance of such material,
such material shall be provided to such
individual, except to the extent that the
disclosure of such material would reveal
the identity of a source who furnished
information to the Government under an
express promise that the identity of the
source would be held in confidence, or,
prior to the effective date of this section,
under an implied promise that the
identity of the source would be held in
confidence.’’ The data collected by the
AbilityOne/OIG–001 Case Management
System falls under these categories and
for this reason, we are proposing to add
41 CFR 51–9.6.
List of Subjects in 41 CFR Part 51–9
Privacy.
For reasons stated in the preamble,
the Committee proposes to amend 41
CFR part 51–9 as follows:
PART 51–9—PRIVACY ACT RULES
1. The authority citation for part 51–
9 continues to read as follows:
■
Authority: 5 U.S.C. 552a.
E:\FR\FM\22JNP1.SGM
22JNP1
Agencies
[Federal Register Volume 88, Number 119 (Thursday, June 22, 2023)]
[Proposed Rules]
[Pages 40728-40741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13250]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2023-0012; FRL-9430-01-OCSPP]
RIN 2070-AL07
Flame Retardants; Significant New Uses Rules for Certain Non-
Ongoing Uses
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
proposing significant new use rules (SNURs) for three flame retardants,
tris(2-chloroethyl) phosphate (TCEP), 4,4'-(1-methylethylidene)bis[2,
6-dibromophenol], also known as ``tetrabromobisphenol A,'' (TBBPA), and
triphenyl phosphate (TPP), which are all undergoing TSCA risk
evaluations. The proposed significant new uses are manufacture
(including import) or processing for any use, with the exception that
the conditions of use the Agency expects to consider within the scope
of the TSCA section 6 risk evaluations are not proposed as significant
new uses. Persons subject to the SNUR would be required to notify EPA
at least 90 days before commencing any manufacturing (including import)
or processing of the chemical substance for a significant new use. Once
EPA receives a notification, EPA must review and make an affirmative
determination on the notification, and take such action as is required
by any such determination before the manufacture (including import) or
processing for the significant new use can commence.
DATES: Comments must be received on or before August 7, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2023-0012, using the Federal eRulemaking Portal
at 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. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Thomas Groeneveld, Office of
Pollution Prevention and Toxics (7404M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: (202) 566-1188; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. 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 those listed in TSCA section 5(a)(2) (see
Unit II.A.). Once EPA determines that a use of a chemical substance is
a significant new use, TSCA section 5(a)(1) requires persons to submit
a significant new use notice (SNUN) to EPA at least 90 days before they
manufacture (including import) or process the chemical substance for
that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA further provides that such
manufacturing (including import) or processing may not commence until
EPA has conducted a review of the notice, made an appropriate
determination on the notice, and taken such actions as are required in
association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). EPA
has long interpreted the statutory term ``significant new use'' to
include the resumption of a use that had ceased prior to promulgation
of the proposed SNUR, for example see, April 25, 2019 (84 FR 17345)
(FRL-9991-33)); March 8, 2016 (81 FR 20535 (FRL-9943-83)); December 29,
2014 (79 FR 77891 (FRL-9915-60)) and October 22, 2013 (78 FR 62443
(FRL-9397-1)), and EPA will not determine that a use is a ``significant
new use'' if information reasonably available to the Agency, including
that received during the period for public comment, establishes that
the use is ongoing at the time the proposed rule is published in the
Federal Register.
B. What action is the Agency taking?
EPA is proposing SNURs for the following three flame retardants
undergoing TSCA section 6 risk evaluations:
Tris(2-chloroethyl) phosphate (TCEP), CASRN 115-96-8 (Ref.
1);
4,4'-(1-methylethylidene)bis[2, 6-dibromophenol], also
known as ``tetrabromobisphenol A,'' (TBBPA), CASRN 79-94-7 (Ref. 2);
and
Triphenyl phosphate (TPP), CASRN 115-86-6 (Ref. 3).
The proposed significant new uses are manufacture (including
import) or processing for any use, with the exception that the
conditions of use that EPA expects to consider within the scope of the
TSCA section 6 risk evaluations are not proposed as significant new
uses (Refs. 1, 2, and 3). The conditions of use that EPA identified for
the TSCA section 6 risk evaluations include all manufacture,
processing, and use the Agency believes to be ongoing, as well as
legacy uses and associated disposal, in the United States based on
reasonably available information. The proposed significant new uses
include manufacture and processing for uses that have ceased;
manufacture and processing for uses that have not yet ceased but for
which all manufacture and processing has ceased; and manufacture and
processing for uses for which EPA has no information demonstrating that
the use has previously commenced in the United States. EPA will
consider any information received during the period for public comment
suggesting that particular uses had commenced in the United States and
not ceased prior to
[[Page 40729]]
publication date of this notice of proposed rulemaking.
EPA is not proposing to make inapplicable the general exemptions
from SNUR notice requirements that are described in 40 CFR 721.45.
These include, for example, exemptions from notification requirements
for persons manufacturing or processing the chemical substance only as
an impurity or certain byproduct, and persons importing or processing
the chemical substance as part of an article. (See also the request for
comment in Unit II.D.).
EPA is requesting public comment on all aspects of this proposal
and specifically on the Agency's description of the significant new
uses for the chemicals identified, including specific documentation of
ongoing uses not identified by the Agency, if any (see details
discussed in Unit III.). Please note that the Agency has listed the
exempted conditions of use from the significant new use proposed
designation as these conditions of use appear in the risk evaluation
scope documents, including both manufacturing and processing for
specific uses and the uses themselves in the same list of exceptions.
EPA is interested in comments on how these conditions of use are
presented as exemptions from the significant new use.
C. Why is the Agency taking this action?
The Agency is proposing these SNURs to ensure that EPA receives
timely advanced notice of any future manufacturing (including
importing) or processing of the chemical substances subject to these
proposed SNURs for uses identified as significant new uses that may
produce changes in human and environmental exposures, and to ensure
that an appropriate determination (relevant to the risks associated
with such manufacturing (including importing), processing, distribution
in commerce, use and disposal) has been issued prior to the
commencement of such manufacturing (including importing) or processing.
The proposed SNURs are necessary to ensure that manufacturing
(including import) or processing for significant new uses cannot
proceed until EPA has responded to the planned new use circumstances by
taking the required actions under TSCA sections 5(e) or 5(f) in the
event that EPA determines under section 5(a)(3) that: (1) The
significant new use presents an unreasonable risk under the conditions
of use (without consideration of costs or other nonrisk factors, and
including an unreasonable risk to a potentially exposed or susceptible
subpopulation (PESS) identified as relevant by EPA); (2) The
information available to EPA is insufficient to permit a reasoned
evaluation of the health and environmental effects of the significant
new use; (3) In the absence of sufficient information, the
manufacturing (including importing), processing, distribution in
commerce, use, or disposal of the substance, or any combination of such
activities, may present an unreasonable risk (without consideration of
costs or other nonrisk factors, and including an unreasonable risk to a
PESS identified as relevant by EPA); or (4) There is substantial
production and sufficient potential for environmental release or human
exposure (as defined in TSCA section 5(a)(3)(B)(ii)(II)). In order for
manufacturing (including importing) or processing for the significant
new use to proceed after EPA has made one of these four determinations,
EPA must take actions under TSCA sections 5(e) or 5(f) to protect
health and the environment. However, EPA may also determine that the
significant new use is not likely to present an unreasonable risk under
TSCA section 5(a)(3)(C), after which manufacturing (including
importing) or processing for the significant new use may proceed.
EPA is separately conducting risk evaluations for the chemical
substances subject to this proposed rule under their respective
conditions of use, pursuant to TSCA section 6(b)(4)(A) (15 U.S.C.
2605(b)(4)(A)). The term ``conditions of use'' is defined in TSCA
section 3(4) to mean the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of. Through scoping and subsequent
information gathering activity for the risk evaluations, EPA identified
conditions of use to consider in the TSCA section 6 risk evaluations
for these chemical substances. The conditions of use identified by EPA
for the TSCA section 6 risk evaluations are listed for each chemical
substance in Unit III.D. These conditions of use include (but are not
limited to) all manufacture, processing, and use that the information
available to the Agency demonstrates to be ongoing in the United
States. EPA is not proposing to designate these conditions of use as
significant new uses.
Additionally, as part of the information gathering activity
associated with the risk evaluations for these chemical substances, EPA
identified certain prior uses that have ceased, as well as industrial,
commercial, or consumer conditions of use that are ongoing but for
which manufacturing (including import) and processing have ceased. EPA
is proposing to determine that manufacture and processing for these two
categories of uses are no longer ongoing. These uses are also listed
for each chemical substance in Unit III.D. Manufacture (including
import) and processing of these chemical substances for these uses, as
well as for any other potential use of these chemical substances not
identified as a condition of use for the TSCA section 6 risk
evaluations, are within the scope of this proposed SNUR.
The rationale and objectives for this proposed SNUR are further
explained in Unit II.B.
D. Does this action apply to me?
1. General applicability.
You may be potentially affected by this action if you manufacture
(including import), process, or distribute in commerce chemical
substances and mixtures. 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.
Textile manufacturing (NAICS code 313).
Fabric coating mills (NAICS code 313320).
All other leather good and allied product manufacturing
(NAICS code 316998).
All other miscellaneous wood product manufacturing (NAICS
code 321999).
Paper bag and coated treated paper manufacturing (NAICS
code 322220).
Coated and laminated paper manufacturing (NAICS code
322222).
All other converted paper product manufacturing (NAICS
code 322299).
Other basic inorganic chemical manufacturing (NAICS code
325180).
Alkalies and chlorine manufacturing (NAICS code 325181).
All other basic inorganic chemical manufacturing (NAICS
code 325188).
All other basic organic chemical manufacturing (NAICS code
325199).
Plastics material and resin manufacturing (NAICS code
325211).
Artificial and synthetic fibers and filaments
manufacturing (NAICS code 325220).
[[Page 40730]]
Noncellulosic organic fiber manufacturing (NAICS code
325222).
Paint and coating manufacturing (NAICS code 325510).
Adhesive manufacturing (NAICS code 325520).
Custom compounding of purchased resins (NAICS code
325991).
Photographic film, paper, plate, and chemical
manufacturing (NAICS code 325992).
All other miscellaneous chemical product and preparation
manufacturing (NAICS code 325998).
Plastics and rubber products manufacturing (NAICS code
326).
Unlaminated plastics film and sheet (except packaging)
manufacturing (NAICS code 326113).
Laminated plastics plate, sheet (except packaging), and
shape manufacturing (NAICS code 326130).
Polystyrene foam product manufacturing (NAICS code
326140).
Urethane and other foam product (except polystyrene)
manufacturing ((NAICS code 326150).
All other plastics product manufacturing (NAICS code
326199).
Other concrete product manufacturing (NAICS code 327390).
Other industrial machinery manufacturing (NAICS code
333249).
Computer and electronic product manufacturing (NAICS code
334).
Bare printed circuit board manufacturing (NAICS code
334412).
Semiconductor and related device manufacturing (NAICS code
334413).
Electronic connector manufacturing (NAICS code 334417).
Other electronic component manufacturing (NAICS code
334419).
Current-carrying wiring device manufacturing (NAICS code
335931).
Carbon and graphite product manufacturing (NAICS code
335991).
Automobile manufacturing (NAICS code 336111).
Other motor vehicle parts manufacturing (NAICS code
336390).
All other motor vehicle parts manufacturing (NAICS code
336399).
Aerospace product and parts manufacturing (NAICS code
336400).
Aircraft manufacturing (NAICS code 336411).
Other aircraft parts and auxiliary equipment manufacturing
(NAICS code 336413).
Furniture and related product manufacturing (NAICS code
337).
Gasket, packing, and sealing device manufacturing (NAICS
code 339991).
Other chemical and allied products merchant wholesalers
(NAICS code 424690).
All other pipeline transportation (NAICS code 486990).
Testing laboratories and services (NAICS code 541380).
Hazardous waste treatment and disposal (NAICS code
562211).
Solid waste landfill (NAICS code 562212).
Other nonhazardous waste treatment and disposal (NAICS
code 562219).
Materials recovery facilities (NAICS code 562920).
All other miscellaneous waste management services (NAICS
code 562998).
National security (NAICS code 928110).
2. Applicability to importers and exporters.
This action may also affect certain entities through pre-existing
import, including import certification, and export notification rules
under TSCA. Chemical importers are subject to the import provision of
TSCA section 13 (15 U.S.C. 2612), which requires that the Secretary of
the Treasury ``refuse entry into the customs territory of the United
States'' of any substance, mixture, or article containing a chemical
substance or mixture that fails to comply with any rule issued under
TSCA or that ``is offered for entry in violation'' of TSCA or certain
rules or orders issued under TSCA, including rules issued under TSCA
section 5. Persons who import any chemical substance in bulk form, as
part of a mixture, or as part of an article (if required by rule) are
also subject to TSCA section 13 import certification requirements and
the corresponding regulations promulgated at 19 CFR 12.118 through
12.127 (see also 19 CFR 127.28). Chemical importers of the chemical
substances in bulk form, as part of a mixture, or as part of an article
(if required by rule) must certify that the shipment of the chemical
substance complies with all applicable rules and orders under TSCA,
including regulations issued under TSCA sections 5, 6, 7 and Title IV.
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 24, 2023 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.
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substances included in this
proposed rule. This analysis (Ref. 4), which is available in the
docket, is briefly summarized here.
1. Estimated costs for SNUN submissions.
In the event that a SNUN is submitted, costs are an estimated
$26,894 per SNUN submission for large business submitters and $11,204
for small business submitters. These estimates include the cost to
prepare and submit the SNUN (including registration for EPA's Central
Data Exchange (CDX)), and the payment of a user fee. Businesses that
submit a SNUN would be subject to either a $19,020 user fee required by
40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as
defined at 13 CFR 121.201, a reduced user fee of $3,300 (40 CFR
700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission
of SNUNs will not be incurred by any company unless a company decides
to pursue a significant new use as defined in this proposed SNUR.
Additionally, these estimates reflect the costs and fees as they are
known at the time this rulemaking.
2. Estimated costs for export notifications.
EPA has also evaluated the potential costs associated with the
export notification requirements under TSCA section 12(b) and the
implementing regulations at 40 CFR part 707, subpart D, which require
exporters to notify EPA if they export or intend to export a chemical
substance or mixture for which, among other things, a rule has been
proposed or promulgated under TSCA section 5. For persons exporting a
substance that is the subject of a SNUR, a one-time notice to EPA must
be provided for the first export or intended export to a particular
country. The total costs of export notification will vary by chemical,
depending on the number of required notifications (i.e., the number of
countries to which the chemical is exported). While EPA is unable to
make any estimate of the likely number of export notifications for the
chemical substances covered by the proposed SNURs, as stated in the
accompanying economic analysis, the estimated cost of the export
notification requirement on a per unit basis is approximately $66.
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
https://www.regulations.gov or email. If you wish to include CBI in
your comment, please follow the instructions at https://
[[Page 40731]]
www.epa.gov/dockets and clearly mark the part or all the information
that you claim to be 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/commenting-epa-dockets. EPA welcomes comment on all aspects of this
proposed rule. In providing comments on an identified condition of use
or a use that EPA proposes to determine is a significant new use for
the chemical substances subject to this rule, please provide sufficient
information for EPA to substantiate any assertions of an ongoing use
for the specific chemical substance(s). EPA has identified in this
notice the conditions of use that it plans to consider in the TSCA
section 6 risk evaluation. It also has sought to identify uses that the
information available to EPA demonstrates have been discontinued in the
United States in Unit III. These lists are intended to provide examples
and may not be exhaustive. Please note requests for comment related to
specific aspects of this proposed rule in sections that follow (see
Units III.B. (impurities and byproducts) and IV. (regulatory
alternatives considered)).
II. Background
A. Significant New Use Determination
1. Determination factors.
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 addition to the factors enumerated in TSCA section 5(a)(2), the
statute authorizes EPA to consider any other relevant factors.
2. Scientific standards, evidence, and available information.
EPA has used reasonably available information, as well as technical
procedures, measures, methods, protocols, methodologies, and models
consistent with the best available science, as applicable. These
information sources supply information relevant to whether a particular
use would be a significant new use, based on relevant factors including
those listed under TSCA section 5(a)(2).
The clarity and completeness of the data, assumptions, methods,
quality assurance, and analyses employed in EPA's decision are
documented, as applicable and to the extent necessary for purposes of
this proposed significant new use rule, in Units III.D. and V. and in
the references cited throughout the preamble of this proposed rule. The
extent to which the various information, procedures, measures, methods,
protocols, methodologies or models used in EPA's decision have been
subject to independent verification or peer review is adequate to
justify their use, collectively, in the record for a significant new
use rule.
3. Determination for these chemical substances.
To determine what would constitute a significant new use of TCEP,
TBBPA and TPP, EPA considered relevant information about the toxicity
or expected toxicity of these substances, likely human exposures and
environmental releases associated with possible uses, and the four
factors listed in TSCA section 5(a)(2). If any entity were to commence
a new use, including to resume a use of TCEP, TBBPA, and TPP that had
been phased out, that use could both change the type and form and
increase the magnitude and duration of human and environmental exposure
to the substances, and thus EPA believes such uses should be identified
as significant new uses. Based on consideration of the statutory
factors discussed herein, EPA is proposing to determine that the
following uses constitute significant new uses: manufacturing
(including importing) or processing of TCEP, TBBPA, and TPP for any
use, with the exception that the conditions of use the Agency expects
to consider within the scope of the TSCA section 6 risk evaluations are
not proposed as significant new uses, as discussed in Unit III.D.
B. Rationale and Objectives of This Proposed Rule
1. Rationale.
Under TSCA, no person may manufacture a new chemical substance or
manufacture or process a chemical substance for a significant new use
until EPA makes a determination as described in TSCA section 5(a) and
takes any required action. The issuance of a SNUR is not a risk
determination itself, only a notification requirement for ``significant
new uses,'' so that the Agency has the opportunity to review the SNUN
for the significant new use and make a TSCA section 5(a)(3) risk
determination.
Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), EPA's decision to propose a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. If a
person decides to begin manufacturing (including importing) or
processing any of these chemicals for the use, the submission of the
SNUN to EPA allows the Agency to evaluate the conditions of use.
EPA has identified the potential for adverse environmental and
health effects from the conditions of use of TCEP, TBBPA, and TPP based
on data and information sources already described in the proposed
designation of TCEP, TBBPA, and TPP as high priority substances for
TSCA section 6 risk evaluation and the final scopes of the risk
evaluations for TCEP, TBBPA, and TPP (Refs. 1, 2, and 3). EPA will
evaluate risk under TSCA section 6 from the conditions of use of TCEP,
TBBPA, and TPP.
As discussed in this unit and Unit III.D., based on an extensive
review of reasonably available information, EPA is proposing to
determine that significant new uses of TCEP, TBBPA, and TPP are
manufacture (including import) or processing for any use, with the
exception that the conditions of use the Agency expects to consider
within the scope of the TSCA section 6 risk evaluations are not
proposed as significant new uses. The conditions of use that EPA
identified for the TSCA section 6 risk evaluations include all
manufacture, processing, and use that the information available to the
Agency demonstrates to be ongoing in the United States. The proposed
significant new uses include manufacture and processing for uses that
have ceased; manufacture and processing for uses that have not yet
ceased but for which all manufacture and processing has ceased; and
manufacture and processing for uses for which EPA has no information
demonstrating that the use has previously commenced in the United
States. Among other things, EPA has identified certain uses of TCEP,
TBBPA, and TPP that have ceased as well as industrial, commercial, or
consumer conditions of use that are
[[Page 40732]]
ongoing but for which manufacturing (including import) or processing
have ceased. In the absence of a SNUR, the manufacturing (including
importing) or processing of TCEP, TBBPA, and TPP for the significant
new uses proposed in this rule could begin at any time, without prior
notice to EPA under section 5 and without providing EPA an opportunity
to review and address potential risks associated with the new use. EPA
is concerned that commencement of manufacturing (including importing)
or processing TCEP, TBBPA, and TPP for the proposed significant new
uses, could significantly increase the volume of manufacturing
(including importing) and processing of these chemicals, as well as the
magnitude and duration of exposure to humans and the environment over
that which would otherwise exist currently, particularly to the
potentially exposed or susceptible subpopulations identified by EPA in
the final scopes for risk evaluation or during risk evaluation. Given
the concerns associated with the conditions of use as described in Unit
III.D., EPA believes that notification and EPA's required review are
warranted for these chemicals prior to the commencement of a
significant new use.
2. Objectives.
Based on the considerations discussed in Unit III.D., EPA wants to
achieve the following objectives with regard to the significant new
use(s) designated in this proposed rule:
EPA would receive notice of any person's intent to
manufacture (including import) or process the chemical substances for
the described significant new use before that activity begins.
EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing
(including importing) or processing the chemical substances for the
described significant new use.
EPA would be able to either determine that the significant
new use is not likely to present an unreasonable risk of injury, or to
take such regulatory action as is associated with any other
determination under TSCA section 5, before the manufacture or
processing for the significant new use could commence.
C. Applicability of General Provisions to These Proposed SNURs
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to SNURs, recordkeeping
requirements, and exemptions to reporting requirements, among other
things.
Provisions relating to user fees appear at 40 CFR part 700.
Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same requirements and EPA regulatory procedures as submitters of
Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In
particular, these requirements include the information submission
requirements of TSCA sections 5(b) and 5(d)(1), the exemptions
authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and
the regulations at 40 CFR part 720.
Once EPA receives a SNUN, EPA must either determine that the
significant new use is not likely to present an unreasonable risk of
injury or take such regulatory action as is associated with an
alternative determination under TSCA section 5 before the manufacture
(including import) or processing for the significant new use can
commence. If EPA determines that the significant new use of the
chemical substance 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 finding.
D. Applicability of General Exemptions to These Proposed SNURs
The general exemptions from SNUR notice requirements that are
described in 40 CFR 721.45 apply to these proposed SNURs.
EPA is requesting public comment on the alternative of making
inapplicable the article exemption at 40 CFR 721.45(f). Under this
alternative, the import and processing of articles containing TCEP,
TBBPA, and TPP would not be exempt from significant new use
notification requirements. As EPA collects and reviews information
about the importing or processing of TCEP, TBBPA, and TPP as part of
articles and the potential exposure to these chemical substances
through articles, EPA may consider whether to make inapplicable the
articles exemption at 40 CFR 721.45(f).
EPA also seeks comment on the potential impact of making
inapplicable the articles exemption on firms that plan to import or
process articles containing TCEP, TBBPA, and TPP, because, while not
required by the proposed SNUR, these parties may take additional steps
to determine whether TCEP, TBBPA, and TPP are part of the articles that
they are considering for importing or processing.
E. Applicability of the Proposed SNURs to Uses Occurring Before the
Effective Date of the Final Rule
Any use that EPA determines, in the final rule, was ongoing as of
the date of publication of this proposal and did not cease prior to
issuance of the final rule, will not be designated as a significant new
use in the final rule.
As discussed in the Federal Register of April 24, 1990 (55 FR 17376
(FRL-3658-5)), EPA has decided that the intent of the TSCA section
5(a)(1)(B) is best served by designating a use as a significant new use
as of the date of publication of the proposed rule rather than as of
the effective date of the final rule. The objective of EPA's approach
is to ensure that a person cannot defeat a SNUR by initiating a
significant new use after publication of the proposed rule but before
the effective date of the final rule. Uses arising after the
publication of the proposed rule are distinguished from uses that are
identified in the final rule as having been ongoing on the date of
publication of the proposed rule. The former would be new uses, the
latter ongoing uses, except that uses that are identified as ongoing as
of the publication of the proposed rule would not be considered ongoing
uses if they have ceased by the date of issuance of a final rule.
Any person who begins commercial manufacturing (including
importing) or processing of the chemical substances for a use that is
designated as a significant new use in the final rule would have to
cease any such activity upon the effective date of the final rule. To
resume their activities, these persons would have to first comply with
all applicable SNUR notification requirements and wait until all TSCA
prerequisites for the commencement of manufacture or processing have
been satisfied.
F. Important Information About SNUN Submissions
1. SNUN submissions.
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notice 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 721.25 and 40 CFR 720.40. E-PMN software is available
electronically at https://www.epa.gov/chemicals-under-tsca.
EPA recommends that SNUN submitters consult with the Agency if,
[[Page 40733]]
for instance, the chemical substance is also subject to a rule, order,
or consent agreement under TSCA section 4. Prior to submitting a SNUN,
submitters should consider what information may be useful in evaluating
a SNUN. Discussions with the Agency prior to submission can afford
ample time to conduct any tests that might be helpful in evaluating
risks posed by the substance.
2. Development and submission of information with the SNUN.
EPA recognizes that TSCA section 5 does not usually require
developing new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is otherwise
required to submit information for a chemical substance subject to the
SNUR pursuant to a rule, TSCA Order or consent agreement under TSCA
section 4, then TSCA section 5(b)(1)(A) requires such information to be
submitted to EPA at the time of submission of the SNUN.
In the absence of a TSCA section 4 test rule, order, or consent
agreement covering the chemical substance, persons are required to
submit only information in their possession or control and to describe
any other information known to or reasonably ascertainable by them (15
U.S.C. 2604(d); 40 CFR 721.25, and 40 CFR 720.50). However, as a
general matter, EPA recommends that SNUN submitters include information
that would permit a reasoned evaluation of risks posed by the chemical
substance during its manufacture (including import), processing,
distribution in commerce, use, or disposal. EPA encourages persons to
consult with the Agency before submitting a SNUN. As part of this
optional pre-notice consultation, EPA would discuss specific
information it believes may be useful in evaluating a significant new
use.
Submitting a SNUN that does not include information sufficient to
permit a reasoned evaluation may increase the likelihood that EPA will
either respond with a determination that the information available to
the Agency is insufficient to permit a reasoned evaluation of the
health and environmental effects of the significant new use or,
alternatively, that in the absence of sufficient information, the
manufacture, processing, distribution in commerce, use, or disposal of
the chemical substance may present an unreasonable risk of injury.
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). For more
information on alternative test methods and strategies to reduce
vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
The potentially useful information listed in Unit III. may not be
the only means of addressing the potential risks of the chemical
substance. However, submitting a SNUN without any test data or other
information 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 substance.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
III. Chemical Substances Subject to This Proposed Rule
The proposed SNURs would apply to manufacturing (including import)
or processing for certain uses of TCEP, TBBPA, and TPP as described in
this unit.
A. What is the designated cutoff date for determining whether the use
is new or ongoing for these chemical substances?
As explained in Unit II.D. EPA proposes to base its determination
on whether a use is an ongoing use, as opposed to a new use, on
information available to the agency (including information received
during the public comment period) on whether the use was ongoing as of
June 22, 2023. This is referred to as the cutoff date for determining
whether a use is ongoing.
B. Do the proposed SNURs apply to impurities or byproducts?
In accordance with the impurity exemption at 40 CFR 721.45(d), the
proposed SNURs would not apply to persons who manufacture (including
import) or process TCEP, TBBPA, or TPP only as an impurity. EPA is not
proposing to lift the impurities exemption for these SNURs. EPA is
requesting public comment on any ongoing manufacturing (including
import) or processing of TCEP, TBBPA, or TPP as an impurity.
There is no broad exemption for byproducts in EPA's general SNUR
regulations at 40 CFR 721.45. Rather, EPA has only exempted byproducts
from SNUR notification requirements in the limited circumstances where
the person manufactures (including imports) or processes the substance
only as a byproduct which is used only by public or private
organizations that (1) burn it as a fuel; (2) dispose of it as a waste,
including in a landfill or for enriching soil; or (3) extract component
chemical substances from it for commercial purposes. See 40 CFR
721.45(e). Therefore, without a broader exemption in the proposed
regulatory text of the SNURs, any other manufacturing (including
importing) or processing of TCEP, TBBPA, or TPP as a byproduct that
does not fall within a proposed exemption from the significant new use
designations would be a significant new use subject to reporting
requirements.
EPA is aware of ongoing activities that produce TBBPA and TPP as
byproducts and continues to research such occurrences. EPA is
requesting public comment on any ongoing manufacturing (including
import) or processing of TCEP, TBBPA, or TPP as a byproduct that may
not fall within the scope of the byproduct exemption at 40 CFR
721.45(e) and whether to include a broader exemption for manufacturing
(including import) or processing as a byproduct in the final SNUR for
these chemicals.
C. What information is provided for each chemical substance?
1. Chemical specific information.
For each chemical substance, EPA provides the following information
in Unit III.D.:
Chemical name and Chemical Abstracts Service Registry
Number (CASRN);
Uses EPA proposes to determine are significant new uses;
Conditions of use and production volumes;
Potential environmental and health effects; and
Potential routes and sources of exposure.
2. Background.
a. Conditions of use and production volumes.
[[Page 40734]]
In the draft scopes of the risk evaluations under TSCA section 6
for these chemicals, EPA identified and described the categories and
subcategories of conditions of use that EPA expects to consider in the
TSCA risk evaluations based on information reported to EPA through the
Chemical Data Reporting (CDR) and Toxics Release Inventory (TRI)
reporting, published literature, public comments and consultation with
stakeholders for both uses currently in production and uses for which
production may have ceased. EPA revised the conditions of use in the
final scope of each risk evaluation based on additional information and
public comments (Refs. 1, 2, and 3). TCEP, TBBPA, and TPP have
conditions of use based on research conducted by the Agency that
identified circumstances under which these chemical substances are
intended, known or reasonably foreseen to be manufactured, processed,
distributed in commerce, used, or disposed of.
In conducting additional research on the conditions of use
described in this proposed rule, EPA assembled information from the CDR
and TRI programs, including production volumes and uses of TCEP, TBBPA,
and TPP. Using this information EPA identified and described the
categories and subcategories of conditions of use for the following
lifecycle stages: manufacturing (including import); processing;
distribution in commerce; industrial, commercial and consumer use; and
disposal. EPA also consulted a variety of other sources to identify
uses of TCEP, TBBPA, and TPP, including published literature, company
websites, government and commercial trade databases and publications.
To identify formulated products, including articles, EPA searched for
safety data sheets (SDS) using internet searches, EPA Chemical and
Product Categories (CPCat) data, and other resources in which SDSs
could be found. SDSs were cross-checked with company websites to ensure
that each product's SDS was current. In addition, EPA considered
communications with companies, industry groups and public comments to
supplement EPA's understanding of the conditions of use information.
Production volume is based on data reported to EPA during the 2020 CDR
submission period for calendar years 2016-2019 and described here as a
range to protect production volumes that were claimed as CBI.
Finally, the Agency provides lists of identified conditions of use
and uses proposed to be determined are significant new uses. In these
lists, EPA specifies where such uses are among industrial, commercial,
or consumer categories based on information in the final scopes for
each chemical (Refs. 1, 2, and 3). In instances where such uses would
include all three categories, EPA only lists the identified conditions
of use and uses proposed to be determined as significant new uses.
b. Potential effects and routes of exposure.
As previously mentioned, certain phrasings of text and headings
used in the proposed SNURs is identical to that used in the scope
documents for each chemical. For example, comparable headings in the
scope documents identify ``Hazards (Effects),'' ``Environmental
Hazards,'' and ``Human Health Hazards.'' In this unit, the Agency is
retaining traditional headings used in SNURs and will discuss such
``effects'' and ``hazards'' using text transferred from the scope
documents.
D. Which chemical substances are subject to this proposed rule?
1. Tris(2-chloroethyl) phosphate (TCEP), CASRN 115-96-8.
a. Uses EPA proposes to determine are significant new uses.
EPA is proposing to designate as a significant new use manufacture
(including import) or processing TCEP for any use, with the exception
that the conditions of use the Agency expects to consider within the
scope of the TSCA section 6 risk evaluation are not proposed as
significant new uses. The conditions of use that EPA identified for the
TSCA section 6 risk evaluation include all manufacture, processing, and
use that the information available to the Agency demonstrates to be
ongoing, as well as legacy uses and associated disposal, in the United
States. At this time, EPA is aware that manufacture and processing for
the following uses of TCEP have been discontinued and thus they are
among the uses EPA proposes to determine are significant new uses:
Domestic manufacturing for any use;
Manufacturing (including import) for use in building and
construction materials (insulation);
Processing for use in building and construction materials
(insulation);
Manufacturing (including import) for use in wood and
engineered wood products (wood resin composites);
Processing for use in wood and engineered wood products
(wood resin composites);
Manufacturing (including import) for use in fabric and
textile products;
Processing for use in fabric and textile products;
Manufacturing (including import) for use in foam seating
and bedding products, except for foam used in aerospace equipment and
products;
Processing for use in foam seating and bedding products,
except for foam used in aerospace equipment and products;
Processing for incorporation into formulation, mixture, or
reaction products, except for industrial and commercial use in polymers
used in aerospace equipment and products; and
Processing for incorporation into article, except for
industrial or commercial use in articles used in aerospace equipment
and products.
b. Conditions of use and production volumes.
EPA is proposing to determine that the conditions of use of TCEP
that EPA expects to consider in the TSCA section 6 risk evaluation
include (but are not limited to) all ongoing manufacture, processing,
and use of TCEP. EPA is proposing that the conditions of use that EPA
expects to consider in the risk evaluation would not be significant new
uses, even if they are not necessarily ``ongoing'' but are intended,
known, or reasonably foreseen.
According to information reasonably available to the Agency, TCEP
is imported into the United States and processed for commercial use in
paints and coatings, which may be present in unoccupied spaces of
consumer homes, and for industrial or commercial use in polymers for
use in aerospace equipment and products (Ref. 1). In addition, TCEP is
imported for commercial use as a laboratory chemical (Ref. 1).
Historically, TCEP was incorporated into building and construction
materials, such as roofing insulation and wood resin composites (Ref.
1). Some of these products may still be present in consumers' homes and
in commercial infrastructure and, therefore, are still listed among the
commercial and consumer conditions of use EPA has identified for risk
evaluation (Ref. 1). Data reported to EPA during the 2020 CDR
submission period indicate there is no reported production volume of
25,000 lbs. or more of TCEP domestically manufactured or imported into
the United States. Because data reported to EPA during the 2016 CDR
submission period indicated that TCEP was being imported, EPA concluded
it is reasonably foreseen that TCEP continues to be imported below CDR
production volume thresholds.
EPA has identified conditions of use of TCEP that are undergoing
TSCA section 6 risk evaluation and are described in this unit in the
same format that appears in the final scope document (Ref. 1), with
minor edits for readability, supported by Agency
[[Page 40735]]
research being conducted during TSCA risk evaluation of TCEP and for
this SNUR. Please note that the following list contains conditions of
use for all lifecycle stages of the chemical substance considered by
TSCA section 6 risk evaluations. The proposed SNUR is directed at
manufacture (including import) and processing for particular uses, but
not other lifecycle stages such as distribution in commerce or
disposal. The full list of conditions of use are included here to
provide a comprehensive scope of conditions of use identified by the
Agency. The conditions of use of TCEP that EPA has identified are:
Import for commercial use as a laboratory chemical;
Import for commercial use in paints and coatings;
Import for industrial or commercial use in polymers used
in aerospace equipment and products;
Import for industrial or commercial use in articles used
in aerospace equipment and products;
Processing for commercial use in paints and coatings;
Processing for industrial or commercial use in polymers
used in aerospace equipment and products;
Processing for industrial or commercial use in articles
used in aerospace equipment and products;
Recycling of articles;
Distribution in commerce;
Commercial use as a laboratory chemical;
Industrial or commercial use in aerospace equipment and
products;
Commercial use in fabric and textile products;
Consumer use in fabric and textile products;
Commercial use in building and construction materials
(insulation);
Consumer use in building and construction materials
(insulation);
Commercial use in foam seating and bedding products;
Consumer use in foam seating and bedding products;
Commercial use in wood and engineered wood products (wood
resin composites);
Consumer use in wood and engineered wood products (wood
resin composites);
Commercial use in paints and coatings;
Consumer use in paints and coatings; and
Disposal.
c. Potential environmental and health effects.
During prioritization for TSCA section 6(b) risk evaluation, EPA
identified environmental hazard effects for aquatic and terrestrial
organisms, and also identified the following potential human health
effects associated with TCEP: acute, repeated dose, genetic,
reproductive, developmental, toxicokinetic, cancer, and neurological
effects (Ref. 1). Since prioritization and as captured in the final
scope, EPA applied automated techniques during the data screening phase
of systematic review to identify the following additional potential
human health hazards and related information that may be considered for
the risk evaluation: cardiovascular, endocrine, gastrointestinal,
hematological and immune, hepatic, mortality, musculoskeletal,
nutritional and metabolic, ocular and sensory, renal, respiratory, skin
and connective tissue, absorption, distribution, metabolism and
excretion (ADME), and physiological based pharmacokinetic modeling and
simulation (Ref. 1). Additional human health and environmental hazards
may be considered during TSCA section 6(b) risk evaluation based on
results from systematic review, as explained in Appendix A of the TCEP
Final Scope (Ref. 1).
d. Potential routes and sources of exposure.
As previously mentioned, certain phrasings of text and headings in
this unit are identical to that used in the scope documents for each
chemical. In this unit, the Agency notes that certain discussions of
environmental and general population exposures may list similar routes
and sources of exposure; however, instead of modifying or synthesizing
such discussions, the Agency is using text transferred from the scope
documents. In addition, new or resumed uses would present potential
routes and sources of exposure that could create concerns and,
therefore, necessitate EPA review.
i. Environmental exposures.
The manufacturing (including import), processing, distribution, use
and disposal of TCEP can result in releases to the environment and
exposure to aquatic and terrestrial receptors (biota) via surface
water, sediment, soil and ambient air. Environmental exposures to biota
are informed by releases into the environment, overall persistence,
degradation, bioaccumulation and partitioning across different media
(Ref. 1). Concentrations of chemical substances in biota provide
evidence of exposure (Ref. 1). TCEP has been identified in surface
water, ground water and sediment, fish samples, seabird samples, and
herring gull eggs (Ref. 1).
ii. Occupational exposures.
There is a potential for occupational exposure under various
conditions of use of TCEP (Ref. 1). There is potential exposure from
the processing of the chemical as it is incorporated into formulations
and products and release from article components during their
manufacture and industrial/commercial use, including handling and
disposal of waste during manufacturing, processing (including
recycling), and use (Ref. 1).
iii. Consumer exposures.
TCEP was previously incorporated into consumer products that may
still be used, specifically fabric, textile, and leather products, and
foam seating and bedding products, as well as building/construction
materials including roofing insulation and wood and engineered wood
products (Ref. 1). The main exposure routes for these uses where
consumers interact with products and articles containing TCEP are
dermal, inhalation, and dust ingestion, including children's mouthing
of articles (e.g., plastics, textiles, wood products) containing TCEP
(Ref. 1).
iv. General population exposures.
Releases of TCEP from certain conditions of use, such as import,
processing or disposal activities, may result in general population
exposures (Ref. 1).
2. 4,4'-(1-methylethylidene)bis[2, 6-dibromophenol] (TBBPA), CASRN
79-94-7.
a. Uses EPA proposes to determine are significant new uses.
EPA is proposing to designate as a significant new use manufacture
(including import) or processing TBBPA for any use, with the exception
that the conditions of use the Agency expects to consider within the
scope of the TSCA section 6 risk evaluation are not proposed as
significant new uses. The conditions of use that EPA identified for the
TSCA section 6 risk evaluation include all manufacture, processing, and
use that the information available to the Agency demonstrates to be
ongoing in the United States. At this time, EPA is aware that
manufacture and processing for the following uses of TBBPA have been
discontinued and thus they are among the uses EPA proposes to determine
are significant new uses:
Manufacturing (including import) for use in batteries
(e.g., adhesive in lead-acid battery casing and in lithium-ion
batteries);
Processing for use in batteries (e.g., adhesive in lead-
acid battery casing and in lithium-ion batteries);
Manufacturing (including import) for use in fabric,
leather, and textile
[[Page 40736]]
products (e.g., carpets, office furniture); and
Processing for use in fabric, leather, and textile
products (e.g., carpets, office furniture).
b. Conditions of use and production volumes.
EPA is proposing to determine that the conditions of use of TBBPA
that EPA expects to consider in the TSCA section 6 risk evaluation
include (but are not limited to) all ongoing manufacture, processing,
and use of TBBPA. EPA is proposing that the conditions of use that EPA
expects to consider in the risk evaluation would not be significant new
uses, even if they are not necessarily ``ongoing'' but are intended,
known, or reasonably foreseen.
According to information reasonably available to the Agency, TBBPA
is manufactured (including imported) in the United States (Ref. 2). The
chemical is processed as a reactant or intermediate to create other
flame retardants; incorporated into formulation, mixture or reaction
products; and incorporated into articles (Ref. 2). Processing also
includes the recycling of TBBPA and TBBPA-containing products (Ref. 2).
The predominant uses for TBBPA are as a reactive flame retardant in
electrical and electronic products (e.g., printed circuit boards and
semiconductor packages) and as an additive flame retardant in
electrical and electronic products (e.g., plastic enclosures) (Ref. 2).
The epoxy resin containing TBBPA can also be used in adhesives,
laminate for aviation and automobile interiors and building/
construction materials (Ref. 2). Data reported to EPA during the 2020
CDR submission period indicate the reported production volume is
between 20 million and 100 million pounds per year (Ref. 2).
EPA has identified conditions of use of TBBPA (Ref. 2), which are
undergoing TSCA section 6 risk evaluation and are described in this
unit in the same format that appears in the final scope document, with
minor edits for readability, supported by Agency research being
conducted during TSCA risk evaluation of TBBPA and for this SNUR.
Please note that the following list contains conditions of use for all
lifecycle stages of the chemical substance considered by TSCA section 6
risk evaluations. The proposed SNUR is directed at manufacture
(including import) and processing for particular uses, but not other
lifecycle stages such as distribution in commerce or disposal. The full
list of conditions of use are included here to provide a comprehensive
scope of conditions of use identified by the Agency. The conditions of
use of TBBPA that EPA has identified are:
Domestic manufacturing;
Import;
Processing for use in adhesive manufacturing;
Processing for use in plastic material and resin
manufacturing;
Processing for use in chemical product and preparation
manufacturing;
Processing for use in electrical equipment, appliance and
component manufacturing;
Processing for use in plastics product manufacturing;
Processing for use in computer and electronic product
manufacturing;
Processing for use in electrical and electronic products;
Processing for use in printed circuit boards and
semiconductor packages;
Processing for use in interior material for transportation
equipment;
Processing for use in plastic electronic enclosures;
Recycling of electronic products;
Distribution in commerce;
Industrial or commercial use in electrical and electronic
products;
Consumer use in electrical and electronic products;
Industrial or commercial use in prepreg material for
automotive and aviation interiors;
Industrial or commercial use in building and construction
materials;
Industrial or commercial use in fabric, textile and
leather products (e.g., carpets, office furniture);
Consumer use in fabric, textile and leather products
(e.g., carpets, office furniture);
Industrial or commercial use as a laboratory chemical;
Disposal.
c. Potential environmental and health effects.
During prioritization for TSCA section 6(b) risk evaluation, EPA
identified environmental hazard effects from TBBPA for aquatic and
terrestrial organisms, and also identified the following potential
human health effects: immunological, neurological, carcinogenic, and
developmental (Ref. 2). Since prioritization and as captured in the
final scope, EPA applied automated techniques during the data screening
phase of systematic review to identify the following additional
potential human health hazards and related information that may be
considered for the risk evaluation: cardiovascular, endocrine,
gastrointestinal, hematological, hepatic, mortality, nutritional and
metabolic ocular and sensory, renal, reproductive, respiratory, skin
and connective tissue, and ADME (Ref. 2). Additional human health and
environmental hazards may be considered during TSCA section 6(b) risk
evaluation based on results from systematic review, as explained in
Appendix A of the TBBPA Final Scope (Ref. 2).
d. Potential routes and sources of exposure.
As previously mentioned, certain phrasings of text and headings in
this unit are identical to that used in the scope documents for each
chemical. In this unit, the Agency notes that certain discussions of
environmental and general population exposures may list similar routes
and sources of exposure; however, instead of modifying or synthesizing
such discussions, the Agency is using text transferred from the scope
documents. In addition, new or resumed uses would present potential
routes and sources of exposure that could create concerns and,
therefore, necessitate EPA review.
i. Environmental exposures.
The manufacturing, processing, distribution, use and disposal of
TBBPA can result in releases to the environment and exposure to aquatic
and terrestrial receptors (biota) (Ref. 2). Environmental exposures to
biota are informed by releases into the environment, overall
persistence, degradation and bioaccumulation within the environment and
partitioning across different media (Ref. 2). Concentrations of
chemical substances in biota provide evidence of exposure (Ref. 2).
ii. Occupational exposures.
Releases of TBBPA from certain conditions of use, such as
manufacturing, processing, industrial/commercial uses, and disposal may
result in occupational exposures (Ref. 2). Examples of occupational
activities associated with the conditions of use identified for TBBPA
include, but are not limited to: unloading and transferring TBBPA to
and from storage containers to process vessels during manufacturing;
processing and use; handling and disposing of waste containing TBBPA
during manufacturing, processing (including recycling), and use;
cleaning and maintaining equipment during manufacturing, processing
(including recycling), and use; sampling chemicals, formulations or
products containing TBBPA for quality control during manufacturing,
processing (including recycling), and use; and performing other work
activities in or near areas where TBBPA is used (Ref. 2).
EPA anticipates inhalation of dust and other respirable particles
as an exposure pathway during the manufacture and processing of various
[[Page 40737]]
articles containing TBBPA (e.g., particulate generated during handling
of plastic resins, finishing operations associated with the manufacture
and finishing of plastics and plastic articles and incorporation of
plastics and other article components into finished products) (Ref. 2).
Dermal exposures for workers are possible during conditions of use
(Ref. 2).
iii. Consumer exposures.
According to CDR reports, TBBPA appears to be used in consumer
products used in indoor environments, specifically fabric, textile, and
leather products, electrical and electronic products (including in the
plastic enclosures), children's products, and building/construction
materials (Ref. 2). Several of these products have the potential to be
mouthed by children (Ref. 2). In addition, handling TBBPA-containing
materials during disposal can lead to consumer and bystander exposures
(Ref. 2). The main exposure routes where consumers interact with
products and articles containing TBBPA are dermal, inhalation and dust
ingestion, including children's mouthing of articles (e.g.,
electronics, plastics, textiles) containing TBBPA (Ref. 2).
iv. General population exposures.
Releases of TBBPA from certain conditions of use, such as
manufacturing, processing or disposal, may result in general population
exposures (Ref. 2). TBBPA has been found in drinking water, ground
water, ambient air, indoor air, fish, human breast milk and dust and
soil (Ref. 2).
3. Triphenyl phosphate (TPP), CASRN 115-86-6.
a. Uses EPA proposes to determine are significant new uses.
EPA is proposing to designate as a significant new use manufacture
(including import) or processing TPP for any use, with the exception
that the conditions of use the Agency expects to consider within the
scope of the TSCA section 6 risk evaluation are not proposed as
significant new uses. The conditions of use that EPA identified for the
TSCA section 6 risk evaluation include all manufacture, processing, and
uses that the information available to the Agency demonstrates to be
ongoing in the United States. At this time, EPA is aware that
manufacture and processing for the following uses of TPP have been
discontinued and thus they are among the uses EPA proposes to determine
are significant new uses:
Manufacturing (including import) for use in photographic
applications; and
Processing for use in photographic applications.
b. Conditions of use and production volumes.
EPA is proposing to determine that the conditions of use of TPP
that EPA expects to consider in the TSCA section 6 risk evaluation
include (but are not limited to) all ongoing manufacture, processing,
and use of TPP. EPA is proposing that the conditions of use that EPA
expects to consider in the risk evaluation would not be significant new
uses, even if they are not necessarily ``ongoing'' but are intended,
known, or reasonably foreseen.
According to information reasonably available to the Agency, TPP is
manufactured (including imported) in the United States (Ref. 3). The
chemical is processed as a reactant; incorporated into formulation,
mixture, or reaction products; and incorporated into articles (Ref. 3).
Several commercial uses were identified, mainly in plastic and rubber
products, and in paints and coatings (Ref. 3). Other uses reported
include use in lubricants and greases. Consumer uses were reported in
foam seating and bedding products (Ref. 3). Data reported to EPA during
the 2020 CDR submission period indicate the reported production volume
is between 1 million and 10 million pounds per year (Ref. 3).
EPA has identified conditions of use of TPP (Ref. 3), which are
undergoing TSCA section 6 risk evaluation and are described in this
unit in the same format that appears in the final scope document, with
minor edits for readability, supported by Agency research being
conducted during TSCA risk evaluation of TPP and for this SNUR. Please
note that the following list contains conditions of use for all
lifecycle stages of the chemical substance considered by TSCA section 6
risk evaluations. The proposed SNUR is directed at manufacture
(including import) and processing for particular uses, but not other
lifecycle stages such as distribution in commerce or disposal. The full
list of conditions of use are included here to provide a comprehensive
scope of conditions of use identified by the Agency. The conditions of
use of TPP that EPA has identified are:
Domestic manufacturing;
Import (including repackaging);
Processing for use in plastics material and resin
manufacturing;
Processing for use in plastic product manufacturing;
Processing for use in computer and electronic product
manufacturing;
Processing for use in rubber product manufacturing;
Processing for use in textiles, apparel, and leather
manufacturing;
Processing for use in furniture and related product
manufacturing;
Processing for use in paint and coating manufacturing;
Processing for use in all other chemical product and
preparation manufacturing;
Processing for use in adhesives, sealants, lubricants, and
greases;
Processing for use in operational fluids, maintenance
fluids and semisolids, reactive fluids, and solids used in aerospace
industry;
Processing for use in turbine engine oils in aviation;
Processing for use in turbine engine oils in non-aviation
industries;
Processing for use in furniture and related product
manufacturing;
Recycling;
Distribution in commerce;
Industrial or commercial use in paints and coatings;
Industrial or commercial use in plastic and rubber
products;
Consumer use in plastic and rubber products;
Industrial or commercial use as a laboratory chemical;
Industrial or commercial use in lubricants and greases;
Consumer use in lubricants and greases;
Industrial or commercial use in operational fluids,
maintenance fluids and semisolids, reactive fluids, and solids used in
aerospace industry;
Industrial or commercial use in turbine engine oils used
in aviation;
Industrial or commercial use in turbine engine oils used
in non-aviation industries;
Industrial or commercial use in electrical and electronic
products;
Consumer use in electrical and electronic products;
Industrial or commercial use in foam seating and bedding
products;
Consumer use in foam seating and bedding products;
Industrial or commercial use in furniture and furnishings;
Industrial or commercial use in building and construction
materials; and
Disposal.
c. Potential environmental and health effects.
During prioritization for TSCA section 6(b) risk evaluation, EPA
identified potential environmental hazard effects from TPP for aquatic
and terrestrial organisms, and also identified the following potential
human health effects and related information: developmental,
irritation, corrosion, and repeated dose (Ref. 3). Since prioritization
and as captured in the final scope, EPA applied automated techniques
during the data
[[Page 40738]]
screening phase of systematic review to identify the following
additional potential human health hazards and related information that
may be considered for the risk evaluation: cancer, cardiovascular,
endocrine, gastrointestinal, hematological and immune, hepatic,
mortality, musculoskeletal, neurological, nutritional and metabolic,
ocular and sensory, renal, reproductive, skin and connective tissue,
and ADME (Ref. 3). Additional human health and environmental hazards
may be considered during TSCA section 6(b) risk evaluation based on
results from systematic review, as explained in Appendix A of the TPP
Final Scope (Ref. 3).
d. Potential routes and sources of exposure.
As previously mentioned, certain phrasings of text and headings in
this unit are identical to that used in the scope documents for each
chemical. In this unit, the Agency notes that certain discussions of
environmental and general population exposures may list similar routes
and sources of exposure; however, instead of modifying or synthesizing
such discussions, the Agency is using text transferred from the scope
documents. In addition, new or resumed uses would present potential
routes and sources of exposure that could create concerns and,
therefore, necessitate EPA review.
i. Environmental exposures.
The manufacturing, processing, distribution, use and disposal of
TPP can result in releases to the environment and exposure to aquatic
and terrestrial receptors (biota) (Ref. 3). TPP was detected in
wastewater effluent, landfill leachate, sediment, soil, ambient air, as
well as in fish (including shellfish) and dolphins (Ref. 3).
ii. Occupational exposures.
There is a potential for occupational exposure under the various
conditions of use (manufacturing (including import), processing,
industrial/commercial uses, and disposal) (Ref. 3). Also, there are
potential exposures from the processing of TPP as it is incorporated
into formulations and products (Ref. 3). There is also potential for
exposure from additive flame retardants due to release from article
components during their manufacture and industrial/commercial use (Ref.
3).
EPA anticipates inhalation of mist, dust, and other respirable
particles as an occupational exposure pathway during the manufacture,
processing, and commercial/industrial use of various products
containing TPP (e.g., particulate generated during manufacture and
handling of foam and plastics and incorporation of foam and plastics
into finished products, and mist generated during application to
textiles and application of paints and coatings) (Ref. 3). For the oral
route, workers and occupational non-users may inadvertently ingest
inhaled particles that deposit in the upper respiratory tract or may
transfer chemicals from their hands to their mouths (Ref. 3). Also,
there is potential dermal exposure from contact with solids during
packaging and repackaging operations at manufacturing and import sites
when TPP is handled as a dry powder (Ref. 3). EPA also anticipates
dermal exposure to liquid if TPP is formulated with liquid chemical and
handled as a liquid (Ref. 3).
iii. Consumer exposures.
TPP is used in consumer products used in indoor environments,
including foam seating and bedding products, and plastic and rubber
products (Ref. 3). TPP use has also been reported in electrical and
electronic products (Ref. 3). Several of these products have the
potential to be mouthed by children. In addition, handling during the
disposal of TPP-containing materials can lead to consumer and bystander
exposures (Ref. 3). The main exposure routes for these uses where
consumers interact with products and articles containing TPP are
dermal, inhalation, and dust ingestion, including children's mouthing
of articles (e.g., textiles, wood products and plastics) containing TPP
(Ref. 3). Therefore, potential sources and pathways of exposure to
consumers include oral, dermal and inhalation; for bystanders, only the
inhalation route may result from the conditions of use of TPP (Ref. 3).
iv. General population exposures.
Releases of TPP from certain conditions of use, such as
manufacturing, processing, or disposal activities, may result in
general population exposures (Ref. 3). TPP was detected in surface
water, ground water, soil, ambient air, indoor air, indoor dust, as
well as in fish (including shellfish) (Ref. 3).
V. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Final Scope of the Risk Evaluation for Tris(2-chloroethyl)
Phosphate (TCEP); CASRN 115-96-8. August 2020. EPA Document # EPA-
740-R-20-009. Available at: https://www.epa.gov/sites/default/files/2020-09/documents/casrn_115-96-8_tris2-chloroethyl_phosphate_tcep_final_scope.pdf.
2. EPA. Final Scope of the Risk Evaluation for 4,4'-(1-
Methylethylidene)bis[2, 6-dibromophenol] (TBBPA); CASRN 79-94-7.
August 2020. EPA Document # EPA-740-R-20-008. Available at: https://www.epa.gov/sites/default/files/2020-09/documents/casrn_79-94-7_44-1-methylethylidenebis2_6-dibromophenol_tbbpa_finalscope.pdf.
3. EPA. Final Scope of the Risk Evaluation for Triphenyl Phosphate
(TPP); CASRN 115-86-6. August 2020. EPA Document # EPA-740-R-20-010.
Available at: https://www.epa.gov/sites/default/files/2020-09/documents/casrn_115-86-6_triphenyl_phosphate_tpp_final_scope.pdf.
4. EPA. Economic Analysis of the Proposed Significant New Use Rules
for Flame Retardants Undergoing TSCA Section 6 Risk Evaluation. May
9, 2023.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review
This action is not a significant regulatory action as defined in
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore
not subject to a requirement for Executive Order 12866 review.
B. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden
under the PRA, 44 U.S.C. 3501 et seq. OMB has previously approved the
information collection activities contained in the existing SNUR
regulations under OMB Control No. 2070-0038 (EPA ICR No. 1188.13). If
an entity were to submit a SNUN to the Agency, the annual burden is
estimated to be less than 100 hours per response, and the estimated
burden for export notifications is less than 1.5 hours per
notification. In both cases, if the firm submitting either a SNUN or
export notification is already registered in CDX, the burden would be
lower than the presented estimates.
An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information that requires OMB approval
under the PRA, unless it has been approved by
[[Page 40739]]
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.
Consistent with the PRA, EPA is interested in comments about the
accuracy of the burden estimate, and any suggested methods for
minimizing respondent burden or improving the automated collection
techniques.
C. Regulatory Flexibility Act (RFA)
I certify this action will not have a significant economic impact
on a substantial number of small entities under the RFA, 5 U.S.C. 601
et seq. The small entities subject to the requirements of this action
are potential future manufacturers (defined by statute to include
importers), processors, and exporters of one or more subject chemical
substances for a significant new use designated in the proposed SNURs.
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, the
Agency has determined 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. EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was 10 in federal fiscal year (FY) FY2016, 14
in FY2017, 16 in FY2018, five in FY2019, seven in FY2020, and 13 in
FY2021, and only a fraction of these were from small businesses. In
addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $19,020 to $3,330.
This lower fee reduces the total reporting and recordkeeping of cost of
submitting a SNUN to about $11,204 for qualifying small firms.
Therefore, the potential economic impacts of complying with this
proposed SNUR are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandates as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. Based on EPA's experience with proposing and
finalizing SNURs, state, local, and tribal governments have not been
impacted by these rulemakings, and EPA does not have any reasons to
believe that any state, local, or tribal government will be impacted by
this action. As such, EPA has determined that this proposed rule would
not impose any enforceable duty, contain any unfunded mandate, or
otherwise have any effect on small governments subject to the
requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et
seq.).
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effect on the 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.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on tribal governments, on the
relationship between the federal government and the Indian tribes, or
on the distribution of power and responsibilities between the federal
government and Indian tribes. This action will not significantly nor
uniquely affect the communities of tribal governments, nor would it
involve or impose any requirements that affect Indian tribes.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern environmental
health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of Executive Order 13045. Since
this is not a ``covered regulatory action,'' Executive Order 13045 does
not apply, and since this action does not address human health
concerns, EPA's policy on Children's Health also does not apply to this
SNUR. However, the EPA Policy on Children's Health will apply to the
consideration of the SNUNs submitted to EPA in response to a SNUR.
Although this action does not concern an environmental health or
safety risk, the designation of certain uses of the subject chemicals
as significant new uses ensures the Agency has an opportunity to review
and address potential risks associated with such uses before an entity
begins commencing any manufacture (including import) or processing of
the chemical substance for that use. Once EPA receives a notification,
EPA must review and make an affirmative determination on the
notification, and take such action as is required by any such
determination before the manufacture (including import) or processing
for the significant new use can commence. Such a review will assess
whether the use identified in the SNUN may present unreasonable risk to
health or the environment and ensure that EPA can prevent future unsafe
environmental releases of the chemical substances subject to the SNUR.
As discussed previously, EPA is concerned about the potential for
adverse health effects from the conditions of use of TCEP, TBBPA, and
TPP for children and will evaluate the risk under TSCA section 6.
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 it is not a ``significant regulatory action''
under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve any technical standards under the
NTTAA section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) directs
federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or
[[Page 40740]]
environmental effects of their programs, policies, and activities on
minority populations (people of color and/or indigenous peoples) and
low-income populations.
EPA believes that it is not practicable to assess whether the human
health or environmental conditions that exist prior to this action
result in disproportionate and adverse effects on people of color, low-
income populations and/or indigenous peoples. The SNURs do not address
any human health or environmental risks or affect the level of
protection provided to human health or the environment. Although this
action does not concern human health or environmental conditions, the
designation of certain uses as significant new uses subject to this
proposed SNUR ensures the Agency has an opportunity to review and
address potential risks associated with such uses. As noted previously,
EPA is concerned about the potential for adverse health effects from
the conditions of use of TCEP, TBBPA, and TPP and will evaluate those
conditions of use under TSCA section 6, including health effects
associated with those conditions of use affecting potentially exposed
or susceptible subpopulations that may be at greater risk of adverse
health effects due to biological susceptibility based on factors such
as race/ethnicity, life stage, lifestyle factors, and nutrition status.
The SNUR would require the submission of a SNUN before the manufacture
(including import) or processing for the significant new use can
commence. EPA would then review the SNUN submission to assess whether
the use identified in the SNUN may present unreasonable risk to health
or the environment and take appropriate action to prevent unreasonable
risk from the chemical substances subject to the SNUR. Furthermore,
information submitted under TSCA can also be used by others to identify
potential problems, set priorities, and take appropriate steps to
reduce any potential risks to human health and the environment and may
make more information available to the public and interested
communities that they can use to better assess potential exposures and
risks to minority, low-income or indigenous populations, or tribes. For
example, EPA provides public access to the information EPA receives and
develops about chemical substances regulated under TSCA via ChemView
(https://chemview.epa.gov/chemview).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 15, 2023.
Denise Keehner,
Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons set forth in the preamble, it is
proposed that 40 CFR chapter I be amended as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
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. 721.11778 through 721.11780 to subpart E to read as
follows:
Sec. 721.11778 Tris(2-chloroethyl) phosphate.
(a) Chemical substance and significant new use subject to
reporting.
(1) The chemical substance identified as tris(2-chloroethyl)
phosphate (TCEP) (CASRN 115-96-8) 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 for the chemical substance identified
in paragraph (a)(1) of this section are:
(i) Any manner or method of manufacture (excluding import) of the
substance associated with any use; and
(ii) Import or processing of the substance for any use, except for:
(A) Commercial use as a laboratory chemical;
(B) Commercial use in paints and coatings;
(C) Industrial or commercial use in polymers used in aerospace
equipment and products and in articles in aerospace equipment and
products; or
(D) Recycling of articles.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section.
Sec. 721.11779 4,4'-(1-methylethylidene)bis[2, 6-dibromophenol].
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as 4,4'-(1-
methylethylidene)bis[2, 6-dibromophenol], also known as
``tetrabromobisphenol A,'' (TBBPA) (CASRN 79-94-7) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses for the chemical substance identified
in paragraph (a)(1) of this section are manufacture (including import)
or processing for any use except in:
(i) Adhesive manufacturing;
(ii) Plastic material and resin manufacturing;
(iii) Chemical product and preparation manufacturing;
(iv) Electrical equipment, appliance and component manufacturing;
(v) Plastics product manufacturing;
(vi) Computer and electronic product manufacturing;
(vii) Electrical and electronic products;
(viii) Printed circuit boards and semiconductor packages;
(ix) Interior material for transportation equipment;
(x) Plastic electronic enclosures;
(xi) Industrial or commercial use in prepreg material for
automotive and aviation interiors for;
(xii) Industrial or commercial use as a laboratory chemical for; or
(xiii) Recycling of electronic products.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section.
Sec. 721.11780 Triphenyl phosphate.
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as Triphenyl phosphate (TPP)
(CASRN 115-86-6) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses for the chemical substance identified
in paragraph (a)(1) of this section are manufacture (including import)
or processing for any use except in:
(i) Plastics material and resin manufacturing;
(ii) Plastic product manufacturing;
(iii) Computer and electronic product manufacturing;
(iv) Rubber product manufacturing;
(v) Textiles, apparel, and leather manufacturing;
(vi) Furniture and related product manufacturing;
(vii) Paint and coating manufacturing;
(viii) Chemical product and preparation manufacturing;
(ix) Adhesives, sealants, lubricants, and greases;
(x) Electrical and electronic products;
(xi) Plastic and rubber products;
(xii) Industrial or commercial use in paints and coatings;
(xii) Industrial use in hydraulic fluid;
(xiii) Industrial or commercial use in turbine engine oils in
aviation industries;
(xiv) Industrial or commercial use in turbine engine oils in non-
aviation industries;
(xv) Industrial or commercial use in operational fluids,
maintenance fluids and semisolids, reactive fluids, and solids used in
aerospace industries;
(xvi) Industrial or commercial use in laboratory chemicals;
[[Page 40741]]
(xvii) Foam seating and bedding products;
(xviii) Industrial or commercial use in furniture and furnishings;
(xix) Industrial or commercial use in building and construction
materials; or
(xx) Recycling.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section.
[FR Doc. 2023-13250 Filed 6-21-23; 8:45 am]
BILLING CODE 6560-50-P