Proposed Rule2023-13250
Flame Retardants; Significant New Uses Rules for Certain Non-Ongoing Uses
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 22, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 119 (Thursday, June 22, 2023)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#53362b3a20273a3d347d303b363e3a30323f7d001d0601133623327d343c25"><span class="__cf_email__" data-cfemail="d7b2afbea4a3beb9b0f9b4bfb2babeb4b6bbf98499828597b2a7b6f9b0b8a1">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#396d6a7a781471564d5550575c795c4958175e564f"><span class="__cf_email__" data-cfemail="ebbfb8a8aac6a3849f8782858eab8e9b8ac58c849d">[email protected]</span></a>.
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:
<bullet> Tris(2-chloroethyl) phosphate (TCEP), CASRN 115-96-8 (Ref.
1);
<bullet> 4,4'-(1-methylethylidene)bis[2, 6-dibromophenol], also
known as ``tetrabromobisphenol A,'' (TBBPA), CASRN 79-94-7 (Ref. 2);
and
<bullet> 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:
<bullet> Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
<bullet> Textile manufacturing (NAICS code 313).
<bullet> Fabric coating mills (NAICS code 313320).
<bullet> All other leather good and allied product manufacturing
(NAICS code 316998).
<bullet> All other miscellaneous wood product manufacturing (NAICS
code 321999).
<bullet> Paper bag and coated treated paper manufacturing (NAICS
code 322220).
<bullet> Coated and laminated paper manufacturing (NAICS code
322222).
<bullet> All other converted paper product manufacturing (NAICS
code 322299).
<bullet> Other basic inorganic chemical manufacturing (NAICS code
325180).
<bullet> Alkalies and chlorine manufacturing (NAICS code 325181).
<bullet> All other basic inorganic chemical manufacturing (NAICS
code 325188).
<bullet> All other basic organic chemical manufacturing (NAICS code
325199).
<bullet> Plastics material and resin manufacturing (NAICS code
325211).
<bullet> Artificial and synthetic fibers and filaments
manufacturing (NAICS code 325220).
[[Page 40730]]
<bullet> Noncellulosic organic fiber manufacturing (NAICS code
325222).
<bullet> Paint and coating manufacturing (NAICS code 325510).
<bullet> Adhesive manufacturing (NAICS code 325520).
<bullet> Custom compounding of purchased resins (NAICS code
325991).
<bullet> Photographic film, paper, plate, and chemical
manufacturing (NAICS code 325992).
<bullet> All other miscellaneous chemical product and preparation
manufacturing (NAICS code 325998).
<bullet> Plastics and rubber products manufacturing (NAICS code
326).
<bullet> Unlaminated plastics film and sheet (except packaging)
manufacturing (NAICS code 326113).
<bullet> Laminated plastics plate, sheet (except packaging), and
shape manufacturing (NAICS code 326130).
<bullet> Polystyrene foam product manufacturing (NAICS code
326140).
<bullet> Urethane and other foam product (except polystyrene)
manufacturing ((NAICS code 326150).
<bullet> All other plastics product manufacturing (NAICS code
326199).
<bullet> Other concrete product manufacturing (NAICS code 327390).
<bullet> Other industrial machinery manufacturing (NAICS code
333249).
<bullet> Computer and electronic product manufacturing (NAICS code
334).
<bullet> Bare printed circuit board manufacturing (NAICS code
334412).
<bullet> Semiconductor and related device manufacturing (NAICS code
334413).
<bullet> Electronic connector manufacturing (NAICS code 334417).
<bullet> Other electronic component manufacturing (NAICS code
334419).
<bullet> Current-carrying wiring device manufacturing (NAICS code
335931).
<bullet> Carbon and graphite product manufacturing (NAICS code
335991).
<bullet> Automobile manufacturing (NAICS code 336111).
<bullet> Other motor vehicle parts manufacturing (NAICS code
336390).
<bullet> All other motor vehicle parts manufacturing (NAICS code
336399).
<bullet> Aerospace product and parts manufacturing (NAICS code
336400).
<bullet> Aircraft manufacturing (NAICS code 336411).
<bullet> Other aircraft parts and auxiliary equipment manufacturing
(NAICS code 336413).
<bullet> Furniture and related product manufacturing (NAICS code
337).
<bullet> Gasket, packing, and sealing device manufacturing (NAICS
code 339991).
<bullet> Other chemical and allied products merchant wholesalers
(NAICS code 424690).
<bullet> All other pipeline transportation (NAICS code 486990).
<bullet> Testing laboratories and services (NAICS code 541380).
<bullet> Hazardous waste treatment and disposal (NAICS code
562211).
<bullet> Solid waste landfill (NAICS code 562212).
<bullet> Other nonhazardous waste treatment and disposal (NAICS
code 562219).
<bullet> Materials recovery facilities (NAICS code 562920).
<bullet> All other miscellaneous waste management services (NAICS
code 562998).
<bullet> 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>. 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:
<bullet> The projected volume of manufacturing and processing of a
chemical substance.
<bullet> The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
<bullet> The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
<bullet> 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:
<bullet> 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.
<bullet> 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.
<bullet> 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 <a href="https://www.epa.gov/chemicals-under-tsca">https://www.epa.gov/chemicals-under-tsca</a>.
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 <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce</a>.
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:
<bullet> Human exposure and environmental release that may result
from the significant new use of the chemical substance.
<bullet> 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.:
<bullet> Chemical name and Chemical Abstracts Service Registry
Number (CASRN);
<bullet> Uses EPA proposes to determine are significant new uses;
<bullet> Conditions of use and production volumes;
<bullet> Potential environmental and health effects; and
<bullet> 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:
<bullet> Domestic manufacturing for any use;
<bullet> Manufacturing (including import) for use in building and
construction materials (insulation);
<bullet> Processing for use in building and construction materials
(insulation);
<bullet> Manufacturing (including import) for use in wood and
engineered wood products (wood resin composites);
<bullet> Processing for use in wood and engineered wood products
(wood resin composites);
<bullet> Manufacturing (including import) for use in fabric and
textile products;
<bullet> Processing for use in fabric and textile products;
<bullet> Manufacturing (including import) for use in foam seating
and bedding products, except for foam used in aerospace equipment and
products;
<bullet> Processing for use in foam seating and bedding products,
except for foam used in aerospace equipment and products;
<bullet> Processing for incorporation into formulation, mixture, or
reaction products, except for industrial and commercial use in polymers
used in aerospace equipment and products; and
<bullet> 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:
<bullet> Import for commercial use as a laboratory chemical;
<bullet> Import for commercial use in paints and coatings;
<bullet> Import for industrial or commercial use in polymers used
in aerospace equipment and products;
<bullet> Import for industrial or commercial use in articles used
in aerospace equipment and products;
<bullet> Processing for commercial use in paints and coatings;
<bullet> Processing for industrial or commercial use in polymers
used in aerospace equipment and products;
<bullet> Processing for industrial or commercial use in articles
used in aerospace equipment and products;
<bullet> Recycling of articles;
<bullet> Distribution in commerce;
<bullet> Commercial use as a laboratory chemical;
<bullet> Industrial or commercial use in aerospace equipment and
products;
<bullet> Commercial use in fabric and textile products;
<bullet> Consumer use in fabric and textile products;
<bullet> Commercial use in building and construction materials
(insulation);
<bullet> Consumer use in building and construction materials
(insulation);
<bullet> Commercial use in foam seating and bedding products;
<bullet> Consumer use in foam seating and bedding products;
<bullet> Commercial use in wood and engineered wood products (wood
resin composites);
<bullet> Consumer use in wood and engineered wood products (wood
resin composites);
<bullet> Commercial use in paints and coatings;
<bullet> Consumer use in paints and coatings; and
<bullet> 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:
<bullet> Manufacturing (including import) for use in batteries
(e.g., adhesive in lead-acid battery casing and in lithium-ion
batteries);
<bullet> Processing for use in batteries (e.g., adhesive in lead-
acid battery casing and in lithium-ion batteries);
<bullet> Manufacturing (including import) for use in fabric,
leather, and textile
[[Page 40736]]
products (e.g., carpets, office furniture); and
<bullet> 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:
<bullet> Domestic manufacturing;
<bullet> Import;
<bullet> Processing for use in adhesive manufacturing;
<bullet> Processing for use in plastic material and resin
manufacturing;
<bullet> Processing for use in chemical product and preparation
manufacturing;
<bullet> Processing for use in electrical equipment, appliance and
component manufacturing;
<bullet> Processing for use in plastics product manufacturing;
<bullet> Processing for use in computer and electronic product
manufacturing;
<bullet> Processing for use in electrical and electronic products;
<bullet> Processing for use in printed circuit boards and
semiconductor packages;
<bullet> Processing for use in interior material for transportation
equipment;
<bullet> Processing for use in plastic electronic enclosures;
<bullet> Recycling of electronic products;
<bullet> Distribution in commerce;
<bullet> Industrial or commercial use in electrical and electronic
products;
<bullet> Consumer use in electrical and electronic products;
<bullet> Industrial or commercial use in prepreg material for
automotive and aviation interiors;
<bullet> Industrial or commercial use in building and construction
materials;
<bullet> Industrial or commercial use in fabric, textile and
leather products (e.g., carpets, office furniture);
<bullet> Consumer use in fabric, textile and leather products
(e.g., carpets, office furniture);
<bullet> Industrial or commercial use as a laboratory chemical;
<bullet> 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:
<bullet> Manufacturing (including import) for use in photographic
applications; and
<bullet> 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:
<bullet> Domestic manufacturing;
<bullet> Import (including repackaging);
<bullet> Processing for use in plastics material and resin
manufacturing;
<bullet> Processing for use in plastic product manufacturing;
<bullet> Processing for use in computer and electronic product
manufacturing;
<bullet> Processing for use in rubber product manufacturing;
<bullet> Processing for use in textiles, apparel, and leather
manufacturing;
<bullet> Processing for use in furniture and related product
manufacturing;
<bullet> Processing for use in paint and coating manufacturing;
<bullet> Processing for use in all other chemical product and
preparation manufacturing;
<bullet> Processing for use in adhesives, sealants, lubricants, and
greases;
<bullet> Processing for use in operational fluids, maintenance
fluids and semisolids, reactive fluids, and solids used in aerospace
industry;
<bullet> Processing for use in turbine engine oils in aviation;
<bullet> Processing for use in turbine engine oils in non-aviation
industries;
<bullet> Processing for use in furniture and related product
manufacturing;
<bullet> Recycling;
<bullet> Distribution in commerce;
<bullet> Industrial or commercial use in paints and coatings;
<bullet> Industrial or commercial use in plastic and rubber
products;
<bullet> Consumer use in plastic and rubber products;
<bullet> Industrial or commercial use as a laboratory chemical;
<bullet> Industrial or commercial use in lubricants and greases;
<bullet> Consumer use in lubricants and greases;
<bullet> Industrial or commercial use in operational fluids,
maintenance fluids and semisolids, reactive fluids, and solids used in
aerospace industry;
<bullet> Industrial or commercial use in turbine engine oils used
in aviation;
<bullet> Industrial or commercial use in turbine engine oils used
in non-aviation industries;
<bullet> Industrial or commercial use in electrical and electronic
products;
<bullet> Consumer use in electrical and electronic products;
<bullet> Industrial or commercial use in foam seating and bedding
products;
<bullet> Consumer use in foam seating and bedding products;
<bullet> Industrial or commercial use in furniture and furnishings;
<bullet> Industrial or commercial use in building and construction
materials; and
<bullet> 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: <a href="https://www.epa.gov/sites/default/files/2020-09/documents/casrn_115-96-8_tris2-chloroethyl_phosphate_tcep_final_scope.pdf">https://www.epa.gov/sites/default/files/2020-09/documents/casrn_115-96-8_tris2-chloroethyl_phosphate_tcep_final_scope.pdf</a>.
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: <a href="https://www.epa.gov/sites/default/files/2020-09/documents/casrn_79-94-7_44-1-methylethylidenebis2_6-dibromophenol_tbbpa_finalscope.pdf">https://www.epa.gov/sites/default/files/2020-09/documents/casrn_79-94-7_44-1-methylethylidenebis2_6-dibromophenol_tbbpa_finalscope.pdf</a>.
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: <a href="https://www.epa.gov/sites/default/files/2020-09/documents/casrn_115-86-6_triphenyl_phosphate_tpp_final_scope.pdf">https://www.epa.gov/sites/default/files/2020-09/documents/casrn_115-86-6_triphenyl_phosphate_tpp_final_scope.pdf</a>.
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 <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
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
(<a href="https://chemview.epa.gov/chemview">https://chemview.epa.gov/chemview</a>).
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 22, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.