Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants, 34147-34154 [2021-13212]
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Federal Register / Vol. 86, No. 122 / Tuesday, June 29, 2021 / Rules and Regulations
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3501 et seq., nor does it require any
special considerations under Executive
Order 12898, entitled ‘‘Federal Actions
to Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance exemption in this action,
do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (5 U.S.C. 601
et seq.) do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or Tribes. As a
result, this action does not alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
EPA has determined that this action will
not have a substantial direct effect on
States or Tribal Governments, on the
relationship between the National
Government and the States or Tribal
Governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, EPA has determined that
Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999), and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
EPA’s consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act (15
U.S.C. 272 note).
V. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
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and pests, Reporting and recordkeeping
requirements.
Dated: June 21, 2021.
Edward Messina,
Acting Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1383 to subpart D to read
as follows:
■
§ 180.1383 Bacillus velezensis strain
RTI301; exemption from the requirement of
a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Bacillus velezensis strain RTI301 in
or on all food commodities when used
in accordance with label directions and
good agricultural practices.
[FR Doc. 2021–13806 Filed 6–28–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 716
[EPA–HQ–OPPT–2020–0474; FRL–10020–
38]
RIN 2070–AB11
Health and Safety Data Reporting;
Addition of 20 High-Priority
Substances and 30 Organohalogen
Flame Retardants
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This final rule, issued
pursuant to the Toxic Substances
Control Act (TSCA) and the TSCA
Health and Safety Data Reporting rule,
requires manufacturers (including
importers) of 50 specified chemical
substances to report certain lists and
copies of unpublished health and safety
studies to EPA. The chemical
substances subject to this rule are listed
in this document and consist of the 20
designated by EPA as High-Priority
Substances and the 30 organohalogen
flame retardants being evaluated for
risks by the Consumer Product Safety
Commission (CPSC) under the Federal
Hazardous Substances Act (FHSA). EPA
is taking this action because the TSCA
Interagency Testing Committee (ITC)
SUMMARY:
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34147
added these chemical substances to the
Priority Testing List through its 69th and
74th Reports and EPA will use this
information to inform the risk
evaluations currently underway for 20
High-Priority Substances and for future
prioritization.
This final rule is effective July
29, 2021. For purposes of judicial
review, this final rule shall be
promulgated at 1 p.m. eastern daylight/
standard time July 13, 2021
A request to withdraw a chemical
substance from this final rule pursuant
to 40 CFR 716.105(c) must be received
on or before July 13, 2021. (See Unit IV.
of the SUPPLEMENTARY INFORMATION.)
Dates for the reporting requirements
are enumerated in Unit III.B. of the
SUPPLEMENTARY INFORMATION.
DATES:
ADDRESSES:
Comments. Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2020–0474, by
using the Federal eRulemaking Portal at
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Do not submit electronically
any information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
Withdrawal requests. For submission
of a withdrawal request, see Unit IV. of
this document. Each withdrawal request
must be identified by docket ID number
EPA–HQ–OPPT–2020–0474.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Diana Fahning, Data Gathering and
Analysis Division (7410M), Office of
Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–8621; email address:
fahning.diana@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
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B. What is the Agency’s authority for
taking this action?
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture (defined
by statute to include import) any of the
chemical substances that are listed in 40
CFR 716.120(d) of the regulatory text of
this document. 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: Chemical
manufacturers (including importers),
(NAICS codes 325 and 324110), e.g.,
persons who manufacture (defined by
statute to include import) one or more
of the subject chemical substances.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through https://
www.regulations.gov or email. Clearly
mark the part or all of the information
that you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
commenting-epa-dockets.
II. Background
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A. What action is the Agency taking?
EPA is issuing a final rule pursuant to
TSCA section 8(d) to require
manufacturers (including importers) of
chemical substances listed in this
document and on the ITC’s TSCA
section 4(e) Priority Testing List to
submit lists and copies of certain
unpublished health and safety studies to
EPA. The regulatory text of this
document lists the chemical substances
and their Chemical Abstracts Service
Registry Numbers (CASRN) that are
being added to the Health and Safety
Data Reporting rule. It also lists the
specific data reporting requirements
imposed by this final rule.
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EPA promulgated the Health and
Safety Data Reporting rule under TSCA
section 8(d) (15 U.S.C. 2607(d)), and it
is codified at 40 CFR part 716. EPA is
using this TSCA section 8(d) rule in
accordance with 40 CFR 716.105 to
gather information on chemical
substances. These studies are expected
to provide EPA with useful information
for conducting TSCA activities such as
prioritization and risk evaluation.
The Agency adds substances to the
rule via rule or notice, in accordance
with 40 CFR 716.105(a) or (b),
respectively. The rule requires certain
past, current, and prospective
manufacturers (which under TSCA
includes importers) to submit copies
and/or lists of unpublished health and
safety studies on the listed chemical
substances that they manufacture. In
some cases, EPA may also require
processors to comply with the rule.
The TSCA section 8(d) Health and
Safety Data Reporting rule provides for
the addition of TSCA section 4(e)
Priority Testing List chemical
substances to the list of chemical
substances subject to the rule (see Table
of Chemicals, 40 CFR 716.120) (Ref. 1).
Whenever EPA announces the receipt of
an ITC Report, EPA may, amend the
TSCA section 8(d) Health and Safety
Data Reporting rule by adding the
recommended (or designated) chemical
substances to the TSCA section 4(e) list.
In doing so, EPA must provide a 14-day
period (measured from the date of
publication of the Federal Register
document announcing the rule) for
persons to submit information showing
why a chemical substance, mixture, or
category of chemical substances should
be withdrawn from the amendment. The
amendment adding these chemical
substances to the Health and Safety Data
Reporting rule is effective July 29, 2021.
If EPA withdraws a chemical substance
from the amendment, a Federal Register
document announcing this decision is
to be published no later than July 29,
2021.
C. Comments Received on the 74th
Report of the ITC
EPA received seven public comments
on the 74th Report of the ITC. One
comment requested additional
information be provided for why certain
organohalogen flame retardants being
added to the Priority Testing List (PTL).
Several comments questioned whether
requiring 8(d) reporting for a chemical
substance for which EPA has issued a
Section 4 Test Order would be
redundant and/or produce data in time
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for use in a risk evaluation under TSCA
section 6 on the applicable chemical
substance. EPA also received a comment
on chemicals substances to remove from
the PTL. Additionally, one commenter
recommended additional activities for
EPA to conduct related to fulfilling data
needs (e.g., via the use of Test Orders
pursuant to section 4 of TSCA).
EPA has reviewed the comments and
continues to believe that it is
appropriate to list these chemical
substances in this document onto the
ITC’s TSCA section 4(e) Priority Testing
List to prompt EPA to implement their
authority pursuant to TSCA section
8(d), to require manufacturers
(including importers) to submit lists and
copies of certain unpublished health
and safety studies to EPA. The 74th ITC
Report provided the basis for its
inclusion of all chemical substances that
were added to the PTL. Regarding
possible redundancies of published and
previously submitted information under
other TSCA programs, under 40 CFR
716.20(a) certain studies are exempt
from the copy and list submission
requirements of 40 CFR 716.30 and
716.35. Within EPA’s current timeline
for risk evaluations under TSCA section
6, data received via this 8(d) action
would be received in time for use in risk
evaluations for chemical substances that
have been designated as high-priority
substances, and data received on the
other chemical substances listed in this
document would help inform future
prioritization activities, as well as help
inform other agency decisions involving
such chemical substances. In regard to
chemical substances being
recommended for deletion from the PTL
and for requests for certain activities to
be undertaken in regard to certain
chemical substances, EPA will consider
such recommendations during future
ITC discussions and during decisionmaking related to its various TSCA
statutory authorities.
D. Why is this action issued as a Final
Rule?
The regulations at 40 CFR 716.105(b)
and (c) establish the process for this
action to amend the TSCA section 8(d)
Health and Safety Data Reporting rule.
III. Final Rule
A. What chemical substances are
added?
In this document, EPA is adding
chemical substances to the TSCA
section 8(d) Health and Safety Data
Reporting rule. This addition
implements 40 CFR 716.105(b), which
generally provides that ‘‘chemical
substances, mixtures, and categories of
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chemical substances that have been
added to the TSCA section 4(e) Priority
List by the Interagency Testing
Committee, established under section 4
of TSCA, will be added to § 716.120
. . .’’ This addition also addresses the
request of the TSCA ITC in its 74th
Report (Ref. 2) to add certain chemical
substances listed in that report to the
TSCA section 8(d) Health and Safety
Data Reporting rule. The specific
chemical substances being added to the
rule are listed in the regulatory text at
the end of this document.
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B. What are the reporting requirements?
Listed in this unit are the reporting
requirements for the chemical
substances added by this final rule to
the TSCA section 8(d) model Health and
Safety Data Reporting rule. The specific
types of health and safety studies that
must be reported for each of the
chemical substances added to the
Health and Safety Data Reporting rule as
a result of this document can be found
in Unit III.C.
1. Persons who, in the 10 years
preceding the date a chemical substance
is listed, either have proposed to
manufacture (including import) or have
manufactured (including imported) the
listed chemical substance must submit
to EPA, during the 60-day reporting
period specified in 40 CFR 716.65 and
according to the reporting schedule set
forth at 40 CFR 716.60, a copy of each
specified type of health and safety study
which is in their possession at the time
the chemical substance is listed in part
716.
2. Persons who, at the time the
chemical substance is listed in part 716,
propose to manufacture (including
import) or are manufacturing (including
importing) the listed chemical substance
must submit to EPA during the 60-day
reporting period specified in 40 CFR
716.65 and according to the reporting
schedule set forth at 40 CFR 716.60:
i. A list of the specified types of
health and safety studies known to them
but not in their possession at the time
the chemical substance is listed.
ii. A list of the specified types of
health and safety studies that are
ongoing at the time the chemical
substance is listed and are being
conducted by or for them.
iii. A list of the specified types of
health and safety studies that are
initiated after the date the chemical
substance is listed and will be
conducted by or for them.
iv. A copy of each specified type of
health and safety study which is in their
possession at the time the chemical
substance is listed.
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v. A copy of each specified type of
health and safety study that was
previously listed as ongoing or
subsequently initiated (i.e., listed in
accordance with reporting requirements
in Unit III.B.2.iii. and iv., respectively)
and is now complete—regardless of
completion date.
3. Persons who, after the time the
chemical substance is listed in part 716,
propose to manufacture (including
import) the listed chemical substance
must submit to EPA during the
reporting period specified in 40 CFR
716.65 and according to the reporting
schedule set forth at 40 CFR 716.60:
i. A list of the specified types of
health and safety studies known to them
but not in their possession at the time
they propose to manufacture (including
import) the listed chemical substance.
ii. A list of the specified types of
health and safety studies that are
ongoing at the time they propose to
manufacture (including import) the
listed chemical substance and are being
conducted by or for them.
iii. A list of the specified types of
health and safety studies that are
initiated after the time they propose to
manufacture (including import) the
listed chemical substance and will be
conducted by or for them.
iv. A copy of each specified type of
health and safety study which is in their
possession at the time they propose to
manufacture (including import) the
listed chemical substance.
v. A copy of each specified type of
health and safety study that was
previously listed as ongoing or
subsequently initiated (i.e., listed in
accordance with reporting requirements
in Unit III.B.3.iii. and 3.iv., respectively)
and is now complete—regardless of the
completion date.
The reporting described in Unit III.B.
is required by September 27, 2021. Any
person who manufactures (including
imports) or who proposes to
manufacture (including import) the
listed chemical substance from July 29,
2021 to September 27, 2021 must inform
EPA (by submitting a list) of any studies
initiated during the period from July 29,
2021 to September 27, 2021 within 30
days of their initiation, but in no case
later than October 27, 2021. In addition,
if any such person has submitted lists of
studies that were ongoing or initiated
during the period from July 29, 2021 to
September 27, 2021 to EPA, such person
must submit a copy of each study
within 30 days after its completion,
regardless of the study’s completion
date. See 40 CFR 716.60 and 716.65.
Detailed guidance for reporting
unpublished health and safety data and
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34149
explanations of reporting exemptions is
provided at 40 CFR part 716.
Persons reporting under this rule may
also assert CBI claims for certain
information included in their
submission. TSCA section imposes the
following requirements:
• CBI claims must be asserted must
be asserted at the time the information
claimed as CBI is submitted to EPA.
Information submitted with a
confidentiality claim may be made
public without further notice.
• Information claimed as CBI must be
substantiated at the time of submission,
with the exception of those types of
information exempt from substantiation
under TSCA section 14(c)(2).
• All persons making a CBI claim
must provide a standard statement
concerning the need for the CBI claim
and a certification that the statement of
need is true and correct.
• Where a specific chemical identity
is claimed as CBI, a structurally
descriptive generic name must be
provided for disclosure to the public.
The 8(d) reporting application
accommodates these requirements,
incorporating the required statements
and certifications, and will prompt the
submitter to provide substantiation
prior to making a submission that
includes CBI claims.
C. What types of studies must be
submitted?
Pursuant to 40 CFR 716.20(b)(5) and
716.50, the types of unpublished health
and safety studies that must be reported
and the chemical grade/purity
requirements that must be met or
exceeded in individual studies for the
chemical substances added to the
Health and Safety Data Reporting rule as
a result of this document are as follows:
Under this rule, manufacturers
(including importers) of High-Priority
Substances are required to submit the
following:
• Lists and copies of unpublished
health and safety studies for all HighPriority Substances specified in this rule
on health effects, such as toxicity
studies (in vivo and in vitro) on
carcinogenicity, reproductive and
developmental effects, genotoxicity,
neurotoxicity, immunotoxicity,
endocrine effects, and other systemic
toxicity and toxicokinetics (absorption,
distribution, metabolism, or
elimination), including modelling
studies, in humans or animals.
• All unpublished studies on
environmental effects, environmental
fate, and physical-chemical properties if
performed as described in 40 CFR
716.50 are also required under this rule.
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• All unpublished studies on
occupational (both users and non-users),
general population, consumer, and
environmental exposure, such as:
Unpublished studies on inhalation and
dermal exposure, human biomonitoring,
environmental monitoring of indoor and
outdoor air, soil, water, and household
dust, chamber emission rates from
products or polymeric matrices, and
unpublished modelling studies that
estimate environmental concentrations
or human exposures.
• Studies showing any measurable
content of the High-Priority Substance
in the tested substance (single
substances or mixture) must be
reported. The composition and purity of
test substances must be reported if
included as part of the study.
• Studies previously submitted to
EPA pursuant to a requirement under
TSCA or of the submitter’s own accord
and studies conducted or to be
conducted pursuant to a TSCA section
4 action are exempt from the submission
of lists of health and safety studies
required under 40 CFR 716.35 and the
submission of studies required under
this rule.
Under this rule, manufacturers
(including importers) of organohalogen
flame retardants are required to submit
the following:
• Lists and copies of unpublished
health and safety studies for all
organohalogen flame retardants
specified in this rule on health effects,
such as toxicity studies (in vivo and in
vitro) on carcinogenicity, reproductive
and developmental effects, genotoxicity,
neurotoxicity, immunotoxicity,
endocrine effects, and other systemic
toxicity and toxicokinetics (absorption,
distribution, metabolism, or
elimination), including modelling
studies, in humans or animals.
• All unpublished studies on
environmental effects, environmental
fate, and physical-chemical properties if
performed as described in 40 CFR
716.50 are also required under this rule.
• All unpublished studies on
occupational (both users and non-users),
general population, consumer, and
environmental exposure, such as
unpublished studies on inhalation and
dermal exposure, human biomonitoring,
environmental monitoring of indoor and
outdoor air, soil, water, and household
dust, chamber emission rates from
products or polymeric matrices, and
unpublished modelling studies that
estimate environmental concentrations
or human exposures, must be submitted.
• Studies showing any measurable
content of the organohalogen flame
retardant in the tested substance (single
substances or mixture) must be
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reported. The composition and purity of
test substances must be reported if
included as part of the study.
• Studies previously submitted to
EPA pursuant to a requirement under
TSCA or of the submitter’s own accord
and studies conducted or to be
conducted pursuant to a TSCA section
4 action are exempt from the submission
of lists of health and safety studies
requirements under 40 CFR 716.35 and
the submission of studies requirements
under this rule.
D. Rationales and Background for
Chemical Additions and Reporting
Requirements
1. High-Priority Substances
The 20 High-Priority Substances
identified in this rule have been
designated High-Priority under TSCA
section 6(b) because EPA has found that
each of these chemical substances may
present an unreasonable risk of injury to
health or the environment (Ref. 3). EPA
is seeking unpublished health and
safety studies to ensure that such
studies are available to EPA to inform
its risk evaluation findings of whether
any of these High-Priority Substances
present an unreasonable risk of injury to
health or the environment. Further, this
information will be considered, as
appropriate, when reviewing potential
analogue data for read across and/or
category development in assessing new
chemicals.
2. Organohalogen Flame Retardants
EPA requests this information to help
support prioritization and evaluation
activities under TSCA (see TSCA
section 6(b), and as discussed above).
Further, this information will be
considered, as appropriate, when
reviewing potential analogue data for
read across and/or category
development in assessing new
chemicals. Additionally, CPSC, a
representative member of the ITC, needs
information on a group of
organohalogen flame retardants because
the Commission voted to grant a
petition to begin rulemaking for this
class of chemicals under the Federal
Hazardous Substances Act (FHSA), (Ref.
5). Organohalogen flame retardants may
be added to consumer products to
prevent or slow combustion, but are
additive, i.e., not covalently bound to
the substrate, which can be textiles,
polymers, or foam. Most organohalogen
flame retardants are semi-volatile
compounds (SVOCs), that can migrate
into air, where they bind to airborne
particles and surfaces in the home. In
addition to direct contact with
organohalogen flame retardant-
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containing products, a substantial
portion of exposure is believed to occur
from exposure to household dust,
especially in children. Biomonitoring
studies and measurements of household
dust and indoor air demonstrate that
exposure to organohalogen flame
retardants is nearly ubiquitous.
Many organohalogen flame retardants
have been shown to cause health effects.
Health effects associated with
organohalogen flame retardants include
carcinogenicity (e.g., halogenated alkyl
phosphates), developmental effects (e.g.,
polybrominated diphenyl ethers
(PBDEs)), and developmental
neurotoxicity (e.g., Decabromodiphenyl
ether (decaBDE)).
In 2015, CPSC was petitioned by a
number of organizations and
individuals, such as consumer groups,
medical associations, workers, and
firefighter organizations, to ban the use
of all additive, non-polymeric
organohalogen flame retardants under
the authority of the FHSA in the
following consumer products: (1)
Durable infant or toddler products,
children’s toys, child care articles, or
other children’s products (other than car
seats, which are under Department of
Transportation’s jurisdiction); (2)
Residential upholstered furniture; (3)
Mattresses and mattress pads; and (4)
The plastic casings of electronic devices
(Ref. 5).
CPSC granted the petition in 2017 and
directed staff to complete a scoping and
feasibility study in cooperation with the
National Academy of Sciences,
Engineering, and Medicine (NASEM).
The task for this project was to develop
a scientifically based scoping plan to
identify the potential health hazards
associated with additive, nonpolymeric
organohalogen flame retardants as a
class. The NASEM Committee
published the report, ‘‘A Class
Approach to Hazard Assessment of
Organohalogen Flame Retardants’’ in
May 2019 (Ref. 6). A key conclusion of
the NASEM Committee is that
organohalogen flame retardants cannot
be treated as a single class. Rather, the
NASEM Committee identified 14
subclasses of organohalogen flame
retardants, based on chemical structure,
physicochemical properties of the
chemicals, and predicted biologic
activity. The NASEM Committee
identified 161 organohalogen flame
retardants and more than 1,000 analog
chemicals. CPSC staff is undertaking the
risk assessment of 14 classes of
organohalogen flame retardants
following the recommendations of the
NASEM Committee.
Because preliminary searches show
that little or no health and safety
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information is available for many of the
161 organohalogen flame retardants,
including the organohalogen flame
retardants being added here to the TSCA
section 8(d) Health and Safety Data
Reporting rule, the submission of the
lists and copies of the unpublished
health and safety studies specified in
this rule is being required under the
TSCA section 8(d) Health and Safety
Data Reporting rule for these OFR
additions. As indicated above, this
information will also inform TSCA
activities such as future prioritization
efforts and, with potential read-across
data, new chemical reviews. Further,
EPA will coordinate with ITC members
to share information received, as
appropriate (e.g., to help inform CPSC’s
evaluation of specific chemicals).
E. What are the incremental economic
implications of this action?
EPA prepared an economic analysis
for the addition of the 50 chemical
substances to the TSCA section 8(d)
Health and Safety Data Reporting rule,
entitled, ‘‘TSCA Section 8(d): Economic
Impact Analysis for Adding 50
Chemicals from the 74th ITC Report of
the TSCA Interagency Testing
Committee to the Health and Safety Data
Reporting Rule.’’ (Economic Analysis,
Ref. 7) a copy of which is included in
the docket for this rulemaking. The total
one-time cost associated with this final
rule is estimated to be approximately
$185,000 based on approximately 1,900
and 420 hours of industry and EPA
burden, respectively.
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IV. Requesting a Chemical Substance
Be Withdrawn From This Final Rule
As specified in 40 CFR 716.105(c),
EPA may, in its discretion, remove a
chemical substance, mixture, or
category of chemical substances from
this final rule for good cause prior to the
effective date of this final rule. Any
person who believes that the reporting
required by this final rule is not
warranted for a chemical substance
listed in this final rule must submit to
EPA detailed reasons for that belief. You
must submit your request to EPA on or
before July 13, 2021 and in accordance
with the instructions provided in 40
CFR 716.105(c) and (d). In addition, to
ensure proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPPT–2020–0474. If the EPA
Administrator withdraws a chemical
substance, mixture, or category of
chemical substances from the
amendment, in accordance with 40 CFR
716.105(c), a Federal Register document
announcing this decision will be
published no later than July 29, 2021.
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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. For
more information about these
references, please consult the technical
person listed under FOR FURTHER
INFORMATION CONTACT.
1. EPA. 40 CFR 716.120. Substances and
listed mixtures to which this subpart
applies. Available online at: https://
www.ecfr.gov/cgibin/textidx?SID=
94b50835053a07b80c3517fff641
aeba&mc=true&node=pt40.33.716&rgn=
div5#se40.33.716_1120.
2. ITC. Notice; Seventy-Fourth Report of the
TSCA Interagency Testing Committee to
the Administrator of the Environmental
Protection Agency; Receipt of Report and
Request for Comments. Federal Register
(86 FR 22414, April 28, 2021) (FRL–
10020–39). Available online at: https://
www.govinfo.gov/content/pkg/FR-202104-28/pdf/2021-08839.pdf.
3. EPA. High-Priority Substance Designations
Under the Toxic Substances Control Act
(TSCA) and Initiation of Risk Evaluation
on High-Priority Substances; Notice of
Availability. Federal Register (84 FR
71924, December 30, 2019) (FRL–10003–
15). Available online at: https://
www.govinfo.gov/content/pkg/FR-201912-30/pdf/2019-28225.pdf.
4. EPA. Procedures for Prioritization of
Chemicals for Risk Evaluation Under the
Toxic Substances Control Act; Final
Rule. Federal Register (82 FR 33753,
December 20, 2017) (FRL–9964–24).
Available online at: https://
www.federalregister.gov/documents/
2017/07/20/2017-14325/procedures-forprioritization-of-chemicals-for-riskevaluation-under-the-toxic-substancescontrol.
5. CPSC. U.S. Consumer Product Safety
Commission Petition: Products
Containing Organohalogen Flame
Retardants. Docket ID number: CPSC–
2015–0022. Available online at: https://
www.regulations.gov/docket?D=CPSC2015-0022.
6. CPSC. National Academies of Sciences,
Engineering, and Medicine 2019. A Class
Approach to Hazard Assessment of
Organohalogen Flame Retardants.
Washington, DC: The National
Academies Press. https://doi.org/
10.17226/25412. Available online at:
https://nap.edu/25412.
7. EPA. TSCA Section 8(d): Economic Impact
Analysis for Adding 50 Chemicals From
the 74th ITC Report of the TSCA
Interagency Testing Committee to the
Health and Safety Data Reporting Rule.
September 10, 2020.
VI. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www2.epa.gov/lawsregulations/laws-and-executive-orders.
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A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
The Office of Management and Budget
(OMB) has exempted actions under
TSCA section 8(d) related to the Health
and Safety Data Reporting rule from the
requirements of Executive Order 12866
(58 FR 51735, October 4, 1993). As such,
this final rule was not reviewed by OMB
under Executive Orders 12866 and
13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to PRA, 44 U.S.C. 3501 et
seq., an agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0004. This action does
not impose any burden requiring
additional OMB approval. You can find
a copy of the ICR in the docket for this
rule, and it is briefly summarized here.
This action requires the reporting of
health and safety data to EPA by
manufacturers (including importers) of
certain chemical substances requested
by the ITC to be added to the Health and
Safety Data Reporting Rule in its
Seventy-Fourth Report of the ITC (Ref.
2). EPA intends to use information
collected under the rule to assist in
chemical assessments under TSCA, and
to inform any additional work necessary
under environmental protection
mandates beyond TSCA. Submitters
may designate information as
confidential, trade secret, or proprietary.
EPA has implemented procedures to
protect any confidential, trade secret or
proprietary information from disclosure.
These procedures comply with TSCA
section 14 and EPA’s confidentiality
regulation, 40 CFR part 2, subpart B.
Respondents/affected entities:
Manufacturers (including importers) of
50 chemical substances requested by the
ITC to be included in the Health and
Safety Data Reporting Rule.
Respondents’ obligation to respond:
Mandatory (15 U.S.C. 2607(d)).
Estimated number of respondents: 23.
Frequency of response: Once.
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Total estimated burden: 1,854 hours
(per year). Burden is defined at 5 CFR
1320.3(b).
Total estimated cost: $146,745 (per
year), with no annualized capital or
operation and maintenance costs.
C. Regulatory Flexibility Act (RFA)
Pursuant to RFA section 605(b), 5
U.S.C. 601 et seq., I hereby certify that
this action will not have a significant
economic impact on a substantial
number of small entities as defined by
the RFA. The small entities subject to
the requirements of this action are
manufacturers (including importers) of
50 chemicals requested by the ITC to be
added to the Health and Safety Data
Reporting Rule. EPA estimates that 106
of the 129 firms in the affected universe
are small entities. Of those small firms,
all would have cost impacts of less than
1% of annual revenue. Details of this
analysis are presented in the Economic
Analysis of this rule (Ref. 7), which can
be found in the docket.
D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain an
unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C.
1531–1538, and does not significantly or
uniquely affect small governments. The
requirements of this action would
primarily affect manufacturers
(including importers) of 50 chemical
substances listed in 40 CFR 716.120(d)
of the regulatory text of this document.
The total quantified one-time costs of
this final rule are approximately
$183,812.
E. Executive Order 13132: Federalism
This action does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999). It will not have substantial direct
effects 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.
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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). 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. Thus,
E.O. 13175 does not apply to this action.
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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 the Agency
has reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order. This action is not a
covered regulatory action because it is
not ‘‘economically significant’’ under
Executive Order 12866 and it does not
concern an environmental health risk or
safety risk. Although this action would
not establish an environmental standard
intended to mitigate health or safety
risks, the information that would be
submitted to EPA in accordance with
this rule would be used to inform the
Agency’s decision-making process
regarding chemical substances to which
children may be disproportionately
exposed. This information may also
assist the Agency and others in
determining whether the chemical
substances covered in this proposed
rule present potential risks, which
would allow the Agency and others to
take appropriate action to investigate
and mitigate those risks.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not a ‘‘significant
energy action’’ as defined in Executive
Order 13211 (66 FR 28355, May 22,
2001) because it is not likely to have a
significant adverse effect on the supply,
distribution, or use of energy and has
not otherwise been designated by the
Administrator of OMB’s Office of
Information and Regulatory Affairs as a
‘‘significant energy action.’’
I. National Technology Transfer and
Advancement Act (NTTAA)
Because this action does not involve
any technical standards, NTTAA section
12(d), 15 U.S.C. 272 note, does not
apply to this action.
J. Executive Order 12898: Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898 (59 FR 7629,
February 16, 1994). However, the
Agency believes that the information
collected through this rule will inform
the TSCA risk evaluations that are
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planned for these chemicals and will
thereby enable the Agency to better
protect human health and the
environment, including in low-income
and minority communities.
L. Congressional Review Act (CRA)
This action is subject to the CRA (5
U.S.C. 801 et seq.), and EPA will submit
a rule report to each House of the
Congress and to the Comptroller General
of the United States. This action is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 716
Environmental protection, Chemicals,
Hazardous substances, Health and
safety, Reporting and recordkeeping
requirements.
Dated: June 17, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 716—HEALTH AND SAFETY
DATA REPORTING
1. The authority citation for part 716
continues to read as follows:
■
Authority: 15 U.S.C. 2607(d).
2. In § 716.21, add paragraphs (a)(9)
and (10) to read as follows:
■
§ 716.21 Chemical specific reporting
requirements.
(a) * * *
(9) For 1,3-Butadiene (106–99–0),
Butyl benzyl phthalate (BBP)—1,2Benzene- dicarboxylic acid, 1- butyl
2(phenylmethyl) ester (85–68–7),
Dibutyl phthalate (DBP) (1,2-Benzenedicarboxylic acid, 1,2- dibutyl ester)
(84–74–2), o-Dichlorobenzene (95–50–
1), p-Dichlorobenzene (106–46–7),
trans-1,2-Dichloroethylene (156–60–5),
1,2-Dichloropropane (78–87–5),
Dicyclohexyl phthalate (84–61–7), Diethylhexyl phthalate (DEHP)—(1,2Benzene- dicarboxylic acid, 1,2- bis(2ethylhexyl) ester) (117–81–7), Diisobutyl phthalate (DIBP)—(1,2Benzene- dicarboxylic acid, 1,2- bis(2methylpropyl) ester) (84–69–5),
Formaldehyde (50–00–0), 1,3,4,6,7,8Hexahydro-4,6,6,7,8,8hexamethylcyclopenta [g]-2-benzopyran
(HHCB) (1222–05–5), Phthalic
anhydride (85–44–9), 4,4′-(1Methylethylidene)bis[2, 6dibromophenol] (TBBPA) (79–94–7),
and 1,1,2-Trichloroethane (79–00–5), all
unpublished studies on health effects
(including toxicity studies (in vivo and
in vitro) on carcinogenicity,
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reproductive and developmental effects,
genotoxicity, neurotoxicity,
immunotoxicity, endocrine effects, and
other systemic toxicity); toxicokinetics
(absorption, distribution, metabolism, or
elimination), including modelling
studies, in humans or animals;
environmental effects; environmental
fate; physical-chemical properties if
performed as described in 40 CFR
716.50; and occupational (both users
and non-users), general population,
consumer, bystander, and
environmental exposure must be
submitted. Studies showing any
measurable content of the High-Priority
Substance in the tested substance
(single substances or mixture) must be
reported. The composition and purity of
test substances must be reported if
included as part of the study. Studies
previously submitted to EPA pursuant
to a requirement under TSCA or of the
submitter’s own accord and studies
conducted or to be conducted pursuant
to a TSCA section 4 action are exempt
from the submission of lists of health
and safety studies required under 40
CFR 716.35 and the submission of
studies required under this rule.
(10) For purposes of this paragraph,
the term organohalogen flame retardant
includes any substances listed in
paragraph(d) of this section under the
category ‘‘Organohalogen flame
retardants’’. For any organohalogen
flame retardant, all unpublished studies
on health effects (including toxicity
studies (in vivo and in vitro) on
carcinogenicity, reproductive and
developmental effects, genotoxicity,
neurotoxicity, immunotoxicity,
endocrine effects, and other systemic
toxicity); toxicokinetics (absorption,
distribution, metabolism, or
elimination), including modelling
studies, in humans or animals;
environmental fate; physical-chemical
properties if performed as described in
40 CFR 716.50; and occupational (both
users and non-users), general
population, consumer, bystander, and
environmental exposure must be
submitted. Studies showing any
measurable content of the
organohalogen flame retardant in the
tested substance (single substances or
mixture) must be reported. The
composition and purity of test
substances must be reported if included
as part of the study. Studies previously
submitted to EPA pursuant to a
requirement under TSCA or of the
submitter’s own accord and studies
conducted or to be conducted pursuant
to a TSCA section 4 action are exempt
from the submission of lists of health
and safety studies requirements under
40 CFR 716.35 and the submission of
studies requirements under this rule.
*
*
*
*
*
■ 3. In § 716.120, amend the table in
paragraph (d) by:
■ a. Adding in alphabetical order the
category ‘‘High-Priority Substances’’ and
entries ‘‘1,3-Butadiene’’, ‘‘Butyl benzyl
phthalate (BBP)—1,2-Benzenedicarboxylic acid, 1-butyl
2(phenylmethyl) ester’’, ‘‘Dibutyl
phthalate (DBP) (1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester)’’,
‘‘o-Dichlorobenzene’’,
‘‘p-Dichlorobenzene’’, ‘‘1,1Dichloroethane’’, ‘‘1,2-Dichloroethane’’,
‘‘Trans-1,2- Dichloroethylene’’, ‘‘1,2Dichloropropane’’, ‘‘Dicyclohexyl
phthalate’’, ‘‘Di-ethylhexyl phthalate
(DEHP)—(1,2-Benzene-dicarboxylic
acid, 1,2- bis(2-ethylhexyl) ester)’’, ‘‘Diisobutyl phthalate (DIBP)—(1,2Benzene- dicarboxylic acid, 1,2- bis(2methylpropyl) ester)’’, ‘‘Ethylene
dibromide’’, ‘‘Formaldehyde’’,
‘‘1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8hexamethylcyclopenta [g]-2-benzopyran
(HHCB)’’, ‘‘4,4′-(1Methylethylidene)bis[2, 6dibromophenol] (TBBPA)’’, ‘‘Phosphoric
acid, triphenyl ester (TPP)’’, ‘‘Phthalic
anhydride’’, ‘‘1,1,2-Trichloroethane’’,
and ‘‘Tris(2-chloroethyl) phosphate
(TCEP)’’; and
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Category
CAS No.
High-Priority Substances:
1,3-Butadiene ........................................................................................
Butyl benzyl phthalate (BBP)—1,2-Benzene-dicarboxylic acid, 1butyl 2(phenylmethyl) ester ...............................................................
Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl
ester) ..................................................................................................
o-Dichlorobenzene ................................................................................
p-Dichlorobenzene ................................................................................
1,1-Dichloroethane ................................................................................
1,2-Dichloroethane ................................................................................
Trans-1,2-Dichloroethylene ...................................................................
1,2-Dichloropropane ..............................................................................
Dicyclohexyl phthalate ..........................................................................
Di-ethylhexyl phthalate (DEHP)—(1,2-Benzene-dicarboxylic acid, 1,2bis(2-ethylhexyl) ester) ......................................................................
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b. Adding in alphabetical order the
category ‘‘Organohalogen flame
retardants’’ and entries ‘‘Bis(2ethylhexyl) tetrabromophthalate’’,
‘‘Bis(hexachlorocyclopentadieno)
cyclooctane’’, ‘‘1,2-Bis(2,4,6tribromophenoxy)ethane’’, ‘‘1,1′-Ethane1,2-diylbis(pentabromobenzene)’’, ‘‘2Ethylhexyl-2,3,4,5-tetrabromobenzoate’’,
‘‘2-(2-Hydroxyethoxy)ethyl 2hydroxypropyl 3,4,5,6tetrabromophthalate’’, ‘‘2,2′-[(1Methylethylidene)bis[(2,6-dibromo-4,1phenylene)oxymethylene]]bis[oxirane]’’,
‘‘Mixture of chlorinated linear alkanes
C14–17 with 45–52% chlorine’’, ‘‘N,NEthylene-bis(tetrabromophthalimide)’’,
‘‘Pentabromochlorocyclohexane’’,
‘‘(Pentabromophenyl)methyl acrylate’’,
‘‘Pentabromotoluene’’, ‘‘Perbromo-1,4diphenoxybenzene’’, ‘‘Phosphonic acid,
(2-chloroethyl)-, bis(2-chloroethyl)
ester’’, ‘‘Phosphoric acid, 2,2bis(chloromethyl)-1,3-propanediyl
tetrakis(2-chloroethyl) ester’’,
‘‘Propanoic acid, 2-bromo-, methyl
ester’’, ‘‘Tetrabromobisphenol A-bis(2,3dibromopropyl ether)’’,
‘‘Tetrabromobisphenol A bis(2hydroxyethyl) ether’’,
‘‘Tetrabromobisphenol A diallyl ether’’,
‘‘Tetrabromobisphenol A dimethyl
ether’’, ‘‘2,4,6-Tribromoaniline’’, ‘‘1,3,5Tribromo-2-(prop-2-en-1yloxy)benzene’’, ‘‘Tris(2-chloroethyl)
phosphite’’, ‘‘Tris(1-chloro-2propyl)phosphate’’, ‘‘Tris(2-chloro-1propyl)phosphate’’, ‘‘Tris(2,3dibromopropyl) phosphate’’, ‘‘1,3,5Tris(2,3-dibromopropyl)-1,3,5-triazine2,4,6(1H,3H,5H)-trione’’, ‘‘Tris(1,3dichloro-2-propyl)phosphate’’,
‘‘Tris(tribromoneopentyl)phosphate’’,
and ‘‘2,4,6-Tris-(2,4,6tribromophenoxy)-1,3,5-triazine’’.
The additions read as follows:
■
§ 716.120 Substances and listed mixtures
to which this subpart applies.
*
*
*
(d) * * *
Special exemptions
*
*
Effective
date
Sunset date
106–99–0
§ 716.21(a)(9)
7/29/21
9/27/21
85–68–7
§ 716.21(a)(9)
7/29/21
9/27/21
84–74–2
95–50–1
106–46–7
75–34–3
107–06–2
156–60–5
78–87–5
84–61–7
§ 716.21(a)(9)
§ 716.21(a)(9)
§ 716.21(a)(9)
§ 716.21(a)(9)
§ 716.21(a)(9)
§ 716.21(a)(9)
§ 716.21(a)(9)
§ 716.21(a)(9)
7/29/21
7/29/21
7/29/21
7/29/21
7/29/21
7/29/21
7/29/21
7/29/21
9/27/21
9/27/21
9/27/21
9/27/21
9/27/21
9/27/21
9/27/21
9/27/21
117–81–7
§ 716.21(a)(9)
7/29/21
9/27/21
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Category
CAS No.
Di-isobutyl phthalate (DIBP)—(1,2-Benzene-dicarboxylic acid, 1,2bis-(2methylpropyl) ester) ..................................................................
Ethylene dibromide ...............................................................................
Formaldehyde .......................................................................................
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta
[g]-2benzopyran (HHCB) ..........................................................................
4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) ..................
Phosphoric acid, triphenyl ester (TPP) .................................................
Phthalic anhydride .................................................................................
1,1,2-Trichloroethane ............................................................................
Tris(2-chloroethyl) phosphate (TCEP) ..................................................
*
*
*
*
Organohalogen flame retardants:
Bis(2-ethylhexyl) tetrabromophthalate ..................................................
Bis(hexachlorocyclopentadieno)cyclooctane ........................................
1,2-Bis(2,4,6-tribromophenoxy)ethane ..................................................
1,1′-Ethane-1,2-diylbis(pentabromobenzene) .......................................
2-Ethylhexyl-2,3,4,5-tetrabromobenzoate .............................................
2-(2-Hydroxyethoxy)ethyl
2-hydroxypropyl
3,4,5,6tetrabromophthalate ...........................................................................
2,2′-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bis[oxirane] ......................................................
Mixture of chlorinated linear alkanes C14–17 with 45–52% chlorine ..
N,N-Ethylene-bis(tetrabromophthalimide) .............................................
Pentabromochlorocyclohexane .............................................................
(Pentabromophenyl)methyl acrylate .....................................................
Pentabromotoluene ...............................................................................
Perbromo-1,4-diphenoxybenzene .........................................................
Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester ..................
Phosphoric acid, 2,2-bis(chloromethyl)-1,3-propanediyl tetrakis(2chloroethyl) ester ...............................................................................
Propanoic acid, 2-bromo-, methyl ester ................................................
Tetrabromobisphenol A-bis(2,3-dibromopropyl ether) ..........................
Tetrabromobisphenol A bis(2-hydroxyethyl) ether ................................
Tetrabromobisphenol A diallyl ether .....................................................
Tetrabromobisphenol A dimethyl ether .................................................
2,4,6-Tribromoaniline ............................................................................
1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene ......................................
Tris(2-chloroethyl)phosphite ..................................................................
Tris(1-chloro-2-propyl)phosphate ..........................................................
Tris(2-chloro-1-propyl)phosphate ..........................................................
Tris(2,3-dibromopropyl)phosphate ........................................................
1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione ....
Tris(1,3-dichloro-2-propyl)phosphate ....................................................
Tris(tribromoneopentyl)phosphate ........................................................
2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine ..................................
[FR Doc. 2021–13212 Filed 6–28–21; 8:45 am]
BILLING CODE 6560–50–P
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rulemaking. All comments received will
be posted without change to https://
www.regulations.gov, including any
personal information provided. Do not
submit electronically any information
you consider to be private, Confidential
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information whose disclosure is
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[Federal Register Volume 86, Number 122 (Tuesday, June 29, 2021)]
[Rules and Regulations]
[Pages 34147-34154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13212]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 716
[EPA-HQ-OPPT-2020-0474; FRL-10020-38]
RIN 2070-AB11
Health and Safety Data Reporting; Addition of 20 High-Priority
Substances and 30 Organohalogen Flame Retardants
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This final rule, issued pursuant to the Toxic Substances
Control Act (TSCA) and the TSCA Health and Safety Data Reporting rule,
requires manufacturers (including importers) of 50 specified chemical
substances to report certain lists and copies of unpublished health and
safety studies to EPA. The chemical substances subject to this rule are
listed in this document and consist of the 20 designated by EPA as
High-Priority Substances and the 30 organohalogen flame retardants
being evaluated for risks by the Consumer Product Safety Commission
(CPSC) under the Federal Hazardous Substances Act (FHSA). EPA is taking
this action because the TSCA Interagency Testing Committee (ITC) added
these chemical substances to the Priority Testing List through its 69th
and 74th Reports and EPA will use this information to inform the risk
evaluations currently underway for 20 High-Priority Substances and for
future prioritization.
DATES: This final rule is effective July 29, 2021. For purposes of
judicial review, this final rule shall be promulgated at 1 p.m. eastern
daylight/standard time July 13, 2021
A request to withdraw a chemical substance from this final rule
pursuant to 40 CFR 716.105(c) must be received on or before July 13,
2021. (See Unit IV. of the SUPPLEMENTARY INFORMATION.)
Dates for the reporting requirements are enumerated in Unit III.B.
of the SUPPLEMENTARY INFORMATION.
ADDRESSES:
Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0474, by using the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
Withdrawal requests. For submission of a withdrawal request, see
Unit IV. of this document. Each withdrawal request must be identified
by docket ID number EPA-HQ-OPPT-2020-0474.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Diana Fahning, Data Gathering
and Analysis Division (7410M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 564-8621; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
[[Page 34148]]
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(defined by statute to include import) any of the chemical substances
that are listed in 40 CFR 716.120(d) of the regulatory text of this
document. 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:
Chemical manufacturers (including importers), (NAICS codes 325 and
324110), e.g., persons who manufacture (defined by statute to include
import) one or more of the subject chemical substances.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
https://www.regulations.gov or email. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
as CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.
II. Background
A. What action is the Agency taking?
EPA is issuing a final rule pursuant to TSCA section 8(d) to
require manufacturers (including importers) of chemical substances
listed in this document and on the ITC's TSCA section 4(e) Priority
Testing List to submit lists and copies of certain unpublished health
and safety studies to EPA. The regulatory text of this document lists
the chemical substances and their Chemical Abstracts Service Registry
Numbers (CASRN) that are being added to the Health and Safety Data
Reporting rule. It also lists the specific data reporting requirements
imposed by this final rule.
B. What is the Agency's authority for taking this action?
EPA promulgated the Health and Safety Data Reporting rule under
TSCA section 8(d) (15 U.S.C. 2607(d)), and it is codified at 40 CFR
part 716. EPA is using this TSCA section 8(d) rule in accordance with
40 CFR 716.105 to gather information on chemical substances. These
studies are expected to provide EPA with useful information for
conducting TSCA activities such as prioritization and risk evaluation.
The Agency adds substances to the rule via rule or notice, in
accordance with 40 CFR 716.105(a) or (b), respectively. The rule
requires certain past, current, and prospective manufacturers (which
under TSCA includes importers) to submit copies and/or lists of
unpublished health and safety studies on the listed chemical substances
that they manufacture. In some cases, EPA may also require processors
to comply with the rule.
The TSCA section 8(d) Health and Safety Data Reporting rule
provides for the addition of TSCA section 4(e) Priority Testing List
chemical substances to the list of chemical substances subject to the
rule (see Table of Chemicals, 40 CFR 716.120) (Ref. 1). Whenever EPA
announces the receipt of an ITC Report, EPA may, amend the TSCA section
8(d) Health and Safety Data Reporting rule by adding the recommended
(or designated) chemical substances to the TSCA section 4(e) list. In
doing so, EPA must provide a 14-day period (measured from the date of
publication of the Federal Register document announcing the rule) for
persons to submit information showing why a chemical substance,
mixture, or category of chemical substances should be withdrawn from
the amendment. The amendment adding these chemical substances to the
Health and Safety Data Reporting rule is effective July 29, 2021. If
EPA withdraws a chemical substance from the amendment, a Federal
Register document announcing this decision is to be published no later
than July 29, 2021.
C. Comments Received on the 74th Report of the ITC
EPA received seven public comments on the 74th Report of the ITC.
One comment requested additional information be provided for why
certain organohalogen flame retardants being added to the Priority
Testing List (PTL). Several comments questioned whether requiring 8(d)
reporting for a chemical substance for which EPA has issued a Section 4
Test Order would be redundant and/or produce data in time for use in a
risk evaluation under TSCA section 6 on the applicable chemical
substance. EPA also received a comment on chemicals substances to
remove from the PTL. Additionally, one commenter recommended additional
activities for EPA to conduct related to fulfilling data needs (e.g.,
via the use of Test Orders pursuant to section 4 of TSCA).
EPA has reviewed the comments and continues to believe that it is
appropriate to list these chemical substances in this document onto the
ITC's TSCA section 4(e) Priority Testing List to prompt EPA to
implement their authority pursuant to TSCA section 8(d), to require
manufacturers (including importers) to submit lists and copies of
certain unpublished health and safety studies to EPA. The 74th ITC
Report provided the basis for its inclusion of all chemical substances
that were added to the PTL. Regarding possible redundancies of
published and previously submitted information under other TSCA
programs, under 40 CFR 716.20(a) certain studies are exempt from the
copy and list submission requirements of 40 CFR 716.30 and 716.35.
Within EPA's current timeline for risk evaluations under TSCA section
6, data received via this 8(d) action would be received in time for use
in risk evaluations for chemical substances that have been designated
as high-priority substances, and data received on the other chemical
substances listed in this document would help inform future
prioritization activities, as well as help inform other agency
decisions involving such chemical substances. In regard to chemical
substances being recommended for deletion from the PTL and for requests
for certain activities to be undertaken in regard to certain chemical
substances, EPA will consider such recommendations during future ITC
discussions and during decision-making related to its various TSCA
statutory authorities.
D. Why is this action issued as a Final Rule?
The regulations at 40 CFR 716.105(b) and (c) establish the process
for this action to amend the TSCA section 8(d) Health and Safety Data
Reporting rule.
III. Final Rule
A. What chemical substances are added?
In this document, EPA is adding chemical substances to the TSCA
section 8(d) Health and Safety Data Reporting rule. This addition
implements 40 CFR 716.105(b), which generally provides that ``chemical
substances, mixtures, and categories of
[[Page 34149]]
chemical substances that have been added to the TSCA section 4(e)
Priority List by the Interagency Testing Committee, established under
section 4 of TSCA, will be added to Sec. 716.120 . . .'' This addition
also addresses the request of the TSCA ITC in its 74th Report (Ref. 2)
to add certain chemical substances listed in that report to the TSCA
section 8(d) Health and Safety Data Reporting rule. The specific
chemical substances being added to the rule are listed in the
regulatory text at the end of this document.
B. What are the reporting requirements?
Listed in this unit are the reporting requirements for the chemical
substances added by this final rule to the TSCA section 8(d) model
Health and Safety Data Reporting rule. The specific types of health and
safety studies that must be reported for each of the chemical
substances added to the Health and Safety Data Reporting rule as a
result of this document can be found in Unit III.C.
1. Persons who, in the 10 years preceding the date a chemical
substance is listed, either have proposed to manufacture (including
import) or have manufactured (including imported) the listed chemical
substance must submit to EPA, during the 60-day reporting period
specified in 40 CFR 716.65 and according to the reporting schedule set
forth at 40 CFR 716.60, a copy of each specified type of health and
safety study which is in their possession at the time the chemical
substance is listed in part 716.
2. Persons who, at the time the chemical substance is listed in
part 716, propose to manufacture (including import) or are
manufacturing (including importing) the listed chemical substance must
submit to EPA during the 60-day reporting period specified in 40 CFR
716.65 and according to the reporting schedule set forth at 40 CFR
716.60:
i. A list of the specified types of health and safety studies known
to them but not in their possession at the time the chemical substance
is listed.
ii. A list of the specified types of health and safety studies that
are ongoing at the time the chemical substance is listed and are being
conducted by or for them.
iii. A list of the specified types of health and safety studies
that are initiated after the date the chemical substance is listed and
will be conducted by or for them.
iv. A copy of each specified type of health and safety study which
is in their possession at the time the chemical substance is listed.
v. A copy of each specified type of health and safety study that
was previously listed as ongoing or subsequently initiated (i.e.,
listed in accordance with reporting requirements in Unit III.B.2.iii.
and iv., respectively) and is now complete--regardless of completion
date.
3. Persons who, after the time the chemical substance is listed in
part 716, propose to manufacture (including import) the listed chemical
substance must submit to EPA during the reporting period specified in
40 CFR 716.65 and according to the reporting schedule set forth at 40
CFR 716.60:
i. A list of the specified types of health and safety studies known
to them but not in their possession at the time they propose to
manufacture (including import) the listed chemical substance.
ii. A list of the specified types of health and safety studies that
are ongoing at the time they propose to manufacture (including import)
the listed chemical substance and are being conducted by or for them.
iii. A list of the specified types of health and safety studies
that are initiated after the time they propose to manufacture
(including import) the listed chemical substance and will be conducted
by or for them.
iv. A copy of each specified type of health and safety study which
is in their possession at the time they propose to manufacture
(including import) the listed chemical substance.
v. A copy of each specified type of health and safety study that
was previously listed as ongoing or subsequently initiated (i.e.,
listed in accordance with reporting requirements in Unit III.B.3.iii.
and 3.iv., respectively) and is now complete--regardless of the
completion date.
The reporting described in Unit III.B. is required by September 27,
2021. Any person who manufactures (including imports) or who proposes
to manufacture (including import) the listed chemical substance from
July 29, 2021 to September 27, 2021 must inform EPA (by submitting a
list) of any studies initiated during the period from July 29, 2021 to
September 27, 2021 within 30 days of their initiation, but in no case
later than October 27, 2021. In addition, if any such person has
submitted lists of studies that were ongoing or initiated during the
period from July 29, 2021 to September 27, 2021 to EPA, such person
must submit a copy of each study within 30 days after its completion,
regardless of the study's completion date. See 40 CFR 716.60 and
716.65.
Detailed guidance for reporting unpublished health and safety data
and explanations of reporting exemptions is provided at 40 CFR part
716.
Persons reporting under this rule may also assert CBI claims for
certain information included in their submission. TSCA section imposes
the following requirements:
CBI claims must be asserted must be asserted at the time
the information claimed as CBI is submitted to EPA. Information
submitted with a confidentiality claim may be made public without
further notice.
Information claimed as CBI must be substantiated at the
time of submission, with the exception of those types of information
exempt from substantiation under TSCA section 14(c)(2).
All persons making a CBI claim must provide a standard
statement concerning the need for the CBI claim and a certification
that the statement of need is true and correct.
Where a specific chemical identity is claimed as CBI, a
structurally descriptive generic name must be provided for disclosure
to the public.
The 8(d) reporting application accommodates these requirements,
incorporating the required statements and certifications, and will
prompt the submitter to provide substantiation prior to making a
submission that includes CBI claims.
C. What types of studies must be submitted?
Pursuant to 40 CFR 716.20(b)(5) and 716.50, the types of
unpublished health and safety studies that must be reported and the
chemical grade/purity requirements that must be met or exceeded in
individual studies for the chemical substances added to the Health and
Safety Data Reporting rule as a result of this document are as follows:
Under this rule, manufacturers (including importers) of High-
Priority Substances are required to submit the following:
Lists and copies of unpublished health and safety studies
for all High-Priority Substances specified in this rule on health
effects, such as toxicity studies (in vivo and in vitro) on
carcinogenicity, reproductive and developmental effects, genotoxicity,
neurotoxicity, immunotoxicity, endocrine effects, and other systemic
toxicity and toxicokinetics (absorption, distribution, metabolism, or
elimination), including modelling studies, in humans or animals.
All unpublished studies on environmental effects,
environmental fate, and physical-chemical properties if performed as
described in 40 CFR 716.50 are also required under this rule.
[[Page 34150]]
All unpublished studies on occupational (both users and
non-users), general population, consumer, and environmental exposure,
such as: Unpublished studies on inhalation and dermal exposure, human
biomonitoring, environmental monitoring of indoor and outdoor air,
soil, water, and household dust, chamber emission rates from products
or polymeric matrices, and unpublished modelling studies that estimate
environmental concentrations or human exposures.
Studies showing any measurable content of the High-
Priority Substance in the tested substance (single substances or
mixture) must be reported. The composition and purity of test
substances must be reported if included as part of the study.
Studies previously submitted to EPA pursuant to a
requirement under TSCA or of the submitter's own accord and studies
conducted or to be conducted pursuant to a TSCA section 4 action are
exempt from the submission of lists of health and safety studies
required under 40 CFR 716.35 and the submission of studies required
under this rule.
Under this rule, manufacturers (including importers) of
organohalogen flame retardants are required to submit the following:
Lists and copies of unpublished health and safety studies
for all organohalogen flame retardants specified in this rule on health
effects, such as toxicity studies (in vivo and in vitro) on
carcinogenicity, reproductive and developmental effects, genotoxicity,
neurotoxicity, immunotoxicity, endocrine effects, and other systemic
toxicity and toxicokinetics (absorption, distribution, metabolism, or
elimination), including modelling studies, in humans or animals.
All unpublished studies on environmental effects,
environmental fate, and physical-chemical properties if performed as
described in 40 CFR 716.50 are also required under this rule.
All unpublished studies on occupational (both users and
non-users), general population, consumer, and environmental exposure,
such as unpublished studies on inhalation and dermal exposure, human
biomonitoring, environmental monitoring of indoor and outdoor air,
soil, water, and household dust, chamber emission rates from products
or polymeric matrices, and unpublished modelling studies that estimate
environmental concentrations or human exposures, must be submitted.
Studies showing any measurable content of the
organohalogen flame retardant in the tested substance (single
substances or mixture) must be reported. The composition and purity of
test substances must be reported if included as part of the study.
Studies previously submitted to EPA pursuant to a
requirement under TSCA or of the submitter's own accord and studies
conducted or to be conducted pursuant to a TSCA section 4 action are
exempt from the submission of lists of health and safety studies
requirements under 40 CFR 716.35 and the submission of studies
requirements under this rule.
D. Rationales and Background for Chemical Additions and Reporting
Requirements
1. High-Priority Substances
The 20 High-Priority Substances identified in this rule have been
designated High-Priority under TSCA section 6(b) because EPA has found
that each of these chemical substances may present an unreasonable risk
of injury to health or the environment (Ref. 3). EPA is seeking
unpublished health and safety studies to ensure that such studies are
available to EPA to inform its risk evaluation findings of whether any
of these High-Priority Substances present an unreasonable risk of
injury to health or the environment. Further, this information will be
considered, as appropriate, when reviewing potential analogue data for
read across and/or category development in assessing new chemicals.
2. Organohalogen Flame Retardants
EPA requests this information to help support prioritization and
evaluation activities under TSCA (see TSCA section 6(b), and as
discussed above). Further, this information will be considered, as
appropriate, when reviewing potential analogue data for read across
and/or category development in assessing new chemicals. Additionally,
CPSC, a representative member of the ITC, needs information on a group
of organohalogen flame retardants because the Commission voted to grant
a petition to begin rulemaking for this class of chemicals under the
Federal Hazardous Substances Act (FHSA), (Ref. 5). Organohalogen flame
retardants may be added to consumer products to prevent or slow
combustion, but are additive, i.e., not covalently bound to the
substrate, which can be textiles, polymers, or foam. Most organohalogen
flame retardants are semi-volatile compounds (SVOCs), that can migrate
into air, where they bind to airborne particles and surfaces in the
home. In addition to direct contact with organohalogen flame retardant-
containing products, a substantial portion of exposure is believed to
occur from exposure to household dust, especially in children.
Biomonitoring studies and measurements of household dust and indoor air
demonstrate that exposure to organohalogen flame retardants is nearly
ubiquitous.
Many organohalogen flame retardants have been shown to cause health
effects. Health effects associated with organohalogen flame retardants
include carcinogenicity (e.g., halogenated alkyl phosphates),
developmental effects (e.g., polybrominated diphenyl ethers (PBDEs)),
and developmental neurotoxicity (e.g., Decabromodiphenyl ether
(decaBDE)).
In 2015, CPSC was petitioned by a number of organizations and
individuals, such as consumer groups, medical associations, workers,
and firefighter organizations, to ban the use of all additive, non-
polymeric organohalogen flame retardants under the authority of the
FHSA in the following consumer products: (1) Durable infant or toddler
products, children's toys, child care articles, or other children's
products (other than car seats, which are under Department of
Transportation's jurisdiction); (2) Residential upholstered furniture;
(3) Mattresses and mattress pads; and (4) The plastic casings of
electronic devices (Ref. 5).
CPSC granted the petition in 2017 and directed staff to complete a
scoping and feasibility study in cooperation with the National Academy
of Sciences, Engineering, and Medicine (NASEM). The task for this
project was to develop a scientifically based scoping plan to identify
the potential health hazards associated with additive, nonpolymeric
organohalogen flame retardants as a class. The NASEM Committee
published the report, ``A Class Approach to Hazard Assessment of
Organohalogen Flame Retardants'' in May 2019 (Ref. 6). A key conclusion
of the NASEM Committee is that organohalogen flame retardants cannot be
treated as a single class. Rather, the NASEM Committee identified 14
subclasses of organohalogen flame retardants, based on chemical
structure, physicochemical properties of the chemicals, and predicted
biologic activity. The NASEM Committee identified 161 organohalogen
flame retardants and more than 1,000 analog chemicals. CPSC staff is
undertaking the risk assessment of 14 classes of organohalogen flame
retardants following the recommendations of the NASEM Committee.
Because preliminary searches show that little or no health and
safety
[[Page 34151]]
information is available for many of the 161 organohalogen flame
retardants, including the organohalogen flame retardants being added
here to the TSCA section 8(d) Health and Safety Data Reporting rule,
the submission of the lists and copies of the unpublished health and
safety studies specified in this rule is being required under the TSCA
section 8(d) Health and Safety Data Reporting rule for these OFR
additions. As indicated above, this information will also inform TSCA
activities such as future prioritization efforts and, with potential
read-across data, new chemical reviews. Further, EPA will coordinate
with ITC members to share information received, as appropriate (e.g.,
to help inform CPSC's evaluation of specific chemicals).
E. What are the incremental economic implications of this action?
EPA prepared an economic analysis for the addition of the 50
chemical substances to the TSCA section 8(d) Health and Safety Data
Reporting rule, entitled, ``TSCA Section 8(d): Economic Impact Analysis
for Adding 50 Chemicals from the 74th ITC Report of the TSCA
Interagency Testing Committee to the Health and Safety Data Reporting
Rule.'' (Economic Analysis, Ref. 7) a copy of which is included in the
docket for this rulemaking. The total one-time cost associated with
this final rule is estimated to be approximately $185,000 based on
approximately 1,900 and 420 hours of industry and EPA burden,
respectively.
IV. Requesting a Chemical Substance Be Withdrawn From This Final Rule
As specified in 40 CFR 716.105(c), EPA may, in its discretion,
remove a chemical substance, mixture, or category of chemical
substances from this final rule for good cause prior to the effective
date of this final rule. Any person who believes that the reporting
required by this final rule is not warranted for a chemical substance
listed in this final rule must submit to EPA detailed reasons for that
belief. You must submit your request to EPA on or before July 13, 2021
and in accordance with the instructions provided in 40 CFR 716.105(c)
and (d). In addition, to ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPPT-2020-0474. If the EPA
Administrator withdraws a chemical substance, mixture, or category of
chemical substances from the amendment, in accordance with 40 CFR
716.105(c), a Federal Register document announcing this decision will
be published no later than July 29, 2021.
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. For more information about these
references, please consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
1. EPA. 40 CFR 716.120. Substances and listed mixtures to which this
subpart applies. Available online at: https://www.ecfr.gov/cgibin/textidx?SID=94b50835053a07b80c3517fff641aeba&mc=true&node=pt40.33.716&rgn=div5#se40.33.716_1120.
2. ITC. Notice; Seventy-Fourth Report of the TSCA Interagency
Testing Committee to the Administrator of the Environmental
Protection Agency; Receipt of Report and Request for Comments.
Federal Register (86 FR 22414, April 28, 2021) (FRL-10020-39).
Available online at: https://www.govinfo.gov/content/pkg/FR-2021-04-28/pdf/2021-08839.pdf.
3. EPA. High-Priority Substance Designations Under the Toxic
Substances Control Act (TSCA) and Initiation of Risk Evaluation on
High-Priority Substances; Notice of Availability. Federal Register
(84 FR 71924, December 30, 2019) (FRL-10003-15). Available online
at: https://www.govinfo.gov/content/pkg/FR-2019-12-30/pdf/2019-28225.pdf.
4. EPA. Procedures for Prioritization of Chemicals for Risk
Evaluation Under the Toxic Substances Control Act; Final Rule.
Federal Register (82 FR 33753, December 20, 2017) (FRL-9964-24).
Available online at: https://www.federalregister.gov/documents/2017/07/20/2017-14325/procedures-for-prioritization-of-chemicals-for-risk-evaluation-under-the-toxic-substances-control.
5. CPSC. U.S. Consumer Product Safety Commission Petition: Products
Containing Organohalogen Flame Retardants. Docket ID number: CPSC-
2015-0022. Available online at: https://www.regulations.gov/docket?D=CPSC-2015-0022.
6. CPSC. National Academies of Sciences, Engineering, and Medicine
2019. A Class Approach to Hazard Assessment of Organohalogen Flame
Retardants. Washington, DC: The National Academies Press. https://doi.org/10.17226/25412. Available online at: https://nap.edu/25412.
7. EPA. TSCA Section 8(d): Economic Impact Analysis for Adding 50
Chemicals From the 74th ITC Report of the TSCA Interagency Testing
Committee to the Health and Safety Data Reporting Rule. September
10, 2020.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
The Office of Management and Budget (OMB) has exempted actions
under TSCA section 8(d) related to the Health and Safety Data Reporting
rule from the requirements of Executive Order 12866 (58 FR 51735,
October 4, 1993). As such, this final rule was not reviewed by OMB
under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to PRA, 44 U.S.C. 3501 et seq., an agency may not conduct
or sponsor, and a person is not required to respond to a collection of
information that requires OMB approval under PRA, unless it has been
approved by OMB and displays a currently valid OMB control number. The
OMB control numbers for EPA's regulations in title 40 of the CFR, after
appearing in the Federal Register, are listed in 40 CFR part 9, and
included on the related collection instrument or form, if applicable.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0004. This action does not impose any burden requiring additional
OMB approval. You can find a copy of the ICR in the docket for this
rule, and it is briefly summarized here.
This action requires the reporting of health and safety data to EPA
by manufacturers (including importers) of certain chemical substances
requested by the ITC to be added to the Health and Safety Data
Reporting Rule in its Seventy-Fourth Report of the ITC (Ref. 2). EPA
intends to use information collected under the rule to assist in
chemical assessments under TSCA, and to inform any additional work
necessary under environmental protection mandates beyond TSCA.
Submitters may designate information as confidential, trade secret, or
proprietary. EPA has implemented procedures to protect any
confidential, trade secret or proprietary information from disclosure.
These procedures comply with TSCA section 14 and EPA's confidentiality
regulation, 40 CFR part 2, subpart B.
Respondents/affected entities: Manufacturers (including importers)
of 50 chemical substances requested by the ITC to be included in the
Health and Safety Data Reporting Rule.
Respondents' obligation to respond: Mandatory (15 U.S.C. 2607(d)).
Estimated number of respondents: 23.
Frequency of response: Once.
[[Page 34152]]
Total estimated burden: 1,854 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $146,745 (per year), with no annualized
capital or operation and maintenance costs.
C. Regulatory Flexibility Act (RFA)
Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I hereby
certify that this action will not have a significant economic impact on
a substantial number of small entities as defined by the RFA. The small
entities subject to the requirements of this action are manufacturers
(including importers) of 50 chemicals requested by the ITC to be added
to the Health and Safety Data Reporting Rule. EPA estimates that 106 of
the 129 firms in the affected universe are small entities. Of those
small firms, all would have cost impacts of less than 1% of annual
revenue. Details of this analysis are presented in the Economic
Analysis of this rule (Ref. 7), which can be found in the docket.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The requirements of
this action would primarily affect manufacturers (including importers)
of 50 chemical substances listed in 40 CFR 716.120(d) of the regulatory
text of this document. The total quantified one-time costs of this
final rule are approximately $183,812.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have
substantial direct effects 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). 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. Thus, E.O. 13175 does not apply to this
action.
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 the Agency has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order. This
action is not a covered regulatory action because it is not
``economically significant'' under Executive Order 12866 and it does
not concern an environmental health risk or safety risk. Although this
action would not establish an environmental standard intended to
mitigate health or safety risks, the information that would be
submitted to EPA in accordance with this rule would be used to inform
the Agency's decision-making process regarding chemical substances to
which children may be disproportionately exposed. This information may
also assist the Agency and others in determining whether the chemical
substances covered in this proposed rule present potential risks, which
would allow the Agency and others to take appropriate action to
investigate and mitigate those risks.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy and has not otherwise been designated by
the Administrator of OMB's Office of Information and Regulatory Affairs
as a ``significant energy action.''
I. National Technology Transfer and Advancement Act (NTTAA)
Because this action does not involve any technical standards, NTTAA
section 12(d), 15 U.S.C. 272 note, does not apply to this action.
J. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994). However, the Agency believes that the
information collected through this rule will inform the TSCA risk
evaluations that are planned for these chemicals and will thereby
enable the Agency to better protect human health and the environment,
including in low-income and minority communities.
L. Congressional Review Act (CRA)
This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 716
Environmental protection, Chemicals, Hazardous substances, Health
and safety, Reporting and recordkeeping requirements.
Dated: June 17, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 716--HEALTH AND SAFETY DATA REPORTING
0
1. The authority citation for part 716 continues to read as follows:
Authority: 15 U.S.C. 2607(d).
0
2. In Sec. 716.21, add paragraphs (a)(9) and (10) to read as follows:
Sec. 716.21 Chemical specific reporting requirements.
(a) * * *
(9) For 1,3-Butadiene (106-99-0), Butyl benzyl phthalate (BBP)--
1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester (85-68-
7), Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2-
dibutyl ester) (84-74-2), o-Dichlorobenzene (95-50-1), p-
Dichlorobenzene (106-46-7), trans-1,2-Dichloroethylene (156-60-5), 1,2-
Dichloropropane (78-87-5), Dicyclohexyl phthalate (84-61-7), Di-
ethylhexyl phthalate (DEHP)--(1,2-Benzene- dicarboxylic acid, 1,2-
bis(2-ethylhexyl) ester) (117-81-7), Di-isobutyl phthalate (DIBP)--
(1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester) (84-
69-5), Formaldehyde (50-00-0), 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-
hexamethylcyclopenta [g]-2-benzopyran (HHCB) (1222-05-5), Phthalic
anhydride (85-44-9), 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol]
(TBBPA) (79-94-7), and 1,1,2-Trichloroethane (79-00-5), all unpublished
studies on health effects (including toxicity studies (in vivo and in
vitro) on carcinogenicity,
[[Page 34153]]
reproductive and developmental effects, genotoxicity, neurotoxicity,
immunotoxicity, endocrine effects, and other systemic toxicity);
toxicokinetics (absorption, distribution, metabolism, or elimination),
including modelling studies, in humans or animals; environmental
effects; environmental fate; physical-chemical properties if performed
as described in 40 CFR 716.50; and occupational (both users and non-
users), general population, consumer, bystander, and environmental
exposure must be submitted. Studies showing any measurable content of
the High-Priority Substance in the tested substance (single substances
or mixture) must be reported. The composition and purity of test
substances must be reported if included as part of the study. Studies
previously submitted to EPA pursuant to a requirement under TSCA or of
the submitter's own accord and studies conducted or to be conducted
pursuant to a TSCA section 4 action are exempt from the submission of
lists of health and safety studies required under 40 CFR 716.35 and the
submission of studies required under this rule.
(10) For purposes of this paragraph, the term organohalogen flame
retardant includes any substances listed in paragraph(d) of this
section under the category ``Organohalogen flame retardants''. For any
organohalogen flame retardant, all unpublished studies on health
effects (including toxicity studies (in vivo and in vitro) on
carcinogenicity, reproductive and developmental effects, genotoxicity,
neurotoxicity, immunotoxicity, endocrine effects, and other systemic
toxicity); toxicokinetics (absorption, distribution, metabolism, or
elimination), including modelling studies, in humans or animals;
environmental fate; physical-chemical properties if performed as
described in 40 CFR 716.50; and occupational (both users and non-
users), general population, consumer, bystander, and environmental
exposure must be submitted. Studies showing any measurable content of
the organohalogen flame retardant in the tested substance (single
substances or mixture) must be reported. The composition and purity of
test substances must be reported if included as part of the study.
Studies previously submitted to EPA pursuant to a requirement under
TSCA or of the submitter's own accord and studies conducted or to be
conducted pursuant to a TSCA section 4 action are exempt from the
submission of lists of health and safety studies requirements under 40
CFR 716.35 and the submission of studies requirements under this rule.
* * * * *
0
3. In Sec. 716.120, amend the table in paragraph (d) by:
0
a. Adding in alphabetical order the category ``High-Priority
Substances'' and entries ``1,3-Butadiene'', ``Butyl benzyl phthalate
(BBP)--1,2-Benzene-dicarboxylic acid, 1-butyl 2(phenylmethyl) ester'',
``Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl
ester)'', ``o-Dichlorobenzene'', ``p-Dichlorobenzene'', ``1,1-
Dichloroethane'', ``1,2-Dichloroethane'', ``Trans-1,2-
Dichloroethylene'', ``1,2-Dichloropropane'', ``Dicyclohexyl
phthalate'', ``Di-ethylhexyl phthalate (DEHP)--(1,2-Benzene-
dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester)'', ``Di-isobutyl
phthalate (DIBP)--(1,2-Benzene- dicarboxylic acid, 1,2- bis-
(2methylpropyl) ester)'', ``Ethylene dibromide'', ``Formaldehyde'',
``1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-
benzopyran (HHCB)'', ``4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol]
(TBBPA)'', ``Phosphoric acid, triphenyl ester (TPP)'', ``Phthalic
anhydride'', ``1,1,2-Trichloroethane'', and ``Tris(2-chloroethyl)
phosphate (TCEP)''; and
0
b. Adding in alphabetical order the category ``Organohalogen flame
retardants'' and entries ``Bis(2-ethylhexyl) tetrabromophthalate'',
``Bis(hexachlorocyclopentadieno)cyclooctane'', ``1,2-Bis(2,4,6-
tribromophenoxy)ethane'', ``1,1'-Ethane-1,2-
diylbis(pentabromobenzene)'', ``2-Ethylhexyl-2,3,4,5-
tetrabromobenzoate'', ``2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl
3,4,5,6-tetrabromophthalate'', ``2,2'-[(1-Methylethylidene)bis[(2,6-
dibromo-4,1-phenylene)oxymethylene]]bis[oxirane]'', ``Mixture of
chlorinated linear alkanes C14-17 with 45-52% chlorine'', ``N,N-
Ethylene-bis(tetrabromophthalimide)'', ``Pentabromochlorocyclohexane'',
``(Pentabromophenyl)methyl acrylate'', ``Pentabromotoluene'',
``Perbromo-1,4-diphenoxybenzene'', ``Phosphonic acid, (2-chloroethyl)-,
bis(2-chloroethyl) ester'', ``Phosphoric acid, 2,2-bis(chloromethyl)-
1,3-propanediyl tetrakis(2-chloroethyl) ester'', ``Propanoic acid, 2-
bromo-, methyl ester'', ``Tetrabromobisphenol A-bis(2,3-dibromopropyl
ether)'', ``Tetrabromobisphenol A bis(2-hydroxyethyl) ether'',
``Tetrabromobisphenol A diallyl ether'', ``Tetrabromobisphenol A
dimethyl ether'', ``2,4,6-Tribromoaniline'', ``1,3,5-Tribromo-2-(prop-
2-en-1-yloxy)benzene'', ``Tris(2-chloroethyl) phosphite'', ``Tris(1-
chloro-2-propyl)phosphate'', ``Tris(2-chloro-1-propyl)phosphate'',
``Tris(2,3-dibromopropyl) phosphate'', ``1,3,5-Tris(2,3-dibromopropyl)-
1,3,5-triazine-2,4,6(1H,3H,5H)-trione'', ``Tris(1,3-dichloro-2-
propyl)phosphate'', ``Tris(tribromoneopentyl)phosphate'', and ``2,4,6-
Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine''.
The additions read as follows:
Sec. 716.120 Substances and listed mixtures to which this subpart
applies.
* * * * *
(d) * * *
----------------------------------------------------------------------------------------------------------------
Effective
Category CAS No. Special exemptions date Sunset date
----------------------------------------------------------------------------------------------------------------
High-Priority Substances:
1,3-Butadiene............................... 106-99-0 Sec. 716.21(a)(9) 7/29/21 9/27/21
Butyl benzyl phthalate (BBP)--1,2-Benzene- 85-68-7 Sec. 716.21(a)(9) 7/29/21 9/27/21
dicarboxylic acid, 1- butyl 2(phenylmethyl)
ester......................................
Dibutyl phthalate (DBP) (1,2-Benzene- 84-74-2 Sec. 716.21(a)(9) 7/29/21 9/27/21
dicarboxylic acid, 1,2-dibutyl ester)......
o-Dichlorobenzene........................... 95-50-1 Sec. 716.21(a)(9) 7/29/21 9/27/21
p-Dichlorobenzene........................... 106-46-7 Sec. 716.21(a)(9) 7/29/21 9/27/21
1,1-Dichloroethane.......................... 75-34-3 Sec. 716.21(a)(9) 7/29/21 9/27/21
1,2-Dichloroethane.......................... 107-06-2 Sec. 716.21(a)(9) 7/29/21 9/27/21
Trans-1,2-Dichloroethylene.................. 156-60-5 Sec. 716.21(a)(9) 7/29/21 9/27/21
1,2-Dichloropropane......................... 78-87-5 Sec. 716.21(a)(9) 7/29/21 9/27/21
Dicyclohexyl phthalate...................... 84-61-7 Sec. 716.21(a)(9) 7/29/21 9/27/21
Di-ethylhexyl phthalate (DEHP)--(1,2-Benzene- 117-81-7 Sec. 716.21(a)(9) 7/29/21 9/27/21
dicarboxylic acid, 1,2- bis(2-ethylhexyl)
ester).....................................
[[Page 34154]]
Di-isobutyl phthalate (DIBP)--(1,2-Benzene- 84-69-5 Sec. 716.21(a)(9) 7/29/21 9/27/21
dicarboxylic acid, 1,2- bis-(2methylpropyl)
ester).....................................
Ethylene dibromide.......................... 106-93-4 Sec. 716.21(a)(9) 7/29/21 9/27/21
Formaldehyde................................ 50-00-0 Sec. 716.21(a)(9) 7/29/21 9/27/21
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8- 1222-05-5 Sec. 716.21(a)(9) 7/29/21 9/27/21
hexamethylcyclopenta [g]-2-benzopyran
(HHCB).....................................
4,4'-(1-Methylethylidene)bis[2, 6- 79-94-7 Sec. 716.21(a)(9) 7/29/21 9/27/21
dibromophenol] (TBBPA).....................
Phosphoric acid, triphenyl ester (TPP)...... 115-86-6 Sec. 716.21(a)(9) 7/29/21 9/27/21
Phthalic anhydride.......................... 85-44-9 Sec. 716.21(a)(9) 7/29/21 9/27/21
1,1,2-Trichloroethane....................... 79-00-5 Sec. 716.21(a)(9) 7/29/21 9/27/21
Tris(2-chloroethyl) phosphate (TCEP)........ 115-96-8 Sec. 716.21(a)(9) 7/29/21 9/27/21
* * * * * * *
Organohalogen flame retardants:
Bis(2-ethylhexyl) tetrabromophthalate....... 26040-51-7 Sec. 716.21(a)(10) 7/29/21 9/27/21
Bis(hexachlorocyclopentadieno)cyclooctane... 13560-89-9 Sec. 716.21(a)(10) 7/29/21 9/27/21
1,2-Bis(2,4,6-tribromophenoxy)ethane........ 37853-59-1 Sec. 716.21(a)(10) 7/29/21 9/27/21
1,1'-Ethane-1,2-diylbis(pentabromobenzene).. 84852-53-9 Sec. 716.21(a)(10) 7/29/21 9/27/21
2-Ethylhexyl-2,3,4,5-tetrabromobenzoate..... 183658-27-7 Sec. 716.21(a)(10) 7/29/21 9/27/21
2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 20566-35-2 Sec. 716.21(a)(10) 7/29/21 9/27/21
3,4,5,6-tetrabromophthalate................
2,2'-[(1-Methylethylidene)bis[(2,6-dibromo- 3072-84-2 Sec. 716.21(a)(10) 7/29/21 9/27/21
4,1-phenylene)oxymethylene]]bis[oxirane]...
Mixture of chlorinated linear alkanes C14-17 85535-85-9 Sec. 716.21(a)(10) 7/29/21 9/27/21
with 45-52% chlorine.......................
N,N-Ethylene-bis(tetrabromophthalimide)..... 32588-76-4 Sec. 716.21(a)(10) 7/29/21 9/27/21
Pentabromochlorocyclohexane................. 87-84-3 Sec. 716.21(a)(10) 7/29/21 9/27/21
(Pentabromophenyl)methyl acrylate........... 59447-55-1 Sec. 716.21(a)(10) 7/29/21 9/27/21
Pentabromotoluene........................... 87-83-2 Sec. 716.21(a)(10) 7/29/21 9/27/21
Perbromo-1,4-diphenoxybenzene............... 58965-66-5 Sec. 716.21(a)(10) 7/29/21 9/27/21
Phosphonic acid, (2-chloroethyl)-, bis(2- 6294-34-4 Sec. 716.21(a)(10) 7/29/21 9/27/21
chloroethyl) ester.........................
Phosphoric acid, 2,2-bis(chloromethyl)-1,3- 38051-10-4 Sec. 716.21(a)(10) 7/29/21 9/27/21
propanediyl tetrakis(2-chloroethyl) ester..
Propanoic acid, 2-bromo-, methyl ester...... 5445-17-0 Sec. 716.21(a)(10) 7/29/21 9/27/21
Tetrabromobisphenol A-bis(2,3-dibromopropyl 21850-44-2 Sec. 716.21(a)(10) 7/29/21 9/27/21
ether).....................................
Tetrabromobisphenol A bis(2-hydroxyethyl) 4162-45-2 Sec. 716.21(a)(10) 7/29/21 9/27/21
ether......................................
Tetrabromobisphenol A diallyl ether......... 25327-89-3 Sec. 716.21(a)(10) 7/29/21 9/27/21
Tetrabromobisphenol A dimethyl ether........ 37853-61-5 Sec. 716.21(a)(10) 7/29/21 9/27/21
2,4,6-Tribromoaniline....................... 147-82-0 Sec. 716.21(a)(10) 7/29/21 9/27/21
1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene. 3278-89-5 Sec. 716.21(a)(10) 7/29/21 9/27/21
Tris(2-chloroethyl)phosphite................ 140-08-9 Sec. 716.21(a)(10) 7/29/21 9/27/21
Tris(1-chloro-2-propyl)phosphate............ 13674-84-5 Sec. 716.21(a)(10) 7/29/21 9/27/21
Tris(2-chloro-1-propyl)phosphate............ 6145-73-9 Sec. 716.21(a)(10) 7/29/21 9/27/21
Tris(2,3-dibromopropyl)phosphate............ 126-72-7 Sec. 716.21(a)(10) 7/29/21 9/27/21
1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine- 52434-90-9 Sec. 716.21(a)(10) 7/29/21 9/27/21
2,4,6(1H,3H,5H)-trione.....................
Tris(1,3-dichloro-2-propyl)phosphate........ 13674-87-8 Sec. 716.21(a)(10) 7/29/21 9/27/21
Tris(tribromoneopentyl)phosphate............ 19186-97-1 Sec. 716.21(a)(10) 7/29/21 9/27/21
2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5- 25713-60-4 Sec. 716.21(a)(10) 7/29/21 9/27/21
triazine...................................
----------------------------------------------------------------------------------------------------------------
[FR Doc. 2021-13212 Filed 6-28-21; 8:45 am]
BILLING CODE 6560-50-P
