4,4′-Methylene bis(2-chloroaniline); Request Under the Toxic Substances Control Act (TSCA) for Records and Reports of Significant Adverse Reactions to Health or the Environment, 88915-88919 [2023-28299]
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Federal Register / Vol. 88, No. 246 / Tuesday, December 26, 2023 / Notices
ENVIRONMENTAL PROTECTION
AGENCY
to describe all the specific entities that
may be interested in this action.
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2017–0127; FRL–11623–
01–OCSPP]
II. What is the Agency’s authority for
taking this action?
[EPA–HQ–OPPT–2023–0312; FRL 11015–
01–OCSPP]
2023 Report; Inventory of Mercury
Supply, Use, and Trade in the United
States; Notice of Availability
TSCA section 8(b)(10), 15 U.S.C.
2507(b)(10), directs EPA to carry out
and publish in the Federal Register not
later than April 1, 2017, and every three
years thereafter, an inventory of
mercury supply, use, and trade in the
United States. TSCA section 8(b)(10)(A)
defines ‘‘mercury’’ as ‘‘elemental
mercury’’ or ‘‘a mercury compound’’ (15
U.S.C. 2507(b)(10)(A)). In carrying out
the mercury inventory, EPA is to
‘‘identify any manufacturing processes
or products that intentionally add
mercury’’ (15 U.S.C. 2607(b)(10)(C)(i))
and ‘‘recommend actions, including
proposed revisions of Federal law or
regulations, to achieve further
reductions in mercury use’’ (15 U.S.C.
2607(b)(10)(C)(ii)).
4,4′-Methylene bis(2-chloroaniline);
Request Under the Toxic Substances
Control Act (TSCA) for Records and
Reports of Significant Adverse
Reactions to Health or the
Environment
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA) is announcing the
availability of the 2023 mercury
inventory report, which summarizes
information on mercury supply, use,
and trade in the United States that is
required to be reported to EPA by rule
directly from mercury manufacturers,
importers, and processors. The Toxic
Substances Control Act (TSCA) directs
the EPA to carry out and publish in the
Federal Register every three years an
inventory of mercury supply, use, and
trade in the United States. TSCA defines
‘‘mercury’’ as ‘‘elemental mercury’’ or
‘‘a mercury compound.’’
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2017–0127, is
available online at https://
www.regulations.gov. Additional
instructions for visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Thomas Groeneveld, Existing Chemicals
Risk Management Division, Office of
Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
566–1188; email address:
groeneveld.thomas@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.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
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88915
This action applies to the public in
general and may be of interest to a wide
range of stakeholders including
members of the public interested in
elemental mercury or mercury
compounds generally. Other topics of
interest include the supply, use, or trade
of elemental mercury or mercury
compounds, including mercury-added
products and manufacturing processes.
As such, the Agency has not attempted
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III. What action is the Agency taking?
EPA is publishing the 2023 report of
the inventory of mercury supply, use,
and trade in the United States (15 U.S.C.
2507(b)(10)(B)). This is the second
report in which the supply, use, and
trade of mercury is presented based on
data collected by EPA under the
mercury reporting requirements under
TSCA that are codified in 40 CFR part
713. Persons subject to the reporting
requirements in 40 CFR part 713
submitted information directly to EPA
via the Mercury Electronic Reporting
(MER) application, which is accessed
through the Agency’s Central Data
Exchange (CDX). For reporting activities
that occurred in the calendar year 2021,
the deadline for reporting mercury
information to EPA was July 1, 2022,
and the inventory collection, reporting,
and publication cycle will continue
every three years thereafter.
IV. How can I access this report?
The 2023 inventory report, and the
previously published report in 2020,
may be found in the docket for this
action and on the EPA mercury website
at https://www.epa.gov/mercury.
Authority: 15 U.S.C. 2607(b)(10)(B).
Dated: December 20, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2023–28376 Filed 12–22–23; 8:45 am]
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Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
Through this notice, the
Environmental Protection Agency (EPA)
is requiring manufacturers (including
importers) and processors of the
chemical substance 4,4′-methylene
bis(2-chloroaniline) to submit the
records and reports of allegations that
this chemical substance causes
significant adverse reactions to health or
the environment that they are required
to maintain and submit to EPA when
requested under the Toxic Substances
Control Act (TSCA). Information
submitted to the Agency in response to
this notice will help inform future EPA
activities regarding this chemical,
including aiding EPA activities related
to this chemical substance having been
identified as a candidate for designation
as a High-Priority Substance for TSCA
risk evaluation.
DATES: Records must be received by
EPA on or before February 26, 2024.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA HQ–OPPT–2023–0312, is
available online at https://
www.regulations.gov or in person at the
Office of Pollution Prevention and
Toxics Docket (OPPT Docket) in the
Environmental Protection Agency
Docket Center (EPA/DC). Additional
instructions on visiting the docket,
along with more information about
dockets generally, are available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Brian Barone, Data Gathering and
Analysis Division (7406M), Office of
Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
566–0233; email address: barone.brian@
epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Executive Summary
A. What action is the Agency taking?
EPA is requiring submission of TSCA
section 8(c) records of allegations of
significant adverse reactions to health or
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the environment for the listed chemical.
Regulations specifying TSCA section
8(c) recordkeeping and reporting
requirements are codified at 40 CFR part
717. Pursuant to TSCA section 8(c) and
40 CFR 717.17(b), each person who is
required to maintain records under
TSCA section 8(c) and implementing
regulations at 40 CFR part 717 shall
submit copies of such records to EPA
upon request. EPA is issuing this TSCA
section 8(c) action so that the health and
environmental risks from exposure to
this chemical substance can be
evaluated. The submitted information is
expected to be used to corroborate
suspected adverse health or
environmental effects of the chemical
under review and to help identify trends
of adverse effects across the industry
that may not be apparent to any one
chemical company.
EPA has initiated the prioritization
process for this chemical substance as a
candidate for designation as a HighPriority Substance for risk evaluation.
EPA plans to use data received through
this request to support the prioritization
process to better understand suspected
adverse health or environmental effects
of the chemical. Further, should EPA
finalize the designation of this chemical
as a high-priority substance for risk
evaluation, then gathering this type of
data before EPA initiates such a risk
evaluation could help make the risk
evaluation process more efficient and
focused. EPA anticipates issuing
additional TSCA section 8(c)
submission requirements for other
chemical substances identified as
candidates for prioritization. EPA is
using this TSCA section 8(c) submission
requirement as a first pilot step in
making use of the TSCA section 8(c)
data gathering authority as part of the
general candidate selection process to
be used by EPA for TSCA section 6
prioritization activities.
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B. What is the Agency’s authority for
taking this action?
Under TSCA section 8(c), chemical
manufacturers (including importers)
and processors must maintain records of
significant adverse reactions to health or
the environment alleged to have been
caused by chemical substances or
mixtures and, upon request, submit or
make the records available to the
Agency. Significant adverse reactions
are reactions that may indicate a
substantial impairment of normal
activities or long-lasting or irreversible
damage to health or the environment.
Regulations implementing TSCA section
8(c) appear in 40 CFR part 717.
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C. Does this action apply to me?
This action may potentially affect you
if you manufacture (defined under
TSCA to include import) or process the
chemical substance described by this
document. The following list of North
American Industry Classification
System (NAICS) codes is neither
intended to be exhaustive nor indicate
expected reporting from a given
industry sector but rather provides a
guide to help readers determine whether
this document applies to them.
Potentially affected entities may
include:
• Manufacturing (NAICS codes 31–
33), and/or
• Other Chemical and Allied
Products Merchant Wholesalers (NAICS
code 424690).
Other types of entities not included
could also be affected. To determine
whether your entity is affected by this
action, you should carefully examine
the applicability criteria found in 40
CFR part 717. If you have questions
regarding the applicability of this action
to a particular entity or information
regarding additional entities that may
not be listed in this Notice, please
consult the person listed in the FOR
FURTHER INFORMATION CONTACT section.
D. What is 4,4′-methylene bis(2chloroaniline) (MBOCA)?
MBOCA is used as a curing agent for
liquid polyurethane elastomers. These
elastomers have been used to produce
shoe soles; rolls for postage stamp
machines; cutting bars in plywood
manufacturing; rolls and belt drives in
cameras, computers, and reproducing
equipment; and pulleys for escalators
and elevators. Animal studies have
reported effects on the lung, liver, and
kidney from chronic oral exposure to
MBOCA. Animal studies have reported
that MBOCA produces tumors of the
liver, lung, urinary bladder, and
mammary glands from oral exposure.
EPA has classified MBOCA as a Group
B2, probable human carcinogen.
II. Request for TSCA Section 8(c)
Records
A. Who must submit records?
This requirement to submit TSCA
section 8(c) allegation records applies to
persons who manufacture (defined
under TSCA to include import) or
process MBOCA, and who are subject to
TSCA section 8(c) recordkeeping
requirements pursuant to 40 CFR 717.5.
The regulations provide limited
exemptions from recordkeeping and
reporting requirements for certain
manufacturers and sites of manufacture,
as described at 40 CFR 717.5(a)(1) and
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717.7(a). Persons or site activities are
exempt pursuant to 40 CFR 717.7(a)(1)
if the means by which they manufacture
a chemical substance solely involves
mining or other solely extractive
functions, e.g., those companies or sites
within a company whose sole function
is to mine mineral ores, extract
petroleum or natural gas, quarry nonmetallic minerals (including extraction
of salts from seawater or brines), mine
or otherwise extract coal, or separate
gases from the atmosphere. In addition,
the regulations exempt persons whose
only manufacturing act is to produce a
substance coincidentally under specific
circumstances, as described in 40 CFR
717.7(a)(2).
Two types of processors (who are not
also manufacturers) are subject to TSCA
section 8(c) recordkeeping under the
regulations at 40 CFR 717.5(b)(1) and to
reporting under this notice: those who
produce and market chemical mixtures
(including solutions) and those who
repackage chemical substances or
mixtures.
A person solely engaged in the
distribution of chemical substances is
exempt from TSCA section 8(c)
recordkeeping and reporting pursuant to
40 CFR 717.7(c) unless such person is
also a manufacturer or processor subject
to the regulations. For example, a
‘‘distributor’’ who repackages chemical
substances or mixtures is considered to
be a processor and, thus, is not a sole
distributor.
Similarly, pursuant to 40 CFR
717.7(d), a person who is a retailer is
exempt from TSCA section 8(c)
recordkeeping and reporting unless
such person is also a manufacturer or a
processor subject to this request.
B. What types of records must be
submitted?
TSCA section 8(c) requires any
manufacturer, processor, or distributor
of a chemical substance or mixture to
keep records of ‘‘significant adverse
reactions’’ to health or the environment,
as determined by rule, alleged to have
been caused by the chemical substance
or mixture. Implementing regulations at
40 CFR part 717 describe the types of
records that must be kept and are briefly
summarized here.
A ‘‘significant adverse reactions’’ is
defined in 40 CFR 717.3(i) as reactions
that may indicate a substantial
impairment of normal activities, or longlasting or irreversible damage to health
or the environment. Allegations subject
to the recordkeeping requirement are
described at 40 CFR 717.10.
‘‘Allegation’’ is defined at 40 CFR
717.3(a) to mean a statement, made
without formal proof or regard for
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evidence, that a chemical substance or
mixture has caused a significant adverse
reaction to health or the environment.
Significant adverse reactions to
human health that must be recorded
could include, but are not limited to,
birth defects, impairment of bodily
functions, or impairment of normal
activities, as described at 40 CFR
717.12(a). TSCA section 8(c) allegations
may focus on serious health effects, but
they can also report lesser effects
experienced by a group of individuals or
repeatedly by an individual. Allegations
that do not meet the definition of a
‘‘significant adverse reaction’’ should
not be reported to EPA in the TSCA
section 8(c) call-in. Additionally, the
regulation at 40 CFR 717.12(b) exempts
‘‘known human effects’’ from this
recordkeeping requirement. The
definition of ‘‘known human effects’’ at
40 CFR 717.3(c) covers commonly
recognized human health effects
resulting from exposure to a substance
as described in publicly available
sources such as Safety Data Sheets
(SDS), product labeling, or scientific
literature, including, but not limited to,
information found at the Agency for
Toxic Substances Disease Registry
website available at https://
www.atsdr.cdc.gov/ and
EPA’s Integrated Risk Management
System available at https://
www.epa.gov/iris. However, pursuant to
40 CFR 717.3(c)(2), the exemption does
not apply if the reaction was a
significantly more severe toxic effect
than previously described, or if the
reaction resulted from a lower exposure
level, a significantly shorter exposure
period, or a different exposure route
than previously described.
Significant adverse reactions to the
environment must also be recorded even
if restricted to the environment
surrounding a plant or disposal site.
Pursuant to 40 CFR 717.12(c), such
reactions could include but are not
limited to: gradual or sudden changes to
composition of animal or plant life,
deaths of organisms such as fish kills,
reduction of reproductive success of
species, changes in behavior or
distribution of species, loss of
agricultural productivity, and
irreversible contamination of the
environment.
Pursuant to 40 CFR 717.12(d), a
significant adverse reaction to the
environment is not required to be
recorded if the alleged cause is directly
attributable to an incident of
environmental contamination that has
already been reported to the Federal
government under any applicable
authority.
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EPA is requiring submission of all
TSCA section 8(c) records that fall
within the record retention period
described in TSCA section 8(c) and 40
CFR 717.15(d). Accordingly, this request
for records includes:
• Records of significant adverse
reactions to the health of employees first
reported to or known by the person
maintaining such records within the
past 30 years, including employee
health-related allegations arising from
any employment-related exposure,
whether or not such allegation was
submitted by or on the behalf of that
recordkeeper’s own employee.
• Any other record of significant
adverse reactions first reported to or
known by the person maintaining the
record within the past five years.
C. What information must be included
with a submission?
Manufacturers of the chemical
substance listed in this notice must
submit any records kept pursuant to 40
CFR part 717 of significant adverse
reactions alleged to have been caused by
the chemical substance. Under the
regulations, a manufacturer is
responsible for collecting allegations
regarding substances it manufactures, as
well as allegations regarding certain
chemical processing and distribution
activities it may carry out. Accordingly,
as provided in 40 CFR 717.5(a)(2),
manufacturers of the listed chemical
substance must submit records of any
collected allegations that:
• Identify the listed chemical
substance or identify operations used in
the manufacture of the chemical
substance;
• Identify any of the manufacturer’s
own processing or distribution in
commerce activities with respect to the
chemical substance;
• Identify emissions, effluents, or
other discharges from activities
described in this paragraph; and
• Identify a substance produced
coincidentally during processing, use,
storage or disposal of a chemical
substance it manufactures, where either
the coincidentally produced chemical
substance or the originally
manufactured chemical substance is
listed in this notice.
Processors of the chemical substance
listed in this notice who are subject to
TSCA section 8(c) recordkeeping
requirements (i.e., persons who process
chemical substances to produce
mixtures, or repackage chemical
substances or mixtures) must also
submit any records kept pursuant to 40
CFR part 717 of significant adverse
reactions alleged to have been caused by
the chemical substance. As provided by
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40 CFR 717.5(b)(2), this includes
allegations that:
• Identify any mixture the processor
produces and distributes in commerce
containing the listed chemical
substance, or identify the listed
chemical substance or mixture
containing the listed chemical substance
that the processor repackages and
distributes in commerce;
• Identify any of the processor’s own
further processing or distribution in
commerce activities of such products;
• Identify emissions, effluents, or
other discharges from activities
described in this paragraph;
• Identify a substance produced
coincidentally during the processing,
use, storage, or disposal of any mixture
the processor produces and distributes
in commerce or any chemical substance
or mixture it repackages and distributes
in commerce, where either the
coincidentally produced chemical
substance or the processed chemical
substance is listed in this notice.
As provided by 40 CFR 717.15(b), in
addition to the original allegation as
received, TSCA section 8(c) reported
allegation records must contain the
name and address of the site that
received the allegation; the date the
allegation was received; the implicated
chemical substance, mixture, article,
company process or operation, or site
discharge; a description of the alleger;
and a description of the alleged health
effect(s) and/or environmental effect(s).
Additionally, the submission must
include the results of any self-initiated
investigation with respect to an
allegation and copies of any further
required records or reports relating to
the allegation, as described at 40 CFR
717.15(b)(3) and (4)).
EPA encourages respondents to
conduct a thorough review of their
TSCA 8(c) records, including a search
for all known synonyms and trade
names associated with the listed
chemical. Alternative identifiers can be
found through many sources, including
PubChem, an open chemistry database
operated by the National Institutes of
Health (NIH) at https://pubchem.ncbi.
nlm.nih.gov, EPA’s CompTox Chemical
Dashboard website at https://comptox.
epa.gov/dashboard and EPA’s
Substance Registry Service (SRS) at
https://cdxapps.epa.gov/oms-substanceregistry-services/search.
D. How does this request for allegation
records differ from TSCA section 8(e)
reporting?
TSCA section 8(e) requires
manufacturers, processors, and
distributors of a chemical substance or
mixture to notify EPA immediately of
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information that reasonably supports
the conclusion that such substance or
mixture presents a substantial risk of
injury to health or the environment,
unless that person knows that EPA has
already been informed. EPA published a
TSCA section 8(e) Policy Statement and
Guidance on June 3, 2003 (68 FR 33129
(FRL–7287–4)), which defines
‘‘substantial-risk information’’ as
information which reasonably supports
the conclusion that a chemical
substance or mixture presents a
substantial risk of injury to health or the
environment, and ‘‘substantial risk of
injury to health or the environment’’ as
a risk of considerable concern because
of the seriousness of the effect, and the
fact or probability of its occurrence—
without consideration for economic or
social benefits of use or costs of
restricting use. Information related to
serious toxic effects should be reported
regardless of exposure. Unlike records
maintained under TSCA section 8(c),
which need only be submitted to EPA
upon request, TSCA requires that
information required by TSCA section
8(e) be reported ‘‘immediately’’ (i.e.,
within 30 days of obtaining the
information).
The source of the information
handled under TSCA sections 8(c) and
8(e) is also different. While allegations
recorded pursuant to TSCA section 8(c)
are likely to be received directly from
workers, consumers, and plant
neighbors, TSCA section 8(e)
submissions usually result from
designed, controlled studies and reports
strongly implicating a chemical. TSCA
section 8(e) health effects submissions
focus on new serious health effects.
TSCA section 8(e) reporting
requirements are also triggered by
information about significant changes in
exposure circumstances with a
recognized hazardous substance, which
may be identified through monitoring
studies or other means. TSCA section
8(c) allegations may focus on serious
health effects, but they can also report
lesser effects experienced by a group of
individuals, or repeatedly by an
individual.
E. How to report?
All submitters must report TSCA
section 8(c) data electronically, using
the CSPP: Submissions for Chemical
Safety and Pesticide Programs software
(CSPP Software) accessible via EPA’s
Central Data Exchange (CDX) system
available at https://cdx.epa.gov/. The
CSPP Software provides a TSCA
Communications application that a
registered CDX user will access to
submit TSCA section 8(c) records.
Guidance on how to submit TSCA
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section 8(c) data is available in the
docket (EPA–HQ–OPPT–2023–0312)
and via EPA’s TSCA section 8(c) web
page for this action at https://
www.epa.gov/assessing-and-managingchemicals-under-tsca/tsca-8c-reporting44-methylene-bis2-chloroaniline-mboca.
You may also obtain help by contacting
EPA’s TSCA Hotline at tsca-hotline@
epa.gov or 202–554–1404. For help with
accessing your CDX account, please
contact the CDX help desk at https://
cdx.epa.gov/contact or (888) 890–1995
(for international callers: (970) 494–
5500).
F. How to submit confidential business
information?
Any person submitting copies of
records may assert a business
confidentiality claim covering all or part
of the submitted information in
accordance with the procedures
described in 40 CFR part 703 (88 FR
37155, June 7, 2023 (FRL–8223–02–
OCSPP)).
Requirements for asserting and
maintaining confidentiality claims are
described in 40 CFR 703.5. Such claim
must be made concurrent with
submission of the information. If no
such claim accompanies the
submission, EPA will not recognize a
confidentiality claim, and the
information in that submission may be
made available to the public without
further notice. Confidentiality claims
must be substantiated at the time of
submission to EPA pursuant to the
requirements of 40 CFR 703.5(b). To
assert a claim of confidentiality for
information contained in a submitted
record, the respondent must submit two
copies of the document. One copy must
be complete. In that copy, the
respondent must indicate what
information, if any, is claimed as
confidential by marking the specific
information on each page with a label
such as ‘‘confidential’’, ‘‘proprietary’’, or
‘‘CBI.’’ The other copy must be a public
version of the submission and
attachments, with all information that is
claimed as confidential removed. See 40
CFR 703.5(c). Both the copy containing
information claimed as CBI and the
‘‘sanitized’’ copy must be submitted
electronically, as discussed in Unit II.F.
The TSCA Communications Tool
incorporates many of the requirements
for asserting CBI claims, including
substantiation questions, a required
certification statement, and prompts to
provide a sanitized copy. Further details
regarding the requirements for
confidentiality claims can be found in
40 CFR part 703.
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G. When is reporting not required?
As provided by 40 CFR part 717,
reporting is not required by certain
persons for certain types of activities
involving the chemical, including:
• Entities considered manufacturers
solely due to mining or other resource
extraction activities are not required to
report (40 CFR 717.7(a)(1));
• Persons whose sole manufacturing
is due to the incidental or coincidental
production of chemical substances in
certain circumstances are not required
to report (40 CFR 717.7(a)(2)(i)–(v));
• Processors are required to report
only if they process chemical substances
to produce mixtures or repackage
chemical substances or mixtures (40
CFR 717.5(b)(1));
• A person solely engaged in the
distribution of chemical substances is
exempt from 8(c) reporting, unless such
person is also a manufacturer or
processor subject to 8(c) requirements
(40 CFR 717.7(c)); and
• A person who is a retailer is exempt
from 8(c) reporting unless such person
is also a manufacturer or a processor
subject to 8(c) requirements (40 CFR
717.7(d)).
Known human effects (i.e., commonly
recognized human health effects in
literature or product labels/SDS) need
not be reported unless the effect is
significantly more severe, occurred after
a significantly shorter exposure period
or lower exposure level, or occurred due
to a different exposure route than
previously described (see 40 CFR
717.12(b) and 717.3(c) for details).
Additionally, firms are not required to
record a significant adverse reaction to
the environment if the alleged cause of
that significant adverse reaction can be
directly attributable to an accidental
spill or other accidental discharge,
emission exceeding permitted limits, or
other incident of environmental
contamination that has been reported to
the Federal Government under any
applicable authority (40 CFR 717.12(d)).
III. 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 Office of Management and
Budget (OMB) approval under the PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable.
E:\FR\FM\26DEN1.SGM
26DEN1
Federal Register / Vol. 88, No. 246 / Tuesday, December 26, 2023 / Notices
The information collection
requirements associated with records of
allegations of significant adverse
reactions to human health or the
environment under TSCA section 8(c)
are contained in 40 CFR part 717 (OMB
Control No. 2070–0224; EPA ICR No.
2703.01) approved by OMB on
November 23, 2022. This action does
not impose any burden requiring
additional OMB approval. The annual
paperwork burden per respondent is
estimated to be 12.25 hours. This
burden estimate includes the time
needed to maintain records of
allegations of significant adverse
reactions, submit copies of these
allegation records when required by
EPA, and review of the Federal Register
notice. For additional details, please see
the Information Collection Request
document that is available in the docket.
Authority: 15 U.S.C. 2607(c).
Dated: December 19, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2023–28299 Filed 12–22–23; 8:45 am]
BILLING CODE P
FEDERAL DEPOSIT INSURANCE
CORPORATION
Sunshine Act Meetings
3:12 p.m. on Wednesday,
December 20, 2023.
PLACE: The meeting was held in the
Board Room located on the sixth floor
of the FDIC Building located at 550 17th
Street NW, Washington, DC.
STATUS: Closed.
MATTERS TO BE CONSIDERED: The Board
of Directors of the Federal Deposit
Insurance Corporation met to consider
matters related to the Corporation’s
supervision, corporate, and resolution
activities. In calling the meeting, the
Board determined, on motion of
Director Rohit Chopra (Director,
Consumer Financial Protection Bureau),
seconded by Director Michael J. Hsu
(Acting Comptroller of the Currency),
and concurred in by Vice Chairman
Travis J. Hill, Director Jonathan P.
McKernan, and Chairman Martin J.
Gruenberg, that the public interest did
not require consideration of the matters
in a meeting open to public observation;
and that the matters could be
considered in a closed meeting by
authority of subsections (c)(2), (c)(4),
(c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and
(c)10 of the ‘‘Government in the
Sunshine Act’’ (5 U.S.C. 552b (c)(2),
(c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B)
and (c)(10)).
khammond on DSKJM1Z7X2PROD with NOTICES
TIME AND DATE:
VerDate Sep<11>2014
20:25 Dec 22, 2023
Jkt 262001
CONTACT PERSON FOR MORE INFORMATION:
Requests for further information
concerning the meeting may be directed
to Debra A. Decker, Executive Secretary
of the Corporation, at 202–898–8748.
Dated this the 20th day of December, 2023.
Federal Deposit Insurance Corporation.
James P. Sheesley,
Assistant Executive Secretary.
[FR Doc. 2023–28472 Filed 12–21–23; 8:45 am]
BILLING CODE 6714–01–P
FEDERAL FINANCIAL INSTITUTIONS
EXAMINATION COUNCIL
[Docket No. AS23–21]
Appraisal Subcommittee; Notice of
Meeting
Appraisal Subcommittee of the
Federal Financial Institutions
Examination Council.
ACTION: Notice of special closed
meeting.
AGENCY:
Description: In accordance with
section 1104(b) of title XI of the
Financial Institutions Reform, Recovery,
and Enforcement Act of 1989, as
amended, notice is hereby given that the
Appraisal Subcommittee (ASC) met for
a special closed meeting on this date.
Location: Virtual meeting via Webex.
Date: December 14, 2023.
Time: 10:30 a.m. ET.
Action and Discussion Item
Personnel Matter
The ASC convened a Special Closed
Meeting to discuss a personnel matter.
No action was taken by the ASC.
James R. Park,
Executive Director.
[FR Doc. 2023–28365 Filed 12–22–23; 8:45 am]
BILLING CODE 6700–01–P
FEDERAL RESERVE SYSTEM
Agency Information Collection
Activities: Announcement of Board
Approval Under Delegated Authority
and Submission to OMB
Board of Governors of the
Federal Reserve System.
SUMMARY: The Board of Governors of the
Federal Reserve System (Board) is
adopting a proposal to extend for three
years, without revision, the Reporting
and Recordkeeping Requirements
Associated with Regulation Y (Capital
Plans) (FR Y–13; OMB No. 7100–0342).
FOR FURTHER INFORMATION CONTACT:
Federal Reserve Board Clearance
Officer—Nuha Elmaghrabi—Office of
AGENCY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
88919
the Chief Data Officer, Board of
Governors of the Federal Reserve
System, nuha.elmaghrabi@frb.gov, (202)
452–3884.
Office of Management and Budget
(OMB) Desk Officer for the Federal
Reserve Board, Office of Information
and Regulatory Affairs, Office of
Management and Budget, New
Executive Office Building, Room 10235,
725 17th Street NW, Washington, DC
20503, or by fax to (202) 395–6974.
SUPPLEMENTARY INFORMATION: On June
15, 1984, OMB delegated to the Board
authority under the Paperwork
Reduction Act (PRA) to approve and
assign OMB control numbers to
collections of information conducted or
sponsored by the Board. Boardapproved collections of information are
incorporated into the official OMB
inventory of currently approved
collections of information. The OMB
inventory, as well as copies of the PRA
Submission, supporting statements
(which contain more detailed
information about the information
collections and burden estimates than
this notice), and approved collection of
information instrument(s) are available
at https://www.reginfo.gov/public/do/
PRAMain. These documents are also
available on the Federal Reserve Board’s
public website at https://www.federal
reserve.gov/apps/reportingforms/home/
review or may be requested from the
agency clearance officer, whose name
appears above.
Final Approval Under OMB Delegated
Authority of the Extension for Three
Years, Without Revision, of the
Following Information Collection
Collection title: Reporting and
Recordkeeping Requirements
Associated with Regulation Y (Capital
Plans).
Collection identifier: FR Y–13.
OMB control number: 7100–0342.
General description of collection: In
addition to other reporting and
recordkeeping requirements, Section
225.8 of Regulation Y—Bank Holding
Companies and Change in Bank Control
(12 CFR 225.8) requires respondents to
submit a capital plan to the Board on an
annual basis and to request prior
approval from the Board under certain
circumstances before making a capital
distribution.
Frequency: Annually and on occasion.
Respondents: Top-tier bank holding
companies (BHCs) domiciled in the
United States with $100 billion or more
in total consolidated assets; U.S.
intermediate holding companies with
total consolidated assets of $100 billion
or more; any other BHC domiciled in
the United States that is made subject to
E:\FR\FM\26DEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 246 (Tuesday, December 26, 2023)]
[Notices]
[Pages 88915-88919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28299]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0312; FRL 11015-01-OCSPP]
4,4'-Methylene bis(2-chloroaniline); Request Under the Toxic
Substances Control Act (TSCA) for Records and Reports of Significant
Adverse Reactions to Health or the Environment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Through this notice, the Environmental Protection Agency (EPA)
is requiring manufacturers (including importers) and processors of the
chemical substance 4,4'-methylene bis(2-chloroaniline) to submit the
records and reports of allegations that this chemical substance causes
significant adverse reactions to health or the environment that they
are required to maintain and submit to EPA when requested under the
Toxic Substances Control Act (TSCA). Information submitted to the
Agency in response to this notice will help inform future EPA
activities regarding this chemical, including aiding EPA activities
related to this chemical substance having been identified as a
candidate for designation as a High-Priority Substance for TSCA risk
evaluation.
DATES: Records must be received by EPA on or before February 26, 2024.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA HQ-OPPT-2023-0312, is available online
at https://www.regulations.gov or in person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket) in the Environmental
Protection Agency Docket Center (EPA/DC). Additional instructions on
visiting the docket, along with more information about dockets
generally, are available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Brian Barone, Data Gathering and
Analysis Division (7406M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 566-0233; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
EPA is requiring submission of TSCA section 8(c) records of
allegations of significant adverse reactions to health or
[[Page 88916]]
the environment for the listed chemical. Regulations specifying TSCA
section 8(c) recordkeeping and reporting requirements are codified at
40 CFR part 717. Pursuant to TSCA section 8(c) and 40 CFR 717.17(b),
each person who is required to maintain records under TSCA section 8(c)
and implementing regulations at 40 CFR part 717 shall submit copies of
such records to EPA upon request. EPA is issuing this TSCA section 8(c)
action so that the health and environmental risks from exposure to this
chemical substance can be evaluated. The submitted information is
expected to be used to corroborate suspected adverse health or
environmental effects of the chemical under review and to help identify
trends of adverse effects across the industry that may not be apparent
to any one chemical company.
EPA has initiated the prioritization process for this chemical
substance as a candidate for designation as a High-Priority Substance
for risk evaluation. EPA plans to use data received through this
request to support the prioritization process to better understand
suspected adverse health or environmental effects of the chemical.
Further, should EPA finalize the designation of this chemical as a
high-priority substance for risk evaluation, then gathering this type
of data before EPA initiates such a risk evaluation could help make the
risk evaluation process more efficient and focused. EPA anticipates
issuing additional TSCA section 8(c) submission requirements for other
chemical substances identified as candidates for prioritization. EPA is
using this TSCA section 8(c) submission requirement as a first pilot
step in making use of the TSCA section 8(c) data gathering authority as
part of the general candidate selection process to be used by EPA for
TSCA section 6 prioritization activities.
B. What is the Agency's authority for taking this action?
Under TSCA section 8(c), chemical manufacturers (including
importers) and processors must maintain records of significant adverse
reactions to health or the environment alleged to have been caused by
chemical substances or mixtures and, upon request, submit or make the
records available to the Agency. Significant adverse reactions are
reactions that may indicate a substantial impairment of normal
activities or long-lasting or irreversible damage to health or the
environment. Regulations implementing TSCA section 8(c) appear in 40
CFR part 717.
C. Does this action apply to me?
This action may potentially affect you if you manufacture (defined
under TSCA to include import) or process the chemical substance
described by this document. The following list of North American
Industry Classification System (NAICS) codes is neither intended to be
exhaustive nor indicate expected reporting from a given industry sector
but rather provides a guide to help readers determine whether this
document applies to them. Potentially affected entities may include:
Manufacturing (NAICS codes 31-33), and/or
Other Chemical and Allied Products Merchant Wholesalers
(NAICS code 424690).
Other types of entities not included could also be affected. To
determine whether your entity is affected by this action, you should
carefully examine the applicability criteria found in 40 CFR part 717.
If you have questions regarding the applicability of this action to a
particular entity or information regarding additional entities that may
not be listed in this Notice, please consult the person listed in the
FOR FURTHER INFORMATION CONTACT section.
D. What is 4,4'-methylene bis(2-chloroaniline) (MBOCA)?
MBOCA is used as a curing agent for liquid polyurethane elastomers.
These elastomers have been used to produce shoe soles; rolls for
postage stamp machines; cutting bars in plywood manufacturing; rolls
and belt drives in cameras, computers, and reproducing equipment; and
pulleys for escalators and elevators. Animal studies have reported
effects on the lung, liver, and kidney from chronic oral exposure to
MBOCA. Animal studies have reported that MBOCA produces tumors of the
liver, lung, urinary bladder, and mammary glands from oral exposure.
EPA has classified MBOCA as a Group B2, probable human carcinogen.
II. Request for TSCA Section 8(c) Records
A. Who must submit records?
This requirement to submit TSCA section 8(c) allegation records
applies to persons who manufacture (defined under TSCA to include
import) or process MBOCA, and who are subject to TSCA section 8(c)
recordkeeping requirements pursuant to 40 CFR 717.5.
The regulations provide limited exemptions from recordkeeping and
reporting requirements for certain manufacturers and sites of
manufacture, as described at 40 CFR 717.5(a)(1) and 717.7(a). Persons
or site activities are exempt pursuant to 40 CFR 717.7(a)(1) if the
means by which they manufacture a chemical substance solely involves
mining or other solely extractive functions, e.g., those companies or
sites within a company whose sole function is to mine mineral ores,
extract petroleum or natural gas, quarry non-metallic minerals
(including extraction of salts from seawater or brines), mine or
otherwise extract coal, or separate gases from the atmosphere. In
addition, the regulations exempt persons whose only manufacturing act
is to produce a substance coincidentally under specific circumstances,
as described in 40 CFR 717.7(a)(2).
Two types of processors (who are not also manufacturers) are
subject to TSCA section 8(c) recordkeeping under the regulations at 40
CFR 717.5(b)(1) and to reporting under this notice: those who produce
and market chemical mixtures (including solutions) and those who
repackage chemical substances or mixtures.
A person solely engaged in the distribution of chemical substances
is exempt from TSCA section 8(c) recordkeeping and reporting pursuant
to 40 CFR 717.7(c) unless such person is also a manufacturer or
processor subject to the regulations. For example, a ``distributor''
who repackages chemical substances or mixtures is considered to be a
processor and, thus, is not a sole distributor.
Similarly, pursuant to 40 CFR 717.7(d), a person who is a retailer
is exempt from TSCA section 8(c) recordkeeping and reporting unless
such person is also a manufacturer or a processor subject to this
request.
B. What types of records must be submitted?
TSCA section 8(c) requires any manufacturer, processor, or
distributor of a chemical substance or mixture to keep records of
``significant adverse reactions'' to health or the environment, as
determined by rule, alleged to have been caused by the chemical
substance or mixture. Implementing regulations at 40 CFR part 717
describe the types of records that must be kept and are briefly
summarized here.
A ``significant adverse reactions'' is defined in 40 CFR 717.3(i)
as reactions that may indicate a substantial impairment of normal
activities, or long-lasting or irreversible damage to health or the
environment. Allegations subject to the recordkeeping requirement are
described at 40 CFR 717.10. ``Allegation'' is defined at 40 CFR
717.3(a) to mean a statement, made without formal proof or regard for
[[Page 88917]]
evidence, that a chemical substance or mixture has caused a significant
adverse reaction to health or the environment.
Significant adverse reactions to human health that must be recorded
could include, but are not limited to, birth defects, impairment of
bodily functions, or impairment of normal activities, as described at
40 CFR 717.12(a). TSCA section 8(c) allegations may focus on serious
health effects, but they can also report lesser effects experienced by
a group of individuals or repeatedly by an individual. Allegations that
do not meet the definition of a ``significant adverse reaction'' should
not be reported to EPA in the TSCA section 8(c) call-in. Additionally,
the regulation at 40 CFR 717.12(b) exempts ``known human effects'' from
this recordkeeping requirement. The definition of ``known human
effects'' at 40 CFR 717.3(c) covers commonly recognized human health
effects resulting from exposure to a substance as described in publicly
available sources such as Safety Data Sheets (SDS), product labeling,
or scientific literature, including, but not limited to, information
found at the Agency for Toxic Substances Disease Registry website
available at https://www.atsdr.cdc.gov/ and EPA's Integrated
Risk Management System available at https://www.epa.gov/iris. However,
pursuant to 40 CFR 717.3(c)(2), the exemption does not apply if the
reaction was a significantly more severe toxic effect than previously
described, or if the reaction resulted from a lower exposure level, a
significantly shorter exposure period, or a different exposure route
than previously described.
Significant adverse reactions to the environment must also be
recorded even if restricted to the environment surrounding a plant or
disposal site. Pursuant to 40 CFR 717.12(c), such reactions could
include but are not limited to: gradual or sudden changes to
composition of animal or plant life, deaths of organisms such as fish
kills, reduction of reproductive success of species, changes in
behavior or distribution of species, loss of agricultural productivity,
and irreversible contamination of the environment.
Pursuant to 40 CFR 717.12(d), a significant adverse reaction to the
environment is not required to be recorded if the alleged cause is
directly attributable to an incident of environmental contamination
that has already been reported to the Federal government under any
applicable authority.
EPA is requiring submission of all TSCA section 8(c) records that
fall within the record retention period described in TSCA section 8(c)
and 40 CFR 717.15(d). Accordingly, this request for records includes:
Records of significant adverse reactions to the health of
employees first reported to or known by the person maintaining such
records within the past 30 years, including employee health-related
allegations arising from any employment-related exposure, whether or
not such allegation was submitted by or on the behalf of that
recordkeeper's own employee.
Any other record of significant adverse reactions first
reported to or known by the person maintaining the record within the
past five years.
C. What information must be included with a submission?
Manufacturers of the chemical substance listed in this notice must
submit any records kept pursuant to 40 CFR part 717 of significant
adverse reactions alleged to have been caused by the chemical
substance. Under the regulations, a manufacturer is responsible for
collecting allegations regarding substances it manufactures, as well as
allegations regarding certain chemical processing and distribution
activities it may carry out. Accordingly, as provided in 40 CFR
717.5(a)(2), manufacturers of the listed chemical substance must submit
records of any collected allegations that:
Identify the listed chemical substance or identify
operations used in the manufacture of the chemical substance;
Identify any of the manufacturer's own processing or
distribution in commerce activities with respect to the chemical
substance;
Identify emissions, effluents, or other discharges from
activities described in this paragraph; and
Identify a substance produced coincidentally during
processing, use, storage or disposal of a chemical substance it
manufactures, where either the coincidentally produced chemical
substance or the originally manufactured chemical substance is listed
in this notice.
Processors of the chemical substance listed in this notice who are
subject to TSCA section 8(c) recordkeeping requirements (i.e., persons
who process chemical substances to produce mixtures, or repackage
chemical substances or mixtures) must also submit any records kept
pursuant to 40 CFR part 717 of significant adverse reactions alleged to
have been caused by the chemical substance. As provided by 40 CFR
717.5(b)(2), this includes allegations that:
Identify any mixture the processor produces and
distributes in commerce containing the listed chemical substance, or
identify the listed chemical substance or mixture containing the listed
chemical substance that the processor repackages and distributes in
commerce;
Identify any of the processor's own further processing or
distribution in commerce activities of such products;
Identify emissions, effluents, or other discharges from
activities described in this paragraph;
Identify a substance produced coincidentally during the
processing, use, storage, or disposal of any mixture the processor
produces and distributes in commerce or any chemical substance or
mixture it repackages and distributes in commerce, where either the
coincidentally produced chemical substance or the processed chemical
substance is listed in this notice.
As provided by 40 CFR 717.15(b), in addition to the original
allegation as received, TSCA section 8(c) reported allegation records
must contain the name and address of the site that received the
allegation; the date the allegation was received; the implicated
chemical substance, mixture, article, company process or operation, or
site discharge; a description of the alleger; and a description of the
alleged health effect(s) and/or environmental effect(s).
Additionally, the submission must include the results of any self-
initiated investigation with respect to an allegation and copies of any
further required records or reports relating to the allegation, as
described at 40 CFR 717.15(b)(3) and (4)).
EPA encourages respondents to conduct a thorough review of their
TSCA 8(c) records, including a search for all known synonyms and trade
names associated with the listed chemical. Alternative identifiers can
be found through many sources, including PubChem, an open chemistry
database operated by the National Institutes of Health (NIH) at https://pubchem.ncbi.nlm.nih.gov, EPA's CompTox Chemical Dashboard website at
https://comptox.epa.gov/dashboard and EPA's Substance Registry Service
(SRS) at https://cdxapps.epa.gov/oms-substance-registry-services/search.
D. How does this request for allegation records differ from TSCA
section 8(e) reporting?
TSCA section 8(e) requires manufacturers, processors, and
distributors of a chemical substance or mixture to notify EPA
immediately of
[[Page 88918]]
information that reasonably supports the conclusion that such substance
or mixture presents a substantial risk of injury to health or the
environment, unless that person knows that EPA has already been
informed. EPA published a TSCA section 8(e) Policy Statement and
Guidance on June 3, 2003 (68 FR 33129 (FRL-7287-4)), which defines
``substantial-risk information'' as information which reasonably
supports the conclusion that a chemical substance or mixture presents a
substantial risk of injury to health or the environment, and
``substantial risk of injury to health or the environment'' as a risk
of considerable concern because of the seriousness of the effect, and
the fact or probability of its occurrence--without consideration for
economic or social benefits of use or costs of restricting use.
Information related to serious toxic effects should be reported
regardless of exposure. Unlike records maintained under TSCA section
8(c), which need only be submitted to EPA upon request, TSCA requires
that information required by TSCA section 8(e) be reported
``immediately'' (i.e., within 30 days of obtaining the information).
The source of the information handled under TSCA sections 8(c) and
8(e) is also different. While allegations recorded pursuant to TSCA
section 8(c) are likely to be received directly from workers,
consumers, and plant neighbors, TSCA section 8(e) submissions usually
result from designed, controlled studies and reports strongly
implicating a chemical. TSCA section 8(e) health effects submissions
focus on new serious health effects. TSCA section 8(e) reporting
requirements are also triggered by information about significant
changes in exposure circumstances with a recognized hazardous
substance, which may be identified through monitoring studies or other
means. TSCA section 8(c) allegations may focus on serious health
effects, but they can also report lesser effects experienced by a group
of individuals, or repeatedly by an individual.
E. How to report?
All submitters must report TSCA section 8(c) data electronically,
using the CSPP: Submissions for Chemical Safety and Pesticide Programs
software (CSPP Software) accessible via EPA's Central Data Exchange
(CDX) system available at https://cdx.epa.gov/. The CSPP Software
provides a TSCA Communications application that a registered CDX user
will access to submit TSCA section 8(c) records. Guidance on how to
submit TSCA section 8(c) data is available in the docket (EPA-HQ-OPPT-
2023-0312) and via EPA's TSCA section 8(c) web page for this action at
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-8c-reporting-44-methylene-bis2-chloroaniline-mboca. You may also obtain
help by contacting EPA's TSCA Hotline at [email protected] or 202-
554-1404. For help with accessing your CDX account, please contact the
CDX help desk at https://cdx.epa.gov/contact or (888) 890-1995 (for
international callers: (970) 494-5500).
F. How to submit confidential business information?
Any person submitting copies of records may assert a business
confidentiality claim covering all or part of the submitted information
in accordance with the procedures described in 40 CFR part 703 (88 FR
37155, June 7, 2023 (FRL-8223-02-OCSPP)).
Requirements for asserting and maintaining confidentiality claims
are described in 40 CFR 703.5. Such claim must be made concurrent with
submission of the information. If no such claim accompanies the
submission, EPA will not recognize a confidentiality claim, and the
information in that submission may be made available to the public
without further notice. Confidentiality claims must be substantiated at
the time of submission to EPA pursuant to the requirements of 40 CFR
703.5(b). To assert a claim of confidentiality for information
contained in a submitted record, the respondent must submit two copies
of the document. One copy must be complete. In that copy, the
respondent must indicate what information, if any, is claimed as
confidential by marking the specific information on each page with a
label such as ``confidential'', ``proprietary'', or ``CBI.'' The other
copy must be a public version of the submission and attachments, with
all information that is claimed as confidential removed. See 40 CFR
703.5(c). Both the copy containing information claimed as CBI and the
``sanitized'' copy must be submitted electronically, as discussed in
Unit II.F. The TSCA Communications Tool incorporates many of the
requirements for asserting CBI claims, including substantiation
questions, a required certification statement, and prompts to provide a
sanitized copy. Further details regarding the requirements for
confidentiality claims can be found in 40 CFR part 703.
G. When is reporting not required?
As provided by 40 CFR part 717, reporting is not required by
certain persons for certain types of activities involving the chemical,
including:
Entities considered manufacturers solely due to mining or
other resource extraction activities are not required to report (40 CFR
717.7(a)(1));
Persons whose sole manufacturing is due to the incidental
or coincidental production of chemical substances in certain
circumstances are not required to report (40 CFR 717.7(a)(2)(i)-(v));
Processors are required to report only if they process
chemical substances to produce mixtures or repackage chemical
substances or mixtures (40 CFR 717.5(b)(1));
A person solely engaged in the distribution of chemical
substances is exempt from 8(c) reporting, unless such person is also a
manufacturer or processor subject to 8(c) requirements (40 CFR
717.7(c)); and
A person who is a retailer is exempt from 8(c) reporting
unless such person is also a manufacturer or a processor subject to
8(c) requirements (40 CFR 717.7(d)).
Known human effects (i.e., commonly recognized human health effects
in literature or product labels/SDS) need not be reported unless the
effect is significantly more severe, occurred after a significantly
shorter exposure period or lower exposure level, or occurred due to a
different exposure route than previously described (see 40 CFR
717.12(b) and 717.3(c) for details).
Additionally, firms are not required to record a significant
adverse reaction to the environment if the alleged cause of that
significant adverse reaction can be directly attributable to an
accidental spill or other accidental discharge, emission exceeding
permitted limits, or other incident of environmental contamination that
has been reported to the Federal Government under any applicable
authority (40 CFR 717.12(d)).
III. 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 Office of Management and Budget (OMB)
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable.
[[Page 88919]]
The information collection requirements associated with records of
allegations of significant adverse reactions to human health or the
environment under TSCA section 8(c) are contained in 40 CFR part 717
(OMB Control No. 2070-0224; EPA ICR No. 2703.01) approved by OMB on
November 23, 2022. This action does not impose any burden requiring
additional OMB approval. The annual paperwork burden per respondent is
estimated to be 12.25 hours. This burden estimate includes the time
needed to maintain records of allegations of significant adverse
reactions, submit copies of these allegation records when required by
EPA, and review of the Federal Register notice. For additional details,
please see the Information Collection Request document that is
available in the docket.
Authority: 15 U.S.C. 2607(c).
Dated: December 19, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-28299 Filed 12-22-23; 8:45 am]
BILLING CODE P
