Notice2023-28299
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 26, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 246 (Tuesday, December 26, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 246 (Tuesday, December 26, 2023)]
[Notices]
[Pages 88915-88919]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#fa989b8895949fd49888939b94ba9f8a9bd49d958c"><span class="__cf_email__" data-cfemail="254744574a4b400b47574c444b654055440b424a53">[email protected]</span></a>.
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:
<bullet> Manufacturing (NAICS codes 31-33), and/or
<bullet> 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 <a href="https://www.atsdr.cdc.gov/index.html">https://www.atsdr.cdc.gov/index.html</a> and EPA's Integrated
Risk Management System available at <a href="https://www.epa.gov/iris">https://www.epa.gov/iris</a>. 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:
<bullet> 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.
<bullet> 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:
<bullet> Identify the listed chemical substance or identify
operations used in the manufacture of the chemical substance;
<bullet> Identify any of the manufacturer's own processing or
distribution in commerce activities with respect to the chemical
substance;
<bullet> Identify emissions, effluents, or other discharges from
activities described in this paragraph; and
<bullet> 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:
<bullet> 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;
<bullet> Identify any of the processor's own further processing or
distribution in commerce activities of such products;
<bullet> Identify emissions, effluents, or other discharges from
activities described in this paragraph;
<bullet> 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 <a href="https://pubchem.ncbi.nlm.nih.gov">https://pubchem.ncbi.nlm.nih.gov</a>, EPA's CompTox Chemical Dashboard website at
<a href="https://comptox.epa.gov/dashboard">https://comptox.epa.gov/dashboard</a> and EPA's Substance Registry Service
(SRS) at <a href="https://cdxapps.epa.gov/oms-substance-registry-services/search">https://cdxapps.epa.gov/oms-substance-registry-services/search</a>.
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 <a href="https://cdx.epa.gov/">https://cdx.epa.gov/</a>. 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
<a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-8c-reporting-44-methylene-bis2-chloroaniline-mboca">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-8c-reporting-44-methylene-bis2-chloroaniline-mboca</a>. You may also obtain
help by contacting EPA's TSCA Hotline at <a href="/cdn-cgi/l/email-protection#3e4a4d5d5f1356514a5257505b7e5b4e5f10595148"><span class="__cf_email__" data-cfemail="2e5a5d4d4f0346415a4247404b6e4b5e4f00494158">[email protected]</span></a> or 202-
554-1404. For help with accessing your CDX account, please contact the
CDX help desk at <a href="https://cdx.epa.gov/contact">https://cdx.epa.gov/contact</a> 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:
<bullet> Entities considered manufacturers solely due to mining or
other resource extraction activities are not required to report (40 CFR
717.7(a)(1));
<bullet> 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));
<bullet> 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));
<bullet> 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
<bullet> 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 26, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.