Document ID: EPA-HQ-OPPT-2023-0312-0001
Agency: epa
Document Type: Notice
Title: 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
Posted Date: 2023-12-26T05:00Z

[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]

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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.

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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/index.html 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]
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