[Federal Register Volume 86, Number 122 (Tuesday, June 29, 2021)]
[Rules and Regulations]
[Pages 34147-34154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13212]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 716

[EPA-HQ-OPPT-2020-0474; FRL-10020-38]
RIN 2070-AB11


Health and Safety Data Reporting; Addition of 20 High-Priority 
Substances and 30 Organohalogen Flame Retardants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule, issued pursuant to the Toxic Substances 
Control Act (TSCA) and the TSCA Health and Safety Data Reporting rule, 
requires manufacturers (including importers) of 50 specified chemical 
substances to report certain lists and copies of unpublished health and 
safety studies to EPA. The chemical substances subject to this rule are 
listed in this document and consist of the 20 designated by EPA as 
High-Priority Substances and the 30 organohalogen flame retardants 
being evaluated for risks by the Consumer Product Safety Commission 
(CPSC) under the Federal Hazardous Substances Act (FHSA). EPA is taking 
this action because the TSCA Interagency Testing Committee (ITC) added 
these chemical substances to the Priority Testing List through its 69th 
and 74th Reports and EPA will use this information to inform the risk 
evaluations currently underway for 20 High-Priority Substances and for 
future prioritization.

DATES: This final rule is effective July 29, 2021. For purposes of 
judicial review, this final rule shall be promulgated at 1 p.m. eastern 
daylight/standard time July 13, 2021
    A request to withdraw a chemical substance from this final rule 
pursuant to 40 CFR 716.105(c) must be received on or before July 13, 
2021. (See Unit IV. of the SUPPLEMENTARY INFORMATION.)
    Dates for the reporting requirements are enumerated in Unit III.B. 
of the SUPPLEMENTARY INFORMATION.

ADDRESSES: 
    Comments. Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2020-0474, by using the Federal eRulemaking 
Portal at http://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
    Withdrawal requests. For submission of a withdrawal request, see 
Unit IV. of this document. Each withdrawal request must be identified 
by docket ID number EPA-HQ-OPPT-2020-0474.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Diana Fahning, Data Gathering 
and Analysis Division (7410M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: (202) 564-8621; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 34148]]

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(defined by statute to include import) any of the chemical substances 
that are listed in 40 CFR 716.120(d) of the regulatory text of this 
document. The following list of North American Industrial 
Classification System (NAICS) codes is not intended to be exhaustive, 
but rather provides a guide to help readers determine whether this 
document applies to them. Potentially affected entities may include: 
Chemical manufacturers (including importers), (NAICS codes 325 and 
324110), e.g., persons who manufacture (defined by statute to include 
import) one or more of the subject chemical substances.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
http://www.regulations.gov or email. Clearly mark the part or all of 
the information that you claim to be CBI. For CBI information in a disk 
or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM 
as CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

A. What action is the Agency taking?

    EPA is issuing a final rule pursuant to TSCA section 8(d) to 
require manufacturers (including importers) of chemical substances 
listed in this document and on the ITC's TSCA section 4(e) Priority 
Testing List to submit lists and copies of certain unpublished health 
and safety studies to EPA. The regulatory text of this document lists 
the chemical substances and their Chemical Abstracts Service Registry 
Numbers (CASRN) that are being added to the Health and Safety Data 
Reporting rule. It also lists the specific data reporting requirements 
imposed by this final rule.

B. What is the Agency's authority for taking this action?

    EPA promulgated the Health and Safety Data Reporting rule under 
TSCA section 8(d) (15 U.S.C. 2607(d)), and it is codified at 40 CFR 
part 716. EPA is using this TSCA section 8(d) rule in accordance with 
40 CFR 716.105 to gather information on chemical substances. These 
studies are expected to provide EPA with useful information for 
conducting TSCA activities such as prioritization and risk evaluation.
    The Agency adds substances to the rule via rule or notice, in 
accordance with 40 CFR 716.105(a) or (b), respectively. The rule 
requires certain past, current, and prospective manufacturers (which 
under TSCA includes importers) to submit copies and/or lists of 
unpublished health and safety studies on the listed chemical substances 
that they manufacture. In some cases, EPA may also require processors 
to comply with the rule.
    The TSCA section 8(d) Health and Safety Data Reporting rule 
provides for the addition of TSCA section 4(e) Priority Testing List 
chemical substances to the list of chemical substances subject to the 
rule (see Table of Chemicals, 40 CFR 716.120) (Ref. 1). Whenever EPA 
announces the receipt of an ITC Report, EPA may, amend the TSCA section 
8(d) Health and Safety Data Reporting rule by adding the recommended 
(or designated) chemical substances to the TSCA section 4(e) list. In 
doing so, EPA must provide a 14-day period (measured from the date of 
publication of the Federal Register document announcing the rule) for 
persons to submit information showing why a chemical substance, 
mixture, or category of chemical substances should be withdrawn from 
the amendment. The amendment adding these chemical substances to the 
Health and Safety Data Reporting rule is effective July 29, 2021. If 
EPA withdraws a chemical substance from the amendment, a Federal 
Register document announcing this decision is to be published no later 
than July 29, 2021.

C. Comments Received on the 74th Report of the ITC

    EPA received seven public comments on the 74th Report of the ITC. 
One comment requested additional information be provided for why 
certain organohalogen flame retardants being added to the Priority 
Testing List (PTL). Several comments questioned whether requiring 8(d) 
reporting for a chemical substance for which EPA has issued a Section 4 
Test Order would be redundant and/or produce data in time for use in a 
risk evaluation under TSCA section 6 on the applicable chemical 
substance. EPA also received a comment on chemicals substances to 
remove from the PTL. Additionally, one commenter recommended additional 
activities for EPA to conduct related to fulfilling data needs (e.g., 
via the use of Test Orders pursuant to section 4 of TSCA).
    EPA has reviewed the comments and continues to believe that it is 
appropriate to list these chemical substances in this document onto the 
ITC's TSCA section 4(e) Priority Testing List to prompt EPA to 
implement their authority pursuant to TSCA section 8(d), to require 
manufacturers (including importers) to submit lists and copies of 
certain unpublished health and safety studies to EPA. The 74th ITC 
Report provided the basis for its inclusion of all chemical substances 
that were added to the PTL. Regarding possible redundancies of 
published and previously submitted information under other TSCA 
programs, under 40 CFR 716.20(a) certain studies are exempt from the 
copy and list submission requirements of 40 CFR 716.30 and 716.35. 
Within EPA's current timeline for risk evaluations under TSCA section 
6, data received via this 8(d) action would be received in time for use 
in risk evaluations for chemical substances that have been designated 
as high-priority substances, and data received on the other chemical 
substances listed in this document would help inform future 
prioritization activities, as well as help inform other agency 
decisions involving such chemical substances. In regard to chemical 
substances being recommended for deletion from the PTL and for requests 
for certain activities to be undertaken in regard to certain chemical 
substances, EPA will consider such recommendations during future ITC 
discussions and during decision-making related to its various TSCA 
statutory authorities.

D. Why is this action issued as a Final Rule?

    The regulations at 40 CFR 716.105(b) and (c) establish the process 
for this action to amend the TSCA section 8(d) Health and Safety Data 
Reporting rule.

III. Final Rule

A. What chemical substances are added?

    In this document, EPA is adding chemical substances to the TSCA 
section 8(d) Health and Safety Data Reporting rule. This addition 
implements 40 CFR 716.105(b), which generally provides that ``chemical 
substances, mixtures, and categories of

[[Page 34149]]

chemical substances that have been added to the TSCA section 4(e) 
Priority List by the Interagency Testing Committee, established under 
section 4 of TSCA, will be added to Sec.  716.120 . . .'' This addition 
also addresses the request of the TSCA ITC in its 74th Report (Ref. 2) 
to add certain chemical substances listed in that report to the TSCA 
section 8(d) Health and Safety Data Reporting rule. The specific 
chemical substances being added to the rule are listed in the 
regulatory text at the end of this document.

B. What are the reporting requirements?

    Listed in this unit are the reporting requirements for the chemical 
substances added by this final rule to the TSCA section 8(d) model 
Health and Safety Data Reporting rule. The specific types of health and 
safety studies that must be reported for each of the chemical 
substances added to the Health and Safety Data Reporting rule as a 
result of this document can be found in Unit III.C.
    1. Persons who, in the 10 years preceding the date a chemical 
substance is listed, either have proposed to manufacture (including 
import) or have manufactured (including imported) the listed chemical 
substance must submit to EPA, during the 60-day reporting period 
specified in 40 CFR 716.65 and according to the reporting schedule set 
forth at 40 CFR 716.60, a copy of each specified type of health and 
safety study which is in their possession at the time the chemical 
substance is listed in part 716.
    2. Persons who, at the time the chemical substance is listed in 
part 716, propose to manufacture (including import) or are 
manufacturing (including importing) the listed chemical substance must 
submit to EPA during the 60-day reporting period specified in 40 CFR 
716.65 and according to the reporting schedule set forth at 40 CFR 
716.60:
    i. A list of the specified types of health and safety studies known 
to them but not in their possession at the time the chemical substance 
is listed.
    ii. A list of the specified types of health and safety studies that 
are ongoing at the time the chemical substance is listed and are being 
conducted by or for them.
    iii. A list of the specified types of health and safety studies 
that are initiated after the date the chemical substance is listed and 
will be conducted by or for them.
    iv. A copy of each specified type of health and safety study which 
is in their possession at the time the chemical substance is listed.
    v. A copy of each specified type of health and safety study that 
was previously listed as ongoing or subsequently initiated (i.e., 
listed in accordance with reporting requirements in Unit III.B.2.iii. 
and iv., respectively) and is now complete--regardless of completion 
date.
    3. Persons who, after the time the chemical substance is listed in 
part 716, propose to manufacture (including import) the listed chemical 
substance must submit to EPA during the reporting period specified in 
40 CFR 716.65 and according to the reporting schedule set forth at 40 
CFR 716.60:
    i. A list of the specified types of health and safety studies known 
to them but not in their possession at the time they propose to 
manufacture (including import) the listed chemical substance.
    ii. A list of the specified types of health and safety studies that 
are ongoing at the time they propose to manufacture (including import) 
the listed chemical substance and are being conducted by or for them.
    iii. A list of the specified types of health and safety studies 
that are initiated after the time they propose to manufacture 
(including import) the listed chemical substance and will be conducted 
by or for them.
    iv. A copy of each specified type of health and safety study which 
is in their possession at the time they propose to manufacture 
(including import) the listed chemical substance.
    v. A copy of each specified type of health and safety study that 
was previously listed as ongoing or subsequently initiated (i.e., 
listed in accordance with reporting requirements in Unit III.B.3.iii. 
and 3.iv., respectively) and is now complete--regardless of the 
completion date.
    The reporting described in Unit III.B. is required by September 27, 
2021. Any person who manufactures (including imports) or who proposes 
to manufacture (including import) the listed chemical substance from 
July 29, 2021 to September 27, 2021 must inform EPA (by submitting a 
list) of any studies initiated during the period from July 29, 2021 to 
September 27, 2021 within 30 days of their initiation, but in no case 
later than October 27, 2021. In addition, if any such person has 
submitted lists of studies that were ongoing or initiated during the 
period from July 29, 2021 to September 27, 2021 to EPA, such person 
must submit a copy of each study within 30 days after its completion, 
regardless of the study's completion date. See 40 CFR 716.60 and 
716.65.
    Detailed guidance for reporting unpublished health and safety data 
and explanations of reporting exemptions is provided at 40 CFR part 
716.
    Persons reporting under this rule may also assert CBI claims for 
certain information included in their submission. TSCA section imposes 
the following requirements:
     CBI claims must be asserted must be asserted at the time 
the information claimed as CBI is submitted to EPA. Information 
submitted with a confidentiality claim may be made public without 
further notice.
     Information claimed as CBI must be substantiated at the 
time of submission, with the exception of those types of information 
exempt from substantiation under TSCA section 14(c)(2).
     All persons making a CBI claim must provide a standard 
statement concerning the need for the CBI claim and a certification 
that the statement of need is true and correct.
     Where a specific chemical identity is claimed as CBI, a 
structurally descriptive generic name must be provided for disclosure 
to the public.
    The 8(d) reporting application accommodates these requirements, 
incorporating the required statements and certifications, and will 
prompt the submitter to provide substantiation prior to making a 
submission that includes CBI claims.

C. What types of studies must be submitted?

    Pursuant to 40 CFR 716.20(b)(5) and 716.50, the types of 
unpublished health and safety studies that must be reported and the 
chemical grade/purity requirements that must be met or exceeded in 
individual studies for the chemical substances added to the Health and 
Safety Data Reporting rule as a result of this document are as follows:
    Under this rule, manufacturers (including importers) of High-
Priority Substances are required to submit the following:
     Lists and copies of unpublished health and safety studies 
for all High-Priority Substances specified in this rule on health 
effects, such as toxicity studies (in vivo and in vitro) on 
carcinogenicity, reproductive and developmental effects, genotoxicity, 
neurotoxicity, immunotoxicity, endocrine effects, and other systemic 
toxicity and toxicokinetics (absorption, distribution, metabolism, or 
elimination), including modelling studies, in humans or animals.
     All unpublished studies on environmental effects, 
environmental fate, and physical-chemical properties if performed as 
described in 40 CFR 716.50 are also required under this rule.

[[Page 34150]]

     All unpublished studies on occupational (both users and 
non-users), general population, consumer, and environmental exposure, 
such as: Unpublished studies on inhalation and dermal exposure, human 
biomonitoring, environmental monitoring of indoor and outdoor air, 
soil, water, and household dust, chamber emission rates from products 
or polymeric matrices, and unpublished modelling studies that estimate 
environmental concentrations or human exposures.
     Studies showing any measurable content of the High-
Priority Substance in the tested substance (single substances or 
mixture) must be reported. The composition and purity of test 
substances must be reported if included as part of the study.
     Studies previously submitted to EPA pursuant to a 
requirement under TSCA or of the submitter's own accord and studies 
conducted or to be conducted pursuant to a TSCA section 4 action are 
exempt from the submission of lists of health and safety studies 
required under 40 CFR 716.35 and the submission of studies required 
under this rule.
    Under this rule, manufacturers (including importers) of 
organohalogen flame retardants are required to submit the following:
     Lists and copies of unpublished health and safety studies 
for all organohalogen flame retardants specified in this rule on health 
effects, such as toxicity studies (in vivo and in vitro) on 
carcinogenicity, reproductive and developmental effects, genotoxicity, 
neurotoxicity, immunotoxicity, endocrine effects, and other systemic 
toxicity and toxicokinetics (absorption, distribution, metabolism, or 
elimination), including modelling studies, in humans or animals.
     All unpublished studies on environmental effects, 
environmental fate, and physical-chemical properties if performed as 
described in 40 CFR 716.50 are also required under this rule.
     All unpublished studies on occupational (both users and 
non-users), general population, consumer, and environmental exposure, 
such as unpublished studies on inhalation and dermal exposure, human 
biomonitoring, environmental monitoring of indoor and outdoor air, 
soil, water, and household dust, chamber emission rates from products 
or polymeric matrices, and unpublished modelling studies that estimate 
environmental concentrations or human exposures, must be submitted.
     Studies showing any measurable content of the 
organohalogen flame retardant in the tested substance (single 
substances or mixture) must be reported. The composition and purity of 
test substances must be reported if included as part of the study.
     Studies previously submitted to EPA pursuant to a 
requirement under TSCA or of the submitter's own accord and studies 
conducted or to be conducted pursuant to a TSCA section 4 action are 
exempt from the submission of lists of health and safety studies 
requirements under 40 CFR 716.35 and the submission of studies 
requirements under this rule.

D. Rationales and Background for Chemical Additions and Reporting 
Requirements

1. High-Priority Substances
    The 20 High-Priority Substances identified in this rule have been 
designated High-Priority under TSCA section 6(b) because EPA has found 
that each of these chemical substances may present an unreasonable risk 
of injury to health or the environment (Ref. 3). EPA is seeking 
unpublished health and safety studies to ensure that such studies are 
available to EPA to inform its risk evaluation findings of whether any 
of these High-Priority Substances present an unreasonable risk of 
injury to health or the environment. Further, this information will be 
considered, as appropriate, when reviewing potential analogue data for 
read across and/or category development in assessing new chemicals.
2. Organohalogen Flame Retardants
    EPA requests this information to help support prioritization and 
evaluation activities under TSCA (see TSCA section 6(b), and as 
discussed above). Further, this information will be considered, as 
appropriate, when reviewing potential analogue data for read across 
and/or category development in assessing new chemicals. Additionally, 
CPSC, a representative member of the ITC, needs information on a group 
of organohalogen flame retardants because the Commission voted to grant 
a petition to begin rulemaking for this class of chemicals under the 
Federal Hazardous Substances Act (FHSA), (Ref. 5). Organohalogen flame 
retardants may be added to consumer products to prevent or slow 
combustion, but are additive, i.e., not covalently bound to the 
substrate, which can be textiles, polymers, or foam. Most organohalogen 
flame retardants are semi-volatile compounds (SVOCs), that can migrate 
into air, where they bind to airborne particles and surfaces in the 
home. In addition to direct contact with organohalogen flame retardant-
containing products, a substantial portion of exposure is believed to 
occur from exposure to household dust, especially in children. 
Biomonitoring studies and measurements of household dust and indoor air 
demonstrate that exposure to organohalogen flame retardants is nearly 
ubiquitous.
    Many organohalogen flame retardants have been shown to cause health 
effects. Health effects associated with organohalogen flame retardants 
include carcinogenicity (e.g., halogenated alkyl phosphates), 
developmental effects (e.g., polybrominated diphenyl ethers (PBDEs)), 
and developmental neurotoxicity (e.g., Decabromodiphenyl ether 
(decaBDE)).
    In 2015, CPSC was petitioned by a number of organizations and 
individuals, such as consumer groups, medical associations, workers, 
and firefighter organizations, to ban the use of all additive, non-
polymeric organohalogen flame retardants under the authority of the 
FHSA in the following consumer products: (1) Durable infant or toddler 
products, children's toys, child care articles, or other children's 
products (other than car seats, which are under Department of 
Transportation's jurisdiction); (2) Residential upholstered furniture; 
(3) Mattresses and mattress pads; and (4) The plastic casings of 
electronic devices (Ref. 5).
    CPSC granted the petition in 2017 and directed staff to complete a 
scoping and feasibility study in cooperation with the National Academy 
of Sciences, Engineering, and Medicine (NASEM). The task for this 
project was to develop a scientifically based scoping plan to identify 
the potential health hazards associated with additive, nonpolymeric 
organohalogen flame retardants as a class. The NASEM Committee 
published the report, ``A Class Approach to Hazard Assessment of 
Organohalogen Flame Retardants'' in May 2019 (Ref. 6). A key conclusion 
of the NASEM Committee is that organohalogen flame retardants cannot be 
treated as a single class. Rather, the NASEM Committee identified 14 
subclasses of organohalogen flame retardants, based on chemical 
structure, physicochemical properties of the chemicals, and predicted 
biologic activity. The NASEM Committee identified 161 organohalogen 
flame retardants and more than 1,000 analog chemicals. CPSC staff is 
undertaking the risk assessment of 14 classes of organohalogen flame 
retardants following the recommendations of the NASEM Committee.
    Because preliminary searches show that little or no health and 
safety

[[Page 34151]]

information is available for many of the 161 organohalogen flame 
retardants, including the organohalogen flame retardants being added 
here to the TSCA section 8(d) Health and Safety Data Reporting rule, 
the submission of the lists and copies of the unpublished health and 
safety studies specified in this rule is being required under the TSCA 
section 8(d) Health and Safety Data Reporting rule for these OFR 
additions. As indicated above, this information will also inform TSCA 
activities such as future prioritization efforts and, with potential 
read-across data, new chemical reviews. Further, EPA will coordinate 
with ITC members to share information received, as appropriate (e.g., 
to help inform CPSC's evaluation of specific chemicals).

E. What are the incremental economic implications of this action?

    EPA prepared an economic analysis for the addition of the 50 
chemical substances to the TSCA section 8(d) Health and Safety Data 
Reporting rule, entitled, ``TSCA Section 8(d): Economic Impact Analysis 
for Adding 50 Chemicals from the 74th ITC Report of the TSCA 
Interagency Testing Committee to the Health and Safety Data Reporting 
Rule.'' (Economic Analysis, Ref. 7) a copy of which is included in the 
docket for this rulemaking. The total one-time cost associated with 
this final rule is estimated to be approximately $185,000 based on 
approximately 1,900 and 420 hours of industry and EPA burden, 
respectively.

IV. Requesting a Chemical Substance Be Withdrawn From This Final Rule

    As specified in 40 CFR 716.105(c), EPA may, in its discretion, 
remove a chemical substance, mixture, or category of chemical 
substances from this final rule for good cause prior to the effective 
date of this final rule. Any person who believes that the reporting 
required by this final rule is not warranted for a chemical substance 
listed in this final rule must submit to EPA detailed reasons for that 
belief. You must submit your request to EPA on or before July 13, 2021 
and in accordance with the instructions provided in 40 CFR 716.105(c) 
and (d). In addition, to ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPPT-2020-0474. If the EPA 
Administrator withdraws a chemical substance, mixture, or category of 
chemical substances from the amendment, in accordance with 40 CFR 
716.105(c), a Federal Register document announcing this decision will 
be published no later than July 29, 2021.

V. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA. For more information about these 
references, please consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT.

1. EPA. 40 CFR 716.120. Substances and listed mixtures to which this 
subpart applies. Available online at: https://www.ecfr.gov/cgibin/textidx?SID=94b50835053a07b80c3517fff641aeba&mc=true&node=pt40.33.716&rgn=div5#se40.33.716_1120.
2. ITC. Notice; Seventy-Fourth Report of the TSCA Interagency 
Testing Committee to the Administrator of the Environmental 
Protection Agency; Receipt of Report and Request for Comments. 
Federal Register (86 FR 22414, April 28, 2021) (FRL-10020-39). 
Available online at: https://www.govinfo.gov/content/pkg/FR-2021-04-28/pdf/2021-08839.pdf.
3. EPA. High-Priority Substance Designations Under the Toxic 
Substances Control Act (TSCA) and Initiation of Risk Evaluation on 
High-Priority Substances; Notice of Availability. Federal Register 
(84 FR 71924, December 30, 2019) (FRL-10003-15). Available online 
at: https://www.govinfo.gov/content/pkg/FR-2019-12-30/pdf/2019-28225.pdf.
4. EPA. Procedures for Prioritization of Chemicals for Risk 
Evaluation Under the Toxic Substances Control Act; Final Rule. 
Federal Register (82 FR 33753, December 20, 2017) (FRL-9964-24). 
Available online at: https://www.federalregister.gov/documents/2017/07/20/2017-14325/procedures-for-prioritization-of-chemicals-for-risk-evaluation-under-the-toxic-substances-control.
5. CPSC. U.S. Consumer Product Safety Commission Petition: Products 
Containing Organohalogen Flame Retardants. Docket ID number: CPSC-
2015-0022. Available online at: https://www.regulations.gov/docket?D=CPSC-2015-0022.
6. CPSC. National Academies of Sciences, Engineering, and Medicine 
2019. A Class Approach to Hazard Assessment of Organohalogen Flame 
Retardants. Washington, DC: The National Academies Press. https://doi.org/10.17226/25412. Available online at: http://nap.edu/25412.
7. EPA. TSCA Section 8(d): Economic Impact Analysis for Adding 50 
Chemicals From the 74th ITC Report of the TSCA Interagency Testing 
Committee to the Health and Safety Data Reporting Rule. September 
10, 2020.

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    The Office of Management and Budget (OMB) has exempted actions 
under TSCA section 8(d) related to the Health and Safety Data Reporting 
rule from the requirements of Executive Order 12866 (58 FR 51735, 
October 4, 1993). As such, this final rule was not reviewed by OMB 
under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to PRA, 44 U.S.C. 3501 et seq., an agency may not conduct 
or sponsor, and a person is not required to respond to a collection of 
information that requires OMB approval under PRA, unless it has been 
approved by OMB and displays a currently valid OMB control number. The 
OMB control numbers for EPA's regulations in title 40 of the CFR, after 
appearing in the Federal Register, are listed in 40 CFR part 9, and 
included on the related collection instrument or form, if applicable.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0004. This action does not impose any burden requiring additional 
OMB approval. You can find a copy of the ICR in the docket for this 
rule, and it is briefly summarized here.
    This action requires the reporting of health and safety data to EPA 
by manufacturers (including importers) of certain chemical substances 
requested by the ITC to be added to the Health and Safety Data 
Reporting Rule in its Seventy-Fourth Report of the ITC (Ref. 2). EPA 
intends to use information collected under the rule to assist in 
chemical assessments under TSCA, and to inform any additional work 
necessary under environmental protection mandates beyond TSCA. 
Submitters may designate information as confidential, trade secret, or 
proprietary. EPA has implemented procedures to protect any 
confidential, trade secret or proprietary information from disclosure. 
These procedures comply with TSCA section 14 and EPA's confidentiality 
regulation, 40 CFR part 2, subpart B.
    Respondents/affected entities: Manufacturers (including importers) 
of 50 chemical substances requested by the ITC to be included in the 
Health and Safety Data Reporting Rule.
    Respondents' obligation to respond: Mandatory (15 U.S.C. 2607(d)).
    Estimated number of respondents: 23.
    Frequency of response: Once.

[[Page 34152]]

    Total estimated burden: 1,854 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated cost: $146,745 (per year), with no annualized 
capital or operation and maintenance costs.

C. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I hereby 
certify that this action will not have a significant economic impact on 
a substantial number of small entities as defined by the RFA. The small 
entities subject to the requirements of this action are manufacturers 
(including importers) of 50 chemicals requested by the ITC to be added 
to the Health and Safety Data Reporting Rule. EPA estimates that 106 of 
the 129 firms in the affected universe are small entities. Of those 
small firms, all would have cost impacts of less than 1% of annual 
revenue. Details of this analysis are presented in the Economic 
Analysis of this rule (Ref. 7), which can be found in the docket.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. The requirements of 
this action would primarily affect manufacturers (including importers) 
of 50 chemical substances listed in 40 CFR 716.120(d) of the regulatory 
text of this document. The total quantified one-time costs of this 
final rule are approximately $183,812.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have 
substantial direct effects on the states, on the relationship between 
the national government and the states, or on the distribution of power 
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and the Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes. Thus, E.O. 13175 does not apply to this 
action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) 
as applying only to those regulatory actions that concern environmental 
health or safety risks that the Agency has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of the Executive Order. This 
action is not a covered regulatory action because it is not 
``economically significant'' under Executive Order 12866 and it does 
not concern an environmental health risk or safety risk. Although this 
action would not establish an environmental standard intended to 
mitigate health or safety risks, the information that would be 
submitted to EPA in accordance with this rule would be used to inform 
the Agency's decision-making process regarding chemical substances to 
which children may be disproportionately exposed. This information may 
also assist the Agency and others in determining whether the chemical 
substances covered in this proposed rule present potential risks, which 
would allow the Agency and others to take appropriate action to 
investigate and mitigate those risks.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy and has not otherwise been designated by 
the Administrator of OMB's Office of Information and Regulatory Affairs 
as a ``significant energy action.''

I. National Technology Transfer and Advancement Act (NTTAA)

    Because this action does not involve any technical standards, NTTAA 
section 12(d), 15 U.S.C. 272 note, does not apply to this action.

J. Executive Order 12898: Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994). However, the Agency believes that the 
information collected through this rule will inform the TSCA risk 
evaluations that are planned for these chemicals and will thereby 
enable the Agency to better protect human health and the environment, 
including in low-income and minority communities.

L. Congressional Review Act (CRA)

    This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA 
will submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. This action is not a ``major 
rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 716

    Environmental protection, Chemicals, Hazardous substances, Health 
and safety, Reporting and recordkeeping requirements.

    Dated: June 17, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 716--HEALTH AND SAFETY DATA REPORTING

0
1. The authority citation for part 716 continues to read as follows:

    Authority:  15 U.S.C. 2607(d).


0
2. In Sec.  716.21, add paragraphs (a)(9) and (10) to read as follows:


Sec.  716.21  Chemical specific reporting requirements.

    (a) * * *
    (9) For 1,3-Butadiene (106-99-0), Butyl benzyl phthalate (BBP)--
1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester (85-68-
7), Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- 
dibutyl ester) (84-74-2), o-Dichlorobenzene (95-50-1), p-
Dichlorobenzene (106-46-7), trans-1,2-Dichloroethylene (156-60-5), 1,2-
Dichloropropane (78-87-5), Dicyclohexyl phthalate (84-61-7), Di-
ethylhexyl phthalate (DEHP)--(1,2-Benzene- dicarboxylic acid, 1,2- 
bis(2-ethylhexyl) ester) (117-81-7), Di-isobutyl phthalate (DIBP)--
(1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester) (84-
69-5), Formaldehyde (50-00-0), 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-
hexamethylcyclopenta [g]-2-benzopyran (HHCB) (1222-05-5), Phthalic 
anhydride (85-44-9), 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] 
(TBBPA) (79-94-7), and 1,1,2-Trichloroethane (79-00-5), all unpublished 
studies on health effects (including toxicity studies (in vivo and in 
vitro) on carcinogenicity,

[[Page 34153]]

reproductive and developmental effects, genotoxicity, neurotoxicity, 
immunotoxicity, endocrine effects, and other systemic toxicity); 
toxicokinetics (absorption, distribution, metabolism, or elimination), 
including modelling studies, in humans or animals; environmental 
effects; environmental fate; physical-chemical properties if performed 
as described in 40 CFR 716.50; and occupational (both users and non-
users), general population, consumer, bystander, and environmental 
exposure must be submitted. Studies showing any measurable content of 
the High-Priority Substance in the tested substance (single substances 
or mixture) must be reported. The composition and purity of test 
substances must be reported if included as part of the study. Studies 
previously submitted to EPA pursuant to a requirement under TSCA or of 
the submitter's own accord and studies conducted or to be conducted 
pursuant to a TSCA section 4 action are exempt from the submission of 
lists of health and safety studies required under 40 CFR 716.35 and the 
submission of studies required under this rule.
    (10) For purposes of this paragraph, the term organohalogen flame 
retardant includes any substances listed in paragraph(d) of this 
section under the category ``Organohalogen flame retardants''. For any 
organohalogen flame retardant, all unpublished studies on health 
effects (including toxicity studies (in vivo and in vitro) on 
carcinogenicity, reproductive and developmental effects, genotoxicity, 
neurotoxicity, immunotoxicity, endocrine effects, and other systemic 
toxicity); toxicokinetics (absorption, distribution, metabolism, or 
elimination), including modelling studies, in humans or animals; 
environmental fate; physical-chemical properties if performed as 
described in 40 CFR 716.50; and occupational (both users and non-
users), general population, consumer, bystander, and environmental 
exposure must be submitted. Studies showing any measurable content of 
the organohalogen flame retardant in the tested substance (single 
substances or mixture) must be reported. The composition and purity of 
test substances must be reported if included as part of the study. 
Studies previously submitted to EPA pursuant to a requirement under 
TSCA or of the submitter's own accord and studies conducted or to be 
conducted pursuant to a TSCA section 4 action are exempt from the 
submission of lists of health and safety studies requirements under 40 
CFR 716.35 and the submission of studies requirements under this rule.
* * * * *

0
3. In Sec.  716.120, amend the table in paragraph (d) by:
0
a. Adding in alphabetical order the category ``High-Priority 
Substances'' and entries ``1,3-Butadiene'', ``Butyl benzyl phthalate 
(BBP)--1,2-Benzene-dicarboxylic acid, 1-butyl 2(phenylmethyl) ester'', 
``Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl 
ester)'', ``o-Dichlorobenzene'', ``p-Dichlorobenzene'', ``1,1-
Dichloroethane'', ``1,2-Dichloroethane'', ``Trans-1,2- 
Dichloroethylene'', ``1,2-Dichloropropane'', ``Dicyclohexyl 
phthalate'', ``Di-ethylhexyl phthalate (DEHP)--(1,2-Benzene-
dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester)'', ``Di-isobutyl 
phthalate (DIBP)--(1,2-Benzene- dicarboxylic acid, 1,2- bis-
(2methylpropyl) ester)'', ``Ethylene dibromide'', ``Formaldehyde'', 
``1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-
benzopyran (HHCB)'', ``4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] 
(TBBPA)'', ``Phosphoric acid, triphenyl ester (TPP)'', ``Phthalic 
anhydride'', ``1,1,2-Trichloroethane'', and ``Tris(2-chloroethyl) 
phosphate (TCEP)''; and
0
b. Adding in alphabetical order the category ``Organohalogen flame 
retardants'' and entries ``Bis(2-ethylhexyl) tetrabromophthalate'', 
``Bis(hexachlorocyclopentadieno)cyclooctane'', ``1,2-Bis(2,4,6-
tribromophenoxy)ethane'', ``1,1'-Ethane-1,2-
diylbis(pentabromobenzene)'', ``2-Ethylhexyl-2,3,4,5-
tetrabromobenzoate'', ``2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 
3,4,5,6-tetrabromophthalate'', ``2,2'-[(1-Methylethylidene)bis[(2,6-
dibromo-4,1-phenylene)oxymethylene]]bis[oxirane]'', ``Mixture of 
chlorinated linear alkanes C14-17 with 45-52% chlorine'', ``N,N-
Ethylene-bis(tetrabromophthalimide)'', ``Pentabromochlorocyclohexane'', 
``(Pentabromophenyl)methyl acrylate'', ``Pentabromotoluene'', 
``Perbromo-1,4-diphenoxybenzene'', ``Phosphonic acid, (2-chloroethyl)-, 
bis(2-chloroethyl) ester'', ``Phosphoric acid, 2,2-bis(chloromethyl)-
1,3-propanediyl tetrakis(2-chloroethyl) ester'', ``Propanoic acid, 2-
bromo-, methyl ester'', ``Tetrabromobisphenol A-bis(2,3-dibromopropyl 
ether)'', ``Tetrabromobisphenol A bis(2-hydroxyethyl) ether'', 
``Tetrabromobisphenol A diallyl ether'', ``Tetrabromobisphenol A 
dimethyl ether'', ``2,4,6-Tribromoaniline'', ``1,3,5-Tribromo-2-(prop-
2-en-1-yloxy)benzene'', ``Tris(2-chloroethyl) phosphite'', ``Tris(1-
chloro-2-propyl)phosphate'', ``Tris(2-chloro-1-propyl)phosphate'', 
``Tris(2,3-dibromopropyl) phosphate'', ``1,3,5-Tris(2,3-dibromopropyl)-
1,3,5-triazine-2,4,6(1H,3H,5H)-trione'', ``Tris(1,3-dichloro-2-
propyl)phosphate'', ``Tris(tribromoneopentyl)phosphate'', and ``2,4,6-
Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine''.
    The additions read as follows:


Sec.  716.120  Substances and listed mixtures to which this subpart 
applies.

* * * * *
    (d) * * *

----------------------------------------------------------------------------------------------------------------
                                                                                         Effective
                    Category                          CAS No.      Special exemptions       date     Sunset date
----------------------------------------------------------------------------------------------------------------
High-Priority Substances:
    1,3-Butadiene...............................        106-99-0   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Butyl benzyl phthalate (BBP)--1,2-Benzene-           85-68-7   Sec.   716.21(a)(9)      7/29/21      9/27/21
     dicarboxylic acid, 1- butyl 2(phenylmethyl)
     ester......................................
    Dibutyl phthalate (DBP) (1,2-Benzene-                84-74-2   Sec.   716.21(a)(9)      7/29/21      9/27/21
     dicarboxylic acid, 1,2-dibutyl ester)......
    o-Dichlorobenzene...........................         95-50-1   Sec.   716.21(a)(9)      7/29/21      9/27/21
    p-Dichlorobenzene...........................        106-46-7   Sec.   716.21(a)(9)      7/29/21      9/27/21
    1,1-Dichloroethane..........................         75-34-3   Sec.   716.21(a)(9)      7/29/21      9/27/21
    1,2-Dichloroethane..........................        107-06-2   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Trans-1,2-Dichloroethylene..................        156-60-5   Sec.   716.21(a)(9)      7/29/21      9/27/21
    1,2-Dichloropropane.........................         78-87-5   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Dicyclohexyl phthalate......................         84-61-7   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Di-ethylhexyl phthalate (DEHP)--(1,2-Benzene-       117-81-7   Sec.   716.21(a)(9)      7/29/21      9/27/21
     dicarboxylic acid, 1,2- bis(2-ethylhexyl)
     ester).....................................

[[Page 34154]]

 
    Di-isobutyl phthalate (DIBP)--(1,2-Benzene-          84-69-5   Sec.   716.21(a)(9)      7/29/21      9/27/21
     dicarboxylic acid, 1,2- bis-(2methylpropyl)
     ester).....................................
    Ethylene dibromide..........................        106-93-4   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Formaldehyde................................         50-00-0   Sec.   716.21(a)(9)      7/29/21      9/27/21
    1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-                 1222-05-5   Sec.   716.21(a)(9)      7/29/21      9/27/21
     hexamethylcyclopenta [g]-2-benzopyran
     (HHCB).....................................
    4,4'-(1-Methylethylidene)bis[2, 6-                   79-94-7   Sec.   716.21(a)(9)      7/29/21      9/27/21
     dibromophenol] (TBBPA).....................
    Phosphoric acid, triphenyl ester (TPP)......        115-86-6   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Phthalic anhydride..........................         85-44-9   Sec.   716.21(a)(9)      7/29/21      9/27/21
    1,1,2-Trichloroethane.......................         79-00-5   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Tris(2-chloroethyl) phosphate (TCEP)........        115-96-8   Sec.   716.21(a)(9)      7/29/21      9/27/21
 
                                                  * * * * * * *
Organohalogen flame retardants:
    Bis(2-ethylhexyl) tetrabromophthalate.......      26040-51-7  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Bis(hexachlorocyclopentadieno)cyclooctane...      13560-89-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
    1,2-Bis(2,4,6-tribromophenoxy)ethane........      37853-59-1  Sec.   716.21(a)(10)      7/29/21      9/27/21
    1,1'-Ethane-1,2-diylbis(pentabromobenzene)..      84852-53-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
    2-Ethylhexyl-2,3,4,5-tetrabromobenzoate.....     183658-27-7  Sec.   716.21(a)(10)      7/29/21      9/27/21
    2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl          20566-35-2  Sec.   716.21(a)(10)      7/29/21      9/27/21
     3,4,5,6-tetrabromophthalate................
    2,2'-[(1-Methylethylidene)bis[(2,6-dibromo-        3072-84-2  Sec.   716.21(a)(10)      7/29/21      9/27/21
     4,1-phenylene)oxymethylene]]bis[oxirane]...
    Mixture of chlorinated linear alkanes C14-17      85535-85-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
     with 45-52% chlorine.......................
    N,N-Ethylene-bis(tetrabromophthalimide).....      32588-76-4  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Pentabromochlorocyclohexane.................         87-84-3  Sec.   716.21(a)(10)      7/29/21      9/27/21
    (Pentabromophenyl)methyl acrylate...........      59447-55-1  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Pentabromotoluene...........................         87-83-2  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Perbromo-1,4-diphenoxybenzene...............      58965-66-5  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Phosphonic acid, (2-chloroethyl)-, bis(2-          6294-34-4  Sec.   716.21(a)(10)      7/29/21      9/27/21
     chloroethyl) ester.........................
    Phosphoric acid, 2,2-bis(chloromethyl)-1,3-       38051-10-4  Sec.   716.21(a)(10)      7/29/21      9/27/21
     propanediyl tetrakis(2-chloroethyl) ester..
    Propanoic acid, 2-bromo-, methyl ester......       5445-17-0  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tetrabromobisphenol A-bis(2,3-dibromopropyl       21850-44-2  Sec.   716.21(a)(10)      7/29/21      9/27/21
     ether).....................................
    Tetrabromobisphenol A bis(2-hydroxyethyl)          4162-45-2  Sec.   716.21(a)(10)      7/29/21      9/27/21
     ether......................................
    Tetrabromobisphenol A diallyl ether.........      25327-89-3  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tetrabromobisphenol A dimethyl ether........      37853-61-5  Sec.   716.21(a)(10)      7/29/21      9/27/21
    2,4,6-Tribromoaniline.......................        147-82-0  Sec.   716.21(a)(10)      7/29/21      9/27/21
    1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene.       3278-89-5  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tris(2-chloroethyl)phosphite................        140-08-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tris(1-chloro-2-propyl)phosphate............      13674-84-5  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tris(2-chloro-1-propyl)phosphate............       6145-73-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tris(2,3-dibromopropyl)phosphate............        126-72-7  Sec.   716.21(a)(10)      7/29/21      9/27/21
    1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-     52434-90-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
     2,4,6(1H,3H,5H)-trione.....................
    Tris(1,3-dichloro-2-propyl)phosphate........      13674-87-8  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tris(tribromoneopentyl)phosphate............      19186-97-1  Sec.   716.21(a)(10)      7/29/21      9/27/21
    2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-         25713-60-4  Sec.   716.21(a)(10)      7/29/21      9/27/21
     triazine...................................
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-13212 Filed 6-28-21; 8:45 am]
BILLING CODE 6560-50-P