[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Rules and Regulations]
[Pages 54386-54390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21164]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 716
[EPA-HQ-OPPT-2020-0474; FRL-8204-02-OCSPP]
RIN 2070-AB11
Health and Safety Data Reporting; Addition of 20 High-Priority
Substances and 30 Organohalogen Flame Retardants; Extension of
Submission Deadline
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule; extension of submission deadline.
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SUMMARY: EPA is amending the deadline for reporting pursuant to the
Toxic Substances Control Act (TSCA) Health and Safety Data Reporting
rule, which requires manufacturers (including importers) of 50
specified chemical substances to report certain lists and copies of
unpublished health and safety studies to EPA. Specifically, EPA will be
amending the deadline from September 27, 2021 to December 1, 2021 for
20 of the 50 chemical substances and to January 25, 2022 for 30 of the
50 chemical substances. The Health and Safety Data Reporting Rule,
promulgated pursuant to TSCA section 8(d), requires manufacturers
(including importers) of certain chemical substances to submit lists
and copies of certain unpublished health and safety studies to EPA.
DATES: This final rule is effective October 1, 2021.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2020-0474, is available at
https://www.regulations.gov or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC.
Please note that 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 the EPA/DC and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Virginia Lee, Data Collections
Branch, 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) 564-4142; email address: lee.virginia@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
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 action is the Agency taking?
EPA promulgated a final rule in the Federal Register of June 29,
2021 (86 FR 34147) (FRL-10020-38) to require 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), The Agency.is extending the submission deadline
established in that final rule from September 27, 2021 to December 1,
2021 for the following chemicals:
Ethylene Dibromide
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-
benzopyran (HHCB)
Tris(2-chloroethyl) phosphate (TCEP)
Phthalic Anhydride
p- Dichlorobenzene
o-Dichlorobenzene
Phosphoric acid, triphenyl ester (TPP)
Di-ethylhexyl phthalate (DEHP)
1,2-Dichloroethane
trans-1,2-Dichloroethylene
1,1,2-Trichloroethane
1,2-Dichloropropane
[[Page 54387]]
1,1-Dichloroethane
1,3-Butadiene
Formaldehyde
Dibutyl phthalate (DBP)
Butyl benzyl phthalate (BBP)
Di-isobutyl phthalate
Dicyclohexyl phthalate
4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)
EPA is also extending the deadline established in the June 29, 2021
final rule from September 27, 2021 to January 25, 2022 for the
following chemicals:
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
2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine
C. Why is the Agency taking this action?
The Agency is taking this action to provide additional time for the
regulated community to familiarize themselves with new TSCA Health and
Safety Data Reporting requirements. EPA has not added chemicals to the
TSCA section 8(d) rule in a manner that would affect a large group of
stakeholders since 2006, for the orphan High Production Volume
chemicals. With respect to the timing of this action, the need for the
Agency to extend the deadline arose, in part, as a result of receiving
a sizable number of requests to extend the reporting deadline.
Additionally, the Agency recognizes that complications exist for
certain entities subject to this rule resulting from the COVID-19
pandemic, which can present challenges to accessing records that may
only be available in hard copy formats (e.g., microfiche).
EPA therefore believes it is appropriate to extend the reporting
period to allow the regulated community additional time for data
reporting. EPA is making available a historic question and answer
document about reporting under TSCA 8(d) and additional content on its
web page for the rulemaking (available at https://www.epa.gov/chemicals-under-tsca/health-and-safety-data-reporting-addition-20-high-priority-substances-and-30), providing reporting entities additional
time to review these materials and prepare any necessary submissions to
improve reporting quality for this rule.
EPA's timeline for risk evaluations under TSCA section 6
necessitates that data received via the TSCA section 8(d) action be
received in time for use in risk evaluations for chemical substances
that have been designated as high-priority substances. Thus, EPA is
limiting the deadline extension to December 1, 2021 for these chemical
substances. Receiving TSCA section 8(d) submissions on these high-
priority substances by December 1, 2021 will ensure that such
information will be received in time for use in risk evaluations on
these chemical substances. For the remaining organohalogen flame
retardants subject to the rule, EPA is extending the deadline to
January 25, 2022.
D. 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. Under
section 553(b)(B) of the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(B), an agency may issue a final rule without providing notice
and an opportunity for public comment if it for good cause finds that
notice and public procedures are impracticable, unnecessary, or
contrary to the public interest. In this instance, the Agency finds
that notice and public comment procedures are unnecessary because this
is merely an extension of the reporting period that does not alter the
substantive TSCA section 8(d) reporting requirements in any way and are
impracticable because there is insufficient time for notice and comment
on an extension to the deadline prior to the reporting deadline, and
EPA only became aware of the need for the extension upon receiving
numerous requests recently. The Agency believes the extension will not
result in a significant delay in the processing and availability of
information to EPA for TSCA section 6 risk evaluations or to Consumer
Product Safety Commission's (CPSC) evaluation for risks under the
Federal Hazardous Substances Act (FHSA). Receiving TSCA section 8(d)
submissions pursuant to these deadlines (i.e., December 1, 2021 for the
high-priority substances and January 25, 2022 for the Organohalogen
Flame Retardants) will ensure that such information will be received in
time for use in these respective activities (i.e., evaluations pursuant
to TSCA and FHSA). Further, any impact on the regulated community is
expected to be beneficial to the public interest given that the
extension provides additional time to submit complete and accurate
unpublished health and safety studies to EPA.
This final rule is effective immediately upon publication. Section
553(d)(1) of the Administrative Procedure Act, 5 U.S.C. 553(d)(1),
provides that final rules shall not become effective until 30 days
after publication in the Federal Register ``except . . . a substantive
rule which grants or recognizes an exemption or relieves a
restriction.'' The purpose of this provision is to ``give affected
parties a reasonable time to adjust their behavior before the final
rule takes effect.'' Omnipoint Corp. v. Fed. Commc'n Comm'n, 78 F.3d
620, 630 (D.C. Cir. 1996); see also United States v. Gavrilovic, 551
F.2d 1099, 1104 (8th Cir. 1977) (quoting legislative history). However,
when the agency grants or recognizes an exemption or relieves a
restriction, affected parties do not need a reasonable time to adjust
because the effect is not adverse. EPA has determined that this rule
relieves a restriction because it provides manufacturers (including
importers) additional time to comply with the Health and Safety Data
Reporting rule.
[[Page 54388]]
II. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
The Office of Management and Budget (OMB) has exempted actions
under TSCA section 8(d) related to the Health and Safety Data Reporting
rule from the requirements of Executive Order 12866 (58 FR 51735,
October 4, 1993). As such, this final rule was not reviewed by OMB
under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
This action does not contain any new or revised information
collections subject to OMB approval under the PRA, 44 U.S.C. 3501 et
seq. Information collection activities contained in the TSCA 8(d) rule
are already approved by the Office of Management and Budget (OMB) under
OMB Control No. 2070-0004.
C. Regulatory Flexibility Act (RFA)
This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA
applies only to rules subject to notice and comment rulemaking
requirements under the APA, 5 U.S.C. 553, or any other statute. This
rule is not subject to notice and comment requirements under the APA
because the Agency has invoked the APA ``good cause'' exemption.
D. Unfunded Mandates Reform Act (UMRA)
This action will not impose any enforceable duty or contain any
unfunded mandate as described under Title II of UMRA, 2 U.S.C. 1531-
1538 et seq.
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.
K. 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: September 23, 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. 716.120(d), amend the table by revising all the entries
under the headings ``High-Priority Substances'' and ``Organohalogen
flame retardants'' to read as follows:
Sec. 716.120 Substances and listed mixtures to which this subpart
applies.
* * * * *
(d) * * *
[[Page 54389]]
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Special Effective Sunset
Category CASRN exemptions date date
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* * * * * * *
High-Priority Substances:
1,3-Butadiene...................................... 106-99-0 Sec. 7/29/21 12/01/21
716.21(a)(9)
Butyl benzyl phthalate (BBP)--1,2-Benzene- 85-68-7 Sec. 7/29/21 12/01/21
dicarboxylic acid, 1-butyl 2(phenylmethyl) ester.. 716.21(a)(9)
Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic 84-74-2 Sec. 7/29/21 12/01/21
acid, 1,2-dibutyl ester).......................... 716.21(a)(9)
o-Dichlorobenzene.................................. 95-50-1 Sec. 7/29/21 12/01/21
716.21(a)(9)
p-Dichlorobenzene.................................. 106-46-7 Sec. 7/29/21 12/01/21
716.21(a)(9)
1,1-Dichloroethane................................. 75-34-3 Sec. 7/29/21 12/01/21
716.21(a)(9)
1,2-Dichloroethane................................. 107-06-2 Sec. 7/29/21 12/01/21
716.21(a)(9)
Trans-1,2-Dichloroethylene......................... 156-60-5 Sec. 7/29/21 12/01/21
716.21(a)(9)
1,2-Dichloropropane................................ 78-87-5 Sec. 7/29/21 12/01/21
716.21(a)(9)
Dicyclohexyl phthalate............................. 84-61-7 Sec. 7/29/21 12/01/21
716.21(a)(9)
Di-ethylhexyl phthalate (DEHP)--(1,2-Benzene- 117-81-7 Sec. 7/29/21 12/01/21
dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester)... 716.21(a)(9)
Di-isobutyl phthalate (DIBP)--(1,2-Benzene- 84-69-5 Sec. 7/29/21 12/01/21
dicarboxylic acid, 1,2-bis-(2methylpropyl) ester). 716.21(a)(9)
Ethylene dibromide................................. 106-93-4 Sec. 7/29/21 12/01/21
716.21(a)(9)
Formaldehyde....................................... 50-00-0 Sec. 7/29/21 12/01/21
716.21(a)(9)
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8- 1222-05-5 Sec. 7/29/21 12/01/21
hexamethylcyclopenta [g]-2-benzopyran (HHCB)...... 716.21(a)(9)
4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] 79-94-7 Sec. 7/29/21 12/01/21
(TBBPA)........................................... 716.21(a)(9)
Phosphoric acid, triphenyl ester (TPP)............. 115-86-6 Sec. 7/29/21 12/01/21
716.21(a)(9)
Phthalic anhydride................................. 85-44-9 Sec. 7/29/21 12/01/21
716.21(a)(9)
1,1,2-Trichloroethane.............................. 79-00-5 Sec. 7/29/21 12/01/21
716.21(a)(9)
Tris(2-chloroethyl) phosphate (TCEP)............... 115-96-8 Sec. 7/29/21 12/01/21
716.21(a)(9)
* * * * * * *
Organohalogen flame retardants:
Bis(2-ethylhexyl) tetrabromophthalate.............. 26040-51-7 Sec. 7/29/21 1/25/22
716.21(a)(10)
Bis(hexachlorocyclopentadieno) cyclooctane......... 13560-89-9 Sec. 7/29/21 1/25/22
716.21(a)(10)
1,2-Bis(2,4,6-tribromophenoxy)ethane............... 37853-59-1 Sec. 7/29/21 1/25/22
716.21(a)(10)
1,1'-Ethane-1,2-diylbis(pentabromobenzene)......... 84852-53-9 Sec. 7/29/21 1/25/22
716.21(a)(10)
2-Ethylhexyl-2,3,4,5-tetrabromobenzoate............ 183658-27-7 Sec. 7/29/21 1/25/22
716.21(a)(10)
2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6- 20566-35-2 Sec. 7/29/21 1/25/22
tetrabromophthalate............................... 716.21(a)(10)
2,2'-[(1-Methylethylidene)bis[(2,6-dibromo-4,1- 3072-84-2 Sec. 7/29/21 1/25/22
phenylene)oxymethylene]]bis[oxirane].............. 716.21(a)(10)
Mixture of chlorinated linear alkanes C14-17 with 85535-85-9 Sec. 7/29/21 1/25/22
45-52% chlorine................................... 716.21(a)(10)
N,N-Ethylene-bis(tetrabromophthalimide)............ 32588-76-4 Sec. 7/29/21 1/25/22
716.21(a)(10)
Pentabromochlorocyclohexane........................ 87-84-3 Sec. 7/29/21 1/25/22
716.21(a)(10)
(Pentabromophenyl)methyl acrylate.................. 59447-55-1 Sec. 7/29/21 1/25/22
716.21(a)(10)
Pentabromotoluene.................................. 87-83-2 Sec. 7/29/21 1/25/22
716.21(a)(10)
Perbromo-1,4-diphenoxybenzene...................... 58965-66-5 Sec. 7/29/21 1/25/22
716.21(a)(10)
Phosphonic acid, (2-chloroethyl)-, bis(2- 6294-34-4 Sec. 7/29/21 1/25/22
chloroethyl) ester................................ 716.21(a)(10)
Phosphoric acid, 2,2-bis(chloromethyl)-1,3- 38051-10-4 Sec. 7/29/21 1/25/22
propanediyl tetrakis(2-chloroethyl) ester......... 716.21(a)(10)
Propanoic acid, 2-bromo-, methyl ester............. 5445-17-0 Sec. 7/29/21 1/25/22
716.21(a)(10)
Tetrabromobisphenol A-bis(2,3-dibromopropyl ether). 21850-44-2 Sec. 7/29/21 1/25/22
716.21(a)(10)
Tetrabromobisphenol A bis(2-hydroxyethyl) ether.... 4162-45-2 Sec. 7/29/21 1/25/22
716.21(a)(10)
Tetrabromobisphenol A diallyl ether................ 25327-89-3 Sec. 7/29/21 1/25/22
716.21(a)(10)
Tetrabromobisphenol A dimethyl ether............... 37853-61-5 Sec. 7/29/21 1/25/22
716.21(a)(10)
2,4,6-Tribromoaniline.............................. 147-82-0 Sec. 7/29/21 1/25/22
716.21(a)(10)
1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene........ 3278-89-5 Sec. 7/29/21 1/25/22
716.21(a)(10)
Tris(2-chloroethyl)phosphite....................... 140-08-9 Sec. 7/29/21 1/25/22
716.21(a)(10)
Tris(1-chloro-2-propyl)phosphate................... 13674-84-5 Sec. 7/29/21 1/25/22
716.21(a)(10)
Tris(2-chloro-1-propyl)phosphate................... 6145-73-9 Sec. 7/29/21 1/25/22
716.21(a)(10)
Tris(2,3-dibromopropyl)phosphate................... 126-72-7 Sec. 7/29/21 1/25/22
716.21(a)(10)
1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine- 52434-90-9 Sec. 7/29/21 1/25/22
2,4,6(1H,3H,5H)-trione............................ 716.21(a)(10)
Tris(1,3-dichloro-2-propyl)phosphate............... 13674-87-8 Sec. 7/29/21 1/25/22
716.21(a)(10)
Tris(tribromoneopentyl)phosphate................... 19186-97-1 Sec. 7/29/21 1/25/22
716.21(a)(10)
2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine.. 25713-60-4 Sec. 7/29/21 1/25/22
716.21(a)(10)
* * * * * * *
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[[Page 54390]]
[FR Doc. 2021-21164 Filed 9-30-21; 8:45 am]
BILLING CODE 6560-50-P