Document ID: EPA-HQ-OPPT-2021-0202-0001
Agency: epa
Document Type: Proposed Rule
Title: Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h)
Posted Date: 2021-03-16T04:00Z

[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Proposed Rules]
[Pages 14398-14401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05138]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2021-0202; FRL-10021-08]

Regulation of Persistent, Bioaccumulative, and Toxic Chemicals 
Under TSCA Section 6(h); Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: In accordance with the January 21, 2021, Executive Order 
entitled ``Protecting Public Health and the Environment and Restoring 
Science to Tackle the Climate Crisis'' and other Biden-Harris 
Administration Executive orders and other direction, the Environmental 
Protection Agency (EPA) is requesting additional public comments on 
five final rules recently issued under the Toxic Substances Control Act 
(TSCA). On January 6, 2021, EPA issued final rules to address its 
obligations under TSCA for five persistent, bioaccumulative, and toxic 
(PBT) chemicals that EPA determined met the criteria for expedited 
action under TSCA. These chemicals are 2,4,6-tris(tert-butyl)phenol 
(2,4,6-TTBP) (CASRN 732-26-3); decabromodiphenyl ether (decaBDE) (CASRN 
1163-19-5); phenol, isopropylated phosphate (3:1) (PIP (3:1)) (CASRN 
68937-41-7); pentachlorothiophenol (PCTP) (CASRN 133-49-3); and 
hexachlorobutadiene (HCBD) (CASRN 87-68-3). PBT chemicals are of 
particular concern in the Agency's efforts to protect human health and 
the environment because they are toxic and remain in the environment 
for long periods of time and can build up or accumulate in the body. As 
a first step in its efforts to immediately review these rules to 
determine whether they are consistent with the Administration policy to 
limit exposure to dangerous chemicals (and to determine whether and how 
these rules should be revised), EPA invites public comment on the final 
rules, including whether there are further exposure reductions that 
could be achieved, including exposure reductions for potentially 
exposed or susceptible subpopulations and the environment; 
implementation issues associated with these final rules; and whether to 
consider additional or alternative measures or approaches. In 
particular, EPA is seeking comment on specifics of recently raised 
issues regarding the compliance date for the prohibition on the 
processing and distribution of PIP (3:1) for use in articles, and PIP 
(3:1)-containing articles.

DATES: Comments must be received on or before May 17, 2021.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2021-0202, through 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. To make special 
arrangements for hand delivery or delivery of boxed information, please 
follow the instructions at http://www.epa.gov/dockets/contacts.html.
    Please note that due to the public health emergency the EPA Docket 
Center (EPA/DC) and Reading Room were closed to public visitors on 
March 31, 2020. Our EPA/DC staff will continue to provide customer 
service via email, phone, and webform. For further information on EPA/
DC services, docket contact information and the current status of the 
EPA/DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Cindy Wheeler, Existing 
Chemicals Risk Management Division (Mail Code 7404T), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 566-0484; email address: TSCA-PBT-rules@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 apply to me?

    This document is directed to the public in general and may be of 
interest to persons who currently or may manufacture (including 
import), process, distribute, use, and/or dispose of the five PBT 
chemicals: 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (CASRN 732-26-3); 
decabromodiphenyl ether (decaBDE) (CASRN 1163-19-5); phenol, 
isopropylated phosphate (3:1) (PIP (3:1)) (CASRN 68937-41-7); 
pentachlorothiophenol (PCTP) (CASRN 133-49-3); and hexachlorobutadiene 
(HCBD) (CASRN 87-68-3). The action may also be of interest to persons 
who currently or may manufacture (including import), process, 
distribute, use, and/or dispose of products and articles containing 
these PBT chemicals. Non-governmental organizations in the 
environmental and public health sectors, state and local government 
agencies, and members of the public may also be interested in this 
action. Since other entities may also be interested, EPA has not 
attempted to describe all the specific entities that may be affected by 
this action.

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

    EPA issued the final rules under TSCA section 6(h), 15 U.S.C. 2601 
et seq., for five persistent, bioaccumulative, and toxic (PBT) chemical 
substances that met the statutory criteria. More specifically, under 
TSCA section 6(h), EPA must take expedited action on those chemical 
substances identified in the 2014 Update to the TSCA Work Plan for 
Chemical Assessments (Ref. 1) that, among other factors, EPA has a 
reasonable basis to conclude are toxic and that with respect to 
persistence and bioaccumulation score high for one and either high or 
moderate for the other, pursuant to the TSCA Work Plan Chemicals: 
Methods Document (Ref. 2). The chemical substances that meet these 
criteria are 2,4,6-TTBP, decaBDE, PIP (3:1), PCTP, and HCBD. Under 
TSCA, if EPA determines that exposure is likely to a chemical meeting 
these criteria, EPA must issue a rule that addresses the risks of 
injury to health or the environment that the Administrator determines 
are presented and reduces exposure to the chemical to the extent 
practicable. Based on the ``Exposure and Use Assessment of Five 
Persistent, Bioaccumulative and Toxic Chemicals Assessment'' (Ref. 3), 
EPA determined that exposure was likely to all five of the PBT 
chemicals. On January 6, 2021, EPA issued a final rule for each of the 
five chemicals under TSCA section 6(h), meeting the Agency's obligation 
to promulgate the rules within 18 months of issuance of the proposed 
rules (Refs. 4-8). With the obligation to promulgate these rules, the 
Agency also has the authority to amend them if circumstances change, 
including in relation to the receipt of new information.

[[Page 14399]]

C. What action is EPA taking?

    EPA is inviting public comment on the provisions of the final 
rules. The Agency is broadly re-examining TSCA section 6(h) 
requirements and other provisions of amended TSCA, including 
determining how the new Executive orders and other direction provided 
by the Biden-Harris Administration (Refs. 9-13) will be addressed, as 
well as new information received from stakeholders. As part of this 
process, EPA will review and consider revising the final PBT rules with 
an eye towards reducing exposure to the extent practicable, 
environmental justice, scientific integrity, and EPA's mission of 
protecting human health and the environment, taking into consideration 
information received while the rules were under development as well as 
any new information submitted since the rules were finalized and 
information received in response to this document. EPA is also aware of 
and plans to consider revisions in response to implementation issues 
that have been raised by a range of stakeholders. In particular, EPA is 
seeking comment on newly-raised issues associated with the March 8, 
2021, compliance date in the PIP (3:1) rule for certain regulated 
articles.

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

    1. Submitting CBI. Do not submit this information to EPA through 
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 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 http://www.epa.gov/dockets/comments.html.

II. Summary of the Final PBT Rules

    This unit provides a summary of the five TSCA section 6(h) final 
rules that published in the Federal Register of January 6, 2021. 
However, each rule should be consulted for additional details on the 
requirements adopted and the rationale for those requirements.

A. 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); Regulation of Persistent, 
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h) (RIN 2070-
AK59)

    Uses of 2,4,6-TTBP may be grouped into four general categories: (1) 
Domestic manufacture and use as an intermediate/reactant in processing 
at chemical facilities; (2) use in formulations and mixtures for fuel 
treatment in refineries and fuel facilities; (3) use in formulations 
intended for the maintenance or repair of motor vehicles and machinery 
at small commercial operations and for retail sale, and (4) use in 
formulations and mixtures for liquid lubricant and grease additives/
antioxidants additives. 2,4,6-TTBP is toxic to aquatic plants, aquatic 
invertebrates, and fish. Surveyed animal data indicate the potential 
for liver and developmental effects. The final rule for 2,4,6-TTBP 
(Ref. 4) prohibits the distribution in commerce of 2,4,6-TTBP and 
products containing 2,4,6-TTBP at concentrations above 0.3% by weight 
in any container with a volume of less than 35 gallons in order to 
minimize the use of 2,4,6-TTBP as a fuel additive or fuel injector 
cleaner by consumers and small commercial operations (e.g., automotive 
repair shops, marinas). The final rule also prohibits the processing 
and distribution in commerce of 2,4,6-TTBP, and products containing 
2,4,6-TTBP, for use as an oil or lubricant additive in concentrations 
above 0.3% by weight regardless of container size. The final rule 
includes a number of broad exclusions or definitions intended to apply 
to each of the five PBT rules, including definitions of article and 
product and exclusions for research and development, disposal, and the 
resale of products and articles previously sold to an end user.

B. Decabromodiphenyl Ether (DecaBDE); Regulation of Persistent, 
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h) (RIN 2070-
AK34)

    DecaBDE (Ref. 5) is used as an additive flame retardant in plastic 
enclosures for televisions, computers, audio and video equipment, 
textiles and upholstered articles, wire and cables for communication 
and electronic equipment, and other applications. DecaBDE is also used 
as a flame retardant for multiple applications for aerospace and 
automotive vehicles, including replacement parts for aircraft and cars. 
DecaBDE is toxic to aquatic invertebrates, fish, and terrestrial 
invertebrates. Data indicate the potential for developmental, 
neurological, and immunological effects, general developmental 
toxicity, liver effects, and carcinogenicity. The final rule for 
decaBDE (Ref. 5) prohibits the manufacture (including import) and 
processing of decaBDE, and products and articles containing decaBDE, as 
of March 8, 2021. Distribution in commerce of products and articles to 
which decaBDE has been added is prohibited as of January 6, 2022. 
Different compliance dates or exclusions include:
     Manufacture, processing, and distribution in commerce for 
use in curtains in the hospitality industry after July 6, 2022;
     Processing and distribution in commerce for use in wire 
and cable insulation in nuclear power generation facilities after 
January 6, 2023;
     Manufacture, processing, and distribution in commerce for 
use in parts for new aerospace vehicles after January 8, 2024;
     Manufacture, processing, and distribution in commerce for 
use in replacement parts for aerospace vehicles until the end of the 
vehicles' service lives;
     Manufacture, processing, and distribution in commerce for 
use in replacement parts for motor vehicles until the end of the 
vehicles' service lives or 2036, whichever is earlier;
     Distribution in commerce of plastic shipping pallets 
manufactured prior to the publication of the final rule that contain 
decaBDE until the end of the pallets service lives; and
     Processing and distribution in commerce for recycling of 
plastic that contained decaBDE before the plastic was recycled, and the 
articles and products made from such recycled plastic so long as no new 
decaBDE is added during the recycling or production process.

C. Phenol, Isopropylated Phosphate (3:1) (PIP 3:1); Regulation of 
Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 
6(h) (RIN 2070-AK58)

    PIP (3:1) (Ref. 6) is used as a plasticizer, a flame retardant, an 
anti-wear additive, or an anti-compressibility additive in hydraulic 
fluid, lubricating oils, lubricants and greases, various industrial 
coatings, adhesives, sealants, and plastic articles. PIP (3:1) is toxic 
to aquatic plants, aquatic invertebrates, sediment invertebrates and 
fish. Data indicate the potential for reproductive and developmental 
effects, neurological effects and effects on systemic organs,

[[Page 14400]]

specifically adrenals, liver, ovary, heart, and lungs. The PIP (3:1) 
final rule (Ref. 6) prohibits processing and distribution in commerce 
of PIP (3:1), and products or articles containing the chemical 
substance, for all uses, except for the following different compliance 
dates or exclusions:
     Use in photographic printing articles after January 1, 
2022;
     Use in aviation hydraulic fluid in hydraulic systems and 
use in specialty hydraulic fluids for military applications;
     Use in lubricants and greases;
     Use in new and replacement parts for the aerospace and 
automotive industries;
     Use as an intermediate in the manufacture of cyanoacrylate 
glue;
     Use in specialized engine air filters for locomotive and 
marine applications;
     Use in sealants and adhesives after January 6, 2025; and
     Recycling of plastic that contained PIP (3:1) before the 
plastic was recycled, and the articles and products made from such 
recycled plastic, so long as no new PIP (3:1) is added during the 
recycling or production process.
    In addition, the final rule requires manufacturers, processors, and 
distributors of PIP (3:1) and products containing PIP (3:1) to notify 
their customers of these restrictions. Finally, the rule prohibits 
releases to water from the remaining manufacturing, processing, and 
distribution in commerce activities, and requires commercial users of 
PIP (3:1) and PIP (3:1)-containing products to follow existing 
regulations and best practices to prevent releases to water during use.

D. Pentachlorothiophenol (PCTP); Regulation of Persistent, 
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h) (RIN 2070-
AK60)

    PCTP was used in rubber manufacturing as a peptizer, or a chemical 
that makes rubber more amenable to processing. Although it is likely 
that PCTP is no longer used as a peptizer, it can be found as an 
impurity in the zinc salt of PCTP (zinc PCTP) (CASRN 117-97-5) after 
zinc PCTP manufacturing. PCTP is toxic to protozoa, fish, terrestrial 
plants, and birds. Data for analogous chemicals 
(pentachloronitrobenzene and hexachlorobenzene) indicate the potential 
for liver and reproductive effects. However, no animal or human hazard 
data has been identified. The final rule for PCTP (Ref. 7) prohibits 
all manufacturing (including import) and processing of PCTP, and 
products or articles containing PCTP, unless PCTP concentrations are at 
or below 1% by weight. A prohibition on the distribution in commerce of 
PCTP or PCTP-containing products or articles, unless PCTP 
concentrations are at or below 1% by weight, will take effect on 
January 6, 2022.

E. Hexachlorobutadiene (HCBD); Regulation of Persistent, 
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h) (RIN 2070-
AK61)

    HCBD is a halogenated aliphatic hydrocarbon that is produced as an 
unintentional byproduct during the manufacture of chlorinated 
hydrocarbons, particularly perchloroethylene, trichloroethylene, and 
carbon tetrachloride, and is subsequently burned as a waste fuel. HCBD 
is toxic to aquatic invertebrates, fish, and birds, and has been 
identified as a possible human carcinogen. Data indicate the potential 
for renal, reproductive, and developmental effects. The final rule for 
HCBD (Ref. 8) prohibits the manufacture (including import), processing, 
and distribution in commerce of HCBD and HCBD-containing products or 
articles, except for the unintentional production of HCBD as a 
byproduct during the production of chlorinated solvents, and the 
processing and distribution in commerce of HCBD for burning as a waste 
fuel.

III. Request for Comment

    During the comment period, the public may submit comments and 
information relevant to any aspect of the final PBT rules. The public 
is encouraged to provide comments and information relating to EPA's 
statutory obligations under TSCA section 6(h) and the extent to which 
there are further exposure reductions that could be achieved, including 
exposure reductions for potentially exposed or susceptible 
subpopulations and the environment. EPA is particularly interested in 
information relating to the impacts of the final rules on human health, 
including potentially exposed or susceptible subpopulations, and the 
environment. EPA is also requesting comment on implementation issues 
associated with these final rules. EPA specifically invites public 
comment on additional measures or approaches that EPA could take in 
addition to the provisions in the final rules.
    In particular, EPA is seeking comment on newly-raised issues 
associated with the March 8, 2021 compliance date in the PIP (3:1) rule 
for certain regulated articles. Stakeholders recently informed EPA that 
the prohibition on processing and distribution of PIP (3:1) could 
impact articles used in a wide variety of electronics, from cell 
phones, to robotics used to manufacture semiconductors, to equipment 
used to move COVID-19 vaccines and keep them at the appropriate 
temperature. Stakeholders note that the complexity of international 
supply chains makes locating the presence of, and finding alternatives 
to, PIP (3:1) in components challenging. They assert that an extension 
to the compliance deadline is necessary to avoid significant disruption 
to the supply chain for a wide variety of articles. It was clearly not 
EPA's intent during the development of the rule to have such a broad 
disruptive impact. Nonetheless, compliance deadlines for the PBT rules 
must be in place ``as soon as practicable'' and provide reasonable 
transition periods, pursuant to the requirements of TSCA section 
6(d)(1). Thus, for EPA to amend the existing deadline, the Agency needs 
additional information regarding the impact of the deadline. EPA 
specifically asks commenters to specify the articles that need the 
alternative deadline; the basis for the alternative deadline, taking 
into consideration the reasons supporting alternative deadlines in the 
final rule already issued, such as the January 1, 2022, date for 
photographic printing articles and the January 6, 2025, date for 
adhesives and sealants, with supporting documentation; and the 
additional time needed for specific articles to clear channels of 
trade. EPA plans to address the compliance deadline in the PIP (3:1) 
rule as part of the broader re-examination of these rules and will take 
into account comments received during this comment period when deciding 
upon future action involving this matter. In the meantime, the Agency 
will exercise its enforcement discretion to not pursue enforcement 
actions for violations of the prohibitions on the processing and 
distribution of PIP (3:1) for use in articles, or articles containing 
PIP (3:1) for up to 180 days, while this review and agency action to 
address this matter are pending.

III. References

1. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update. 
October 2014. https://www.epa.gov/assessingandmanaging-chemicals-under-tsca/tscawork-plan-chemical-assessments-2014-update. Accessed 
March 1, 2019.
2. EPA. TSCA Work Plan Chemicals: Methods Document. February 2012. 
https://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf. Accessed March 1, 2019.

[[Page 14401]]

3. EPA. Exposure and Use Assessment of Five Persistent, 
Bioaccumulative, and Toxic Chemicals. December 2020.
4. EPA. 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP); Regulation of 
Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 
6(h); Final Rule. Federal Register (86 FR 866, January 6, 2021) 
(FRL-10018-90).
5. EPA. Decabromodiphenyl Ether (DecaBDE); Regulation of Persistent, 
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Final 
Rule. Federal Register (86 FR 880, January 6, 2021) (FRL-10018-87).
6. EPA. Phenol, Isopropylated Phosphate (3:1) (PIP 3:1)); Regulation 
of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA 
Section 6(h); Final Rule. Federal Register (86 FR 894, January 6, 
2021) (FRL-10018-88).
7. EPA. Pentachlorothiophenol (PCTP); Regulation of Persistent, 
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Final 
Rule. Federal Register (86 FR 911, January 6, 2021) (FRL-10018-89).
8. EPA. Hexachlorobutadiene (HCBD); Regulation of Persistent, 
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Final 
Rule. Federal Register (86 FR 922, January 6, 2021) (FRL-10018-91).
9. Executive Order 13985. Advancing Racial Equity and Support for 
Underserved Communities Through the Federal Government. Federal 
Register (86 FR 7009, January 25, 2021).
10. Executive Order 13990. Protecting Public Health and the 
Environment and Restoring Science to Tackle the Climate Crisis. 
Federal Register (86 FR 7037, of January 25, 2021).
11. Executive Order 14008. Tackling the Climate Crisis at Home and 
Abroad. Federal Register (86 FR 7619, February 1, 2021).
12. Presidential Memorandum. Memorandum on Restoring Trust in 
Government Through Scientific Integrity and Evidence-Based 
Policymaking. Federal Register (January 27, 2021).
13. Fact Sheet: List of Agency Actions for Review (January 21, 
2021).

    Authority: 15 U.S.C. 2601 et seq.

    Dated: March 8, 2021.
Michal Freedhoff,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2021-05138 Filed 3-15-21; 8:45 am]
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