[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Rules and Regulations]
[Pages 866-880]
[FR Doc No: 2020-28690]

Vol. 86

Wednesday,

No. 3

January 6, 2021

Part V

Environmental Protection Agency

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40 CFR Part 751

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2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Final
Rules

Federal Register / Vol. 86 , No. 3 / Wednesday, January 6, 2021 /
Rules and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2019-0080; FRL-10018-90]
RIN 2070-AK59

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is finalizing a rule
under the Toxic Substances Control Act (TSCA) to address its
obligations under TSCA for 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP)
(CASRN 732-26-3), which EPA has determined meets the requirements for
expedited action under TSCA. This final rule prohibits the distribution
in commerce of 2,4,6-TTBP and products containing 2,4,6-TTBP at
concentrations above 0.3% in any container with a volume of less than
35 gallons for any use, in order to effectively prevent the use of
2,4,6-TTBP as an antioxidant in fuel additives or fuel injector
cleaners by consumers and small commercial operations (e.g., automotive
repair shops, marinas). This final rule also prohibits the processing
and distribution in commerce of 2,4,6-TTBP, and products containing
2,4,6-TTBP at concentrations above 0.3 percent by weight, for use as an
oil or lubricant additive, regardless of container size. These
requirements will reduce the exposure to humans and the environment, by
reducing the potential for consumer exposures to 2,4,6-TTBP and
potential occupational exposure in certain industries where workers are
unprotected, as well as potential releases to the environment from
consumer and small commercial operations use.

DATES: This final rule is effective February 5, 2021. For purposes of
judicial review and 40 CFR 23.5, this rule shall be promulgated at 1
p.m. (e.s.t.) on January 21, 2021.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2019-0080, is available at
http://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. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
    Please note that due to the public health emergency, the EPA Docket
Center (EPA/DC) and Reading Room was 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:
Peter Gimlin, Existing Chemicals Risk Management Division, Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 566-0515; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture
(including import), process, distribute in commerce, or use products
containing this chemical, 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP),
especially fuel additives, fuel injector cleaners and oil and
lubricants. 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:
     Petroleum Refineries (NAICS Code: 324110);
     Petrochemical Manufacturing (NAICS Code: 325110);
     All Other Basic Organic Chemical Manufacturing (NAICS
Code: 325199);
     Polish and Other Sanitation Good Manufacturing (NAICS
Code: 325612);
     All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS Code: 325998);
     Lawn and Garden Tractor and Home Lawn and Garden Equipment
Manufacturing (NAICS Code: 333112);
     Aircraft Manufacturing (NAICS Code: 336411);
     Motor Vehicle Supplies and New Parts Merchant Wholesalers
(NAICS Code: 423120);
     Petroleum and Petroleum Products Merchant Wholesalers
(except Bulk Stations and Terminals) (NAICS Code: 424720);
     Farm Supplies Merchant Wholesalers (NAICS Code: 424910);
Boat Dealers (NAICS Code: 441222);
     Automotive Parts and Accessories Stores (NAICS Code:
441310);
     Gasoline Stations with Convenience Stores (NAICS Code:
447110);
     Other Gasoline Stations (NAICS Code: 447190);
     General Merchandise Stores (NAICS Code: 452);
     Aircraft Maintenance and Repair Services (NAICS Code:
488190);
     Marinas (NAICS Code: 713930); and
     General Automotive Repair (NAICS Code: 811111).
    If you have any questions regarding the applicability of this
action to a particular entity, consult the technical information
contact listed under FOR FURTHER INFORMATION CONTACT.

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

    Section 6(h) of TSCA, 15 U.S.C. 2601 et seq., directs EPA to issue
a final rule under TSCA section 6(a) on certain persistent,
bioaccumulative, and toxic (PBT) chemical substances. More
specifically, EPA must take 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). 2,4,6-TTBP is one such chemical substance. TSCA section 6(h)
directs EPA to take expedited action on these chemical substances,
regardless of whether that substance is primarily found as an impurity
or byproduct, to reduce exposure to the substance, including to
exposure to the substance as an impurity or byproduct, to the extent
practicable. This final rule is final agency action for purposes of
judicial review under TSCA section 19(a).

C. What action is the Agency taking?

    EPA published a proposed rule on July 29, 2019 to address the five
PBT

chemicals EPA identified pursuant to TSCA section 6(h) (84 FR 36728;
FRL-9995-76). After publication of the proposed rule, EPA determined to
address the five PBT chemicals in separate final actions. This final
rule prohibits the distribution in commerce of 2,4,6-TTBP and products
containing 2,4,6-TTBP at concentrations above 0.3% (i.e., present as a
functional additive instead of as impurity) in any container with a
volume of less than 35 gallons for any use, beginning on January 6,
2026, in order to effectively prevent 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). This final rule
also prohibits the processing and distribution in commerce of 2,4,6-
TTBP, and products containing 2,4,6-TTBP at concentrations above 0.3%,
for use as an oil or lubricant additive, regardless of container size,
beginning on January 6, 2026. Beginning on January 6, 2026, affected
persons are required to maintain, for three years from the date the
record is generated, ordinary business records related to compliance
with these restrictions. For this specific chemical, ordinary business
records that include the name of the purchaser and the sizes of the
containers supplied would be sufficient. This provision is not intended
to require subject companies to retain records in addition to those
specified herein, except as needed pursuant to normal business
operations.

D. Why is the Agency taking this action?

    EPA is issuing this final rule to fulfill EPA's obligations under
TSCA section 6(h) to take timely regulatory action on PBT chemicals--
specifically, ``to address the risks of injury to health or the
environment that the Administrator determines are presented by the
chemical substance and to reduce exposure to the substance to the
extent practicable.'' Consistent with that requirement, the Agency is
finalizing this rule to reduce exposures to 2,4,6-TTBP to the extent
practicable.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of these final restrictions
and prohibitions and the associated reporting and recordkeeping
requirements. The ``Economic Analysis for Final Regulation of 2,4,6-
Tris(tert-butyl)phenol (2,4,6-TTBP) Under TSCA Section 6(h)'' (Economic
Analysis) (Ref. 3) is available in the docket and is briefly summarized
here.
     Benefits. EPA was not able to quantify the benefits of
reducing the potential for human and environmental exposures to 2,4,6-
TTBP. As discussed in more detail in Unit II.A., EPA did not perform
risk evaluations for 2,4,6-TTBP, nor did EPA develop quantitative risk
estimates. Therefore, the Economic Analysis (Ref. 3) qualitatively
discusses the benefits of reducing the exposure under the final action
and the primary alternative regulatory action for 2,4,6-TTBP.
     Costs. Total quantified annualized social costs for this
final rule are approximately $5.6 million at a 3% discount rate and
$4.9 million at a 7% discount rate. Potential unquantified costs are
those associated with testing, reformulation, importation of articles,
foregone profits, and indirect costs. The limited data available for
those costs prevents EPA from constructing a quantitative assessment.
     Small entity impacts. This rule will impact approximately
three small businesses of which none are expected to incur cost impacts
of 1% or greater of their revenue.
     Environmental Justice. This rule will increase the level
of protection for all affected populations without having any
disproportionately high and adverse human health or environmental
effects on any population, including any minority or low-income
population or children.
     Effects on State, local, and Tribal governments. This rule
does not have any significant or unique effects on small governments,
or federalism or tribal implications.

F. Children's Environmental Health

    Executive Order 13045 applies if the regulatory action is
economically significant and concerns an environmental health risk or
safety risk that may disproportionately affect children. This final
rule is not subject to Executive Order 13045 because it is not an
economically significant regulatory action as defined by Executive
Order 12866. While the action is not subject to Executive Order 13045,
the Agency's Policy on Evaluating Health Risks to Children (https://www.epa.gov/children/epas-policy-evaluating-risk-children) is to
consider the risks to infants and children consistently and explicitly
during its decision making process. This regulation will reduce the
exposure that could occur from activities now prohibited under this
final rule to 2,4,6-TTBP for the general population and for potentially
exposed or susceptible subpopulations such as children. More
information can be found in the Exposure and Use Assessment (Ref. 4).

II. Background

A. History of This Rulemaking: TSCA Sections 6(h) and the TSCA Work
Plan

    TSCA section 6(h) requires EPA to take expedited regulatory action
under TSCA section 6(a) for certain PBT chemicals identified in the
2014 Update to the TSCA Work Plan for Chemical Assessments (Ref. 1). As
required by the statute, EPA issued a proposed rule to address five
persistent, bioaccumulative, and toxic chemicals identified pursuant to
TSCA section 6(h) (84 FR 36728, July 29, 2019). The statute required
that this be followed by promulgation of a final rule no later than 18
months after the proposal. While EPA proposed regulatory actions on
each chemical substance in one proposal, in response to public comments
requesting these five actions be separated, EPA is finalizing five
separate actions to individually address each of the PBT chemicals. EPA
intends for the five separate final rules to publish in the same issue
of the Federal Register. More discussion on these comments is in the
response to comments document (Ref. 5). The details of the proposal for
2,4,6-TTBP are described in more detail in Unit II.D.
    Under TSCA section 6(h)(1)(A), chemical substances subject to
expedited action are those that:
     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 2012 TSCA Work
Plan Chemicals: Methods Document or a successor scoring system;
     Are not a metal or a metal compound; and
     Are chemical substances for which EPA has not completed a
TSCA Work Plan Problem Formulation, initiated a review under TSCA
section 5, or entered into a consent agreement under TSCA section 4,
prior to June 22, 2016, the date that TSCA was amended by the Frank R.
Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182,
130 Stat. 448).
    In addition, in order for a chemical substance to be subject to
expedited action, TSCA section 6(h)(1)(B) states that EPA must find
that exposure to the chemical substance under the conditions of use is
likely to the general population or to a potentially exposed or
susceptible subpopulation identified by the Administrator (such as
infants, children, pregnant women, workers, or the elderly), or to the
environment on

the basis of an exposure and use assessment conducted by the
Administrator. TSCA section 6(h)(2) further provides that the
Administrator shall not be required to conduct risk evaluations on
chemical substances that are subject to TSCA section 6(h)(1).
    Based on the criteria set forth in TSCA section 6(h), EPA proposed
to determine that five chemical substances meet the TSCA section
6(h)(1)(A) criteria for expedited action, and 2,4,6-TTBP is one of
these five chemical substances. In addition, and in accordance with the
statutory requirements to demonstrate that exposure to the chemical
substance is likely under the conditions of use, EPA conducted an
Exposure and Use Assessment for 2,4,6-TTBP. As described in the
proposed rule, EPA conducted a review of available literature with
respect to 2,4,6-TTBP to identify, screen, extract, and evaluate
reasonably available information on use and exposures. This information
is in the document entitled ``Exposure and Use Assessment of Five
Persistent, Bioaccumulative and Toxic Chemicals'' (Ref. 4). Based on
this review, which was subject to peer review and public comment, EPA
finds that exposure to 2,4,6-TTBP is likely, based on information
detailed in the Exposure and Use Assessment.

B. Other Provisions of TSCA Section 6

    1. EPA's approach for implementing TSCA section 6(h)(4).
    TSCA section 6(h)(4) requires EPA to issue a TSCA section 6(a) rule
to ``address the risks of injury to health or the environment that the
Administrator determines are presented by the chemical substance and
reduce exposure to the substance to the extent practicable.'' EPA reads
this text to require action on the chemical, not specific conditions of
use.
    The approach EPA takes is consistent with the language of TSCA
section 6(h)(4) and its distinct differences from other provisions of
TSCA section 6 for chemicals that are the subject of required risk
evaluations. First, the term ``condition of use'' is only used in TSCA
section 6(h) in the context of the TSCA section 6(h)(1)(B) finding
relating to likely exposures under ``conditions of use'' to ``the
general population or to a potentially exposed or susceptible
subpopulation . . . or the environment.'' In contrast to the risk
evaluation process under TSCA section 6(b), this TSCA section
6(h)(1)(B) threshold criterion is triggered only through an Exposure
and Use Assessment regarding the likelihood of exposure and does not
require identification of every condition of use (Ref. 4). As a result,
EPA collected all the information it could on the use of each chemical
substance, without regard to whether any chemical activity would be
characterized as ``known, intended or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed
of,'' and from that information created use profiles and then an
Exposure and Use Assessment to make the TSCA section 6(h)(1)(B) finding
for at least one or more ``condition of use'' activities where some
exposure is likely. EPA did not attempt to precisely classify all
activities for each chemical substance as a ``condition of use'' and
thus did not attempt to make a TSCA section 6(h)(1)(B) finding for all
chemical activities summarized in the Exposure and Use Assessment.
Second, TSCA section 6 generally requires a risk evaluation under TSCA
section 6(b) for chemicals based on the identified conditions of use.
However, pursuant to TSCA section 6(h)(2), for chemical substances that
meet the criteria of TSCA section 6(h)(1), a risk evaluation is neither
required nor contemplated to be conducted for EPA to meet its
obligations under TSCA section 6(h)(4). Rather, as noted in Unit
II.B.3., if a previously prepared TSCA risk assessment exists, EPA
would have authority to use that risk assessment to ``address risks''
under TSCA section 6(h)(4), but even that risk assessment would not
necessarily be focused on whether an activity is ``known, intended or
reasonably foreseen,'' as those terms were not used in TSCA prior to
the 2016 amendments and a preexisting assessment of risks would have
had no reason to use such terminology or make such judgments. It is for
this reason EPA believes that the TSCA section 6(h)(4) ``address risk''
standard refers to the risks the Administrator determines ``are
presented by the chemical substance'' and makes no reference to
``conditions of use.'' Congress did not contemplate or require a risk
evaluation identifying the conditions of use as defined under TSCA
section 3(4). The kind of analysis required to identify and evaluate
the conditions of use for a chemical substance is only contemplated in
the context of a TSCA section 6(b) risk evaluation, not in the context
of an expedited rulemaking to address PBT chemicals.
    Similarly, the TSCA amendments require EPA to ``reduce exposure to
the substance to the extent practicable,'' without reference to whether
the exposure is found ``likely'' pursuant to TSCA section 6(h)(1)(B).
    Taking this into account, EPA reads its TSCA section 6(h)(4)
obligation to apply to the chemical substance generally, thus requiring
EPA to address risks and reduce exposures to the chemical substance
without focusing on whether the measure taken is specific to an
activity that might be characterized as a ``condition of use'' as that
term is defined in TSCA section 3(4) and interpreted by EPA in the Risk
Evaluation Rule, 82 FR 33726 (July 20, 2017). This approach ensures
that any activity involving a TSCA section 6(h) PBT chemical, past,
present or future, is addressed by the regulatory approach taken. Thus,
under this final rule, EPA grouped all activities with 2,4,6-TTBP into
four general categories, and addressed the practicability of specific
standards for each group. As described in detail in Unit II.F., EPA has
considered the uses of 2,4,6-TTBP in these 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 entities and for retail sale, and (4) use in
formulations and mixtures for liquid lubricant and grease additives/
antioxidants additives. This final rule prohibits distribution of
2,4,6-TTBP and products containing 2,4,6-TTBP in any container with a
volume of less than 35 gallons for any use, as well as processing and
distribution of 2,4,6-TTBP and products containing 2,4,6-TTBP for use
as an oil or lubricant additive, and thus reduces the exposures that
will result with resumption of past activities or the initiation of
similar or other activities in the future. Therefore, EPA has
determined that prohibiting these activities will reduce exposures to
the extent practicable. The approach taken for this rulemaking is
limited to implementation of TSCA section 6(h) and is not relevant to
any other action under TSCA section 6 or other statutory actions.
    2. EPA's interpretation of ``practicable.''
    The term ``practicable'' is not defined in TSCA. EPA interprets
this requirement as generally directing the Agency to consider such
factors as achievability, feasibility, workability, and reasonableness.
In addition, EPA's approach to determining whether particular
prohibitions or restrictions are practicable is informed in part by a
consideration of certain other provisions in TSCA section 6, such as
TSCA

section 6(c)(2)(A) which requires the Administrator to consider health
effects, exposure, and environmental effects of the chemical substance;
benefits of the chemical substance; and the reasonably ascertainable
economic consequences of the rule. In addition, pursuant to TSCA
section 6(c)(2)(B), in selecting the appropriate TSCA section 6(a)
regulatory approach to take, the Administrator is directed to ``factor
in, to the extent practicable'' those same considerations.
    EPA received comments on the proposed rule regarding this
interpretation of ``practicable.'' EPA has reviewed these comments and
believes the interpretation described previously within this Unit is
consistent with the intent of TSCA and has not changed that
interpretation. EPA's interpretation of an ambiguous statutory term
receives deference. More discussion on these comments is in the
Response to Comments document for this rulemaking (Ref. 5).
    3. EPA did not conduct a risk assessment.
    As EPA explained in the proposed rule, EPA does not interpret the
``address risk'' language to require EPA to determine, through a risk
assessment or risk evaluation, whether risks are presented. EPA
believes this reading gives the Administrator the flexibility Congress
intended for issuance of expedited rules for PBTs and is consistent
with TSCA section 6(h)(2) which makes clear that a risk evaluation is
not required to support this rulemaking.
    EPA received comments on the proposed rule regarding its
interpretation of TSCA section 6(h)(4) and regarding EPA's lack of risk
assessment or risk evaluation of 2,4,6-TTBP. A number of commenters
commented that, while EPA was not compelled to conduct a risk
evaluation, EPA should have conducted a risk evaluation under TSCA
section 6(b) regardless. The rationales provided by the commenters for
such a risk assessment or risk evaluation included that one was needed
for EPA to fully quantify the benefits to support this rulemaking, and
that without a risk evaluation, EPA would not be able to determine the
benefits, risks, and cost effectiveness of the rule in a meaningful
way. As described by the commenters, EPA would therefore not be able to
meet the TSCA section 6(c)(2) requirement for a statement of these
considerations. Regarding the contradiction between the mandate in TSCA
section 6(h) to expeditiously issue a rulemaking and the time needed to
conduct a risk evaluation, some commenters argued that EPA would have
had enough time to conduct a risk evaluation and issue a proposed rule
by the statutory deadline.
    For similar reasons, EPA does not believe that TSCA section 6(c)(2)
requires a quantification of benefits, much less a specific kind of
quantification. Under TSCA section 6(c)(2)(A)(iv), EPA must consider
and publish a statement, based on reasonably available information, on
the reasonably ascertainable economic consequences of the rule, but
that provision does not require quantification, particularly if
quantification is not possible. EPA has reasonably complied with this
requirement by including a quantification of direct costs and a
qualitative discussion of benefits in each of the preambles to the
final rules. EPA was unable to quantify the indirect costs associated
with the rule. Further discussion on these issues can be found in the
Response to Comment document. (Ref. 5)
    EPA disagrees with the commenters' interpretation of EPA's
obligations with respect to chemicals subject to TSCA section 6(h)(4).
TSCA section 6(h)(4) provides that EPA shall: (1) ``Address the risks
of injury to health or the environment that the Administrator
determines are presented by the chemical substance'' and (2) ``reduce
exposure to the substance to the extent practicable.'' With respect to
the first requirement, that standard is distinct from the
``unreasonable risk'' standard for all other chemicals for which a
section 6(a) rule might be issued. EPA does not believe that TSCA
section 6(h) contemplates a new evaluation of any kind, given that
evaluations to determine risks are now addressed through the TSCA
section 6(b) risk evaluation process and that TSCA section 6(h)(2)
explicitly provides that no risk evaluation is required. Moreover, it
would have been impossible to prepare a meaningful evaluation under
TSCA and subsequently develop a proposed rule in the time contemplated
for issuance of a proposed rule under TSCA section 6(h)(1). Although
EPA does not believe the statute contemplates a new evaluation of any
kind for these reasons, EPA reviewed the hazard and exposure
information on the five PBT chemicals EPA had compiled. However, while
this information appropriately addresses the criteria of TSCA section
6(h)(1)(A) and (B), it did not provide a basis for EPA to develop
sufficient and scientifically robust and representative risk estimates
to evaluate whether or not any of the chemicals present an identifiable
risk of injury to health or the environment.
    Rather than suggesting a new assessment is required, EPA reads the
``address risk'' language in TSCA section 6(h)(4) to contemplate
reliance on an existing EPA assessment under TSCA, similar to a risk
assessment that may be permissibly used under TSCA section 26(l)(4) to
regulate the chemical under TSCA section 6(a). This interpretation
gives meaning to the ``address risk'' phrase, without compelling an
evaluation contrary to TSCA section 6(h)(2), and would allow use of an
existing determination, or development of a new determination based on
such an existing risk assessment, in the timeframe contemplated for
issuance of a proposed rule under TSCA section 6(h). However, there
were no existing EPA assessments of risk for any of the PBT chemicals.
Thus, because EPA had no existing EPA risk assessments or
determinations of risk, the regulatory measures addressed in this final
rule focus on reducing exposures ``to the extent practicable.''
    In sum, because neither the statute nor the legislative history
suggests that a new evaluation is compelled to identify and thereby
provide a basis for the Agency to ``address risks'' and one could not
be done prior to preparation and timely issuance of a proposed rule,
and no existing TSCA risk assessment exists for any of the chemicals,
EPA has made no risk determination finding for any of the PBT
chemicals. Instead, EPA implements the requirement of TSCA section
6(h)(4) by reducing exposures of each PBT chemical ``to the extent
practicable.''
    More discussion on these comments is in the response to comments
document (Ref. 5).

C. 2,4,6-TTBP Overview, Health Effects and Exposure

    1. Uses of 2,4,6-TTBP.
    The use information presented in this Unit is based on the EPA's
review of the reasonably available information, as presented in the
rulemaking record, including public comments on the use documents,
proposed regulation and other stakeholder input.
    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. EPA summarizes below these uses and its conclusions
regarding the exposures and the practicability of reducing such
exposures.
    i. Manufacture and use as an intermediate/reactant.
    SI Group is currently the only large volume domestic manufacturer
of 2,4,6-TTBP. Historical CDR data indicate that in the 1986 to 1998
reporting years, the aggregate range of production of 2,4,6-TTBP was
between one and 10 million pounds per year and increased to a range of
10 to 50 million pounds per year in reporting years 2002 and 2006. The
range of production in 2012, 2013, 2014, and 2015 was confidential
business information (CBI) in the 2016 CDR (Ref. 6). There have not
been any indications of substantial importation of 2,4,6-TTBP into the
United States from other countries.
    2,4,6-TTBP is predominantly created in chemical reactions as a co-
product with a closely related alkylphenol, 2,6 di(tert-butyl)phenol
(2,6-DTBP). Neither chemical can be effectively produced commercially
without co-production of the other. The chemical is produced as a
mixture with its co-products, primarily 2,6-DTBP, at a concentration of
approximately 85% 2,6-DTBP and 12% 2,4,6-TTBP. (Ref. 7, EPA-HQ-OPPT-
2019-0080-0537). SI Group notes that while the reaction profile for
this trans-alkylation process can be shifted based on temperature of
the reaction and ratio of isobutylene to phenol, there is no feasible
way to eliminate the production of 2,4,6-TTBP in this reaction
chemistry.
    Approximately 94% of the 2,4,6-TTBP produced by SI Group is
consumed by the company in internal chemical processes as a feedstock
for further production of other alkylphenol chemicals. This quantity of
the chemical is not sold to other chemical processors; it is used by SI
Group itself. 2,4,6-TTBP has value as a chemical intermediate in the
production of dialkylphenol chemicals. Moreover, SI Group reports it is
not possible to significantly suppress the formation of 2,4,6-TTBP
without severely constraining the yield of other desired dialkylphenol
products, therefore its manufacture has impacts beyond the commercial
use of 2,4,6-TTBP itself. The production of other dialkylphenol
products, including alternative antioxidants, is therefore a benefit of
ongoing 2,4,6-TTBP manufacture.
    As noted, approximately 94% of the 2,4,6-TTBP produced by SI Group
is consumed by the company in internal processes, being used as a
feedstock for further production of alkylphenol chemical products. The
chemical reactions that use 2,4,6-TTBP as a chemical feedstock consume
(destroy) the feedstock during the process, on site within the
facility. An additional 4% of 2,4,6-TTBP produced by SI Group, which is
in excess of what it requires for chemical feedstock use, is sold as a
waste fuel for energy use. This excess material stream containing
2,4,6-TTBP is used as a waste fuel for energy value, which is burned
and destroyed during use (Ref. 8). A hydrocarbon, 2,4,6-TTBP has a high
energy value and can be sold as a fuel. (The remaining 2% manufactured
is used as a fuel additive, discussed later in this document.)
    SI Group notes that in the course of normal operations, the
manufacturing stream of the 2,4,6-TTBP containing product is as a
liquid, eliminating the possibility of fugitive and stack air (dust)
emissions and therefore inhalation or exposure to dust (EPA-HQ-OPPT-
2018-0314-0018). Based on the low vapor pressure of 2,4,6-TTBP, 6.6 x
10-4 mg Hg, EPA expects minimal chance of exposure by
inhalation of vapor from such liquid (Ref. 4). Dermal exposure
resulting from manufacturing and processing conditions of use at
chemical production facilities is expected to be minimal due to use of
specified engineering controls and required personal protective
equipment (PPE) identified by the SI Group. For example, at the
manufacturer/processing facilities, required worker PPE consists of
nitrile gloves, chemical-resistant slicker suits, chemical resistant
boots, respirators with face shield and hard hats; workers are trained
and monitored in the correct use of their PPE. Sampling during
production is accomplished using controlled sampling spigots, which
prevent aerosol formation, splashing and spillage, minimizing potential
worker exposure. Controlled sampling spigots are also used for transfer
activities (loading and unloading) (EPA-HQ-OPPT-2018-0314-0018).
    EPA has not identified releases, or potential releases from SI
Group's operations, that are posing an exposure to the environment and
that can be targeted for reduction with practicable measures under TSCA
section 6(a). Similarly, EPA has not identified exposure or potential
exposures to workers (or the general population from chemical facility
production and use) that can be targeted for reduction with specific
measures in this rule. As discussed in Unit II.F., EPA believes that in
industrial settings worker protection measures used by employers reduce
exposures to the extent practicable and EPA has determined that it is
not practicable to regulate worker exposures in this rule through
engineering or process controls or PPE requirements.
    The production and use of 2,4,6-TTBP as a chemical intermediate has
significance for other alkylphenol chemical products beyond the
immediate uses of 2,4,6-TTBP itself, as a result of the difficulty in
commercially producing these other chemicals without generating or
using 2,4,6-TTBP (EPA-HQ-OPPT-2018-0314-0018), EPA did not propose to
prohibit the manufacture of 2,4,6-TTBP or processing and use of 2,4,6-
TTBP as a chemical intermediate. During the public comment period, EPA
received no specific information addressing these issues as it might
related to 2,4,6-TTBP chemical facility operations. EPA therefore is
not imposing any additional regulatory controls for the manufacture of
2,4,6-TTBP for any use.
    ii. Use for fuel treatment in refineries and fuel facilities.
    As noted, of the 2,4,6-TTBP it produces, SI Group itself consumes
94% as a chemical intermediate and sells off another 4% as waste fuel.
The remaining 2% of 2,4,6-TTBP produced by SI Group is sold for use in
fuel as an antioxidant. The chemical is sold in a mixture with its co-
products, primarily 2,6-DTBP, at a concentration of approximately 85%
2,6-DTBP and 12% 2,4,6-TTBP (primarily two proprietary chemical
mixtures, Isonox[supreg] 133 and Ethanox[supreg] 4733) (Ref. 7). SI
Group also stated that it does not sell, supply, or distribute into
commerce 2,4,6-TTBP in a pure (neat) form.
    Most of SI Group's antioxidant product goes to use at refineries:
After refining, petroleum products such as fuels quickly begin to
degrade due to oxidation. A small portion of its sales volume goes to
processors of aftermarket fuel treatment products (discussed in the
next section). SI Group does not sell its mixtures containing 2,4,6-
TTBP directly to consumers. The majority of the 2,4,6-TTBP mixtures
sold are blended into the fuel at the refinery or soon after at tank
farms prior to commercial distribution of the fuel. Once blended into
fuel, the resultant concentration of 2,4,6-TTBP in fuel is low, in the
five to 50 ppm range.
    As summarized in the proposed rule, the 2,4,6-TTBP mixture is a
widely used antioxidant for jet, automotive, and marine fuels.
Antioxidant additives are essential to the storage and transport of
fuel, as without them, fuel quickly begins to degrade and form harmful
sludge and varnish. The 2,4,6-TTBP mixtures are the primary
antioxidants

used in aviation, marine, and automotive fuel streams in the United
States. Many current performance specifications for fuel require their
use; including for specialty fuels for aviation and the military. The
Aerospace Industries Association identified critical uses of 2,4,6-TTBP
as a fuel additive/antioxidant in formulations designed to meet
specific technical performance requirements that are documented in a
number of engineering specifications over the service life of complex
aerospace products (EPA-HQ-OPPT-2016-0734-0010). The American Petroleum
Institute also confirmed that their members use 2,4,6-TTBP as an
antioxidant in gasoline, diesel, and aviation fuels at concentrations
of between five and 50 parts per million to reduce gasoline deposits in
engines and subsequently reduce emissions (EPA-HQ-OPPT-2016-0734-0006).
With respect to use as an antioxidant in the general fuel supply, EPA
has received comment supporting the beneficial properties of 2,4,6-TTBP
as an antioxidant component blended in fuel. SI Group identified
numerous U.S. military and ASTM standards that its proprietary blended
products containing 2,4,6-TTBP satisfy for the antioxidant requirements
in fuel (Ref. 8), notably jet fuel that is supplied to and used by the
U.S. military. Although particular specifications do not list 2,4,6-
TTBP by CASRN or trade name, 2,4,6-TTBP is the preferred antioxidant
component for fuel standards due to its chemical reaction potential and
physical property characteristics (Ref. 8 and 9). According to the
manufacturers and processors, any substitution of 2,4,6-TTBP with
another alkylphenol or antioxidant compound would materially change the
performance characteristics of that fuel and compliance with mandatory
reference standards could not be assured (Ref. 9). Introducing a new
jet fuel component into use involves the fuel component supplier,
engine manufacturers, airplane makers and regulators in a complicated
process that may take several years and involve significant cost. New
fuel additives must be tested and approved to ensure they would have no
negative impact on engine safety, durability or performance (Ref. 8).
    Once blended into fuel, the resultant concentration of 2,4,6-TTBP
in fuel is low, in the five to 50 ppm range. Treated fuel is
distributed through the nation's fuel supply chain (pipeline or vehicle
transportation, storage and distribution to end points such as
airports, gas stations and military facilities). 2,4,6-TTBP, a
hydrocarbon, is destroyed (burned) as the fuel to which it is added is
consumed during end use (Ref. 7).
    SI Group typically ships its product to refineries in tankers or
other large containers. Fugitive air releases of 2,4,6-TTBP are
expected to be minimal (due to the low vapor pressure) from unloading
and transfer operations. Releases may possibly occur from spills and
leaks from loading operations, but exposure would be addressed at these
industrial sites through spill control measures. Waste from equipment
cleaning with organic cleaning solutions is anticipated to be collected
for incineration. Water releases are possible from equipment and
general area cleaning with aqueous cleaning solutions. Dermal exposure
to 2,4,6-TTBP to workers may occur from transfer and fuel loading
operations; however, dermal exposure at fuel production facilities is
expected to be minimal due to the required use of engineering controls
and personal protective equipment (PPE) noted above (EPA-HQ-OPPT-2018-
0314-0018). Refineries, fuel distribution and fuel storage facilities
also operate with the same or similar engineering controls, PPE
(gloves, slickers, boots, respirators, etc.), worker training, leak
detection and spill control measures; vapor recovery systems are used
during distribution and storage (EPA-HQ-OPPT-2016-0734-0006), similar
to procedures used at the manufacturing facility. Once blended into
fuel, the resultant concentration of 2,4,6-TTBP in fuel is low, in the
five to 50 ppm range, limiting the exposure resulting from handling and
spills or leaks.
    EPA has not identified releases, or potential releases from the use
of 2,4,6-TTBP for fuel treatment at refineries and fuel facilities that
can be targeted for reduction with practicable measures under TSCA
section 6(a). Similarly, EPA has not identified exposure or potential
exposures to workers (or the general population from refinery and fuel
facility use) that can be targeted for reduction with practicable
measures under TSCA section 6(a). As discussed in Unit II.F., EPA
believes that in industrial settings worker protection measures used by
employers reduce exposures to the extent practicable and EPA has
determined that it is not practicable to regulate worker exposures in
this rule through additional engineering or process controls or PPE
requirements.
    The benefit to continuing the use of existing antioxidants
containing 2,4,6-TTBP is a result of the necessity of antioxidants to
the nation's fuel supply and the difficulties inherent in removing
2,4,6-TTBP in terms of standards and performance specifications. Given
the absence of and difficulty with identifying and adopting
alternatives, EPA did not propose to prohibit the manufacturing,
processing, or distribution for use of 2,4,6-TTBP as an additive at
refineries and fuel facilities.
    iii. Formulations intended for the maintenance or repair of motor
vehicles and machinery.
    SI Group does not sell its Isonox or Ethanox mixtures directly to
consumers. However, a portion (approximately 6%) of the 2,4,6-TTBP
mixtures SI Group sells for use in fuels are sold to processors who
blend and distribute antioxidant products that are intended to be added
to the fuel tanks/systems in vehicles or machinery by repair shops or
the owner/operators of the equipment themselves. These fuel stabilizer
products, which contain a percentage of Isonox or Ethanox as an
antioxidant component, are sold to consumers at various retail
locations, as well as online. These additives are typically sold in
small bottles containing up to 32 ounces; gallon containers are
available through some retailers. Specialty products are also sold for
cleaning fuel injectors or use in 2-stroke engines (pre-blended with
oil).
    Regarding the retail sale of fuel additives and fuel injector
cleaners, EPA was unable to find any specifications or standards for
retail fuel antioxidants or additives that explicitly require the use
of 2,4,6-TTBP. As discussed in Unit III.B, EPA has identified a number
of substitute chemicals and substitute products in the Exposure and Use
Assessment for this rule for this specific use.
    Use of retail fuel additive products which are sold in small
containers to mechanics and consumers to service cars, boats, small
engines, etc., present opportunities for release and dermal exposure
during transfer activities if users are unprotected. Use of the product
involves pouring it from the bottle either into a fuel storage
container, such as a gas can that is used to refill equipment such as
lawn mowers, or it may be poured directly into the fuel tank of the
lawn equipment, or car, boat, etc.
    EPA believes that the general public does not routinely use PPE
while using this product in these mundane activities, and has not
received special training in the handling of the product. No PPE is
specified for the use of retail fuel additive products and EPA has no
information to indicate that the general public takes any further
protective measures when adding this product to

fuel containers. Similarly, EPA received no comment that workers who
use these fuel additive products, such as mechanics or lawn care
workers, routinely use PPE that would provide protection against
chemical exposure, such as nitrile gloves, slickers or respirators,
while using these products, or have received any special training in
the handling of the products or use of PPE with the product. Therefore,
this scenario is in contrast to the assumed use of PPE in industrial
settings discussed in Unit II.C.1.i and II.C.1.ii. As discussed in Unit
II.F., while EPA assumes compliance with other federal requirements,
including the OSHA standards and regulations, it would be difficult to
support broadly applicable and safe additional measures for each
specific activity without a risk evaluation and in the limited time for
issuance of this regulation under TSCA section 6(h), but imposing such
measures without sufficient analysis could inadvertently result in
conflicting or confusing requirements and make it difficult for
employers to understand their obligations. Such regulations would not
be practicable.
    Spillage may occur when the product is being poured into fuel tanks
and storage cans. Retail product containers may also leak during
transportation, handling, storage and disposal. After use by mechanics
and consumers, used retail product containers are disposed of in the
municipal solid waste stream without special handling. If released to
the indoor environment, 2,4,6-TTBP could partition to particulates and
dust based on its chemical relationship with organic carbon compared to
that of air. If released into a sanitary sewer system or storm water
system, 2,4,6-TTBP would likely transport to nearby wastewater
treatment plants due to relative mobility in water due to high water
solubility and low Koc (soil organic carbon/water partitioning
coefficient).
    EPA believes these identified releases and potential releases can
be targeted for reduction with practicable measures under TSCA section
6(a). Accordingly, EPA proposed to prohibit the distribution in
commerce of 2,4,6-TTBP in formulations intended for the maintenance or
repair of motor vehicles and machinery through a container size
restriction. EPA is finalizing these regulations, with changes based on
public comments discussed elsewhere in this notice.
    iv. Oil/lubricant uses.
    The Agency is addressing the use of 2,4,6-TTBP in liquid lubricant
and grease additives/antioxidants. Although EPA has not identified
users of 2,4,6-TTBP for liquid lubricant and grease additives/
antioxidants, it found indications of current use, and a manufacturer
has reported that it is aware that some customers may use its products
for this end use, although it does not actively market products with
2,4,6-TTBP for lubricant applications.
    Other countries have reported that 2,4,6-TTBP is, or has been, used
as an additive in oils and lubricants (EPA-HQ-OPPT-2016-0734-0002). SI
Group states that it does not actively market products containing
2,4,6-TTBP for lubricant applications, but that it is aware that some
customers may use these products in lubricant applications (Ref. 8).
Regarding the use of 2,4,6-TTBP as an antioxidant additive in oil and
lubricants, EPA was unable to find any specifications or standards for
oil, lubricant, or grease additives that require the use of 2,4,6-TTBP.
No commenters during this rulemaking identified uses without
substitutes.
    While no releases were specifically identified, EPA believes
potential for exposure can be targeted for reduction with practicable
measures under TSCA section 6(a). Given this and the general
availability of substitutes, EPA is prohibiting the use of 2,4,6-TTBP
in oil and lubricant additives.
    2. Health Effects, Exposure and TSCA section 6(h)(1) findings.
    Exposure information for 2,4,6-TTBP is detailed in EPA's Exposure
and Use Assessment (Ref. 4). Based on reasonably available information,
EPA did not identify any studies with extractable 2,4,6-TTBP data in
drinking water or any studies with detectable levels of 2,4,6-TTBP in
soil, sludge/biosolids, or vegetation/diet. Additionally, EPA did not
identify any studies with detectable levels of 2,4,6-TTBP in human
blood (serum), other human organs, aquatic invertebrates, aquatic
vertebrates, terrestrial invertebrates, birds, or terrestrial mammals.
    2,4,6-TTBP is toxic to aquatic plants, aquatic invertebrates, and
fish. Data indicate the potential for liver and developmental effects.
The studies presented in the document entitled ``Environmental and
Human Health Hazards of Five Persistent, Bioaccumulative and Toxic
Chemicals (Hazard Summary) (Ref. 10) demonstrate these hazardous
endpoints. EPA did not perform a systematic review or a weight of the
scientific evidence assessment for the hazard characterization of these
chemicals. As a result, this hazard characterization is not definitive
or comprehensive. Other hazard information on these chemicals may exist
in addition to the studies summarized in the Hazard Summary that could
alter the hazard characterization. In the 2014 Update to the TSCA Work
Plan for Chemical Assessments (Ref. 1), 2,4,6-TTBP scored moderate (2)
for hazard (based on toxicity following chronic exposure including
liver effects); moderate (2) for exposure (based on its wide use in
consumer products, presence in indoor environments, and estimation to
have moderate releases to the environment); and high (3) for
persistence and bioaccumulation (based on moderate environmental
persistence and high bioaccumulation potential). The overall screening
score for 2,4,6-TTBP was high (7).
    Taking all this into account, EPA determines that 2,4,6-TTBP meets
the TSCA section 6(h)(1)(A) criteria. In addition, EPA determines, in
accordance with TSCA section 6(h)(1)(B), that, based on the Exposure
and Use Assessment and other reasonably available information, exposure
to 2,4,6-TTBP is likely under the conditions of use to the general
population, to a potentially exposed or susceptible subpopulation, or
to the environment. EPA's determination is based on the opportunities
for exposure to 2,4,6-TTBP including the potential for consumer
exposures.

D. EPA's Proposed Rule Under TSCA Section 6(h) for 2,4,6-TTBP

    In the proposed rule (84 FR 36728), EPA proposed to restrict all
distribution in commerce of 2,4,6-TTBP and products containing 2,4,6-
TTBP in containers with a volume of less than 55 gallons. This was
intended to effectively prevent use of 2,4,6-TTBP as a retail fuel
additive or fuel injector cleaner by consumers and small commercial
operations. Exposures to humans and the environment would be reduced by
eliminating retail uses of 2,4,6-TTBP that have a higher potential for
releases. EPA believed that this proposal intentionally would not
impact use of this chemical in the nation's fuel supply system (i.e.,
at refineries and bulk petroleum storage facilities), where the
distribution, transfer, blending, and general end use of 2,4,6-TTBP-
containing blends/mixtures is managed through highly-regulated
engineering controls designed to mitigate environmental and human
health exposures. EPA proposed a 55-gallon threshold based on a belief
that much, if not all use of 2,4,6-TTBP containing blends/mixtures at
refineries and petroleum storage facilities are sourced in quantities
larger than 55 gallons at a time; and are typically sourced by the
tanker or batch load in quantities over

500 gallons at a time. EPA also sought comment on the optimal container
size limit to impose, e.g., for instance, whether a 35-gallon container
size would impact industrial use less while also preventing the sale of
retail products with 2,4,6-TTBP.
    EPA proposed to define 2,4,6-TTBP to mean the chemical substance
2,4,6-tris(tert-butyl)phenol (CASRN 732-26-3) at any concentration
above 0.01% by weight. EPA stated its belief that this concentration
limit would distinguish between products which contain 2,4,6-TTBP as a
functional additive and those in which it may be present in low
concentrations as a byproduct or impurity, noting that 2,4,6-TTBP is a
co-product and byproduct present in other alkylphenols, including other
antioxidants that are potential substitutes for it.
    EPA also proposed to prohibit all processing and distribution in
commerce of 2,4,6-TTBP for use as an additive in oils and lubricants.
There are numerous available substitutes for this use of 2,4,6-TTBP. To
support this provision, EPA proposed a definition of oil and lubricant
additive for this rule to mean any intentional additive to a product of
any viscosity intended to reduce friction between moving parts, whether
mineral oil or synthetic base, including engine crankcase oils and
bearing greases.
    Regarding the timing of these prohibitions, EPA stated in the
proposed rule that at that time it had no information indicating a
compliance date of 60 days after publication of the final rule is not
practicable for the activities that would be prohibited, or that
additional time is needed for products to clear the channels of trade.
    EPA proposed for recordkeeping that after 60 days following the
date of publication of the final rule, distributors of 2,4,6-TTBP and
products containing 2,4,6-TTBP must maintain ordinary business records,
such as invoices and bills-of-lading, that demonstrate 2,4,6-TTBP is
not distributed in containers with a volume less than 55 gallons or for
use as an oil and lubricant additive. These records would have to be
maintained for a period of three years from the date the record is
generated.

E. Public Comments and Other Public Input

    The proposed rule provided a 60-day public comment period, with an
additional 30-day extension granted. (84 FR 50809, September 26, 2019).
The comment period closed on October 28, 2019. EPA received a total of
48 comments, with three commenters sending multiple submissions with
attached files, for a total of 58 submissions on the proposal for all
the PBT chemicals. This includes the previous request for a comment
period extension (EPA-HQ-OPPT-2019-0080-0526). Two commenters submitted
confidential business information (CBI) or copyrighted documents with
information regarding economic analysis and market trends. Copies of
all the non-CBI documents, or redacted versions without CBI are
available in the docket for this action. EPA also communicated with
companies, and other stakeholders to identify and verify uses of 2,4,6-
TTBP. These interactions and comments further informed EPA's
understanding of the current status of uses for 2,4,6-TTBP. Public
comments and stakeholder meeting summaries are available in the public
docket at EPA-HQ-OPPT-2019-0080.
    In this preamble, EPA has responded to the major comments relevant
to the 2,4,6-TTBP final rule. Of the comment submissions, 12 directly
addressed EPA's proposed regulation of 2,4,6-TTBP. EPA's more
comprehensive responses to comments related to this final action are in
the Response to Comments document (Ref. 5).

F. Activities Not Directly Regulated by This Rule

    EPA proposed not to use its TSCA section 6(a) authorities to
directly regulate occupational exposures in industrial settings. As
explained in the proposed rule, as a matter of policy, EPA assumes
compliance with federal and state requirements, such as worker
protection standards, unless case-specific facts indicate otherwise.
The Occupational Safety and Health Administration (OSHA) has not
established a permissible exposure limit (PEL) for 2,4,6-TTBP. However,
under section 5(a)(1) of the Occupational Safety and Health Act of
1970, 29 U.S.C. 654(a)(1), each employer has a legal obligation to
furnish to each of its employees employment and a place of employment
that are free from recognized hazards that are causing or are likely to
cause death or serious physical harm. The OSHA Hazard Communication
Standard at 29 CFR 1910.1200 requires chemical manufacturers and
importers to classify the hazards of chemicals they produce or import,
and all employers to provide information to employees about hazardous
chemicals to which they may be exposed under normal conditions of use
or in foreseeable emergencies. The OSHA standard at 29 CFR
1910.134(a)(1) requires the use of feasible engineering controls to
prevent atmospheric contamination by harmful substances. Other
provisions of 29 CFR 1910.134 require the use of respirators where
effective engineering controls are not feasible and spell out details
of the required respiratory protection program. The OSHA standard at 29
CFR 1910.132(a) requires the use of personal protective equipment (PPE)
when workers are exposed to chemical and other hazards; 29 CFR 1910.133
requires the use of eye and face protection when employees are exposed
to hazards from, among other things, liquid chemicals; and 29 CFR
1910.138 requires the use of PPE to protect employees' hands from,
among other hazards, skin absorption of harmful substances. The
provisions of 29 CFR 1910.132(d) and (f) address hazard assessment, PPE
selection, and training with respect to PPE required under 29 CFR
1910.133, 29 CFR 1910.138, and certain other standards. EPA assumes
that employers will require, and workers will use, appropriate PPE
consistent with OSHA standards, taking into account employer-based
assessments, in a manner sufficient to prevent occupational exposures
that are capable of causing injury.
    EPA assumes compliance with other federal requirements, including
OSHA standards and regulations. EPA does not read TSCA section 6(h)(4)
to direct EPA to adopt potentially redundant or conflicting
requirements. Not only would it be difficult to support broadly
applicable and safe additional measures for each specific activity
without a risk evaluation and in the limited time for issuance of this
regulation under TSCA section 6(h), but imposing such measures without
sufficient analysis could inadvertently result in conflicting or
confusing requirements and make it difficult for employers to
understand their obligations. Such regulations would not be
practicable. Rather, where EPA has identified worker exposures and
available substitutes, EPA is finalizing measures to reduce those
exposures, e.g., by prohibiting the sale of 2,4,6-TTBP in the small
containers that contribute to potential exposures for workers in
smaller commercial establishments, as well as to consumers. While some
commenters agreed with EPA's approach, others thought that EPA should
establish worker protection requirements for those uses not regulated
under the final rule. EPA disagrees with those commenters who thought
that EPA should establish specific worker protection requirements.
Information provided to EPA before and during the public comment period
on the proposed rule indicates that employers are using engineering and

process controls and providing appropriate personal protective
equipment (PPE) to their employees consistent with these requirements.
EPA received no information on 2,4,6-TTBP to the contrary. Further, EPA
has not conducted a risk evaluation on 2,4,6-TTBP or any of the five
PBT chemicals. Without a risk evaluation and given the time allotted
for this rulemaking, EPA cannot identify additional engineering or
process controls or PPE requirements that would be appropriate to each
chemical-specific circumstance. For these reasons, EPA has determined
that it is not practicable to regulate worker exposures in this rule
through engineering or process controls or PPE requirements.
    Under a newly created general provisions section at 40 CFR
751.401(b), EPA is listing three activities to which the prohibitions
and restrictions under the PBT regulations at subpart E of 40 CFR 751
do not apply in general, unless otherwise specified in the individual
chemical regulations.
    The first activity is distribution in commerce of any chemical
substance, or products and articles that contain the chemical
substance, that has previously been sold or supplied to an end user,
i.e., an individual or entity that purchased or acquired the finished
good for purposes other than resale. An example of this is a consumer
who resells a product they no longer intend to use through the internet
or donates a used article to charity. EPA does not believe it
practicable to attempt to regulate such activity, given the small
quantities involved in end user resale relative to overall sales, the
multitude of potentially affected persons, the difficulties of making
consumers and other end users aware of potential compliance
obligations, and the difficulties the Agency would have enforcing such
resale prohibitions on the general public and other end users.
    The second activity is disposal of any chemical substance, or
products and articles that contain the chemical substance, including
importation, processing and distribution-in-commerce for purposes of
disposal. EPA explained in the proposed rule the basis of its
determination that, as a general matter, disposal is adequately
regulated under the authority of the Resource Conservation and Recovery
Act (RCRA) which governs the disposal of hazardous and non-hazardous
wastes, and it is not practicable to impose additional requirements
under TSCA on the disposal of the PBT chemicals in the proposed rule.
(84 FR 36744.) EPA received a number of comments on this aspect of its
proposal. Some commenters agreed with EPA's proposed determination that
it is not practicable to regulate disposal, while others disagreed.
Comments specific to other PBT chemicals, are addressed in those
chemicals' final rule notices. More information on the comments
received and EPA's responses can be found in the Response to Comments
document (Ref. 5). One commenter noted that, while EPA proposed to not
regulate disposal of the PBT chemicals under TSCA, the effect of EPA's
proposed prohibition on manufacturing, processing, and distribution in
commerce would prohibit the processing and distribution in commerce of
the PBTs and articles and products containing the PBT chemicals for
disposal. EPA did not intend such an effect, and is including a general
provision in the final regulatory text in the new section 40 CFR
751.401(b) to address disposal of any chemical substance, or products
and articles that contain the chemical substance, including
importation, processing and distribution in commerce for purposes of
disposal. In regard to the disposal of 2,4,6-TTBP, use of the chemical
as a feedstock, use as a waste fuel, and use as a fuel additive all
result in the destruction of the chemical through combustion. This
final rule will ultimately eliminate releases from the use of 2,4,6-
TTBP-containing retail fuel additive products which are sold in small
containers, such as spillage which may occur when the product is poured
into fuel tanks or fuel cans, as well as releases from the disposal of
used small containers that held those products in the municipal solid
waste stream.
    EPA also received comments regarding the use of PBT chemicals in
research and development and lab use. The final activity addressed
under newly established 40 CFR 751.401(b) is the manufacturing,
processing, distribution in commerce and use of any chemical substance,
or products and articles that contain the chemical substance, for
research and development, as defined in new 40 CFR 751.403. Research
and Development is defined in new 40 CFR 751.403 to mean laboratory and
research use only for purposes of scientific experimentation or
analysis, or chemical research on, or analysis of, the chemical
substance, including methods for disposal, but not for research or
analysis for the development of a new product, or refinement of an
existing product that contains the chemical substance. This will allow,
for example, for samples of environmental media containing PBTs, such
as contaminated soil and water, to be collected, packaged and shipped
to a laboratory for analysis. Laboratories also must obtain reference
standards containing PBTs to calibrate their equipment, otherwise they
may not be able to accurately quantify these chemical substances in
samples being analyzed. However, research to develop new products that
use PBTs subject to subpart E of 40 CFR 751, or the refinement of
existing uses of those chemicals, is not included in this definition,
and those activities remain potentially subject to the chemical
specific provisions in subpart E of 40 CFR 751. EPA believes it is not
practicable to limit research and development activity as defined,
given the critical importance of this activity to the detection,
quantification and control of these chemical substances.

III. Provisions of This Final Rule

A. Scope and Applicability

    EPA carefully considered all public comments related to the
proposal. This rule finalizes EPA's proposal to prohibit all
distribution in commerce of 2,4,6-TTBP and products containing 2,4,6-
TTBP in small containers, and prohibit all 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, with changes being made from the
proposal to the container size limit, the concentration limit for
2,4,6-TTBP, and the compliance date for the prohibitions.
    1. Container size.
    In the proposed rule, EPA solicited comment from the public on the
optimal container size limit to impose: Specifically, whether a 35-
gallon container size would impact industrial use less than a 55-gallon
container size while also preventing the sale of retail products with
2,4,6-TTBP. Two comments were received on this issue. SI Group
recommended EPA adopt a 35-gallon size limit, commenting that:
``Industrial users of chemicals occasionally ship materials in the non-
standard 55-gallon drum size. This slight decrease in container size
will not impact the intent or outcome of the original proposal--
consumer access to 2,4,6-TTBP will be restricted'' (EPA-HQ-OPPT-2019-
0080-0537). API stated that: ``A 35-gallon container size would be more
appropriate, because it would impact industrial use less while also
preventing the commercial and retail sale of products with 2,4,6-
TTBP.'' Based on this information EPA is adopting a 35-gallon container
size limit in the final regulation, which will still reduce the
exposure to consumers to the same extent (EPA-HQ-OPPT-2019-0080-0539).

    2. Concentration limit for 2,4,6-TTBP.
    EPA proposed to define 2,4,6-TTBP to mean the chemical substance
2,4,6-tris(tert-butyl)phenol (CASRN 732-26-3) at any concentration
above 0.01% by weight for the purpose of distinguishing between
products which contain 2,4,6-TTBP as a functional additive and those in
which it may be present in low concentrations as a byproduct or
impurity, noting that 2,4,6-TTBP is a co-product and byproduct present
in other alkylphenols, including other antioxidants that are potential
substitutes for it.
    In response to EPA's concentration proposal to distinguish between
products that contain 2,4,6-TTBP as a functional additive and those
with low concentrations as a byproduct or impurity, SI Group (EPA-HQ-
OPPT-2019-0080-0537) provided more detailed information:
     Impurity levels of 2,4,6-TTBP are typically very low, but
may range up to 0.3%. SI Group's engineering staff recently conducted
modeling studies of its processes and the output suggests the company
is unable to decrease impurity levels of 2,4,6-TTBP with current
manufacturing operations.
     These models indicate there is no way to achieve a zero
residual value for 2,4,6-TTBP as an impurity due to numerous factors.
     The hindered phenolic antioxidant 2,6-di-tert-4-
secbutylphenol contains an average 2,4,6-TTBP impurity concentration of
0.3%, the highest in SI's portfolio. This substance is the predominant
antioxidant technology utilized in automotive brake fluid in the United
States.
    Given these detailed comments from the manufacturer of 2,4,6-TTBP,
EPA believes adopting a 0.3% concentration limit in the final
regulation will better achieve the distinction between functional
additives and impurities EPA seeks to establish, and thereby avoid
unintended and unassessed impacts on other alkylphenols used in
products such as brake fluid. For clarity, EPA is stating this
concentration limit within the prohibitions for 2,4,6-TTBP under 40 CFR
751.409(a) in the final regulation; EPA believes this will reduce
opportunity for the concentration limit to be overlooked by readers of
the regulation.
    3. Compliance date for the prohibitions.
    The proposed rule did not delay the compliance date beyond the
rule's effective date; the processing and distribution bans would come
into effect 60 days after publication of the final rule notice. EPA
stated in the proposed rule that at that time it had no information
indicating that a compliance date of 60 days after publication of the
final rule is not practicable for the activities that would be
prohibited, or that additional time is needed for products to clear the
channels of trade. The phrases ``as soon as practicable'' and
``reasonable transition period'' as used in TSCA section 6(d)(1) are
undefined, and the legislative history on TSCA section 6(d) is limited.
Given the ambiguity in the statute, for purposes of this expedited
rulemaking, EPA presumed a 60-day compliance date was ``as soon as
practicable,'' unless there was support for a lengthier period of time
on the basis of reasonably available information, such as information
submitted in comments on the Exposure and Use Assessment or in
stakeholder dialogues. Such a presumption is consistent with the
general effective date often adopted for rulemakings and ensures the
compliance schedule is ``as soon as practicable,'' particularly in the
context of the TSCA section 6(h) rules for chemicals identified as
persistent, bioaccumulative and toxic, and given the expedited
timeframe for issuing a TSCA section 6(h) proposed rule did not allow
time for collection and assessment of new information separate from the
comment opportunities during the development of and in response to the
proposed rule. Such presumption also allows for submission of
information from the sources most likely to have the information that
will affect an EPA determination on whether or how best to adjust the
compliance deadline to ensure that the chosen final compliance deadline
is both ``as soon as practicable'' and provides a ``reasonable
transition period.''
    On this issue, SI Group provided comment and recommended a 5-year
delay in implementation, commenting that ``. . . there could be
significant implications to the current aftermarket fuel additives and
oil/lubricant value chains with enactment of this rule and the very
short time for implementation. Complying with this rule will likely
require a considerable amount of time given the requirements of
Federal, State, standardization bodies, Original Equipment
Manufacturers (OEMs), and brand holders in reformulating and
requalifying products as well as managing current inventory'' (EPA-HQ-
OPPT-2019-0080-0537). EPA also received comment on this issue from Gold
Eagle Company, which identifies itself as the maker of the #1 selling
fuel stabilizer in the United States, and produces several brands of
fuel stabilizer under various brand names; it commented that ``over 100
OEMs [original equipment manufacturers] endorse this fuel stabilizer in
their owners manual and/or sell the product in their dealerships, or
buy a private label product from Gold Eagle.'' (EPA-HQ-OPPT-2019-0080-
0533). It states that 2,4,6-TTBP is an essential component of its fuel
stabilizers; that it has used the same antioxidant chemistry since
1988; that evaluated alternative antioxidant chemistries do not provide
equivalent fuel stability; and that ``even if an effective substitute
could be found, ASTM approval would likely take about six years.''
(EPA-HQ-OPPT-2019-0080-0533). Gold Eagle comments that an alternative
antioxidant must be evaluated using ASTM D525 Fuel Stability test
referenced in ASTM D4814, Standard Specification for Automotive Spark-
Ignition Engine Fuel, used to test refinery gasoline for compliance to
fuel specifications for automotive use.
    Overall, EPA considers these comments to have considerable merit.
EPA does not agree with Gold Eagle on the availability of substitute
antioxidants for use in fuel additive products; EPA has identified
alternative fuel additive products without 2,4,6-TTBP as an active
ingredient that are available and can be substituted for fuel additive
products with 2,4,6-TTBP that will be removed from the market (Ref. 3).
EPA therefore concludes that it is possible for Gold Eagle to
reformulate its products to remove the 2,4,6-TTBP component and replace
it with other antioxidants. However, EPA does agree with the assertion
that it will take time to develop new formulations for various product
lines, test them and obtain required approvals. Additionally, as a
predominant supplier, Gold Eagle has a complex supply network and
relationships with many other companies that supply its product, sell
it under other brand names, or endorse its use in their equipment; EPA
acknowledges that Gold Eagle's modifications to the formulation of its
product line may require it to engage with these customers and business
partners to assure them that its products provide similar performance,
a process that will also take time. EPA also agrees with the comment
that managing existing inventory will require time. Like other basic
automotive supplies, such as engine oil and windshield wiper fluid,
aftermarket fuel additive products are widely available nationally at
varied retail outlets, such as auto parts stores, hardware stores,
general retail outlets, gas stations and convenience stores. Unopened
product is stable and may be

stored for several years in the distribution system or on a store shelf
before final sale to customers. Products that are unsold as of the
compliance date would have to be pulled from the shelf and disposed of.
A sudden removal of product from the shelves might also create
temporary or spot shortages of fuel additives. Gold Eagle will also
incur costs, if it is required to cease sales of its fuel additive
products because it can replace them with reformulated products without
2,4,6-TTBP before the compliance date. If its products are off the
market for several years, sales losses could be significant.
    In consideration of these comments and the issues that they raise,
especially in regard to potential unquantified potential costs and
market disruption with provision of these needed products, EPA does not
believe it is practicable to implement this prohibition without a delay
in the compliance date. However, Gold Eagle expresses some uncertainty
about its six-year estimate and does not establish the reasoned basis
to support that a six-year estimate is ``as soon as practicable,''
compared to the five-year period estimated by SI Group. Therefore, EPA
is delaying the compliance date for the prohibition on distribution of
2,4,6-TTBP and products containing 2,4,6-TTBP in any container with a
volume of less than 35 gallons for any use, as well as processing and
distribution in commerce of 2,4,6-TTBP for use in oil and lubricant
additives and of 2,4,6-TTBP-containing oil and lubricant additives, for
five years, to give the producers of fuel additives containing 2,4,6-
TTBP sufficient time to reformulate their products, requalify them with
the necessary entities and clear non-compliant inventory from their
distribution chains.
    In this final rule, EPA is also establishing a new subpart E of 40
CFR 751 for TSCA section 6(h) PBT chemical provisions, including
general provisions at 40 CFR 751.401 as discussed in Unit II.F. of this
document, and definitions applicable to subpart E at 40 CFR 751.403.
Terms defined in 40 CFR 751.403 include article, product, and research
and development. These definitions are intended to respond to comments
requesting additional clarity on the regulatory provisions. (Note the
definitions of article and product are not used in 40 CFR 751.409.)
    EPA is requiring that distributors of 2,4,6-TTBP and products
containing 2,4,6-TTBP must maintain ordinary business records, such as
invoices and bills-of-lading, related to compliance with the
prohibitions and restrictions in this regulation. These records must be
maintained for a period of three years from the date the record is
generated. EPA revised this language slightly from the proposal to
improve clarity.

B. TSCA Section 6(c)(2) Considerations

    1. Health effects, exposure, and environmental effects.
    2,4,6-TTBP is toxic to aquatic plants, aquatic invertebrates, and
fish. Data indicate the potential for liver and developmental effects.
The studies presented in the Hazard Summary (Ref. 10) demonstrate these
hazardous endpoints. These hazard statements are not based on a
systematic review of the available literature and information may exist
that could refine the hazard characterization.
    Additional information about 2,4,6-TTBP health effects, use, and
exposure is in Unit II.C. and is further detailed in the Hazard Summary
(Ref. 10), and information on use and exposure is also in Unit II.C.
and is further detailed in EPA's Exposure and Use Assessment (Ref. 4).
    2. The value of the chemical substance or mixture for various uses.
    2,4,6-TTBP has value as a chemical intermediate in the production
of dialkylphenol chemicals. With respect to use as an antioxidant in
the general fuel supply, antioxidant additives are essential to the
storage and transport of fuel, as without them, fuel quickly begins to
degrade and form harmful sludge and varnish. The 2,4,6-TTBP mixtures
are the primary antioxidants used in aviation, marine, and automotive
fuel streams in the United States. Many current performance
specifications for fuel require their use, including for specialty
fuels for aviation and the military. Antioxidants are also an important
component in retail fuel additives and fuel injector cleaners, which
are used for engines maintenance. Similarly, antioxidants are also used
in oil and lubricants to prevent degradation of the product.
    3. The reasonably ascertainable economic consequences of the rule.
    i. Overview of cost methodology. EPA has evaluated the potential
costs of the final rule and primary alternative regulatory actions for
this chemical. Costs of the final rule were estimated based on the
assumption that under regulatory limitations on 2,4,6-TTBP,
manufactures and processors that use the regulated chemical would
switch to available alternative chemicals to manufacture the product,
or to products that do not contain the chemical. For 2,4,6-TTBP, costs
were assessed based on product substitutes where product information
was more substantial than information on chemical substitutes alone.
    Substitution costs were estimated on the industry level using the
price differential between the cost of the chemical and identified
substitutes. Costs for rule familiarization and recordkeeping were
estimated based on burdens estimated for other similar rulemakings.
Costs were annualized over a 25-year period. Other potential costs
include, but are not limited to, those associated with testing,
reformulation, imported articles, and some portion of potential revenue
loss. However, these costs are discussed only qualitatively, due to
lack of data availability to estimate quantified costs. More details of
this analysis are presented in the Economic Analysis (Ref. 3), which is
in the public docket for this action.
    ii. Estimated costs of this final rule. Total quantified annualized
industry costs for the final rule is $5.6 million at 3% discount rate
and $4.9 million at 7% discount rate annualized over 25 years. Total
annualized Agency costs associated with implementation of the final
rule were based on EPA's best judgment and experience with other
similar rules. For the final regulatory action, EPA estimates it will
require 0.5 FTE at $77,600 per year (Ref. 3).
    4. Benefits.
    As discussed in Unit II.A., while EPA reviewed hazard and exposure
information for the PBT chemicals, this information did not provide a
basis for EPA to develop scientifically robust and representative risk
estimates to evaluate whether or not any of the chemicals present a
risk of injury to health or the environment. Benefits were not
quantified due to the lack of risk estimates. A qualitative discussion
of the potential benefits associated with the proposed and alternative
actions for each chemical is provided. 2,4,6-TTBP is persistent and
bioaccumulative, and has been associated with liver toxicity and
reproductive and developmental effects in mammals. Under the final
regulatory action, 2,4,6-TTBP and products containing 2,4,6-TTBP at
concentrations above 0.3% would be prohibited for distribution in
containers less than 35 gallons and would be prohibited in processing
and distribution for use as an additive to oil/lubricants. Therefore,
the rule is expected to reduce the exposure to humans and the
environment, by reducing the potential for consumer exposures to 2,4,6-
TTBP and potential occupational exposure in certain industries, where
workers are unprotected, as well as potential releases to the
environment from

consumer and small commercial operations use.
    5. Cost effectiveness, and effect on national economy, small
business, and technological innovation.
    With respect to the cost effectiveness of the final regulatory
action and the primary alternative regulatory action, EPA is unable to
perform a traditional cost-effectiveness analysis of the actions and
alternatives for the PBT chemicals. As discussed in the proposed rule,
the cost effectiveness of a policy option would properly be calculated
by dividing the annualized costs of the option by a final outcome, such
as cancer cases avoided, or to intermediate outputs such as tons of
emissions of a pollutant curtailed. Without the supporting analyses for
a risk determination, EPA is unable to calculate either a health-based
or environment-based denominator. Thus, EPA is unable to perform a
quantitative cost-effectiveness analysis of the final and alternative
regulatory actions. However, by evaluating the practicability of the
final and alternative regulatory actions, EPA believes that it has
considered elements related to the cost effectiveness of the actions,
including the cost and the effect on exposure to the PBT chemicals of
the final and alternative regulatory actions.
    EPA considered the anticipated effect of this rule on the national
economy and concluded that this rule is highly unlikely to have any
measurable effect on the national economy (Ref. 3). EPA analyzed the
expected impacts on small business and found that no small entities are
expected to experience impacts of more than 1% of revenues (Ref. 3).
Finally, EPA has determined that this rule is unlikely to have
significant impacts on technological innovation.
    6. Consideration of alternatives.
    EPA conducted a screening level analysis of two possible
substitutes for 2,4,6-TTBP based on the TSCA Work Plan Chemicals:
Methods Document (Ref. 2). One alternative antioxidant suitable as a
fuel additive is 2,4-dimethyl-6-tert-butylphenol, CASRN 1879-09-0, and
the other is 2,6-di-tert-butyl-p-cresol, also known as butylated
hydroxytoluene or BHT, CASRN 128-37-0. Both chemicals have a lower
bioaccumulation potential than 2,4,6-TTBP, but equivalent or higher
scores for persistence, environmental hazard and human health hazard
(Ref. 11). EPA did not assess the hazard of the chemical mixtures in
commercial products containing 2,4,6-TTBP, nor did it assess the hazard
of substitute products that do not contain 2,4,6-TTBP, so no
conclusions as to the relative hazard of product substitutes can be
drawn.
    Based on a screening level analysis of likely alternatives, as
noted previously, EPA believes that there are readily available
substitutes for the retail fuel additives, as well as oil and lubricant
additives containing 2,4,6-TTBP. EPA believes that the overwhelming
predominance in the marketplace of oil and lubricant products that do
not contain 2,4,6-TTBP is itself sufficient evidence of the
availability of those substitute chemicals or products. While EPA did
not identify the specific alternative chemicals used in each product,
for the Economic Analysis (Ref. 3), EPA was able to determine 35
product substitutes exist for retail fuel stabilizer products and 15
product substitutes exist for retail fuel injector cleaner products
(for purposes of the analysis, product substitutes are considered those
that serve the same purpose but do not contain 2,4,6-TTBP).

C. TSCA Section 26(h) Considerations

    In accordance with TSCA section 26(h) and taking into account the
requirements of TSCA section 6(h), EPA has used scientific information,
technical procedures, measures, and methodologies that are fit for
purpose and consistent with the best available science. For example,
EPA based its determination that human and environmental exposures are
likely with 2,4,6-TTBP in the Exposure and Use Assessment (Ref. 4)
discussed in Unit II.A.2, which underwent a peer review and public
comment process, as well as using best available science and methods
sufficient, to make that determination. The extent to which the various
information, procedures, measures, and methodologies, as applicable,
used in EPA's decision making have been subjected to independent
verification or peer review is adequate to justify their use,
collectively, is in the record for this rule. Additional information on
the peer review and public comment process, such as the peer review
plan, the peer review report, and the Agency's Response to Comments
document, are in the public docket for this action (EPA-HQ-OPPT-2019-
0080). In addition, in accordance with TSCA section 26(i) and taking
into account the requirements of TSCA section 6(h), EPA has made
scientific decisions based on the weight of the scientific evidence.

IV. References

    The following is a list of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. All
records in docket EPA-HQ-OPPT-2019-0080 are part of the record for this
rulemaking. For assistance in locating these other documents, please
consult the technical person listed under FOR FURTHER INFORMATION
CONTACT.

1. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update.
October 2014. https://www.epa.gov/assessingand-managing-chemicals-under-tsca/tsca-work-plan-chemical-ssessments-2014-update. Accessed
March 1, 2019.
2. EPA. TSCA Work Plan Chemicals: Methods Document. https://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf. Accessed March 1, 2019.
3. EPA. Economic Analysis for Regulation of 2,4,6-Tris(tert-
butyl)phenol (2,4,6-TTBP) Under TSCA Section 6(h). December 2020.
4. EPA. Exposure and Use Assessment of Five Persistent,
Bioaccumulative, and Toxic Chemicals. December 2020.
5. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h); Response to Public Comments.
December 2020.
6. EPA. Public Database 2016 Chemical Data Reporting. Washington,
DC: US Environmental Protection Agency, Office of Pollution
Prevention and Toxics.
7. EPA. Preliminary Information on Manufacturing, Processing,
Distribution, Use, and Disposal: 2,4,6-TTBP. August 2017. (EPA-HQ-
OPPT-2016-0739-0003).
8. SI Group. Comments for the economic impact of 2,4,6-tri-tert-
butylphenol (2,4,6-TTBP); letter from Kevin M. Kransler to Doug
Parsons, EPA. December 21, 2018.
9. EPA. Afton Chemical conference call with U.S. EPA, regarding
2,4,6-TTBP chemical uses. July 28, 2017.
10. EPA. Environmental and Human Health Hazards of Five Persistent,
Bioaccumulative and Toxic Chemicals. December 2020.
11. EPA. Persistence, Bioaccumulation, Environmental Hazard and
Human Health Hazard Rating for Alternatives to PBT Chemicals
Proposed for Regulation. April 2019.
12. Keweenaw Bay Indian Community. Re: Notification of Consultation
and Coordination on a Rulemaking Under the Toxic Substances Control
Act: Regulation of Persistent, Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h). September 25, 2018.
13. Harper, Barbara and Ranco, Darren, in collaboration with the
Maine Tribes. Wabanaki Traditional Cultural Lifeways Exposure
Scenario. July 9, 2009.

V. Statutory and Executive Order Reviews

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

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

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review under Executive
Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011). Any changes made in response to OMB recommendations
have been documented in the docket for this action as required by
section 6(a)(3)(E) of Executive Order 12866.
    EPA prepared an economic analysis of the potential costs and
benefits associated with this action. A copy of this economic analysis
Economic Analysis for Regulation of 2,4,6-Tris(tert-butyl)phenol
(2,4,6-TTBP) Under TSCA Section 6(h) (Ref. 3) is in the docket and is
briefly summarized in Unit III.B.3.

B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs

    This action is considered a regulatory action under Executive Order
13771 (82 FR 9339, February 3, 2017). Details on the estimated costs of
this final rule can be found in the Economic Analysis (Ref. 3), which
is briefly summarized in Unit III.B.3.

C. Paperwork Reduction Act (PRA)

    The information collection activities in this rule have been
submitted for approval to the Office of Management and Budget (OMB)
under the PRA, 44 U.S.C. 3501 et seq. The Information Collection
Request (ICR) document that the EPA prepared has been assigned EPA ICR
number 2599.02 and OMB Control No. 2070-0213. A copy of the ICR is
available in the docket for this rule, and it is briefly summarized
here. The information collection requirements are not enforceable until
OMB approves them.
    Respondents/affected entities: Entities potentially affected by
paperwork requirements of this final rule include one manufacture and
nine processors.
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 10.
    Frequency of response: On occasion.
    Total estimated burden: Five hours (per year). Burden is defined at
5 CFR 1320.3(b).
    Total estimated cost: $393(per year), includes $0 annualized
capital or operation & maintenance costs.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves
this ICR, the Agency will announce that approval in the Federal
Register and publish a technical amendment to 40 CFR part 9 to display
the OMB control number for the approved information collection
activities contained in this final rule.

D. Regulatory Flexibility Act (RFA)

    This action will not have a significant economic impact on a
substantial number of small entities under the RFA, 5 U.S.C. 601 et
seq. The small entities subject to the requirements of this action are
small businesses that process, or distribute-in-commerce 2,4,6-TTBP. In
total, three small businesses are expected to be affected by the rule.
Of the small entities assessed, none (0%) are expected to incur impacts
of 1% (or greater) of their revenue. Because only three small
businesses are directly impacted and impacts are less than 1% for all
small entities, EPA presumes no significant economic impact on a
substantial number of small entities (no SISNOSE). Details of this
analysis are presented in the Economic Analysis (Ref. 3).

E. 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 would not
significantly or uniquely affect small governments. The final rule is
not expected to result in expenditures by State, local, and Tribal
governments, in the aggregate, or by the private sector, of $100
million or more (when adjusted annually for inflation) in any one year.
Accordingly, this final rule is not subject to the requirements of
sections 202, 203, or 205 of UMRA. The total quantified annualized
social costs for this final rule under are approximately $5.6 million
at a 3% discount rate and $4.9 million at a 7% discount rate, which
does not exceed the inflation-adjusted unfunded mandate threshold of
$160 million.

F. Executive Order 13132: Federalism

    This action does not have federalism implications because it is not
expected to 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 as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). Thus, Executive Order 13132 does not apply to this action.

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

    This action does not have tribal implications because it is not
expected to 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 as specified in Executive Order
13175 (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does
not apply to this final rule.
    Consistent with the EPA Policy on Consultation and Coordination
with Indian Tribes, the EPA consulted with tribal officials during the
development of this action. EPA consulted with representatives of
Tribes via teleconference on August 31, 2018, and September 6, 2018,
concerning the prospective regulation of the five PBT chemicals under
TSCA section 6(h). Tribal members were encouraged to provide additional
comments after the teleconferences. EPA received two comments from the
Keweenaw Bay Indian Community (Ref. 12) and Maine Tribes (Ref. 13).

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

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not an economically significant
regulatory action as defined by Executive Order 12866. Although the
action is not subject to Executive Order 13045, the Agency considered
the risks to infants and children under EPA's Policy on Evaluating
Health Risks to Children. EPA did not perform a risk assessment or risk
evaluation of 2,4,6-TTBP, however available data indicate the potential
for reproductive and developmental effects from 2,4,6-TTBP. More
information can be found in the Exposure and Use Assessment (Ref. 4)
and the ``Environmental and Human Health Hazards of Five Persistent,
Bioaccumulative and Toxic Chemicals'' (Ref. 10). This regulation will
reduce the exposure to 2,4,6-TTBP for the general population and for
susceptible subpopulations such as workers and children.

I. 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 the Office of Information and Regulatory Affairs
as a significant energy action. While this action regulates a fuel
additive, because the restrictions are limited to fuel additives
purchased and used by consumers, it will not significantly affect the
nation's fuel supply.

J. National Technology Transfer and Advancement Act (NTTAA)

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

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

    EPA believes that this action does not have disproportionately high
and adverse health or environmental effects on minority populations,
low-income populations and/or indigenous peoples, as specified in
Executive Order 12898 (59 FR 7629, February 16, 1994). The
documentation for this decision is contained in the Economic Analysis
(Ref. 3), which is in the public docket for this action.

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 751

    Environmental protection, Chemicals, Export Notification, Hazardous
substances, Import certification, Reporting and recordkeeping.

Andrew Wheeler,
Administrator.

    Therefore, for the reasons stated in the preamble, 40 CFR part 751
is amended as follows:

PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT

0
1. The authority citation for part 751 continues to read as follows:

    Authority:  15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).

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2. Add and reserve subpart D.

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3. Add subpart E, consisting of Sec. Sec.  751.401 through 751.413, to
read as follows:

Subpart E--Persistent, Bioaccumulative, and Toxic Chemicals

Sec.
751.401 General.
751.403 Definitions.
751.405 [Reserved].
751.407 [Reserved].
751.409 2,4,6-TTBP.
751.411 [Reserved].
751.413 [Reserved].

Sec.  751.401   General.

    (a) This subpart establishes prohibitions and restrictions on the
manufacturing, processing, and distribution in commerce of persistent,
bioaccumulative, and toxic chemicals in accordance with TSCA section
6(h), 15 U.S.C 2605(h).
    (b) Unless otherwise specified in this subpart, prohibitions and
restrictions of this subpart do not apply to the following activities:
    (1) Distribution in commerce of any chemical substance, or any
product or article that contains the chemical substance, that has
previously been sold or supplied to an end user, i.e., any person that
purchased or acquired the finished good for purposes other than resale.
An example of an end user is a consumer who resells a product they no
longer intend to use or who donates an article to charity.
    (2) Disposal of any chemical substance, or any product or article
that contains the chemical substance, as well as importation,
processing and distribution in commerce of any chemical substance or
any product or article that contains the chemical substance for
purposes of disposal.
    (3) Manufacturing, processing, distribution in commerce, and use of
any chemical substance, or any product or article that contains the
chemical substance, for research and development, as defined in Sec.
751.403.

Sec.  751.403   Definitions.

    The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section.
    2,4,6-TTBP means the chemical substance 2,4,6-tris(tert-
butyl)phenol (CASRN 732-26-3).
    2,4,6-TTBP oil and lubricant additives means any 2,4,6-TTBP-
containing additive to a product of any viscosity intended to reduce
friction between moving parts, whether mineral oil or synthetic base,
including engine crankcase and gear oils and bearing greases. 2,4,6-
TTBP oil and lubricant additive does not include hydraulic fluid and
other oils whose primary purpose is not friction reduction.
    Article means a manufactured item:
    (1) Which is formed to a specific shape or design during
manufacture,
    (2) Which has end use function(s) dependent in whole or in part
upon its shape or design during end use, and
    (3) Which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article, and that result from a
chemical reaction that occurs upon end use of other chemical
substances, mixtures, or articles; except that fluids and particles are
not considered articles regardless of shape or design.
    Product means the chemical substance, a mixture containing the
chemical substance, or any object that contains the chemical substance
or mixture containing the chemical substance that is not an article.
    Research and Development means laboratory and research use only for
purposes of scientific experimentation or analysis, or chemical
research on, or analysis of, the chemical substance, including methods
for disposal, but not for research or analysis for the development of a
new product, or refinement of an existing product that contains the
chemical substance.

Sec.  751.405   Reserved]

Sec.  751.407   Reserved]

Sec.  751.409   2,4,6-TTBP.

    (a) Prohibitions. (1) After January 6, 2026, all persons are
prohibited from all distribution in commerce of 2,4,6-TTBP, at any
concentration above 0.3 percent by weight, in containers with a volume
less than 35 gallons.
    (2) After January 6, 2026, all persons are prohibited from all
processing and distribution in commerce of 2,4,6-TTBP oil and lubricant
additives at any concentration above 0.3 percent by weight.
    (b) Recordkeeping. After January 6, 2026, distributors of 2,4,6-
TTBP must maintain ordinary business records, such as invoices and
bills-of-lading, related to compliance with the

prohibitions, restrictions, and other provisions of this section. These
records must be maintained for a period of three years from the date
the record is generated.

Sec.  751.411   [Reserved]

Sec.  751.413   [Reserved]

[FR Doc. 2020-28690 Filed 1-5-21; 8:45 am]
BILLING CODE 6560-50-P