[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Rules and Regulations]
[Pages 866-880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28690]



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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: gimlin.peter@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. 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

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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

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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

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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

[[Page 870]]

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

[[Page 871]]

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

[[Page 872]]

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

[[Page 873]]

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

[[Page 874]]

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).

[[Page 875]]

    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

[[Page 876]]

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

[[Page 877]]

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.

[[Page 878]]

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.

[[Page 879]]

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).

0
2. Add and reserve subpart D.

0
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

[[Page 880]]

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


