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RULE
2,4,6-TRIS(TERT-BUTYL)PHENOL (2,4,6-TTBP); REGULATION OF PERSISTENT,
BIOACCUMULATIVE, AND TOXIC CHEMICALS UNDER TSCA SECTION 6(H)
A Rule by the Environmental Protection Agency on 01/06/2021
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DOCUMENT DETAILS
Information about this document as published in the Federal Register.
Printed version: PDF Publication Date: 01/06/2021 Agency: Environmental
Protection Agency 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. Effective Date: 02/05/2021 Document Type:
Rule Document Citation: 86 FR 866 Page: 866-880 (15 pages) CFR: 40 CFR 751
Agency/Docket Numbers: EPA-HQ-OPPT-2019-0080 FRL-10018-90 RIN: 2070-AK59
Document Number: 2020-28690
DOCUMENT DETAILS
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PUBLISHED DOCUMENT
* ENHANCED CONTENT - TABLE OF CONTENTS
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within the legal text of Federal Register documents. This repetition of
headings to form internal navigation links has no substantive legal effect.
* AGENCY:
* ACTION:
* SUMMARY:
* DATES:
* ADDRESSES:
* FOR FURTHER INFORMATION CONTACT:
* SUPPLEMENTARY INFORMATION:
* I. Executive Summary
* A. Does this action apply to me?
* B. What is the Agency's authority for taking this action?
* C. What action is the Agency taking?
* D. Why is the Agency taking this action?
* E. What are the estimated incremental impacts of this action?
* F. Children's Environmental Health
* II. Background
* A. History of This Rulemaking: TSCA Sections 6(h) and the TSCA Work Plan
* B. Other Provisions of TSCA Section 6
* C. 2,4,6-TTBP Overview, Health Effects and Exposure
* D. EPA's Proposed Rule Under TSCA Section 6(h) for 2,4,6-TTBP
* E. Public Comments and Other Public Input
* F. Activities Not Directly Regulated by This Rule
* III. Provisions of This Final Rule
* A. Scope and Applicability
* B. TSCA Section 6(c)(2) Considerations
* C. TSCA Section 26(h) Considerations
* IV. References
* V. Statutory and Executive Order Reviews
* A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
* B. Executive Order 13771: Reducing Regulation and Controlling Regulatory
Costs
* C. Paperwork Reduction Act (PRA)
* D. Regulatory Flexibility Act (RFA)
* E. Unfunded Mandates Reform Act (UMRA)
* F. Executive Order 13132: Federalism
* G. Executive Order 13175: Consultation and Coordination With Indian Tribal
Governments
* H. Executive Order 13045: Protection of Children From Environmental Health
and Safety Risks
* I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
* J. National Technology Transfer and Advancement Act (NTTAA)
* K. Executive Order 12898: Federal Actions To Address Environmental Justice
in Minority Populations and Low-Income Populations
* L. Congressional Review Act (CRA)
* List of Subjects in 40 CFR Part 751
* PART 751—REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES UNDER
SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
* Subpart E—Persistent, Bioaccumulative, and Toxic Chemicals
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PUBLIC INSPECTION
PUBLISHED DOCUMENT
This document has been published in the Federal Register. Use the PDF linked in
the document sidebar for the official electronic format.
Start Preamble Start Printed Page 866
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
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.
Start Further Info
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.
End Further Info End Preamble Start Supplemental Information
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 Start
Printed Page 867chemicals 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 Start Printed Page 868the 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 Start Printed Page 869section 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 Start Printed Page
870and 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 × 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® 133 and Ethanox® 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 Start Printed Page 871used 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 Start Printed
Page 872fuel 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 Start Printed Page 873500 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 Start Printed Page 874process 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).Start
Printed 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 Start Printed Page 876stored 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
Start Printed Page 877consumer 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.
Start Printed 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.Start Printed 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).
Start List of Subjects
LIST OF SUBJECTS IN 40 CFR PART 751
* Environmental protection
* Chemicals
* Export Notification
* Hazardous substances
* Import certification
* Reporting and recordkeeping
End List of Subjects Start Signature
Andrew Wheeler,
Administrator.
End Signature
Therefore, for the reasons stated in the preamble, 40 CFR part 751 is amended as
follows:
Start Part
PART 751—REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES UNDER SECTION 6
OF THE TOXIC SUBSTANCES CONTROL ACT
End Part Start Amendment Part
1. The authority citation for part 751 continues to read as follows:
End Amendment Part Start Authority
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
End Authority Start Amendment Part
2. Add and reserve subpart D.
End Amendment Part Start Amendment Part
3. Add subpart E, consisting of §§ 751.401 through 751.413, to read as follows:
End Amendment Part
SUBPART E—PERSISTENT, BIOACCUMULATIVE, AND TOXIC CHEMICALS
751.401 General. 751.403 Definitions. 751.405 [Reserved]. 751.407 [Reserved].
751.409 2,4,6-TTBP. 751.411 [Reserved]. 751.413 [Reserved].
§ 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 § 751.403.
§ 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.
§ 751.405
Reserved]
§ 751.407
Reserved]
§ 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 Start Printed Page 880prohibitions, 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.
§ 751.411
[Reserved]
§ 751.413
[Reserved]
End Supplemental Information
[FR Doc. 2020-28690 Filed 1-5-21; 8:45 am]
BILLING CODE 6560-50-P
PUBLISHED DOCUMENT
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