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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
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the basis of an exposure and use assessment conducted by the Administrator. TSCA section 6h2
further provides that the Administrator shall not be required to conduct risk evaluations on chemical substances that are subject to TSCA section 6h1.
Based on the criteria set forth in TSCA section 6h, EPA proposed to determine that five chemical substances meet the TSCA section 6h1A
criteria for expedited action, and 2,4,6TTBP 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. EPAs approach for implementing TSCA section 6h4.
TSCA section 6h4 requires EPA to issue a TSCA section 6a 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 6h4 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 6h in the context of the TSCA
section 6h1B 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 6b, this TSCA section 6h1B
threshold criterion is triggered only through an Exposure and Use Assessment regarding the likelihood of exposure and does not require
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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 6h1B
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 6h1B finding for all chemical activities summarized in the Exposure and Use Assessment. Second, TSCA
section 6 generally requires a risk evaluation under TSCA section 6b for chemicals based on the identified conditions of use. However, pursuant to TSCA section 6h2, for chemical substances that meet the criteria of TSCA section 6h1, a risk evaluation is neither required nor contemplated to be conducted for EPA to meet its obligations under TSCA section 6h4.
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 6h4, 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 6h4
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 34. 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 6b 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 6h1B.

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Taking this into account, EPA reads its TSCA section 6h4 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 34 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 6h 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 2,4,6TTBP and products containing 2,4,6TTBP in any container with a volume of less than 35 gallons for any use, as well as processing and distribution of 2,4,6TTBP and products containing 2,4,6TTBP 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 6h and is not relevant to any other action under TSCA section 6 or other statutory actions.
2. EPAs 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, EPAs approach to determining whether particular prohibitions or restrictions are practicable is informed in part by a consideration of certain other provisions in TSCA section 6, such as TSCA

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