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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 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 identification of every condition of use.
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 Ref. 4 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 Ref. 4. 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
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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.
Taking all of 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, manufacturing, processing, and distribution in commerce activities that are not specifically excluded are prohibited. The specified excluded activities are those which EPA
determined were not appropriate to regulate under TSCA section 6h4
standard. Consistently, based on the Exposure and Use Assessment, activities associated with PCTP are that are no longer occurring are addressed by this rule and thus the prohibitions adopted in this rule reduce 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 final rule is limited to implementation of TSCA section 6h and is not relevant to any other action under TSCA section 6 or other TSCA
statutory actions.

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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 certain other provisions in TSCA
section 6, such as TSCA section 6c2A, 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 6c2B, in selecting the appropriate TSCA section 6a regulatory approach, 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. EPAs interpretation of an ambiguous statutory term receives deference. More discussion on these comments can be found in the Response to Comments document for this rulemaking Ref. 4.
3. EPA did not conduct a risk evaluation or 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 6h2
which makes clear risk evaluation is not required to support this rulemaking.
EPA received comments on the proposed rule regarding its interpretation of TSCA section 6h4
and regarding EPAs lack of risk assessment or risk evaluation of PCTP.
A number of commenters asserted that while EPA was not compelled to conduct a risk evaluation, EPA should have conducted a risk evaluation under TSCA section 6b 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
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