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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 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 if found likely pursuant to TSCA section 6h1B.
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, manufacturing, processing, and distribution in commerce activities that are not specifically excluded are
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prohibited. The specified activities with particular exclusions are those which EPA determined were not appropriate to regulate under the TSCA section 6h4
standard. Consistently, based on the Exposure and Use Assessment, activities associated with decaBDE that may no longer be occurring, such as domestic manufacture of the chemical substance or production of plastic enclosure for electronics, 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.
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 is in the Response to Comments document for this rulemaking Ref. 5.
3. EPA did not conduct a risk evaluation or 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
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gives the Administrator the flexibility Congress intended for issuance of expedited rules for PBTs and is consistent with TSCA section 6h2
which makes clear a 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 decaBDE. 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 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 6c2 requirement for a statement of these considerations.
Regarding the contradiction between the mandate in TSCA section 6h 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.
EPA disagrees with the commenters interpretation of EPAs obligations with respect to chemicals subject to TSCA
section 6h4. TSCA section 6h4
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 6a rule might be issued. EPA
does not believe that TSCA section 6h contemplates a new evaluation of any kind, given that evaluations to determine risks are now addressed through the TSCA section 6b risk evaluation process and that TSCA
section 6h2 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 6h1. Although EPA does not believe the statute contemplates a new
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