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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations regulate under the TSCA section 6h4
standard. Consistently, based on the Exposure and Use Assessment, activities associated with HCBD 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.
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. 4.
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 gives the Administrator the flexibility Congress intended for issuance of expedited rules for PBTs and is consistent with TSCA section 6h2,
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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 HCBD.
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 stated 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 the TSCA section 6h contemplates a new evaluation of any kind, given evaluations to determine risks are now addressed through the TSCA section 6b risk evaluation process and 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 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
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criteria of TSCA section 6h1A 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 6h4 to contemplate reliance on an existing EPA assessment under TSCA, similar to a risk assessment that may be permissibly used under TSCA
section 26l4 to regulate the chemical under TSCA section 6a. This interpretation gives meaning to the address risk phrase, without compelling an evaluation contrary to TSCA section 6h2 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 6h. 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 6h4 by reducing exposures of each PBT chemical to the extent practicable.
For similar reasons, EPA does not believe that TSCA section 6c2
requires a quantification of benefits, much less a specific kind of quantification. Under TSCA section 6c2Aiv, 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 raised in the
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