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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
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 that 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 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
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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. More discussion on the issue raised is in the Response to Comments document Ref.
4.
4. Replacement parts and articles.
In the preamble to the proposed rule, EPA explained that it did not read provisions of TSCA that conflict with TSCA section 6h to apply to TSCA
section 6h rules. Specifically, TSCA
sections 6c2D and E require a risk finding pursuant to a TSCA section 6b risk evaluation to regulate replacement parts and articles. Yet, TSCA section 6h neither compels nor contemplates a risk evaluation to precede or support the compelled regulatory action to address the risks. . . and reduce exposures to the substance to the extent practicable.
TSCA section 6h2 makes clear no risk evaluation is required, and the timing required for conducting a risk
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evaluation is not consistent with the timing compelled for issuance of a proposed rule under TSCA section 6h.
Moreover, even assuming a prior risk assessment might allow a risk determination under the TSCA section 6h4 address risk standard, such assessment would still not satisfy the requirement in TSCA section 6c2D
and E for a risk finding pursuant to a TSCA section 6b risk evaluation.
Because of the clear conflict between these provisions, EPA determined that those provisions of TSCA section 6c that assume the existence of a TSCA
section 6b risk evaluation do not apply in the context of this TSCA section 6h rulemaking. Instead, EPA resolves this conflict in these provisions by taking into account the TSCA section 6c considerations in its determinations as to what measures reduce exposure to the substance to the extent practicable.
Commenters contended that TSCA
section 6c2D and E bar a TSCA
section 6h rule in the absence of a risk evaluation, representing Congresss recognition of the special burdens associated with regulating replacement parts and articles and the difficulty importers face in knowing what chemicals are present in the articles they import. As noted earlier in this Unit and further discussed in the Response to Comment document, while EPA determined that provisions of TSCA section 6c2D and E do not apply because they conflict with the requirements of TSCA section 6h, EPA
interpreted the practicability standard in TSCA section 6h4 to reasonably contemplate the considerations embodied by TSCA section 6c2D
and E. As a result, EPA disagrees with any suggestions that the clear conflict between Congress mandates in TSCA
section 6h and TSCA section 6c2D
and E must be read to bar regulation of replacement parts and articles made with chemicals that Congress believed were worthy of expedited action under TSCA section 6h and in the absence of a risk evaluation. The statute does not clearly communicate that outcome.
Instead, Congress left ambiguous how best to address the conflict in these provisions, and EPAs approach for taking into consideration the TSCA
section 6c2D and E concepts in its TSCA section 6h4 practicability determinations is a reasonable approach. In addition, with respect to comments that TSCA section 6c2D
and E were intended to address Congresss concerns regarding burdens associated with regulation of replacement parts and articles, EPA
agrees that these concerns are relevant
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