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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
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00800562 requesting these five actions be separated, EPA is finalizing five separate actions to individually address each of the PBT chemicals. EPA intends for the five separate final rules to publish in the same issue of the Federal Register. More discussion on these comments is in the Response to Comments document which is available in the docket Ref. 4. The details of the proposal for HCBD are described in more detail in Unit II.D.
Under TSCA section 6h1A, the chemical substances subject to expedited action are those that:
EPA has a reasonable basis to conclude are toxic and that with respect to persistence and bioaccumulation score high for one and either high or moderate for the other, pursuant to the 2012 TSCA Work Plan Chemicals:
Methods Document or a successor scoring system;
Are not a metal or a metal compound; and Are chemical substances for which EPA has not completed a TSCA Work Plan Problem Formulation, initiated a review under TSCA section 5, or entered into a consent agreement under TSCA section 4, prior to June 22, 2016, the date that TSCA was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act Pub. L. 114182, 130 Stat. 448.
In addition, in order for a chemical substance to be subject to expedited action, TSCA section 6h1B states that EPA must find that exposure to the chemical substance under the conditions of use is likely to the general population or to a potentially exposed or susceptible subpopulation identified by the Administrator such as infants, children, pregnant women, workers, or the elderly, or to the environment on the basis of an exposure and use assessment conducted by the Administrator. TSCA sections 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 HCBD
is one of these five chemical substances.
In addition, 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 HCBD. As described in the proposed rule, EPA conducted a
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literature review with respect to HCBD
to identify, screen, extract, and evaluate the 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. 5. Based on this review, which was subject to peer review and public comment, EPA proposed to find that exposure to HCBD 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 final 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 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,
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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.
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
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