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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
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Economic Analysis for Regulation of Phenol, Isopropylated Phosphate 3:1
PIP 3:1 under TSCA section 6h Economic Analysis Ref. 3, is available in the docket and is briefly summarized here.
Benefits. EPA was not able to quantify the benefits of reducing human and environmental exposures to PIP
3:1. As discussed in more detail in Unit II.A., EPA did not perform a risk evaluation for PIP 3:1, nor did EPA
develop quantitative risk estimates.
Therefore, the Economic Analysis Ref.
3 qualitatively discusses the benefits of reducing exposure under the final rule for PIP 3:1, as summarized in Unit III.B.2.
Costs. Total quantified annualized social costs for this final rule are approximately $23.8 million at a 3%
discount rates, and $23.0 million at a 7% discount rate. Potential unquantified costs are those associated with testing, reformulation, importation of articles, foregone profits, and indirect costs. The limited data available for those costs prevents EPA from constructing a quantitative assessment.
Small entity impacts. This final rule will impact approximately four small businesses of which none are expected to incur cost impacts of 1% or greater of their revenue.
Environmental Justice. This final rule will increase the level of protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population or children.
Effects on State, local, and Tribal governments. This final rule does not have any significant or unique effects on small governments, or federalism or tribal implications.
F. Childrens Environmental Health Executive Order 13045 applies if the regulatory action is economically significant and concerns an environmental health risk or safety risk that may disproportionately affect children. While the action is not subject to Executive Order 13045, the Agencys Policy on Evaluating Health Risks to Children https www.epa.gov/
children/epas-policy-evaluating-riskchildren is to consider the risks to infants and children consistently and explicitly during its decision making process. This final rule will reduce the exposures to PIP 3:1 that could occur from activities now prohibited under this final rule for the general population and for potentially exposed or susceptible subpopulations such as children. More information can be
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found in the Exposure and Use Assessment Ref. 4.
II. Background A. History of This Rulemaking TSCA section 6h requires EPA to take expedited regulatory action under TSCA section 6a for certain PBT
chemicals identified in the 2014 Update to the TSCA Work Plan for Chemical Assessments Ref. 1. As required by the statute, EPA issued a proposed rule to address five persistent, bioaccumulative, and toxic PBT
chemicals identified pursuant to TSCA
section 6h 84 FR 36728 July 29, 2019. The statute required that this be followed by promulgation of a final rule no later than 18 months after the proposal. While EPA proposed regulatory actions on each chemical substance in one proposal, in response to public comments EPAHQOPPT
201900800544, EPAHQOPPT
201900800553, EPAHQOPPT
201900800556, EPAHQOPPT
201900800562 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. The details of the proposal for PIP 3:1 are described in more detail in Unit II.D.
Under TSCA section 6h1A, 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
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or susceptible subpopulation identified by the Administrator such as infants, children, pregnant women, workers, including occupational nonusers, consumers, or the elderly, or to the environment on the basis of an exposure and use assessment conducted by the Administrator. TSCA section 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 PIP
3:1 is one of these five chemical substances. In addition, and 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 PIP 3:1. As described in the proposed rule, EPA conducted a review of available literature with respect to PIP 3:1 to identify, screen, extract, and evaluate 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. 4. Based on this review, which was subject to peer review and public comment, EPA proposed to find that exposure to PIP 3:1 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
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