Federal Register - January 6, 2021

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Source: Federal Register

Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations chemicals EPA identified pursuant to TSCA section 6h 84 FR 36728; FRL
999576. After publication of the proposed rule, EPA determined to address the five PBT chemicals in separate final actions. This final rule prohibits the distribution in commerce of 2,4,6-TTBP and products containing 2,4,6-TTBP at concentrations above 0.3% i.e., present as a functional additive instead of as impurity in any container with a volume of less than 35
gallons for any use, beginning on January 6, 2026, in order to effectively prevent the use of 2,4,6-TTBP as a fuel additive or fuel injector cleaner by consumers and small commercial operations e.g., automotive repair shops, marinas. This final rule also prohibits the processing and distribution in commerce of 2,4,6-TTBP, and products containing 2,4,6-TTBP at concentrations above 0.3%, for use as an oil or lubricant additive, regardless of container size, beginning on January 6, 2026. Beginning on January 6, 2026, affected persons are required to maintain, for three years from the date the record is generated, ordinary business records related to compliance with these restrictions. For this specific chemical, ordinary business records that include the name of the purchaser and the sizes of the containers supplied would be sufficient. This provision is not intended to require subject companies to retain records in addition to those specified herein, except as needed pursuant to normal business operations.
D. Why is the Agency taking this action?
EPA is issuing this final rule to fulfill EPAs obligations under TSCA section 6h to take timely regulatory action on PBT chemicalsspecifically, to address the risks of injury to health or the environment that the Administrator determines are presented by the chemical substance and to reduce exposure to the substance to the extent practicable. Consistent with that requirement, the Agency is finalizing this rule to reduce exposures to 2,4,6TTBP to the extent practicable.

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E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs of these final restrictions and prohibitions and the associated reporting and recordkeeping requirements. The Economic Analysis for Final Regulation of 2,4,6-Tristertbutylphenol 2,4,6-TTBP Under TSCA
Section 6h Economic Analysis Ref.
3 is available in the docket and is briefly summarized here.

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Benefits. EPA was not able to quantify the benefits of reducing the potential for human and environmental exposures to 2,4,6-TTBP. As discussed in more detail in Unit II.A., EPA did not perform risk evaluations for 2,4,6-TTBP, nor did EPA develop quantitative risk estimates. Therefore, the Economic Analysis Ref. 3 qualitatively discusses the benefits of reducing the exposure under the final action and the primary alternative regulatory action for 2,4,6TTBP.
Costs. Total quantified annualized social costs for this final rule are approximately $5.6 million at a 3%
discount rate and $4.9 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 rule will impact approximately three small businesses of which none are expected to incur cost impacts of 1% or greater of their revenue.
Environmental Justice. This 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 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. This final rule is not subject to Executive Order 13045 because it is not an economically significant regulatory action as defined by Executive Order 12866. 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 regulation will reduce the exposure that could occur from activities now prohibited under this final rule to 2,4,6-TTBP 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
Sections 6h and the TSCA Work Plan 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 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 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 Ref. 5. The details of the proposal for 2,4,6-TTBP
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 or susceptible subpopulation identified by the Administrator such as infants, children, pregnant women, workers, or the elderly, or to the environment on
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Federal Register - January 6, 2021

TitreFederal Register

PaysÉtats-Unis

Date06/01/2021

Page count522

Edition count7799

Première édition14/03/1936

Dernière édition22/06/2026

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