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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations consumer and small commercial operations use.
5. Cost effectiveness, and effect on national economy, small business, and technological innovation.
With respect to the cost effectiveness of the final regulatory action and the primary alternative regulatory action, EPA is unable to perform a traditional cost-effectiveness analysis of the actions and alternatives for the PBT chemicals.
As discussed in the proposed rule, the cost effectiveness of a policy option would properly be calculated by dividing the annualized costs of the option by a final outcome, such as cancer cases avoided, or to intermediate outputs such as tons of emissions of a pollutant curtailed. Without the supporting analyses for a risk determination, EPA is unable to calculate either a health-based or environment-based denominator. Thus, EPA is unable to perform a quantitative cost-effectiveness analysis of the final and alternative regulatory actions.
However, by evaluating the practicability of the final and alternative regulatory actions, EPA believes that it has considered elements related to the cost effectiveness of the actions, including the cost and the effect on exposure to the PBT chemicals of the final and alternative regulatory actions.
EPA considered the anticipated effect of this rule on the national economy and concluded that this rule is highly unlikely to have any measurable effect on the national economy Ref. 3. EPA
analyzed the expected impacts on small business and found that no small entities are expected to experience impacts of more than 1% of revenues Ref. 3. Finally, EPA has determined that this rule is unlikely to have significant impacts on technological innovation.
6. Consideration of alternatives.
EPA conducted a screening level analysis of two possible substitutes for 2,4,6-TTBP based on the TSCA Work Plan Chemicals: Methods Document Ref. 2. One alternative antioxidant suitable as a fuel additive is 2,4dimethyl-6-tert-butylphenol, CASRN
1879090, and the other is 2,6-di-tertbutyl-p-cresol, also known as butylated hydroxytoluene or BHT, CASRN 128
370. Both chemicals have a lower bioaccumulation potential than 2,4,6TTBP, but equivalent or higher scores for persistence, environmental hazard and human health hazard Ref. 11. EPA
did not assess the hazard of the chemical mixtures in commercial products containing 2,4,6-TTBP, nor did it assess the hazard of substitute products that do not contain 2,4,6TTBP, so no conclusions as to the
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relative hazard of product substitutes can be drawn.
Based on a screening level analysis of likely alternatives, as noted previously, EPA believes that there are readily available substitutes for the retail fuel additives, as well as oil and lubricant additives containing 2,4,6-TTBP. EPA
believes that the overwhelming predominance in the marketplace of oil and lubricant products that do not contain 2,4,6-TTBP is itself sufficient evidence of the availability of those substitute chemicals or products. While EPA did not identify the specific alternative chemicals used in each product, for the Economic Analysis Ref.
3, EPA was able to determine 35
product substitutes exist for retail fuel stabilizer products and 15 product substitutes exist for retail fuel injector cleaner products for purposes of the analysis, product substitutes are considered those that serve the same purpose but do not contain 2,4,6-TTBP.
C. TSCA Section 26h Considerations In accordance with TSCA section 26h and taking into account the requirements of TSCA section 6h, EPA
has used scientific information, technical procedures, measures, and methodologies that are fit for purpose and consistent with the best available science. For example, EPA based its determination that human and environmental exposures are likely with 2,4,6-TTBP in the Exposure and Use Assessment Ref. 4 discussed in Unit II.A.2, which underwent a peer review and public comment process, as well as using best available science and methods sufficient, to make that determination. The extent to which the various information, procedures, measures, and methodologies, as applicable, used in EPAs decision making have been subjected to independent verification or peer review is adequate to justify their use, collectively, is in the record for this rule. Additional information on the peer review and public comment process, such as the peer review plan, the peer review report, and the Agencys Response to Comments document, are in the public docket for this action EPAHQOPPT20190080. In addition, in accordance with TSCA
section 26i and taking into account the requirements of TSCA section 6h, EPA
has made scientific decisions based on the weight of the scientific evidence.
IV. References The following is a list of the documents that are specifically referenced in this document. The docket includes these documents and other
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information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. All records in docket EPA
HQOPPT20190080 are part of the record for this rulemaking. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
1. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update. October 2014. https www.epa.gov/assessingandmanaging-chemicals-under-tsca/tscawork-plan-chemical-ssessments-2014update. Accessed March 1, 2019.
2. EPA. TSCA Work Plan Chemicals:
Methods Document. https
www.epa.gov/sites/production/files/
2014-03/documents/work_plan_
methods_document_web_final.pdf.
Accessed March 1, 2019.
3. EPA. Economic Analysis for Regulation of 2,4,6-Tristert-butylphenol 2,4,6-TTBP
Under TSCA Section 6h. December 2020.
4. EPA. Exposure and Use Assessment of Five Persistent, Bioaccumulative, and Toxic Chemicals. December 2020.
5. EPA. Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6h; Response to Public Comments. December 2020.
6. EPA. Public Database 2016 Chemical Data Reporting. Washington, DC: US
Environmental Protection Agency, Office of Pollution Prevention and Toxics.
7. EPA. Preliminary Information on Manufacturing, Processing, Distribution, Use, and Disposal: 2,4,6-TTBP. August 2017. EPAHQOPPT20160739
0003.
8. SI Group. Comments for the economic impact of 2,4,6-tri-tert-butylphenol 2,4,6-TTBP; letter from Kevin M.
Kransler to Doug Parsons, EPA.
December 21, 2018.
9. EPA. Afton Chemical conference call with U.S. EPA, regarding 2,4,6-TTBP chemical uses. July 28, 2017.
10. EPA. Environmental and Human Health Hazards of Five Persistent, Bioaccumulative and Toxic Chemicals.
December 2020.
11. EPA. Persistence, Bioaccumulation, Environmental Hazard and Human Health Hazard Rating for Alternatives to PBT Chemicals Proposed for Regulation.
April 2019.
12. Keweenaw Bay Indian Community. Re:
Notification of Consultation and Coordination on a Rulemaking Under the Toxic Substances Control Act:
Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6h. September 25, 2018.
13. Harper, Barbara and Ranco, Darren, in collaboration with the Maine Tribes.
Wabanaki Traditional Cultural Lifeways Exposure Scenario. July 9, 2009.

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