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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
what is manufactured is destroyed via incineration by the manufacturer. A
small percentage of the HCBD is sent off-site for burning as a waste fuel by cement manufacturers.
3. The reasonably ascertainable economic consequences of the rule.
a. Overview of cost methodology.
EPA has evaluated the potential costs of the final action for HCBD. Costs of the final rule were estimated based on the assumption that under regulatory limitations on HCBD, processors that use HCBD in their products would switch to available alternative chemicals to manufacture the product, or to products that do not contain HCBD.
Costs for rule familiarization and recordkeeping were estimated based on burdens estimated for other similar rulemakings. Costs were annualized over a 25-year period. Other potential costs include, but are not limited to, those associated with testing, reformulation, imported articles, and some portion of potential revenue loss.
However, these costs are discussed only qualitatively, due to lack of data availability to estimate quantified costs.
More details of this analysis are presented in the Economic Analysis Ref. 3.
b. Estimated costs of this final rule.
Total quantified annualized industry costs for the final rule is $354. Total annualized Agency costs associated with implementation of the final rule were based on EPAs best judgment and experience with other similar rules. For the final regulatory action, EPA
estimates it will require 0.5 FTE at $77,576 per year Ref. 3.
Total quantified annualized social costs for the final rule are estimated to be $77,930 at both 3% and 7% discount rates annualized over 25 years. As described earlier in Unit III.B.3, potential costs such as testing, reformulation, and imported articles, could not be quantified due to lack of data availability to estimate quantified costs. These costs are discussed qualitatively in the Economic Analysis Ref. 3.
c. Benefits.
As discussed in Unit II., although EPA
reviewed hazard and exposure information for the PBT chemicals, this information did not provide a basis for EPA to develop scientifically robust and representative risk estimates to evaluate whether or not any of the chemicals present a risk of injury to health or the environment. Benefits were not quantified due to the lack of risk estimates. A qualitative discussion of the potential benefits associated with the final action for HCBD is provided.
HCBD is persistent, bioaccumulative,
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and a possible human carcinogen. It is not intentionally manufactured in the United States. Since EPA is effectively excluding from prohibition all current activities involving HCBD as a byproduct, no benefits to human health or the environment are expected; the benefit is the prevention of individuals from being occupationally exposed to HCBD via the inhalation and dermal routes in the future. The toxicity of potential substitutes for HCBD has not been assessed at this time.
d. 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.
4. Consideration of alternatives.
EPA has not identified any uses of HCBD. Therefore, chemical alternatives were not considered.
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
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methodologies that are fit for purpose and consistent with the best available science. For example, EPA based its determination that human and environmental exposures to the HCBD
byproduct are likely in the Exposure and Use Assessment Ref. 5 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 subject to independent verification or peer review is adequate to justify their use, collectively, in the record for this final 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, are in the public docket for this action EPAHQOPPT
20190080. 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 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. February 2012.
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 Hexachlorobutadiene HCBD Under TSCA Section 6h. December 2020.
4. EPA. Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6h. Response to Public Comments. December 2020.
Docket EPAHQOPPT20190080.

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