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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations information about PIP 3:1 health effects, use, and exposure is in Unit II.C.
and is further detailed in EPAs Hazard Summary Ref. 8 and Exposure and Use Assessment Ref. 4.
2. The benefits of the chemical substance or mixture for various uses.
PIP 3:1 has multiple functional uses, including as a plasticizer, flame retardant, anti-wear additive, or as an anti-compressibility additive Ref. 4.
When PIP 3:1 is included in a formula, it is often for a combination of these functional uses; for example, as a flame retardant and an anti-wear additive.
Additionally, PIP 3:1 is an isomer mixture, and through manufacturing, the proportion of various isomers can be manipulated to achieve specific properties which can affect the performance of a formula Ref. 16. As an additional benefit, when used as an intermediate in the processing of cyanoacrylate glues, PIP 3:1 aids in the ability of these glues to meet the requisite performance standards for specialized markets EPAHQOPPT
201900800538.
3. The reasonably ascertainable economic consequences of the rule.
i. Overview of cost methodology. EPA
has evaluated the potential costs of the final action for PIP 3:1. Costs of the final rule were estimated based on the assumption that under regulatory limitations on PIP 3:1, processors that use PIP 3:1 in their products would switch to available alternative chemicals to manufacture the product, or to products that do not contain PIP 3:1.
Substitution costs were estimated on the industry level using the price differential between the cost of the chemical product and identified substitutes. 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, release prevention, 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.
ii. Estimated costs of this final rule.
Total quantified annualized industry costs for the final rule is $23.6 million at a 3% discount rate and $22.8 million at a 7% discount rate annualized over 25 years. 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
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action, EPA estimates it will require 1
FTE at $155,152 per year Ref. 3.
Total quantified annualized social costs for the final rule are $23.8 million at a 3% discount rates, and $23.0
million at a 7% discount rate. As described earlier in Unit III.B.3, potential costs such as testing, reformulation, release prevention, 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.
iii. Benefits. As discussed in Unit II.A.
and the Response to Comments Document, while 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 PIP
3:1 is provided. PIP 3:1 is a neurotoxicant and aquatic toxicant with high persistence and high potential for bioaccumulation. Under this final rule, PIP 3:1 is prohibited for processing and distribution in all uses except for those specifically excluded from the prohibition, as detailed in Unit I.C.
Additionally, releases to water are prohibited during manufacturing, processing, and distribution, and are restricted during commercial use. EPA
anticipates that these requirements will result in decreased potential for occupational exposures, decreased potential for PIP 3:1 releases, and reduce potential for exposures to the general population, potentially exposed or susceptible subpopulations, and the environment.
iv. 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 costeffectiveness 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
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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, although the rule may create some incentives for chemical manufacturers to develop new chemical alternatives to PIP 3:1.
4. Consideration of alternatives.
EPA believes there are viable substitutes for PIP 3:1, except for the specified processing and distribution in commerce activities excluded from the final rule. In addition, EPA conducted an analysis of three identified potential substitutes for PIP 3:1 based on the process described in the TSCA Work Plan Chemicals: Methods Document Ref. 2. Those potential substitutes all scored lower than PIP 3:1 in at least one criterion, indicating lower concern for hazard, exposure, or bioaccumulation/persistence. The economic feasibility of alternatives for all activities other than those excluded from the final rule is discussed in the Economic Analysis Ref. 3.
C. TSCA Section 26 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 PIP 3:1 on 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 subject to independent verification or peer review
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