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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 2. The benefits of the chemical substance or mixture for various uses.
During the manufacture of rubber, PCTP has been used as a peptizer to reduce the viscosity of rubber during processing. PCTP has been used as a mastication agent in the rubber industry and, more specifically, a peptizing agent for natural rubber viscosity reduction in the early stages of rubber manufacturing Ref. 13. Mastication and peptization are processing stages during which the viscosity of rubber is reduced to a level facilitating further processing Ref. 14.
It is possible to reduce the viscosity of natural and synthetic rubbers through solely mechanical efforts, but peptizers allow this process to be less sensitive to varying time and temperature, which improves the uniformity between batches Ref. 13.
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 PCTP. Costs of the final rule were estimated based on the assumption that under regulatory limitations on PCTP, processors that use PCTP in their products would switch to available alternative chemicals to manufacture the product, or to products and articles that do not contain PCTP.
Costs were assessed based on the assumption that manufacturers will use an alternative chemical, rather than an evaluation of the pricing of pre-existing PCTP-free products. For PCTP, the costs were assessed based on chemical substitutes only. Substitution costs were estimated on the industry level using the price differential between the cost of the chemical or 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.
b. Estimated costs of this final rule.
Total quantified annualized industry costs for the final rule are approximately $30,000 at both 3% and 7% discount rates 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 action, EPA

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estimates it will require 0.5 FTE at $77,600 per year Ref. 3.
Total quantified annualized social costs for the final rule are approximately $108,000 at both 3% and 7% discount rates. 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.
c. Benefits. As discussed in Unit II.A., 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 PCTP is provided. PCTP is persistent, bioaccumulative, and an aquatic toxicant. There are limited data on the potential effects of PCTP in mammals and no data were identified on the potential effects of PCTP in humans.
Under the final regulatory action, manufacture and processing of PCTP
and PCTP-containing products and articles will be limited to PCTP
concentrations of 1% by weight or lower. With the final rule, there will be lower concentrations of PCTP in products and articles. These impacts will decrease the potential for dermal and inhalation PCTP exposures in workers involved in the manufacturing and processing of PCTP-containing products and articles, e.g., rubber products and golf balls, and decrease the potential for releases of PCTP to the environment, including through disposal activities. With decreased potential for releases to the environment and reduced presence of PCTP in products and articles, there will also be a decrease of the potential for exposures in the general population and potentially exposed or susceptible subpopulations, including through consumption of food from the persistence and bioaccumulation of food in animals or through persistence and uptake in agricultural food products.
Thus, by reducing the concentration threshold for manufacturing and processing of PCTP for use in products and articles overall, the final regulatory action will have benefits for the environment, general population, and potentially exposed or susceptible subpopulations, such as workers.

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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 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 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 PCTP.
4. Consideration of alternatives.
As the result of a screening level analysis of likely alternatives based on the TSCA Work Plan Chemicals:
Methods Document Ref. 2, EPA
believes that there are viable substitutes for PCTP in rubber manufacturing.
Although this final rule is not prohibiting the manufacture or processing of PCTP and PCTPcontaining products and articles for any use when PCTP concentrations are at or below 1% by weight, it is possible that some manufacturers and processors may choose to use alternatives instead of using PCTP at the concentration limit.
At this time, EPA does not know whether products, including golf balls, are currently being made with halogenated organosulfur compound substitutes instead of PCTP. Based on information from patents, EPA believes
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