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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
stored for several years in the distribution system or on a store shelf before final sale to customers. Products that are unsold as of the compliance date would have to be pulled from the shelf and disposed of. A sudden removal of product from the shelves might also create temporary or spot shortages of fuel additives. Gold Eagle will also incur costs, if it is required to cease sales of its fuel additive products because it can replace them with reformulated products without 2,4,6TTBP before the compliance date. If its products are off the market for several years, sales losses could be significant.
In consideration of these comments and the issues that they raise, especially in regard to potential unquantified potential costs and market disruption with provision of these needed products, EPA does not believe it is practicable to implement this prohibition without a delay in the compliance date. However, Gold Eagle expresses some uncertainty about its six-year estimate and does not establish the reasoned basis to support that a sixyear estimate is as soon as practicable, compared to the five-year period estimated by SI Group.
Therefore, EPA is delaying the compliance date for the prohibition on distribution of 2,4,6-TTBP and products containing 2,4,6-TTBP in any container with a volume of less than 35 gallons for any use, as well as processing and distribution in commerce of 2,4,6-TTBP
for use in oil and lubricant additives and of 2,4,6-TTBP-containing oil and lubricant additives, for five years, to give the producers of fuel additives containing 2,4,6-TTBP sufficient time to reformulate their products, requalify them with the necessary entities and clear non-compliant inventory from their distribution chains.
In this final rule, EPA is also establishing a new subpart E of 40 CFR
751 for TSCA section 6h PBT chemical provisions, including general provisions at 40 CFR 751.401 as discussed in Unit II.F. of this document, and definitions applicable to subpart E at 40 CFR
751.403. Terms defined in 40 CFR
751.403 include article, product, and research and development. These definitions are intended to respond to comments requesting additional clarity on the regulatory provisions. Note the definitions of article and product are not used in 40 CFR 751.409.
EPA is requiring that distributors of 2,4,6-TTBP and products containing 2,4,6-TTBP must maintain ordinary business records, such as invoices and bills-of-lading, related to compliance with the prohibitions and restrictions in this regulation. These records must be
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maintained for a period of three years from the date the record is generated.
EPA revised this language slightly from the proposal to improve clarity.
B. TSCA Section 6c2 Considerations 1. Health effects, exposure, and environmental effects.
2,4,6-TTBP is toxic to aquatic plants, aquatic invertebrates, and fish. Data indicate the potential for liver and developmental effects. The studies presented in the Hazard Summary Ref.
10 demonstrate these hazardous endpoints. These hazard statements are not based on a systematic review of the available literature and information may exist that could refine the hazard characterization.
Additional information about 2,4,6TTBP health effects, use, and exposure is in Unit II.C. and is further detailed in the Hazard Summary Ref. 10, and information on use and exposure is also in Unit II.C. and is further detailed in EPAs Exposure and Use Assessment Ref. 4.
2. The value of the chemical substance or mixture for various uses.
2,4,6-TTBP has value as a chemical intermediate in the production of dialkylphenol chemicals. With respect to use as an antioxidant in the general fuel supply, antioxidant additives are essential to the storage and transport of fuel, as without them, fuel quickly begins to degrade and form harmful sludge and varnish. The 2,4,6-TTBP
mixtures are the primary antioxidants used in aviation, marine, and automotive fuel streams in the United States. Many current performance specifications for fuel require their use, including for specialty fuels for aviation and the military. Antioxidants are also an important component in retail fuel additives and fuel injector cleaners, which are used for engines maintenance. Similarly, antioxidants are also used in oil and lubricants to prevent degradation of the product.
3. The reasonably ascertainable economic consequences of the rule.
i. Overview of cost methodology. EPA
has evaluated the potential costs of the final rule and primary alternative regulatory actions for this chemical.
Costs of the final rule were estimated based on the assumption that under regulatory limitations on 2,4,6-TTBP, manufactures and processors that use the regulated chemical would switch to available alternative chemicals to manufacture the product, or to products that do not contain the chemical. For 2,4,6-TTBP, costs were assessed based on product substitutes where product information was more substantial than
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information on chemical substitutes alone.
Substitution costs were estimated on the industry level using the price differential between the cost of the chemical 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, 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, which is in the public docket for this action.
ii. Estimated costs of this final rule.
Total quantified annualized industry costs for the final rule is $5.6 million at 3% discount rate and $4.9 million at 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 action, EPA estimates it will require 0.5
FTE at $77,600 per year Ref. 3.
4. 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 proposed and alternative actions for each chemical is provided. 2,4,6-TTBP
is persistent and bioaccumulative, and has been associated with liver toxicity and reproductive and developmental effects in mammals. Under the final regulatory action, 2,4,6-TTBP and products containing 2,4,6-TTBP at concentrations above 0.3% would be prohibited for distribution in containers less than 35 gallons and would be prohibited in processing and distribution for use as an additive to oil/
lubricants. Therefore, the rule is expected to reduce the exposure to humans and the environment, by reducing the potential for consumer exposures to 2,4,6-TTBP and potential occupational exposure in certain industries, where workers are unprotected, as well as potential releases to the environment from
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