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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
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sections 6c2D and 6c2E to be inapplicable to this rulemaking. While this interpretation has not changed, EPA
has reviewed the practicability of regulating replacement parts and articles in accordance with the statutory directive in TSCA section 6h4 to reduce exposures to the PBT chemicals to the extent practicable. The results of those reviews are in Unit III.A.
C. PIP 3:1 Overview, Health Effects, and Exposure PIP 3:1 is used as a plasticizer, a flame retardant, an anti-wear additive, or an anti-compressibility additive in hydraulic fluid, lubricating oils, lubricants and greases, various industrial coatings, adhesives, sealants, and plastic articles. As a chemical that can perform several functions simultaneously, sometimes under extreme conditions, it has several distinctive applications. In lubricating oils, PIP 3:1 is a flame retardant, antiwear additive, anti-compressibility additive, or some combination of the three. In adhesives and sealants, PIP
3:1 is a plasticizer and flame retardant Ref. 4. PIP 3:1 can also be added to paints, coatings, and plastic components, where it is a plasticizer or flame-retardant additive. In the past, some plastic components to which PIP
3:1 may have been added included those intended for use by children. EPA
received comments that PIP 3:1 acts as a flame-retardant gel in filters surrounding engines in some marine and locomotive applications EPAHQ
OPPT201900800569.
Exposure information for PIP 3:1 is summarized here and is detailed in EPAs Exposure and Use Assessment Ref. 4, and the proposal. There is potential for exposure to PIP 3:1 under the conditions of use at all stages of its lifecycle i.e., manufacturing, processing, use industrial, commercial, and consumer, distribution, and disposal Ref. 4. PIP 3:1 is manufactured, processed, distributed, and used domestically. For the 2012
Chemical Data Reporting CDR period, data indicate that four sites manufactured including imported PIP
3:1 in the United States. For the 2016
CDR period, data indicate nine sites manufactured including imported PIP
3:1 in the United States Refs. 6 and 7.
The total volume of PIP 3:1
manufactured including imported in the United States was 14,904,236 lbs in 2011; 3,191,017 lbs in 2012; 2,968,861
lbs in 2013; 5,632,272 lbs in 2014; and 5,951,318 in 2015 Ref. 7.
PIP 3:1 is toxic to aquatic plants, aquatic invertebrates, sediment invertebrates, and fish. Data indicate the
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potential for reproductive and developmental effects, neurological effects and effects on systemic organs, specifically adrenals, liver, ovary, and heart in mammals. The studies presented in the document entitled Environmental and Human Health Hazards of Five Persistent, Bioaccumulative and Toxic Chemicals Hazard Summary Ref. 8 demonstrate these hazardous endpoints. EPA did not perform a systematic review or a weight of the scientific evidence assessment for the hazard characterization of these chemicals. As a result, this hazard characterization is not definitive or comprehensive. Other hazard information on these chemicals may exist in addition to the studies summarized in the Hazard Summary that could alter the hazard characterization Ref. 8.
In the 2014 Update to the TSCA Work Plan for Chemical Assessments, PIP
3:1 scored high 3 for hazard based on neurotoxicity in mammals and aquatic toxicity; high 3 for exposure based on use as a flame retardant in industrial and consumer products; and high 3 for persistence and bioaccumulation based on high environmental persistence and high bioaccumulation potential Ref. 1. The overall screening score for PIP 3:1 was high 9.
Taking all this into account, and the discussion in Response to Comments document and in this Unit and in Unit III., EPA determines in this final rule that PIP 3:1 meets the TSCA section 6h1A criteria. Comments received pertaining to this finding are discussed further in Unit III.A.1. In addition, EPA
determines, in accordance with TSCA
section 6h1B, that based on the Exposure and Use Assessment and other reasonably available information, exposure to PIP 3:1 is likely under the conditions of use to the general population, to a potentially exposed or susceptible subpopulation, or the environment. EPAs determination is based on the opportunities for exposure throughout the lifecycle of PIP 3:1.
EPA did not receive any comments with information to call the exposure finding into question.
D. EPAs Proposed Rule Under TSCA
Section 6h for PIP 3:1
In the proposed rule 84 FR 36728, EPA proposed to prohibit the processing and distribution in commerce of PIP
3:1, and products containing the chemical substance except for the following:
Processing and distribution in commerce for use in aviation hydraulic fluid;

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Processing and distribution in commerce for use in lubricants and greases; and Processing and distribution in commerce for use in new and replacement parts for the automotive industry, and the distribution in commerce of those parts to which PIP
3:1 has been added.
EPA proposed to prohibit releases to water from manufacture, processing, distribution in commerce, and commercial use activities that are permitted to occur. EPA also proposed to require persons manufacturing, processing, and distributing PIP 3:1, and products containing PIP 3:1, in commerce to notify their customers of these prohibitions on processing and distribution, and the prohibition on releases to water.
In addition, EPA proposed to require that all persons who manufacture, process, or distribute in commerce PIP
3:1 and articles and products containing PIP 3:1 maintain ordinary business records, such as invoices and bills-of-lading, that demonstrate compliance with the prohibitions and restrictions. EPA proposed that these records would have to be maintained for a period of three years from the date the record is generated.
E. Public Comments and Other Public Input The proposed rule provided a 60-day public comment period, with a 30-day extension provided Ref. 5. The comment period closed on October 28, 2019. EPA received a total of 48
comments, with three commenters sending multiple submissions with attached files, for a total of 58
submissions on the proposal for all the PBT chemicals. This includes the previous request for a comment period extension EPAHQOPPT20190080
0526. Two commenters submitted confidential business information CBI
or copyrighted documents with information regarding economic analysis and market trends. Copies of all the non-CBI documents, or redacted versions without CBI, are available in the docket for this action.
In this preamble, EPA has responded to the major comments relevant to the PIP 3:1 final rule. Of these comment submissions, thirty addressed EPAs proposed regulation of PIP 3:1.
Additional discussion related to this final action can be found in the Response to Comments document Ref.
5.

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