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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
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and takes them into account in its implementation of the TSCA section 6h4 mandate, with respect to the circumstances for each chemical.
Finally, EPA does not believe that Congress intended, through the article provisions incorporated into the TSCA
amendments, to absolve importers of the duty to know what they are importing.
Importers can and should take steps to determine whether the articles they are importing contain chemicals that are prohibited or restricted. Therefore, as discussed earlier in this Unit and in the Response to Comment document, EPA
is continuing to interpret TSCA 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. This is discussed further in Unit III.A.
C. PCTP Overview, Health Effects, and Exposure Historically, PCTP was used in rubber manufacturing as a peptizer, or a chemical that makes rubber more amenable to processing. As described in the proposed rule, there are few data on end-use products and articles that contain PCTP. For years, PCTP was produced in the United States, but domestic manufacture appears to have ceased Ref. 6. Although it is likely that PCTP is no longer used as a peptizer, it can be found as an impurity in the zinc salt of PCTP zinc PCTP CASRN 117
975 after zinc PCTP manufacturing Ref. 7. As shown by a number of patents, zinc PCTP can be used as a peptizer in rubber manufacturing and as an ingredient in the rubber core of golf balls to enhance certain performance characteristics of the ball, such as spin, rebound, and distance Ref. 8, 9, and 10. EPA considers the presence of PCTP in rubber during manufacturing, whether as a peptizer or an impurity, to be processing under TSCA. Zinc PCTP
is imported into the United States, with approximately 65,000 lbs. imported in 2017 Ref. 3. EPA believes that some or all of the zinc PCTP could contain PCTP. The importation of PCTP, including as an impurity with zinc PCTP, is considered manufacturing under TSCA.
There is likely exposure to the general population, workers, and the environment, including water releases from process water and from cleaning the processing area and equipment, and worker exposure during unloading and transfer of the chemical. Women of
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childbearing age exposed in the workplace may transfer PCTP to infants via breastmilk. Exposure information for PCTP is detailed in EPAs Exposure and Use Assessment Ref. 5 and the proposed rule.
PCTP is toxic to protozoa, fish, terrestrial plants, and birds. Data for analogous chemicals pentachloronitrobenzene and hexachlorobenzene indicate the potential for liver effects in mammals and systemic body weight effects for PCTP in mammals no repeated-dose animal or human epidemiological data were identified for PCTP Ref. 11. The studies presented in the document entitled Environmental and Human Health Hazards of Five Persistent, Bioaccumulative and Toxic Chemicals Hazard Summary Ref. 11
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.
In the 2014 Update to the TSCA Work Plan for Chemical Assessments Ref. 1, PCTP scored high 3 for hazard based on toxicity for acute and chronic exposures; low 1 for exposure based on 2012 CDR data; and high 3 for persistence and bioaccumulation based on high environmental persistence and high bioaccumulation potential. The overall screening score for PCTP was high 7.
In consideration of the production and use of PCTP, the environmental and human health hazards of PCTP, and the public comments on the proposed rule that are further discussed in Unit III.A., EPA determines that PCTP meets the TSCA section 6h1A criteria. 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 PCTP under the conditions of use is likely to the general population, to a potentially exposed or susceptible subpopulation, or to the environment. EPAs determination is based on the opportunities for exposure throughout the lifecycle of PCTP, including the potential for consumer exposures. EPA did not receive any significant comments or information to call the exposure finding into question.

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D. EPAs Proposed Rule Under TSCA
Section 6h for PCTP
In the proposed rule, EPA proposed to prohibit all manufacturing, processing, and distribution of PCTP and PCTPcontaining products and articles for any use, unless PCTP concentrations are at or below 1% by weight.
In addition, EPA proposed to require, that all persons who manufacture, process, or distribute in commerce PCTP and articles and products containing PCTP maintain ordinary business records, such as invoices and bills-of-lading, that demonstrate compliance with the prohibitions and restrictions. EPA proposed that these records will 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. 4. 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. This includes the previous request for a comment period extension EPAHQOPPT201900800526.
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 PCTP final rule. Of the comment submissions, 10 directly addressed EPAs proposed regulation of PCTP.
Additional discussion related to this final action can be found in the Response to Comments document Ref.
4.
F. Activities Not Directly Regulated by This Rule EPA is not regulating all activities or exposures to PCTP, even though the Exposure and Use Assessment Ref. 5
identified potential for exposures under many conditions of use. One such activity is disposal. EPA generally presumes compliance with federal and state laws and regulations, including, for example, the Resource Conservation and Recovery Act RCRA and its implementing regulations and state laws, as well as the Clean Air Act, the Clean Water Act, and the Safe Drinking Water Act SDWA. As described in the
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