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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
using zinc PCTP at this purity Ref. 9.
Since manufacturing or processing zinc PCTP at 99% purity will comply with the proposed concentration limit, as will zinc PCTP at lower purities that contains PCTP at or below 1%
concentration by weight, EPA believes that the proposed concentration limit is practicable and is finalizing a limit prohibiting manufacturing, processing, and distribution in commerce of PCTP
or PCTP-containing products and articles, unless PCTP concentrations are at or below 1% by weight. Any manufacturing, including import, or processing of zinc PCTP containing PCTP above the 1% concentration by weight threshold would not be permitted, including for use in the manufacture of golf balls. In addition, any manufacturing, including import, or processing of PCTP above the 1%
concentration by weight threshold to create zinc PCTP would not be permitted. Thus, the manufacture and processing of PCTP and the presence of PCTP in any products and articles is significantly impacted by the prohibitions codified in the final rule.
EPA believes restricting the allowable concentration will result in limited use options for PCTP and will encourage the use of available PCTP alternatives, if other PCTP-related production occurs.
EPA is finalizing a limit for PCTP
concentrations above 1% by weight rather than prohibiting any manufacture or processing of PCTP for this reason.
3. Compliance date for the prohibitions.
The proposed rule did not delay the compliance date beyond the rules effective date; the manufacturing and processing bans would come into effect 60 days after publication of the final rule notice. EPA stated in the proposed rule that at that time it had no information indicating that a compliance date of 60 days after publication of the final rule is not practicable for the activities that would be prohibited, or that additional time is needed for products to clear the channels of trade. The phrases as soon as practicable and reasonable transition period as used in TSCA
section 6d1 are undefined, and the legislative history on TSCA section 6d is limited. Given the ambiguity in the statute, for purposes of this expedited rulemaking, EPA presumed a 60-day compliance date was as soon as practicable, unless there was support for a lengthier period of time on the basis of reasonable available information, such as information submitted in comments on the Exposure and Use Assessment or in stakeholder dialogues. Such a presumption ensures
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the compliance schedule is as soon as practicable, particularly in the context of the TSCA section 6h rules for chemicals identified as persistent, bioaccumulative and toxic, and given the expedited timeframe for issuing a TSCA section 6h proposed rule did not allow time for collection and assessment of new information separate from the comment opportunities during the development of and in response to the proposed rule. Such presumption also allows for submission of information from the sources most likely to have the information that will impact an EPA
determination on whether or how best to adjust the compliance deadline to ensure that the final compliance deadline chosen is both as soon as practicable and provides a reasonable transition period.
EPA received public comments regarding the 60-day compliance date for the prohibition in the proposed rule.
Commenters stated that this date would be unrealistic and requested that EPA
phase in the compliance deadlines for the bans on importation or distribution of products and articles containing PCTP over a longer period following promulgation of the final rule EPA
HQOPPT201900800549, EPAHQ
OPPT201900800557. In addition, one commenter requested EPA allow products or articles containing PCTP
that are manufactured and imported prior to the compliance deadlines to be distributed thereafter without restriction EPAHQOPPT201900800549.
Commenters stated this would be needed to prevent an untold number of lawfully manufactured and imported articles from suddenly becoming unsaleable, which would result in significant costs for retailers and importers. Other commenters supported the compliance date EPAHQOPPT
201900800566.
However, in response to commenters requesting additional time for products and articles to clear the channels of trade, e.g., given complex supply chains, including the request for a sellthrough provision to clear products and articles containing PCTP prior to the compliance deadlines, EPA is extending the compliance date for the prohibition on distribution in commerce to one year. Extending the compliance date to one year will, as commenters note, allow additional time for products and articles containing PCTP that were produced prior to the compliance date for the prohibition on manufacture and processing to clear channels of trade.
EPA is not extending the compliance date for the prohibition on manufacture and therefore is not extending the compliance deadline for the prohibition
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on import which under TSCA section 3
is a subset of manufacture activities.
Unless reasonably available information otherwise supports that it is not practicable to impose a 60-day compliance deadline for manufacture, which includes import, or for processing of PCTP and PCTPcontaining products and articles, for purposes of meeting EPAs obligations under TSCA section 6h, EPA presumes a compliance date of 60 days is as soon as practicable. EPA received only general comments taking the position, without support, that the 60-day compliance period for the prohibition on manufacture or processing is not practicable, while also receiving more specific support from a manufacturer of PCTP-containing products for the proposed 60-day timeframe EPAHQ
OPPT201900800566.
Therefore, this final rule includes a compliance date of 60 days after publication of the final rule for the restrictions on manufacturing and processing and, to address commenters concerns, a compliance date of one year after the publication of this final rule for the restrictions on distribution in commerce of PCTP and PCTPcontaining products and articles, unless PCTP concentrations are at or below 1%
by weight.
4. Recordkeeping.
In addition, EPA is requiring that all persons who manufacture, process, or distribute in commerce PCTP and articles and products containing PCTP
maintain ordinary business records related to compliance with the prohibitions and restrictions, such as invoices and bills-of-lading. EPA
revised this language slightly from the proposal to improve clarity. These records will have to be maintained for a period of three years from the date the record is generated, beginning on March 8, 2021.
B. TSCA Section 6c2 Considerations 1. Health effects, exposure, and environmental effects.
PCTP is toxic to protozoa, fish, terrestrial plants, and birds, with data for analogous chemicals indicating the potential for liver effects in mammals and systemic effects for PCTP in mammals. 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 PTCPs health effects, use, and exposure is in Unit II.C. and is further detailed in EPAs Hazard Summary Ref.
11 and Exposure and Use Assessment Ref. 5.

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