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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations experimentation or analysis, or chemical research on, or analysis of, the chemical substance, including methods for disposal, but not for research or analysis for the development of a new product, or refinement of an existing product that contains the chemical substance. This will allow, for example, for samples of environmental media containing PBTs, such as contaminated soil and water, to be collected, packaged and shipped to a laboratory for analysis.
Laboratories also must obtain reference standards containing PBTs to calibrate their equipment, otherwise they may not be able to accurately quantify these chemical substances in samples being analyzed. However, research to develop new products that use PBTs subject to 40 CFR part 751, subpart E, or the refinement of existing uses of those chemicals, is not included in this definition, and those activities remain potentially subject to the chemical specific provisions in 40 CFR part, 751
subpart E. EPA believes it is not practicable to limit research and development activity as defined, given the critical importance of this activity to the detection, quantification, and control of these chemical substances.
Finally, EPA received comments regarding requirements for recycling and resale of PCTP-containing products and articles, as well as other PBT
chemicals undergoing Section 6h rulemaking. One commenter stated that because the proposed definition of person includes any natural person, the proposed prohibitions would seem to apply to anyone selling golf balls containing PCTP above the 1%
concentration by weight threshold at a garage or yard sale EPAHQOPPT
201900800559. EPA did not intend to impose these final PCTP regulations on yard sales or used golf ball sales and has added a provision in 40 CFR
751.401 to clarify this issue.
Distribution in commerce of PCTP, or products and articles that contain PCTP, that have previously been sold or supplied to an end user are excluded.
The prohibition and recordkeeping requirements in this final rule exclude PCTP-containing products and articles that have previously been sold or supplied to an end user for purposes other than resale. An individual or entity that purchased or acquired the finished good in good faith for purposes other than resale are excluded; for example, a consumer who resells a product they no longer intend to use or donates a product or article to charity, such as a golf course that resells used PCTP-containing golf balls it no longer
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intends to use, or donates used PCTPcontaining golf balls to charity.
III. Provisions of This Final Rule A. Scope and Applicability EPA carefully considered all public comments related to the proposal. This rule finalizes EPAs proposal to prohibit the manufacturing, processing, and distribution in commerce of PCTP or PCTP-containing products and articles, unless PCTP concentrations are at or below 1% by weight, with changes being made from the proposal to the compliance date of distribution in commerce of PCTP and PCTPcontaining products and articles.
1. Banning PCTP.
EPA received numerous comments regarding the practicability of regulating PCTP. Specifically, commenters expressed concern with EPAs statement that it would be unreasonable, because of the low concentrations of PCTP in golf balls, for example, and thus, impracticable to prohibit or otherwise restrict the continued commercial use of the products 84 FR 145. Some commenters stated that a ban would be practicable given that EPA had already identified the sole golf ball manufacturer using PCTP. Commenters also discussed practicability in the context of availability of PCTP
alternatives. Other commenters supported EPAs proposed rule and stated that EPAs regulation will allow manufacturers to continue the safe use of zinc PCTP while restricting potentially more dangerous uses of PCTP in greater concentrations or in its pure form.
EPA received comments from one processor of PCTP i.e., a golf ball manufacturer stating that its processes are currently within the proposed 1%
concentration by weight threshold. This commenter provided data regarding potential exposures, showing little to no exposure to humans or the environment.
This commenter stated that even if the PCTP product e.g., within the rubber of the golf balls core is exposed to the environment through some mechanism, the zinc-PCTP compound is bound-up in the solid rubber that makes up the core material EPAHQOPPT2019
00800566. This commenter also provided EPA with information from tests assessing leachability of the core material using U.S. EPA Method 1311
i.e., the toxicity characteristic leaching procedure TCLP. The TCLP test resulted in non-detectable levels of PCTP leaching from the rubber cores of golf balls when they were cut in half or quartered. These study results were
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provided in EPA Docket EPAHQ
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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 does not expect any domestic production of PCTP or domestic use of PCTP to prepare zinc PCTP, which is the only known intermediate use of PCTP. Import of zinc PCTP may occur but only if meeting the concentration threshold of 1% by weight or less of PCTP. As a result, EPA believes these stringent measures will result in limited use of PCTP and encourage the use of alternatives, if that has not already occurred.
To the extent there are continued manufacturing and processing of products and articles, within the permitted 1% threshold, the potential for consumer exposures is not expected from these known activities or products, e.g., as a component of golf ball cores.
Therefore, EPA does not believe it is practicable to impose a ban on all manufacture and processing of PCTP at this time.
2. 1% Concentration limit.
EPA requested comment on the proposed concentration limit, including whether the option is practicable, and whether further exposure reductions would be practicable. EPA specifically requested comment on the practicability of a lower limit on the PCTP content in zinc PCTP, and whether it is possible to completely eliminate unreacted PCTP in the manufacture of zinc PCTP. EPA did not receive comments on an alternative or lower concentration limit. However, some commenters did express concern that EPA has not demonstrated that levels below 1% by weight do not present risks. Comments regarding eliminating the concentration limit altogether and issuing a total ban are discussed in Unit III.A.1. Other commenters supported the proposed concentration limit and one commenter provided information on studies to support their opinion that the 1%
concentration threshold provides a more-than-adequate level of safety for workers and the public, and the available science does not support any further restrictions EPAHQOPPT
201900800566.
As noted earlier, zinc PCTP is manufactured using PCTP, by reacting PCTP with zinc oxide, and depending on the yield of the reaction, zinc PCTP
may contain PCTP as an impurity. Zinc PCTP is sold with varying concentrations of zinc salt, including at a purity of 99% Ref. 12. According to several patents, golf balls can be made
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