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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations would it be difficult to support broadly applicable and safe additional measures for each specific activity without a risk evaluation and in the limited time for issuance of this regulation under TSCA
section 6h, but imposing such measures without sufficient analysis could inadvertently result in conflicting or confusing requirements and make it difficult for employers to understand their obligations. Such regulations would not be practicable. Rather, where EPA has identified worker exposures and available substitutes, EPA is finalizing measures to reduce those exposures. As discussed in the proposed rule, EPA assumes that the worker protection methods used by employers, including in response to existing OSHA
regulations, 29 CFR 1910.1200, 29 CFR
1910.132 through 1910.140, in addition to the regulatory measures taken for each chemical, meaningfully reduce the potential for occupational exposures.
While some commenters agreed with this approach, others thought that EPA
should establish worker protection requirements for those uses that would be allowed to continue under the final rule. Information provided to EPA
before and during the public comment period on the proposed rule indicates that employers are using engineering and process controls and providing appropriate personal protective equipment PPE to their employees consistent with these requirements, and EPA received no information on PIP
3:1 to suggest this is not the case.
Further, EPA has not conducted a risk evaluation on PIP 3:1 or any of other PBT chemicals. Without a risk evaluation and given the time allotted for this rulemaking, EPA cannot identify additional engineering or process controls or PPE requirements that would be appropriate to each chemical-specific circumstance. For these reasons, EPA
has determined that it is not practicable to regulate worker exposures in this rule through engineering or process controls or PPE requirements.
EPA received comments regarding the use of PBT chemicals in research and development and lab use. Lab use is addressed under newly established 40
CFR 751.401b as the manufacturing, processing, distribution in commerce and use of any chemical substance, or products and articles that contain the chemical substance, for research and development, as defined in new 40 CFR
751.403. Research and Development is defined in new 40 CFR 751.403 to mean laboratory and research use only for purposes of scientific experimentation or analysis, or chemical research on, or analysis of, the chemical substance,
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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 resale of PIP
3:1-containing products and articles, as well as products and articles containing 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 products or articles containing PIP 3:1 at a garage or yard sale EPAHQOPPT2019
00800559. EPA did not intend to impose these final PIP 3:1 regulations on yard sales or used product or article sales and has added language in 40 CFR
751.401 to clarify this. The prohibition and recordkeeping requirements in this final rule exclude PIP 3:1-containing products and articles that have previously been sold or supplied to an end user, i.e., any person who purchased or acquired the finished good for the purposes of resale.
III. Provisions of This Final Rule A. Scope and Applicability EPA carefully considered all public comments related to the proposal. This rule finalizes with some modifications EPAs proposal to prohibit the processing and distribution in commerce of PIP 3:1, and products containing the chemical substance. The following are excluded from the prohibition in this final rule:
Processing and distribution in commerce for use in hydraulic fluids
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either for the aviation industry or to meet military specifications for safety and performance where no alternative chemical is available that meets U.S.
Department of Defense specification requirements;
Processing and distribution in commerce for use in lubricants and greases;
Processing and distribution in commerce for use in new and replacement parts for the automotive and aerospace industry, and the distribution in commerce of those parts to which PIP 3:1 has been added;
Processing and distribution in commerce for use as an intermediate in a closed system to produce cyanoacrylate adhesives;
Processing and distribution in commerce for use as an adhesive and sealant until January 6, 2025, after which such activity is prohibited;
Processing and distribution in commerce for use in specialized engine filters for locomotive and marine applications;
Processing for recycling and distribution in commerce for the recycling of PIP 3:1 containing plastic provided no new PIP 3:1 is added during the recycling process;
Processing and distribution in commerce of articles and products made from recycled PIP 3:1 containing plastic provided no new PIP 3:1 is added during the recycling process or to the articles and products made from the recycled plastic; and Processing and distribution in commerce of PIP 3:1 for use in photographic printing articles and PIP
3:1-containing photographic printing articles until January 1, 2022.
This final rule also prohibits releases to water from manufacture, processing, distribution in commerce, and commercial uses that are permitted to occur, as outlined in the preceding bullets.
Persons manufacturing, processing, and distributing in commerce PIP 3:1
and products containing PIP 3:1 are required to notify their customers of these prohibitions on processing and distribution, and the prohibition on releases to water via Safety Data Sheet SDS or labeling.
Persons manufacturing, processing, and distributing in commerce PIP 3:1
are required to maintain, for three years from the date the record is generated, ordinary business records related to compliance with the restrictions, prohibitions, and other requirements set forth in this rule. These records must include a statement of compliance with this final rule and be made available to
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