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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
EPA has not conducted a risk evaluation on HCBD or any of the 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 additional engineering or process controls or PPE requirements.
Finally, EPA received comments regarding the use of PBT chemicals in research and development and laboratory use. Laboratory 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, 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.
More information on the comments received and EPAs responses can be found in the Response to Comments document Ref. 4.
III. Provisions of This Final Rule A. Scope and Applicability EPA carefully considered all public comments related to the proposal. This
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final rule differs from EPAs proposal by finalizing a prohibition on the manufacturing including import, processing, and distribution in commerce of HCBD, and HCBDcontaining products and articles, except for the unintentional production of HCBD as a byproduct during the production of chlorinated solvents, and the limited processing and distribution of HCBD for burning as a waste fuel.
The effective date is 30 days after publication of the final rule.
1. Regulating HCBD.
EPA received comments disagreeing with EPAs proposal not to regulate HCBD. One commenter stated that EPA
must act under TSCA section 6h to include a total phase-out of the chemical EPAHQOPPT20190080
0575. Another commenter stated that by not prohibiting uses of HCBD, EPAs approach allowed ongoing exposures, including to potentially exposed and susceptible subpopulations, and potential expansion of uses EPAHQ
OPPT201900800567. Three commenters noted that HCBD was listed in the Stockholm Convention on Persistent Organic Pollutant POPs which prohibits the intentional manufacture of HCBD and stated that the manufacture of HCBD should be eliminated EPAHQOPPT2019
00800570 EPAHQOPPT2019
00800567 EPAHQOPPT2019
00800531. EPA received one comment supporting EPAs proposal and finding that no new risk management measures are required to reduce exposure of HCBD to the extent practicable EPA
HQOPPT201900800557.
In response to comments, EPA is finalizing a prohibition on the manufacturing, processing, and distribution of HCBD and HCBDcontaining products or articles, recognizing that there is unintentional production of HCBD as a byproduct during the production of chlorinated solvents, that results in processing and distribution in commerce of a very limited subset of that byproduct for burning as a waste fuel. However, as explained below, EPA disagrees with commenters that a total ban of HCBD
production as a byproduct is practicable. The potential for exposure from incineration and distribution for incineration of the byproduct is substantially addressed by actions taken under other statutes. As discussed in EPAs proposed rule and in Unit II.F., HCBD is regulated under various statutes implemented by the Federal Government, such as CAA and RCRA.
According to TRI data, most of the byproduct HCBD manufactured in the United States is subsequently destroyed
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via incineration due in large part to the high waste treatment efficiencies achieved by the chemical manufacturers. Chemical manufacturers that submit TRI reports for HCBD
byproduct are treating the chemical via incineration at greater than 99.99%
treatment efficiency with some reporting an efficiency greater than 99.9999%.
Given the known uses and efficiency of the destruction of HCBD created as a byproduct, EPA is issuing a final rule to prohibit all manufacturing, processing, and distribution in commerce of HCBD
and products and articles containing HCBD, while recognizing the continuation of the production of HCBD
as a byproduct during the production of chlorinated solvents, and the resulting processing and distribution of HCBD for burning as a waste fuel. This final rule allows the current, highly regulated, unintentional production as a byproduct and incineration and distribution for incineration of such byproduct to continue and ensures that other uses do not commence.
2. HCBD uses.
Multiple commenters submitted comments to EPA discussing HCBD
uses. Commenters pointed out that EPAs website had previously identified uses of HCBD as a solvent in rubber manufacturing and in hydraulic, heat transfer, or transformer fluid EPAHQ
OPPT201900800575 EPAHQ
OPPT201900800546. Commenters further noted that EPAs Preliminary Information on Manufacturing, Processing, Distribution, Use, and Disposal for HCBD document identified numerous uses for HCBD beyond its production as a byproduct Ref. 4
EPAHQOPPT201900800575
EPAHQOPPT201900800546.
According to one commenter, EPA had not addressed these activities in its proposed rule, much less established that it would be impracticable to ban these uses to reduce exposure. This commenter stated that EPA should ban these past uses EPAHQOPPT2019
00800546. Another commenter felt that EPAs proposed rule neglected to discuss or mention legacy uses and legacy disposals of PBT chemicals, and other commenters stated that HCBD has been listed in Annex A of the Stockholm Convention in order to avoid new possible future uses of HCBD
EPAHQOPPT201900800541
EPAHQOPPT201900800531
EPAHQOPPT201900800575.
In addition, multiple commenters expressed concerns about EPAs conclusion that a prohibition on the manufacture of HCBD would effectively prohibit the manufacture of the three
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