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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations solvents trichloroethylene, carbon tetrachloride, and perchloroethylene and therefore that a ban was impracticable. The commenters made recommendations for alternative regulatory approaches. One commenter stated that EPA had failed to consider banning HCBD, except as a byproduct to the manufacture of other chemicals, to reduce exposure to the extent practicable EPAHQOPPT2019
00800546. The commenter further stated that EPA could have considered banning all manufacture except as a byproduct of manufacture of perchloroethylene, trichloroethylene, and carbon tetrachloride, to ensure that HCBD is not manufactured for a purpose other than its incidental production as a byproduct EPAHQOPPT2019
00800546.
EPA appreciates the comments provided regarding HCBD. EPAs Preliminary Information on Manufacturing, Processing, Distribution, Use, and Disposal for HCBD document was a preliminary summary of available information on uses, past and present, of HCBD Ref. 4. EPA requested comment on the document but did not receive confirmation of ongoing uses other than those discussed in the proposed rule. EPA has not identified any uses of HCBD. The only activity involving HCBD is burning as a waste fuel as a result of unintentional HCBD
production as a byproduct.
However, recognizing commenters concern about prohibiting HCBD uses that are not currently ongoing to avoid, for example, the return of past uses, EPA is finalizing a change from the proposal and is prohibiting all manufacturing, processing, and distribution in commerce of HCBD and products and articles containing HCBD, but allowing the continuation of the unintentional 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 approach ensures that the types of allowable activities involving HCBD are severely limited by precluding the manufacture, processing, or distribution of HCBD for a purpose other than its incidental and unintentional production as a byproduct and allows burning of that byproduct as a waste fuel. Any other activity involving HCBD is prohibited by the final rule, and thus the final requirements are consistent with restrictions on the intentional production and use of HCBD under Annex A of the Stockholm Convention.
Moreover, the highly regulated burning of the byproduct as a waste fuel is also consistent with Article 6 of the same
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Convention. Thus, the final rule requirements reduce the exposures to humans and the environment that could occur with any activity involving HCBD
not directly related to its manufacture as a byproduct or burning as a waste fuel.
3. Chlorinated Solvents Resulting in HCBD as a Byproduct.
EPA received comments regarding the chlorinated solvents that unintentionally produce HCBD as a byproduct. One commenter recommended that EPA consider whether viable alternative synthetic routes exist that do not result in such production EPAHQOPPT2019
00800541. One commenter stated that EPA should solicit information, regarding whether HCBD-free production methods for chlorinated solvents exist from industry before concluding that a ban on HCBD would entail a ban on chlorinated solvents EPAHQOPPT201900800551.
Another commenter stated that EPA
must act under section 6h to include a total phase-out of the chemical and any processes that lead to creation of HCBD as a byproduct EPAHQOPPT
201900800575. Others requested EPA require best available techniques and environmental practices to control emissions and releases from sources of HCBD, and suggested EPA develop a plan to eliminate HCBD to the extent practicable through alternative chlorinated solvent manufacturing EPAHQOPPT201900800567.
EPA appreciates the comments regarding alternatives and actions to be taken on chlorinated hydrocarbons, particularly perchloroethylene, trichloroethylene, and carbon tetrachloride, that unintentionally create HCBD as a byproduct. EPA is not aware of alternative methods for the production of chlorinated solvents that do not unintentionally produce HCBD
as a byproduct and did not receive additional information in the comments on the proposal. As discussed in the proposed rule, prohibiting all manufacture of HCBD would effectively preclude the manufacture of trichloroethylene, carbon tetrachloride and perchloroethylene and EPA does not believe precluding manufacture of these solvents to reduce the exposure to the HCBD byproduct is practicable at this time. EPA is not addressing these three solvents during this TSCA section 6h rule making, which applies solely to PBT chemicals. Additionally, the solvents are the subject of the risk evaluation process pursuant to TSCA
section 6b. Where unreasonable risks are identified as part of those risk evaluations, EPA is required to take action under TSCA section 6a to
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address unreasonable risk. In addition, these chlorinated solvents are widely used in dry cleaning, metal degreasing, and other industries. To broadly assess the economic impact of a prohibition of the manufacture of these three chemicals, EPA estimated the potential market value loss by multiplying the national production volume of each of these chemicals by an average price per pound. This resulted in an estimated impact $213 million to $541 million average $368 million worth of production see the Economic Analysis for the proposed rule for details on this estimation Ref. 10. Therefore, EPAs final rule allows the continuation of the unintentional production of HCBD as a byproduct during the production of chlorinated solvents and processing and distribution of the HCBD byproduct for burning as a waste fuel, and prohibits all other manufacturing, processing, and distribution in commerce of HCBD and products and articles containing HCBD.
4. Recordkeeping.
In addition, EPA is requiring that all persons who manufacture, process, or distribute in commerce HCBD and HCBD-containing products or articles 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.
HCBD is toxic to aquatic invertebrates, fish, and birds. Data indicate the potential for renal, liver, and developmental effects in mammals.
HCBD has been identified as a possible human carcinogen. The studies presented in the Hazard Summary Ref.
8 demonstrate these hazardous endpoints. 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 HCBD health effects, use, and exposure is in Unit II.C. and further detailed in the Hazard Summary Ref.
8. Information on use and exposures is also in Unit II.C. and is further detailed in EPAs Exposure and Use Assessment Ref. 5, Ref. 8.
2. The benefits of the chemical substance or mixture for various uses.
HCBD is unintentionally manufactured as a waste byproduct by chemical manufacturers. The majority of
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