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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
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comments is in the Response to Comment document. Ref. 4
C. HCBD Overview, Health Effects, and Exposure HCBD is a halogenated aliphatic hydrocarbon that is produced as a byproduct during the manufacture of chlorinated hydrocarbons, particularly perchloroethylene, trichloroethylene, and carbon tetrachloride Ref. 6. As described in the proposed rule, the majority of HCBD that is unintentionally produced as a byproduct is destroyed via incineration by the manufacturer, which EPA views as being consistent with the approach taken at the international level under Article 6 of the Stockholm Convention. The remainder of the HCBD byproduct is sent off-site for incineration or for burning as a waste fuel by cement manufacturers in cement kilns EPAHQOPPT2016
07380012, an identified source category under Annex C of the Stockholm Convention. EPA views this burning of such waste as consistent with the approach taken at the international level under Article 6 of the Stockholm Convention. EPA has not identified any current intentional use of HCBD. The destruction and removal efficiency from incineration of the HCBD byproduct is expected to be significant but not complete, resulting in potential for air releases from incinerator flue gas and land releases from disposal of ash and slag. Minor water releases from equipment cleaning are possible Ref. 5.
According to EPA Toxics Release Inventory TRI data, over 9 million lbs of HCBD byproduct were generated by chemical manufacturers in reporting year 2017, with almost 8.9 million lbs treated for destruction on-site via incineration. TRI reports show other waste management activities of HCBD
byproduct including 58,000 lbs being treated for destruction off-site, 33,000
lbs burned for energy recovery off-site, and 2,400 lbs released to air Ref. 7.
Exposure information for HCBD is further detailed in EPAs Exposure and Use Assessment Ref. 5 and discussed in the Response to Comments Ref. 4.
As described in EPAs Environmental and Human Health Hazards of Five Persistent, Bioaccumulative, and Toxic Chemicals, HCBD is considered a possible human carcinogen Ref. 8.
Inhalation and oral animal data for HCBD indicate renal, reproductive, and developmental effects in rats Ref. 8.
Health effects included renal adenomas and carcinomas, reduced body weight in adults, and reduced fetal body weight.
Women who are occupationally exposed may transfer HCBD to infants via breastmilk Ref. 5.

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HCBD is toxic to aquatic life following acute and chronic exposures at very low concentrations Ref. 8. Data show acute toxicity in aquatic invertebrates, fish and algae, and chronic toxicity in fish.
A single toxicity test was identified for terrestrial organisms, showing reduced chick survival in quail. The Hazard Summary provides more information on these hazardous endpoints Ref. 8. The studies presented in the document entitled Environmental and Human Health Hazards of Five Persistent, Bioaccumulative and Toxic Chemicals Hazard Summary Ref. 8 demonstrate these hazardous endpoints. EPA did not perform a systematic review or a weight of the scientific evidence assessment for the hazard characterization of these chemicals. As a result, this hazard characterization is not definitive or comprehensive. Other hazard information on these chemicals may exist in addition to the studies summarized in the Hazard Summary that could alter the hazard characterization.
In the 2014 Update to the TSCA Work Plan for Chemical Assessments Ref. 1, HCBD scored high 3 for hazard possible human carcinogen; moderate 2 for exposure based on TRI data; and high 3 for persistence and bioaccumulation based on high environmental persistence and high bioaccumulation potential. The overall screening score for HCBD was high 8
Ref. 1.
In consideration of the production, use, and destruction of HCBD, the environmental and human health hazards of HCBD, and the public comments on the proposed rule that are further discussed in Unit III.A., EPA
determines that HCBD meets the TSCA
section 6h1A criteria. EPA
determines in accordance with TSCA
section 6h1B that, based on the Exposure and Use Assessment and the reasonably available information, exposure to HCBD under the conditions of use is likely to the general population, to a potentially exposed or susceptible subpopulation, or to the environment. EPAs determination is based on the opportunities for exposure throughout the lifecycle of HCBD, including the potential for exposures, and EPA did not receive any significant comments or information to call the exposure finding into question.
D. EPAs Proposed Rule Under TSCA
Section 6h for HCBD
EPA did not propose to regulate HCBD under TSCA section 6h because of the limited releases and given that the potential for exposure from uses of this chemical is already addressed by
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actions taken under other statutes and EPA determined further measures would not be practicable. As discussed in the proposed rule, HCBD is regulated under various statutes implemented by the Federal Government, such as the Clean Air Act CAA and Resource Conservation and Recovery Act RCRA.
According to TRI data, most of the HCBD manufactured in the United States is subsequently destroyed via incineration.
EPA, however, proposed an alternative regulatory action of prohibiting the manufacture of HCBD, which is further discussed in the proposed rule.
E. Public Comments and Other Public Input The proposed rule provided a 60-day public comment period, with a 30-day extension provided. Ref. 4. The comment period closed on October 28, 2019. EPA received a total of 48
comments, with three commenters sending multiple submissions with attached files, for a total of 58
submissions on the proposal for all the PBT chemicals. This includes the previous request for a comment period extension EPAHQOPPT20190080
0526. Two commenters submitted confidential business information CBI
or copyrighted documents with information regarding economic analysis and market trends. Copies of all the non-CBI documents, or redacted versions without CBI, are available in the docket for this action.
In this preamble, EPA has responded to the major comments relevant to the HCBD final rule. Of the comment submissions, 10 directly addressed EPAs proposal regarding HCBD.
Additional discussion related to this final action can be found in the Response to Comments document Ref.
4.
F. Activities Not Directly Regulated by This Final Rule EPA is not regulating all activities or exposures to HCBD in this rule, even though the Exposure and Use Assessment Ref. 5 identified potential for exposures under conditions of use.
One such activity is disposal. EPA
generally presumes compliance with federal and state laws and regulations, including, for example, RCRA and its implementing regulations and state laws, as well as the CAA, the Clean Water Act, and the Safe Drinking Water Act SDWA. As described in the proposed rule, regulations promulgated under the authority of the RCRA govern the disposal of hazardous and nonhazardous wastes. HCBD is listed as a
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