Federal Register - January 6, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations information for decaBDE is detailed in EPAs Exposure and Use Assessment Ref. 4, and the proposal. There is potential for exposure to decaBDE under the conditions of use at all stages of its lifecycle i.e., manufacturing, processing, use industrial, commercial, and consumer, distribution, and disposal of the chemical Ref 4.
DecaBDE was produced and released at higher levels in the past but continues to be released. Releases from manufacturing and processing are declining over time, as are releases associated with use, disposal, and recycling Ref. 4.
Exposure assessments on decaBDE
have been conducted by EPA including industry-supplied information as part of the Voluntary Childrens Chemical Evaluation Program, the National Academy of Sciences, and international governments. These assessments describe exposure potential for polybrominated diphenyl ethers PBDEs, including decaBDE, through a variety of pathways. Adult and child exposures occur via dust ingestion, dermal contact with dust, and dietary exposures such as dairy consumption.
Household consumer products have been identified as the main source of PBDEs including decaBDE in house dust. The next highest exposure pathways included dairy ingestion, and inhalation of indoor air via dust. Infant and child exposures occur via breastmilk ingestion and mouthing of hard plastic toys and fabrics.
Occupational exposures for breastfeeding women were highest in women engaged in activities resulting in direct contact with decaBDE Ref. 4.
DecaBDE is toxic to aquatic invertebrates, fish, and terrestrial invertebrates. Data indicate the potential for developmental, neurological, and immunological effects, general developmental toxicity and liver effects in mammals. There was some evidence of genotoxicity and carcinogenicity. The studies presented in the document entitled Environmental and Human Health Hazards of Five Persistent, Bioaccumulative and Toxic Chemicals Hazard Summary Ref. 9 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
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Assessments Ref. 1, decaBDE scored high 3 for hazard based on developmental effects in mammals and aquatic toxicity; high 3 for exposure based on its use in textiles, plastics, and polyurethane foam; and information reported to the 2012 and 2016 Chemical Data Reporting CDR and the 2017
Toxics Release Inventory TRIRef.
10,11,12; and high 3 for persistence and bioaccumulation based on high environmental persistence and high bioaccumulation potential. The overall screening score for decaBDE was high 9.
Taking all this into account, and the discussion in Response to Comments Document and in this preamble, EPA
determines in this final rule that decaBDE meets the TSCA section 6h1A criteria. In addition, EPA
determines, in accordance with TSCA
section 6h1B, that, based on the Exposure and Use Assessment and other reasonably-available information, exposure to decaBDE is likely under the conditions of use to the general population, to a potentially exposed or susceptible subpopulation, or the environment. EPAs determination is based on the opportunities for exposure throughout the lifecycle of decaBDE, including the potential for consumer exposures. EPA did not receive any comments with information to call the exposure finding into question.
D. EPAs Proposed Rule Under TSCA
Section 6h for decaBDE
In the proposed rule 84 FR 36728, EPA proposed to prohibit the manufacture including import, processing, and distribution in commerce of decaBDE, and articles and products to which decaBDE has been added. Proposed compliance dates or exclusions from the date of publication of the prohibition included:
18 months for any manufacture, processing and distribution in commerce of decaBDE for use in curtains in the hospitality industry, and the curtains to which decaBDE has been added.
Three years for manufacture, processing and distribution in commerce of decaBDE for use in parts installed in and distributed as part of new aerospace vehicles, and the parts to which decaBDE has been added for such vehicles.
The exclusion from prohibitions for manufacturing including import, processing, and distribution in commerce for use in replacement parts for motor and aerospace vehicles, and the replacement parts to which decaBDE
has been added for such vehicles.
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The exclusion from prohibitions for processing and distribution in commerce for recycling of plastic that contains decaBDE, i.e., the plastic to be recycled is from products and articles that were originally made with decaBDE, so long as no new decaBDE
is added during the recycling process.
The exclusion from processing and distribution in commerce of finished products and articles made from plastic recycled from products and articles containing decaBDE, where no new decaBDE was added during the production of the products and articles.
In addition, EPA proposed to require that all persons who manufacture, process, or distribute in commerce decaBDE and decaBDE-containing products and articles maintain ordinary business records, such as invoices and bills-of-lading, that demonstrate compliance with the prohibitions and restrictions. EPA proposed that these records would have to be maintained for a period of three years from the date the record is generated with an exclusion for persons processing and distributing in commerce for recycling of plastic that contains decaBDE, and those products or articles containing decaBDE from recycled plastic, as long as no new decaBDE was added during the recycling process.
E. Public Comments and Other Public Input The proposed rule provided a 60-day public comment period, with a 30-day extension provided. Ref. 5 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. EPA also communicated with companies, and other stakeholders to identify and verify uses of decaBDE. These interactions and comments further informed EPAs understanding of the current status of uses for decaBDE. Public comments and stakeholder meeting summaries are available in the public docket at EPA
HQOPPT20190080.
In this preamble, EPA has responded to the major comments relevant to the decaBDE final rule. Of the comment
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