Today, the U.S. Environmental Protection Agency (EPA) finalized a revision to the risk determination for cyclic aliphatic bromide cluster (HBCD), finding that HBCD, as a whole chemical substance, presents an unreasonable risk of injury to human health and the environment when evaluated under its conditions of use. Uses and Risks Associated with HBCD HBCD is primarily used as an additive in building insulation, and used in solder paste, recycled plastics, and automobile replacement parts. In its revised risk determination based on the September 2020 risk evaluation, EPA found that HBCD presents unreasonable risk to workers from both short- and long-term inhalation exposure if personal protective equipment (PPE), such as respirators, is not used. The unreasonable risk presented by HBCD is driven by exposures from import, processing, commercial use, and disposal of HBCD. Risks from acute exposures include developmental effects such as decreased fetal viability and body weight. Risks can also include short-term changes in thyroid hormones, which may result in irreversible developmental outcomes such as neurotoxicity and other effects. Risks from chronic exposures can include disruption of the thyroid, which can cause other health impacts. EPA also determined in the revised risk determination that HBCD presents unreasonable risks to the environment from the import, processing, recycling, commercial use, and disposal of HBCD. EPA found risks to aquatic and sediment-dwelling organisms, including delayed hatching and reduced growth of offspring for some fish. In this revised risk determination, EPA made its determination of unreasonable risk for HBCD as a whole chemical substance. EPA used the whole chemical risk determination approach for HBCD in part because there are benchmark exceedances for multiple conditions of use (spanning across most aspects of the chemical life cycle from manufacturing (import), processing, commercial use, and disposal) for both health and the environment; HBCD is a persistent, bioaccumulative and toxic substance; and the health effects associated with HBCD exposures are irreversible. Because these chemical-specific properties cut across the conditions of use within the scope of the risk evaluation, and a substantial amount of HBCD's conditions of use drive the unreasonable risk, EPA is better positioned to achieve its TSCA objectives by issuing a whole chemical determination for HBCD. The revised risk determination supersedes the condition of use-specific no unreasonable risk determinations that were previously issued by order under TSCA section 6(i) in the September 2020 HBCD risk evaluation. EPA's revised risk determination for HBCD does not reflect an assumption that all workers always appropriately wear personal protective equipment (PPE), even though some facilities might be using PPE as one means to reduce workers' exposures. EPA understands that there could be occupational safety protections in place at workplace locations; however, not assuming use of PPE reflects EPA's recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by Occupational Safety and Health Administration (OSHA) standards, or their employers are out of compliance with OSHA standards, or because OSHA has not issued a permissible exposure limit (as is the case for HBCD). EPA's decision not to assume that PPE is always and appropriately used should not be viewed as an indication that EPA believes there is widespread non-compliance with applicable OSHA standards. In fact, EPA received public comments from industry respondents about occupational safety practices currently in use at their facilities. EPA will consider these comments, as well as other information on use of PPE and other ways industry protects its workers, as potential ways to address unreasonable risk during the risk management process. Next Steps for HBCD EPA is now moving forward on risk management to protect communities from the unreasonable risk presented by HBCD. Note that in taking this action, EPA has not conducted a new scientific analysis on this chemical and the risk evaluation continues to characterize risks associated with individual conditions of use in the risk evaluation of HBCD in order to inform risk management. In June 2021, EPA announced a path forward for the first 10 chemicals to undergo risk evaluation under the Toxic Substances Control Act (TSCA) to ensure the public is protected from unreasonable risks from these chemicals in a way that is supported by science and the law. The revised risk determination for HBCD was developed in accordance with these policy changes, as well as the Biden-Harris Administration's Executive Orders and other directives, including those on environmental justice, scientific integrity, and regulatory review. EPA's revisions ensure that the HBCD risk determination better aligns with the objectives of protecting health and the environment under the amended TSCA. |