1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-Hexamethylcyclopenta [g]-2-Benzopyran (HHCB) and Phthalic Anhydride Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comment

A group of scientists, academics, and clinicians, including representatives from Stanford University, argue that the EPA's draft risk evaluation for HHCB fails to use the "best available science." They contend that the EPA used deficient study quality metrics, ignored significant health hazards like thyroid effects, and relied on industry-aligned frameworks to downplay risks.

The commenter is providing scientific research and data regarding the presence and removal of synthetic musk fragrances, specifically HHCB, in drinking water treatment plants. The submission appears to be a technical data contribution rather than a direct expression of support or opposition to the draft risk evaluation.

The Natural Resources Defense Council and Earthjustice argue that the EPA's use of new approach methods (NAMs) in the draft risk evaluations for HHCB and dichlorobenzenes is unjustified and inconsistent with "best available science." They contend that the EPA is relying on insufficient 5-day transcriptomic studies to dismiss evidence of carcinogenicity and is failing to follow its own guidance regarding uncertainty factors and the inclusion of both male and female test subjects.

The Fragrance Creators Association (FCA) supports the EPA's draft risk evaluation concluding that HHCB does not present an unreasonable risk to human health or the environment. They argue that the evaluation is based on robust scientific evidence and real-world industry practices, and they encourage the EPA to finalize this determination to provide regulatory certainty.

The U.S. Environmental Protection Agency (EPA) submitted a brief in support of its own 2024 Rule regarding procedures for chemical risk evaluation under the Toxic Substances Control Act (TSCA). The EPA argues that its framework correctly requires holistic risk evaluations considering all conditions of use, a single risk determination per chemical, and the inclusion of "overburdened communities" as a susceptible subpopulation.

The commenter is submitting a scientific study on behalf of several environmental and health advocacy organizations (including Earthjustice and the Natural Resources Defense Council). The study provides evidence of the distribution, volatilization, and environmental persistence of HHCB in the Great Lakes, supporting the need for risk evaluation and monitoring.

The Science Advisory Committee on Chemicals (SACC), a federal advisory committee, submitted meeting minutes and a final report regarding the peer review of the EPA's draft risk evaluation for formaldehyde. The document provides a scientific review and recommendations on various aspects of the evaluation, including human health hazards, environmental pathways, and occupational assessments.

The People’s Republic of China submitted comments regarding the draft risk evaluations for HHCB and Phthalic Anhydride. They request that the EPA recognize equivalent overseas safety measures, clarify specific high-risk conditions of use to avoid broad trade restrictions, and provide precise definitions for "spray-type" consumer products.

A coalition of environmental and health advocacy organizations opposes the EPA's draft risk evaluation of HHCB, arguing that the agency failed to assess all conditions of use and ignored significant exposure pathways. They contend that the EPA's "tiered approach" is unlawful under TSCA and that the agency failed to incorporate "reasonably available" toxicity studies and aggregate exposure data.

The commenter is providing supporting documentation for comments submitted by several advocacy organizations regarding the EPA's draft risk evaluation for HHCB. The text provided is a table of contents for a risk evaluation for 1,2-Dichloroethane, which appears to be an unrelated document or a technical attachment.