1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-Hexamethylcyclopenta [g]-2-Benzopyran (HHCB); Phthalic Anhydride; o-Dichlorobenzene (o-DCB) and p-Dichlorobenzene (p-DCB); Science Advisory Committee on Chemicals (SACC) Peer Review; Draft Risk Evaluations; Notice of SACC Meeting; Availability of Draft Documents and Request for Comment

The American Chemistry Council is providing updated technical data regarding respirator types and life cycle stages for Phthalic Anhydride. The comment is a technical correction and submission of an appendix to the docket rather than a statement of support or opposition to the proposed action.

Chad Thompson, a Senior Managing Scientist at ToxStrategies (a BlueRidge Life Sciences Company), provides technical comments on the EPA's draft risk evaluation of Phthalic Anhydride. He supports the EPA's selection of specific uncertainty factors (UFH-TK of 1 and UFL of 3), arguing that the data and modeling support a total UF of 10.

Earthjustice, an environmental advocacy organization, opposes the draft risk evaluations for HHCB and o-dichlorobenzene. They argue that the EPA's evaluation of HHCB is impermissibly narrow in scope and that the EPA failed to apply necessary uncertainty factors to the o-dichlorobenzene risk assessment.

Julie Panko, representing ToxStrategies LLC (funded by the American Chemistry Council’s Phthalic Anhydride TSCA Risk Evaluation Consortium), argues that the EPA's risk evaluation of Phthalic Anhydride overestimates worker exposure. She recommends that the EPA use more granular job titles to avoid misclassification, use task-level data rather than extrapolated 8-hour TWAs, and account for standard operating procedures regarding dermal PPE.

Bergeson & Campbell, P.C. is submitting oral comments on behalf of Willert Home Products, an importer and processor of p-dichlorobenzene (p-DCB). The commenter supports the EPA's use of existing risk assessments and BMD modeling but argues that a specific study (Bernatowicz et al., 1994) is not robust enough to serve as the key study for acute oral toxicity.

Rashmi Joglekar, representing the Woodruff Science Policy Lab at Stanford University, argues that the EPA's draft risk evaluations for HHCB, Phthalic Anhydride, o-DCB, and p-DCB are based on incomplete evidence and scientifically unsupported assumptions. The commenter criticizes the EPA's use of industry-aligned frameworks and New Approach Methodologies (NAMs) to downplay health hazards and calls for a revision of the assessments using gold-standard systematic review methodologies.

Andreas Stucki, representing the PETA Science Consortium International, argues that the agency should exercise caution when using rat inhalation toxicity data to determine human health risks. He specifically notes that certain findings in rats, such as eosinophilic globules, may be age-related background findings rather than treatment-related effects, and advocates for the use of human-relevant in vitro and in silico methods.

Dr. Paige Varner, representing the Environmental Defense Fund, argues that the EPA's draft risk evaluation for phthalic anhydride substantially underestimates risks to the public. She identifies several deficiencies, including the failure to assess ambient air exposure for fenceline communities, the omission of mixture effects with o-phthalic acid, and the use of insufficiently protective uncertainty factors.

Adam Bettmann, representing PETA's Regulatory Toxicology Department, supports the EPA's integration of new approach methodologies (NAMs) in the risk evaluations for HHCB, phthalic anhydride, and dichlorobenzenes. He praises the use of AOP frameworks and transcriptomic data while urging the EPA to further transition toward human-relevant in vitro and in silico methods to reduce reliance on vertebrate animal testing.

Gina Hilton, a senior toxicologist at People for the Ethical Treatment of Animals (PETA), supports the EPA's use of the ReCAAP framework for the risk evaluations of o-dichlorobenzene and HHCB. She argues that this weight-of-evidence approach is scientifically sound, reduces uncertainty in risk characterization, and avoids the need for long-term rodent bioassays.