Strategies for refinement of occupational inhalation exposure evaluation in the EPA TSCA risk evaluation process.

The focus on occupational exposures in the first published risk evaluations of existing chemicals by the Environmental Protection Agency (EPA) under the amended Toxic Substances Control Act (TSCA) puts a welcome spotlight on protecting the health of workers in the United States. Because new, fit-for-purpose occupational exposure assessment methodologies were developed by EPA, the objective of this analysis was to evaluate these methodologies in light of other existing occupational risk assessment frameworks. We focused our analysis on three chlorinated chemicals (methylene chloride, carbon tetrachloride, perchloroethylene). The EPA's methods were evaluated relative to peer-reviewed and professional organizations' guidelines for conducting site- and facility-based exposure assessment. Analyses of several key phases in the EPA approach were conducted to evaluate the effect of alternative approaches on exposure estimates. The revised exposure estimates using these alternative approaches yielded substantially different exposure estimates from those in the TSCA risk evaluations for these chemicals. The results also demonstrated the importance of utilizing a tiered approach to exposure estimation that includes collecting qualitative data, defining similar exposure groups, and integrating well-parameterized models with empirical data. These approaches aid in preventing mischaracterization of exposures and generating exposure estimates representative of current industrial practices. Collaboration among industry, EPA, and other government agencies to develop a harmonized approach to exposure assessment would improve the methodological rigor of, and increase stakeholder confidence in, the results of TSCA risk evaluations.

Assessment of formaldehyde exposures under contemporary embalming conditions in U.S. funeral homes.

The funeral service profession has used formaldehyde-containing embalming solutions for the preparation of decedents since the early 1900s. The available literature regarding funeral director exposure to formaldehyde largely consists of data collected prior to 2000, with most studies reporting task-length exposure concentrations rather than full-shift time-weighted average concentrations. As formaldehyde undergoes review in the U.S. Environmental Protection Agency Toxic Substances Control Act (TSCA) risk evaluation process, accurately characterizing long-term exposure potential in this profession is critical. This study presents passive badge sampling and air change rate measurement results conducted at 13 funeral home locations across the United States. Full-shift (approximately 8-hr) samples were collected on one embalmer per day in each funeral home and on one occupational non-user (ONU), e.g., a receptionist. Additionally, task-length samples were collected during each embalming that occurred during the shift, were one to occur. Full-shift concentrations ranged from 0.007 to 1.1 ppm and 0.007 to 0.042 ppm for embalmers and ONUs, respectively. Task-length formaldehyde concentrations ranged from 0.058 to 1.4 ppm, with the average embalming taking 72.8 min to complete. Air change rates in the preparation rooms ranged from 2.8 to 28.3 air changes per hour; however, no correlation between task-length formaldehyde concentrations and air change rate was observed. Following empirical data collection, a Monte Carlo analysis of estimated annual 8-hr time-weighted average (TWA) exposure was conducted to determine the potential exposure distribution for embalmers employed at private funeral homes. Inputs to the simulation were derived from responses to a National Funeral Directors Association survey and from empirical measurements collected during the study. With respect to the reconstructed 8-hr TWAs, the median 8-hr TWA was 0.037 ppm, with 93.6% of the predicted concentrations below 0.1 ppm. This study provides a robust characterization of contemporary formaldehyde exposures in the funeral service profession. Further, it provides a strategy for interpreting the results along with surveyed responses regarding embalming frequency to better inform risks associated with formaldehyde exposure in this profession.

An evaluation of health-based federal and state PFOA drinking water guidelines in the United States.

Perfluorooctanoic acid (PFOA) is a synthetic, perfluorinated organic acid previously used in fluoropolymer production in the United States. PFOA has been a recent focal point for regulation because of its ubiquitous presence in drinking water throughout the United States. In 2016, the United States Environmental Protection Agency (US EPA) issued a lifetime drinking water Health Advisory (HA) for PFOA of 0.07 µg/L; several states have also implemented their own drinking water guidelines for PFOA. The current study aimed to evaluate the basis and derivation of state and federal guidelines for PFOA in drinking water, with particular emphasis on the exposure parameters utilized. Twelve distinct PFOA drinking water standards were identified ranging from 0.0051 to 2 µg/L. The US EPA HA assumptions were evaluated using a Monte Carlo analysis that included distributions for drinking water intake (DWI) rate and the relative source contribution (RSC). We determined that US EPA's HA of 0.07 µg/L is protective of 99% of the population of lactating women. We also demonstrated that the health-based guidelines were highly variable across states and that the actual RSC of PFOA from drinking water is likely greater than 20%, based on studies of actual PFOA exposures from dust, water, and food. A sensitivity analysis was performed using the same equations as the US EPA, while substituting the RSC and DWI variables; resulting in HAs ranging from 0.074 to 0.346 µg/L. We also evaluated the contribution of PFOA in drinking water to the systemic PFOA body burden of the general population using an available biokinetic model. We conclude that more rigorous efforts are warranted to establish consistent health-based drinking water guidelines for PFOA, given that drinking water is a primary source of human exposure to PFOA in the United States.