A science-based agenda for health-protective chemical assessments and decisions: overview and consensus statement.

The manufacture and production of industrial chemicals continues to increase, with hundreds of thousands of chemicals and chemical mixtures used worldwide, leading to widespread population exposures and resultant health impacts. Low-wealth communities and communities of color often bear disproportionate burdens of exposure and impact; all compounded by regulatory delays to the detriment of public health. Multiple authoritative bodies and scientific consensus groups have called for actions to prevent harmful exposures via improved policy approaches. We worked across multiple disciplines to develop consensus recommendations for health-protective, scientific approaches to reduce harmful chemical exposures, which can be applied to current US policies governing industrial chemicals and environmental pollutants. This consensus identifies five principles and scientific recommendations for improving how agencies like the US Environmental Protection Agency (EPA) approach and conduct hazard and risk assessment and risk management analyses: (1) the financial burden of data generation for any given chemical on (or to be introduced to) the market should be on the chemical producers that benefit from their production and use; (2) lack of data does not equate to lack of hazard, exposure, or risk; (3) populations at greater risk, including those that are more susceptible or more highly exposed, must be better identified and protected to account for their real-world risks; (4) hazard and risk assessments should not assume existence of a "safe" or "no-risk" level of chemical exposure in the diverse general population; and (5) hazard and risk assessments must evaluate and account for financial conflicts of interest in the body of evidence. While many of these recommendations focus specifically on the EPA, they are general principles for environmental health that could be adopted by any agency or entity engaged in exposure, hazard, and risk assessment. We also detail recommendations for four priority areas in companion papers (exposure assessment methods, human variability assessment, methods for quantifying non-cancer health outcomes, and a framework for defining chemical classes). These recommendations constitute key steps for improved evidence-based environmental health decision-making and public health protection.

Current practice and recommendations for advancing how human variability and susceptibility are considered in chemical risk assessment.

A key element of risk assessment is accounting for the full range of variability in response to environmental exposures. Default dose-response methods typically assume a 10-fold difference in response to chemical exposures between average (healthy) and susceptible humans, despite evidence of wider variability. Experts and authoritative bodies support using advanced techniques to better account for human variability due to factors such as in utero or early life exposure and exposure to multiple environmental, social, and economic stressors.This review describes: 1) sources of human variability and susceptibility in dose-response assessment, 2) existing US frameworks for addressing response variability in risk assessment; 3) key scientific inadequacies necessitating updated methods; 4) improved approaches and opportunities for better use of science; and 5) specific and quantitative recommendations to address evidence and policy needs.Current default adjustment factors do not sufficiently capture human variability in dose-response and thus are inadequate to protect the entire population. Susceptible groups are not appropriately protected under current regulatory guidelines. Emerging tools and data sources that better account for human variability and susceptibility include probabilistic methods, genetically diverse in vivo and in vitro models, and the use of human data to capture underlying risk and/or assess combined effects from chemical and non-chemical stressors.We recommend using updated methods and data to improve consideration of human variability and susceptibility in risk assessment, including the use of increased default human variability factors and separate adjustment factors for capturing age/life stage of development and exposure to multiple chemical and non-chemical stressors. Updated methods would result in greater transparency and protection for susceptible groups, including children, infants, people who are pregnant or nursing, people with disabilities, and those burdened by additional environmental exposures and/or social factors such as poverty and racism.

Toxic Substances Control Act (TSCA) Implementation: How the Amended Law Has Failed to Protect Vulnerable Populations from Toxic Chemicals in the United States.

Exposures to industrial chemicals are widespread and can increase the risk of adverse health effects such as cancer, developmental disorders, respiratory effects, diabetes, and reproductive problems. The amended Toxic Substances Control Act (amended TSCA) requires the U.S. Environmental Protection Agency (EPA) to evaluate risks of chemicals in commerce, account for risk to potentially exposed and susceptible populations, and mitigate risks for chemicals determined to pose an unreasonable risk to human health and the environment. This analysis compares EPA's first 10 chemical risk evaluations under amended TSCA to best scientific practices for conducting risk assessments. We find EPA's risk evaluations underestimated human health risks of chemical exposures by excluding conditions of use and exposure pathways; not considering aggregate exposure and cumulative risk; not identifying all potentially exposed or susceptible subpopulations, and not quantifying differences in risk for susceptible groups; not addressing data gaps; and using flawed systematic review approaches to identify and evaluate the relevant evidence. We present specific recommendations for improving the implementation of amended TSCA using the best available science to ensure equitable, socially just safeguards to public health. Failing to remedy these shortcomings will result in continued systematic underestimation of risk for all chemicals evaluated under amended TSCA.

Using wildland fire smoke modeling data in gerontological health research (California, 2007-2018).

Widespread population exposure to wildland fire smoke underscores the urgent need for new techniques to characterize fire-derived pollution for epidemiologic studies and to build climate-resilient communities especially for aging populations. Using atmospheric chemical transport modeling, we examined air quality with and without wildland fire smoke PM2.5. In 12-km gridded output, the 24-hour average concentration of all-source PM2.5 in California (2007-2018) was 5.16 µg/m3 (S.D. 4.66 µg/m3). The average concentration of fire-PM2.5 in California by year was 1.61 µg/m3 (~30% of total PM2.5). The contribution of fire-source PM2.5 ranged from 6.8% to 49%. We define a "smokewave" as two or more consecutive days with modeled levels above 35 µg/m3. Based on model-derived fire-PM2.5, 99.5% of California's population lived in a county that experienced at least one smokewave from 2007 to 2018, yet understanding of the impact of smoke on the health of aging populations is limited. Approximately 2.7 million (56%) of California residents aged 65+ years lived in counties representing the top 3 quartiles of fire-PM2.5 concentrations (2007-2018). For each year (2007-2018), grid cells containing skilled nursing facilities had significantly higher mean concentrations of all-source PM2.5 than cells without those facilities, but they also had generally lower mean concentrations of wildland fire-specific PM2.5. Compared to rural monitors in California, model predictions of wildland fire impacts on daily average PM2.5 carbon (organic and elemental) performed well most years but tended to overestimate wildland fire impacts for high-fire years. The modeling system isolated wildland fire PM2.5 from other sources at monitored and unmonitored locations, which is important for understanding exposures for aging population in health studies.

The Promise and Challenge of Integrating Multidisciplinary and Civically Engaged Learning.

Today's students need to become specialists in their profession while also recognizing the blinders that specialization brings- they need both disciplinary and meta-disciplinary learning. Today's universities need to innovate by providing an education responsive to contemporary demands. They also need to show their relevance to the broader publics they serve. This article critically assesses a teaching initiative that brings together existing courses from multiple disciplines working for publicoriented clients to collaborate on closely related problems. The Michigan Engaging Community through the Classroom initiative was designed to enhance students' learning by making them smarter, more pragmatic, and wiser while simultaneously enhancing the university's public service. This article assesses the promise and the challenges of such a complex initiative and summarizes preliminary findings from student and community partner evaluations. The initiative has been challenging to implement because of the faculty dedication it requires. Developing robust evaluations of student learning has proven difficult as well. We have found that when student, faculty, and partner expectations are raised but not fulfilled, frustrations run high. When coordination and collaboration align, however, student learning can be enriched and public service enhanced. The article concludes by discussing lessons learned and presenting models of collaboration developed in turn.

Assessing perceptions and priorities for health impacts of climate change within local Michigan health departments.

Climate change affects Michigan's public health in several primary ways, including increased incidences of vector-borne, waterborne, heat-related, and respiratory illness. Because local health departments (LHDs) play a central role in surveillance and preventative health services, they are among the first institutions to contend with the local impacts of climate change. To assess current perceptions among Michigan public health officials, an online survey was conducted in partnership with the Michigan Association for Local Public Health (MALPH). Most of the Michigan respondents (62%, n = 34) agreed that their jurisdictions have experienced climate change in the last 20 years, and 77% agreed that climate change will impact their jurisdictions in the coming 20 years. However, only 35% (n = 34) of Michigan officials agreed that climate change is a priority in their departments. About one quarter (25%, n = 34) of Michigan LHD respondents did not know about the level of expertise of either the state and federal agencies, responsible for assisting them with information and programs related to climate change and health. Uncertainty regarding the resources available to them may hinder LHDs from developing necessary preparedness, so meeting this need could bolster the public health response to climate change. Supplementary Information: The online version contains supplementary material available at 10.1007/s13412-021-00679-0.

Mapping Modeled Exposure of Wildland Fire Smoke for Human Health Studies in California.

Wildland fire smoke exposure affects a broad proportion of the U.S. population and is increasing due to climate change, settlement patterns and fire seclusion. Significant public health questions surrounding its effects remain, including the impact on cardiovascular disease and maternal health. Using atmospheric chemical transport modeling, we examined general air quality with and without wildland fire smoke PM2.5. The 24-h average concentration of PM2.5 from all sources in 12-km gridded output from all sources in California (2007-2013) was 4.91 µg/m3. The average concentration of fire-PM2.5 in California by year was 1.22 µg/m3 (~25% of total PM2.5). The fire-PM2.5 daily mean was estimated at 4.40 µg/m3 in a high fire year (2008). Based on the model-derived fire-PM2.5 data, 97.4% of California's population lived in a county that experienced at least one episode of high smoke exposure ("smokewave") from 2007-2013. Photochemical model predictions of wildfire impacts on daily average PM2.5 carbon (organic and elemental) compared to rural monitors in California compared well for most years but tended to over-estimate wildfire impacts for 2008 (2.0 µg/m3 bias) and 2013 (1.6 µg/m3 bias) while underestimating for 2009 (-2.1 µg/m3 bias). The modeling system isolated wildfire and PM2.5 from other sources at monitored and unmonitored locations, which is important for understanding population exposure in health studies. Further work is needed to refine model predictions of wildland fire impacts on air quality in order to increase confidence in the model for future assessments. Atmospheric modeling can be a useful tool to assess broad geographic scale exposure for epidemiologic studies and to examine scenario-based health impacts.

MI-Environment: Geospatial patterns and inequality of relative heat stress vulnerability in Michigan.

Heat stress causes morbidity and mortality and is increasing with climate change. Heat stress can pose particular challenges in northern regions not well adapted to heat. To assist decision makers, we identified the relative vulnerability of census tracts within Michigan to factors that increase exposure to heat stress or reflect susceptibilities in the population based on a California heat vulnerability index. In the MI-Environment assessment, we used a Geographic Information System (GIS) to combine future ensemble climate model projections to create a total of 9 geospatial and demographic variables. As part of a broader planned cumulative environmental exposure assessment, the statewide heat vulnerability index (HVI) maps display the location and relative magnitude of exposure on three metrics: built environment (Place), future expected long-term temperature averages (Temperature), and population susceptibility (People). We observed varied and distinct patterns for each of the three component indices. We assessed how equitably those exposures are distributed by racial and socioeconomic factors. This analysis showed that each of the component indices and the aggregate HVI are disproportionately distributed along racial and socioeconomic lines in Michigan. Census tracts with higher percentages of people of color had larger exposure to HVI factors with a deviation from equity of -0.115 [95% CI -0.108, -0.122]. Similarly, for census tracts with higher percentage of people experiencing poverty, the deviation from equity was -0.101 [95% CI -0.094, -0.107]. The MI-Environment visualization tool can help communities prepare for climate change and resolve inequities by identifying census tracts with the most vulnerable residents and highest potential exposures.

Population susceptibility: A vital consideration in chemical risk evaluation under the Lautenberg Toxic Substances Control Act.

The 2016 Frank Lautenberg Chemical Safety for the 21st Century Act (Lautenberg TSCA) amended the 1976 Toxic Substances Control Act (TSCA) to mandate protection of susceptible and highly exposed populations. Program implementation entails a myriad of choices that can lead to different degrees of public health protections. Well-documented exposures to multiple industrial chemicals occur from air, soil, water, food, and products in our workplaces, schools, and homes. Many hazardous chemicals are associated with or known to cause health risks; for other industrial chemicals, no data exist to confirm their safety because of flaws in 1976 TSCA. Under the 2016 Lautenberg amendments, the United States Environmental Protection Agency (EPA) must evaluate chemicals against risk-based safety standards under enforceable deadlines, with an explicit mandate to identify and assess risks to susceptible and highly exposed populations. Effective public health protection requires EPA to implement the Lautenberg TSCA requirements by incorporating intrinsic and extrinsic factors that affect susceptibility, adequately assessing exposure among vulnerable groups, and accurately identifying highly exposed groups. We recommend key scientific and risk assessment principles to inform health-protective chemical policy such as consideration of aggregate exposures from all pathways and, when data are lacking, the use of health-protective defaults.

Examining Joint Effects of Air Pollution Exposure and Social Determinants of Health in Defining "At-Risk" Populations Under the Clean Air Act: Susceptibility of Pregnant Women to Hypertensive Disorders of Pregnancy.

Pregnant women are uniquely susceptible to adverse effects of air pollution exposure due to vulnerabilities and health consequences during pregnancy (e.g., hypertensive disorders of pregnancy [HDP]) compared to the general population. Because the Clean Air Act (CAA) creates a duty to protect at-risk groups, the regulatory assessment of at-risk populations has both policy and scientific foundations. Previously, pregnant women have not been specially protected in establishing the margin of safety for the ozone and particulate matter (PM) standards. Due to physiological changes, pregnant women can be at greater risk of adverse effects of air pollution and should be considered an at-risk population. Women with preexisting conditions, women experiencing poverty, and groups that suffer systematic discrimination may be particularly susceptible to cardiac effects of air pollutants during pregnancy. We rigorously reviewed 11 studies of over 1.3 million pregnant women in the United States to characterize the relationship between ozone or PM exposure and HDP. Findings were generally mixed, with a few studies reporting a joint association between ozone or PM and social determinants or pre-existing chronic health conditions related to HDP. Adequate evidence associates exposure to PM with an adverse effect of HDP among pregnant women not evident among non-gravid populations.

Overlooking the coast: Limited local planning for coastal area management along Michigan's Great Lakes.

This paper presents an evaluation of local efforts to manage Great Lakes coastal shorelands through master plans, focusing on Michigan localities. We framed the analysis around the concepts of capacity, knowledge, and commitment. We conducted plan content evaluations, structured surveys of local officials, and multiple unstructured interviews of local officials and citizens through a participatory action research (PAR) program. We analyzed those data, along with census data, using descriptive statistics, correlations, regression analyses, and triangulation of observations. We found that Michigan's coastal localities are largely failing to consider their coastal areas in their planning, or to adopt meaningful plan policies to manage them, for at least four reasons: damaging erosion and storm events have been relatively infrequent; localities rely on the state to address coastal issues; insurance programs effectively indemnify them when a storm does happen; and-to some extent-shoreland owners push back against proactive local management. To the extent localities are planning, higher overall plan quality is associated with having in-house planning staff (a measure of both capacity and knowledge) and development pressure (knowledge and commitment). To the extent plans address their coastal areas specifically, the adoption of plan policies advancing coastal area management is associated directly with having higher median house values (capacity), in-house planning staff (capacity and knowledge), and development pressure (knowledge and commitment). Focus on coastal management is inversely associated, however, with the use of planning consultants. Higher plan quality is correlated significantly with the adoption of more robust plan policies overall. In sum, having knowledge about coastal dynamics appears important in explaining local planning efforts, but having the capacity to act on that knowledge and the commitment to do so are equally or more important.

Ozone Exposure, Cardiopulmonary Health, and Obesity: A Substantive Review.

From 1999-2014, obesity prevalence increased among adults and youth. Obese individuals may be uniquely susceptible to the proinflammatory effects of ozone because obese humans and animals have been shown to experience a greater decline in lung function than normal-weight subjects. Obesity is independently associated with limitations in lung mechanics with increased ozone dose. However, few epidemiologic studies have examined the interaction between excess weight and ozone exposure among adults. Using PubMed keyword searches and reference lists, we reviewed epidemiologic evidence to identify potential response-modifying factors and determine if obese or overweight adults are at increased risk of ozone-related health effects. We initially identified 170 studies, of which seven studies met the criteria of examining the interaction of excess weight and ozone exposure on cardiopulmonary outcomes in adults, including four short-term ozone exposure studies in controlled laboratory settings and three community epidemiologic studies. In the studies identified, obesity was associated with decreased lung function and increased inflammatory mediators. Results were inconclusive about the effect modification when data were stratified by sex. Obese and overweight populations should be considered as candidate at-risk groups for epidemiologic studies of cardiopulmonary health related to air pollution exposures. Air pollution is a modifiable risk factor that may decrease lung function among obese individuals with implications for environmental and occupational health policy.