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.

Modelling the global economic costs of tobacco product waste.

Tobacco smoking continues to cause considerable premature mortality and morbidity worldwide. Most of the approximately six trillion cigarettes sold globally each year are discarded improperly as toxic environmental waste. Tobacco product waste, including cigarette butts, is the most commonly collected waste item worldwide. Of particular concern is the cellulose acetate filter, a poorly degradable plastic additive attached to most commercially manufactured cigarettes. This filter was introduced by the tobacco industry to reduce smokers' perception of harm and risk but it has no health benefit. To inform health policy and practice and improve public health outcomes, governments and society can benefit from cost estimates of preventing, properly disposing of and/or cleaning up tobacco product waste. Estimating the costs of tobacco product waste to communities and responsible authorities could encourage the development of health, environmental and fiscal policy interventions and shift accountability for the costs of tobacco product waste onto the global tobacco industry. To support health and environmental policy-making, we therefore propose an empirical approach to estimate the economic costs of tobacco product waste based on its negative environmental externalities. We first present general estimates for six representative countries and then identify data gaps that need to be addressed to develop global estimates. Interventions against tobacco product waste may be new channels to regulate tobacco products across sectors - for example, health, environment and finance - and consequently reduce overall tobacco use.

Le tabagisme continue à entraîner un taux de morbidité et de mortalité précoce considérable à travers le monde. La plupart des quelque six billions de cigarettes vendues chaque année à l'échelle planétaire ne sont pas correctement éliminées et deviennent une source de pollution environnementale toxique. Les déchets liés aux produits du tabac, notamment les mégots, sont les résidus les plus fréquemment collectés dans le monde. C'est surtout le filtre qui pose problème car il est composé d'acétate de cellulose, un additif plastique difficilement biodégradable que l'on retrouve dans la majorité des cigarettes commercialisées. Ce filtre a été introduit par l'industrie du tabac afin de donner aux fumeurs l'impression qu'ils courent moins de risques, alors qu'il n'a aucun effet bénéfique sur la santé. Les gouvernements et la société pourraient récolter les fruits d'une estimation des coûts engendrés par la prévention, l'élimination correcte et/ou le nettoyage des déchets liés aux produits du tabac, qui leur permettrait de mieux orienter les politiques et pratiques en la matière, mais aussi d'améliorer les résultats de santé publique. Estimer l'impact de ces déchets sur les communautés et les autorités compétentes pourrait encourager à adopter des mesures sanitaires, environnementales et fiscales, et pousser à responsabiliser davantage l'industrie mondiale du tabac vis-à-vis des coûts qu'ils entraînent. En vue de soutenir l'élaboration de politiques sanitaires et environnementales, nous proposons donc une approche empirique visant à déterminer les conséquences économiques des déchets générés par les produits du tabac en nous fondant sur l'influence néfaste qu'ils exercent sur l'environnement. Nous commençons par présenter des estimations globales pour six pays représentatifs, puis nous identifions les lacunes à combler dans les données afin de produire des estimations mondiales. Prendre des mesures de lutte contre ce type de déchets pourrait constituer un nouveau moyen de réglementer les produits du tabac dans différents secteurs comme la santé, l'environnement et les finances par exemple ­ et, par conséquent, faire diminuer la consommation de tabac en général.

El tabaquismo sigue causando una considerable tasa de mortalidad y morbilidad prematura en todo el mundo. La mayor parte de los casi seis billones de cigarrillos que se venden cada año en el mundo se desechan de forma inadecuada como residuos tóxicos para el medio ambiente. Los residuos de los productos del tabaco, incluidas las colillas, son los que más se recogen en todo el mundo. Un aspecto especialmente preocupante es el filtro de acetato de celulosa, un aditivo plástico poco degradable que se adhiere a la mayoría de los cigarrillos fabricados en el mercado. La industria del tabaco introdujo este filtro para reducir la percepción de daño y riesgo de los fumadores, pero no tiene ningún beneficio para la salud. A fin de fundamentar las políticas y prácticas sanitarias y mejorar los resultados en materia de salud pública, los gobiernos y la sociedad se pueden beneficiar de las estimaciones de costes de la prevención, la eliminación adecuada o la limpieza de los residuos de productos del tabaco. La estimación de los costes de los residuos de productos del tabaco para las comunidades y las autoridades responsables podría fomentar el desarrollo de intervenciones de política sanitaria, medioambiental y fiscal y trasladar la responsabilidad de los costes de los residuos de productos del tabaco a la industria del tabaco mundial. Para apoyar la elaboración de políticas sanitarias y medioambientales, se propone un enfoque empírico para estimar los costes económicos de los residuos de los productos del tabaco en función de sus consecuencias negativas para el medio ambiente. En primer lugar, se presentan estimaciones generales para seis países representativos y, a continuación, se identifican las deficiencias de información que se deben abordar para desarrollar estimaciones globales. Las intervenciones contra los residuos de productos del tabaco pueden constituir canales nuevos para regular los productos del tabaco en todos los sectores, por ejemplo, la salud, el medio ambiente y las finanzas, y, en consecuencia, reducir el consumo general de tabaco.

Development of an Evidence-Based Risk Assessment Framework.

Assessment of potential human health risks associated with environmental and other agents requires careful evaluation of all available and relevant evidence for the agent of interest, including both data-rich and data-poor agents. With the advent of new approach methodologies in toxicological risk assessment, guidance on integrating evidence from mul-tiple evidence streams is needed to ensure that all available data is given due consideration in both qualitative and quantitative risk assessment. The present report summarizes the discussions among academic, government, and private sector participants from North America and Europe in an international workshop convened to explore the development of an evidence-based risk assessment framework, taking into account all available evidence in an appropriate manner in order to arrive at the best possible characterization of potential human health risks and associated uncertainty. Although consensus among workshop participants was not a specific goal, there was general agreement on the key consider-ations involved in evidence-based risk assessment incorporating 21st century science into human health risk assessment. These considerations have been embodied into an overarching prototype framework for evidence integration that will be explored in more depth in a follow-up meeting.

Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks.

The workshop titled "Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks" was co-organized by the Evidence-based Toxicology Collaboration and the European Food Safety Authority (EFSA) and hosted by EFSA at its headquarters in Parma, Italy on October 2 and 3, 2019. The goal was to explore integration of systematic review with mechanistic evidence evaluation. Participants were invited to work on concrete products to advance the exploration of how evidence-based approaches can support the development and application of adverse outcome pathways (AOP) in chemical risk assessment. The workshop discussions were centered around three related themes: 1) assessing certainty in AOPs, 2) literature-based AOP development, and 3) integrating certainty in AOPs and non-animal evidence into decision frameworks. Several challenges, mostly related to methodology, were identified and largely determined the workshop recommendations. The workshop recommendations included the comparison and potential alignment of processes used to develop AOP and systematic review methodology, including the translation of vocabulary of evidence-based methods to AOP and vice versa, the development and improvement of evidence mapping and text mining methods and tools, as well as a call for a fundamental change in chemical risk and uncertainty assessment methodology if to be conducted based on AOPs and new approach methodologies (NAM). The usefulness of evidence-based approaches for mechanism-based chemical risk assessments was stressed, particularly the potential contribution of the rigor and transparency inherent to such approaches in building stakeholders' trust for implementation of NAM evidence and AOPs into chemical risk assessment.

Investigating the Feasibility of a Restaurant Delivery Service to Improve Food Security among College Students Experiencing Marginal Food Security, a Head-to-Head Trial with Grocery Store Gift Cards.

Restaurant delivery services have gained in popularity among college students; however, students participating in the Supplemental Nutrition Assistance Program (SNAP) are not allowed to redeem their benefits via restaurant delivery services. This mixed-methods head-to-head crossover trial assessed whether college students experiencing marginal food security prefer benefits via a grocery store gift card (as a proxy for traditional SNAP benefits) or via a restaurant delivery service gift card of equivalent value, and which type of benefit is more effective at improving food security status. Thirty college students experiencing marginal food security were recruited to receive $80 in cash equivalent benefits to spend over a two-month period in the form of grocery store gift cards and restaurant delivery service gift cards. Participants completed surveys and interviews to measure their food security status and share their experiences with each benefit type. After four months of benefits, 48.3% of participants improved their food security status. However, neither type of benefit was statistically better at improving food security status. Most participants preferred grocery store benefits (89.7%) over restaurant delivery service benefits (10.3%). However, more research is needed to explore whether allowing SNAP recipients to redeem their benefits with restaurant delivery services is a viable mechanism to address food challenges among college students experiencing marginal food security.

Exposure to formaldehyde and asthma outcomes: A systematic review, meta-analysis, and economic assessment.

BACKGROUND: Every major federal regulation in the United States requires an economic analysis estimating its benefits and costs. Benefit-cost analyses related to regulations on formaldehyde exposure have not included asthma in part due to lack of clarity in the strength of the evidence. OBJECTIVES: 1) To conduct a systematic review of evidence regarding human exposure to formaldehyde and diagnosis, signs, symptoms, exacerbations, or other measures of asthma in humans; and 2) quantify the annual economic benefit for decreases in formaldehyde exposure. METHODS: We developed and registered a protocol in PROSPERO (Record ID #38766, CRD 42016038766). We conducted a comprehensive search of articles published up to April 1, 2020. We evaluated potential risk of bias for included studies, identified a subset of studies to combine in a meta-analysis, and rated the overall quality and strength of the evidence. We quantified economics benefit to children from a decrease in formaldehyde exposure using assumptions consistent with EPA's proposed formaldehyde rule. RESULTS: We screened 4,821 total references and identified 150 human studies that met inclusion criteria; of these, we focused on 90 studies reporting asthma status of all participants with quantified measures of formaldehyde directly relevant to our study question. Ten studies were combinable in a meta-analysis for childhood asthma diagnosis and five combinable for exacerbation of childhood asthma (wheezing and shortness of breath). Studies had low to probably-low risk of bias across most domains. A 10-µg/m3 increase in formaldehyde exposure was associated with increased childhood asthma diagnosis (OR = 1.20, 95% CI: [1.02, 1.41]). We also found a positive association with exacerbation of childhood asthma (OR = 1.08, 95% CI: [0.92, 1.28]). The overall quality and strength of the evidence was rated as "moderate" quality and "sufficient" for asthma diagnosis and asthma symptom exacerbation in both children and adults. We estimated that EPA's proposed rule on pressed wood products would result in 2,805 fewer asthma cases and total economic benefit of $210 million annually. CONCLUSION: We concluded there was "sufficient evidence of toxicity" for associations between exposure to formaldehyde and asthma diagnosis and asthma symptoms in both children and adults. Our research documented that when exposures are ubiquitous, excluding health outcomes from benefit-cost analysis can underestimate the true benefits to health from environmental regulations.

Cumulative Risk and Impact Modeling on Environmental Chemical and Social Stressors.

PURPOSE OF REVIEW: The goal of this review is to identify cumulative modeling methods used to evaluate combined effects of exposures to environmental chemicals and social stressors. The specific review question is: What are the existing quantitative methods used to examine the cumulative impacts of exposures to environmental chemical and social stressors on health? RECENT FINDINGS: There has been an increase in literature that evaluates combined effects of exposures to environmental chemicals and social stressors on health using regression models; very few studies applied other data mining and machine learning techniques to this problem. The majority of studies we identified used regression models to evaluate combined effects of multiple environmental and social stressors. With proper study design and appropriate modeling assumptions, additional data mining methods may be useful to examine combined effects of environmental and social stressors.

Implementing systematic review techniques in chemical risk assessment: Challenges, opportunities and recommendations.

Systematic review (SR) is a rigorous, protocol-driven approach designed to minimise error and bias when summarising the body of research evidence relevant to a specific scientific question. Taking as a comparator the use of SR in synthesising research in healthcare, we argue that SR methods could also pave the way for a "step change" in the transparency, objectivity and communication of chemical risk assessments (CRA) in Europe and elsewhere. We suggest that current controversies around the safety of certain chemicals are partly due to limitations in current CRA procedures which have contributed to ambiguity about the health risks posed by these substances. We present an overview of how SR methods can be applied to the assessment of risks from chemicals, and indicate how challenges in adapting SR methods from healthcare research to the CRA context might be overcome. Regarding the latter, we report the outcomes from a workshop exploring how to increase uptake of SR methods, attended by experts representing a wide range of fields related to chemical toxicology, risk analysis and SR. Priorities which were identified include: the conduct of CRA-focused prototype SRs; the development of a recognised standard of reporting and conduct for SRs in toxicology and CRA; and establishing a network to facilitate research, communication and training in SR methods. We see this paper as a milestone in the creation of a research climate that fosters communication between experts in CRA and SR and facilitates wider uptake of SR methods into CRA.