Health impact assessment should be based on correct methods.

The methodology of health impact assessment (HIA), originally proposed by WHO, is widely used to predict the potential health effects in a community living in a place in which a new project (e.g., an industrial plant) will be implemented. One of the key quantities to calculate the impact (i.e., the number of attributable cases) is the baseline (i.e., before the project implementation) rate of selected diseases in the community. In a recent paper on this journal, this methodology has been challenged. Specifically, the use of baseline rate has been questioned, proposing to use only the fraction of the baseline rate due to the exposures related to the project, and not the rate due to all risk factors for the disease. In this commentary, we argue that the proposal is logically and epidemiologically unsound, and devoid of scientific motivation. The conclusion that the traditional approach overestimates the health impact should be rejected as based on flawed assumptions. On the contrary, the proposal may produce a (seriously biased) underestimation of attributable cases.

[Health impact: considering only a plant assessment is not enough, an area assessment is also needed]. / Impatto sanitario: la valutazione del singolo impianto non è sufficiente, occorre anche una valutazione di area.

Environmental Impact Assessments (EIAs) often conclude with a "low" or at least "negligible" final health impact assessment (HIA) of the industrial plant under assessment. We explore the reasons for this - often simplistic - conclusion and offer suggestions on how to extend the assessment focus from just the plant to an appropriate impact area. For many assessments, the conclusions are easily predictable: the application of available risk functions to modest increases in pollution, in the presence of numerically small populations in the areas of greatest fallout and considering rather rare health outcomes, can only result in quantitatively modest health impacts. This is the classic situation of low sensitivity of the observation system due to the impossibility of containing the type II error (false negatives) since we cannot increase the exposed population at will. The risk is to give the green light to an industrial plant in which the apparently null or very limited damage is simply not properly detectable. There is hardly any trace of these elements in the HIA scoping phase. In environmental complex territories, the renewal or authorization of a new plant should consider not only the impact of the individual plant, but also the health profile of the population concerned and the context in which the industrial project is located. An 'HIA area' is therefore configured, aimed at the complex of environmental pressure factors that insist on the same area of impact of the plant. Epidemiology focuses on the exposed population, considers the 'current' state of health, hazard, and risk information from toxicology, and estimates individual exposure and the effects of exposure. The 'HIA area' can assess the impact of the complex of persistent emission sources, considering in the analysis the health status of the exposed population and the presence of specific vulnerabilities. The proposal is in line with what is already foreseen in the Essential levels of care and Environmental technical performance of the National Health Service.A basic condition is the establishment of functions dedicated to integrated environmental and health surveillance to update the health profile and carry out the 'HIA area' as an accompanying tool for local strategic planning. On these issues, the Italian Environment and Health Network (RIAS) has opened a discussion within the network and with any Italian regions.

[Exposure assessment of air pollution in Italy 2016-2019 for future studies on air pollution and COVID-19]. / La valutazione dell'esposizione della popolazione italiana all'inquinamento atmosferico nel periodo 2016-2019 per lo studio della relazione tra inquinamento atmosferico e COVID-19.

Air pollution is one of the leading causes of death worldwide, with adverse effects related both to short-term and long-term exposure. It has also recently been linked to COVID-19 pandemic. To analyze this possible association in Italy, studies on the entire area of the peninsula are necessary, both urban and non-urban areas. Therefore, there is a need for a homogeneous and applicable exposure assessment tool throughout the country.Experiences of high spatio-temporal resolution models for Italian territory already exist for PM estimation, using space-time predictors, satellite data, air quality monitoring data.This work completes the availability of these estimations for the most recent years (2016-2019) and is also applied to nitrogen oxides and ozone. The spatial resolution is 1x1 km.The model confirms its capability of capturing most of PM variability (R2=0.78 and 0.74 for PM10 e PM2.5, respectively), and provides reliable estimates also for ozone (R2=0.76); for NO2 the model performance is lower (R2=0.57). The model estimations were used to calculate the PWE (population-weighted exposure) as the annual mean, weighted on the resident population in each individual cell, which represents the estimation of the Italian population's chronic exposure to air pollution.These estimates are ready to be used in studies on the association between chronic exposure to air pollution and COVID-19 pathology, as well as for investigations on the role of air pollution on the health of the Italian population.

Methods and data needs to assess health impacts of chemicals in industrial contaminated sites.

BACKGROUND: human exposure to mixtures of chemicals of toxicological interest, typically found in industrial contaminated sites (ICSs), has been associated with a broad range of different health outcomes. Deprived population groups endure most of the burden of disease and premature death associated to the exposure to those pollutants. Characterising the impacts on health of an ICS is a challenging process. Currently the two main methodological approaches used are Human Health Risk Assessment (HHRA) and Environmental Epidemiological (EE) studies. OBJECTIVES: review existing guidance and scientific evidence for HHRA and EE studies applied to contaminated sites that orientate in selecting the most suitable methodological approach for characterising health impacts in ICSs according to the site characteristics, and the availability of environmental, health and sociodemographic data. RESULTS: HHRA has evolved into a more holistic approach, placing more emphasis in planning, community involvement and adapting the dimension of the assessment to the problem formulation and to the availability of resources. Many different HHRA guidelines for contaminated sites has been published worldwide, and although they share a similar framework, the scientific evidence used for deriving reference values and the variet of policy options can result in a wide variability of health risk estimates. This paper condenses different options with the recommendations to use those tools, default values for environmental and exposure levels and toxicological reference values that most suit to the population and characteristics of the ICSs under evaluation. CONCLUSIONS: the suitability to use one or another approach to assess the impact of ICSs on health depends on the availability of data, cost-benefit aspects and the kind of problem that needs to be answered. Risk assessment based on toxicological data can be very rapid and cheap, providing direct information when the intervention to protect the health of population is urgent and no suitable dose-response functions are available from epidemiological studies. Conducting EE studies provide a deeper insight into the problem of the exposure to industrial pollutants that do not require extrapolation from data obtained from toxicological studies or other population, addressing the community concern's more directly. Complementing the results obtained from different approaches, including those from public health surveillance systems, might provide an efficient and complete response to the impact of ICSs.

Human biomonitoring as a tool for exposure assessment in industrially contaminated sites (ICSs). Lessons learned within the ICS and Health European Network.

BACKGROUND: the mixed and complex nature of industrially contaminated sites (ICSs) leads to heterogeneity in exposure and health risk of residents living nearby. Health, environment, and social aspects are strongly interconnected in ICSs, and local communities are often concerned about potential health impact and needs for remediation. The use of human biomonitoring (HBM) for impact assessment of environmental exposure is increasing in Europe. The COST Action IS1408 on Industrially Contaminated Sites and Health Network (ICSHNet) decided to reflect on the potential and limitations of HBM to assess exposure and early health effects associated with living near ICSs. OBJECTIVES: to discuss challenges and lessons learned for addressing environmental health impact near ICSs with HBM in order to identify needs and priorities for HBM guidelines in European ICSs. METHODS: based on the experience of the ICSHNet research team, six case studies from different European regions that applied HBM at ICSs were selected. The case studies were systematically compared distinguishing four phases: the preparatory phase; study design; study results; the impact of the results at scientific, societal, and political levels. RESULTS: all six case studies identified opportunities and challenges for applying HBM in ICS studies. A smart choice of (a combination of) sample matrices for biomarker analysis produced information about relevant time-windows of exposure which matched with the activities of the ICSs. Combining biomarkers of exposure with biomarkers of (early) biological effects, data from questionnaires or environmental data enabled fine-tuning of the results and allowed for more targeted remediating actions aimed to reduce exposure. Open and transparent communication of study results with contextual information and involvement of local stakeholders throughout the study helped to build confidence in the study results, gained support for remediating actions, and facilitated sharing of responsibilities. Using HBM in these ICS studies helped in setting priorities in policy actions and in further research. Limitations were the size of the study population, difficulties in recruiting vulnerable target populations, availability of validated biomarkers, and coping with exposure to mixtures of chemicals. CONCLUSIONS: based on the identified positive experiences and challenges, the paper concludes with formulating recommendations for a European protocol and guidance document for HBM in ICS. This could advance the use of HBM in local environmental health policy development and evaluation of exposure levels, and promote coordination and collaboration between researchers and risk managers.

A review of exposure assessment methods for epidemiological studies of health effects related to industrially contaminated sites.

BACKGROUND: this paper is based upon work from COST Action ICSHNet. Health risks related to living close to industrially contaminated sites (ICSs) are a public concern. Toxicology-based risk assessment of single contaminants is the main approach to assess health risks, but epidemiological studies which investigate the relationships between exposure and health directly in the affected population have contributed important evidence. Limitations in exposure assessment have substantially contributed to uncertainty about associations found in epidemiological studies. OBJECTIVES: to examine exposure assessment methods that have been used in epidemiological studies on ICSs and to provide recommendations for improved exposure assessment in epidemiological studies by comparing exposure assessment methods in epidemiological studies and risk assessments. METHODS: after defining the multi-media framework of exposure related to ICSs, we discussed selected multi-media models applied in Europe. We provided an overview of exposure assessment in 54 epidemiological studies from a systematic review of hazardous waste sites; a systematic review of 41 epidemiological studies on incinerators and 52 additional studies on ICSs and health identified for this review. RESULTS: we identified 10 multi-media models used in Europe primarily for risk assessment. Recent models incorporated estimation of internal biomarker levels. Predictions of the models differ particularly for the routes 'indoor air inhalation' and 'vegetable consumption'. Virtually all of the 54 hazardous waste studies used proximity indicators of exposure, based on municipality or zip code of residence (28 studies) or distance to a contaminated site (25 studies). One study used human biomonitoring. In virtually all epidemiological studies, actual land use was ignored. In the 52 additional studies on contaminated sites, proximity indicators were applied in 39 studies, air pollution dispersion modelling in 6 studies, and human biomonitoring in 9 studies. Exposure assessment in epidemiological studies on incinerators included indicators (presence of source in municipality and distance to the incinerator) and air dispersion modelling. Environmental multi-media modelling methods were not applied in any of the three groups of studies. CONCLUSIONS: recommendations for refined exposure assessment in epidemiological studies included the use of more sophisticated exposure metrics instead of simple proximity indicators where feasible, as distance from a source results in misclassification of exposure as it ignores key determinants of environmental fate and transport, source characteristics, land use, and human consumption behaviour. More validation studies using personal exposure or human biomonitoring are needed to assess misclassification of exposure. Exposure assessment should take more advantage of the detailed multi-media exposure assessment procedures developed for risk assessment. The use of indicators can be substantially improved by linking definition of zones of exposure to existing knowledge of extent of dispersion. Studies should incorporate more often land use and individual behaviour.

Towards an assessment of the health impact of industrially contaminated sites: waste landfills in Europe.

OBJECTIVES: this paper is based upon work from COST Action ICSHNet. To develop and apply recently proposed methods for assessing the health impact of pollution from contaminated sites and apply them to the case of landfills using available large European datasets. METHODS: standard methods for health impact assessment and burden of disease were applied using the available evidence on the health effects of living near a landfill. Geo-referenced data on landfills from the European Pollutant and Transfer Register (E-PRTR) were combined with population density data (European Environment Agency dataset) and disease frequency data from European health for all database (HfA); uncertainty was assessed via simulation methods. Countries covered by the European Environment Agency's E-PRTR registry on contaminated sites were considered (European Union Member States plus four additional European Countries) for the period 2007-2014. Four outcomes, for which suggestive evidence is available, were included: - low birth weight; - congenital anomalies; - respiratory disease; - annoyance from odour. Firstly, they were analysed separately, in terms of excess number of cases, and then combined into disability-adjusted life years (DALYs). RESULTS: 1,544 landfill sites were considered. 29.3 million people (6% of the total population) live within 4 km from one or more of these sites. The number of yearly attributable cases associated with low birth weight, congenital anomalies, respiratory diseases, and annoyance from odour were estimated, respectively, at 1,239, 70, 33,039, and 1,582,624. Associated DALYs were 10,192, 958, 2,688, and 47,505, respectively; 61,325 in total. CONCLUSIONS: estimates indicate a sizable health impact, largest for annoyance from odour, given the high frequency of the outcome and in spite of its lesser severity compared to the other ones. Application of the methodology is relatively straightforward, once the main assumption of causality is made. The present work offers a first approximation of the impact on health of waste landfills in Europe and can be further applied to other contaminated sites.

Estimating deaths attributable to airborne particles: sensitivity of the results to different exposure assessment approaches.

BACKGROUND: Epidemiological evidences support the existence of an effect of airborne particulate on population health. However, few studies evaluated the robustness of the results to different exposure assessment approaches. In this paper, we estimated short term effects and impacts of high levels of particulate matter with aerodynamic diameter ≤10 µm (PM10) and ≤2.5 µm (PM2.5) in the Emilia-Romagna region (Northern Italy), one of the most polluted areas in Europe, in the period 2006-2010, and checked if the results changed when different exposure definitions were used. METHODS: Short-term impact of particles on population mortality was assessed, both considering the 9 provincial capitals of the Emilia-Romagna and the region as a whole. We estimated the effects of PM10 and PM2.5 on natural mortality by combining city-specific results in a Bayesian random-effects meta-analysis, and we used these estimates to calculate impacts in terms of attributable deaths. For PM10, we considered different definitions of exposure, based on the use of the air pollutant levels measured by different monitoring stations (background or traffic monitors) or predicted by a dispersion model. RESULTS: Annual average concentrations of PM10 and PM2.5 exceeding the WHO limits of 20 and 10 µg/m3 were respectively responsible for 5.9 and 3.0 deaths per 100 000 inhabitants per year in the provincial capitals, during the period 2006-2010. The total impact in the region in 2010 amounted to 4.4 and 2.8 deaths per 100 000 for PM10 and PM2.5, respectively. The impact estimates for PM10 did not substantially change when the exposure levels were derived from background or traffic monitoring stations, or arose from the dispersion model, in particular when the counterfactual value of 20 µg/m3 was considered. The effect estimates appeared more sensitive to the exposure definition. CONCLUSIONS: A reduction in particle concentrations could have produced significant health benefits in the region. This general conclusion did not change when different exposure definitions were used, provided that the same exposure assessment approach was used for both effect and impact estimations. Caution is therefore recommended when using effect estimates from the literature to assess health impacts of air pollution in actual contexts.

[Health impact assessment of policies for municipal solid waste management: findings of the SESPIR Project]. / Impatto sulla salute delle politiche di gestione dei rifiuti solidi urbani: i risultati del Progetto SESPIR.

The SESPIR Project (Epidemiological Surveillance of Health Status of Resident Population Around the Waste Treatment Plants) assessed the impact on health of residents nearby incinerators, landfills and mechanical biological treatment plants in five Italian regions (Emilia-Romagna, Piedmont, Lazio, Campania, and Sicily). The assessment procedure took into account the available knowledge on health effects of waste disposal facilities. Analyses were related to three different scenarios: a Baseline scenario, referred to plants active in 2008-2009; the regional future scenario, with plants expected in the waste regional plans; a virtuous scenario (Green 2020), based on a policy management of municipal solid waste (MSW) through the reduction of production and an intense recovery policy. Facing with a total population of around 24 million for the 5 regions, the residents nearby the plants were more than 380,000 people at Baseline. Such a population is reduced to approximately 330.000 inhabitants and 170.000 inhabitants in the regional and Green 2020 scenarios, respectively. The health impact was assessed for the period 2008-2040. At Baseline, 1-2 cases per year of cancer attributable to MSW plants were estimated, as well as 26 cases per year of adverse pregnancy outcomes (including low birth weight and birth defects), 102 persons with respiratory symptoms, and about a thousand affected from annoyance caused by odours. These annual estimates are translated into 2,725 years of life with disability (DALYs) estimated for the entire period. The DALYs are reduced by approximately 20% and 80% in the two future scenarios. Even in these cases, health impact is given by the greater effects on pregnancy and the annoyance associated with the odours of plants. In spite of the limitations due to the inevitable assumptions required by the present exercise, the proposed methodology is suitable for a first approach to assess different policies that can be adopted in regional planning in the field of waste management. The greatest reduction in health impact is achieved with a virtuous policy of reducing waste production and a significant increase in the collection and recycling of waste.

[Methods for health impact assessment of policies for municipal solid waste management: the SESPIR Project]. / Metodologia di valutazione degli impatti sulla salute delle politiche di gestione dei rifiuti solidi urbani: il Progetto SESPIR.

The Project Epidemiological Surveillance of Health Status of Resident Population Around the Waste Treatment Plants (SESPIR) included five Italian regions (Emilia-Romagna, Piedmont, Lazio, Campania, and Sicily) and the National Institute of Health in the period 2010-2013. SESPIR was funded by the Ministry of Health as part of the National centre for diseases prevention and control (CCM) programme of 2010 with the general objective to provide methods and operational tools for the implementation of surveillance systems for waste and health, aimed at assessing the impact of the municipal solid waste (MSW) treatment cycle on the health of the population. The specific objective was to assess health impacts resulting from the presence of disposal facilities related to different regional scenarios of waste management. Suitable tools for analysis of integrated assessment of environmental and health impact were developed and applied, using current demographic, environmental and health data. In this article, the methodology used for the quantitative estimation of the impact on the health of populations living nearby incinerators, landfills and mechanical biological treatment plants is showed, as well as the analysis of three different temporal scenarios: the first related to the existing plants in the period 2008-2009 (baseline), the second based on regional plans, the latter referring to MSW virtuous policy management based on reduction of produced waste and an intense recovery policy.

A review of exposure assessment methods in epidemiological studies on incinerators.

Incineration is a common technology for waste disposal, and there is public concern for the health impact deriving from incinerators. Poor exposure assessment has been claimed as one of the main causes of inconsistency in the epidemiological literature. We reviewed 41 studies on incinerators published between 1984 and January 2013 and classified them on the basis of exposure assessment approach. Moreover, we performed a simulation study to explore how the different exposure metrics may influence the exposure levels used in epidemiological studies. 19 studies used linear distance as a measure of exposure to incinerators, 11 studies atmospheric dispersion models, and the remaining 11 studies a qualitative variable such as presence/absence of the source. All reviewed studies utilized residence as a proxy for population exposure, although residence location was evaluated with different precision (e.g., municipality, census block, or exact address). Only one study reconstructed temporal variability in exposure. Our simulation study showed a notable degree of exposure misclassification caused by the use of distance compared to dispersion modelling. We suggest that future studies (i) make full use of pollution dispersion models; (ii) localize population on a fine-scale; and (iii) explicitly account for the presence of potential environmental and socioeconomic confounding.

Health impact assessment of waste management facilities in three European countries.

BACKGROUND: Policies on waste disposal in Europe are heterogeneous and rapidly changing, with potential health implications that are largely unknown. We conducted a health impact assessment of landfilling and incineration in three European countries: Italy, Slovakia and England. METHODS: A total of 49 (Italy), 2 (Slovakia), and 11 (England) incinerators were operating in 2001 while for landfills the figures were 619, 121 and 232, respectively. The study population consisted of residents living within 3 km of an incinerator and 2 km of a landfill. Excess risk estimates from epidemiological studies were used, combined with air pollution dispersion modelling for particulate matter (PM10) and nitrogen dioxide (NO2). For incinerators, we estimated attributable cancer incidence and years of life lost (YoLL), while for landfills we estimated attributable cases of congenital anomalies and low birth weight infants. RESULTS: About 1,000,000, 16,000, and 1,200,000 subjects lived close to incinerators in Italy, Slovakia and England, respectively. The additional contribution to NO2 levels within a 3 km radius was 0.23, 0.15, and 0.14 µg/m3, respectively. Lower values were found for PM10. Assuming that the incinerators continue to operate until 2020, we are moderately confident that the annual number of cancer cases due to exposure in 2001-2020 will reach 11, 0, and 7 in 2020 and then decline to 0 in the three countries in 2050. We are moderately confident that by 2050, the attributable impact on the 2001 cohort of residents will be 3,621 (Italy), 37 (Slovakia) and 3,966 (England) YoLL. The total exposed population to landfills was 1,350,000, 329,000, and 1,425,000 subjects, respectively. We are moderately confident that the annual additional cases of congenital anomalies up to 2030 will be approximately 2, 2, and 3 whereas there will be 42, 13, and 59 additional low-birth weight newborns, respectively. CONCLUSIONS: The current health impacts of landfilling and incineration can be characterized as moderate when compared to other sources of environmental pollution, e.g. traffic or industrial emissions, that have an impact on public health. There are several uncertainties and critical assumptions in the assessment model, but it provides insight into the relative health impact attributable to waste management.

Mortality and morbidity among people living close to incinerators: a cohort study based on dispersion modeling for exposure assessment.

BACKGROUND: Several studies have been conducted on the possible health effects for people living close to incinerators and well-conducted reviews are available. Nevertheless, several uncertainties limit the overall interpretation of the findings. We evaluated the health effects of emissions from two incinerators in a pilot cohort study. METHODS: The study area was defined as the 3.5 km radius around two incinerators located near Forlì (Italy). People who were residents in 1/1/1990, or subsequently became residents up to 31/12/2003, were enrolled in a longitudinal study (31,347 individuals). All the addresses were geocoded. Follow-up continued until 31/12/2003 by linking the mortality register, cancer registry and hospital admissions databases. Atmospheric Dispersion Model System (ADMS) software was used for exposure assessment; modelled concentration maps of heavy metals (annual average) were considered the indicators of exposure to atmospheric pollution from the incinerators, while concentration maps of nitrogen dioxide (NO2) were considered for exposure to other pollution sources. Age and area-based socioeconomic status adjusted rate ratios and 95% Confidence Intervals were estimated with Poisson regression, using the lowest exposure category to heavy metals as reference. RESULTS: The mortality and morbidity experience of the whole cohort did not differ from the regional population. In the internal analysis, no association between pollution exposure from the incinerators and all-cause and cause-specific mortality outcomes was observed in men, with the exception of colon cancer. Exposure to the incinerators was associated with cancer mortality among women, in particular for all cancer sites (RR for the highest exposure level = 1.47, 95% CI: 1.09, 1.99), stomach, colon, liver and breast cancer. No clear trend was detected for cancer incidence. No association was found for hospitalizations related to major diseases. NO2 levels, as a proxy from other pollution sources (traffic in particular), did not exert an important confounding role. CONCLUSIONS: No increased risk of mortality and morbidity was found in the entire area. The internal analysis of the cohort based on dispersion modeling found excesses of mortality for some cancer types in the highest exposure categories, especially in women. The interpretation of the findings is limited given the pilot nature of the study.