Advancing human health risk assessment

Lanzoni, Anna; Castoldi, Anna Federica; Kass, George E.N.; Terron, Andrea; Seze, Guilhem De; Bal‐Price, Anna; Bois, Frédéric; Delclos, K. Barry; Doerge, Daniel R.; Fritsche, Ellen; Halldórsson, Thorhallur I.; Kolossa-Gehring, Marike; Bennekou, Susanne Hougaard; Koning, Frits; Lampen, Alfonso; Leist, Marcel; Mantus, Ellen; Rousselle, Christophe; Siegrist, Michael; Steinberg, Pablo; Tritscher, Angelika; Water, Bob van de; Víneis, Paolo; Walker, Nigel J.; Wallace, Heather M.; Whelan, Maurice; Younes, Maged

doi:10.2903/j.efsa.2019.e170712

Cited by 33 publications

(29 citation statements)

References 64 publications

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“…Apart from general limitations in terms of bias (including confounding), use of human studies is complicated due to the occurrence of other co-exposures and the fact that unexposed individuals usually do not exist. The variability in terms of susceptibility to chemical exposures and interaction with other lifestyle factors means that results from different epidemiological studies can be conflicting (Lanzoni et al 2019). However, epidemiological studies of sufficient size and quality that include precise exposure monitoring are not yet available.…”

Section: Epidemiological Studies Of Adverse Health Effects Associatedmentioning

confidence: 99%

Critical evaluation of human health risks due to hydraulic fracturing in natural gas and petroleum production

Wollin¹,

Damm

Foth³

et al. 2020

Arch Toxicol

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The use of hydraulic fracturing (HF) to extract oil and natural gas has increased, along with intensive discussions on the associated risks to human health. Three technical processes should be differentiated when evaluating human health risks, namely (1) drilling of the borehole, (2) hydraulic stimulation, and (3) gas or oil production. During the drilling phase, emissions such as NO x , NMVOCs (non-methane volatile organic compounds) as precursors for tropospheric ozone formation, and SO x have been shown to be higher compared to the subsequent phases. In relation to hydraulic stimulation, the toxicity of frac fluids is of relevance. More than 1100 compounds have been identified as components. A trend is to use fewer, less hazardous and more biodegradable substances; however, the use of hydrocarbons, such as kerosene and diesel, is still allowed in the USA. Methane in drinking water is of low toxicological relevance but may indicate inadequate integrity of the gas well. There is a great concern regarding the contamination of ground-and surface water during the production phase. Water that flows to the surface from oil and gas wells, so-called 'produced water', represents a mixture of flow-back, the injected frac fluid returning to the surface, and the reservoir water present in natural oil and gas deposits. Among numerous hazardous compounds, produced water may contain bromide, arsenic, strontium, mercury, barium, radioactive isotopes and organic compounds, particularly benzene, toluene, ethylbenzene and xylenes (BTEX). The sewage outflow, even from specialized treatment plants, may still contain critical concentrations of barium, strontium and arsenic. Evidence suggests that the quality of groundwater and surface water may be compromised by disposal of produced water. Particularly critical is the use of produced water for watering of agricultural areas, where persistent compounds may accumulate. Air contamination can occur as a result of several HF-associated activities. In addition to BTEX, 20 HF-associated air contaminants are group 1A or 1B carcinogens according to the IARC. In the U.S., oil and gas production (including conventional production) represents the second largest source of anthropogenic methane emissions. High-quality epidemiological studies are required, especially in light of recent observations of an association between childhood leukemia and multiple myeloma in the neighborhood of oil and gas production sites. In conclusion, (1) strong evidence supports the conclusion that frac fluids can lead to local environmental contamination; (2) while changes in the chemical composition of soil, water and air are likely to occur, the increased levels are still often below threshold values for safety; (3) point source pollution due to poor maintenance of wells and pipelines can be monitored and remedied; (4) risk assessment should be based on both hazard and exposure evaluation; (5) while the concentrations of frac fluid chemicals are low, some are known carcinogens; therefore, thorough, well-designed st...

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Section: Epidemiological Studies Of Adverse Health Effects Associatedmentioning

confidence: 99%

Critical evaluation of human health risks due to hydraulic fracturing in natural gas and petroleum production

Wollin¹,

Damm

Foth³

et al. 2020

Arch Toxicol

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“…To further frame ERA, plausible pathways (also called conceptual models) are constructed to describe how the proposed activity could lead to possible harm to operational protection goals (Raybould, , , ; Johnson et al., ; Nickson, ; Wolt et al., ; Gray, ; Tepfer et al., ; Layton et al., ; Sauve‐Ciencewicki et al., ). As with adverse outcome pathways (Lanzoni et al., ), a pathway to harm is a causal chain of events that need to occur for a harm to be realised (Tepfer et al., ; Craig et al., ).…”

Section: Problem Formulation In Theory: Conceptsmentioning

confidence: 99%

Using problem formulation for fit‐for‐purpose pre‐market environmental risk assessments of regulated stressors

Devos

Devlin

Ippolito

et al. 2019

EFS2

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Pre-market/prospective environmental risk assessments (ERAs) contribute to risk analyses performed to facilitate decisions about the market introduction of regulated stressors. Robust ERAs begin with an explicit problem formulation, which involves among other steps: (1) formally devising plausible pathways to harm that describe how the deployment of a regulated stressor could be harmful; (2) formulating risk hypotheses about the likelihood and severity of such events; (3) identifying the information that will be useful to test the risk hypotheses; and (4) developing a plan to acquire new data for hypothesis testing should tests with existing information be insufficient for decision-making. Here, we apply problem formulation to the assessment of possible adverse effects of RNA interference-based insecticidal genetically modified (GM) plants, GM growth hormone coho salmon, gene drive-modified mosquitoes and classical biological weed control agents on non-target organisms in a prospective manner, and of neonicotinoid insecticides on bees in a retrospective manner. In addition, specific considerations for the problem formulation for the ERA of nanomaterials and for landscape-scale population-level ERAs are given. We argue that applying problem formulation to ERA maximises the usefulness of ERA studies for decision-making, through an iterative process, because: (1) harm is defined explicitly from the start; (2) the construction of risk hypotheses is guided by policy rather than an exhaustive attempt to address any possible differences; (3) existing information is used effectively; (4) new data are collected with a clear purpose; (5) risk is characterised against well-defined criteria of hypothesis corroboration or falsification; and (6) risk assessment conclusions can be communicated clearly. However, problem formulation is still often hindered by the absence of clear policy goals and decision-making criteria (e.g. definition of protection goals and what constitutes harm) that are needed to guide the interpretation of scientific information. We therefore advocate further dialogue between risk assessors and risk managers to clarify how ERAs can address policy goals and decision-making criteria. Ideally, this dialogue should take place for all classes of regulated stressors, as this can promote alignment and consistency on the desired level of protection and maximum tolerable impacts across regulated stressors.

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“…EFSA applies and develops up‐to‐date methods and approaches to deliver pertinent scientific advice to risk managers. Science is continuously progressing and, in five breakout sessions, the advance of risk assessment science was addressed in the areas of: human health (Hougaard‐Bennekou, ; Lanzoni et al., ), the environment (Devos et al., ,d), biological hazards (Messens et al., ; Waltner‐Toews, ), nutrition (Mathers, ; Woodside et al., ) and managing evidence (Cavalli et al., ; Hartung, ). In each of these sessions, the state‐of‐the‐art was presented and challenges and opportunities for future risk assessment were identified.…”

Section: Sciencementioning

confidence: 99%

“…In the area of human health and chemical risk assessment (Hougaard‐Bennekou, ; Lanzoni et al., ), many challenges were identified: moving away from the ‘current/traditional’ risk assessment paradigm (which is substantially hazard‐driven and largely relying on animal studies), and requiring a better understanding of the mechanisms that lead to adverse effects and the more accurate prediction of the biological response to establish causality. Data and information from new approach methods are increasingly used to support regulatory science, and datasets beyond the traditional toxicological animal data are available (e.g.…”

Section: Sciencementioning

confidence: 99%

EFSA's third Scientific Conference ‘Science, Food, Society’: concluding remarks

Verhagen

Robinson

Gallani

et al. 2019

EFS2

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From 18-21 September 2018, EFSA hosted its third Scientific Conference on Science, Food and Society in Parma, Italy. This paper summarises the overall recommendations on future actions and research priorities of the conference and complements the earlier multi-authored papers in this issue. The conference started and closed with the plenary sessions 'where science meets society: putting risk assessment in context' and 'staying relevant in a changing world', respectively. In between, there were seven breakout sessions five of which aimed at advancing risk assessment science in the areas of human health, the environment, biological hazards, nutrition and managing evidence, and two of which were dedicated to the societal aspects of risk assessment: engaging with society and envisioning the expertise of the future. During the 4 days of the event, participants addressed the complex interplay between science, risk assessment, policy and society, and explored how to advance food safety risk assessment to address the challenges of a changing world and ensure preparedness. Acknowledging that good science alone is no longer sufficient to ensure fit-for-purpose food safety risk assessments, EFSA must further build on its current five Strategic Objectives. To ensure that its risk assessments remain scientifically robust and sound, EFSA should strive for robust and fit-for-purpose risk assessments; consider food in the context of safety, nutrition and sustainability; and explore further how EFSA can work with other organisations to achieve the One Health/One Environment goals. In addition, EFSA should base scientific risk assessments on reliable science while capitalising on scientific advances; address scientific uncertainties; and fully publish the evidence and data used. In line with societal expectations, EFSA, in coordination with risk managers, should frame risk assessments through clear policy goals and problem formulation; be explicit about value judgements; communicate clearly and consistently and in coordination with risk assessors and risk managers; involve society; avoid conflicts of interest; and follow trustworthy processes.

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Advancing human health risk assessment

Cited by 33 publications

References 64 publications

Critical evaluation of human health risks due to hydraulic fracturing in natural gas and petroleum production

Critical evaluation of human health risks due to hydraulic fracturing in natural gas and petroleum production

Using problem formulation for fit‐for‐purpose pre‐market environmental risk assessments of regulated stressors

EFSA's third Scientific Conference ‘Science, Food, Society’: concluding remarks

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