Approaches to advancing quantitative human health risk assessment of environmental chemicals in the post-genomic era

Chiu, Weihsueh A.; Euling, Susan Y.; Scott, Cheryl Siegel; Subramaniam, Ravi P.

doi:10.1016/j.taap.2010.03.019

Cited by 23 publications

(18 citation statements)

References 92 publications

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“…The plan focuses on using chemically induced mechanisms of action to prioritize chemicals and developing toxicological models to predict human response to chemicals. Chiu et al (2013) provided additional detail on timelines and the steps needed to transition from risk assessments based on in vivo data to primary reliance on high throughput/high content pathway and biomarker data.…”

Section: Toxicity Testing In the 21st Centurymentioning

confidence: 99%

“…The NexGen framework is based on three cornerstones: a ) the toxicity pathway–based approach to risk assessment elaborated by the NRC (2007) in its vision for the future of toxicity testing; b ) a population health approach to risk assessment, taking into account multiple determinants of health and their interactions (Chiu et al 2013; Krewski et al 2007); and c ) the emergence of new risk assessment methodologies, such as those described by the NRC in the “Silver Book,” Science and Decisions: Advancing Risk Assessment (NRC 2009). Here we describe the complementary nature of the three perspectives characterizing the NexGen framework for risk science—a pathway-based toxicity testing paradigm, a population health approach, and advanced risk assessment.…”

Section: Introductionmentioning

confidence: 99%

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A Framework for the Next Generation of Risk Science

Krewski

Westphal

Andersen

et al. 2014

Environ Health Perspect

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110

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Objectives: In 2011, the U.S. Environmental Protection Agency initiated the NexGen project to develop a new paradigm for the next generation of risk science.Methods: The NexGen framework was built on three cornerstones: the availability of new data on toxicity pathways made possible by fundamental advances in basic biology and toxicological science, the incorporation of a population health perspective that recognizes that most adverse health outcomes involve multiple determinants, and a renewed focus on new risk assessment methodologies designed to better inform risk management decision making.Results: The NexGen framework has three phases. Phase I (objectives) focuses on problem formulation and scoping, taking into account the risk context and the range of available risk management decision-making options. Phase II (risk assessment) seeks to identify critical toxicity pathway perturbations using new toxicity testing tools and technologies, and to better characterize risks and uncertainties using advanced risk assessment methodologies. Phase III (risk management) involves the development of evidence-based population health risk management strategies of a regulatory, economic, advisory, community-based, or technological nature, using sound principles of risk management decision making.Conclusions: Analysis of a series of case study prototypes indicated that many aspects of the NexGen framework are already beginning to be adopted in practice.Citation: Krewski D, Westphal M, Andersen ME, Paoli GM, Chiu WA, Al-Zoughool M, Croteau MC, Burgoon LD, Cote I. 2014. A framework for the next generation of risk science. Environ Health Perspect 122:796–805; http://dx.doi.org/10.1289/ehp.1307260

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Section: Toxicity Testing In the 21st Centurymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Framework for the Next Generation of Risk Science

Krewski

Westphal

Andersen

et al. 2014

Environ Health Perspect

Self Cite

110

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“…This framework incorporates multiple health determinants and multiple interventions to manage population health risk (Krewski et al, 2007). A more recent publication by Chiu et al (2013) discusses many of the same principles among a more modern dynamic of scientific tools and techniques (see Figure 2). There is also feedback between this biological information and knowledge and methods to estimate the risks and/or costs of human disease (large block arrow pointing to the right).…”

Section: A Population Heath Perspectivementioning

confidence: 99%

“…Examples of non-chemical stressors include factors such as amount of exercise, access to healthcare, and socio-economic status. Source: Reproduced from Chiu et al (2013) Determinants of health, those factors that make people healthy or not, include those mentioned above, and many others such as income and social status; education; employment; physical environment; personal health practices; early childhood development; biology; gender; and culture. Table 2 presents a list and description of health determinants developed by the World Health Organization (WHO) and the Commission on the Social Determinants of Health (World Health Organization, 2008.…”

Section: A Population Heath Perspectivementioning

confidence: 99%

“…These frameworks are: 1 the NRC vision framework for toxicity testing (TT21C) (National Research Council, 2007), which promotes an evidence-based approach to risk assessment based on high throughput in vitro methods combined with in silico computation 2 the framework for population health risk assessment (Krewski et al, 2007;Chiu et al, 2013), which represents a first attempt to integrate the fields of risk science and population health 3 the Science and Decisions framework for the advancement of risk assessment (National Research Council, 2009), which outlines new directions in the design and conduct of risk assessment of environmental agents.…”

Section: Introductionmentioning

confidence: 99%

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Future directions in risk science

Westphal

Paoli²,

Andersen

et al. 2017

IJRAM

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The report also calls for changes within the risk assessment process, including the enhanced role of problem formulation, the unification of non-cancer and cancer methods for deriving dose-response relationships, and cumulative risk assessment. The integration of these three driving concepts is discussed in this review expanding the strengths of these three frameworks and what they brought to the NexGen framework for risk science.

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Evolution of the Use of Toxicological Data for Evaluating Chemical Safety and Occupational Exposure Limits

Tyshenko,

Willhite,

Levy

et al. 2023

Patty's Toxicology

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Conventional approaches to setting occupational exposure limits (OELs) by regulatory agencies are reviewed. Example OEL derivations show how guidance values are developed in practice. OEL values from various agencies may differ. We present a framework to help select the most appropriate OELs in practice. Use of the framework is demonstrated by OELs for n ‐hexane, a data‐rich chemical and methamphetamine, a data‐poor chemical. Looking forward, “New Approach Methodologies” (NAMs) continue to develop generating chemical toxicological data via high‐throughput in vitro screening assays, computational toxicology, and other methods. NAMs for chemical risk assessment have received support from organizations such as the Organization for Economic Cooperation and Development (OECD), which has validated a number of alternative test methods. Seven NAMs case studies for chemical screening and priority‐setting are presented. Future applications of NAMs in toxicological risk assessment and occupational environments are reviewed using a four‐level tiered testing framework previously proposed by Andersen and colleagues. The use of NAMs provides increased throughput, improved mechanistic understanding in toxicological testing and reduced costs compared to traditional mammalian toxicity testing. The formal application of NAMs in setting OELs is an area of ongoing development, and more widespread application of NAMs in deriving OELs is expected in the future.

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Approaches to advancing quantitative human health risk assessment of environmental chemicals in the post-genomic era

Cited by 23 publications

References 92 publications

A Framework for the Next Generation of Risk Science

A Framework for the Next Generation of Risk Science

Future directions in risk science

Evolution of the Use of Toxicological Data for Evaluating Chemical Safety and Occupational Exposure Limits

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