The Risk Assessment determines whether there is a risk to employees’ health from using a hazardous substance in the workplace, and any substances that may be generated by its use. Background: Over the past 20 years, knowledge of the genome and its function has increased dramatically, but risk assessment methodologies using such knowledge have not advanced accordingly. Methods: We are developing prototype risk assessments that compare the results of traditional, data-rich risk assessments with insights gained from new types of molecular and systems biology data. Risk assessment is a dominant public policy tool used to identify and evaluate scientific information to fulfill the missions of the U.S. Figure 1 – The proposed assessment paradigm is tailored to meet specific risk management needs for different types of environmental problems.
A key feature of the NexGen program is the development of targeted prototype assessments to help engender movement from strategy to practical application. Crafting the changes needed for the next generation of risk assessment, however, should begin now.
The NRC framework for risk-based decision making provides a structure for such stakeholder engagement.
Figure 1 shows distinct tiers with differing assessment approaches; in practice, these differing approaches lie on a continuum that could be modified for various situations. They are also integrating a diversity of scientific disciplines to develop new prediction techniques, pioneering the use of innovative technologies for chemical toxicity testing, and designing tools to advance the management of chemical risks.
Commensurate efforts required to advance exposure assessments are described elsewhere (Cohen Hubal et al. Key to Tier 2 is the use of both high and medium throughput bioassay data that provide some insight into tissue- and organism-level contributions to risk, as well as use of limited, conventional data.
The program, described briefly in this commentary, maps a course forward and engenders movement from strategy to practical application in risk assessment. Moving from current risk assessment practices to risk assessment based on a modern view of disease will require a paradigm shift.
EPA thoughtfully for the future and to contribute to meaningful change within the larger risk assessment community. Hence, we are embarking on an exploration of new science and methods that can be incorporated into currently emerging and future risk assessments. Objective: This commentary describes a collaborative effort among several federal and state agencies to advance the next generation of risk assessment. Discussion and Conclusions: We anticipate that these new approaches will have a variety of applications, such as assessment of new and existing chemicals in commerce and the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances.


Although the ongoing efforts to develop new methods and data are significant, how risk assessments will incorporate this new information is not entirely clear.
The objective of the NexGen program is to begin to incorporate recent progress in molecular and systems biology into risk assessment practice. An important task for NexGen is to match risk context to specific methodologies and to the level of scientific certainty required for decision making. Although federal human health assessment guidelines explicitly encourage the use of mechanistic information, these guidelines largely reflect the knowledge and thinking of the 1980s and early 1990s. We describe here a program that is advancing the next generation of risk assessment by incorporating recent progress in molecular and systems biology into risk assessment. The NRC and others have stated that 10–20 years might be required before risk assessment can rely primarily on new advances in science. Results of this research will inform risk assessment as a tool for sustainability assessment and provide key input into sustainability decision making, thus enhancing “the ability to analyze present and future consequences of alternative decision options on the full range of social, environmental, and economic indicators” (NRC 2011). The Risk Assessment determines whether there is a risk to workers health from the use of a hazardous substance in the workplace, and any substances that may be generated by its use.
Initially, this effort will ensure that risk assessments include state-of-the-science information. With these initial prototypes, we seek to demonstrate proof of concept, to characterize the value of information, and to determine decision rules for using new types of data and knowledge in risk assessment. The Office of Health Assessment and Translation: a problem-solving resource for the National Toxicology Program.
These agencies are pooling knowledge, data, and analyses to explore the use of new science in risk assessment and to provide advice to the U.S. Advancing the Next Generation (NexGen) of Risk Assessment: Public Dialogue Conference Summary Report. REACH legislation requires industry to provide information necessary for adequate evaluations of public health risks in response to concerns related to approximately 120, 000 chemicals in European commerce, addressing a desire for increased assessment efficiencies and a reduced reliance on in vivo animal testing. Developing and implementing new approaches to risk assessment will require engaging a broad spectrum of stakeholders.
To begin tailoring risk assessment approaches to the risk context, the NexGen program has constructed a three-tier scheme (Figure 1). Over 30 years we have written more than 1,000,000 COSHH Risk Assessments for more than 150,000 products and substances, offering an ever increasing library for our clients to use, and is the most comprehensive database available anywhere. Approaches to advancing quantitative human health risk assessment of environmental chemicals in the post-genomic era.


The cost of assessment in time, resources, and the number of animals used increases as one moves from Tier 1 to Tier 2 and then to Tier 3; scientific certainty also increases. Concomitantly, focus is increasing on the design and synthesis of less hazardous chemicals and processes, thus avoiding many environmental problems and fostering sustainability (Anastas and Eghbali 2010; Anastas et al.
We anticipate development and use of new higher throughput risk assessment methods to identify both safer and more toxic chemicals.
EPA has developed a program, Advancing the Next Generation of Risk Assessment (NexGen), which focuses on how to use this new information in hazard identification and dose–response assessment. Consequently, “omics” data have been used rarely in risk assessment and management decisions (Judson et al. Estimating toxicity-related biological pathway altering doses for high-throughput chemical risk assessment. Current understanding of the mechanism of benzene-induced leukemia in humans: implications for risk assessment.
Application of transcriptional benchmark dose values in quantitative cancer and noncancer risk assessment.
Integration of dosimetry, exposure and high-throughput screening data in chemical toxicity assessment. The effort focuses on iterative development of the next generation of risk assessment prototypes, learning from these efforts, and then refining subsequent efforts based on this new knowledge.
It means having the information and methods needed to make more informed, timelier decisions about chemicals, many of which have not been thoroughly evaluated for potential risks.
Use of “Omic” Technology to Inform the Risk Assessment, Support Document for Case Study: Propiconazole. We anticipate that these new approaches will have a variety of applications, such as the assessment of new and existing chemicals in commerce and the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances. We envision that these new methods will facilitate assessment of new and existing chemicals as well as the design of “greener” chemicals for a more sustainable future. EPA’s Aggregated Computational Toxicology Resource database, the NIH Comparative Toxicogenomic Database, and the National Library of Medicine Gene Expression Omnibus, in addition to textual descriptions of health end points found in hundreds of papers in the open literature, might contain, in combination, the necessary information to characterize hazard and exposure–response for a risk assessment.



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