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New approach methodologies (NAMs) play a key role in accelerating the pace of chemical risk assessment and are an important tool for the future of regulatory decision making. Accelerating the Pace of Chemical Risk Assessment (APCRA) is a government-to-government initiative whose...

New approach methodologies (NAMs) play a key role in accelerating the pace of chemical risk assessment, and are an important tool for the future of regulatory decision making. Accelerating the Pace of Chemical Risk Assessment (APCRA) is a government-to-government initiative whos...

The purpose of this presentation is to demonstrate how work under the APCRA and in EPA-ORD-CCTE has advanced our understanding of the utility of new approach methods-based points-of-departure (POD-NAMs).

This follow up to a 2016 international workshop continues to bring together international regulators to discuss progress and barriers in applying new approach methods (NAMs) to prioritization, screening, and quantitative risk assessment. Updates to ongoing collaborative case stud...

Overview presentation to US federal agencies on APCRA activities.

Overview presentation of the annual meeting of the APCRA group and discussion of next steps.

The tides of acceptance of new alternative methods (NAMs) are changing. Numerous scientific papers have been published recently that explore the boundaries of data applicability and propose approaches that bridge new and conventional methods. The modernization of the Toxic Substa...

The proof-of-concept case study demonstrated that the Public Information Curation and Synthesis (PICS) approach 1) Generally resulted in higher metrics for the high-priority candidates compared to the low-priority candidates, 2) Identified areas for potential information gatherin...

We aim to demonstrate that High Throughput Toxicokinetics (HTTK), with appropriately propagated uncertainty, enhances NAM-based prediction of in vivo points of departure to inform regulatory decision making. We will describe a framework for decision makers to make use of toxicoki...

Characterization of exposure risk for chemicals found in the environment is a task that often exceeds the capacity of government agencies due to the sheer number of chemicals found in the environment. Often, a manual screening process is performed using scientifically sound appro...

Presentation to be given to the Accelerating the Pace of Chemical Risk Assessment (APCRA) virtual teleconference in August 2020. This work seeks to address the problem of integration, use and application of NAMs in a regulatory setting supporting TSCA efforts and the TSCA Alterna...

New approach methodologies (NAM) for assessing chemical hazard are now established, and are being evaluated for inclusion in regulatory decision-making strategies. However, to implement true risk-based decision-making, analogous methods for assessing exposure potential are neede...

Overview: Challenges: Challenges for timely testing analysis of volatile organic chemicals (VOCs) Determining the optimized assays and analysis for data comparable to traditional in-vitro chemical testing Increasing regulatory interest in supplementing and replacing in-vivo testi...

This product will investigate how HTTK, with appropriately propagated uncertainty, enhances new approach methodology (NAM)-based prediction of in vivo points of departure to inform regulatory decision making. Since 2017 a series of Accelerating the Pace of Chemical Risk Assessmen...

New Approach Methodologies, or NAMs, are technologies, methods or approaches that do not rely on, or reduce, the use of vertebrates for chemical safety testing and evaluation. NAMs for chemical hazard, exposure and risk assessment continue to emerge as alternatives to traditional...

This presentation will cover work performed over the last two years by a team of ORD staff on a project to evaluate toxicity testing methodologies. The project developed two approaches for evaluating testing methodologies one based on Cost Effectiveness Analysis and the second on...

Overviews the workflow for the development of HTTr-PODs

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The attached presentation provides an update on a case study for Accelerating the Pace of Chemical Risk Assessment (APCRA). This update will be presented at an APCRA teleconference to be held November 10, 2022.

The timely assessment of the risks posed to public health by tens of thousands of existing and emerging commercial chemicals is a critical challenge facing the U.S. Environmental Protection Agency and regulatory bodies worldwide. The pace of conducting risk assessments is limited...

Toxicokinetics provides critical information linking external chemical exposures to internal tissue concentrations, persistence in the body, and route of elimination. Unfortunately, most chemicals in commerce and the environment lack toxicokinetic data. Since 2017 a series of int...

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Thousands of chemicals exist in commerce internationally with constant introduction of new and complex substances, highlighting the ongoing importance of innovative approaches to identify emerging genotoxicants of concern. For many chemicals, there is an absence of genotoxicity d...

Presentation Description: Use of new approach methodologies (NAMs), including high-throughput, in vitro bioactivity data, in setting a point-of-departure (POD) has the potential to accelerate the pace of human health risk assessments. Combining hazard and exposure predictions as ...

Use of new approach methodologies (NAMs), including high-throughput, in vitro bioactivity data, in setting a point-of-departure (POD) has the potential to accelerate the pace of human health risk assessments. Combining hazard and exposure predictions as a bioactivity:ex...