Citation:

Jarabek, A. New Approach Methods (NAMs) and lntegrated Approaches to Testing and Assessment (IATA). Toxicology 510 Guest Lecture at the University of Rochester Medical Center, NA, NY, April 13, 2023.

Impact/Purpose:

This presentation represents an invited guest lecture to the Toxicology 510 course entitled "Toxicology in Risk Assessment" offered to graduate students at the University of Rochester Medical Center (URMC).  This course is focused on the role of toxicologists and use of toxicological data in the risk assessment process. It combines didactic instruction with specialist presentations to cover major topics in the risk assessment field to build understanding about human health-based decision making. By the end of this course, students are expected to have a deeper understanding of how toxicological data that are critical to the risk assessment process are generated, evaluated, interpreted, and applied, as well as the varied roles that toxicologists play in the broad risk assessment paradigm. The course started with lectures focused on the principles of risk assessment as described by the National Academy of Sciences paradigm. The various bodies that evaluate risk were then discussed, the fundamental differences in the ways that these bodies operate as per their respective missions, and the ways in which decision-making contributes to risk management. Information about risk perception and risk inequities was also presented. The second part of the course addressed the ways in which toxicologists specifically contribute to risk assessment. This will be accomplished by delving into examples from the real world that illustrate how toxicological findings contribute to the overall risk assessment process. This latter part of the course will be facilitated in part by guest lectures (Toxicology Training Program alumni and others who have built careers in the field). This course fulfills two missions of the URMC Toxicology Training Program, namely 1) the delivery of exceptional didactic toxicology training and 2) career mentoring via the maintenance of strong connections between Program graduates and current trainees.

Description:

The guest lecture / presentation focused on how various data streams used in evidence integration for risk assessment can be better integrated through use of mechanistic constructs, including source to outcome modeling with dosimetry providing the critical link between aggregate exposure pathway (AEP) and adverse outcome pathway (AOP) frameworks.  Emphasis was placed on the need to create context for the use of new approach methods (NAMs) by advancing integrated approaches to testing and assessment (IATA) with some examples for inhalation exposures for two chemical categories (PSLT and surfactants) under TSCA Section 5.  The need for reporting standards as a roadmap for translation was emphasized.  Specific learning objectives included the following:  Appreciate challenges of evidence integration; Define AEP and AOP:  with a Depiction of processes and data organization; Discuss transitions and translations in modernizing risk assessment; Introduce NAMs and defined approaches (DAs); Distinguish empirical models from mechanistic constructs; Provide basic understanding of inhalation dosimetry models; Convey relationships among NAMs, DAs and IATAs; Consider confidence building strategies; Present role for reporting standards and Encourage innovation in experimental designs.

Record Details: