The Toxicology Forum is an international, nonprofit organization that is devoted to conducting open dialogues among various segments of society concerned with problems in toxicology.
At our meetings, views are exchanged among experts from domestic and international government regulatory and health agencies, industry, academia, 'political policymakers', and public interest groups. The Toxicology Forum aims to provide a scrupulously balanced approach to the topics and issues presented at The Forum, with alternative positions presented for each issue.
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MEETING SESSION TOPICS
- E-Cigarettes: Hazard and Exposure
- The Role of Systematic review in Toxicology—The Rigor, Resources, and Tools Required, and Implementation Considerations for the Toxicology Community
- Human Relevant Toxicity Testing and Risk Assessment
- Medium Throughput Pathway Based Alternatives to HTS for Product Stewardship
MEETING UPDATE TOPICS
- Evaluating the Hazard of Exposure to Environmental Chemicals Produced Endogenously
- Requirements for Children’s Environmental Health Science to Inform EPA actions, Current Examples
- Policy Resulting from Endocrine Disruption Studies
SESSION SUMMARIES & HIGHLIGHTS
-E-Cigarettes: Hazard and Exposure
This session will discuss the present knowledge concerning the toxicological assessment of e-cigarettes, and their role in achieving harm/risk reduction. In particular, this session will discuss the challenges associated with assessment of e-cigarettes taking into account the multitude of product variants currently on the market. While scientific understanding relating to the use of such e-cigarette is quickly building, there remains a lack of consensus regarding appropriate product standards and regulatory guidance for assessment. While there is general agreement that standards are needed, it will be important to ensure that they do not inhibit further innovation of these products. Specific topics to be discussed will include
- characterization of e-cigarettes aerosol
- in vitro assessment
- in vivo assessment
-The Role of Systematic review in Toxicology—The Rigor, Resources, and Tools Required, and Implementation Considerations for the Toxicology Community
Systematic review methods are increasingly being recommended for and applied to the assessment of chemicals in the environment and foods to ensure objectivity and transparency in the process of reaching conclusions on potential health effects associated with exposures. Although these procedures build on best practices in environmental health, the additional structure and objectivity taken from evidence-based medicine are unfamiliar to many in the toxicology, risk assessment, and regulatory community. The case studies presented in this session seek to demonstrate the rigorous methods, tools and resources required to conduct a systematic review. The session will conclude with a discussion on the integration of evidence-based approaches in regulatory and health agency practices. Through this session, we aim to provide an overview of key features of systematic review, a demonstration of implementation challenges and successes, and a discussion of the current and future use of systematic review in the field of toxicology.
-Human Relevant Toxicity Testing and Risk Assessment
In toxicity testing for regulatory purposes, safety factors are typically used for species extrapolation (10-fold) and susceptible subpopulations (10-fold) to estimate a human safe dose from an animal study. While safety factors are purposefully protective, their use is driven by the lack of more appropriate data. How do we acquire more human relevant toxicity data, and does this matter?
This session will have 3 presentations on new approaches that provide human relevant toxicity data: human tissue xenotransplantation, 3-dimensiomal human in vitro microtissues, and human biomarkers. The risk assessment context for the use of data generated by these kinds of human relevant studies will then be presented from the perspective of a regulatory agency (FDA), and industry (pharmaceutical company).
The goal of this session is to update the toxicology community on the state-of-the-art in new human relevant toxicity testing approaches, and to grapple with their utility and applicability to the risk assessment process.
-Medium Throughput Pathway Based Alternatives to HTS for Product Stewardship
The next step for in vitro-based toxicity testing is to move from prioritization to prediction -- i.e., replacing animal-based risk assessment strategies with safety assessments based on human biology queried with in vitro assays. Coupling in vitro based points of departure (PoD) for chemical activity with predicted human exposures can support decisions on potential risk to guide early down-selection of chemicals for product development. This session highlights methodologies that support this transition, including development of appropriate cellular assays, selection of predictive in vitro biomarkers, definition of PoDs in vitro, and development and improvement of in vitro-in vivo extrapolation (IVIVE) tools. We also present case studies that demonstrate the use of these tools to improve product safety decisions.
-Evaluating the Hazard of Exposure to Environmental Chemicals Produced Endogenously
A number of environmental pollutants are chemicals that are also produced endogenously in healthy organisms as a part of normal metabolism. These endogenously produced chemicals present unique challenges in evaluating hazards from their exogenous exposure. A question that arises is what level of perturbation from normal endogenous levels could lead to significant or adverse effects? Some research concludes that endogenous levels of chemicals are "safe." Other research suggests that normal levels of endogenous chemicals may contribute to background rates of disease. A further understanding of these issues becomes important when the health effects from environmental exposures to endogenous chemicals are evaluated. This presentation will focus on evolving scientific research and debate about the characterization of health risks from exogenous exposure to chemicals that are also produced endogenously.
-Requirements for Children’s Environmental Health Science to Inform EPA actions, Current Examples
There is increasing public concern around prevalence of children's health outcomes and a desire to understand potential role of environmental factors. Recent studies have identified associations between environmental factors and risk of diseases including asthma, autism, and childhood obesity. While evidence is building of links between children's health and environmental factors, the science in many cases is still far from actionable. EPA is investing heavily in children's environmental health (CEH) research with the goal of enabling the Agency's ability to take actions that minimize early-life exposures for optimal wellbeing across all developmental lifestages. The newly published EPA CEH Research Roadmap connects the dots among these efforts and provides a platform for building stronger bridges between EPA, its partners, and stakeholders who care about CEH issues. Realizing the potential of the EPA CEH Research Roadmap to provide science for Agency actions will be facilitated by engagement and collaboration across sectors.
-Policy Resulting from Endocrine Disruption Studies
The US EPA and European Commission have both developed approaches, using a series of harmonized test methods, to identify chemicals that disrupt the endocrine system. The challenge with these programs is translating the fundamental information gained from in vitro and animal studies into clinical studies and practice. This session will explore how government, industry, and academia is using or can use the information gained from ED screening programs to inform policy decisions, protect communities, continue safe operations and seed future research.