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The Toxicology Forum—2024 Summer Meeting Program


The Toxicology Forum—2024 Summer Meeting

 

The Toxicology Forum seeks to be the foremost platform among influential stakeholders for deliberative dialogue which shapes decision-making and outcomes on critical issues in toxicology and its applications.

Each scientific session features time for questions at the end of each presentation along with an extended panel discussion of at least 30 minutes at the end of each session.

The 2024 Summer Meeting will be held as an in-person meeting to facilitate dialogue and networking among participants.

Registration includes all breakfasts and lunches, breaks, networking receptions, and access to the sessions! The Toxicology Forum meeting supports unparalleled networking and discussion with other meeting attendees in an intimate atmosphere, not available at large professional conferences. 

July 15:
Lunch: 12:00 noon–1:00 pm
Networking Reception: 5:30 pm–6:30 pm

July 16:
Lunch: 12:30 pm–1:30 pm
Networking Reception: 5:45 pm–6:45 pm

 

Meeting Schedule and Agenda

 

 

The landscape of circularity represents a suite of rapidly developing and diverse operations, processes, and products which aim to reduce waste and emissions. There is an ever-increasing need for new risk assessment approaches to keep pace with this evolution (including advances in mechanical and chemical recycling, innovations in the design of materials for recyclability, alternative feeds and starting materials, as well as many others). Recent calls have been made for more comprehensive considerations of risk tradeoffs in circular economy paradigms, including, for example, food safety vulnerabilities (European Food Safety Authority, 2022). Currently, many of the tools available to incorporate health and environmental concepts into circularity decision-making are one-dimensional or incomplete, and toxicity concerns of materials are cited as one of the most challenging dimensions for advancing in sustainability practices (Unal and Sinha, 2023). This further necessitates innovative approaches to traditional risk assessment practices in this space. The goal of the session is to build awareness of technical risk assessment challenges and possible solutions, which arise due to the nature and diversity of circularity initiatives resulting in novel processes and products, with a focus on toxicology and exposure science principles. This discussion also aims to highlight where existing risk assessment tools and approaches can appropriately be leveraged as-is or be refined to incorporate new approach methods in response to circularity drivers. It is hoped that the discussion will facilitate an understanding of diverse stakeholder goals in the circularity space, the pace of new technology development and how they couple with risk assessment needs to meet those goals, as well as how to balance the dynamic nature of data and specific uncertainties that are unique to circularity considerations.



—Presentation Schedule—

Introduction: A Contemporary Evolution of Circularity Drivers and their Influence on Risk Assessment
Sharon Dubrow, American Chemistry Council

Post-Consumer Recycled Content: Considerations for Safety Assessments
Jim Huang, The Coca-Cola Company

Computational Toxicology in Life Cycle Impact Assessment: Opportunities to Address Uncertainty, Variability, and Generalizability 
Weihsueh Chiu, Texas A&M University

Framework for Prioritization and Screening of Polymer Additives and Associated Chemistries  
Hesbon Nyambego, ExxonMobil Biomedical Sciences Inc.


Panel Discussion

Sharon Dubrow, American Chemistry Council 
Jim Huang, The Coca-Cola Company 
Weihsueh Chiu, Texas A&M University 
Hesbon Nyambego, ExxonMobil Biomedical Sciences In
c.
 

 

—Session Chair—

Ammie Bachman, ExxonMobil Biomedical Sciences Inc.

 


 

 

—Presentation Schedule—

Introduction
Grace Robiou, US EPA/OCHP

Panel Discussion

Deirdre Murphy, US EPA/OAR 
Susan Euling, US EPA/OW 
Stiven Foster, US EPA/OLEM
 
Susanna Wegner, US EPA/OCSPP

—Session Chair—

Gregory G. Miller, US EPA/OCHP

 


 

 

Members and nonmembers alike are welcome to learn more about the Toxicology Forum and the unique opportunities that Forum meetings can provide. As a small organization, the Toxicology Forum is uniquely positioned to be adaptive to your needs and expectations when it comes to meeting organization and offerings! 


 


 

Assessment of human health effects has long relied on toxicology as the foundational science through which direct and indirect effects of physical stressors can be understood. However, routine application of hazard identification and characterization in a chemical-by-chemical approach to risk assessment is insufficient to meet a growing interest in assessing the totality of exposures and their effects on health. This broad process, termed cumulative impact assessment was defined by the Office of Research and Development in 2022 as “a process of evaluating both quantitative and qualitative data representing cumulative impacts to inform a decision.” The process requires that combined effects from exposures to chemical and non-chemical stressors be characterized. Over the past several years, there has been growing interest focused on assessing how different stressors interact and how that overall exposure is influenced by uptake via different routes and pathways. Notably, this has also included understanding how risk assessment for combined exposures (i.e., resulting from human exposure to multiple substances from a single source or multiple source) differs from aggregate exposure assessment (i.e., combined exposures to a single substance or stressor across multiple routes and multiple pathways). Additionally, EPA, along with the scientific and lay communities, now indicate that cumulative impacts research is a priority, leaving us with the question - What toxicological methods, data, and approaches exist or need to be developed to ensure effects can be adequately characterized with evidence? This session will explore insights across sectors, related to understanding mechanistic challenges, study design considerations, frameworks, all through the lens of informing decision making. 


—Presentation Schedule—

Introduction to Cumulative Impacts
Maureen Gwinn, US FDA

Generating Data to Inform Cumulative Risk Assessment of Mixtures Containing Diverse Chemical Stressors
Cynthia Rider, NIEHS

Mixtures, Mechanisms, and Non-chemical Stressors 
Chris Borgert, University of Florida

Frameworks & Approaches  
Melissa Heintz, ToxStrategies


Panel Discussion

Chris Borgert, University of Florida 
Maureen Gwinn, US EPA 
Melissa Heintz, ToxStrategies
 
Anna Lowit, US EPA 
Cynthia Rider, NIEHS

 

—Session Chair—

Kimberly Wise White, American Chemistry Council


 

Many government agencies and expert groups have estimated a dose-rate of perfluorooctanoate (PFOA) that would protect human health. Most of these evaluations are based on the same studies and all note various uncertainties in our existing knowledge.  Nonetheless, the values of these various, estimated, safe doses vary widely, with some being more than 7,000-fold different.  This sort of discrepancy invites scrutiny and explanation.   

The Steering Committee of the Alliance for Risk Assessment (ARA) called for scientists interested in attempting to understand and narrow these disparities. An advisory committee of nine scientists from four countries was selected from nominations received, and a subsequent invitation to scientists internationally led to the formation of three, independent technical teams (for a total of 24 scientists from 8 countries).  The teams reviewed relevant information and independently developed ranges for estimated PFOA safe doses.  All three teams determined that the available epidemiologic information could not form a reliable basis for a PFOA safe dose-assessment in the absence of mechanistic data that are relevant for humans at serum concentrations seen in the general population, but that a range in the PFOA safe dose could be developed from the available data in experimental animals. In this session we will focus on the discordance amongst regulatory bodies worldwide on the safe dose of PFOA, we will explore why these differences exist around the world and share our findings regarding a safe dose range for PFOA.
 

 

Presentation Schedule 

Introduction 
Lyle Burgoon, Raptor Pharm & Tox, Ltd.


Mode of Action Considerations with PFOA 
Harvey Clewell, Ramboll

Determining the Critical Effect of PFOA – Independent Panel Evaluations of the Immunotoxicity Endpoint
Phil Goodrum, GSI Environmental, Inc.

The Safe Dose Range of PFOA: A 3-Team Approach
?
Michael Dourson, Toxicology Excellence for Risk Assessment


Panel Discussion
Harvey Clewell, Ramboll
Michael Dourson, Toxicology Excellence for Risk Assessment
Phil Goodrum, GSI Environmental, Inc.
Penny Rice US FDA

 

—Session Chairs—

Lyle Burgoon, Raptor Pharm & Tox, Ltd.
Tamara House-Knight, GHD, Inc.

 

 

 

Many chemicals have been shown to produce liver tumors in chronic studies performed in rodents (i.e. rat and mouse). In recent years frameworks for analysing the modes of action (MOAs) by which chemicals produce tumors in laboratory animals have been developed. Key and associative events in the MOA for rodent tumor formation are identified, which can subsequently be compared both qualitatively and then quantitatively with effects in humans. MOAs have been established for nongenotoxic chemicals which produce liver tumors in rodents due to activation of either the constitutive androstane receptor (CAR) or the peroxisome proliferator-activated receptor alpha (PPARα). Key events for liver tumor formation by both CAR (e.g. phenobarbital (PB), dieldrin, oxazepam) and PPARα (e.g. clofibrate, ciprofibrate, Wy-14,643) activators include receptor activation, altered gene expression specific to receptor activation, increased replicative DNA synthesis (RDS), clonal expansion leading to altered liver foci and ultimately liver tumors. Associated events include liver hypertrophy and induction of cytochrome P450 (CYP) enzymes, namely CYP2B and CYP4A subfamily enzymes by CAR and PPARα activators, respectively. The most important key event is the stimulation of hepatocyte RDS, which is the key species difference between rats and mice and other species including humans. Many in vivo and in vitro studies have demonstrated that CAR and PPARα activators do not stimulate hepatocyte RDS in species such as the Syrian hamster, guinea pig and primates. Studies conducted in a number of laboratories have demonstrated that while CAR and PPARα activators stimulate RDS in cultured rat and mouse hepatocytes, such effects are not observed in cultured human hepatocytes, where RDS can be induced by treatment by agents such as epidermal growth factor. These findings are supported by in vivo studies in chimeric mice with humanised livers where CAR and PPARα activators have been shown not to increase RDS in human hepatocytes, In addition, gene array studies indicate a lack of effect on genes associated with cell proliferation. Finally, a number of human epidemiological studies have demonstrated that prolonged administration of PB, some other CAR activators and PPARα activators (e.g. hypolipidemic drugs) does not result in increased liver tumor formation. Overall, robust MOAs have been established for rodent liver tumor formation by CAR and PPARα activators. Based on extensive literature data, the MOAs for rodent liver tumor formation by CAR and PPARα activators are considered to be qualitatively not plausible for humans. This conclusion is supported by available epidemiological data.      

 

—Award Recipient—

Dr. Brian G. Lake, University of Surrey, Guildford, UK



 

In this session, we seek to survey and discuss the current landscape of applications for these evidence-based methods, focusing on fundamental aspects of toxicity and risk assessment for which required adaptations have been identified and proposed, as well as tools and techniques that facilitate the application of systematic review to a broad variety of research questions in chemical risk assessment. Speakers will provide case study examples of lessons learned in making systematic review more efficient through careful problem formulation and leveraging existing reviews, adapting critical appraisal tools to address both relevance and reliability, and reframing standard systematic review methods for evaluating a body of evidence to improve evidence integration and toxicity value derivation. As a key component of lessons learned, the session will address the increased reliance on the use of epidemiological data in risk assessment, which has occurred concurrent with the increased use of systematic review, and highlight areas where adaptations of existing methods have been proposed to evaluate causation, dose-response, and mode of action more directly. 


This proposed session is supported, in part, by the Center for Truth in Science, a non-profit organization. Some of the research presented herein was supported by the Center for Truth in Science, however the research and presentations are conducted and developed independently; funders were not involved with the design, conduct, or reporting of the research.

 

—Presentation Schedule

A Decade of Systematic Review in Toxicology – Impact of the OHAT Approach 
Andrew Rooney, NIEHS
Kyla W. Taylor, NIEHS

A Cross-Walk of Risk Assessment and Systematic Review - Strengths, Challenges, and a Path Forward
Lynne Haber, University of Cincinnati

Applying Existing Assessments for Problem Formulation in the IRIS Program: Case Example for the Uranium Oral Toxicological Review 
Xabier Arzuaga, US EPA
Martha B. Powers, US EPA

Strategies for Improving Consideration of Study Quality in Evidence Integration and Causality Assessment              
Heather Lynch, Integral

Pragmatic Solutions for Better Using Evidence-Based Methods to Assess Causality and Facilitate Risk Assessment
Daniele Wikoff, ToxStrategies

Moving from Evidence to Action: A New Framework to Facilitate Integration of Systematic Reviews with Additional Considerations for Decision-making 
Emily Senerth, Evidence-Based Toxicology Collaboration


Panel Discussion

All Speakers

 

—Session Chairs—

Emily Senerth, Evidence-Based Toxicology Collaboration
Daniele Wikoff, ToxStrategies

 


 

—Presentation Schedule—

Thomas Luechtefeld, Insilica

 

 


 

—Presentation Schedule—

US Cosmetic Updates - Modernization of Cosmetics Regulation Act (MoCRA)               
Jannavi R. Srinivasan, US FDA/CFSAN

 

Best Practices in Interpretation of Conventional and NAM-centric Data to Substantiate Cosmetic Safety 

Jennifer Ator, ToxServices LLC
Jennifer Rutkiewicz, ToxServices LLC
Meg Whittaker, ToxServices LLC

 

Group Exercises 

 

—Session Chair—

Margaret (Meg) Whittaker, ToxServices LLC

 


 

 

Please be sure to register in advance for the meeting. Registration includes access to all meeting sessions, lunch, and networking receptions.

 

Registration Fees:


Member: $850*
Nonmember (Academic/Government/Nonprofit): $1000*
Nonmember (Industry): $1375*
Graduate Student/Postdoc/Retired: $300
Speaker: $300

*Early Registration discount of $100 is available through June 15.


 Click Here to Register

 

Toxicology Forum Members and Returning Nonmembers: Please sign into your profile using this link before registering. {https://toxforum.site-ym.com/login.aspx}

New Users: If you do not already have an account with the Toxicology Forum, please create a free nonmember account using this link. {https://toxforum.site-ym.com/general/register_member_type.asp?}

Questions: Please contact Shannon Frohm at The Toxicology Forum, either  via email or phone {1.703.547.0876}

Hotel/Location: The meeting is held at the Hilton Alexandria Old Town. 1767 King Street, Alexandria, VA 22314

Parking: $36 per day on-site. Valet parking is not available.

Transportation: Washington National Airport (DCA) is the closest airport to the Hilton Alexandria Old Town. The Hilton Alexandria Old Town is located across the street from the King Street Metro Station. Other area airports include Dulles International Airport (IAD) located 30 miles away and Baltimore/Washington International Thurgood Marshall Airport (BWI) located 38 miles away. Visit the Hilton Alexandria Old Town website for details and driving directions. 

Refund Policy: Full Refund (minus $50 processing fee) until the COB on Friday, June 28
No Refund after the COB Friday, June 28