Upcoming Events
To be announced.
Past Events
Expanded Decision Tree: US FDA's Food Chemical Toxicity Screening Tool
Thursday, December 4, 2025
11:00 AM to 12:00 Noon (US EDT, UTC -5)
Hosted by: The SOT Food Safety & Computational Toxicology Specialty Sections
Scientific innovation has rapidly expanded the number and diversity of chemicals to which humans may be exposed, creating an urgent need for efficient tools to screen and prioritize substances based on their chronic toxic potential and to estimate safe exposure levels. At the same time, there is growing momentum to reduce reliance on animal testing in safety assessment. In response, the FDA developed the Expanded Decision Tree (EDT)—a chemical structure-based classification system that sorts chemicals into one of six classes of chronic oral toxic potential, each associated with a threshold of toxicological concern (TTC) level. Under this framework, exposures below the class-specific TTC can be reasonably anticipated to present minimal risk. While originally designed with food-related chemicals in mind, the EDT has broad applicability. It can support the evaluation of structurally diverse compounds across many domains, assist with prioritization and read-across for data-poor substances, and provide approaches for assessing mixtures and cumulative exposures. While focused on oral toxicity, the EDT also shows promise for inhalation and dermal applications with further development. This presentation will provide an overview of the EDT, including recent progress in external validation efforts, outcomes from peer review, and the current status of EDT software development. Potential applications of the tool will also be discussed, highlighting its potential to advance chemical safety evaluations and reduce reliance on animal testing.
Speaker:
- Szabina Stice, PhD, Senior Toxicologist, US FDA
Materials:
Webinar Recording and Materials
Cultivated Chocolate: The Sweet Side of Cellular Agriculture
Wednesday, October 28, 2025
2:00 PM to 3:00 PM (US EDT, UTC -5)
Hosted by: The SOT Food Safety Specialty Section
Production of chocolate through the means of cellular agriculture is an emerging, sustainable alternative to traditional cocoa production. This innovative approach involves cultivating cacao cells within controlled bioreactor environments, enabling a consistent and high-quality chocolate product without the inherent vulnerabilities associated with conventional agricultural practices. Cellular agriculture promises to offer consumers consistent and high-quality chocolate experience while promoting a more ethical and sustainable chocolate supply chain. As research and development in this field continues to advance, cellular agriculture may become a key driver of innovation and sustainability in the chocolate industry. This session will feature two expert speakers: the first speaker will delve into the science behind cultivated chocolate, including the cellular agriculture techniques used to produce cocoa without relying on conventional farming as well as addressing potential chemical and safety issues related to the development of this novel process. The second speaker will examine the current domestic and international regulatory landscape of cultivated foods, offering insights into how cultivated chocolate fits within food safety standards, labeling requirements, and future policy developments. We will also be discussing the evolving landscape for generally recognized as safe (GRAS) substances and potential implications that this can have for novel foods. Together, these perspectives will provide a comprehensive overview of the scientific and regulatory dimensions shaping the future of chocolate. The session will be moderated by FS3 Vice-President, René Viñas.
Speakers:
- Steven Lang, PhD, Vice President of Science & Technology, California Cultured
- Deepti Kulkami, Esq., Partner, Covington & Burling LLP
Materials:
Webinar Recording and Materials
The Great Additive Debate: Does the US Actually Permit Significantly More Food Additives than the EU?
Tuesday, June 17, 2025
Description:If you have been following discussions on food additives over the past year, then you have likely heard the comparison of 10,000 food additives in the US vs. 400 in the EU. Comparisons are popular but do not necessarily provide context. Nevertheless, these numbers have been a primary talking point in mainstream media, state legislation, congressional hearings, and discussions around the safety of the US food supply. If you have ever wondered where these numbers came from, or if they are even accurate (spoiler alert, they are not), you will not want to miss this webinar to hear about the safety evaluations of food additives and an in depth analysis of the number of food additives in the US compared with the EU.
Speaker:
- Qingdong (Karin) Ke, PhD, DABT, ERT, Keller and Heckman LLP
- Anthony (Tony) Pavel, JD, Keller and Heckman LLP
An Introduction to Precision Fermentation: Application and Challenges
Thursday, October 12, 2023
Co-Hosted by: SOT Biotechnology Specialty Section (BTSS), Ethical, Legal, Forensics, and Societal Issues Hosted by: The SOT Biotechnology and Food Safety Specialty Sections
Vincent Sewalt Presentation
Alex Eapen Tomiyama Presentation
Adam Leman Presentation
Description:Precision fermentation is a rapidly emerging technology that promises to revolutionize various industries, from food and beverages to pharmaceuticals and biotechnology. This 90-minute session will provide an in-depth exploration of the science behind precision fermentation, the techno-economic challenges faced by this innovative approach, and the regulatory and safety hurdles that must be navigated for its successful integration into the global market. Furthermore, the session will examine the sustainability outlook and potential challenges associated with implementing precision fermentation on a large scale.
Speaker:
- Vincent Sewalt, PhD, Head of Scientific & Public Affairs, International Flavors & Fragrances
- Alex Eapen, PhD, DABT, Director, R&D Scientific & Regulatory Affairs, Cargill
- Adam Leman, PhD, Lead Scientist, Fermentation, Good Food Institute
Cultivated Meat: Regulatory & Safety Challenges for a Developing Industry
Thursday, February 9, 2023
Co-Hosted by: SOT Biotechnology Specialty Section (BTSS), Ethical, Legal, Forensics, and Societal Issues Specialty Section (ELFSI), and Food Safety Specialty Section (FS3)
David Tonucci Presentation
A. Janet Tomiyama Presentation
David E. Block Presentation
Description: The development of cultivated meat (e.g., chicken, beef, seafood) holds the potential of solving environmental, ethical, and health challenges associated with the production and consumption of traditional animal-based foods. At the end of 2021, more than 100 companies have emerged across the globe, all aiming to provide meat without slaughtering animals. This emerging technology has, however, raised the need for the rapid development of risk assessment protocols to address the safety of these novel products adequately. In addition, many global regulatory agencies have also found themselves quickly needing to adapt and develop their own regulations to determine how these products can be safely manufactured, distributed, and labeled. This session aims to provide participants with 1) an overview of the molecular methodologies and challenges in the creation of cultivated meat, 2) an examination of the regulatory and safety challenges faced by this novel industry and regulators as well as 3) a brief discussion on consumer expectations on the sustainability, nutritional, and ethical considerations associated with the production of cultivated meat. This session will consist of three presentations followed by a panel discussion moderated by BTSS Secretary/Treasurer René Viñas, PhD, DABT.
Speaker:
- “Molecular Methodologies in Cultivated Meat Technology”
David Block, PhD, Professor, Department of Chemical Engineering, University of California - Davis - “Regulatory & Safety Challenges in Cultivated Meat”
Dave Tonnuci, PhD, Vice President, Regulatory & Toxicology, SciFi Foods, Inc. - “Consumer Expectations and Perceptions on Cultivated Meat”
Janet Tomiyama, PhD, Professor, Department of Psychology, University of California - Los Angeles
Metals on the Menu and other Food for Thought
Jointly Sponsored Webinar with the Metals Specialty Section (MSS)
Thursday, February 24, 2022 | 12:00 PM (EDT)
With ongoing challenges of connecting in person, we have taken initiative to offer more virtual content. After polling FS3 membership, metal contaminants in food were the topic of most interest. We thus partnered with the Metals SS to develop this highly relevant and timely content. This webinar will begin by providing an overview of typical exposures in different age groups and dietary components of most concern. We will then discuss experimental health outcomes with dietary challenges and in a transgenerational model. The webinar will conclude with a live panel discussion.
Title: Dietary Exposures to Lead and Cadmium
Speaker(s): Judith Spungen, Dietitian and Nutritionis, US FDAt and Alexandra Gavelek, Senior Analyst, US FDAAbstract: The US Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition(CFSAN) uses a systematic, evidence-based approach to evaluate and reduce potential risks to public health from the presence of contaminants, including the toxic elements lead and cadmium, in the products FDA regulates. CFSAN’s Closer to Zero action plan focuses on reducing exposures to toxic elements from foods consumed by infants and young children. As part of CFSAN’s effort to reduce dietary exposures to toxic elements, CFSAN estimated dietary exposures to lead from young children (1–6 y), older children (7–17 y), females of childbearing age (16–49 y), and adults (18 + y). CFSAN also estimated dietary exposures to cadmium for young children. The lead and cadmium exposures were estimated based on concentration data from FDA’s Total Diet Study (TDS) from 2014-2016 and on food consumption data from What We Eat In America (WWEIA), the food survey portion of the National Health and Nutrition Examination Study (NHANES), from 2009-2014. Estimated mean exposures varied based on the population and on substitution scenarios for values below the limit of detection (non-detects = 0; non-detects = limit of detection; or a hybrid approach). Estimated lead exposures for young children declined slightly since 2004–08, but cadmium exposures did not decline. Key sources of lead and cadmium exposure were not necessarily the foods/food groups with the highest concentrations; in most cases, key sources of exposure were the most highly consumed foods. Fruits and grains were the major sources of lead exposure for young children. Grains and mixtures (e.g., hamburgers, pizza, lasagna, soups) were the major sources of lead exposure for older populations. Grains, mixtures, and vegetables were major contributors to cadmium exposures for young children. The data on lead and cadmium exposures, and on key food contributors to exposures, are informing CFSAN’s Closer to Zero action plan and other efforts to mitigate exposures to these toxic elements.
Title: Cadmium and High-Fat Diet Disrupt Renal, Cardiac and Hepatic Essential Metals
Speaker(s): Dr. Jamie Lynn Young, Postdoctoral Associate, University of LouisvilleAbstract: Exposure to the environmental toxicant cadmium (Cd) contributes to the development of obesity-associated diseases. Obesity is a risk factor for a spectrum of unhealthy conditions including systemic metabolic dyshomeostasis. In the present study, the effects of whole-life exposure to environmentally-relevant concentrations of Cd on systemic essential metal distribution in adult mice fed a high-fat diet (HFD) were examined. For these studies, male and female mice were exposed to Cd-containing drinking water for >2 weeks before breeding. Pregnant mice and dams with offspring were exposed to Cd-containing drinking water. After weaning, offspring were continuously exposed to the same Cd concentration as their parents, and divided into HFD and normal (low) fat diet (LFD) groups. At 10 and 24 weeks, mice were sacrificed and blood, liver, kidney and heart harvested for metal analyses. There were significant concentration dependent increases in Cd levels in offspring with kidney > liver > heart. Sex significantly affected Cd levels in kidney and liver, with female animals accumulating more metal than males. Mice fed the HFD showed > 2-fold increase in Cd levels in the three organs compared to similarly treated LFD mice. Cadmium significantly affected essential metals levels in blood, kidney and liver. Additionally, HFD affected essential metal levels in these three organs. These findings suggest that Cd interacts with HFD to affect essential metal homeostasis, a phenomenon that may contribute to the underlying mechanism responsible for the development of obesity-associated pathologies.
Title: Lineage- and Sex-Dependent Behavioral and Biochemical Transgenerational Consequences of Developmental Exposure to Lead, Prenatal Stress, and Combined Lead and Prenatal Stress in Mice
Speaker(s): Dr. Deborah Cory-Slechta, Faculty, University of RochesterAbstract: Lead (Pb) exposure and prenatal stress (PS) during development are co-occurring risk factors with shared biological substrates. PS has been associated with transgenerational passage of altered behavioral phenotypes, whereas the transgenerational behavioral or biochemical consequences of Pb exposure, and modification of any such effects by PS, is unknown. The present study sought to determine whether Pb, PS, or combined Pb and PS exposures produced adverse transgenerational consequences on brain and behavior. Maternal Pb and PS exposures were carried out in F0 mice. Outside breeders were used at each subsequent breeding, producing four F1-F2 lineages: [F1 female-F2 female (FF), FM (male), MF, and MM]. F3 offspring were generated from each of these lineages and examined for outcomes previously found to be altered by Pb, PS, or combined Pb and PS in F1 offspring: behavioral performance [fixed-interval (FI) schedule of food reward, locomotor activity, and anxiety-like behavior], dopamine function [striatal expression of tyrosine hydroxylase (Th)], glucocorticoid receptor (GR) and plasma corticosterone, as well as brain-derived neurotrophic factor (BDNF) and total percent DNA methylation of Th and Bdnf genes in the frontal cortex and hippocampus. Maternal F0 Pb exposure produced runting in F3 offspring. Considered across lineages, F3 females exhibited Pb-related alterations in behavior, striatal BDNF levels, frontal cortical Th total percentage DNA methylation levels and serum corticosterone levels, whereas F3 males showed Pb- and PS-related alterations in behavior and total percent DNA methylation of hippocampal Bdnf. However, numerous lineage-specific effects were observed, most of greater magnitude than those observed across lineages, with outcomes differing by F3 sex. These findings support the possibility that exposures of previous generations to Pb or PS may influence the brain and behavior of future generations. Observed changes were sex-dependent, with F3 females showing multiple changes through Pb-exposed lineages. Lineage effects may occur through maternal responses to pregnancy, altered maternal behavior, epigenetic modifications, or a combination of mechanisms, but they have significant public health ramifications regardless of mechanism.
Updates to the Cramer et al. Decision Tree and the Threshold of Toxicological Concern: The Expanded Decision Tree and Its Use in Safety Assessments
Wednesday, November 10, 2021
Presentation
Speaker: Szabina Stice, PhD, Senior Toxicologist, Division of Science and Technology, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, US Food and Drug Administration
Webinar recording.
From Protein Toxins to Applied Toxicological Testing Virtual Workshop
Wednesday and Thursday, October 21–22, 2020
Food-Relevant Chemicals in ToxCast and Potential Integration of High-Throughput Toxicity Testing in Assessing Chemical Safety Webinar
Wednesday, January 15, 2020
Microbiome: The Missing Piece in the Diet and Health Puzzle
Speaker: Tiffany Weir, Assistant Professor, Colorado State University
Food Safety-Applicability of In Silico/In Vitro Test Methodologies for Food Ingredients
Thursday, August 18, 2016
In Silico/In Vitro Test Methods for Genetic Toxicology Assessment of Food Ingredients: Benefits and Challenges
Speaker: Marilyn J. Aardema, Marilyn Aardema Consulting, LLCUse of In Vitro Metabolism Assays to Substantiate the Safety Substantiate the Safety of Novel Steviol Glycosides
Speaker: Alex Eapen, Scientific & Regulatory Affairs CargillPotential Applicability and Challenges of Using In Vitro and In Silico Methodologies in Food Ingredients Safety Assessment
Speaker: Suzanne Fitzpatrick, US Food and Drug Administration
Webinar recording
Food-Relevant Chemicals in ToxCast and Potential Integration of High-Throughput Toxicity Testing in Assessing Chemical Safety Webinar
Thursday, July 28, 2016
Overview
Identification of a Comprehensive Inventory of Food-Relevant Chemicals and their Effects in the ToxCast High-Throughput Screening Program
Speaker: Agnes Karmaus, Integrated Laboratory Systems, Inc.
Curation of Food-Related ToxCast Chemicals Database Using Exposure Groupings to Identify Current Relevance
Speaker: Lori Fix, ILSI North America Member Scientist
Assessing Bioactivity-Exposure Profiles of Fruit and Vegetable Juices
Speaker: Barbara Wetmore, US EPA
Webinar recording