March 29 SOT FDA Colloquium Features Cramer Classification and Threshold of Toxicological Concern


By Betty Eidemiller posted 03-10-2016 15:08


The next SOT FDA Colloquium will provide background on the development, use, and possible adaptation of the Cramer Classification Scheme for food additives. This colloquia will be held March 29, 2016, from 8:00 am–12:50 pm at the US Food and Drug Administration (FDA) Wiley Auditorium, College Park Maryland and a "Live Webcast" also is available. The Cramer Classification was the basis for the development of the Threshold of Toxicological Concern.

Register to participate on-site by March 23

Register to participate in the webcast

Colloquium website

Chaired by Ivan Rusyn, Texas A&M, College Station, Texas, and Co-Chaired by Timothy Adams, FDA, College Park, Maryland, this is the seventh colloquium of a series presented by the Society of Toxicology (SOT) in conjunction with the FDA Center for Food Safety and Applied Nutrition. The series presents scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of FDA employees. Open to the public to attend in person or via webcast, these events are not a public forum for discussion of toxicology regulatory issues.

The objectives of this colloquium include a review of the evolution of the Cramer Decision Tree and Threshold of Toxicological Concern (TTC) approach, presentation of possible revisions to the original Cramer Decision Tree and its impact on TTC levels for other routes of exposure, and a discussion of the possible expansion of the Cramer Decision Tree or other computational approaches to more diverse chemicals, multiple structural classes, and the chemical specificity of questions.     


(All times are Eastern US, GMT-5) 


8:00 AM–8:30 AM                 

 Badge Pick Up

8:30 AM–8:40 AM         

FDA Welcome and Overview: Mary Torrence, invited, Director, Office of Applied Research and Safety Assessment Laboratories (OARSA), FDA, College Park, Maryland

8:40 AM–8:50 AM               

Welcome from SOT and Introductions:  Peter L. Goering, SOT 2015–2016 President, US FDA, Silver Spring, Maryland

 8:50 AM–9:30 AM        

Threshold of Toxicological Concern Approach in Regulatory Decision-Making: The Past, Present, and Future, Grace Tier, US Environmental Protection Agency, Research Triangle Park, North Carolina

9:30 AM–10:10 AM   

Advancements in Food Ingredient Safety Prioritization: An Expanded Cramer Decision Tree Schema, Timothy Adams, FDA, College Park, Maryland

10:10 AM–10:30 AM  


10:30 AM–11:10 AM              

In Silico Methods for Threshold of Toxicological Concern Assessment, Andrew Worth, European Commission, Joint Research Centre, Ispra, Italy

11:10 AM–11:50 AM  

Quantitative Prediction of Continuous Toxicity Values Using Chemical Structure Information, Jessica Wignall, ICF International,  Arlington, Virginia

11:50 AM–12:50 PM    

Roundtable Discussion:  Ivan Rusyn, Moderator, and All Speakers

The recording and slides for the January 25 colloquium “Role of Mode of Action in Dose-Response Assessment for Carcinogens” are now available, along with the materials from other previous colloquia, are on the SOT FDA Colloquium webpage.