SOT and the US Food and Drug Administration (US FDA) Center for Food Safety and Applied Nutrition (CFSAN) cordially invite you to join us for our February 20 colloquium, “Redesigning the Rodent Bioassay for the 21st Century.” This session is open to the public to attend in person or via webcast. These colloquia are an update on toxicological science and not a public forum for discussion of toxicology regulatory issues. The colloquium will take place from 8:30 am to 12:50 pm (EST) in the Wiley Auditorium at US FDA in College Park, Maryland. The Chair of the colloquium is Suzanne Fitzpatrick with US FDA, College Park, Maryland. The Co-Chair is Warren M. Casey with National Toxicology Program of the National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina.
Today, toxicological evaluation of chemicals is beginning to take advantage of the ongoing revolution in biology and biotechnology. This revolution is making it increasingly possible to study the effects of chemicals using cells, cellular components, and tissues—preferably of human origin—rather than whole animals. In carrying out its mission to protect and promote public health, US FDA must use the best scientific and technological information available to make decisions on the products it regulates. Regulators must assure their toxicology toolbox keeps pace with advances in science and technology. This workshop will discuss how one important toxicology tool, the rodent chronic bioassay, should be redesigned to meet the needs of 21st-century risk assessment.
US FDA envisions that this workshop will be the beginning of an ongoing dialogue between stakeholders on the utility of the chronic rodent bioassay for regulatory risk assessment.
Presentations include:
| 8:30 AM–8:45 AM |
US FDA Welcome and Overview, TBD
Welcome from SOT and Introductions, TBD |
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| 8:45 AM–9:25 AM |
The Chronic Cancer Bioassay Is Frequently Conducted for Pesticides When It Is Not Always Needed to Protect Human Health
Doug Wolf, Syngenta Crop Protection Inc., Research Triangle Park, NC |
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| 9:25 AM–10:05 AM |
Threshold-Based Risk Assessment Is the Same for Cancer and Noncancer Endpoints for Non-DNA Reactive Carcinogens
Samuel Monroe Cohen, University of Nebraska Medical Center, Omaha, NE |
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| 10:25 AM–11:05 AM |
Is the Two-Year Rodent Bioassay Needed to Address Carcinogenic Risk for Human Pharmaceuticals?
Frank D. Sistare, Merck & Co Inc., West Point, PA |
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| 11:05 AM–11:45 AM |
A Weight of Evidence Approach to Cancer Assessment
Alan R. Boobis, Imperial College, London, UK |
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| 11:45 AM–12:45 PM |
Roundtable Discussion: How Can the Rodent Bioassay Evolve to Meet the Needs of Predictive Toxicology?
Moderator: A. Wallace Hayes, University of South Florida and Michigan State University, Temple Terrace, FL; all speakers |
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Questions concerning the regulatory science are solicited from the audience on-site and from webcast participants for the roundtable discussion. Regulatory policy will not be discussed.
The SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety present scientific training that is high-quality, cutting-edge, future-oriented toxicological science for US FDA employees and are open to the public at no cost. However, the colloquia are not a public forum for discussion of toxicology regulatory issues.
Recordings and slides from the previous colloquia are available free via the SOT FDA Colloquia website, including the October 11, 2018, session, “The Big 8: Advances in Food Allergy Risk Assessment and Management.”
Deadline for nonfederal employees: February 12, 2019