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SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety—February 20, 2019

Due to inclement weather, this event will be webcast only. The on-site event at Wiley Auditorium, FDA, College Park, MD, has been cancelled.

Chair: Suzanne Fitzpatrick, US FDA, College Park, MD

Co-chair: Warren M. Casey, NTP/NIEHS, Research Triangle Park, NC

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Overview

The Society of Toxicology in conjunction with the US FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide this colloquia series. 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 US FDA employees. These sessions are open to the public to attend in person or via webcast. These events are not a public forum for discussion of toxicology regulatory issues.

Today, toxicological evaluation of chemicals is beginning to take advantage of the on-going 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, 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 at how one important toxicology tool, the rodent chronic bioassay, should be redesigned to meet the needs of 21st century risk assessment.

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.

Schedule
8:00 AM–8:30 AM Badge Pick Up
8:30 AM–8:45 AM US FDA Welcome and Overview
TBD
Welcome from SOT and Introductions
TBD
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
Douglas C. Wolf, Syngenta Crop Protection Inc., Research Triangle Park, NC

9:25 AM–10:05 AM

Threshold-based Risk Assessment is the Same for Cancer and Non-Cancer Endpoints for Non-DNA Reactive Carcinogens.
Samuel Monroe Cohen, University of Nebraska Medical Center Omaha, NE

10:05 AM–10:25 AM Break
10:25 AM–11:05 AM

Is the 2-Year Rodent Bioassary Needed to Address Carcinogenic Risk for Human Pharmaceuticals?
Frank D. Sistare, Merck & Co Inc., West Point, PA

11:05 AM–11:45 AM

A Weight of Evidence Approach to Cancer Assessment
Alan R. Boobis, Imperial College, London, UK

11:45 AM–12:45 PM Roundtable Discussion
Moderator: A. Wallace Hayes, University of South Florida and Michigan State University, Temple Terrace, FL
All Speakers
Speaker Abstracts

The Chronic Cancer Bioassay Is Frequently Conducted for Pesticides When It Is Not Always Needed to Protect Human Health
Douglas C. Wolf, Syngenta Crop Protection Inc., Research Triangle Park, NC

A systematic approach that evaluates and integrates mechanism-based knowledge with exposure consideration allows for hazard characterization that is scientifically defensible and appropriate for regulatory decision-making of crop protection products. Using a problem formulation based and exposure driven evaluation strategy enables public health protective decisions to be made without unnecessary use of animals in large scale and redundant studies. Using the knowledge accumulated form, the intended use, pesticide indication, and class of chemistry of the proposed pesticide will focus the questions that need to be answered to protect human populations from cancer risk. Investigation of the metabolic profile and basic hazard knowledge such as genetic toxicity, hormonal activity, immune suppression, target organ toxicity, and cell proliferation measures are sufficient to screen for the known drivers of human cancer. A case example will be provided to illustrate how a weight of evidence approach using kinetic, in vitro, and short-term in vivo studies can inform a health protective chronic risk assessment of crop protection products without the need for a cancer bioassay.


Threshold-based Risk Assessment is the Same for Cancer and Non-Cancer Endpoints for Non-DNA Reactive Carcinogens
Samuel Monroe Cohen, University of Nebraska Medical Center, Omaha, NE

Non-DNA reactive carcinogens are either mitogenic or cytotoxic with regenerative proliferation. The non-cancer effect is the precursor for the cancer effect, so the risk assessment for the non-cancer effect will be protective for any cancer effect. Short-term assays can screen for the non-cancer effects, obviating the need for any two-year cancer bioassay.


Is the 2-Year Rodent Bioassay Needed to Address Carcinogenic Risk for Human Pharmaceuticals?
Frank D. Sistare, Merck & Co Inc., West Point, PA

Based on decades of pharmaceutical carcinogenicity testing experience, modification to ICH Guidance has been proposed which would allow a weight-of-evidence (WOE) based approach to address carcinogenic risk without the need for conducting a 2-year rat carcinogenicity study. This initiative would allow flexibility in approaches to carcinogenicity assessment but will also require worldwide alignment by regulatory agencies on each case-by-case decision if it is to be successful. Future success in this regard, would benefit from regulatory qualification of a toolbox of novel molecular endpoints that confidently inform mechanism and risk. A practical view into the issues surfacing as WOE are being applied by sponsors to address pharmaceutical carcinogenicity risk, and collaborative efforts being considered to develop a qualified molecular toolbox, will be discussed.


A Weight of the Evidence Approach to Cancer Assessment
Alan R. Boobis, Imperial College, London, UK

This talk will present a weight of evidence approach using cancer and non-cancer data (e.g., precursor pathology, clinical chemistry, MOA information), which can be used to assess acceptable exposure levels. The speaker will explain how the level of protection would be the same with or without the cancer data. Some examples from the risk assessment of pesticides at JMPR will be demonstrated.

On-site Participation

SOT FDA Colloquium February 20 Registration

Registration for participation on-site is closed; US federal employees may register on-site.

On-site seating has no cost. Preregistration is required for those who are not Federal employees.

A cafeteria is located outside the security entrance to the facility.

Webcast Registration
Webcast Registration

Webcast participants can submit questions online during the event. These will be answered as time allows.

Questions about the SOT FDA Colloquia registration?
Contact Jim Dailey or 703.438.3115 Ext. 1428.

Location, Transportation, and Parking

Location

Wiley Auditorium

Harvey W. Wiley Federal Building
US FDA, Center for Food Safety and Applied Nutrition
5001 Campus Dr., College Park, Maryland 20740

Transportation

Metro Rail
We strongly encourage visitors to take the Metro via the Green Line to the College Park-University of Maryland station stop, which is across the street from the Wiley Building.

Driving
Directions from the Capital Beltway (I-495) to CFSAN

  • Take the Capital Beltway in Maryland and exit at Exit 23
  • Drive on MD-201 S/Hwy 201S/Kenilworth Ave in Greenbelt
  • Proceed to Campus Drive in College Park; turn left onto River Road
  • The CFSAN campus is on the left
  • CFSAN is across from the College Park/U of MD Metro Station

Parking

For those who must drive, there is limited public parking at CFSAN which must be reserved in advance by indicating the parking request on the registration form. Alternatively, paid parking is available at the College Park Metro Station across the street from the campus.

Security

Wiley Auditorium is a secured space. All on-site participants will pass through security, which will require a photo ID for those who are not FDA employees. In addition, anyone who is not a US citizen or permanent resident will be required to complete a Foreign Visitor Form to submit to SOT by February 10, 2019.

Organizing Committee
  • Bryan Delaney, PhD, DABT, ATS, Colloquium Series Chair, DuPont Pioneer, Johnston, IA
  • Allen Rudman, PhD, Colloquium Series Co-chair, US FDA, College Park, MD
  • Jason L. Aungst, PhD, US FDA, College Park, MD
  • Suzanne Compton Fitzpatrick, PhD, DABT, US FDA, Member, Colloquium Chair, College Park, MD
  • Jieun Lee, PhD, DABT, Kellogg, Battle Creek, MI
  • Stephen M. Roberts, PhD, University of Florida, Gainesville, FL
  • Jia-Sheng Wang, MD, PhD, University of Georgia, Athens, GA
  • Jeffrey J. Yourick, PhD, DABT, ATS, US FDA, Laurel, MD
  • Patricia Ganey, PhD, Council Contact, Michigan State University, East Lansing, MI
  • Betty Eidemiller, PhD, SOT Staff, Reston, VA