U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
October 15, 2002


FDA Workshop on the Notification Process for Food Contact Substances

Carcinogenic Risk Assessment

October 15, 2002


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Author: Michelle L Twaroski


Table of Contents

  1. Carcinogenic Risk Assessment
  2. Overview
  3. Food and Drug Law
  4. Food and Drug Law
  5. Committees Involved in Risk Assessment
  6. Carcinogenic Activity
  7. Carcinogenic Activity
  8. Carcinogenic Risk Assessment Using Neoplastic Data
  9. Risk Assessment
  10. Review and submission of bioassay data.
  11. Calculation of Unit Cancer Risk (UCR)
  12. Example of UCR Calculation.
  1. Example of UCR Calculation
  2. Example of UCR Calculation
  3. Perform Risk Assessment
  4. Mutagenicity data and/or structure activity relationship data and risk assessments.
  5. Non-negative mutagenicity data?
  6. Estimating Risk Using SAR
  7. Estimating Risk Using SAR
  8. SAR Approach: Example 1
  9. SAR Approach: Example 2
  10. Does the chemical have the potential for carcinogenic activity?
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