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

FDA Workshop on the Notification for Food Contact Substances: Environmental Requirements for Food Contact Notifications (FCNs)

October 15, 2002


Begin Presentation

Author: Paul C. DeLeo


Table of Contents

  1. FDA Workshop on the Notification for Food Contact Substances: Environmental Requirements for Food Contact Notifications (FCNs)
  2. OVERVIEW
  3. Background on the National Environmental Policy Act (NEPA)
  4. NEPA
  5. NEPA – continued
  6. NEPA – continued
  7. Why FCNs are subject to NEPA
  8. Why FCNs are subject to NEPA?
  9. NEPA and the FCN process
  10. NEPA and the FCN process: Major Actions
  11. NEPA and the FCN process: Finality
  12. NEPA and the FCN process – cont.
  13. Environmental Requirements for FCNs
  14. NEPA requirements for FCNs
  15. What is a Categorical Exclusion?
  16. About Categorical Exclusions
  17. About Categorical Exclusions (cont.)
  18. Categorical Exclusions for FCNs
  19. Categorical Exclusion 21 CFR 25.32(i)
  1. Categorical Exclusion 21 CFR 25.32(j)
  2. Categorical Exclusion 25.32(q)
  3. Claiming Categorical Exclusion
  4. Form 3480 – Categorical Exclusions
  5. Form 3480 – EAs
  6. What is an EA?
  7. About EAs for FCNs
  8. When is an EA Required?
  9. Extraordinary Circumstances
  10. What are Extraordinary Circumstances?
  11. Typical Impacts Assessed in EAs
  12. Suggestions for Preparing an EA
  13. Fate and Effects Data
  14. Fate and Effects Data – cont.
  15. Environmental Prediction Models
  16. Estimation Software
  17. EPA’s EPI Suite Estimation Software
  18. ECOSAR
  19. Polymeric Food-Packaging Material: Resource & Energy Use
  20. Summary

FCN Workshop Agenda & Presentations

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