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
FDA Workshop on the Notification for Food Contact Substances: Environmental Requirements for Food Contact Notifications (FCNs)
OVERVIEW
Background on the National Environmental Policy Act (NEPA)
NEPA
NEPA – continued
NEPA – continued
Why FCNs are subject to NEPA
Why FCNs are subject to NEPA?
NEPA and the FCN process
NEPA and the FCN process: Major Actions
NEPA and the FCN process: Finality
NEPA and the FCN process – cont.
Environmental Requirements for FCNs
NEPA requirements for FCNs
What is a Categorical Exclusion?
About Categorical Exclusions
About Categorical Exclusions (cont.)
Categorical Exclusions for FCNs
Categorical Exclusion 21 CFR 25.32(i)
Categorical Exclusion 21 CFR 25.32(j)
Categorical Exclusion 25.32(q)
Claiming Categorical Exclusion
Form 3480 – Categorical Exclusions
Form 3480 – EAs
What is an EA?
About EAs for FCNs
When is an EA Required?
Extraordinary Circumstances
What are Extraordinary Circumstances?
Typical Impacts Assessed in EAs
Suggestions for Preparing an EA
Fate and Effects Data
Fate and Effects Data – cont.
Environmental Prediction Models
Estimation Software
EPA’s EPI Suite Estimation Software
ECOSAR
Polymeric Food-Packaging Material: Resource & Energy Use
Summary
FCN Workshop Agenda & Presentations
Download presentation source
(PPT format)
Food Ingredients and Packaging
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