National Environmental Policy Act; Food Contact Substance Notification System

The Food and Drug Administration (FDA) is amending its regulations on environmental impact considerations as part of the agency's implementation of the FDA Modernization Act (FDAMA) of 1997. FDAMA amended the Federal Food, Drug, and Cosmetic Act (the act) to establish a notification process for food contact substances (FCS); this process will be the primary method for authorizing new uses of food additives that are FCS, and it will largely replace the existing food additive petition process for such substances. The regulations will expand the existing categorical exclusions to include allowing a notification submitted under the act to become effective and will amend the list of those actions that require an environmental assessment (EA) to add allowing a notification under the act to become effective in cases where a categorical exclusion doesn't apply. This will allow notifiers of FCS to claim the categorical exclusions now available to sponsors of other requests for authorization of FCS. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.