National Environmental Policy Act; Food Contact Substance Notification System; Companion to Direct Final Rule

Resumo

The Food and Drug Administration (FDA) is proposing to amend 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. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.