Environmental Assessments

In Part nine of our StepLadder Series, we discussed Food Contact Notifications (FCNs) – filings that companies (notifiers) submit to the US Food and Drug Administration (FDA) to request premarket review and authorization for a new or expanded use of a food contact substance (FCS) in one or more food-contact applications. In that article, we stated that:

In accordance with The National Environmental Policy Act of 1969 (NEPA) (Pub. L. 91–190 (1970)), federal agencies – including FDA – are required to evaluate and assess the environmental impacts of their activities. In response, FDA requires under 21 C.F.R. Section 25.40 that notifiers of an FCN either submit an Environmental Assessment (EA) of the potential effects of the use and disposal (but not the production) of the FCS, or submit a justification for a claim of categorical exclusion under one or more appropriately-defined criteria.