Two previously unrelated trends, the demise of the returnable glass bottle and the evolution of NEPA into a substantive statute, have recently converged in a suit brought by the Environmental Defense Fund (EDF).¹ EDF is challenging a regulation recently promulgated by the Food and Drug Administration (FDA) that severely restricts the impact of NEPA on the agency's decisionmaking process.² If upheld, the agency rule will effectively render the FDA powerless to regulate the nationwide use of non-biogradable plastic beer and soft drink bottles on the grounds of their adverse environmental effects.

The regulation in question is general in scope, dealing with all FDA decisions involving NEPA. It acknowledges the agency's responsibility to comply with the procedural requirements of §102(2)(c) of NEPA, concerning the preparation of environmental impact statements. The agency, however, reads its enabling statute, the Federal Food, Drug, and Cosmetic Act (FFDCA),³ as both specifically restricting the criteria for FDA regulatory action to considerations of public health and safety, and requiring approval of any substance or packaging scheme if those criteria are not violated. FDA Commissioner Schmidt declined to read NEPA's declarations of environmental policy as broadening this regulatory mandate by supplementing or amending the agency's enabling act. Unless adverse environmental impacts can be shown to be either directly or indirectly related to a public health or safety hazard within the FDA's traditional areas of concern, the agency maintains that it has no legal authority to take these impacts into consideration.