FOOD, DRUGS, AND THE ENVIRONMENT: HOW THE FOOD AND DRUG ADMINISTRATION HAS INTERACTED WITH THE NATIONAL ENVIRONMENTAL POLICY ACT OF 1969

Abstract

The paper proceeds in three parts. Part II provides an overview of NEPA. The section examines the statutory text and foundational case law to understand how the statute operates and the obligations it imposes on agencies. The section also examines the legislative history of the statute to determine to what extent, if any, Congress directly addressed the issue of how food safety or human health could impact the environment. Part III examines the FDA and the statutes it administers, the Food, Drug, and Cosmetic Act (FDCA). The purpose of the section is to outline the scope of the agency's jurisdiction and highlight those areas of jurisdiction where decision making could affect the environment. In Part IV, the paper takes a largely historical approach to analyze how the FDA and NEPA have interacted. In six major episodes, or 'rounds,' the FDA has confronted its obligations under NEPA. There are two categories of episodes: those in which the FDA has taken steps, some more grudging than others, to comply with NEPA and those in which NEPA could have played a more extensive role in FDA decision making to identify or avoid environmental harm. Several of these six rounds have been independently addressed by academic literature. This paper does not attempt to replicate the scope or detail of those efforts. The principal intent of this paper is to compile all these episodes in one place -- to examine the FDA's interaction with NEPA holistically and to observe change in attitudes and strategies through time.