University of Miami Inter-American Law Review


Congress enacted the Food Safety Modernization Act (“FSMA”), to regulate the fresh produce industry in the United States and increase consumer safety when handling and consuming raw produce. But FSMA risks imposing a zero tolerance policy on raw produce, even where a naturally occurring low-level pathogen, such as listeria, is found in negligible amounts. A zero tolerance policy for all naturally-occurring pathogens does not increase consumer safety, and only serves to increase the cost of raw produce for consumers. This article begins with a summary of the modern history of FSMA, including a brief overview of how the law has been used in the past to impose liability on producers. The article also includes an explanation of a common naturally occurring pathogen—listeria. Although other countries impose a tolerance level for listeria, the FDA relies on FSMA to enforce an unreasonable zero tolerance policy. Next, this article analyzes the term “adulterated” for purposes of United States food safety, and the article reviews support in U.S. case law for not deeming products with low levels of pathogen “adulterated.” Lastly, this article examines the unintended repercussions of the “real-world,” absurd effects of the FDA’s zero-tolerance policy. This article discusses regulations that apply to all food industries, but focuses specifically on the fresh, unprocessed produce industry. Accordingly, this article concludes that the FDA should promulgate risk and science-based tolerance levels for listeria in minimally processed produce.