There are no set microbiological performance standards for food products, yet demonstrating that hazards are sufficiently controlled is a key component of FDA's Food Safety Modernization Act. For some products, such as canned goods, these standards have been set over many decades of scientific testing. For others, these performance standards have yet to be established, particularly for new, unique ingredients with minimal processing steps. This article explores the history of performance standards and provides guidance on how to establish such standards where currently lacking.